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Beyond Medication Management: A Multi-Disciplinary Approach to Pain Management and Fall Risk Reduction

Learning Objectives

 

After completing this application-based continuing education activity, pharmacists will be able to:

1.     Recognize opportunities to reduce pain medication and mitigate risk of falls
2.     Identify appropriate patients for referral to physical therapy for non-pharmacologic pain management
3.     Discuss deprescribing of "fall risk increasing pain medication" (FRIDs) with prescribers
4.     Review the types of OTC assistive and adaptive devices available at the pharmacy to support pain relief, safety, or mobility

After completing this application-based continuing education activity, pharmacy technicians will be able to:

  1. Identify classes of FRIDs that contribute to fall risk
  2. Complete fall risk screening to identify at-risk patients
  3. Recognize patients to refer to the pharmacist or other healthcare providers (HCPs) for further consultation
  4. List OTC assistive and adaptive devices to support pain relief and safer mobility

    Older adult fallen on the floor

     

    Release Date: November 15, 2023

    Expiration Date: November 15, 2026

    Course Fee

    Pharmacists: $7

    Pharmacy Technicians: $4

    There is no funding for this CE.

    ACPE UANs

    Pharmacist: 0009-0000-23-056-H08-P

    Pharmacy Technician: 0009-0000-23-056-H08-T

    Session Codes

    Pharmacist:  23YC56-TKF43

    Pharmacy Technician:  23YC56-FTX83

    Accreditation Hours

    2.0 hours of CE

    Accreditation Statements

    The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-056-H08-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

     

    Disclosure of Discussions of Off-label and Investigational Drug Use

    The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

    Faculty

    Carolyn J. Graziano, DPT, MSPT, MBA
    Senior Manager
    Global Strategic Marketing
    Health Economics & Reimbursement
    Avanos Medical
    Alpharetta, GA

    Faculty Disclosure

    In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

    Carolyn Graziano works for Avanos Medical and any potential conflicts of interest have been mitigated.

     

    ABSTRACT

    Pharmacists and pharmacy technicians often come in contact with older adults who have had or are at risk for falls. Often they are treated with opioid analgesics or non-steroidal anti-inflammatory drugs. Unfortunately, using medication alone to treat pain and discomfort can often increase risk for falls. If members of the multidisciplinary team work together, they can use a combination of non-pharmacologic approaches and medication management to improve the patient’s functioning and reduce risks of falls. Knowing which drugs are associated with falls is a first step to identifying patients who need additional attention. Pharmacies can provide screening for fall risk and help ensure that patients get the help they need to find appropriate assistive devices. Including a physical therapist on the team is one way to ensure that patients take advantage of the many services they provide.

    CONTENT

    Content

    INTRODUCTION

    Dotty is an 84-year-old widow suffering from osteoarthritis of the knees. Most days, she manages her pain with acetaminophen and has remained active in her community. Some days however, her painful knees make her unsteady on her feet and she has come close to falling, especially during the long walk from the parking lot through the senior center to get to BINGO.

    Managing chronic pain—pain lasting three months or more—in older community dwellers is a challenge due to the link between pain and increased risk of falls. Over-the-counter (OTC) and prescribed pain medication further compound fall risk through adverse effects. More than 100 million adults in the United States (U.S.) suffer from chronic pain.1 Common types of chronic pain include neuropathic, musculoskeletal, inflammatory, and mechanical pain. Between 30% and 40% of community-dwelling people older than 65 and 50% older than 80 fall each year.2

    Despite the use of fall prevention programs, the rate of falls resulting in injury has not declined. Researchers conducted a pragmatic, cluster-randomized trial (N = 5451) at 86 primary care practices across 10 U.S. health care systems. The trial evaluated the effectiveness of a multifactorial intervention including fall risk assessment and individual fall reduction plans compared to a control group receiving usual care. The results of the study found intervention did not significantly lower fall rates.3

    Many factors contribute to falls, but compelling evidence suggests that chronic musculoskeletal pain increases fall risk and people living with chronic pain show poorer executive function (mental skills that include working memory, flexible thinking, and self-control). Signs of poor executive function such as impaired impulse control, reduced ability to pay attention or focus, and problems starting, organizing or planning tasks can all contribute to fall risk. Treatment options for chronic pain include physical and behavioral medicine, neuromodulation, and surgical intervention. Despite a variety of treatment options, providers most frequently use pharmacologic approaches.

    Integrated, patient-centric, multi-disciplinary management of chronic pain offers a practical solution to reducing pain, over-medication, and risk of falls. Practitioners from several disciplines can help:

    • Pharmacists understand how medications work individually and in combination and provide medication management that is more informed than other professionals’ medication management.
    • Pharmacists and pharmacy technicians interact routinely with the community and can provide risk screening, patient education, and referrals to other HCPs.
    • Primary care physicians provide medication management including medication review and reconciliation and oversight for changes from multiple providers. Providers correctly prescribe but may not evaluate medications regularly for appropriateness.
    • Physical therapists can reduce pain and improve functional mobility through exercise, modalities (i.e., ultrasound, electric stimulation, iontophoresis), manual techniques, and prescription and training on assistive and adaptive devices.
    • Physical or occupational therapists may provide in-home safety evaluation and recommend modifications and equipment to reduce the risk of falls.
    • Collaborative relationships between community rehabilitation therapists and local pharmacies can support patient decisions and pathways for obtaining needed devices and aids to reduce pain and fall risk.

    THE CLINICAL PROBLEM

    Scope of Chronic Pain and Fall Risk

    Falls are the leading cause of death and injury in people 65 years of age and older. Pain often contributes to fall-risk. According to a recent Helsinki Aging Study, 61% of community-dwelling people 74 years and older reported they suffer from musculoskeletal pain that interferes with activities of daily living.4

    Because pain contributes to falls that result in further painful injuries, a cyclical pattern occurs. More than 50% of older Americans report pain at multiple sites.5 The most prevalent painful conditions affecting older adults include arthritis, chronic disease complications (i.e., diabetes, cancer) and post-stroke pain).6

    In Dotty’s case, her painfully arthritic knees prompted her to purchase a three-wheeled folding walker with a seat from an infomercial she saw on daytime television. Unfortunately, it folded while in use, collapsing to the ground along with Dotty. She ended up with a severely bruised and painful hip as a result of the fall.

    While environmental accidents and age-related changes can contribute to falls, chronic pain with medication use is a significant fall risk factor. In addition to polypharmacy, studies have shown both opioid use and exposure to nonsteroidal anti-inflammatory drugs (NSAIDs) contribute to fall risk. A retrospective, observational, multicenter cohort study of registry data in Canada (N = 67,929) concluded that recent opioid use is associated with an increased risk of falls in older adults and an increased likelihood of death from fall-related injuries.7 A systematic review also found an increased risk of falls is probable when elderly individuals are exposed to NSAIDs.8

    A pharmacologic approach to pain may be necessary when pain is significant, unremitting, and affects physical function or quality of life. However, health care professionals should not overlook the importance of nonpharmacologic pain management. Non-pharmacologic pain management and the reduction of falls is an important health topic for consideration by pharmacists and pharmacy technicians.9

    Economic and Socioeconomic Burden of Pain Related Falls

    Serious injuries from falls can lead to permanent injury, functional and cognitive decline, reduced quality of life and the need for institutional care resulting in significant cost.10 The American College of Rheumatology, a leading authority and partner of rheumatology professionals, considers pain chronic when it lasts more than three months, the normal time for tissue healing. Chronic pain is a major cause of disability and linked to mental health deterioration including depression and anxiety.11

    Professionals use many evidence-based fall prevention programs, such as those listed on the National Council on Aging website (Evidence-Based Falls Prevention for Older Adults (ncoa.org) to reduce falls in the community. These interventions vary in length such as 2-hour workshops, in-home interviews, or 8 week to 5-month programs that focus on aging in place, exercise, balance, removal of home hazards, adaptive equipment, task modification, education, and self-management.

    Even with fall prevention programs, the number of falls among older community dwellers is increasing. The reason for the rising number of elderly falls is multifaceted12,13:

    • The population of older adults is growing with more people living longer and remaining in their homes.
    • Access to and participation in fall prevention programs varies among community elderly.
    • In an aging population, musculoskeletal disability and resulting pain increases.
    • As musculoskeletal disability increases, the number of invasive joint surgeries such as hip and knee replacements rises. The projected volume of primary total knee replacements alone will increase by more than 400% over the next 20 years.
    • 7% to 23% of patients after hip and 10% to 34% after knee replacement have long-term post-operative pain.

    When surgeries such as joint replacement result in chronic pain, providers primarily use medication to address pain due to limited treatment options. The combination of aging, more joint replacement surgeries, and concomitant medication use requires more attention to pharmaceutical services in the role of fall prevention. Furthermore, age-related changes in pharmacokinetics and pharmacodynamics may increase the risk and incidence of adverse drug events related to falls.6

    IMPACT OF PAIN MEDICATION ON FALLS

    Risk of Opioid Use in the Elderly

    After her fall, an ambulance whisked Dotty to the hospital. Luckily, she did not sustain any fractures and the emergency department physician sent her home with a prescription for opioids, advised follow up with her primary care doctor, and gave her a flyer for a local fall prevention program.

    The use of opioids for pain management is a significant public health concern particularly among older community dwellers at risk for falls. Prescribed opioid use among middle-aged and older adults is more prevalent than among younger adults.14 Moreover, one-fourth (25.4%) of adults aged 65 years and older who take opioids report being long-time opioid users for a period of 90 days or longer (see Figure 1).15

    Age 40-59 have the highest opioid use, followed by age 60+

    An average of 8.6 million non-institutionalized older adults filled at least one opioid prescription between 2018 and 2019, while 2.7 million older people filled five or more opioid prescriptions or refills. Older women were more likely than men to fill one or more opioid prescriptions.16 In addition to age, socioeconomic factors and patient demographics impact opioid use. According to the statistical brief published by the Agency for Healthcare Research and Quality (AHRQ), elderly adults who were poor filled five or more opioid prescriptions compared to low- and middle-income adults (see Figure 2).16

    Poor and low income elderly adults have the highest amounts of individuals filling 5 or more opioid prescriptions

    A large retrospective, observational, multicenter cohort study of registry data of 67,929 Canadian patients with a mean age of 80.9 (±8.0) evaluated the link between recent opioid use and fall-related injuries. The study identified patients who had filled an opioid prescription in the two weeks preceding an injury were 2.4 times more likely to have a fall than any other type of injury. Patients who had a fall-related injury who used opioids were also at increased risk of in-hospital death.7

    A systematic review and meta-analysis of 30 studies evaluated the impact of opioid use on falls, fall injuries, and factures among adults at least 65 years old. The study found that opioid use was associated with falls, fall injuries, and fractures.17

    Sedation is a common adverse effect of opioids. Medication with sedative effects can lead to daytime drowsiness, reduced alertness, and impaired motor function. Older adults experience these adverse effects more frequently, particularly during the first few days of taking a new pain medication.18 Anticholinergic burden is one of the opioids’, such as oxycodone, lesser-known effects. Anticholinergic drugs impact central nervous system functions and can result in cognitive impairment, confusion, and blurred vision compounding the risks of sedation.19

    Because opioids cause drowsiness, orthostatic hypotension (dizziness or lightheadedness when standing up or otherwise changing position), and hyponatremia (low sodium levels leading to nausea, vomiting, loss of energy and confusion), they can increase fall risk. Risk is more prominent in older adults already prone to falls. Active drug half-life and metabolites are prolonged in older adults with renal impairment because most drugs, particularly water-soluble drugs, are eliminated by the kidneys.20 Understanding renal function is therefore important when assessing dosing risks in the older population. Reviewing for combination opioid use is also important in all patients, and particularly older patients. For example, physicians and pharmacists must take caution with patients using codeine and oxycodone together.21

    Risk of OTC Pain Medication

    Physicians often prescribe acetaminophen as a first-line or preferred OTC pain medication for older adults with nociceptive pain, which is pain caused by physical trauma, burns or surgery, because of potential adverse effects of NSAID (diclofenac, etodolac, fenoprofen, ibuprofen, ketorolac, meloxicam , naproxen) use. Long-term NSAID use is associated with adverse gastrointestinal, renal, and cardiovascular effects. An observed decrease in prescription NSAID and acetaminophen use may be due in part to the increased availability and variety of OTC NSAIDs over time, a phenomenon reported for other medications after becoming available OTC.22

    NSAIDs are among the 5% to 10% most commonly prescribed medications for pain and inflammation. The prevalence of NSAID use in the over-65 population is as high as 96%.23 Physicians and other healthcare providers often prescribe NSAIDs for acute or chronic arthritic pain because of their anti-inflammatory results over just the analgesic effect of acetaminophen.22

    Problems may arise related to NSAID-related toxicity in the elderly. Similar to opioids, age-related changes in pharmacokinetics may affect how the elderly metabolize NSAIDs. Dose reduction is appropriate for naproxen, ketoprofen, and salicylates in healthy older patients. Additionally, prescribers may need to reduce the dosage of diflunisal, indomethacin, sulindac, and mefenamic acid for the elderly in the presence of renal disease.24

    Table 1 lists the adverse effects of long-term use of NSAIDs that can impact fall risk.

    Table 1. NSAIDs Adverse Effects23

    System Adverse Effects
    Kidney Increased risk of nephrotoxicity

    Promotes renal vasoconstriction and reduced renal perfusion

    Electrolyte imbalance such as hyperkalemia

    Reduced glomerular filtration rate

    Nephrotic syndrome

    Chronic kidney disease

    Acute interstitial nephritis

    Sodium retention

    Edema

    Renal papillary necrosis

    Gastrointestinal Increased risk of GI bleeding
    Cardiovascular Edema

    Myocardial infarction

    Thrombotic events

    Stroke

    Hypertension

     

    Study data has been inconsistent but overall trends support an association of falls with NSAIDs use in the elderly. A systematic review of 13 studies published between 1966 and 2008 specifically reviewed fall risk associated with NSAIDs in the elderly population. The overall mean age of study participants was high, preventing generalizability to a larger population. However, all studies showed an increased risk of falling associated with NSAIDs.8 A similar systematic review identified 22 studies that enrolled patients older than 60 years to assess the association between medication use and falling. These analysts reviewed nine different drug classes (antidepressants, antihypertensives, benzodiazepines, beta-blockers, diuretics, narcotics, neuroleptics and antipsychotics, NSAIDs, and sedatives and hypnotics) encompassing 79,081 participants. The use of sedatives and hypnotics, neuroleptics and antipsychotics, antidepressants, benzodiazepines and NSAIDS resulted in an increased likelihood of falling. The unadjusted odds ratio estimate for likelihood of falls related to NSAIDs was 1.21 (95% CI, 1.01-1.44) compared to 0.96 (95%CI, 0.78-1.18) for narcotics.25

    The Case for Non-Pharmacologic Pain Management

    The evidence supporting the need for nonpharmacologic pain management treatment is compelling. The population is aging, the prevalence and incidence of musculoskeletal disability is on the rise, and use of pain medication is associated with known risks. While all adverse effects of taking pain medication are important, falls can be among the most debilitating and costly for the elderly.

     

    Pharmacists and pharmacy technicians are front line community healthcare providers in pivotal positions to positively impact fall reduction. By moving beyond medication management, pharmacists and pharmacy technicians can proactively participate in a multi-disciplinary approach to reduce reliance on pain medication and facilitate non-pharmacologic treatment including physical therapy.

    DEVELOPING AN INTEGRATED PATIENT-CENTRIC TEAM-BASED APPROACH TO FALL PREVENTION

    Pharmacists’ Role in Medication Management

    Pharmacists play a key role in fall prevention by recognizing “fall risk-increasing drugs” (FRIDs), identifying at-risk patients, and collaborating with other healthcare professionals including physicians, home care nurses, and physical therapists by making appropriate referrals.

     

    A traditional first step for pharmacists and pharmacy technicians is medication management. Knowing FRIDs is important (see Table 2).

    Table 2. FRIDs at-a-glance

    Classes of Fall Risk-Increasing Drug
    Antidepressants Antihypertensives Opioids NSAIDs
    Anticonvulsants Antipsychotics Sedative hypnotics Antispasmodics
    Anticholinergics Benzodiazepines Antihistamines Antispastics

     

    Polypharmacy, exposure to FRIDs, or the combination of polypharmacy including FRIDs can be associated with fall risk. Pharmacists should also consider exposure to potentially inappropriate medications (PIMs) as described in prescribing guidance tools such as the American Geriatric Society (AGS) Beers Criteria.26

    The Beers Criteria considers five broad categories of potentially inappropriate medications used in the elderly27:

    1. Medications considered potentially inappropriate
    2. Medications potentially inappropriate in patients with certain diseases or syndromes
    3. Medications to be used with caution
    4. Potentially inappropriate drug-drug interactions
    5. Medications whose dosages should be adjusted based on renal function.

    Additionally, the National Council on Aging (NCOA) advocates for a thorough medication review for older adults at risk of falling, noting that OTC medications can cause harmful interactions and increase falls.

    The five important problem areas identified by pharmacists in conjunction with the program’s algorithms include28

    1. Unnecessary therapeutic duplication
    2. Use of medications that can cause falls and confusion
    3. Use of medications that can cause cardiovascular problems
    4. Inappropriate use of non-steroidal anti-inflammatory drugs
    5. Review for effectiveness of opioid prescriptions and alternate options

    An example of unnecessary therapeutic duplication occurs when patients take a muscle relaxer such as meloxicam with an OTC for inflammation like naproxen. Many patients are also unaware of medications that can cause falls and confusion such as OTC antihistamines. Patient education directly from pharmacists or pharmacy technicians can be beneficial in preventing falls related to these types of OTC drugs.

    After her fall, Dotty filled her opioid prescription and continued taking acetaminophen due to the pain in her knees and hip from the fall. Since her providers or pharmacist had not “prescribed” acetaminophen, they were unaware of the unnecessary analgesic duplication.

    While medication management and identification of FRIDs is important to reducing risk of falls, it is not a substitute for a comprehensive multi-disciplinary approach. A recently published systematic review of the use of fall risk-increasing drugs looked at 14 observational or intervention studies that assessed FRID use in participants 60 years or older. Participants had experienced a fall resulting in a hospitalization or emergency department (ED) visit. The studies reported the prevalence of FRID use was 65% to 93% at the time of hospitalization or ED admission among older adults with a fall-related injury. Further, studies within the review found FRID use did not decrease at one and six months following a fall. Intervention trials included in the review demonstrated that interventions to reduce FRIDs did not result in a significant reduction in falls. The authors conclude that medication review with suggestions to the primary care provider as a stand-alone intervention was ineffective in preventing falls. Interventions to reduce FRID use are only one part of a more comprehensive strategy.29

    Dosing and Deprescribing to Reduce Falls

    When making decisions to deprescribe opioids, prescribers and pharmacists should consider whether the opioid use matches an appropriate indication. Since opioids are strong analgesics, their indications should be for moderate to severe acute pain, post-operative pain, or palliative care. Prescribers and pharmacists should always consider deprescribing when there are no indications for prescribing an opioid and safer alternatives are available.6

    Opioid dosing should always be specific to the individual with lower doses for older adults. Reducing the dose or switching to a less potent analgesic to maintain effective pain management is a viable strategy while implementing other nonpharmacologic techniques such as physical therapy.6

    Pharmacists are skilled in identifying medications for discontinuation based on known risks. A careful plan for tapering and discontinuing drugs at an appropriate pace is critical to avoid increasing patients’ pain, stress, and discouragement. Various tools are available to pharmacists to collaborate with patients to create a deprescribing plan.30 Examples of resources to assist healthcare providers optimize medications while minimizing adverse events include the Medication Appropriateness Index Calculator ( https://globalrph.com/medcalcs/medication-appropriateness-index-calculator/) and the AGS Beers Criteria available from the American Geriatrics Society (https://agsjournals.onlinelibrary.wiley.com/doi/full/10.1111/jgs.18372). No one tool is the gold standard and inconsistencies exist among the various resources.31

    For example, the STOPPFall tool provides deprescribing in a stepwise manner.18 STOPPFall recommends reducing the opioid dose by 5% to 25% of the daily dose every one to four weeks. If adverse effects occur during deprescribing, prescribers can reduce the dose more slowly. If the patient dose is high or he or she has been using the opioid for a longer period, deprescribing should proceed very slowly.

    Conversely another tool, MedStopper, indicates when a patient has been taking an opioid daily for more than four weeks, prescribers should reduce the dose by 25% every three to four days. Upon any symptoms of withdrawal, they should increase the dose back to 75% of the previous tolerated dose. Once at 25% of the original dose with no withdrawal symptoms, they can discontinue the drug.32 Prescribers and pharmacists should monitor patients during and after deprescribing for symptoms of withdrawal such as musculoskeletal or gastrointestinal symptoms, restlessness, anxiety, insomnia, diaphoresis (excessive sweating), anger, and chills.

    Pharmacy Fall Risk Prevention Service

    To be an integral part of a more comprehensive fall prevention intervention, pharmacies should consider offering a fall prevention service. Establishing a community fall prevention service consists of fall risk screening, consultation to assess modifiable fall risk factors with referral to appropriate non-pharmacological intervention, medication check, and comprehensive medication review and adjustment by the pharmacy and primary prescriber.

    Use of an appropriate screening tool by pharmacists or pharmacy technicians is a major step to reducing risk of falls. To assist healthcare professionals in reducing fall risk, the Centers for Disease Control and Prevention (CDC) developed the STEADI (Stopping Elderly Accidents, Deaths, and Injuries) initiative. This initiative includes three steps for providers to address their patient’s fall risk.31,33

    • Screening for fall risk by asking patients if they have experienced past falls, feel unsteady, or are afraid of falling
    • Reviewing and managing their medications to determine if they impact fall risk and stopping, switching, or reducing them
    • Studies shows recommending vitamin D supplements to improve bone, muscle, and nerve can reduce risk of falls in the elderly

    The CDC and the University of North Carolina Eshelman School of Pharmacy and School of Medicine developed an algorithm called STEADI-RX to improve collaboration between healthcare providers and pharmacists based on the CDC’s STEADI initiative. STEADI-RX incorporates the Joint Commission of Pharmacy Practitioners (JCPP) Pharmacists’ Patient Care Process and an algorithm for integrating fall screening and prevention into pharmaceutical care. It also includes a tool kit for use by healthcare providers to help reduce risk of falls.34 Figure 3 shows the STEADI-Rx’s key steps.

    Steadi-Rx steps: 1 (screen), 2 (assess), 3 (coordinate care), 4 (response)                                                                     

    The STEADI-RX Community Fall Risk Checklist35 (https://www.cdc.gov/steadi/pdf/provider/steadi-rx/STEADIRx_pharmacy_fallrisk_checklist-508.pdf) is available to help the pharmacy staff quickly identify risk factors including fall history, postural hypotension episodes, and review medication classes associated with fall risk.

    Getting Started with A Fall Risk Service

    The STEADI-Rx Older Adult Fall Prevention Guide for Community Pharmacists, available from the CDC at https://www.cdc.gov/steadi/steadi-rx.html,36 provides a framework for how to start a fall prevention service, identifies best practices, and provides tools and references for implementing a successful program.

    To start an in-pharmacy fall reduction program, a key recommendation is to first identify a program champion. This is either a pharmacist or trained pharmacy technician who will serve as the lead role and ensure proper design and implementation of the program. Next, an environmental scan may help identify the patient population that will benefit from the service and how it fits into existing workflow. A fundamental aspect of conducting an environmental scan may include an analysis of strengths, weaknesses, opportunities, and threats (SWOT) to identify any internal or external obstacles to implementation, described in Sample Fall Prevention SWOT Analysis.

     

    SIDEBAR: SAMPLE FALL PREVENTION SERVICE SWOT ANALYSIS

    STRENGTHS - Internal factors include available resources and staff

    WEAKNESSES - Internal obstacles may be poor workflow or documentation procedures

    OPPORTUNITIES - External factors to support a successful service include an age-appropriate population, supportive providers, and state physical therapy direct access provisions to facilitate referrals

    THREATS - External factors that may hinder a successful service such as nearby pharmacies with strong prevention services, reimbursement or other financial factors inhibiting patient participation

     

    The guide also recommends conducting a readiness assessment to determine the steps needed to implement the service and to develop an action plan. The readiness assessment addresses staffing, resources, and training needed and assure there is appropriate support from leadership before moving forward. Depending upon existing pharmacy workflow, a pharmacy technician can lead a fall prevention service with pharmacist support when they need clinical judgement and expertise.

     

    Coordinating Care: Physical Therapy and Physician Support

    Dotty eventually came into the pharmacy looking for a “better” assistive device. She seemed confused about what device to choose and reported she recently had a fall. With her permission, a fall risk screening revealed she was taking both NSAIDs and opioids and had not been referred to physical therapy. She stated the ED gave her a flyer for a fall prevention program, but she didn’t go because it conflicted with BINGO at the senior center.

     

    Pharmacists and prescribers should consider practice guideline recommendations to determine when to make referrals to physical therapy for the nonpharmacologic treatment of pain. It is important to consider reducing reliance on opioids and inappropriate use of NSAIDs.

     

    Data from the National Ambulatory Medical Care Survey identified 11,994 visits representing a cross-section of all age patients between 2007-2015 where ICD-9 (diagnosis) codes indicated new chronic musculoskeletal pain. The survey found that healthcare providers prescribed patients opioids 21.5% of the time when they presented with new symptoms of chronic musculoskeletal pain but prescribed physical therapy just 10% of the time.37

    Numerous studies have examined the relationship between early physical therapy and opioid use for chronic musculoskeletal pain including back neck, shoulder, and knee. Due to its incidence, prevalence and associated costs, a preponderance of studies focused on low back pain (LBP). A retrospective analysis using commercial health insurance claims data from 2009-2013 observed 148,866 patients aged 18 to 64 years with a new primary diagnosis of LBP over a 1-year period. Compared to patients who received late or no physical therapy, patients who saw a PT first had an 89.4% lower probability of obtaining an opioid prescription.38

    Another cross-sectional observational study using the National Ambulatory and National Hospital Ambulatory Medical Care Surveys between 1997 and 2010 also identified lower PT referral rates among LBP patients aged 16 to 90 years old insured by Medicare and Medicaid. The study estimated 170 million visits for LBP led to 17.1 million PT visits. Further, visits not associated with PT referrals were more likely to be associated with opioid prescriptions.39

    Healthcare providers do not always prescribe nor do patients use physical therapy as a frontline treatment for chronic pain. Patients may use physical therapy along with other nonpharmacologic treatments, such as behavior health interventions or medication. Physical therapy is an integral part of multidisciplinary care, particularly to support success with opioid taper or cessation. Physical therapy treatments to reduce pain include exercise, manual therapy, electrical nerve stimulation, and other physical agents.

    When conducting a pharmacy fall risk service, pharmacy staff may encounter patients with chronic pain who have not received physical therapy prior to treatment with pain medication. The screening process will be the first step in assessing true risk.

    Pharmacy staff can use the STEADI-RX Provider Consult Form(s) for Medication or Fall Screening to share medication therapy problems with the patient’s provider or to refer the patient to a physical therapist for a full fall risk assessment.40,41 A physical therapist’s formal fall risk assessment is more in-depth than the screening tool used at the pharmacy and includes an evaluation of gait, balance, and strength. When using these forms or any other type of communication, states have different physical therapy direct access provisions and limitations. Pharmacies can verify the levels of patient access to physical therapist services in the U.S. through the American Physical Therapy Association (https://www.apta.org/contentassets/4daf765978464a948505c2f115c90f55/direct-access-by-state-map.pdf). After referral, physical therapists should respond within seven days. If they don’t, the patients or pharmacy should contact the PT again.

    Pharmacists and pharmacy technicians identifying at-risk patients during an initial fall risk screening performed at the pharmacy should refer patients to physical therapy for a full fall risk assessment. Physical therapists use a variety of objective assessment tools to address gait and balance such as the Tinetti Balance and Gait Assessment, Berg Balance Scale, or Timed Up and Go test to determine fall risk and areas for intervention. Therefore, when implementing a pharmacy fall reduction service, it is important for pharmacists to develop relationships with local outpatient physical therapy clinics able to accept referrals for fall risk evaluations.

    Because musculoskeletal pain is highly prevalent and a leading cause of disability, physical therapists are crucial members of the interdisciplinary pain management team. Physical therapists work effectively by providing nonpharmacologic treatment of pain incorporating various pain-relieving modalities such as transcutaneous electrical stimulation, heat or cold therapy, joint or soft tissue mobilizations or the use of braces or splints. In addition to physical therapy treatment to address pain, physical therapists also recommend various assistive and adaptive devices. Patients may use these devices to reduce pain through off-loading a painful limb or making mobility including ambulation and transfers (i.e., moving from one position to another such as from sitting to standing, or getting in or out of bed) easier and safer.

    Improperly selected or poorly fitted devices can result in further injury, pain or falls. Receiving instructions and training on proper use of assistive devices and compliance with instructions has not been strongly correlated. A small (N=17) observational cross-sectional study and focus group investigated older adults’ use of walkers in the home setting compared to current guidance in an attempt to identify circumstances leading to deviation from instructions for use. This study observed incorrect use of walkers 16% to 29% of the time associated with reduced stability.42 Another study found comparable results from a questionnaire of 94 patients using a cane for hip pathology.;47% of these patients were using the aid in the incorrect hand and of this group, 64% used their dominant hand. Furthermore, 66% of respondents reported they never received instruction on the correct hand to use. The study concluded that a significant percentage of patients are using canes incorrectly which may be due to lack of education.43

    A patient-appropriate assistive device, when fitted and used correctly, can reduce pain and increase physical activity in patients with chronic pain, painful or impaired gait and other mobility issues. Selection and fitting of an assistive device should always be conducted through a PT evaluation. PTs use a multi-factorial assessment of the patient’s physical and cognitive abilities of and consider the environment in which the patient will use the device (see 5 Factors of Device Prescription). PTs will also ensure devices match a patient’s height, weight, and size when selecting the best assistive device.

     

    SIDEBAR: 5 FACTORS OF DEVICE PRESCRIPTION

    1. Cognitive Function
    2. Coordination
    3. Upper-body, hand and grip strength
    4. Physical endurance
    5. Walking environment

     

    Upon competition of their evaluation, it is important for the therapists to know what types of OTC assistive and adaptive devices are available for purchase at local pharmacies to support patient needs. Although assistive devices are often available at physical therapy clinics, a patient’s health insurance plan may not include reimbursement for devices. Often OTC devices and aids are priced lower at retail locations and purchased directly by patients or family members.

    Rather than have Dotty guess and purchase a “better” assistive device, the pharmacy referred her to a physical therapist who determined that at least initially, a 4-point walker with front wheels would provide her the most stability and allow her to walk safely in both her home and the community.

    Table 3 describes items often recommended by therapists to reduce pain, fall risk, and improve home safety. See Fun Facts to learn about the history of walkers.

    Table 3. Assistive & Adaptive Devices

    Item Description Purpose
    Bed Rails Railing inserted between mattress and box spring or physically attached to bedframe Assist with transfer out of bed by allowing people to pull their body to change position using arms/upper body
    Cane, Walker Ambulation assist devices. Canes can be single point, multi point (quad) and walkers with or without wheels Provides additional point of contact to improve balance, alleviate weakness, or offload a painful joint
    Commode, Raised Toilet Seat, Toilet Seat Rails Portable toilet, elevated seat or arm rails Assist with safe transfer on and off toilet
    Grab Bars Bars and railings permanently affixed to walls near showers, toilets, entry ways, steps, stairs Promotes safe transfers from sit to stand, up and down stairs, in and out of shower
    Grabbers or Reachers Reaching aid with grab assist Allows items to be safely grabbed if out of reach or if mobility, pain, or strength impairs reaching and grabbing
    Neoprene braces and wraps Supportive and compressive wraps and braces for ankles, knees, wrists Provide joint protection, stability, and pain relief
    Shoe wedges or inserts Partial or full inserts used inside of shoes Cushion or improve postural alignment to offload painful foot
    Shower Chairs Waterproof, quick dry, slip resistant stool or chair Allows safe seating in shower to reduce slipping or falling and fatigue with standing

     

     

    SIDEBAR: FUN FACTS43,44,45,46

    A walker, walking frame, or rollator is a mobility device used by people suffering from leg or back pain, weakness, impaired balance, amputation, or poor stamina.

    • Walkers first appeared in the 1950s.
    • The first US Patent was awarded in 1953 to William Cribbes Robb of the United Kingdom for device called a “walking aid” filed with the British patent office in 1949.
    • Two US patents in 1957 are for variants with wheels.
    • The first non-wheeled designed walker was patented in 1965 by Elmer F. Ries of Ohio. In 1970, Alfred Smith of California patented the first walker resembling modern day walkers.

     

    Establishing Effective Team Communications

    Communication between pharmacists, prescribers, and therapists is important to monitor progress and avoid symptoms of medication withdrawal. As patients progress with their therapy plan of care, medication dosing may be easier to adjust. Ongoing patient education from pharmacists and pharmacy technicians can help avoid unnecessary patient self-medication with OTC pain relievers during the transition period.

     

    The physician or primary care provider receives regular updates from the physical therapy team and can provide the pharmacy with necessary progress to help coordinate dose reduction or deprescribing. When designing the workflow for a pharmacy fall prevention service, the program champion should be sure to include a schedule for giving and receiving team updates.

     

    With ongoing treatment, the physical therapist reported Dotty was making progress toward her therapy plan of care goals. Upon completion of therapy Dotty would be stronger, have less pain, and reduce or eliminate pain medication, and graduate to using a single point cane as needed. Since Dotty’s Medicare insurance plan only covered the cost of the 4-point wheeled walker, she would have to purchase the cane out-of-pocket and would be returning to the pharmacy with the PT’s recommendation so that the PT could fit and train Dotty on its proper use during her therapy sessions.

    Closing the Treatment Gap

    The benefits of a pharmacy fall reduction service are multi-fold. Moving beyond medication management closes the current treatment gap in the delivery of consistent and effective fall prevention. By working collaboratively with other HCPs, pharmacists help achieve better fall prevention outcomes by reducing or eliminating pain medications while facilitating non-pharmacologic pain management and improved functional mobility improvement.

    Contact Joanne Nault to describe this figure

    Pharmacist Post Test (for viewing only)

    Beyond Medication Management: A Multi-Disciplinary Approach to Pain Management & Fall Risk Reduction

    Pharmacists Post-test
    After completing this continuing education activity, pharmacists will be able to
    1. Recognize opportunities to reduce pain medication and mitigate risk of falls
    2. Identify appropriate patients for referral to physical therapy for non-pharmacological pain management
    3. Discuss deprescribing of fall risk increasing pain medication with physician prescribers
    4. Review the types of OTC assistive and adaptive devices available at the pharmacy to support pain relief, safety, or mobility

    1. Which of the following patients presents with an opportunity to reduce pain medication and fall risk?
    a. 53-year-old male tennis coach taking methocarbamol and hydrocodone/acetaminophen for recent back surgery
    b. 84-year-old frail widow taking ibuprofen, diazepam, lisinopril and gabapentin
    c. 62-year-old male with a transtibial amputation taking metformin and acetaminophen
    d. 74-year-old female with early onset Alzheimer’s taking meloxicam, alendronic acid, and vitamin D

    2. Which of the following patients should be referred to physical therapy for fall risk assessment?
    A. 92-year-old male who plays tennis daily but fell trying to jump over the net after a victory and is now taking ibuprofen for pain
    B. 85-year-old female active in her community who takes gabapentin for nerve pain
    C. 82-year-old female who lives alone, has a history of advanced cancer and has “tripped” several times at home without injury and takes lisinopril, bupropion, and pilocarpine

    3. Betty is 84 years old, suffers from osteoarthritis of the spine and has fallen twice in the past year. Which of the following is an example of unnecessary therapeutic duplication?
    A. Metformin and Valium
    B. Meloxicam and Aleve
    C. Lisinopril and Lipitor
    4. What class of medication is among the top 5-10% of drugs prescribed for pain and inflammation?
    A. Muscle relaxers
    B. Opioids
    C. NSAIDs

    5. Which of the 5 broad categories of the Beers Criteria is particularly important when performing pain medication management for fall risk prevention?
    A. Use of cardiovascular medications
    B. Medications whose dosages should be adjusted based on renal function
    C. Medications considered as potentially inappropriate

    6. Which of the following items are adaptive devices used for safety commonly sold in pharmacies?
    A. Reachers
    B. Cordless telephones
    C. Canes
    D. Crutches

    7. A template for starting a pharmacy fall service can be found through which CDC initiative?
    A. STEADI-Rx
    B. MedStopper
    C. STOPPFall

    8. Which of the following are ambulation assistive devices a patient may request to purchase at a pharmacy?
    A. Canes and walkers
    B. Shower chairs
    C. Raised toilet seats
    9. In addition to antidepressants, anticonvulsants and antihypertensives, which category of drugs is often overlooked as a contributor to falls?
    A. NSAIDs
    B. Antivirals
    C. Antibiotics

    10. 84-year-old Dotty is nearing the completion of physical therapy and her PT reports a significant reduction in her bilateral arthritis knee pain but is still currently being prescribed opioids since a recent fall what should you do?
    A. Nothing. Opioids were correctly prescribed by the ED physician and continued by her primary care doctor
    B. Have a discussion with the primary care about deprescribing the opioids
    C. Just tell her to wean off the opioids herself in a step-wise fashion

    Pharmacy Technician Post Test (for viewing only)

    Beyond Medication Management: A Multi-Disciplinary Approach to Pain Management and Fall Risk Reduction

    Pharmacy Technician Post-test

    After completing this continuing education activity, pharmacy technicians will be able to
    1. Identify classes of fall-risk increasing drugs (FRIDs) that contribute to fall risk
    2. Complete fall risk screening to identify at-risk patients
    3. Recognize patients to refer to the pharmacist or other healthcare providers (HCPs) for further consultation
    4. List OTC assistive and adaptive devices to support pain relief and safer mobility
    1. What percentage of people over the age of 65 fall each year?
    A. Between 5 and 10%
    B. Between 30 and 40%
    C. Over 50%

    2. Which of the following patients should be referred to the pharmacist for consultation?
    A. An 88-year-old female reporting new onset of dizziness after beginning a new pain medication
    B. A 68-year-old male purchasing acetaminophen while picking up a prescription for oxycodone
    C. A 90-year-old male asking where he can find canes to replace the one he is using
    3. Which of the following is a common adverse effect of taking opioids?
    A. Increased energy
    B. Improved vision
    C. Drowsiness

    4. Which one of the 5 important problem areas that the National Council on Aging (NCOA) identified can be corrected through medication review to reduce fall risk?
    A. Low vitamin D levels
    B. Unnecessary therapeutic duplication
    C. Past history of falling

    5. Which of the following are Fall-Risk Increasing Drugs?
    A. Opioids, NSAIDs, Antidepressants
    B. Antihistamines, Antibiotics, Statins
    C. Antihypertensives, Antivirals, Proton Pump Inhibitors

    6. What is the first step of the STEADI-RX program?
    A. Eliminate all fall-risk increasing medications
    B. Screen patients for fall risk in the pharmacy
    C. Assess modifiable risk factors

    7. Which of the following assistive devices may make mobility safer and reduce pain?
    A. Reacher
    B. Cane or walker
    C. Shower chair

    8. Which initiative recommends reducing an opioid dose by 25% if patients have been taking opioids daily for four or more weeks?
    A. STEADI-Rx
    B. MedStopper
    C. STOPPFall

    9. In addition to antidepressants, anticonvulsants and antihypertensives, which category of drug is often overlooked as a contributor to falls?
    A. NSAIDs
    B. Antivirals
    C. Antibiotics

    10. What class of medication is among the top 5-10% of drugs prescribed for pain and inflammation?
    A. Muscle relaxers
    B. Opioids
    C. NSAIDs

    References

    Full List of References

    References

       
      1. Nahin RL. Estimates of pain prevalence and severity in adults: United States, 2012. J Pain. 2015;16(8):769. Epub 2015 May 29.
      2. Moreland B, Kakara R, Henry A. Trends in Nonfatal Falls and Fall-Related Injuries Among Adults Aged ≥65 Years - United States, 2012-2018. MMWR Morb Mortal Wkly Rep. 2020;69(27):875-881. doi:10.15585/mmwr.mm6927a5
      3. Bhasin S, Gill TM, Reuben DB, et al. A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries. N Engl J Med. 2020;383(2):129-140. doi:10.1056/NEJMoa2002183
      4. Lehti TE, Rinkinen MO, Aalto U, et al. Prevalence of musculoskeletal pain and analgesic treatment among community dwelling older adults: changes from 1999 to 2019. Drugs Aging. 2021;38(10):931-937. doi:10.1007/s40266-021-00888-w
      5. Patel KV, Guralnik JM, Dansie EJ, et al. Prevalence and impact of pain among older adults in the United States: findings from the 2011 national health and aging trends study. Pain. 2013;154:2649-2657.
      6. Virnes RE, Tiihonen M, Karttunen N, van Poelgeest EP, van der Velde N, Hartikainen S. Opioids and Falls Risk in Older Adults: A Narrative Review. Drugs Aging. 2022;39(3):199-207. doi: 10.1007/s40266-022-00929-y.
      7. Daoust R, Paquet JM, Moore L, Emond M, Gosselin S, Lavigne G, et al. Recent opioid use and fall related-injury among older patients with trauma. CMAJ 2018; 190:E500-6. Doi:10.1503/cmaj.171286
      8. Hegeman, J., van den Bemt, B.J.F., Duysens, J. et al. NSAIDs and the Risk of Accidental Falls in the Elderly. Drug-Safety 2009;32;489-498.. https://doi.org/10.2165/00002018-200932060-00005
      9. Gemmeke M, Koster ES, van der Velde N, Taxis K, Bouvy ML. Establishing a community pharmacy-based fall prevention service - An implementation study. Res Social Adm Pharm. 2023;19(1):155-166. doi:10.1016/j.sapharm.2022.07.044
      10. Woo AK. Depression and anxiety in pain. Rev Pain. 2010; 4(1):8-12.
      11. Burns E, Kakara R. Deaths from falls among persons aged ≥ 65 years—United States, 2007–2016. Morb Mortal Wkly Rep. 2018;67:509–514.
      12. Singh JA, Yu S, Chen L, Cleveland JD. Rates of Total Joint Replacement in the United States: Future Projections to 2020-2040 Using the National Inpatient Sample. J Rheumatol. 2019;46(9):1134-1140. doi:10.3899/jrheum.170990
      13. Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What portion of patients report long-term pain after total hip or knee replacement for osteoarthritis. A systematic review of prospective studies in unselected patients. BMJ Open. 2012;2(1):e000435.
      14. Frenk SM, Porter KS, Paulozzi LJ. Prescription opioid analgesic use among adults: United States, 1999–2012. NCHS Data Brief. Hyattsville, MD: National Center for Health Statistics;2015:89.
      15. Mojtabai R. National trends in long-term use of prescription opioids. Pharmacoepidemiol Drug Saf. 2018;27:526–534. doi: 10.1002/pds.4278
      16. Moriya AS, Fang Z. Any Use and “Frequent Use” of Opioids among Elderly Adults in 2018–2019, by Socioeconomic Characteristics. 2022 Mar. In: Statistical Brief (Medical Expenditure Panel Survey (US)) [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2001-. STATISTICAL BRIEF #541. Accessed July 13, 2023. https://www.ncbi.nlm.nih.gov/books/NBK581184/
      17. Yoshikawa A, Ramirez G, Smith ML, et al. Opioid Use and the Risk of Falls, Fall Injuries and Fractures among Older Adults: A Systematic Review and Meta-Analysis. J Gerontol A Biol Sci Med Sci. 2020;75(10):1989-1995. doi:10.1093/gerona/glaa038
      18. Seppala LJ, Petrovic M, Ryg J, et al. STOPPFall (Screening Tool of Older Persons Prescriptions in older adults with high fall risk): a Delphi study by the EuGMS Task and Finish Group on Fall-Risk-Increasing Drugs. Age Ageing. 2021;50(4):1189-1199. doi:10.1093/ageing/afaa249
      19. Staskin DR, Zoltan E. Anticholinergics and central nervous system effects: are we confused?. Rev Urol. 2007;9(4):191-196
      20. Merck Manual, Le J. Drug Elimination. Sep 2022. Accessed July 6, 2023. https://merckmanuals.com/professional/clinical-pharmacology/pharmacokinetics/drug-excretion
      21. Niscola P, Scaramucci L, Vischini G, Giovannini M, Ferrannini M, Massa P, Palumbo R. The use of major analgesics in patients with renal dysfunction. Curr Drug Targets. 2010;11:752-758.
      22. Davis JS, Lee HY, Kim J, et al. Use of non-steroidal anti-inflammatory drugs in US adults: changes over time and by demographic. Open Heart 2017;4:e000550. doi: 10.1136/openhrt-2016-000550
      23. Wongrakpanich S, Wongrakpanich A, Melhado K, Rangaswami J. A Comprehensive Review of Non-Steroidal Anti-Inflammatory Drug Use in The Elderly. Aging Dis. 2018;9(1):143-150. Published 2018 Feb 1. doi:10.14336/AD.2017.0306
      24. Johnson AG, Day RO. The problems and pitfalls of NSAID therapy in the elderly (Part I). Drugs Aging. 1991;1(2):130-143. doi:10.2165/00002512-199101020-00005
      25. Woolcott JC, Richardson KJ, Wiens MO, Patel B, Marin J, Khan KM, et al. Meta-analysis of the impact of 9 medication classes on falls in elderly persons. Arch Intern Med. 2009;169:1952-1960.
      26. Fick DM, Semla TP, Steinman M, et al. American Geriatrics Society 2019 updated AGS Beers Criteria® for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2019;67(4):674–694. doi: 10.1111/jgs.15767
      27. By the 2023 American Geriatrics Society Beers Criteria® Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria® for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023;1- 30. doi:10.1111/jgs.18372
      28. National Council on Aging. How Can Medication-Related Falls Be Prevented in Older Adults? Accessed June 20, 2023. https://ncoa.org. How Can Medication-Related Falls Be Prevented in Older Adults? (ncoa.org)
      29. Hart LA, Phelan EA, Yi JY, Marcum ZA, Gray SL. Use of Fall Risk-Increasing Drugs Around a Fall-Related Injury in Older Adults: A Systematic Review. J Am Geriatr Soc. 2020;68(6):1334-1343. doi:10.1111/jgs.16369
      30. Murphy L, Ng K, Isaac P, Swidrovich J, Zhang M, Sproule BA. The Role of the Pharmacist in the Care of Patients with Chronic Pain. Integr Pharm Res Pract. 2021;10:33-41. doi:10.2147/IPRP.S248699
      31. Karani MV, Haddad Y, Lee R. The Role of Pharmacists in Preventing Falls among America's Older Adults. Front Public Health. 2016;4:250. doi:10.3389/fpubh.2016.00250
      32. MedStopper: MedStopper. Accessed 21 Jun 2023. https://medstopper.com/
      33. Murad MH, Elamin KB, Abu Elnour NO, et al. Clinical review: The effect of vitamin D on falls: a systematic review and meta-analysis [published correction appears in J Clin Endocrinol Metab. 2021 Mar 8;106(3):e1495]. J Clin Endocrinol Metab. 2011;96(10):2997-3006. doi:10.1210/jc.2011-1193
      34. Pharmacy Care (STEADI-Rx) | STEADI - Older Adult Fall Prevention | CDC Injury Center https://www.cdc.gov/steadi/steadi-rx.html. Accessed Jun 22, 2023.
      35. Steadi-Rx Community Pharmacy Fall Risk Checklist (cdc.gov) https://www.cdc.gov/steadi/pdf/provider/steadi-rx/STEADIRx_pharmacy_fallrisk_checklist-508.pdf. Accessed Jun 27, 2023.
      36. Steadi-rx Older Adult Fall Prevention Guide for Community Pharmacists (cdc.gov) https://www.cdc.gov/steadi/pdf/Steadi-Implementation-Plan-508.pdf. Accessed Jun 22, 2023.
      37. George SZ, Goode AP. Physical therapy and opioid use for musculoskeletal pain management: competitors or companions? Pain Rep. 2020;5(5):e827. Published 2020 Sep 24. doi:10.1097/PR9.0000000000000827
      38. Frogner BK, Harwood K, Andrilla CHA, Schwartz M, Pines JM. Physical therapy as the first point of care to treat low back pain: an instrumental variables approach to estimate impact on opioid prescription, health care utilization, and costs. Health Serv Res. 2018;53:4629-4646
      39. Zheng P, Kao MC, Karayannis NV, Smuck M. Stagnant Physical Therapy Referral Rates Alongside Rising Opioid Prescription Rates in Patients with Low Back Pain in the United States 1997-2010. Spine (Phila Pa 1976). 2017;42(9):670-674. doi:10.1097/BRS.0000000000001875
      40. Provider Consult - Medication (cdc.gov) https://www.cdc.gov/steadi/pdf/provider/steadi-rx/STEADIRx_provider_consult_medication_form-508.pdf. Accessed Jun 27, 2023.
      41. Provider Consult - Fall Screening (cdc.gov). https://www.cdc.gov/steadi/pdf/provider/steadi-rx/STEADIRx_provider_consult_fallscreening_form-508.pdf. Accessed Jun 27, 2023.
      42. Thies SB, Bates A, Costamagna E, et al. Are older people putting themselves at risk when using their walking frames?. BMC Geriatr. 2020;20(1):90. Published 2020 Mar 4. doi:10.1186/s12877-020-1450-253. Shepherd AJ. Incorrect use of walking aids in patients with hip pathology. Hip Int. 2005;15(1):52–4.
      43. Walking Aid. U.S. Patent US2656874. Accessed August 31, 2023. https://patents.google.com/patent/US2656874
      44. Invalid walker and transfer device. U.S. Patent US2792052. Accessed August 31, 2023. https://patents.google.com/patent/US2792052
      45. Orthopedic walker. U.S. Patent US2792874. Accessed August 31, 2023. https://patents.google.com/patent/US2792874
      46. Invalid walker. U.S. Patent US3517677. Accessed August 31, 2023. https://patents.google.com/patent/US3517677

      Who are you? Who are We? Professional Identity in Experiential Learning

      Learning Objectives

       

      After completing this application-based continuing education activity, pharmacist preceptors will be able to

        1. Describe professional identify formation
        2. Apply the steps in development of a professional identity
        3. Identify activities that develop professional identity appropriately

        Healthcare professionals with arms crossed.

         

        Release Date: November 1, 2023

        Expiration Date: November 1, 2026

        Course Fee

        Pharmacists: $7

        UConn Faculty & Adjuncts:  FREE

        There is no grant funding for this CE activity

        ACPE UANs

        Pharmacist: 0009-0000-23-049-H04-P

        Session Code

        Pharmacist:  23PC49-ABC37

        Accreditation Hours

        2.0 hours of CE

        Accreditation Statements

        The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-049-H04-P  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

         

        Disclosure of Discussions of Off-label and Investigational Drug Use

        The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

        Faculty

        Jennifer Luciano, PharmD
        Director, Office of Experiential Education; Associate Clinical Professor
        UConn School of Pharmacy
        Storrs, CT

        Jeannette Y. Wick, RPh, MBA, FASCP
        Director, Office of Pharmacy Professional Development
        UConn School of Pharmacy
        Storrs, CT

        Ethan Yazdanpanah
        PharmD Candidate 2025
        UConn School of Pharmacy
        Storrs, CT

         

         

        Faculty Disclosure

        In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

        Jeannette Wick, Ethan Yazdanpanah, and Jennifer Luciano do not have any relationships with ineligible companies

         

        ABSTRACT

        Discovering what it means to be a good healthcare provider goes beyond knowledge acquisition and education for pharmacy students; it demands a transformative journey of professional identity formation (PIF). The pharmacy profession, through its professional organizations, has identified a number of core values, but as the profession changes, new core values are emerging. PIF occurs over a trajectory, starting in pharmacy school (or even before) and continuing throughout life. Preceptors can use a number of techniques to help pharmacy students with PIF, assuring that our future pharmacists hold the same values ats the profession at large. Exposing students to a variety of situations, asking open-ended questions, using teach-back methods, and introducing students to professional organizations are a few.

        CONTENT

        Content

        INTRODUCTION

        Let’s begin this continuing education activity with some questions. What makes a nurse a nurse? What makes a nurse a good or exceptional nurse? What makes an electrician an electrician? What makes an electrician a good or exceptional electrician? What makes a pharmacist a pharmacist? What makes a pharmacist a good or exceptional pharmacist? Those questions are no doubt difficult to answer. Preceptors may be making a list mentally of the qualities that the ideal nurse, electrician, or pharmacist should possess. Certainly, for each of these professions, education will be the foundation. Here’s a harder question: Is it possible to be a good or exceptional nurse, electrician, or pharmacist but a terrible person? And is it possible to be a good and loyal pharmacy employee, but not such a good pharmacist? All these questions speak to the concept discussed here: professional identity.

         

        Discovering what it truly means to be a healthcare provider goes beyond knowledge acquisition and education for pharmacy students; it demands a transformative journey of professional identity formation (PIF) starting even before introductory pharmacy practice experiences (IPPE) (perhaps with acceptance into a pharmacy program or during professionalism ceremonies) and continuing past graduation and over an entire career. As the introduction hints, preceptors must distinguish between education, professionalism, and professional identity. A quick way to differentiate between the latter two is that a student’s professionalism is outwardly observable. Professional identity, however, is defined by a student’s internal thinking, feeling, and acting like a member of the pharmacy profession and its community.1

         

        Pharmacists can use their extensive, science-based education to assume many professional identities; they may work in community, hospital, health-system, research, information technology, marketing, or a vast number of other positions. Viewing the history of the profession in just the last century, various identities have accumulated (rather than shifted) over time.2 The typical pharmacist’s main responsibility was once compounding. As the industrial revolution made it possible to produce dosage forms en masse, compounding fell out of favor and dispensing manufactured products became the primary focus of a typical pharmacist. Within just the last 20 years, pharmacists have made major inroads into establishing their role as necessary health care professionals rather than just retailers.3 Pharmacists have been shown to be key in improving therapeutic outcomes with a new focus on patient focused intervention.4 Pharmacists’ employment opportunities are growing and adapting to a changing field but the profession’s fundamental or core values are somewhat fixed. Table 1 lists the pharmacy profession’s current core values as promulgate by the American Pharmacists Association.

         

        Table 1. The Pharmacist’s Core Values5,6

        Commitment to the patient’s well-being ·       Engage in shared decision making and respect patients’ right to self determination

        ·       Protect patient life and aim for best outcomes

        Pharmaceutical expertise ·       Maintain competence in knowledge and abilities to ensure the safe and effective use of medication
        Reliability and care ·       Find balance between risk and benefit in treatments

        ·       Maintain trust and confidentiality with patients

        ·       Collaborate reliably with other healthcare professionals to ensure best health outcomes

        Social responsibility ·       Act with honesty and integrity in professional relationships

        ·       Avoid discrimination and seek healthcare equity in society

         

        PAUSE AND PONDER: Look at Table 1. What other values would you add to the table?

         

        As the profession’s identity evolves, pharmacists’ identities and their core values must follow suit. While pharmacists must be lifelong learners and adapt over time to new conditions, change is most readily achieved in the initial learning process as pharmacy students. In other words, you can teach old dogs new tricks, but it’s easier to teach puppies. In class, faculty teach students information a pharmacist should know and address how to outwardly act like a professional, but the profession demands something more: the development of a professional identity. We rely on our community of pharmacist preceptors to augment the various didactic courses to cultivate new pharmacist graduates who identify strongly with our core values.

         

        PIF is a crucial aspect of pharmacy experiential education. Students require experiential learning and immersion into the profession to assimilate the qualities that make pharmacists unique and different from other healthcare providers. The Accreditation Council for Pharmacy Education (ACPE)-required IPPE rotations provide students with important opportunities to influence PIF, and the PIF process continues during a student’s advanced pharmacy practice experiences (APPE).7

         

        The Pharmacy Student’s IPPE Rotation

        IPPE rotations serve a much broader purpose than students fulfilling educational requirements and completing dreaded 50-page workbooks that some schools use that aim to help them reflect on or consolidate learning. IPPE rotations should introduce students to the way front line pharmacists navigate real-world pharmacy practice situations. Students primarily relegated to counting pills and organizing stock in the back of a pharmacy are unlikely to develop professional identities. If students perceive that preceptors think of them as free labor or burdensome obligations, they will not engage in the deeper discussions about the preceptor as a person fulfilling professional obligations. Students should observe and actively take part in various aspects of the profession, applying theoretical knowledge acquired in classrooms to real-world situations. Practical knowledge gained through these experiences helps students to develop essential professional skills and test their learning.

         

        Experiential learning rotations should also expose students to different types of pharmacist positions and responsibilities. By observing different practice settings and interacting with pharmacists, patients, and other healthcare professionals, students can explore their interests, while realizing their strengths and developing professional values.

         

        Step-by-Step to Professional Identity

        Throughout pharmacy education, faculty members encourage students to exhibit professionalism; they may

        • suggest more productive ways to present ideas
        • prompt students to elevate or refine language or speak in ways patients will understand, or
        • suggest that certain clothing choices can diminish peoples’ view of them and their credibility

         

        While classroom faculty can teach and model the concept of professionalism, preceptors have the responsibility of supporting students in their PIF journey. Teaching starts the learning process; ultimately, students will need to “create their own adventures.” In other words, they must learn to apply aspects of specific material and explore different experiences to develop a professional identity. Relating to the definition of PIF, a pharmacy student’s PIF process must involve thinking, feeling, and acting like a pharmacist.

         

        To discuss professional identity, preceptors and all pharmacists who influence the student’s learning process must acknowledge the steps inherent in PIF. Personal identity is based on an individual’s concept of who they are and how others perceive them.7 Individuals develop personal identity in stages starting at birth but personal identity begins at birth and continues throughout life. Professional identity develops in a similar but slightly different way.

         

        Robert Kegan, a Harvard psychologist, developed a framework for longitudinal development of the self into a moral meaning-making entity that has had lasting impact on PIF in education of professionals.3,8-10 His framework includes six stages with stage 0 beginning at birth. Stages 0 and 1 concern young children’s development of basic motor function and sensing the physical world around them (and are not discussed here).8

         

        In relation to PIF, the health professional must pass through at least stages 2 through 4 of the framework: imperial, interpersonal, and institutional.10 This framework, with steps 2 through 5 shown in Table 2, defines the personal characteristics and related professional context of an individual in continuous stages of development. Individuals who reach the final stage, stage 5, or the inter-individual self-transforming stage, open themselves to multiple identities and other value systems, achieving full personal autonomy.8 Research shows that not all individuals reach stage 5.10,11 However, with effective socialization partnered with experience in the pharmacist’s potential identities, students may reach this level during their careers.

         

        Table 2. Kegan’s Stages of Personal and Professional Identity Development­8,10

        Stage Personal characteristics Professional context
        2. Imperial Individuals put their own needs and interests first but consider other people’s views. Individuals fill their professional roles but do so with a primary motivation of following rules. Individuals exhibit low self-reflection and may struggle to balance emotions with reason.
        3. Interpersonal Individuals are concerned with others’ perceptions of them and able to reduce focus on self-interest. Individuals balance multiple perspectives simultaneously. Individuals are idealistic and self-reflective, seeking others to guide them. Individuals manage emotions acceptably and generally understand right and wrong.
        4. Institutional Individuals assess relationships with a focus on self-defined principles and standards. Individuals define themself independently of others. Individuals can understand relationships by appreciating different values and expectations. They internalize professional values and do not allow emotion relating to needs, desires, and passion to gain control over reason.
        5. Self-transforming Individuals reconcile contradictory or paradoxical ways of constructing meaning. They can recognize the interdependencies of different systems or ways of thinking. The self-transforming professional has a strong sense of self but also relies upon others knowledge and opinion in professional development. The professional integrates other identities into the total professional identity.

         

         

        The constantly evolving pharmacy profession and the lack of a specific list of steps for PIF makes it challenging for students to define an identity (and preceptors to help them). As the profession continues to develop to offer a wide range of opportunities for pharmacists, preceptors will observe students finding varying paths of PIF. Different pharmacists will define the profession differently depending on their experiences. Pharmacy students might generally navigate this list of steps, common among many young people developing professionally12-15:

         

        1. Exploration: In any career path, exploration is the first step in PIF. In pharmacy, the American Pharmacists Association offers the Career Pathway Evaluation (https://www.pharmacist.com/Career/Career-Pathways) to help aspiring pharmacists find a path forward. IPPE and APPE rotations should ideally provide students with opportunities to explore various pharmacy practice settings and work with pharmacists with a range of responsibilities. Students need to augment their existing identities—formed by their upbringing and personal beliefs—as they begin their pharmacy education and careers. Students come from diverse backgrounds with varying past experiences, cultural values, learning styles, and personal characteristics.
        2. Reflection and integration: Educators should encourage students to reflect on their experiences, strengths, values, and areas for improvement. Reflection helps students align personal and professional values, shaping their professional identities. Self-reflection and reflection from preceptors during IPPE rotations is necessary for growth. For example, a technician told Jayne, a pharmacist for a chain pharmacy, that a patient was in the counseling room and ready for an immunization. Jayne took her student with her to observe. Jayne asked the student to review the necessary paperwork and make sure the patient, a 17-year-old adolescent, met all the criteria for the human papilloma virus vaccine. The student said he did. When Jayne reviewed the paperwork, she found one problem. She asked the patient, “Which of your parents is here with you today?” In Jayne’s state, the legal age of consent was 18. When contacted by phone, the parent agreed to come in immediately and Jayne administered the vaccination. After all was done, she spent just a few minutes talking to the student about the duty to protect and comply with the law, describing a couple of other instances when she encountered similar situations.
        3. Commitment and advocacy: Commitment to the pharmacy profession and dedication to lifelong learning are essential elements in the development of a professional identity. Pharmacy students will become spokespeople for the profession and advocate for the inevitable change from retail-based to clinically- or service-based work. Pharmacists with solid professional identities will be lifelong learners and educators.

         

        Students who have never worked in a pharmacy or observed a pharmacist at work (and some who have) may have inaccurate ideas about the profession. Preceptor Eddie encountered a curious situation when Adam, a P2 student, reported for an IPPE rotation. Adam was more than self-assured; Adam had an exaggerated sense of self-worth. He was bumptious (self-important or smug), so Eddie needed to work around Adam’s personal identity. Adam told Eddie that his older brother was a pharmacist who had told him that pharmacy schooling is pretty worthless. Adam said, “All you need to do is pass and you’re on your way to a darned good salary.” Eddie was astounded. Adam needed help reaching Step 2 of the PIF model—he was putting his own needs and beliefs first and disregarding others’ views. Eddie created a plan to help Adam develop more insight.

         

        Each day when Adam came to work, Eddie presented two or three situations from his work experience that required more than just a body behind a computer. He would ask Adam to work through the problems and present the answers by the end of the day. In this way, he educated Adam about professional responsibility and clarified the difference between a person with a pharmacy degree and an exceptional pharmacist. PIF’s goal is for students to move from playing or imagining the pharmacist’s role to internalizing the pharmacist’s identity and acting as pharmacists at the unconscious level. The process shifts emphasis from ‘doing’ to ‘being.’ While professionalism can be put on and taken off like a white coat, professional identity stays with the healthcare professional at all times. Eddie was able to improve Adam’s professionalism, which was poor at the rotations start, and contribute to Adam’s professional identity.

         

        PAUSE AND PONDER: When you were a student, which preceptors influenced your core values and how did you internalize them?

         

        Activities that Develop Professional Identity

        Preceptors who work in different types of positions need to acknowledge their personal and professional strengths and limitations to determine what they can realistically offer to students. Before taking on the preceptor’s or mentor’s responsibilities, professionals must be familiar with their own skillsets.7,14

        • The first step preceptors should take is to embrace self-reflection. Just as preceptors should encourage students to engage in reflective practice, pharmacy is a profession in which preceptors must be lifelong learners. Established pharmacists will continue to accumulate PIF-related experiences over time to aid their effectiveness in guiding others.
        • Preceptors will then need to plan intentionally and commit to helping students develop professional identity. A reluctant or unprepared preceptor usually cannot teach students effectively. Sometimes pharmacists with extensive work experience on the frontlines might feel that students come with a more contemporary knowledge base and therefore, they have nothing to teach them. However, that pharmacist could be well-positioned to support the student’s PIF by embracing how their professional experiences led to a deeper understanding of their profession and the pharmacist’s role in supporting patient outcomes.

         

        PAUSE AND PONDER: What are the most efficient ways to help your students develop professional identity in your practice location? What are the most important ideas you can teach? Are they the same?

         

        PIF is a gradual process that revolves around socialization, not classroom lecture. IPPE rotations provide an ideal platform for students to engage in activities that promote professional development. Preceptors can work with students to facilitate PIF during an IPPE rotation in several ways. 7,16,17

         

        Patient interactions: Direct patient interaction during IPPE can help students apply theoretical learning and develop communication skills, empathy, and a patient-centered approach to care. These experiences help students internalize a sense of responsibility toward patient well-being and strengthen trust in the caregiver-patient relationship.

         

        Preceptors should expose students to patient counseling sessions as observers as often as possible. Consider Leonard, a preceptor who frequently tells students, “I am not going to bring you into this counseling session because it is too complicated. You won’t understand what’s going on.” This is a mistake. IPPE is an opportunity for students to be exposed to difficult real-life examples before they have to handle them alone. These experiences help develop professional identity and may even stimulate an “ah-HA!” moment about pharmacist responsibility for the student. Preceptors who ask students a few open-ended questions (e.g., What did you see that surprised you? What three points did I emphasize? What counseling techniques will you remember from this?) prompt students to engage. Inviting students to see a situation that requires pharmacists to work at the top of their license introduces step 4 (institutional)  and epitomizes PIF. Leonard has the opportunity to show his version of an independent and talented pharmacist who contributes to healthcare positively.

         

        PIF opportunities need not be complicated. Sometimes PIF occurs concurrent with simple everyday tasks. Preceptors who walk students through their thought process when processing an order (i.e., Why does this document go here in the electronic medical record? Why am I looking at that lab before processing the order?) introduce students to the necessity of questioning routinely as a professional function. They can also ask students to find or calculate doses, explore drug interactions, and then provide the information to another interdisciplinary team member.

         

        Not all patient interactions are pleasant or welcome, but they may be professionally necessary. Alex, the pharmacist, was dismayed when a technician came to him and said, “Mrs. Royce is here and wants to talk to you,” while rolling her eyes. Mrs. Royce was notorious for being loud, disrespectful, and a know-it-all. Alex didn’t answer immediately. The technician said, “Shall I tell her you are busy?” Alex said he would talk to her and briefed the IPPE student on Mrs. Royce’s personality. He said he was concerned because Mrs. Royce had recently had surgery, had a reaction to the opioid that was prescribed, and was switched to tramadol. He explained that regardless of his personal feelings, he needed to deal with the situation. When he asked Mrs. Royce how he could help her, she said, “The oxycodone made me sick as a dog. My friend up the street who is a nurse says the tramadol I am taking now is not worth anything. I am taking it and it is super mild but at least it’s something. I have an anti-inflammatory, too. I know this is a first-world problem since this was an elective surgery, so I should not complain. I am just a whiner with pain.” Alex reassured her that no one deserves pain, even if the surgery was elective. Alex counseled the patient with these points18-20:

        • Tramadol is a funny drug. People with certain genetic variations called CYP2D6 deficiencies get less relief from it. It gets a bad reputation because many clinicians don't know that. Take it if it helps. And it sounds like it helps a bit.
        • Schedule your anti-inflammatory around the clock. Don't wait until the pain is horrible. Take it every four to six hours for a few days. Eat a little something when you take it.
        • Use warm or cold compresses if they help but use them only for 10 minutes at a time once every hour. (You don't want to fry or freeze your skin.) If warm helps, use warm. If cold helps, use cold.
        • Move around as much as you can. It increases blood flow to the area.
        • Have you tried some acetaminophen? Some people find that taking a couple of acetaminophen once or twice a day for a couple of days helps--it won't address the inflammation but it may help with pain.
        • Consider finding an acupuncturist and/or a massage therapist who specializes in pain.

        After the session, Alex explained that dealing with patients like Mrs. Royce is an obligation, as is not showing whether he likes her. This attitude aligns with the “interpersonal” step of PIF (step 3)—balancing multiple perspectives and putting others’ needs first. He said that all pharmacists encounter difficult patients. He also said that he planned to check in on her by phone the next day. He asked the student if anything surprised her, and she said, “Yes. You didn’t say anything about the nurse’s bad advice!” Alex explained that professionals don’t speak badly of each other, especially when the information from Mrs. Royce was hearsay. He said he trusts that Mrs. Royce, the consummate know-it-all, will talk to the nurse and the nurse will call if she wants more information. The student was able to teach-back the key points of professional identity:

        • Treat all patients with respect, even when they don’t return the favor
        • Counsel carefully
        • Do not disparage other healthcare providers (talk to them directly if you have a concern about their advice)
        • Follow-up.

        When the student asked this preceptor for a letter of reference several months later, the preceptor said, “Remember Mrs. Royce? Her attitude is entirely different now. She’s kind and respectful when she comes in.”

         

        Collaborative Practice: Preceptors can highlight interdisciplinary healthcare experiences, demonstrating teamwork, collaboration, and the ability to contribute effectively within a healthcare setting. In a health system setting, for example, many different pharmacists work in the same organization with varying responsibilities. A health system may include an inpatient and outpatient, specialized clinical, emergency department, investigational drug service, and oncology pharmacy. Each position requires modified professional identities and collaboration with different healthcare professionals. A preceptor can join forces with other pharmacists—a model that is increasingly popular and often called team precepting—to ensure students receive a well-rounded education in the short period of time provided.

         

        Exposure to eustress (healthy, stimulating kind and level of stress): A preceptor should take the time to facilitate a learning environment that optimizes the likelihood that PIF will occur. Preceptors can discuss situations that present ethical dilemmas during IPPE rotations, prompting critical thinking, ethical decision-making, and the development of moral reasoning. As students are exposed to common ethical dilemmas, they will begin to develop problem solving skills; build confidence; and think, act, and feel like pharmacists. Students who have not yet assimilated the second step of PIF—the imperial—may be more concerned with packing up to leave at their assigned quitting time than finishing a task. Helping students learn that sometimes the clock should not dictate decisions also develops professional identity.

         

        Exposure to unanticipated, stressful misadventure. Marguerite was precepting a student when a technician came behind the bench with arms raised and a robber holding a gun behind her. The four other employees and the student froze, and Marguerite handled the situation, emptying the vault into the robber’s duffel bag. After the robbery, everyone was shaken but no one was hurt. Although the store manager’s opinion was to send the student home, Marguerite insisted on a post-incident stress debriefing. It gave everyone the opportunity to vent and identify what they did well and what they could do better, and reduced the likelihood of post-incident stress.21 As they met, the police returned and said they had apprehended the robber because Marguerite had placed a tracking device in the duffel bag. Marguerite has traversed all the steps of PIF. She considered others in her decisions, balanced multiple perspectives, and maintained her standards.

         

        Although this is an extreme example that underscores the meaning of “unanticipated,” the student reported feeling better and understanding more about the pharmacist’s responsibilities. Other unanticipated events that can convey PIF include dealing with irrationally irate customers, diffusing the situation with a vaccine refuser who wants to espouse her opinion loudly to other patients, or dealing with a patient or employee medical emergency in the workplace. Appropriate and deliberate use of emotion can also focus learners and enhance learning, especially when the material is moving or highlights the patient’s perspective. Preceptors should employ emotion as a teaching tool carefully, since negative emotion (e.g., anger, embarrassment) erodes trust and can disenfranchise students.

         

        Professional involvement: If time allows, preceptors can encourage students to engage with professional organizations. Attending conferences, workshops, state pharmacy board meetings, or seminars that promote professional growth, networking, and exposure to current trends in the pharmacy field builds professional identity. Preceptor Eddie, discussed previously, took Adam to a Board of Pharmacy meeting. Adam seemed uninterested until the Board discussed disciplinary action against a pharmacist who had failed to perform due diligence, leading to a patient’s death and a pharmacist with a drug abuse problem. Adam was less bumptious in the car on the way back to work, and Eddie took time to ask open-ended questions to mold Adam’s professional identity. He asked, “What questions do you have for me?” Adam said, “What is the chance they will get their licenses back?” It created a chance to talk about professional responsibilities and how state boards monitor and ensure public safety. Eddie asked a question of his own “What do you think the patients who experienced poor care or unprofessional behavior from those pharmacists think about the profession of pharmacy? In the world of social media, how far do you think those negative sentiments about pharmacists can spread?" This discussion moved Adam further through Step 2, and away from a preoccupation with self-interest.

         

        Formative feedback (feedback that helps students recognize knowledge gaps and molds the student’s beliefs and values; see the SIDEBAR) and encourage reflection. Preceptors should7

        • Provide students with regular feedback, but also schedule time for check-ins and reviews mid-rotation. As students’ professional identities develop, they will become their own sources of feedback.
        • Employ teaching methods such as using teach-back and open-ended questions.
        • Schedule time for students to work on workbooks or other tools for reflection and encourage discussion and questions.
        • Assign meaningful work to help students integrate ethical principles, evidence-based practice, effective communication, and patient-centered care.

         

         

        SIDEBAR: Formative Feedback22,23

        Formative feedback

        • refers to informal constructive feedback provided throughout a learning process
        • is ongoing and proactive
        • is specific and actionable
        • helps to develop self-awareness and independence
        • gives students the opportunity to reflect and adjust without being graded
        • and is not summative feedback (a method of assessment where students are evaluated and/or graded on their overall performance usually at the end of a learning period)

         

        Open ended questions are important in formative feedback. Just as healthcare professionals are encouraged to ask patients open-ended questions, preceptors should do the same with their students. Open-ended questions

        • give students the opportunity to participate in discussion actively and gain a deeper understanding of a topic or situation
        • can help the preceptor identify gaps in a student’s understanding
        • develop students’ critical thinking skills and autonomy to further their PIF
        • are especially useful after patient counseling or other interaction.

         

        Teach-back, or the "show-me" method, confirms whether a person—a patient or in this case, a student—understands the topic being explained. Pharmacists and other healthcare providers use the teach-back in patient counseling to facilitate better communication between patient and provider. This tool allows a healthcare provider to assess patient understanding by having a patient explain, or teach-back, what they took away from the counseling session. The healthcare provider can gently correct misunderstandings. Using teach-back with students is especially effective when

        • Students observe a complicated counseling session or process
        • Students are learning about a new medical device or a medication with an unusual administration route or schedule
        • Students need to research a topic that is new to them and may have missed some critical information
        • Students witness a situation that is emotionally charged or creates a safety concern

         

         

        Demonstrating vulnerability. Preceptors often want to hide their deficiencies, limitations, or weaknesses from students so students will have greater confidence in the preceptor’s expertise. Students need to see how mistakes happen and lead to improvement. They also need to see the ethical challenges that are inherent in pharmacy practice. Preceptor Terry received a phone call from a pharmacist who worked at another of her chain’s locations. She knew the pharmacist quite well, and the pharmacist said she had received a prescription for a patient well known to them for hydromorphone 8 milligrams. They were out of hydromorphone and the pharmacist asked if Terry had any 8 milligram tablets. Terry said she did, and the pharmacist said she would send the patient over and to expect him within 30 minutes. When the patient arrived, Terry filled the prescription and being alone with just the IPPE student, prepared to dispense it at the cash register. As required by law, she asked the patient for identification. Much to her surprise, the person presented his driver’s license and he was not the patient. In fact, the identification card was for the prescriber who had written the prescription, a medical resident at a local hospital. She asked the prescriber why he was picking up the prescription and he said that he was helping out the patient who was in terrible pain. It was late in the day, and Terry had received this referral from a colleague who she trusted. She dispensed the prescription despite her misgivings.

         

        The next day when the IPPE student arrived, Terry explained the immediacy of the situation and conflicting professional interests led to dispensing the prescription yesterday, but she still had some nagging doubts. With the prescription volume a bit slower now, she decided to do some follow up. She found that the “patient” had a number of prescriptions filled over months, most of which were filled at her colleague’s pharmacy. However, the initial prescriptions were filled in a town 40 miles away. She eventually called the hospital, found the name of the residents’ supervising physician, and contacted him. After brief discussion, he indicated that he would handle it going forward and that he appreciated the information. Although the supervising physician did not say outright that he suspected this resident of wrongdoing, the implication was that was the case. The supervising physician did follow through and eventually, the state requested documentation. Terry was able to talk through the situation with the student and explain the pharmacist's responsibility in cases like this. Terry exemplifies Step 4 of PIF. She was secure in her identity and despite the way others had handled this situation, she was concerned and confident enough to do the right thing.

         

        Teach-back is useful in many situations, but especially when processes are involved. In one busy pharmacy, a man approached the pharmacy student at counter. He said, “Can I get a shingles vaccine today?” The student, having no prior experience in a community pharmacy, politely asked the patient to wait while she asked the pharmacist. Her preceptor said quickly, “Get the patient’s insurance information and enter him into the system.” With the patient’s insurance card in hand, she began to enter his information. Unsure how to proceed, she asked the pharmacist for assistance again. A line began to form behind the man, so the pharmacist said, “Don’t worry, I’ll do it and you can watch.” The intern watched and thought the process looked easy enough. The pharmacist asked if she understands (a close-ended question), and she said yes. Later in the day, a new patient came in and the student began to enter the patient’s insurance information. She hit a point where she was unsure how to continue. But earlier she told her preceptor that she understood how to do it! She really thought she did know how! The student, becoming flustered, was embarrassed to ask for help again on something she had just learned. How could this situation have been avoided? If the preceptor had asked the student to describe the process, correcting any inaccuracies in recollection, and explained why pharmacies need to provide accurate information, the student would have been in a better position to help.

         

        Overall, preceptors need to provide students with the best experience possible with available time and resources. For example, a student may be in a health systems rotation in a department that has little patient interaction and plenty of down time. The preceptor may worry he cannot give the student the experience she deserves. This preceptor could assign the student to review a journal article on a relevant subject and present it to an interprofessional team of nurses, pharmacists, and doctors. Subsequently, the student may realize the pharmacist’s potential impact and help the student internalize what it means to be a pharmacist.

         

        PAUSE AND PONDER: Can you recall a time when you were taught how to do something, told your teacher you understood it, then could not perform the action on your own? As a preceptor, how would you avoid this situation with your own student?

         

        Finally, let's return to the questions asked at the beginning of this continuing education activity. In particular, the question of whether a pharmacist can be a good employee, but a bad pharmacist, is of tremendous interest right now. The situation it brings to mind is that of the good employee pharmacist whose supervisors urge him to dispense opioid prescriptions as written and avoid asking too many questions. Doing so makes customers happy, increases prescription volume, and reflects positively in the store’s metrics. Many pharmacists conducted themselves this way for many years, despite the fact that they probably had an inkling that they should be checking more closely or perhaps turning some prescriptions away. These pharmacists were not necessarily bad pharmacists, but their employers considered them good employees because they followed directions and turned a blind eye to a developing opioid epidemic.

         

        In November 2021, a federal jury in Ohio found three of the nation's largest pharmacy chains liable for contributing to the U.S. opioid crisis.24,25 The jury found that the prosecution provided ample evidence that some medications dispensed at chain pharmacies legally were sold on the black market. That finding has resonated nationally as state after state filed similar lawsuits. In December of 2022, two chain pharmacies agreed to share a $10.7 billion fine to settle allegations that they failed to oversee opioid analgesic prescriptions adequately. These funds are being distributed to states, local governments, and federally recognized tribes to improve opioid crisis abatement and remediation programs. Both chains agreed to improve their controlled substance compliance programs and provide mandatory training to pharmacists. Expediency in the short term and compliance with procedures that are unethical seldom avoid long term consequences.

         

        Other states have also secured settlements from pharmacies, and independent pharmacies have also been prosecuted. Discussing situations related to pharmacy that appear in the media is another way that preceptors can introduce discussion of our professional values. The nation is hopeful that pharmacists everywhere have learned that part of our professional identity is the necessity to speak up and to challenge our employers when they ask us to do things that walk the line of professionally ethical behaviors. Starting discussions with students about newsworthy events like this in which preceptors talk about self-interest, other people’s perception of pharmacy and pharmacists, and maintaining standards can advance our profession. Pharmacists are part of a complex system of drug distribution. We need to establish our core values and uphold them to keep society’s respect.

         

        CONCLUSION

        Pharmacy educators, preceptors, and mentors must realize the significance of IPPE and APPE rotations and their influence in shaping future pharmacists’ professional identities. Professional identity formation is essential for students’ transformation into successful and compassionate pharmacists. IPPE rotations with effective preceptors enable students to observe, participate, and reflect on various aspects of pharmacy practice. Often these exercises take very little time, and small actions can have tremendous impact. Through exploration, reflection, and commitment to the profession, students can develop professional identities that align with the core values and beliefs of the pharmacy profession and their own personal values.

         

        As students grow throughout their educational and professional careers, they will internalize what it means to be a pharmacist. Changes may not be apparent in the short amount of time a preceptor is with a student. If students are comfortable with the idea, preceptors can connect with them on LinkedIn, stay in contact through email, and be open to being a mentor to the student after the rotation ends. Pharmacy is a profession of many interconnected individuals with unique and valuable professional identities.

         

         

        Pharmacist Post Test (for viewing only)

        Who are you? Who are We? Professional Identity in Experiential Learning

        Post-test

        After competing this continuing education activity, preceptors will be able to
        ● Describe professional identify formation
        ● Apply the steps in development of a professional identity
        ● Identify activities that develop professional identity appropriately

        1. Lyle is a preceptor whose student arrives to work wearing a tee shirt with a silly slogan on it, a ball cap, and brightly colored foam clogs. The student puts on a wrinkled and somewhat dirty white coat and steps out behind the register to start helping patients in the line. What is Lyle’s main concern with regard to this student?
        A. Professionalism
        B. Cleanliness
        C. Professional identity

        2. As the end of the day approaches, a prescriber calls in a set of prescriptions for a child who has a serious infection. Lyle assigns his student to check the dosing. The student asks if he can do the task tomorrow morning, as it's late and he'd like to head home for dinner. He also says that the prescriber probably double checked her own work. What is the BEST way for Lyle to explain the importance of completing the task today?
        A. Explaining that one never knows when a patient will arrive to pick up prescriptions and how that reflects on the pharmacy staff. He is trying to help develop the student’s professionalism.
        B. Explaining that most prescribers rarely double check their own work so the pharmacy needs to do it before the prescriber leaves for the day. This encourages professional identity formation.
        C. Explaining that pharmacists have a duty to be diligent about medication doses, especially in pediatric patients. This should contribute to the student’s professional identity formation.

        3. Mr. Walker, a patient who has successfully overcome an addiction to heroin, presents a prescription for oxycodone after having dental work. He wants to talk to the pharmacist, and you invite your student to join you. Mr. Walker asks if the prescription is for an addictive substance and says that the dentist never asked if he had a current or previous addiction problem. He would like you to call the dentist and have the prescription changed. You agree, and when you return to the pharmacy, your student asks, “Why don't you have him call the dentist himself? We're really busy.” What part of the pharmacist core values should you discuss with this student?
        A. Pharmaceutical expertise
        B. Commitment to the patient’s well-being
        C. Social responsibility

        4. Which of the following describes Step 2 in Kegan’s Stages of Personal and Professional Identity Development?
        A. A student's primary concern is understanding others’ values and expectations.
        B. A student's primary concern is ensuring the team approves of her work.
        C. A student’s primary concern is in learning and following the rules of dispensing.

        5. Which of the following accurately represents the sequence in which students can be expected to develop professional identity?
        A. Learning the rules of pharmacy; learning to differentiate between right and wrong and working with other team members; removing emotion and using reason to make decisions
        B. Learning to differentiate between right and wrong and work with other team members; removing emotion and using reason to make decisions; learning the rules of pharmacy
        C. Removing emotion and using reason to make decisions; learning the rules of pharmacy; learning to differentiate between right and wrong and work with other team members

        6. Which of the following accurately describes PIF opportunities in the pharmacy?
        A. Preceptors who take IPPE students should use the simplest of examples to help students with PIF because students have little experience.
        B. Preceptors should concentrate on situations that are complex so that students see pharmacists practicing at the top of their licenses.
        C. Preceptors can use simple everyday tasks to help students understand the pharmacist's role and develop their professional identities.

        7. Which of the following activities would be MOST appropriate for an IPPE student who has never worked in a pharmacy with regard to professional identity formation?
        A. Having the student observe a controlled substance inventory and asking questions like, “Why do you think we conduct an inventory every day? What would we do if we found a discrepancy?”
        B. Having the student observe a technician who is running the cash register and coaching the technician to ask questions like, “Do you have any experience running a cash register or dealing with customers?”
        C. Having the student restock the OTC section of the pharmacy and make a list of OTCs that need to be ordered, and asking the student to justify her reasons for ordering the various drugs and the quantity she designates.

        8. Which of the following activities is MORE appropriate for an APPE student than an IPPE student to develop professional identity?
        A. Reviewing the case of a patient with drug resistant tuberculosis and several drug allergies and presenting the case on medical rounds with physicians and nurses
        B. Checking that the dose of amoxicillin for a 5-year-old child who weighs 36 pounds is correct and that the child has no allergy to penicillin antibiotics
        C. Asking the student to shadow you while you provide counseling to a patient who has a question about OTC cough and cold formulations

        9. A new IPPE student has a casual attitude about pharmacy and expresses opinions that indicate that she knows very little about professional responsibilities. Several times and despite gentle correction, she has counted controlled substances incorrectly and returned control substance bottles to the regular shelves, not the vault. Which of the following activities might increase her awareness of the pharmacist’s responsibilities and legal obligations?
        A. Having the student accompany you to your state’s Board of Pharmacy meeting
        B. Abandoning formative feedback and pointing out the student’s errors forcefully
        C. Restricting this student’s activity to handling the front end of the store only

        10. Your state announces that it will now impose significant restrictions on all prescriptions for a certain drug because of a growing number of patient deaths related to its abuse. During the morning huddle, your staff discusses the increased paperwork burden and the potential that patients will be upset. After the huddle, the student asks, “Why is this our problem? Shouldn't this be handled by the drug’s manufacturer?” What is the best answer?
        A. Technically pharmacists are nothing more than the medication police. Our job is to enforce the rules other create strictly and unemotionally.
        B. In an ideal world, pharmaceutical companies would take complete responsibility for the damage their drugs do. This is not an ideal world.
        C. Pharmacists are part of a complex system of drug distribution. We need to establish our core values and uphold them to keep society’s respect.

        References

        Full List of References

        REFERENCES
        1. Larose-Pierre M, Cleven AJ, Renaud A, et al. Reevaluating core elements of emotional intelligence in professional identity formation for inclusion in Pharmacy Education. American Journal of Pharmaceutical Education. 2023;87(6):100082. doi:10.1016/j.ajpe.2023.100082
        2. Kellar J, Paradis E, van der Vleuten CPM, oude Egbrink MGA, Austin Z. A historical discourse analysis of Pharmacist Identity in Pharmacy Education. American Journal of Pharmaceutical Education. 2020;84(9). doi:10.5688/ajpe7864
        3. Jarvis‐Selinger, S., Pratt, D.D., and Regehr, G. (2012). Competency is not enough: integrating identity formation into the medical education discourse. Academic Medicine 87: 1185
        4. Toklu HZ, Hussain A. The changing face of pharmacy practice and the need for a new model of pharmacy education. J Young Pharm. 2013;5(2):38-40. doi:10.1016/j.jyp.2012.09.001
        5. Kruijtbosch M, Göttgens-Jansen W, Floor-Schreudering A, van Leeuwen E, Bouvy ML. Moral dilemmas reflect professional core values of pharmacists in community pharmacy. Int J Pharm Pract. 2019;27(2):140-148. doi:10.1111/ijpp.12490
        6. https://www.ashp.org/-/media/assets/policy-guidelines/docs/endorsed-documents/code-of-ethics-for-pharmacists.ashx
        7. Johnson JL, Arif S, Bloom TJ, Isaacs AN, Moseley LE, Janke KK. Preparing pharmacy educators as expedition guides to support professional identity formation in Pharmacy Education. American Journal of Pharmaceutical Education. 2023;87(1). doi:10.5688/ajpe8944
        8. Kegan, R. (1982). The Evolving Self: Problem and Process in Human Development. Cambridge, MA: Harvard University Press
        9. Irby, D.M. and Hamstra, S.J. (2016). Parting the clouds: three professionalism frameworks in medical education. Academic Medicine 91: 1606–1611
        10. Swanwick T, Forrest K, O’Brien BC, Cruess RL, Cruess SR. The Development of Professional Identity. In: Understanding Medical Education: Evidence, Theory and Practice. Wiley-Blackwell; 2019:239-254.
        11. Hafferty, F.W. (2016). Professionalism and the socialization of medical students. In: Teaching Medical Professionalism (ed. R.L. Cruess, S.R. Cruess and Y. Steinert), 54–68. Cambridge: Cambridge University Press.
        12. Briceland LL, Martinez T. Exploring the impact of reflecting upon pharmacy experts’ written career guidance on Student Professional Identity Formation. INNOVATIONS in pharmacy. 2022;13(3):5. doi:10.24926/iip.v13i3.4778
        13. Arnoldi J, Kempland M, Newman K. Assessing student reflections of significant professional identity experiences. Currents in Pharmacy Teaching and Learning. 2022;14(12):1478-1486. doi:10.1016/j.cptl.2022.10.003
        14. Janke KK, Bloom TJ, Boyce EG, et al. A pathway to professional identity formation: Report of the 2020-2021 AACP student affairs standing committee. American Journal of Pharmaceutical Education. 2021;85(10). doi:10.5688/ajpe8714
        15. Luyckx K, Goossens L, Soenens B, Beyers W. Unpacking commitment and exploration: Preliminary validation of an integrative model of late adolescent identity formation. Journal of Adolescence. 2005;29(3):361-378. doi:10.1016/j.adolescence.2005.03.008

        16. AFPC Educational Outcomes for First Professional Degree Programs in Pharmacy in Canada 2017. Association of Faculties of Pharmacy of Canada. Accessed August 26, 2023. http://www.afpc.info/system/files/public/AFPC-educational%20Outcomes%202017_final%20Jun2017.pdf
        17. Elnicki DM. Learning with emotion: which emotions and learning what? Acad Med 2010;85:1111.
        18. Poulsen L, Brosen K, Arendt-Nielsen L, et al. Codeine and morphine in extensive and poor metabolizers of sparteine:pharmacokinetics, analgesic effect and side effects. Eur J Clin Pharmacol. 1996. 51(3-4): 289-295.
        19. Caraco Y, Sheller J, and Wood AJ. Pharmacogenetic determination of the effects of codeine and prediction of drug interactions. J Pharmacol Exp Ther. 1996. 278: 1165-1174.
        20. Lalovic B, Phillips B, Resler LL, et al. Quantitative contribution of CYP2D6 & CYP3A4 to oxycodone metabolism in human liver and intestinal microsomes. Drug Metab Dispos. 2004. 32: 447-454.
        21. Campfield KM, Hills AM. Effect of timing of critical incident stress debriefing (CISD) on posttraumatic symptoms. J Trauma Stress. 2001;14(2):327-340. doi:10.1023/A:1011117018705
        22. Formative Assessment and Feedback. Stanford | Teaching Commons. Accessed August 16, 2023. https://teachingcommons.stanford.edu/teaching-guides/foundations-course-design/feedback-and-assessment/formative-assessment-and-feedback#:~:text=Formative%20feedback%20helps%20students%20recognize,to%20meet%20the%20course%20outcomes.
        23. Formative and Summative Feedback. Teaching@Tufts. Accessed August 6, 2023. https://sites.tufts.edu/teaching/assessment/assessment-approaches/formative-and-summative-feedback/.
        24. Mann B. 3 of America's biggest pharmacy chains have been found liable for the opioid crisis. November 23, 2023. Accessed August 16, 2023. Ohio jury holds CVS, Walgreens and Walmart liable for opioid crisis : NPR
        25. Wile R. CVS and Walgreens to pay a combined $10.7 billion settlement for alleged opioid prescription lapses. December 12, 2022. Accessed August 16, 2023. CVS, Walgreens to pay $10.7 billion for alleged opioid prescription lapses (nbcnews.com)

        Considerations in Veterinary Compounding

        Learning Objectives

         

        After completing this application-based continuing education activity, pharmacists and pharmacy technicians will be able to

        1.     List food items which may be harmful to certain pets
        2.     Identify additives which should not be used in veterinary compounding
        3.     Discover when veterinary compounding is acceptable
        4.     Recognize federal laws pertaining to veterinary compounding
        5.     Investigate labeling requirements for veterinary compounds

         

          Watercolor cat veterinarian treating smaller cat.

           

          Release Date: October 15, 2023

          Expiration Date: October 15, 2026

          Course Fee

          Pharmacists: $7

          Pharmacy Technicians: $4

          There is no funding for this CE.

          ACPE UANs

          Pharmacist: 0009-0000-23-046-H07-P

          Pharmacy Technician: 0009-0000-23-046-H07-T

          Session Codes

          Pharmacist:  23YC46-BMX34

          Pharmacy Technician:  23YC46-XBM78

          Accreditation Hours

          2.0 hours of CE

          Accreditation Statements

          The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-047-H07-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

           

          Disclosure of Discussions of Off-label and Investigational Drug Use

          The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

          Faculty

          Laura Nolan, CPhT, CSPT
          Academic Assistant
          UConn School of Pharmacy
          Storrs, CT

          Faculty Disclosure

          In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

          Laura Nolan does not have any relationships with ineligible companies.

           

          ABSTRACT

          With an estimated 65.1 million households with dogs and another 46.5 million households with cats in the U.S., veterinary practices are booming with business. Knowing what to feed them and how to keep them well is becoming increasingly important in compounding pharmacies.

          CONTENT

          Content

          Introduction:

          For many people, pets are a major part of everyday life. They become part of their households and are like family, but like children, none of them come with true owner’s manuals. Sure, there are many books on the subject, but who do you trust? And who has the time to read all that stuff? What happens if or when they become sick or injured and need medication?

          As a somewhat reticent parent of a very large Weimaraner (OK, my husband and daughter bought him without my knowledge), I was forced to learn rather quickly about the ins and outs of pet ownership. Still, he arrived, and we needed to determine what’s best for this 99-pound dufus, who amazingly survived eating an entire box of oatmeal raisin cookies. It wasn’t pretty, but that story is reserved for an antidote CE.

          At the University of Connecticut School of Pharmacy, advanced compounding students are trained in some veterinary compounding, but most pharmacy schools do not teach it. This is a bit upsetting since people spend millions of dollars on pets every year. An estimated 65.1 million households are home to dogs and another 46.5 million households have cats in the U.S. With pet ownership comes the responsibility of caring for them. The average cost of veterinary care for a dog is $730 per year, with cats averaging $253 per year. In 2022, Americans spent $136.8 billion dollars on their pets.1

          Increasingly, pharmacy staff need to know some basics about companion animals and their health issues. Pet owners can request a paper prescription from the veterinarian and fill it at community pharmacies. The American Veterinary Medical Association (AVMA) incorporated prescription guidelines into their 1991 bylaws. It states that “a veterinarian shall honor a client's request for a prescription or veterinary feed directive in lieu of dispensing but may charge a fee for this service.”2 What do you do when a pet owner brings a prescription to your pharmacy?

          People’s perceptions about feeding human food to dogs and cats are surprising. An old wives’ tale, passed from generation to generation, tells us that dogs can eat just about anything, including bones. Most of us now know that sharp bone shards can penetrate the soft tissues at the back of the throat, they can lodge in the esophagus, or they can pierce the intestines. It is also possible for a piece of bone to lodge in the trachea (windpipe), interfering with a dog’s ability to breathe.3 The controversy still continues today, but no pet owner wants their pet to have broken teeth, mouth injuries, or intestinal blockages if they can avoid it. If cooked bones are out, what else is bad for them? Certain foods create a risk for most pets, so compounders must not use these items as ingredients in their compounds. Table 1 contains a list of some human foods that should be avoided in pets.

          Table 1. Human Foods That Should Not Be Given to Pets4

           

          Food Item Type of Pet Toxicity/Reasoning
          Alcohol Dogs, cats, chickens, rabbits Alcohol poisoning
          Tobacco Dogs, cats Nicotine
          Onions, chives, garlic (Allium family) Dogs, cats, chickens,  rabbits Sulfates, disulfides
          Avocado Dogs, cats, chickens, horses, cows, pet birds Persin
          Salt Dogs, cats, chickens Fluid imbalance
          Spicy foods Dogs G.I. upset
          Grapes, raisins Dogs, cats, rabbits Kidney failure
          Caffeine Dogs, cats, rabbits Methylxanthines
          Chocolate Dogs, cats, horses, rabbits Theobromine and caffeine
          Citrus fruits Cats, chickens Citric Acid, essential oils
          Cinnamon Dogs, cats Mouth and throat irritant
          Nutmeg Dogs, cats Myristicin
          Macadamia nuts Dogs, cats Toxicity unknown
          Mushrooms Dogs, cats Mycotoxins
          Green tomatoes, raw potatoes Dogs, cats, chickens, horses, rabbits Solanine
          Raw bread dough, raw yeast, bread Dogs, cats, horses, rabbits G.I. upset, bloating, empty calories
          Rhubarb Chickens, rabbits
          Dairy items, ice cream Dogs, cats, chickens, horses, rabbits High sugar, high fat, lactose intolerance. Adult cats become lactose intolerant
          Sugar free gum and sugar free candy Dogs, cats Xylitol
          Seeds and Pits Dogs, cats, chickens, horses, rabbits Cyanide
          Turkey skin, chicken skin, ham Dogs, cats, rabbits High fat content, can cause acute pancreatitis
          Marijuana Dogs, cats, horses, rabbits Tetrahydrocannabinol (THC)

           

          Items like alcohol, tobacco, caffeine, and chocolate make sense. Alcohol and tobacco affect dogs and cats as they do humans, but our pets are much smaller, so it takes significantly less alcohol or tobacco to cause catastrophic events such as breathing problems, vomiting, diarrhea, coma, or even death. Dogs are curious, and a tobacco or marijuana “cigarette” on the ground might be pretty tasty. The average tobacco cigarette contains 10 to 12 milligrams of nicotine. A toxic dose of nicotine for a pet is 0.5 to 1 milligram per pound, and a 4-milligram dose per pound can be lethal.5 Doing some quick math, consuming as little as three or four cigarettes could be fatal to a 10-pound dog.

          Vaping has become extremely popular, which has caused an increase in nicotine poisonings. An average 6 mL, 5% nicotine e-cigarette can contain up to 300 mg of nicotine. Pets can be subjected to nicotine poisoning by secondhand smoke, through spillage on skin, and by drinking the vaping liquid. Consider this: a 40-pound dog would only need to be exposed to a 1 mL dose for it to become poisoned.5 Nicotine is not the only toxin in e-cigarettes. They also contain volatile organic compounds, heavy metals (e.g., cadmium, copper, lead, nickel, tin) and they contain propylene glycol. All of these components are harmful to pets.

          Those other “cigarettes” can be pretty tasty too. Marijuana use is on the rise in the U.S. since it is now legal in more than 21 states, and for the first time, it has now made its way onto the list of the top 10 items that cause pet poisonings. The two major components of marijuana are cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC). CBD is nontoxic to animals, whereas THC is the psychoactive ingredient that is extremely toxic. CBD is widely advertised for human and pet use, but consumers must read labels carefully. Most CBD products are not entirely pure. They contain small amounts of THC.6

          Although secondhand smoke and consuming raw marijuana leaves can be toxic, the most reported intoxications come from pets eating infused edibles. Edibles like brownies, cookies or gummies are made with concentrated THC infused oils or THC-infused butter. They tend to be a more significant threat since most edibles also contain chocolate or xylitol.7  If pets exhibit any symptoms, they should be taken to a veterinarian. THC poisoning closely mimics the signs of antifreeze poisoning which is fatal and an antidote needs to be given as quickly as possible.6,7

          Symptoms of marijuana intoxication can become visible within 30 to 60 minutes after ingestion. Pets may stumble and cross their feet, walking as if they were drunk, they may have enlarged pupils, become lethargic and flinch in reaction to sudden movements. Pets with severe cases of intoxication may vomit, have tremors, shake uncontrollably and in extreme cases become comatose. Roughly 50% of dogs develop urinary incontinence and dribble urine uncontrollably (which might make the drug less popular if this happened in humans).7

          Some medications contain significant amounts of alcohol. If unsecured, a dog or cat could consume them. Certain formulations of diphenhydramine (Benadryl, Sominex), guaifenesin with codeine (Cheracol Plus), dextromethorphan, guaifenesin, pseudoephedrine combinations (Dimetane, Robitussin, Triaminic, Vicks), hydrocodone and pseudoephedrine combinations (Novahistine), and certain multivitamin liquids (Geritol) contain alcohol. Some remedies can contain up to 25% alcohol, which can harm pets (and children).8  Alcohol is sweet tasting to dogs, so they will not stop drinking it until it is all gone.

          Caffeine and chocolate ingestion should also be taken seriously. Caffeine contains methylxanthines, which can cause bronchodilatory and stimulatory effects in humans. In animals, they can also cause vomiting, diarrhea, hyperactivity, seizures, and cardiac arrhythmias. Chocolate, derived from the roasted seeds of Theobroma cacao, contains methylxanthine, theobromine, and caffeine. The theobromine content in chocolate is three to ten times that of caffeine. Cats do not have taste buds that can detect sweetness, but dogs do have a sweet tooth and love the taste of chocolate. One ounce (28 grams) of chocolate could be a lethal dose in a small dog. Theobromine has a half-life of two to three hours in humans, but it is longer in dogs. The half-life of theobromine in dogs is 17.5 hours.9,10 The SIDEBAR provides more information about chocolate toxicity in dogs.

           

          How Much Chocolate is Too Much?10,11

          Different cocoa beans and chocolate products contain various amounts of methylxanthines. Compounders and veterinary care providers must consider the dog or cat’s weight and the amount of chocolate consumed.

          Methylxanthine doses of 15 mg/kg (7.5 mg per pound) or less should not harm a dog. This is equivalent to one square of dark chocolate for a 3 kg (6 lb.) dog or seven squares of chocolate for a 15 kg (33lb.) dog. One square of chocolate is approximately 6 grams (0.21 oz). This formula calculates the dose consumed:

          Theobromine dose = concentration in type of chocolate x amount eaten/weight

          Caffeine dose = concentration in type of chocolate x amount eaten/weight

          Theobromine + caffeine = Total methylxanthines

          The caffeine and theobromine amounts in the specific type of chocolate may be on the label, and the Table10 below provides some information about common products. However, in emergencies, healthcare providers can use calculators on the Internet that performs this calculation quickly and efficiently. This is not to say that cats never get into chocolate and get sick. There are also cat chocolate toxicity calculators online in case of emergency.

          Methylxanthines in Chocolate 10

          Product Methylxanthines per 1 gram chocolate mg methylxanthines /ounce of chocolate
          Dry cocoa powder 28.5 mg 800 mg
          Unsweetened bakers chocolate 16 mg 450 mg
          Milk Chocolate bar 2.3 mg 64 mg
          Dark Chocolate bar 5.7 mg 150- 160 mg
          Cocoa bean hulls (mulch) 9.1 mg 225 mg
          White chocolate Negligible

           

          Excess salt (sodium chloride) can cause fluid imbalances which could lead to seizures and spicy foods can cause painful vomiting, diarrhea, or stomach ulcers. Dogs, cats, and even birds are very sensitive to salt, so pet owners and compounders should be aware of common items that contain large amounts of salt. For example, sea water, baking soda, homemade play dough, and driveway deicer all contain high concentrations of salt. Sodium chloride poisonings in dogs are most often caused by pet owners who use salt to induce vomiting after the dog has ingested a different toxin. It is important to consult with a veterinarian or pet helpline before administering any type of antidote.12

          Even seemingly harmless spices can be harmful. Cinnamon can cause mouth irritations and nutmeg, which contains myristicin, can cause hallucinations in smaller animals. Mushrooms contain mycotoxins which can also cause hallucinations, diarrhea, vomiting, or kidney failure and in extreme cases, liver failure.4

          Although more toxic to cats than dogs, onions, chives, garlic,  and all members of the allium family of herbs contain sulfoxides and disulfides, and an oxidant called n-propyl disulfide. These can cause a fatal anemia, called oxidative hemolysis, which affects dogs, cats, rabbits and chicken. Signs of anemia may take several days to appear.4,17,18  If a dog is fed a little garlic once in a while it should not be a problem but avoid giving pets garlic supplements. It was once believed that garlic supplements given to dogs could help to repel fleas and ticks, but this has now been proven to be ineffective.13

          Other problematic vegetables include green tomatoes, raw potatoes, and avocado. The tomato plant’s green parts, its stems and leaves, and raw potatoes contain solanine. Solanine is poisonous, even to humans. It has pesticide-like properties and is part of the plant’s natural defenses. Solanine can be found in green potatoes and potato tubers (eyes).14 It is also found in other members of the nightshade family (e.g., eggplant skin).

          Avocado is only slightly dangerous to dogs and cats, but extremely dangerous to birds and large animals such as cows, goats, sheep and horses. The bark, leaves, skin, pits and fruit of the avocado contain persin, which is a fungicidal toxin. Persin is an oil soluble compound that seeps into the fruit from the large seed inside. It is similar in structure to a fatty acid, and is harmless to humans, but toxic to most animals. Symptoms of persin toxicity range from edema and mastitis to respiratory distress and heart failure.15,16

          Chickens, which are increasingly popular in back yards, are sensitive to many food items. They should not be fed most human foods, but especially avoid feeding them citrus fruits, uncooked rice and uncooked dried beans, fruit seeds and pits, tomato leaves, green potatoes, and rhubarb.17 Rhubarb’s high oxalic acid content binds to minerals and can form kidney stones. Although high in calcium and phosphorus, certain dried beans are acidic and contain hemagglutinin. Hemagglutinins bind to receptors on red blood cells to initiate viral attachment and infection.

          Rabbits, guinea pigs, and most herbivores have similar dietary restrictions. Fruit seeds and pits contain small amounts of cyanide, which can be a concern to smaller animals. Cabbage, cauliflower, other gassy vegetables and iceberg lettuce must be avoided. Iceberg lettuce contains lactucarium. Lactucarium (also called lettuce opium), a milky fluid excreted near the base of the lettuce plant, has sedative properties. Rabbits and other herbivores should stick to darker greens.18

          Factors That Influence Toxicity

          Each species of animal reacts to toxins differently due to variations in absorption, metabolism, or elimination. The dose of toxin per body weight is a major concern. Other factors include the animal’s age, size, nutritional status, stress level, and overall health. For example, most young animals do not have a fully developed system of metabolism, which may cause a toxin to remain in their system longer, causing more harm. Horses, rabbits, and small rodents do not have the ability to vomit, which means that they may be poisoned at a lower dose.19

          One must also consider the chemical nature of a food, drug or poison that is consumed. If the drug or toxin dissolves in water easily, it will spread throughout the body easier. If there are substances added to an active ingredient, such as a binding agent or outer coating, or if it is a sustained release product, it will affect absorption.19 Overall, pharmacists should become familiar with species specific toxins and the factors that affect the risk of toxicity. Animals absorb, distribute, metabolize, and eliminate medications and toxins differently from humans, and the interspecies differences are also notable. See the SIDEBAR for a list of the top ten toxic items.

           

          ASPCA: The Official Top 10 Toxins of 202220

          Each year, the Animal Poison Control Center of America (ASPCA) compiles a yearly list of toxic items. They received 335,136 pet poisoning calls in 2022 and have tabulated the results as follows:

          1. Over the Counter Medications. Ibuprofen and acetaminophen are the most common.
          2. Food items. Protein bars, xylitol, grapes and raisins top the list.
          3. Human prescription medications
          4. ASPCA received approximately five calls per hour regarding chocolate.
          5. Plants
          6. Household chemicals. Disinfecting wipes top the list.
          7. Veterinary products
          8. Rodenticides
          9. Insecticides. Ant baits are an example.
          10. Recreational drugs. Edible THC products are the most common.

           

          Evolution has influenced species-specific diets. Dogs have evolved to become opportunistic gorgers, while cats are very picky. A dog will eat every bit of chocolate once he starts, which is the reason why dog poisonings are more common. Cat poisonings are less common and are usually the result of intentional harm by human beings.

          Pause and Ponder: Have you tried to give a dog a tablet or capsule? Did you wrap it in some meat or cheese? How did you get a cat to take his dose?

          When to Compound

          Pharmacists should consider compounding veterinary products under three conditions:

          1. When a commercial product is unavailable. This could be due to drug recalls, drug shortages, or because a commercial product has yet to be developed. In some cases, rapid changes in disease state management create an urgent need for medication.
          2. When an approved drug needs to be modified. This would include an increase or decrease in dosage due to a lack of appropriate dosage size, or a lack of formulation for a desired route, for example, making a dilution, adding flavoring, or changing the form of the drug. A popular compounding task is changing a tablet into a suspension.
          3. When the likelihood of nonadherence is high. Owners’ adherence is greater when they can administer one combination product instead of two or three. For example, combining two injectable vaccines or allergy medications into one syringe for ease of use would be helpful to the pet owner. Of course, it is also more beneficial to the animal, since it will minimize harm and stress, which will lead to a better prognosis. Our students have recently formulated a compound of ketoconazole, gentamicin sulfate, and mometasone furoate all in one for a dog with an external ear bacterial yeast infection.

          Dogs and cats can be very particular, and their sense of smell will give that medication away every time. This means that compounding must be creative. The most popular forms of medications for veterinary consideration include capsules, transdermal medications, flavored liquids, tablets, chews, or treats. Oral formulations can be difficult to give, but devices such as droppers, mechanical pill injectors, oral syringes, and oral pastes and gels can mask medications. Pill pockets—soft, flexible treats—can be molded around a tablet or capsule. Medicated oral pastes and gels, when placed on a cat’s paw, are an ingenious way for the cat to lick his medicine up. Compounders make a variety of products from hairball pastes and pectin gels, used for diarrhea, to dental licks and probiotic powders which are placed on a cat’s fur.

          Human compounding caters to the customer, and the same is true for pets. Tuna or salmon flavoring attracts cats; beef or chicken flavoring may fool dogs; and birds love seeds. Other ingredients can be rather generic. Compounders can choose from a myriad of thickeners, sweeteners, and preservatives. Choosing the correct excipient could be crucial.

          Pause and Ponder: Take another look at the list of forbidden foods. Which items on your pharmacy compounding shelf could be harmful to pets?

          Ingredients for veterinary compounding

          In human compounding we tend to lean toward avocado or grapeseed oil to soothe and treat the skin, which are lighter than other oils. We use alcohol, propylene glycol, polysorbate 80 (Tween 80), and essential oils in compounds and peanut butter quite often for dog treats. These may not be the best choices in some veterinary situations. Let’s look at what is safe and what should not be used for pets.

          Sweeteners

          Sugar substitutes are game changers for people who have diabetes or are on low calorie diets. Xylitol is a current human favorite, occuring naturally in small amounts in berries, cauliflower, corn, mushrooms, oats, plums, and pumpkins. In industrial production, the purest form is extracted from raw biomass materials such as hard and soft wood, and especially from the birch tree. More economical processing uses hydrolyzed, purified agricultural corn, wheat, and rice waste. Economists expect xylitol production to become a $1.4 billion industry by 2025.21 Why the increase in popularity? Xylitol contains two-thirds of the calories of sucrose and has a mild increased saliva effect. Unfortunately, xylitol is extremely toxic to dogs.

          When dogs consume xylitol, it is quickly released into the bloodstream, causing an immediate and potent release of insulin from the pancreas. This leads to severe hypoglycemia, with onset that can occur anywhere from 10 to 60 minutes after ingestion. Without treatment, the dog may develop liver failure, have seizures, or become comatose.22

          Products that contain xylitol are ubiquitous. It’s found in foods such as barbeque sauce, candy, gum, jam, ketchup, low calorie maple syrup, and peanut butter (meaning that compounders who use peanut butter need to check labels carefully; xylitol may be listed as 1,4-anhydro-d-xylitol, anhydroxylitol, birch bark extract, birch sugar, D-xylitol, Xylite, xylitylglucoside, or zylatol). In fact, sugar-free gum is the most common source of xylitol poisoning in dogs. For example, one piece of gum or one breath mint can be fatal to a 10-pound dog. The Pet Poison Helpline responded to 5,846 xylitol poisoning cases in 2020.22

          Xylitol can also be found in many pharmaceuticals and personal care products: cough syrup, deodorant, digestive aids, gummy vitamins, laxatives, mouthwash, nasal sprays, shampoo, skin care products, sleep supplements, toothpaste, and especially orally dissolving tablets. Small traces of xylitol can even be found in prescription medications.22 Gabapentin tablets and capsules do not contain xylitol, but gabapentin oral solution contains xylitol. The side bar discusses one xylitol poisoning case.

           

          SIDE BAR: POOR MIMI23

          In 2020, Mimi, a pet poodle passed away after receiving gabapentin. The veterinarian prescribed gabapentin oral solution, for ease of use and medication adherence for Mimi’s seizures. The owner administered the dose and Mimi’s seizures increased, so the owner called the veterinarian, who increased the dose of medication to be given. Within 24 hours Mimi was gone.

          How could this happen?

          Many veterinarians are unfamiliar with the added ingredients in human formulations. Also, drug manufacturers may change sweeteners without notice. A retail pharmacist filled her prescription for gabapentin oral solution with the commercially available product, which contained xylitol.  When the dogs owners went to the pharmacy to investigate, they found several factors which caused the problem.

          • They were told that the pharmacist did not know that the solution contained xylitol and he was also unaware that xylitol was harmful to dogs.
          • The pharmacy had no drug utilization reviews processes in place for veterinary drugs.
          • The existing built-in computer software was not programmed to issue alerts for xylitol or other veterinary toxins.
          • The pharmacy did not have a veterinary drug reference book, for example, Plumbs Veterinary Medicine, or a veterinary drug formulary. Unfortunately, the majority of state boards of pharmacy do not require pharmacies to carry a veterinary drug reference book.

          Pharmacists and pharmacy technicians need to be aware of additives in human drug formulations that can be harmful to pets. Mimi’s death could have been avoided.23

           

          Many other sugar substitutes are considered safe to use in veterinary compounding. Erythritol, a sugar used mainly in keto desserts and baked goods, is safe in small amounts. Stevia and aspartame are also considered safe to use, although pets may experience stomach aches or slight diarrhea. Saccharin (Sweet-n-Low), sucralose (Splenda), or monk fruit, a newer sweetener, are all considered safe in pets.24 Dogs have more of a sweet tooth than cats, but in general, sweeteners should be kept to a minimum.

          Flavors

          Using an optimal flavor profile helps mask the active ingredient’s taste and will promote animal adherence. Compounders should use only flavorings that are intended for compounding use. They shouldn’t use meat-flavored bouillon cubes or bouillon powders for compounding since they contain high amounts of salt, onion powder, and other harmful spices. Table 2 lists common flavorings and the species that find them enjoyable.

           

          Table 2. Common Flavorings for Pets25

          Animal Flavor Reasoning
          Birds Banana, grape, orange, raspberry, tangerine, tutti-fruiti, piña colada Birds prefer sweet and fruity flavors
          Dogs Bacon, beef, liver, chicken, turkey, cheese, peanut butter, molasses, caramel, anise, marshmallow, raspberry, strawberry, honey Dogs prefer meats and sweets
          Cats Fish, liver, tuna, cod liver oil, sardines, mackerel, salmon, beef, chicken, cheese, bacon, molasses, peanut butter, butterscotch, marshmallow Cats do not like very much sweetness but hate bitterness
          Gerbil Banana cream, orange, peach, tangerine, tutti-fruiti Gerbils like sweet and fruity flavors
          Iguana Banana, cantaloupe, kiwi, orange, tangerine, watermelon, other melons Iguanas and most reptiles rely on their sense of smell more than taste, so it must smell good
          Rabbits Banana cream, carrot, celery, lettuce, parsley, pineapple, vanilla, butternut Find their favorite vegetable or fruit and use it
          Poultry Cantaloupe, corn, meal, milk, vanilla, butternut, watermelon Research is ongoing to determine the sense of taste in chickens.

           

          Preservatives and Additives

          The Food and Drug Administration (FDA) maintains a list of additives generally recognized as safe (GRAS) for use in pet foods. Manufacturers must submit food additives used in their pet foods for FDA review, which if approved, are added to the GRAS list.26

          Still, many excipients should not be used for veterinary compounding 27,28,31

          • Butylated hydroxyanisole (BHA)
          • Butylated hydroxytoluene (BHT)
          • Ethoxyquin
          • Propylene glycol
          • Polysorbate 80 (Tween 80)

          BHA and BHT are preservatives that are added to oils and rendered fats in certain pet foods and treats. They have been found to be carcinogens and can cause liver and kidney damage in rats, but the FDA has cleared them for use in small amounts in pet foods and treats. Ethoxyquin, a preservative, is used as a hardening agent. It is also used in pesticides and rubber and is illegal for human use, yet the FDA has ruled the additive “may be safely used in animal feeds” when used according to regulations.27 Which is the best preservative to use? The answer is to stick to more natural preservatives. Vitamin C and E are great choices, as are lemon, except for use in cats and chickens, and honey. Honey is packed with vitamins A, B, C, D, E, and K and also contains potassium, calcium, magnesium, copper, and antioxidants. Giving a pet a small amount of honey can even help to build immunity from some allergens, such as pollen.29

          Propylene glycol is a controversial excipient used as a humectant, or moisturizing agent, in many pharmaceutical formulations. Propylene glycol is derived from ethylene glycol, which is antifreeze’s main component. Small amounts may be used in dog formulations, but it is extremely toxic to cats. Extended exposure to propylene glycol over several years has been shown to cause seizures and possible blood disorders in both dogs and cats.28 Cats may develop Heinz body hemolytic anemia, which can lead to death.

          Cats and dogs are also extremely reactive to essential oils. Popular essential oils (e.g., eucalyptus oil, peppermint oil, tea tree oil) can be found in some natural flea repellents, perfumes, and aromatherapy products. These are safe to use in humans and can be found in many topical preparations; using these oils in topical preparations for dogs or especially cats (since they are continual groomers), can be harmful. Signs of toxicity are lethargy, depression, ataxia, tremors, seizures, or death.30

          Polysorbate 80 (Tween 80) is a surfactant used in soaps and as a lubricant in eye drops. It is also used as an excipient quite often to stabilize aqueous formulations of lipophilic drugs for vaccines and for parenteral administration. Many Chinese herbal injectable medications contain high amounts of polysorbate 80. When dogs are given intravenous (IV) medications that contain high levels of polysorbate 80, for example vitamin K, it causes systemic histamine release, which causes allergic reactions and tachycardia and may lead to an anaphylactic reaction.31

          Corn syrup is a cheap humectant, sweetener, and flavoring agent all-in-one, but it can be addictive to dogs and can increase blood sugar significantly. A vegetable-based glycerin, such as coconut glycerin is a better choice.32

          Food dyes and colorants should be used sparingly when compounding. Blue dye #2, red #40, yellow #5 and #6 can cause hypersensitivity or allergic reactions in some pets. Also, caramel color 4-methylimidazole (4-MIE) is under investigation as a possible carcinogen in pets.32 In actuality, pets do not care about the color of the compound. Artificial coloring only appeals to the pet owner.

           

          When to Call a Professional

          When should pet owners or concerned pharmacy staff call a professional for a suspected pet poisoning? The sooner the better. The first call should be to the pet’s veterinarian, but national hotlines are also available for emergencies 24/7 for a fee.

          • ASPCA Animal Poison Control

          https://www.aspca.org/pet-care/animal-poison-control

          888-426-4435

          Free access to website

          $95.00 fee for hotline service

          *90% of the fee is covered with ASPCA insurance

           

          • Pet Poison Helpline

          http://www.petpoisonhelpline.com

          855-746-7661

          Free access to website. $85.00 fee for hotline service

           

          General Recommendations for Compounding

          Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA permits compounding of animal drugs when the source of the active ingredient is a finished FDA-approved drug, and not a bulk drug substance (BDS), unless certain exceptions, described below, are followed. A “bulk drug substance” is a substance used to make a drug that becomes an active ingredient in the drug’s finished dosage form.33 Most pharmacists would recognize that as an active pharmaceutical ingredient (API).

          A commercially available drug may not always be available or appropriate for veterinary use. For example, an FDA-approved drug may have excipients or preservatives that are unsuitable for pets, the dose may be too large, or the flavoring may be unacceptable. In this case, the FDA has acknowledged the need for certain bulk drug substances. On April 14, 2022, the FDA released the Guidance for Industry (GFI #256), entitled “Compounding Animal Drugs from Bulk Drug Substances” which became effective in April 2023.The FDA has also created approved BDS lists for use in veterinary preparations.35  Separate BDS lists exist for non-food producing animals, for food producing animals, for veterinary office stock drugs, and certain wildlife species.36 GFI #256 allows pharmacies to purchase and use bulk drug substances from FDA-registered suppliers if a certificate of analysis (COA) is included with the compounding record. The FDA also requires compounders to report any adverse reactions to the FDA within 15 days. Veterinarians must also provide more patient specific detailed clinical information explaining why a pet cannot use an FDA approved manufactured product.

          The FDA has composed a check list for pharmacists regarding veterinary compounding.34

          1. Confirm whether patient(s) is a nonfood-producing animal or a food-producing animal. Make sure that chicken is just a pet! Food-production animals (cattle, chickens, etc.) have an additional set of rules (not discussed here). Check the FDA guidelines for more information.33
          2. Follow all state laws and regulations that apply to compounding animal drugs. Compounders need to check their state regulations. It appears that most states tend to merely restate FDA animal compounding guidance.
          3. Meet USP standards and FD&C Act requirements. Use FDA-approved drugs or FDA-approved BDS, follow USP guidelines and monographs, if they exist, and follow FD&C act requirements.
          4. Include all labeling information. See below.
          5. Dispense the compounded drug(s) to the patient’s owner or caretaker or the veterinarian who prescribed or ordered it. A valid veterinarian-client relationship must exist, and a veterinarian must provide a valid prescription.
          6. Report adverse events and product defects associated with the compounded drug to the FDA on Form FDA 1932a.
          7. Consider other FDA-approved options first. Check to see if alternative options are available. Compounding is permitted if the active ingredient is a different salt, ester, or other derivative.
          8. Determine if you are compounding a copy of an FDA-approved product. If the exact form of medication is commercially available, it cannot be compounded.
          9. Obtain a medical rationale and retain it in your records if a copy is needed. The rationale for the compound must be documented on the prescription.

          Other considerations include determining the physical and chemical compatibility of the drugs, the drugs’ solubility and stability, and the active ingredients’ pharmacodynamics.

          Labeling

          In addition to including the client's name on the label, the American Veterinary Medical Association (AVMA) recommends veterinarians and compounders in veterinary offices convey the following information to animal owners when prescribing all compounded preparations37:

          • Name, address, and telephone number of veterinarian
          • Identification of animal(s) treated, species, and number of animals treated, when possible
          • Date of treatment, prescribing, or dispensing of drug
          • Name, active ingredient, and quantity of the drug (or drug preparation) to be prescribed or dispensed
          • Drug strength (if more than one strength available)
          • Dosage and duration
          • Route of administration
          • Number of refills
          • Cautionary statements, as needed
          • Beyond-use date (BUD)
          • Slaughter withdrawal and/or milk withholding times, if applicable

          Per FDA regulations, pharmacies must include the following on the compounded drug’s labeling: name and strength or concentration of drug; species and name or identifier of patient(s); name, address, and contact information for the compounding pharmacy and name of the prescribing veterinarian; a beyond use date; the withdrawal time as determined by the prescribing veterinarian; and the following statements must be included33:

          • “Report suspected adverse reactions to the pharmacist who compounded the drug and to FDA using online Form FDA 1932a.”
          • “This is a compounded drug. Not an FDA approved or indexed drug.”
          • “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

          CONCLUSION

          On June 10, 2021, the FDA finalized Guidance for Industry (GFI) # 263, (not to be confused with GFI #256 which was mentioned previously) requesting that participating animal drug companies voluntarily transition certain antimicrobials from over-the-counter availability to veterinary prescription within two years. The aim of this guidance is to decrease antibiotic resistance in animals, and the target date to introduce new prescription labels onto the market was June 11, 2023.38 These include well known antibiotics such as erythromycin, gentamicin, penicillin, sulfamethoxazole, and tetracycline. This FDA requirement is now in effect for food-production animals and pets, and it may be one reason why many pharmacies have seen an increase in pet prescriptions. Another reason may be that more pet owners trust their local pharmacy to prepare the correct formula for their furry family members.

          The field of veterinary medicine is expanding seemingly daily, and it is a field where compounding pharmacies can be instrumental. Veterinary compounding has its challenges, but when collaborating with a veterinarian, the compounder can impart professional judgment to ensure that the compound is safe, effective, and therapeutic. That’s a rewarding practice in the end.

           

           

           

          Pharmacist Post Test (for viewing only)

          Considerations in Veterinary Compounding
          Post-test
          Learning Objectives: After completing this continuing education activity, pharmacists and pharmacy technicians will be able to
          1. List food items which may be harmful to certain pets
          2. Identify additives which should not be used in veterinary compounding
          3. Discover when veterinary compounding is acceptable
          4. Recognize federal laws pertaining to veterinary compounding
          5. Investigate labeling requirements for veterinary compounds

          1. Which of the following is a major source of poisoning in dogs?
          a. Turkey skin
          b. Chocolate
          c. Bones

          2. A client asks if she can feed her chickens dried corn, table scraps, or dried beans. Which of those foods would be inappropriate?
          a. Dried corn
          b. Table scraps
          c. Dried beans

          3. Which is not considered a factor when evaluating the toxicity of a drug or food item?
          a. The age or maturity of an animal
          b. The weight and size of an animal
          c. Whether it is a food-producing animal

          4. A compounder receives a prescription for a feline. This cat is picky, and the final product needs a humectant and flavoring. Which ingredient is contraindicated?
          a. Propylene glycol
          b. Glycerin
          c. Salmon flavoring

          5. When a sweetener is required, what is a good choice for veterinary compounding?
          a. Xylitol
          b. Sucralose
          c. Corn syrup

          6. Select the safe preservative to use when compounding for dogs.
          a. Vitamin C and E
          b. Ethoxyquin
          c. Propylene glycol

          7. Which of the following is an appropriate flavoring agent for dogs?
          a. Chicken bouillon cubes
          b. Bacon flavoring
          c. Grape flavoring

          8. Mrs. MacDonald, wife of Old MacDonald, brings you a prescription for her favorite chicken. She confirms that all of the following facts (answers a, b, and c) are true. Which fact forces you to tell her you cannot compound the medication?
          a. The chicken needs a small dose of medication
          b. The owner has a valid prescription from a veterinarian
          c. The chicken is food producing

          9. Under what condition can a pharmacist compound a veterinary prescription?
          a. The drug is on the FDA list of approved drugs
          b. The drug is cheaper to make than the available product
          c. There is no USP monograph for this drug

          10. According to GFI 256, a compounder must not
          a. Use a product on the FDA bulk drug substance list
          b. Attach the COA to the compounding record
          c. Purchase BDS from a non-FDA approved supplier

          11. What should a compounder do before mixing a prescription?
          a. Confirm that the patient is a pet
          b. Inform the FDA
          c. Call the veterinarian

          12. How soon should compounders report adverse events in veterinary compounding to the FDA?
          a. Within 7 days
          b. Within 15 days
          c. Within 30 days

          13. As you prepare a prescription label for a compounded product for a pet hamster, what must you include on the label?
          a. Not for use in food producing animals
          b. For office use only, not for resale
          c. This is a compounded drug. Not an FDA approved or indexed drug

          14. The compounding technician has prepared a label for a compounded veterinary product. The label is terribly crowded and hard to read. Which of the following can you tell the technician to remove?
          a. Species of pet
          b. Name of active ingredient
          c. Veterinary phone number

          15. Which FDA Guidance for Industry mandates the transition of certain antibiotics from OTC to prescription?
          a. 256
          b. 263
          c. 265

          Pharmacy Technician Post Test (for viewing only)

          Considerations in Veterinary Compounding
          Post-test
          Learning Objectives: After completing this continuing education activity, pharmacists and pharmacy technicians will be able to
          1. List food items which may be harmful to certain pets
          2. Identify additives which should not be used in veterinary compounding
          3. Discover when veterinary compounding is acceptable
          4. Recognize federal laws pertaining to veterinary compounding
          5. Investigate labeling requirements for veterinary compounds

          1. Which of the following is a major source of poisoning in dogs?
          a. Turkey skin
          b. Chocolate
          c. Bones

          2. A client asks if she can feed her chickens dried corn, table scraps, or dried beans. Which of those foods would be inappropriate?
          a. Dried corn
          b. Table scraps
          c. Dried beans

          3. Which is not considered a factor when evaluating the toxicity of a drug or food item?
          a. The age or maturity of an animal
          b. The weight and size of an animal
          c. Whether it is a food-producing animal

          4. A compounder receives a prescription for a feline. This cat is picky, and the final product needs a humectant and flavoring. Which ingredient is contraindicated?
          a. Propylene glycol
          b. Glycerin
          c. Salmon flavoring

          5. When a sweetener is required, what is a good choice for veterinary compounding?
          a. Xylitol
          b. Sucralose
          c. Corn syrup

          6. Select the safe preservative to use when compounding for dogs.
          a. Vitamin C and E
          b. Ethoxyquin
          c. Propylene glycol

          7. Which of the following is an appropriate flavoring agent for dogs?
          a. Chicken bouillon cubes
          b. Bacon flavoring
          c. Grape flavoring

          8. Mrs. MacDonald, wife of Old MacDonald, brings you a prescription for her favorite chicken. She confirms that all of the following facts (answers a, b, and c) are true. Which fact forces you to tell her you cannot compound the medication?
          a. The chicken needs a small dose of medication
          b. The owner has a valid prescription from a veterinarian
          c. The chicken is food producing

          9. Under what condition can a pharmacist compound a veterinary prescription?
          a. The drug is on the FDA list of approved drugs
          b. The drug is cheaper to make than the available product
          c. There is no USP monograph for this drug

          10. According to GFI 256, a compounder must not
          a. Use a product on the FDA bulk drug substance list
          b. Attach the COA to the compounding record
          c. Purchase BDS from a non-FDA approved supplier

          11. What should a compounder do before mixing a prescription?
          a. Confirm that the patient is a pet
          b. Inform the FDA
          c. Call the veterinarian

          12. How soon should compounders report adverse events in veterinary compounding to the FDA?
          a. Within 7 days
          b. Within 15 days
          c. Within 30 days

          13. As you prepare a prescription label for a compounded product for a pet hamster, what must you include on the label?
          a. Not for use in food producing animals
          b. For office use only, not for resale
          c. This is a compounded drug. Not an FDA approved or indexed drug

          14. The compounding technician has prepared a label for a compounded veterinary product. The label is terribly crowded and hard to read. Which of the following can you tell the technician to remove?
          a. Species of pet
          b. Name of active ingredient
          c. Veterinary phone number

          15. Which FDA Guidance for Industry mandates the transition of certain antibiotics from OTC to prescription?
          a. 256
          b. 263
          c. 265

          References

          Full List of References

          References

             
            REFERENCES
            1. Megna M. Pet Ownership Statistics, June 21.2023. Forbes Magazine. Accessed August 5, 2023. https://www.forbes.com/advisor/pet-insurance/pet-ownership-statistics/#
            2.Principles of Veterinary Medical Ethics of the AVMA. American Veterinary Association. August 2019. Accessed July 6, 2023 https://www.avma.org/resources-tools/avma-policies/principles-veterinary-medical-ethics-avma
            3.Veterinary Centers of America (VCA) Animal Hospitals: Why Bones are not Safe for dogs. By Ryan Llera, BSc, DVM; Robin Downing, DVM, CVPP, CCRP, DAAPM. Accessed 07/04/2023. https://vcahospitals.com/know-your-pet/why-bones-are-not-safe-for-dogs#:~:text=Dogs%20can%20choke.,your%20dog's%20ability%2
            4. 20 Foods Dogs Can’t Eat, and 13 Foods Safe for your Pup! Dr. Chris Roth DVM, July 21, 2022. Accessed August 5, 2023. https://www.petsbest.com/blog/20-foods-dogs-shouldnt-eat/?utm_source=nmpi&utm_medium=pmax&utm_campaign=max&utm_term=p
            5. Brooks, Wendy, DVM,DABVP. Nicotine Poisoning in Pets. Revised January 23, 2023. Accessed August 5, 2023. https://veterinarypartner.vin.com/default.aspx?pid=19239&id=4952080#
            6. Chapin. Pets On Pot, Just High or Highly Dangerous? Michigan State College of Veterinary Medicine, Decenber 4, 2018. Accessed August 5, 2023. https://cvm.msu.edu/vetschool-tails/pets-on-pot-just-high-or-highly-dangerous#
            7. Johnstone, Gemma, American Kennel Club. Marijuana Poisoning in Dogs. April 10, 2023. Accessed August 5, 2023. https://www.akc.org/expert-advice/health/marijuana-poisoning-in-dogs/.
            8. Liquid medicine may contain a high level of alcohol. Use with caution when administering to a child. Consumer Med Safety.org. Accessed August 5, 2023. https://www.consumermedsafety.org/safety-articles/liquid-medicine-may-contain-a-high-level-of-alcohol-use-with-caution-when#:~
            9. Myers J. Chocolate toxicosis (Methylxanthine Toxicosis) in Dogs. September 9, 2022. Accessed August 5, 2023. https://vetster.com/en/conditions/dog/chocolate-toxicosis-methylxanthine-toxicosis-in-dogs
            10. Gwaltney-Brant SM. Chocolate Toxicosis in Animals. Accessed August 5, 2023. https://www.merckvetmanual.com/toxicology/food-hazards/chocolate-toxicosis-in-animals#:~:text=DVM%2C%20PhD%2C%20DABVT,Modified%20Nov%202022
            11. Zaborowska, Ł. Dog Chocolate Toxicity Calculator. Accessed August 5, 2023. https://www.omnicalculator.com/biology/dog-chocolate-toxicity.
            12. American College of Veterinary Pharmacists. Salt. Accessed August 5, 2023. https://vetmeds.org/pet-poison-control-list/salt/#!form/PPCDonations.
            13. Burle A. Can Dogs Eat Garlic? August 4,2022. Accessed August 5, 2023.. https://www.akc.org/expert-advice/nutrition/can-dogs-eat-garlic/
            14. Medline plus, National Library of Medicine. Potato plant poisoning. Accessed August 5, 2023. https://medlineplus.gov/ency/article/002875.htm
            15. Oelrichs PB, Ng JC, Seawright AA, Ward A, Schäffeler L, MacLeod JK. Isolation and identification of a compound from avocado (Persea americana) leaves which causes necrosis of the acinar epithelium of the lactating mammary gland and the myocardium. Nat Toxins. 1995;3(5):344-349. doi:10.1002/nt.2620030504
            16. Avocado. Pet Poison Helpline. Accessed August 5, 2023. https://www.petpoisonhelpline.com/poison/avocado/#
            Reviewed/Revised Jun 2021 | Modified Nov 20
            17. What not to feed chickens, 33 Foods to Avoid. Backyard chicken project.com. Accessed August 5, 2023. https://backyardchickenproject.com/what-not-to-feed-chickens/
            18. Foods Rabbits should never eat. February 15, 2021. Oxbow Animal Health. Accessed August 5, 2023. https://oxbowanimalhealth.com/blog/foods-rabbits-should-never-eat/
            19. Factors Affecting the Activity of Poisons. Merck Veterinary Manual. Accessed August 5, 2023.https://www.merckvetmanual.com/special-pet-topics/poisoning/factors-affecting-the-activity-of-poisons#
            20. The Official Top 10 Toxins of 2022. March 23,2023. ASPCA. Accessed August 5, 2023. https://www.aspca.org/news/official-top-10-pet-toxins-2022
            21. Xylitol, Drugs.com. Accessed August 5, 2023. https://www.drugs.com/npp/xylitol.html
            22. Xylitol Poisoning in Dogs. VCA. Accessed August 5, 2023. https://vcahospitals.com/know-your-pet/xylitol-toxicity-in dogs#:~:text=What%20is%20xylitol%3F,corn%20fiber%20or%20birch%20trees.
            23. Dog Dies After Being Treated with Gabapentin Exposing Flaws in the Divide Between Human and Animal Drugs. Pet Food Safety News and Information. Accessed August 5, 2023. https://www.poisonedpets.com/dog-dies-after-being-treated-with-gabapentin-exposing-flaws-in-the-divide-between-human-and-animal-drugs/.
            24. Brahlek A. Not-So Sweet Toxic Sweeteners for Dogs: Xylitol and Others. November 21, 2022, Accessed August 5, 2023. https://grubblyfarms.com/blogs/the-flyer/toxic-for-dogs-xylitol
            25. Allen, LV Chapter 29, Veterinary Pharmaceuticals. The Art, Science, and Technology of Pharmacy Compounding. 6th edition, American Pharmacists Association, 2020.
            26. Current Animal Food GRAS Notices Inventory. U.S. Food and Drug Administration. Accessed August 5, 2023. https://www.fda.gov/animal-veterinary/generally-recognized-safe-gras-notification-program/current-animal-food-gras-notices-inventory
            27. Mahaney P. Pet Food: The Good, the Bad, and the Healthy. Accessed August 5, 2023. https://www.petsafe.net/learn/pet-food-the-good-the-bad-and-the-healthy
            28. Dog Food Advisor. These 6 Dog Food Preservatives Could Be Toxic to Your Pet. Accessed August 5, 2023. https://www.dogfoodadvisor.com/red-flag-ingredients/dog-food-preservatives/
            29. People Foods Dogs Can and Can’t Eat. AKC staff. April 3, 2022. Accessed August 5, 2023. https://www.akc.org/expert-advice/nutrition/human-foods-dogs-can-and-cant-eat/
            30. Schmid R, Brutlag A. Flint C. DVM Essential Oil and Liquid Potpourri Poisoning in Cats. Accessed August 5, 2023. https://vcahospitals.com/know-your-pet/essential-oil-and-liquid-potpourri-poisoning-in-cats#
            31. Qiu S, Liu Z, Hou L, et al. Complement activation associated with polysorbate 80 in beagle dogs. Int Immunopharmacol. 2013;15(1):144-149. doi:10.1016/j.intimp.2012.10.021
            32. 10 Ingredients to avoid in dog food. TPLO info. November 12, 2021. Accessed August 5, 2023. https://tploinfo.com/blog/10-ingredients-to-avoid-in-dog-food/
            33. Animal Drug Compounding. U.S. Food and Drug Administration. Accessed August 5, 2023. https://www.fda.gov/animal-veterinary/unapproved-animal-drugs/animal-drug-compounding
            34. Check List for Pharmacists: Compounding Animal Drugs. U.S. Food and Drug Administration. Accessed August 5, 2023. https://www.fda.gov/media/157331/download
            35. GFI # 256- Compounding Animal Drugs from Bulk Drug Substances. August 2022. U.S. Food and Drug Administration Center for Veterinary Medicine. Accessed August 5, 2023. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-256-compounding-animal-drugs-bulk-drug-substances
            36. FDA list of Bulk Drug Substances for compounding office stock drugs for Non-food producing animals. Accessed August 5, 2023. https://www.fda.gov/animal-veterinary/animal-drug-compounding/list-bulk-drug-substances-compounding-office-stock-drugs-use-nonfood-producing-animals
            37. Compounding: Facts for Veterinarians. American Veterinary Medicine Association. Accessed August 5, 2023. https://www.avma.org/resources-tools/animal-health-and-welfare/animal-health/compounding/compounding-faq-veterinarians
            38. Over-the-counter antimicrobials changing to prescription-only . American Veterinary Medicine Association. Accessed August 5, 2023. https://www.avma.org/resources-tools/one-health/antimicrobial-use-and-antimicrobial-resistance/over-counter-antimicrobials-changin

            The Path to Time Management: Time to Hit the Road!

            Learning Objectives

            After completing this knowledge-based continuing education activity, pharmacy technicians will be able to

              • Describe how an individual technician’s time management impacts the whole pharmacy’s efficiency
              • List three time management techniques that could improve a technician's function
              • Recognize time management techniques to apply in specific settings and situations

               

              Re-Release Date: September 24, 2023

              Expiration Date: September 24, 2026

              Course Fee

              Pharmacy Technicians: $4

              There is no funding for this CE.

              ACPE UAN

              Pharmacy Technician: 0009-0000-23-027-H04-T

              Session Codes

              Pharmacy Technician:  20YC65-TJX49

              Accreditation Hours

              1.0 hours of CE

              Accreditation Statements

              The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-027-H04-T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

               

              Disclosure of Discussions of Off-label and Investigational Drug Use

              The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

              Faculty

               

              Isabella Bean
              PharmD Candidate 2022
              UConn School of Pharmacy
              Storrs, CT

              Sara Miller, PharmD, RPh
              CVS
              Foxboro, MA

              May Zhang
              PharmD Candidate 2022
              UConn School of Pharmacy
              Storrs, CT

              Faculty Disclosure

              In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

              Isabella Bean, Sarah Miller and May Zang do not have any relationships with ineligible companies.

               

              VIDEO

              html

              Pharmacy Technician Post Test (for viewing only)

              The Path to Time Management: Time to Hit the Road!

              LEARNING OBJECTIVES
              After completing this continuing education activity, the pharmacy technician should be able to
              1. Describe how an individual technicians' time management impacts the whole pharmacy’s efficiency
              2. List three time management techniques that could improve a technician's function
              3. Recognize time management techniques to apply in specific settings and situations

              1. Barbara and Linda are great multitaskers. They are able to work and talk while getting everything done effectively. While ringing out a customer, Barbara continues her conversation with Linda. What should Barbara have done instead?
              a. Paused the conversation, because it makes the customer feel unimportant
              b. Done nothing different—in situations like this, she never makes errors
              c. Asked someone else to ring the customer so she can go on her 15 minute break

              2. Lilly makes it to work within the 7 minute grace period every day. Technically she is on time, but she’s not ready and at her station at her 7:30 shift time. How does this disturb workflow when she takes advantage of the grace period every day?
              a. It doesn’t disturb workflow because she is not late. The grace period is in effect so that she doesn’t have to be in right when her shift starts.
              b. Exploiting the grace period means the other technicians who arrive before the official start time have to cover her station until she comes in.
              c. Employers know how often employees are late and why, and communicate problems like traffic congestion to local governments, so the effect on the workplace is positive.

              3. You’re heading to work and you know it takes exactly 11 minutes to travel there. Your shift starts at 9 am. What time do you leave?
              a. I leave by 8:40 am at the latest so that I have time to park and walk in.
              b. I leave at 8:49 am because I know it takes 11 minutes to get there.
              c. I leave at 9:00 am because I know they can handle me being a little late.

              4. You are entering in an insurance card that you haven’t seen before. You’ve been struggling with it for five minutes and can’t figure it out. You are unsure of how to proceed, but the pharmacist is busy. What do you do?
              a. Politely interrupt the pharmacist to ask your question
              b. Ask a more senior technician if they have seen it before
              c. Go to a different station to avoid this insurance card

              5. Laura is a new pharmacy technician. The customers will ask her where to find an OTC or grocery item frequently, but she doesn’t know yet. She asks you how she can become more familiar with where everything is. What do you say?
              a. Suggest that she ask the manager for front store training so that she can become more familiar with the store
              b. Tell Laura that it takes time to learn the store, and to keep asking the other techs and pharmacists
              c. Tell Laura she that she should identify this problem’s quadrant and decide whether to ask or act

              6. You are working in the pharmacy and a huge order arrives. You know you have to finish putting away the order before your shift ends, but prescriptions and patients keep popping up. What do you do?
              a. Prioritize the customers and prescriptions that are here now and do as much of the order as possible
              b. The other technicians are busy too, but leave it for them because you’ve had to put the order away on three recent days
              c. Multitask by putting the order away as you ring customers and retrieve and count controlled substances

              7. The phone is ringing! When you answer it, a provider is on the line. She’s very frustrated because she’s been on hold for 10 minutes, and she “doesn’t have the time for this kind of thing” and “needs an answer ASAP.” She has a clinical question about a medication you fill very frequently. What is the most appropriate response?
              a. ACT—you’ve been a tech for four years; you’ve seen this medication dozens of times. You know enough to answer the provider’s question.
              b. ASK—you’re in the middle of something else right now. Ask another tech to handle this provider.
              c. ASK—the pharmacist should take the call, since it involves a clinical question and you may not know all the details.

              8. The phone is ringing! When you answer it, a provider is on the line. She’s very frustrated because she’s been on hold for 10 minutes, and she “doesn’t have the time for this kind of thing” and “needs an answer ASAP.” She has a clinical question about a medication you fill very frequently. What quadrant of workplace activity best describes this situation?
              a. Quadrant 1: important and urgent
              b. Quadrant 2: important but not urgent
              c. Quadrant 4: not important and not urgent

              9. Flu season is coming. Martha, an experienced pharmacy technician, knows that the store serves a very elderly population. She decides to ask the pharmacist to order more high potency flu vaccines, in anticipation of a higher customer demand. This best describes which time management technique?
              a. Good organization
              b. Planning ahead
              c. Multitasking effectively

              10. You’ve just transferred pharmacies, and you’re trying to figure out the lay of the land. It’s really hard to find things in your new pharmacy. Some meds are ordered by brand name, some by generic. Topicals, inhalers, and DME are all combined on the same shelf. When you bring this up to other techs, they sympathize but say you’ll figure it out eventually, like they had to. Which time management technique would best solve this issue?
              a. Acting instead of asking
              b. Multitasking effectively
              c. Good organization

              References

              Full List of References

              References

                 

                Motivation to be the Best Drug Information Station

                Learning Objectives

                 

                After completing this application-based continuing education activity, pharmacists will be able to

                • Recognize key elements of a drug information request
                • Describe a typical process for researching drug information requests
                • Prioritize information in the final written response
                • Identify the best language to use based on the inquiring party’s needs

                After completing this application-based continuing education activity, pharmacy technicians will be able to

                • Identify questions that are within the pharmacy technician’s scope of practice
                • Recognize tools and resources to use when attempting to answer a drug information question
                • Complete the steps to completing a drug information request that is within the pharmacy technician’s scope of practice

                  Cartoon person standing in front of gigantic question mark

                   

                  Release Date: September 15, 2023

                  Expiration Date: September 15, 2026

                  Course Fee

                  Pharmacists: $7

                  Pharmacy Technicians: $4

                  There is no funding for this CE.

                  ACPE UANs

                  Pharmacist: 0009-0000-23-035-H01-P

                  Pharmacy Technician: 0009-0000-23-035-H01-T

                  Session Codes

                  Pharmacist:  23YC35-PXK63

                  Pharmacy Technician:  23YC35-KPX44

                  Accreditation Hours

                  2.0 hours of CE

                  Accreditation Statements

                  The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-035-H01-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

                   

                  Disclosure of Discussions of Off-label and Investigational Drug Use

                  The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

                  Faculty

                  Sumoda Achar
                  PharmD and MBA Candidate 2024
                  UConn School of Pharmacy
                  Storrs, CT

                  Shelly Evia
                  PharmD Candidate 2024
                  UConn School of Pharmacy
                  Storrs, CT

                  Stefanie Nigro, PharmD, BCACP, CDCES
                  Associate Clinical Professor
                  UConn School of Pharmacy
                  Storrs, CT

                  Jeannette Y. Wick, RPh, MBA
                  Director Office of Pharmacy Professional Development
                  UConn School of Pharmacy
                  Storrs, CT

                  Faculty Disclosure

                  In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

                  Samoda Achar, Shelly Evia, Jeannette Wick, and Stefanie Nigro do not have any relationships with ineligible companies.

                   

                  ABSTRACT

                  Pharmacists and pharmacy technicians often field questions from patients or other healthcare providers. Pharmacists may be more accustomed to answering questions than pharmacy technicians are, but that doesn't mean that pharmacy technicians can't answer appropriate questions. Pharmacy staff members should know their scope of practice and be willing and able to answer questions that fall within the scope of practice. Using an organized approach can help pharmacy staff members answer questions efficiently and effectively. Documentation is also an important aspect of drug information questions, as is saving the information in case it is needed later.

                  CONTENT

                  Content

                  INTRODUCTION

                  A drug information (DI) request is a medication-related question posed by any interested party, but usually a healthcare professional or a patient. As the healthcare team’s drug expert, one of a pharmacist’s main duties is answering these queries effectively and providing an answer that is appropriate for the inquirer’s level of expertise. Pharmacy technicians and pharmacy interns also answer some drug information questions (see TECH TALK SIDEBAR). This continuing education activity outlines various drug information questions that pharmacy staff field most often and describes a methodical approach to ensure pharmacy staff answer requests effectively and accurately.1

                   

                   

                  TECH TALK SIDEBAR: Questions within the Pharmacy Technician’s Scope of Practice?2,3

                  Pharmacy technicians and interns can answer general questions that are within the bounds of their education and training. That vague statement requires some interpretation. If the answer is common knowledge (not specialized pharmaceutical knowledge), technicians can answer. In addition to working with supervising pharmacists to interpret the statement, pharmacy technicians and interns need to know state law governing their scope of practice.

                   

                  Pharmacy technicians and interns are often the first point of contact for customers who want over-the-counter (OTC) medications. Technicians can answer general questions about ingredients if the information is on the label. Some examples include

                  • Does this product contain acetaminophen? What brands of acetaminophen do you stock?
                  • Where are the medicines for pain?
                  • Is there a less expensive generic or store brand for this product?
                  • Do you have any [insert name of prescription medication] in stock?
                  • Do I need to refrigerate this liquid antibiotic?
                  • What does “analgesic” mean?
                  • What does “sustained release” mean?
                  • Is this prescription for a controlled substance?
                  • Why can’t I refill this prescription today?

                   

                  Pharmacy technicians and interns can also convey information from the pharmacist but should be careful. A PRO TIP is that if technicians or interns don’t understand what the pharmacist says, they should ask the pharmacist to make the information clearer. And if the answer is long or complicated, they should write it down and recite it back to the pharmacist before transmitting it to the person with the question.

                   

                  Helping customers find specific medications or classes of medications is within the technician’s scope of practice. When patients have questions about their medications, doses, and how best to administer them, technicians may hesitate to answer. If the information is clearly printed on the prescription label, on the auxiliary labels, or contained in an FDA-approved Medication Guide, the technician or intern can answer.

                   

                  Technicians and interns need to work with the supervising pharmacist to determine if they can answer other questions. When in doubt, technicians should consult with or refer the question to the pharmacist. Technicians and interns must refer questions about potential adverse effects, administration problems, possible alternative medications, and clinical issues to the pharmacist. Before referring the patient, they can collect some baseline information. They cannot counsel or give advice, even if the medication is OTC.

                   

                   

                  Depending on the practice setting, the nature and complexity of DI requests can vary. Being able to answer DI requests is every pharmacy employee’s responsibility (although the type of information varies and at a certain level, the response is the pharmacist’s primary responsibility). Having an organized approach to answering DI questions is highly relevant when working within the community and hospital settings.4

                   

                  Pharmacy employees who work primarily within a community setting can expect to receive DI requests from patients and from practitioners. These requests can range from asking about drug storage requirements (which a technician can usually answer) to consequences of taking an OTC medication in combination with prescription drugs, to requests regarding the safety of a medication for an uncommon or off-label indication. Pharmacists who work in hospital settings can expect to receive most DI requests from colleagues within the care team. For instance, a DI request could come from a prescriber asking about medication absorption and distribution in a patient with comorbid conditions, or from a nurse asking if a medication can be crushed. Pharmacists who work in industry settings, however, may receive medication information requests that vary greatly from those received in clinical settings.4

                   

                  All DI requests require referencing reliable materials and sometimes, various internal policy or research documents. While DI requests are diverse, they all require similar analysis of sources and communication to provide a quality answer. Because pharmacy employees at different levels of responsibility can answer DI questions, this continuing education activity will call the person asking the question the requestor and the person finding the answer the respondent.

                   

                  SCREENING THE REQUEST

                  One of the most confounding situations in the pharmacy occurs when someone asks a question, the respondent spends times finding an answer, and then the requestor says, “Oh, that’s not what I needed to know!” Sometimes, requestors don’t really know how to ask questions effectively. This is a problem that all customer service fields encounter, and answering DI requests is both a clinical function and a customer service. It’s why when you call many customer service lines, the customer service representative will say, “OK, what I hear you asking is….” and then rephrase the question.5

                   

                  To answer DI requests effectively, the respondent must thoroughly understand the question.5 Very specific questions tend to be easily answerable, while others are more general or vague. In both instances, respondents need to ensure they understand the question. They can rephrase the question in their own words and say, “Let me make sure I understand. Do you mean….”, or they can use open ended questions (questions that cannot be answered with a yes or a no) to ask the requestor to provide more information. This avoids answering a question that wasn’t asked or intended or was poorly formulated.

                   

                  Often, requestors don’t know how to ask a question that will provide the information they need. The hallmark of this type of question is that the requestor may use jargon inappropriately or words that don’t seem to make sense. Respondents can say, “Excuse me, I’m not sure I understood entirely. Can you rephrase the question?” or “Pardon me, but I didn’t quite understand the question. Can you tell me a little more about what you want to know and why?” That final word—WHY—provides the impetus for the requestor to provide necessary information.

                   

                  Once the question has coalesced and both parties agree on its intent, the respondent can solicit important details from the requester and, if applicable, the patient, before delving into a search. At this point, the respondent needs to spend time actively listening to the requestor’s explanations.

                   

                  This can be difficult if the requestor is long-winded, difficult to understand, or cognitively impaired, so it requires patience. Here’s a PRO TIP for listening: it’s called the traffic-light-rule.6 During the first 30 seconds (which seems like a short period of time, but is actually relatively long), the requestor’s “talking light” is green. Pharmacy staff should let them talk. In the next 30 seconds, the requestor’s light is yellow: pharmacy staff probably have enough information and should make note of comments or questions. After one minute, the requestor’s talking light is red: pharmacy staff should be comfortable stopping the requestor politely or asking questions.6

                   

                  Before continuing, review the following DI requests. How would you proceed? Later  in this activity, we’ll provide a description of the ideal process.

                   

                  Pharmacist DI request #1: TN, 35-year-old obese female (BMI = 32.4 kg/m2) with uncontrolled type 2 diabetes will start on an atypical antipsychotic today to manage schizophrenia. TN’s psychiatric nurse practitioner (NP) calls with questions about drug selection. The NP mentions that TN’s drug formulary lists aripiprazole, haloperidol, olanzapine, and quetiapine as tier 1 preferred options. The NP wants your opinion as to which atypical antipsychotic may be most appropriate to prescribe for TN. What do you suggest?

                   

                  Pharmacist DI Request #2: You work at a tertiary care internal medicine center. MS, an 80-year-old female, was recently admitted to the medicine floor. She had fallen when she was trying to use the restroom at her nursing home and presented to the emergency department with a wrist fracture. She suffers from insomnia and other comorbidities. Her medication list includes lisinopril 20 mg daily, metformin 500 mg twice daily, rosuvastatin 20 mg daily, and lorazepam 0.5 mg PRN anxiety and sleep. The nursing home staff states that MS received more doses of lorazepam in recent weeks. The medical resident believes that the increased lorazepam use could have contributed to the fall and wants to know if trazodone would be a safer replacement for MS’s insomnia. How do you respond?

                   

                  Technician DI Request #1: I left this medication in my bathroom for four days, and then I noticed it says, “Keep in the refrigerator.” My house is cold, and the bottle didn’t feel warm. Is this still good, and if it isn’t, what should I do?

                   

                  Technician DI Request #2: My child is having trouble swallowing her medication and refuses to take it. Are there any easier ways I could give it to her?

                   

                  Identify Critical Information

                  Although it may seem counterintuitive, beginning with the end in mind is critical and the person gathering information must determine the requestor’s preferred response format. This means asking how the requester wants to receive the response. The respondent will need to adjust the answer according to the requestor’s preferences. Some requestors will want to wait for an answer. If the information is to be communicated through email or an electronic medical record, respondents may use their organization’s required format (a SOAP note or similar formats; see Table 1), but formats used in medical records may not be the most efficient approach in person or over phone. In person or on the phone, respondents need to use a more conversational tone. Furthermore, the respondent will need to determine the requestor’s level of medical competency and tailor the response accordingly. If the requestor is a patient, it is more appropriate to use simple language than if a provider asked the same or  similar question. Respondents will have to evaluate these factors critically to provide a sound and comprehensive answer.7

                  Table 1. Formats for Communicating Critical Information8,9

                  Communication Format Parts of the format Uses
                  SOAP S: Subjective information

                  This section includes descriptive information about a patient’s symptoms, feelings and experiences.

                   

                  O: Objective information

                  This section includes pertinent lab values, imaging, or diagnostic tests.

                   

                  A: Assessment

                  In this section the subjective and objective information are taken into consideration to make an assessment regarding the patient's disease states.

                   

                  P: Plan/ Follow Up

                  This section outlines a detailed plan regarding the patient's treatment and the follow-up and monitoring required.

                  This format is a widely-used written format in healthcare. It helps organize pertinent patient information and efficiently present an answer. This format is especially useful when the respondent must consider multiple pieces of information.
                  ISBAR I: Introduction

                  Introduction of the pharmacist and the respondent, and the pharmacist’s role and location.

                   

                  S: Situation

                  What are the current events regarding the patient?

                   

                  B: Background

                  What has happened in the past with the patient?

                   

                  A: Assessment

                  Identify the problem at hand and make assessments regarding the patient's disease state.

                   

                  R: Recommendation

                  Outline the next steps and your plan.

                  This format is beneficial for verbal communication. It helps the presenter explain the problem at hand and the solution in a time efficient way.
                  TITRS T: Title

                  Introduction of who you are and your purpose in helping the patient.

                   

                  I: Introduction

                  Present the patient and the problems that the patient needs help with.

                   

                  T: Text

                  State subjective and objective information that is necessary to support any recommendations.

                   

                  R: Recommendation

                  Outline the treatment plan in a clear, complete, and concise manner.

                   

                  S: Signature

                  Include name, title, and phone number.

                  This format is beneficial when a brief and concise formal consult is needed to communicate a progress note towards a medical team.

                   

                  Assess the Urgency of the Response

                  While it is critical to provide an appropriate response for the question, doing so in a timely manner is just as critical. Asking the requestor is the simplest way to determine the expected response time. However, many times the requestor isn’t present or cannot be reached, and it is up to the respondent to determine which questions require immediate responses and which may not. Clinically critical topics include

                  • Medication safety: does the DI request ask if a certain therapy could cause or have caused harm to the patient?
                  • Time sensitivity of the treatment: how important is timeliness to the treatment and disease progression?
                  • How much of a concern is the problem to the requestor: does it seem that the requestor needs an immediate response?

                   

                  Sometimes, respondents don’t know the answer to the question immediately.10,11 Pharmacy staff will never be able to answer every question, but they can handle every question gracefully and provide a complete, accurate answer within a reasonable time. When they don’t know the whole answer, they should answer what they can immediately and tell the respondent that they need to do a little more research to answer the remainder. A PRO TIP is to tell the requestor when to expect an answer (and to be sure to follow through).10-12

                   

                  Obtain Sufficient Background Information

                  In simple words, this step is about getting to know the patient or problem or establishing a strong understanding of the patient’s relevant characteristics by obtaining background information. Since some patients have low health literacy, obtaining this information can be a challenge. However, narrowing the search to only include relevant information and filtering unnecessary information can make the process more efficient. This could be achieved by7

                  • Asking targeted questions to patients. For example, instead of asking patients if they take their medication regularly (a closed-ended question that can be answered with yes or no), asking when they last took their medications provides a more precise answer.
                  • Identifying avenues that can provide accurate information. For example, instead of asking patients what other medications they take, checking the local profile and/or contacting their community or specialty pharmacist to receive a medication list can be more accurate.
                  • Reviewing any available records like medical charts or dispensing records.

                   

                  Identify Extraneous Information

                  Obtaining complete information is important but ensuring that the information is pertinent to the question being asked is just as important.

                   

                  Many times, DI requests are in-depth and require researching two or more sources before arriving at an answer. While conducting this search, ensure that the sources are relevant to the problem at hand. For example, if a study suggests that a medication is contraindicated in a patient, determine if the patient’s characteristics are similar to the study’s population. Furthermore, extraneous information could come from data gathering as well. For example, a patient may have multiple diseases, but they may not all impact the problem at hand. Making this distinction is important to provide a thorough and accurate answer.7

                   

                  Answers to Pause and Ponder

                  Pharmacist DI request #1: Haloperidol is not an atypical antipsychotic; therefore, it would be eliminated immediately and the remaining atypical antipsychotics would be reviewed as outlined below:

                  Screen Request Pertinent patient information: past medical conditions (uncontrolled diabetes, schizophrenia). Medications on tier 1 of patient's formulary: quetiapine, olanzapine, haloperidol, aripiprazole.
                  Reformulate Request This is a therapeutics drug information request because the provider is looking for the best medication to treat the patient's schizophrenia without adding any contraindications to the patient's current medication list or concomitant medical conditions.
                  Formulate Response The provider made the request in writing, so a written response is most appropriate. The SBAR format would succinctly and effectively convey the message. First, we conducted a Google search and a tertiary source search (PubMed) including the pertinent patient information and request. Our search read "effects of antipsychotics on obesity and diabetes." Through this, we determined that some antipsychotics lead to changes in metabolic activity. Because the patient has diabetes that is exacerbated by weight gain, the best choice is an antipsychotic that does not have a significant effect on the metabolism. After conducting a more thorough primary source search on the metabolic effects of antipsychotics, we found that the best drug would be aripiprazole. Additionally, monitoring the BMI and efficacy would be appropriate.
                  Assess Understanding Provide the response in a professional and timely manner. Document the request to display accountability and in case there is a similar question in the future. Follow up with the requestor to access the outcomes and ensure that there are no lingering questions or concerns.

                   

                  Pharmacist DI request #2:  Off-label use of low-dose (25 to 100 mg) trazodone, a decades-old antidepressant with drowsiness as a side effect, is common.13 In fact, off-label usage for insomnia has surpassed its use for depression.14 The American Academy of Sleep Medicine does not recommend trazodone because of limited supporting data. A 2018 Cochrane review found equivocal evidence supporting its short-term use for insomnia, but little data on long‐term safety and efficacy exists.15 The Beers Criteria doesn’t highlight trazodone as a potentially inappropriate medication in older adults, not because of evidence demonstrating safety, but because of lack of studies demonstrating harm. However, a retrospective cohort study found low-dose trazodone was no safer with respect to fall-related injury risk than benzodiazepines among 15,582 nursing home residents aged 66 years and older. Future studies need to confirm trazodone’s safety with respect to other risks such as dependence, withdrawal, and cognitive impairment.16

                   

                  Technician DI request #1:

                  It would depend on the medication. Some medications, like amoxicillin, are refrigerated to preserve the taste while most others, such as insulin, are refrigerated to preserve the compound. The technician should ask what medication the patient is referring to and then look up the specific storage requirements for that medication. Some places where this information is available include Drugs.com (https://www.drugs.com/medical-answers/drugs-that-require-cold-storage-166784/) and (https://www.iehp.org/en/members/helpful-information-and-resources?target=emergency-safety). If the medication is not listed in these resources or the medication’s stability has possibly been compromised (such as exposure to extreme heat), the technician should consult the pharmacist.

                   

                  Technician DI request #2:

                  It would vary depending on the medication. Some medications have specific coating that needs to stay intact to ensure proper drug delivery, and such medications should not be crushed. Other medications do not have such restrictions and can be crushed, split in half, sprinkled in foods like applesauce, or have a liquid formulation that can be considered as an alternative with a doctor’s approval. The technicians should ask, “What medication is your child taking so that I can look it up?” Information regarding which medications can be crushed can be found in the following website https://pharmacist.therapeuticresearch.com/Content/Segments/PRL/2014/Aug/Meds-That-Should-Not-Be-Crushed-7309. If the medication or the specific dosage form is not available on the list, the technician should ask the pharmacist to review the medication.

                   

                  Recognize when to ask for additional support or information. While drug information requests can be challenging, involving other healthcare professionals to hear about their experiences with similar clinical situations can offer a new perspective. Some benefits of consulting with experts include formulating a patient-specific answer to the question whereas a study may be irrelevant. When the request requires analysis beyond the scope of a drug information search, it is appropriate to reach out to a professional. While this may take additional time, arriving at the correct answer is more important than to harm the patient unknowingly. And a PRO TIP is that if reaching out will mean you cannot answer the question in the time frame promised, contact the requestor and say you need more time and why.

                   

                  REFORMULATING THE REQUEST 

                  To ensure the core request is clear, the respondent will need to ask many questions, especially if requesters don’t know what question they need to ask. Before starting to research the answer, respondents need to gather information needed from the requestor. In addition, it’s prudent to identify resources the requestor has already consulted (and their reliability in case information needs to be corrected).

                   

                  Categorize the Request

                  Requests can be based on complex patient specific cases, for educational purposes, or geared towards a decision-making process in medication therapy for a specific patient demographic. To fully optimize patient care and provide evidence-based recommendations, it is helpful to ask specific questions and consider all factors pertinent to the specific DI request. Categorizing the request can help stay on track, address all concerns, and point the respondent to the appropriate resources. Table 2 lists common categories and the questions that can clarify the request.

                   

                  Table 2. Common DI Categories and Related Questions1

                  DI Category Related Questions
                  Allergy/Cross-reactivity

                   

                  Does the patient have any documented allergies?

                  What caused or is suspected to have caused the allergic reaction?

                  When did the patient take the medication, and when did the reaction occur?

                  What type of allergic reaction occurred?

                  Is this a class or drug specific effect?

                  Alternative, or Complementary Medicine

                   

                  Where did the patient obtain the medication?

                  Why is the requestor taking or interested in taking the medication?

                  What other medications or treatments are available?

                  ADR/Safety

                   

                  What are the possible side effects?

                  What monitoring parameters need to be considered?

                  Compatibility (Y-site, syringe, IV)

                   

                  What solution will medication be used in?

                  If applicable, how will the medications be administered?

                  Dosage/Route/Administration

                   

                  What is the route of administration?

                  What is the recommended therapeutic dose for pediatrics, adults, and geriatrics?

                  How should the medication be taken (with/without food, with water, etc)

                  Drug Identification

                   

                  What was the source of the medication (e.g., domestic or foreign)?

                  What is the generic and brand name?

                  Where did the medication come from?

                  Ingredients/Stability

                   

                  What physical conditions exist? (Temperature, light protectant, storage duration, diluents)

                  Are there IV admixture compatibility/non-admixture stability data available?

                  Interactions

                   

                  What are the possible interactions between:

                  ●      Drug-drug

                  ●      Drug-food

                  ●      Drug-lab

                  ●      Drug allergy

                  Kinetics

                   

                  What is the onset/half-life/duration?

                  What are the serum levels?

                  Is dialysis a consideration?

                  What is the medication’s bioavailability?

                  Pharmacoeconomics

                   

                  Are there other competitors on the market?

                  Are there cheaper alternatives with the same therapeutic effects?

                  What is the AWP pricing?

                  Pharmaceutics

                   

                  What is the drug route of administration and drug dosage?

                  What patient factors will affect the drug?

                  Age, weight, gender, organ function, current medications

                  Pharmacology What factors will affect drug metabolism and bioavailability?
                  Pregnancy/Lactation What health conditions does the mother have?

                  What medications is the mother currently taking?

                  What is the current trimester?

                  How long has the mother been taking the medication or expected to take this medication?

                  Will the drug be present in breast milk?

                  How will the drug affect the infant?

                  What is the infant's age?

                  What health conditions do the mother and infant have?

                  Was the infant a full term or premature delivery?

                  Vaccinations

                   

                  Is the vaccination appropriate for the patient?

                  What are some side effects to monitor?

                  When should the patient get the vaccination?

                  Therapeutics

                   

                  What is the desired effect?

                  Is the goal cure or prophylaxis?

                  What previous medications and doses has the patient used?

                  Is this medication being used for an FDA approved or off-label use?

                  Toxicity

                   

                  What are possible sequelae?

                  What management strategies are available?

                  Abbreviations: ADR = adverse drug reaction; AWP = Average Wholesale Price; FDA = Food Drug Administration; IV = Intravenous

                   

                  Finding Reliable Sources

                  Being able to locate sources efficiently and correctly for a DI request is very important. Three main types of sources are available: primary, secondary, and tertiary.

                  • A primary source is any original research found in journals. Examples of primary sources are trial results found in the New England Journal of Medicine (NEJM) or similar journals in which researchers use a trial design to answer a specific question. (Note that NEJM and similar journals also publish secondary source materials, too.) This is the strongest Limitations of using this evidence include lack of access to journals that require paid subscriptions and lack of good search skills to find relevant papers.
                  • Secondary sources analyze, interpret, present, or restate information from primary sources. Textbooks, books and review articles, commentaries, guidelines, and Medline are examples of secondary sources.
                  • Tertiary sources compile information from other sources and organize it. Lexicomp , Micromedex, and DynaMed are common tertiary sources for DI requests as they use information from Food and Drug Administration-approved complete prescribing information (package inserts) and clinical studies. One limitation to be aware of is these sources are not updated rapidly therefore the information could be old and outdated.

                   

                  Determine the Best Source

                  When evaluating DI requests, in most cases the best course of action is to start with tertiary sources, such as textbooks or DI databases, when possible.1 These platforms provide a starting point and often suggest a basic idea for the answer. For many DI requests such as dosage, half-life, or adverse effects, the tertiary resource may provide a sound answer. Requests asking to compare two medications’ efficacy or assess the appropriateness of an uncommon or off-label medication use may require further research. Databases that identify off-label use include Micromedex.  In such cases, a primary source is the best resource. References sections of databases like DynaMed and Micromedex can be a great start for finding appropriate primary sources. Using search engines such as MEDLINE, PubMed or Google Scholar (scholargoogle.com) can provide access to relevant primary literature as well.1 Reviewing two to three sources is good practice for most drug information requests. Respondents must determine the relevance of the studies by evaluating if the trial size was large enough to be statistically reliable, if its findings were clinically significant, and if the patient population is similar to the patient.

                   

                  Use General Search Engines Appropriately

                  Using general search engines like Google, and Microsoft Edge can be an acceptable starting point for a search. A metasearch engine is usually better. A metasearch engine is a platform that aggregates the results from multiple search engines and organizes them based on their relevance. Examples of metasearch engines include Dogpile, ixquick, and Metacrawler which aggregate information from sources like Google and Yahoo as well as videos posted on various platforms.

                  Researchers must consider the following factors when determining a source’s credibility17:

                  • Is the information’s original source listed and reliable?
                  • Does the funding for the site come from a sound source such as a university (.edu), an established patient advocacy organization or a professional society (.org), or a government-funded organization (.gov)?
                  • How is the information presented and how is it supported?
                  • Who wrote the article on the webpage? Is the author a credible healthcare provider or a journalist writing about a medical topic?
                  • Is the information updated and verifiable with other sources?

                   

                  Table 3 matches types of information and reliable sources to find information.

                   

                  Table 3. Finding Reliable Sources for Drug Information Requests

                  Type of Request Source
                  Alternative or Complementary medicine Natural Medicine Comprehensive Database
                  ADR/Safety Lexicomp*, UpToDate*, Micromedex*, Package Inserts
                  Compatibility FDA-approved prescribing information, Trissel’s Stability of Compounded Formulations*
                  Dosage/Route/Administration Complete prescribing information, Lexicomp*, Micromedex*, etc.
                  Drug Identification Lexicomp* (Drug I.D) Drugs.com, WebMD Pill identifier, RxResouce.org (pill identification tool)
                  Ingredients/Stability Complete prescribing information, Lexicomp*
                  Interactions

                   

                  CYP Complete prescribing information, Lexicomp*
                  HIV HIV Drug Interactions

                  Clinicalinfo Drug Database

                  Kinetics Complete prescribing information, Lexicomp*
                  Pharmacoeconomics Studies published in pharmacoeconomics journals
                  Pharmaceutics PubMed* and primary sources
                  Pharmacology Lexicomp*, Micromedex* and could require further research with primary sources
                  Pregnancy/Lactation LactMed
                  Regulatory The Pharmacy Practice Act, Pharmacist's Manual
                  Therapeutics Dynamed*, UpToDate*, DiPiro’s textbook
                  Toxicity MSDS, PubChem, Micromedex*
                  Vaccinations CDC vaccine and immunization schedule, Lexicomp
                  Veterinary Information Plumb’s Veterinary Drug Handbook

                  *=sources requiring a subscription or payment

                  Abbreviations: ADR = Adverse Drug Reactions; CDC = Center for Disease Control and Prevention; CYP = Cytochrome P450; FDA = Food and Drug Administration; MSDS = Material Safety Data Sheet;  HIV = Human immunodeficiency virus

                   

                  Another relevant option that many healthcare professionals are considering for answering drug information requests is artificial intelligence (AI) platforms such as ChatGPT. While these seem to be able to provide responses that are based on data and research, the issue that users run into is the AI is not able to approach/appraise situations critically. While AI can provide information that may be or seem accurate, it is cannot assess the data that it uses to ensure that it is relevant to the situation or specific patient. Additionally, AI doesn’t cite its sources, meaning that it can be difficult to assess the appropriateness of the source. Last, it is important to realize that AI has sometimes provided wrong answers that could lead to patient harm and therefore need to be checked against reliable sources.

                   

                  Figure 2 summarizes a typical drug information process.

                  Figure 2. The Drug Information Process


                  FORMULATE THE RESPONSE 

                  Verbal responses tend to be easier for most people than written responses, but respondents should document every request. One simple rule should guide the response: Use principles of clear communication. Clear communication reduces risks of misinterpretation and increases the requestor’s understanding. It optimizes patient care. Clear, concise sentences that are short (fewer than 25 to 32 words) and straightforward create an ideal response.18 It is best to be comprehensive with adequate information and complete sentences that leave no confusion. Each statement should have a clear purpose with no extraneous information or unnecessary words. Respondents must paraphrase important information from accumulated data taken from reliable sources, while avoiding copying and pasting from other outside sources. The response must focus on the audience (the requestor) and the requestor’s background, remembering that different types of professionals have different education and focus.18

                   

                  Organize and Evaluate Information 

                  Organizing information makes research and presentation straightforward and simple for the audience to understand quickly. Templates are available to help keep information organized and formulated, but they have advantages and disadvantages.

                   

                  • Pros: Templates provide consistency that makes it easier for requesters to follow. (Saving your responses to DI requests is a PRO TIP, discussed in the SIDEBAR) Templates also provide an idea about how the completed presentation will look and reduce the time associated with creating the response. Some organizations provide templates for their employees. Lacking an approved template, respondents can find customizable templates from their workplace or university. Example templates found in the appendices show how useful templates can be. Templates can act as checklists to remember what should be included in a drug information response.
                  • Cons: Many templates limit the amount of allowable customization or text, and respondents must be knowledgeable about editing templates. Templates may also limit the approach to the topic and limit the information to standard or predictable fields; this is a problem when the question is unique or unusual. It is important to understand that templates are guides in answering requests and are not restrictions.

                   

                  Templates that can be used while answering drug information questions have different strengths and limitations. The choice of template can be dependent on the pharmacist’s preference as well as the type of drug information request. We reviewed the templates in the addendum and assessed their utility. Take a minute to look at them. How do your assessments compare to ours?

                   

                  Template 1 located in Appendix 1:

                  Pros: Extensive prompts for what should be included in a drug information response. This format is very detailed which could be useful for less experienced users.

                  Cons: Could be too detailed to be used for a wide range of requests. It lacks space, so users will have to use it against a document that they have already created.

                   

                  Template 2 located in Appendix 2:

                  Pros: This format displays the drug information request topic quickly, organizes patient information and the response, and includes references to use for evidence-based literature support. It is broad enough to be used for multiple types of requests. It could be especially helpful for pharmacists who receive a wide variety of requests as it allows them to focus and tailor responses appropriately.

                  Cons: Insufficient prompts or guidance responders, making it more suitable for experienced pharmacy staff. This would too broad for beginners or pharmacy students because it does not outline various aspects of drug information responses.

                   

                  SIDEBAR: Saving FAQs for Future Use: The FAQ File19,20

                  Pharmacy staff often notice that they receive the same or similar questions repeatedly. Each time a requestor asks the question, the respondent must answer again. When employees in the pharmacy discuss questions they receive, they may find that although each of them has only answered a specific question once or twice, collectively they are answering the same question often. A frequently asked question (FAQ) file has numerous advantages. It can

                  • Save time for everyone including the requestor
                  • Standardize the answer so that it is consistent each time staff answer the specific question
                  • Provide the answer in clear language
                  • Create an answer that technicians and students can give to requestors without asking the pharmacist to intervene
                  • Refer requestors to web sites or documents for additional information

                   

                  To develop a reliable FAQ file, pharmacy staff should take several steps:

                  • Identify the questions that are asked frequently.
                  • Develop a simple format for all FAQs. Usually, the actual question appears at the top of the documents, with the answer below.
                  • Start small and ask one employee to draft the FAQ.
                  • Have two or three people review the FAQ, including a pharmacist and at least one or two support personnel. Encourage reviewers to provide constructive criticism. If the FAQ usually comes from a colleague or patient, involve colleagues and patients in the review.
                  • A good process for reviewing FAQs is to ask a reviewer to read to a certain point and then stop. The project coordinator should ask, “Can you tell me in your own words what you just read?” If the reviewer explains and the information is incorrect, the project coordinator should not correct the reviewer; rather, the project coordinator should make a note that the section needs work and why.
                  • The project reviewer should ask additional, open-ended questions including
                    • What’s your general reaction to this draft FAQ?
                    • What did you like about this draft FAQ?
                    • What did you dislike about this draft FAQ?
                    • Is anything in this draft FAQ confusing?
                    • What would you do if you got this document?
                    • What do you think the writer was trying to do with this document?
                    • And here’s a PRO TIP: Often, people will not answer directly because they do not want to appear uneducated or picky. A way to circumvent this issue is to ask, “Thinking of other people you know who might get this document…”
                      • What about the document might work well for them?
                      • What about the document might cause them problems?
                    • Once the FAQ completes the process and is ready for “prime time,” save it in a format that cannot be edited (i.e. a PDF that is locked for editing) and upload it to a shared file or drive where all employees can access the document and print or clip it to an email when needed.

                   

                  Finally, drugs and drug information change over time. Organizations that use FAQ files must schedule routine review (at least annually and more often if necessary) to ensure that the content in FAQ files remains current and correct.

                   

                  Proofing and Editing Drafts 

                  Proofing and editing written drafts entails first fact-checking the narrative and the sources used, and then reviewing the text to ensure it is clear and professional. The respondent must re-assess and re-evaluate each source and the information gathered. Asking other healthcare professionals who have expertise to contribute to or proofread the draft is smart. Collaborating with colleagues can be beneficial, especially in healthcare. The recent emphasis on interdisciplinary approaches reminds us that healthcare professionals from multiple backgrounds need to collaborate and exchange information more often than not. Colleagues can also help confirm or modify any information, while also giving feedback to learn how to better future drug information requests.

                  Once the data is confirmed as accurate, the last step is to double check for spelling and grammar errors and ensure the response is clear and concise. A skilled pharmacy technician is often an exceptional collaborator in this step.

                   

                  Document, Document, Document

                  Documentation is helpful when pharmacy employees have to refer back to that specific topic on a similar drug information question or when colleagues have a similar request in the future. Documenting the response will aid as a reference point and could help clinicians in the future make decisions regarding patient care.21 Documentation will also display accountability and the respondent’s value to the organization and the interdisciplinary team. Many healthcare organizations have policies and procedures for documenting DI requests, and all staff should follow them if they exist.

                   

                  ASSESS REQUESTOR’S UNDERSTANDING AND SATISFACTION 

                  Following up after responding to a DI request is a professional action. The respondent should follow up with the requestor in a timely manner and assess the outcomes. If the requestor is not completely satisfied, the respondent can adjust the answer and recommendations appropriately.7 Follow-up will also reveal if the requestor has implemented the recommendation (and if it worked), provide feedback for potential modifications in future DI requests, and show professionalism and dedication to patient care. A PRO TIP is to document the follow-up and outcomes.

                   

                  CONCLUSION

                  Pharmacy teams have serious responsibilities related to DI requests, which can cover a broad spectrum of topics and specialties. Pharmacists, pharmacy technicians, and pharmacy students should use a methodical approach, followed by documentation. As the ever-changing landscape of healthcare, medicine, and technology continues to advance, the providing drug information will remain an integral part of the pharmacist’s responsibilities.

                   

                  Table 4 provides additional resources.

                   

                  Table 4. Additional Resources

                  Systematic Approach to Answering Drug Information Requests

                   

                  This resource helps characterize the various types of drug information requests

                  https://www.ashp.org/-/media/assets/pharmacy-practice/resource-centers/preceptor-toolkit/sicp-busy-day-systematic-approach-answering-drug-info-requests.ashx?la=en&hash=7C8B36648FAB999DE761D3AE37BFE48A847B8551
                  7 Tips on Improving Communication in Your Pharmacy

                   

                  This resource provides guidance on how best to speak with patients

                  https://www.pbahealth.com/elements/7-tips-on-improving-communication-in-your-pharmacy/
                  Formulating an Effective Response: A Structured Approach

                   

                  This resource provides strategies to answer formulated drug information requests.

                  https://accesspharmacy.mhmedical.com/content.aspx?bookid=2275&sectionid=177197497 :
                  ASHP Guidelines on the Pharmacist’s Role in Providing Drug Information

                   

                  This resource provides suggestions on how to answer a formulated drug information request.

                  https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/pharmacists-role-providing-drug-information.pdf
                  How To Evaluate Health Information on the Internet: Questions and Answers

                   

                  This resource provides approaches on how to find credible sources to answer drug information requests.

                  https://ods.od.nih.gov/HealthInformation/How_To_Evaluate_Health_Information_on_the_Internet_Questions_and_Answers.aspx

                   

                   

                  Templates:

                  Requirements checklist for drug information Response1 - UBC Blogs. Accessed July 3, 2023. https://blogs.ubc.ca/oeetoolbox/files/2019/01/Requirements-Checklist-for-Drug-Information-Response.pdf.

                  Drug Information Request and Response Form.; 2017. Accessed July 3, 2023.

                  https://blogs.ubc.ca/oeetoolbox/files/2019/01/DIR-Example.pdf

                  PHRM Handbook. Accessed July 3, 2023.

                  https://blogs.ubc.ca/oeetoolbox/files/2019/01/Drug-Information-Request-and-Response-Fillable-Form-.pdf

                  Pharmacist Post Test (for viewing only)

                  Pharmacy: Motivation to be the Best Drug Information Station

                  Pharmacists Post-test

                  After completing this education activity, pharmacists will be able to
                  1) Recognize key elements of a drug information request
                  2) Describe a typical process for researching drug information requests
                  3) Prioritize information in the final written response
                  4) Identify the best language to use based on the inquiring party’s needs

                  1. Which of the following describes a good practice in answering complicated drug information requests?
                  A. Reviewing at least two sources when looking for answers
                  B. Using a couple of metasearch engines (e.g., Dogplie)
                  C. Using tertiary sources (e.g., Micromedex, Lexicomp)

                  2. A patient approaches the community pharmacy counter asking about experiencing GI upset when taking his daily medications. His medications include metformin, prednisone and lisinopril. Which of the following is an appropriate targeted question to obtain key information?
                  A. Are you taking your medications at the correct times?
                  B. How are you taking your medications?
                  C. Are you taking your medications with food?

                  3. Which of the following are elements of screening a response to correctly identify the key elements in a drug information request?
                  A. Setting aside extraneous information to focus on pertinent information
                  B. Relying solely on the patient’s recollection of medical information
                  C. Asking closed-ended questions to extract targeted information

                  4. Which of the following correctly identifies the process of answering a drug information request?
                  A. Screen request for pertinent information, reformulate request, formulate response, assess understanding
                  B. Assess understanding, reformulate request, screen request for pertinent information, formulate response
                  C. Formulate response, reformulate request, access understanding, screen request for pertinent information

                  5. A doctor asks how many hours prior to dialysis medication X should be administered to ensure an optimal response. Which category would the question fall under?
                  A. ADR inquiry
                  B. Therapeutics
                  C. Kinetics

                  6. If asked a question about the dosing for atorvastatin for a 40-year-old patient recently diagnosed with dyslipidemia, which of the following sources would be the most appropriate place to look for the answer?
                  A. Natural medicine comprehensive database
                  B. LactMed
                  C. Lexicomp

                  7. Which of the following correctly pairs the appropriate language and the type of requestor who is asking for information?
                  A. Patient: “Possible adverse events include gastrointestinal upset and an increase frequency of bowel movements.”
                  B. Provider: “The patient may have a tummy ache and have to go to the bathroom to poop a lot.”
                  C. Nurse: “Patients who take this medication may develop some side effects including nausea and diarrhea”

                  8. Which of the following statements identifies the purpose of the “assess understanding” step
                  A. To gauge requestors’ satisfaction and determine if they implemented the recommendation or need further assistance
                  B. To test the requesters health literacy and attempt to match the language you use to the language they understand
                  C. To provide new information to requestors so that they have multiple options in case the first answer didn’t resolve their problem

                  9. You have been tasked with creating a general drug information template. Which of the following are important aspects to include in your template
                  A. Prior medical history; lab values; current medications
                  B. Patient’s education; reference authors; siblings’ ages
                  C. Patient’s age, financial status, current medications

                  10. A patient approaches the pharmacy stating that she left a refrigerated medication on her front porch for more than 24 hours. She asks if it is still safe to use the medication. Which of the following is the most efficient way to answer?
                  A. Google the name of the drug and look for a patient or nurse blog site
                  B. Look at the package insert for the medication in the pharmacy database
                  C. Find two the primary sources for the stability in various temperatures

                  Pharmacy Technician Post Test (for viewing only)

                  Pharmacy: Motivation to be the Best Drug Information Station

                  Pharmacy Technician Post-test

                  After completing this education activity, pharmacy technician’s will be able to
                  1) Identify questions that are within the pharmacy technician’s scope of practice
                  2) Recognize tools and resources to use when attempting to answer a drug information question
                  3) Complete the steps to completing a drug information request that is within the pharmacy technician’s scope of practice

                  1. Which of the following questions would require counseling from a licensed pharmacist?
                  A. Do I store this liquid antibiotic at room temperature or refrigerate it?
                  B. Is there a less expensive generic or store brand for this product?
                  C. What other medications should I avoid taking with this prescription?

                  2. A patient approaches the community pharmacy counter asking about experiencing GI upset when taking his daily medications. His medications include metformin, prednisone, and lisinopril. Which of the following is an appropriate targeted question to obtain key information?
                  A. Are you taking your medications at the correct times?
                  B. How are you taking your medications?
                  C. Are you taking your medications with food?

                  3. When can pharmacy technicians answer questions and help customers find specific medications or classes of medications while staying within their scope of practice?
                  A. If information is clearly printed on the prescription label, on auxiliary labels, or in an FDA-approved Medication Guide.
                  B. If the supervising pharmacist is busy and will not have time to help a customer for at least 15 minutes to an hour.
                  C. When the technician does not like the specific customer and would like to see the customer leave as soon as possible

                  4. Which of the following correctly identifies the process of answering a drug information request?
                  A. Screen request for pertinent information, reformulate request, formulate response, assess understanding
                  B. Assess understanding, reformulate request, screen request for pertinent information response, formulate response
                  C. Formulate response, reformulate request, access understanding, screen request for pertinent information

                  5. A 58-year-old woman comes to the pharmacy counter and tells you she received her Shingrix vaccine two weeks ago and does not remember when she needs to come back for her next Shingrix dose. Where would a pharmacy technician be able to find information about vaccine scheduling to answer the patient’s question?
                  A. Trissel’s Stability Compendium
                  B. LactMed and lexicomp
                  C. CDC Vaccine and Immunization Schedule

                  6. According to the traffic-light-rule, what should the pharmacy staff member do after one minute of listening?
                  A. Pharmacy staff should let patients continue to talk because it’s unlikely they have disclosed enough information.
                  B. Pharmacy staff probably has enough information and should make note of comments or questions.
                  C. Pharmacy staff should be comfortable stopping the requestor politely or asking additional questions.

                  7. A mother is picking up her son’s antibiotic prescription and asks if there is a specific way that her son should take the medication. Where would you find this information about the route of administration for antibiotics?
                  a) PubMed
                  b) Pharmacists Manual
                  c) Lexicomp

                  8. Which of the following statements identifies the purpose of the “assess understanding” step
                  A. To gauge requestors’ satisfaction and determine if they implemented the recommendation or need further assistance
                  B. To test the requesters health literacy and attempt to match the language you use to the language they understand
                  C. To provide new information to requestors so that they have multiple options in case the first answer didn’t resolve their problem

                  9. You have been tasked with creating a general drug information template. Which of the following are important aspects to include in your template
                  A. Prior medical history; lab values; current medications
                  B. Patient’s education; reference authors; siblings’ ages
                  C. Patient’s age, financial status, current medications

                  10. A patient approaches the pharmacy stating that she left a refrigerated medication on her front porch for more than 24 hours. She asks if it is still safe to use the medication. Which of the following is most efficient way to answer?
                  A. Google the name of the drug and look for a patient or nurse blog site
                  B. Look at the package insert for the medication in the pharmacy database
                  C. Find two the primary sources for the stability in various temperatures

                  References

                  Full List of References

                  References

                     
                    1. Systematic Approach to Answering Drug Information Requests Systematic Approach to Answering Drug Information Requests Step 1: Obtain Background Information. Accessed August 8, 2023. https://www.ashp.org/-/media/assets/pharmacy-practice/resource-centers/preceptor-toolkit/sicp-busy-day-systematic-approach-answering-drug-info-requests.ashx?la=en&hash=7C8B36648FAB999DE761D3AE37BFE48A847B8551
                    2. Understanding Your Scope of Practice as a Pharmacy Technician. Career Advice. Accessed March 25, 2023. https://www.careerstep.com/blog/news/understanding-your-scope-of-practice-as-a-pharmacy-technician/
                    3. Foster P. What You Can and Can’t Say to Customers as a Pharmacy Technician. October 28, 2016. Accessed March 25, 2023. https://www.pennfoster.edu/blog/2016/october/what-you-can-and-can-not-you-say-to-customers-as-a-pharmacy-technician
                    4. ASHP Guidelines on the Pharmacist’s Role in Providing Drug Information Background and Rationale. Accessed August 8, 2023. https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/pharmacists-role-providing-drug-information.pdf
                    5. Martin SW. Strategies for Answering Your Customers’ Toughest Questions. Harvard Business Review. June 28, 2012. Accessed March 25, 2023. https://hbr.org/2012/06/handling-customers-toughest-qu
                    6. Nemko M. How to handle difficult clients. Psychology Today. February 25, 2021. Accessed March 25, 2023. https://www.psychologytoday.com/us/blog/how-do-life/202102/how-handle-difficult-clients
                    7. Malone PM, Witt BA, Malone MJ, Peterson DM. Formulating an Effective Response: A Structured Approach | Drug Information: A Guide for Pharmacists, 6e | AccessPharmacy | McGraw Hill Medical. Accessed August 8, 2023. https://accesspharmacy.mhmedical.com/content.aspx?bookid=2275§ionid=177197497
                    8. Podder V, Lew V, Ghassemzadeh S. SOAP Notes. Published 2022. Accessed August 8, 2023. https://www.ncbi.nlm.nih.gov/books/NBK482263
                    9. Burgess A, van Diggele C, Roberts C, Mellis C. Teaching clinical handover with ISBAR. BMC Medical Education. 2020;20(2):1-8. doi:https://doi.org/10.1186/s12909-020-02285-0
                    https://bmcmededuc.biomedcentral.com/articles/10.1186/s12909-020-02285-0
                    10. Compassionate Geek. IT Customer Service Skills: What To Do When You Don’t Know The Answer To A Customer Question. Accessed March 25, 2023. https://compassionategeek.com/customer-service-skills-when-you-dont-know-the-answer/
                    11. Expert Panel Forbes Councils Member. Leaders: Nine Good Ways To Handle A Business Question You Don't Know The Answer To. June 7, 2021. Accessed March 25, 2023. https://www.forbes.com/sites/theyec/2021/06/07/leaders-nine-good-ways-to-handle-a-business-question-you-dont-know-the-answer-to/?sh=39d2b40823ba
                    12. Csizmadia A. Oops, I don’t know: How to respond to a customer’s question when you don’t know the answer. September 25, 2018. Accessed March 25, 2023. https://www.liveagent.com/blog/oops-i-don’t-know-how-to-respond-to-a-customers-question-when-you-don’t-know-the-answer/
                    13. Gill LL. Consumer Reports. Should You Take Trazodone for Insomnia? Accessed January 26, 2022. https://www.consumerreports.org/insomnia/trazodone-for-insomnia-should-you-take-a9455377183/
                    14. Jaffer KY, Chang T, Vanle B et al. Trazodone for insomnia: a systematic review. Innov Clin Neurosci 2017;14:24-34.
                    15. Everitt H, Baldwin DS, Stuart B et al. Antidepressants for insomnia in adults. Cochrane Database of Systematic Reviews 2018;5:CD010753.
                    16. Bronskill SE, Campitelli MA, Iaboni A et al. Low-dose trazodone, benzodiazepines, and fall-related injuries in nursing homes: a matched-cohort study. J Am Geriatr Soc 2018;66:1963-71.
                    17. How To Evaluate Health Information on the Internet: Questions and Answers. ods.od.nih.gov. National Institutes of Health. Published June 24, 2011. Accessed August 8, 2023. https://ods.od.nih.gov/HealthInformation/How_To_Evaluate_Health_Information_on_the_Internet_Questions_and_Answers.aspx
                    19. U.S. Department of Health & Human Services. National Institutes of Health Naional Cancer Institute. Making Health Communications Programs Work. Accessed March 25, 2023. https://www.cancer.gov/publications/health-communication/pink-book.pdf
                    18. Clear Writing Assessment. Centers for Disease Control and Prevention. Accessed match 25, 2023. https://www.cdc.gov/nceh/clearwriting/docs/Clear_Writing_Assessment-508.pdf
                    20. JIMDO. How to Write an FAQ Page–with Example. October 21, 2021. Accessed March 25, 2023. https://www.jimdo.com/blog/how-to-write-an-faq-page-with-examples/
                    21. 7 Steps to Respond to Drug Information Requests. Pharmacy Times. Accessed August 8, 2023. https://www.pharmacytimes.com/view/7-steps-to-respond-to-drug-information-requests

                    The upcoming USP changes and its impact on immediate use medications

                    Learning Objectives

                     

                    After completing this application-based continuing education activity, pharmacists and pharmacy technicians will be able to

                      1. Point out an immediate use medication
                      2. Recognize locations where immediate use medications may be compounded
                      3. Investigate the designated person’s responsibilities
                      4. Identify core competencies required for immediate use compounding

                      Image of person with syringe between their teeth.

                       

                      Release Date: September 1, 2023

                      Expiration Date: September 1, 2026

                      Course Fee

                      Pharmacists: $5

                      Pharmacy Technicians: $2

                      There is no grant funding for this CE activity

                      ACPE UANs

                      Pharmacist: 0009-0000-23-031-H07-P

                      Pharmacy Technician: 0009-0000-23-031-H07-T

                      Session Codes

                      Pharmacist:  23YC31-ABC28

                      Pharmacy Technician:  23YC31-BCA82

                      Accreditation Hours

                      1.5 hours of CE

                      Accreditation Statements

                      The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-031-H07-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

                       

                      Disclosure of Discussions of Off-label and Investigational Drug Use

                      The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

                      Faculty

                      Laura Nolan, CPhT, CSPT
                      Pharmacy Lab Coordinator
                      UConn School of Pharmacy
                      Storrs, CT

                       

                                 

                      Faculty Disclosure

                      In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

                      Laura Nolan does not have any financial relationships with ineligibile companies.

                       

                      ABSTRACT

                      The United States Pharmacopeia (USP) recently published updated guidelines on sterile compounding that become effective on November 1, 2023. These guidelines affect not only sterile medications compounded in pharmacy clean rooms, but also injectable medications that may be compounded in healthcare institutions, medical and surgical treatment sites, infusion facilities, pharmacies, and physician and veterinarian practice sites. This affects personnel such as chiropractors, dentists, naturopaths, nurses, pharmacists, pharmacy technicians, physicians, veterinarians, and any other medical professional who compounds sterile products. The USP made these changes to minimize harm, including death, to human and animal patients. By reviewing these updates, and by making changes, medical professionals will be able to comply with state and federal regulations and prevent harm to their patients.

                      CONTENT

                      Content

                      INTRODUCTION

                      In 1905, a person in excruciating pain in a dentist’s office would have been thrilled to receive an injection of procaine (Novocain) delivered in a reusable glass hypodermic syringe. Besides the dentist’s white coat, it’s likely nothing else used in the procedure was clean or remotely sterile. Today, given what we know about sterile products, an educated patient would have turned and run in the opposite direction.

                      Yet, according to the U.S. Food and Drug Administration (FDA), the number of trendy med spas and intravenous (IV) hydration clinics, some mobile, that treat patients with medications such as injectable vitamin infusions, have exploded. Many operate under the FDA’s radar. The FDA may not be aware of which compounders are making such drugs, and some states may have insufficient resources to adequately oversee them. The FDA has recently documented varying offenses from personnel  wearing street clothing and not wearing gloves while preparing injections to using toaster ovens for sterilization.2

                       

                      Human drug compounding is a practice in which ingredients are combined, mixed, or altered to create a medication tailored to an individual patient’s medical needs. The Federal Food, Drug and Cosmetic Act (FD&C Act) governs human compounding. Section 503A describes the conditions under which compounded human drug products are exempt from its regulations2:

                      • Section 505 concerning approval prior to marketing
                      • Section 501(a)(2)(B) concerning current good manufacturing practice (CGMP) requirements
                      • Section 502(f)(1) concerning labeling with adequate directions for use

                      The FDA act exempts one condition—compounds are exempt when a licensed pharmacist or physician prepares the medication in a licensed facility based on a valid patient specific prescription. An explosion of naturopathic clinics, which often use unapproved nutritional, herbal, and homeopathic products and administer them by injection, have become a growing concern for the FDA. A brief Internet search revealed that nurses run many clinics with a physician consulting offsite. The FDA has become increasingly aware of drug products compounded at medical offices and clinics that may be prepared under unsanitary conditions. The FDA has also become aware of business models, such as IV hydration clinics, medical spas, and mobile IV infusion services, that are compounding drugs that may not meet the conditions of the FD&C Act’s section 503A or comply with state regulations.2

                      Unsanitary conditions are more common than one would think. The FDA cites a recent example (February 2021) wherein a 50-year-old patient was hospitalized and treated for suspected septic shock with multi-organ failure after receiving an IV vitamin infusion in her home.2 The patient’s blood cultures grew Pseudomonas fluorescens, which is a gram-negative bacterium of emerging concern.3 A California medical clinic that specialized in services including IV therapies and vitamin injectables, sexual health products, hormone replacement therapy, weight loss/management products, and diagnostic laboratory assays prepared and dispensed the contaminated bag.2 When state and federal agents inspected the facility, they observed several deficiencies2:

                      • Lack of an International Organization for Standardization (ISO) air quality classification of ISO-5; in other words, a clean room which is certified to contain a particle count of less than 3,520 particles per cubic meter in the air, required for sterile compounding
                      • Contamination in compounding areas including peeling paint, stained work surfaces, visibly dirty equipment, and air vents with dust and grime
                      • Difficult-to-clean equipment and surfaces (e.g., carpeting in the IV storage and mixing room)
                      • Standing water in a refrigerated storage area used to store sterile vials
                      • Use of expired active pharmaceutical ingredients to prepare drug products intended to be sterile

                      The full extent of this nationwide problem is unknown since many practitioners operating in medical offices or clinics do not register with the FDA. The FDA encourages all patients who experience adverse effects to report them to the FDA MedWatch Adverse Event Reporting program (www.fda.gov/medwatch/report.htm).2 

                      Defining Immediate Use Medication

                      According to the proposed USP<797> Pharmaceutical Compounding-Sterile Preparations, sterile compounding is defined as combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug product or bulk drug substance to create a sterile preparation. Compounding personnel must follow aseptic techniques, processes, and procedures for preparing any sterile medication.1

                      Within a hospital setting, urgent situations may arise where compounding cannot occur in a USP<797> compliant area. Often, acute care situations require STAT (meaning with no delay; at once) doses for critical patients, or medication for an unanticipated procedure.4 Compounders do not necessarily need to comply with all requirements detailed in USP<797> to make these immediate use medications. These frequently asked questions can help clarify when an immediate use medication may be needed and who can compound it.1,4

                      • Can nurses mix compounded sterile preparations (CSPs) for immediate use? Any qualified health professional can prepare an immediate use preparation as long as (1) it is within their scope of practice, (2) the facility’s policies allow it, and (3) the designated person (defined and discussed below) has documented the health care professional’s competency.
                      • Is docking a vial onto a proprietary bag system considered an immediate use medication? Yes and no. Docking a vial onto a proprietary bag for future activation and use is considered compounding and must be performed in an ISO class 5 environment. However, docking a vial onto a proprietary bag according to manufacturer's instructions for immediate administration to a single patient is considered an immediate use medication and is not considered compounding.
                      • Can a nurse prepare an immunoglobulin (IGG) solution in a home care setting, by reconstituting the powder vial with the sterile water supplied by the manufacturer in a kit? This is an example of preparation that is compliant with FDA-approved labeling. Preparing a sterile product in accordance with the manufacturer's approved labeling is not considered compounding as long as
                        • the product is prepared as a single dose for a single patient
                        • the approved labeling includes the following information: the diluent, the final strength, the container closure system, and storage time
                      • If a nurse reconstitutes an antibiotic vial and adds it to a piggyback bag, is this considered immediate use? If the pharmacy is open, this should be done in a sterile clean room. If it is a STAT dose or the pharmacy is closed, then this could be considered immediate use. The nurse mixing the medication needs to have documented competency and the compound should not involve more than three products. One vial of drug, one vial of diluent, and one piggyback bag are three products, which is allowed.

                      In 2020, the American Society of Health Systems Pharmacists conducted a study among professionals who compounded outside of the pharmacy setting. Of the 444 respondents, 77% were nurses, and the rest were primarily anesthesia providers and decentralized pharmacists. Eighty-one percent performed compounding in a acute care settings; other locations included ambulatory surgery centers, infusion centers, physicians’ practices, and long-term care.5

                      The most frequently prepared items were5

                      • IV pushes drawn directly from vials into syringes. (i.e., antibiotics, antiemetics, opioids, proton pump inhibitors)
                      • Intermittent infusions, all of which were proprietary vial and bag systems.
                      • Intramuscular injections including vaccines, antipsychotics, and antibiotics

                       

                      Personnel and Settings Affected by USP<797>

                      All personnel who prepare CSPs are required to comply with USP<797> guidelines. This includes but is not limited to chiropractors, dentists, naturopaths, nurses, pharmacists, technicians, physicians, and veterinarians.1

                      All sites including but not limited to hospitals, infusion facilities, medical and surgical patient treatment sites, pharmacies, physician or veterinarian sites, and other healthcare institutions must meet at least the minimum requirements in USP<797>.1

                      The compounding facility must designate one or more individuals to be responsible and accountable for the facility’s performance, operation, and personnel in the preparation of CSPs and for performing other functions described in USP<797>.1 The facility’s standard operating procedures (SOPs) must identify the person deemed “the designated person.” All designated persons now have immense jobs; failure to meet the USP’s expectations  comes with considerable consequences.

                      The Designated Person

                      The USP mentions the designated person more than 50 times in section <797> alone and several other chapters also refer to the designated person. Below is a list of some, but not all tasks required of a designated person, which will become effective on November 1, 2023. Many states, such as Connecticut and Texas, have already embraced the designated person. The designated person or persons must be identified in the facilities SOPs and registered with the state. In Texas and Connecticut, pharmacists must also complete 30 hours of sterile compounding training to become a designated person. Duties include1

                      • Overseeing a training program to ensure competency of personnel involved in compounding, handling, and preparing CNSPs
                      • Selecting components
                      • Monitoring and observing compounding activities and taking immediate corrective action if deficient practices are observed
                      • Ensuring that SOPs are fully implemented. The designated person(s) must ensure that follow-up is carried out if problems, deviations, or errors are identified
                      • Establishing, monitoring, and documenting procedures for the handling and storage of CNSPs and/or components of CNSPs.

                      The SIDEBAR discusses an issue of emerging importance.

                      SIDEBAR: Who Inspects Physicians’ Offices? 6

                      In 2016, the Pew Charitable Trust conducted a study and asked boards of pharmacy in all 50 states and the District of Columbia to respond to several compounding questions. Of the 51 states, 43 responded to the questionnaire. Although the survey consisted of pages of questions, three of them were forward thinking.

                      1. Does your state have a mechanism to track which in-state physicians’ offices or clinics perform sterile compounding? The answer: 2 % yes, 74% no, 24% don’t know.
                      2. Does the state require physicians’ offices or clinics to be held to the same quality standards as pharmacies? The answer: 17% yes, 38% no, 45% don’t know.
                      3. How do states provide oversight of physician’s offices or clinics that perform sterile compounding to ensure compliance with applicable standards? The answer: 7 by the state board of medicine, 1 by the board of pharmacy (way to go, IDAHO!), 24 reported no oversight system to ensure compliance and 11 states chose not to respond to this question.

                      Who knew Idaho would be so revolutionary? Keep in mind that this study took place in 2016, four years after the New England Compounding mishap of 2012. The Pew study reported, “The Drug Quality and Security Act of 2013, among other reforms, added a new category of compounders called outsourcing facilities that can compound supplies of drugs without obtaining prescriptions.”

                      The new category—outsourcing facilities—was intended to reduce the number of medications made in offices. However, it is obvious that state policies are not uniform. Some states are still working to advance change, and others have yet to act. The Pew report concluded that we are still in a state of transition and that “The variations in sterile compounding policy across states suggest that an opportunity exists to review state oversight systems for potential weaknesses, and consequently to advance regulatory practices to better protect patients.”

                       

                      Gap Analysis

                      In some states, as in the state of Connecticut, the designated person must be a pharmacist. That means that the designated person or persons are responsible for the oversight of all compounding within an institution including the operating room, emergency room, clinics, and nursing station medication rooms.

                      PAUSE AND PONDER: In what areas of your facility could people possibly be compounding without your designated person’s knowledge?

                      A gap analysis compares the current situation with a future state. Creating a gap analysis could help identify areas where compounding is done without the designated person’s knowledge. A gap analysis is performed in three steps7:

                      1. Identify objectives and goals. Most designated persons will create a sheet with three columns: current state, future state, and actions. They will need to identify who, what, where and when immediate use compounding occurs. Using a team approach and including nurses and physicians is a good place to start.
                      2. Analyze the current state. Gather data. One critical area to examine is medications in short supply or backordered. (Aren’t there always a few of these lately!?!) Checking purchasing records and delivery slips to see where medications are being used can be eye-opening. Facilities that substitute vials because the premixed bag is backordered will find that this is a target area.
                      3. Determine how to bridge the gap. Collaborating with the team to create policies and procedures for compounding and writing them into standard operating procedures is critical. Facilities should create a designated compounding area in each unit and establish a cleaning routine. They should also create a training document for nurses and other professionals who compound and set date that each person should complete training as a goal.

                      Immediate Use Gap Analysis

                      All facilities that compound need to compare the current (2008) USP<797> Pharmaceutical Compounding-Sterile Preparations guidelines with the proposed (2022) USP<797> guidelines. In short, the proposed changes are few in number but may cause significant impact throughout the facility.8 Table 1 compares a few minor changes.

                      Table 1.  Less Strict Changes to USP<797> 1,8,9

                      Subject Current Proposed
                      Compounding Process

                      and number of components

                      Only low risk level

                      NMT 3 sterile packages

                      NMT 3 sterile products
                      Situation Emergency use or immediate

                      administration

                      No emergency stipulation
                      Number of manipulations NMT 2 entries into any container/bag Not defined
                      Maximum BUD 1 Hour 4 hours
                      Aseptic technique Aseptic technique is followed Aseptic technique, processes, and procedures followed per written SOPs
                      Risk Level Medium and high risk not prepared as immediate use Category 1, 2, and 3 requirements do not apply
                      Hazardous Drugs Only non-hazardous drugs may be used Must follow USP<800>

                      BUD = beyond use date; NMT = Not More Than

                      A quick glance at the table shows that compounders can now assign a beyond use date (BUD) of four hours for immediate use products. Hurray! This prompts the question, “Is that all I need to implement, and can I do it right now?” Not so fast! These are changes to existing subjects within <797> guidelines, but the proposed guidelines also include many new stipulations, so let’s dig deeper. The following requirements have now been added which pertain to immediate use medications1,8:

                      • Written SOPs must be in place and compounding personnel must follow aseptic technique, processes, and procedures.
                      • Personnel must be trained and demonstrate competency according to the facility SOPs.
                      • SOPs must include methods to minimize contamination and decrease mix-up errors.
                      • The product must be compounded in accordance with evidence-based information for physical and chemical compatibility, per labeling or stability studies.
                      • Any unused starting component from a single use container must be discarded.
                      • Single dose containers must not be used for more than one patient.
                      • A compounding record is required when preparing immediate use medications for more than one patient.

                       

                      Training and Evaluation

                      Training is the elephant in the room. Many nurses and other health professionals have mixed or prepared single use medications for ages, so it might be difficult to teach an old dog new tricks. Demonstration of competency can be difficult and perhaps this is where the nursing team can shine. Luckily, immediate use compounders need not perform fingertip and thumb sampling, or media fill tests as is required for sterile clean room staff.

                      All personnel who compound must now be initially trained and qualified by demonstrating their knowledge and competency of sterile compounding before they can perform their job independently. The designated person(s) is responsible for creating and implementing a training program but may assign training to other qualified personnel. The training procedure for immediate use CSPs must be written into the facilities SOPs.1 One interesting note, the proposed USP<797> states that personnel who are compounding in a clean room, or who have direct oversight of those personnel, must complete training initially, and at least every 12 months. However, immediate use compounders only need to complete training as required by the facilities SOPs.1 A best practice would be to evaluate yearly.

                      Skills may vary from one location to another, but at a minimum, healthcare professionals who will perform immediate use compounding must demonstrate the following core skills8:

                      • Hand hygiene and proper gloving
                      • Calculations, measuring and mixing
                      • Aseptic technique and compounding procedures

                      Required skills will depend on the clinic’s location; for example, an oncology clinic will need to follow USP<800> Standards for Hazardous Drugs, along with USP<797>. Other skills may include cleaning, garbing, documentation, and labeling and should align with the immediate use procedures in the facilities SOPs.

                      Competency assessment must be based on the aseptic processes that are related to the tasks being performed, which can be difficult to recreate. Demonstration of a simulated manipulation may be acceptable in most cases. A simulated aseptic manipulation using empty vials, syringes, sterile water, or saline could consist of the three maximum products allowed, with no need to incubate the sample.7 Using a convenient checklist, like the one in Table 2, helps trainers evaluate staff and document consistently.

                      The SIDEBAR highlights one practice that needs to end immediately.

                      Normal Saline Flush Prefilled Syringes7,10

                      The Institute for Safe Medical Practices (ISMP) released the results of a 2018 immediate use compounding survey. Of the 977 practitioners who responded to the survey, almost all were nurses. ISMP discovered that 81% of the respondents used premixed 5 mL and 10 mL normal saline flushes to dilute medications. The FDA considers a premixed normal saline flush as a medical device and they are “not approved for dilution and administration of IV push medications.”

                      Some clever (but forbidden) uses of prefilled syringes include

                      • Using prefilled syringes as vials: withdrawing and or adding part of a prefilled syringe into another prefilled syringe for administration (Example: adding 5 mL from one syringe to another 5 mL syringe to make a 10 mL syringe).
                      • Using a prefilled syringe to reconstitute a powder vial, then drawing the dose back into the same syringe. (Example, using a 10 mL flush, adding 5 mL from the flush, reconstituting, and withdrawing the 5 mL back into the syringe to create a 10 mL dose.)

                      Using prefilled syringes in these ways is dangerous, since most of the time the health care professional conducting these “procedures” fail to relabel these syringes, so the syringes still have a bright yellow or white label and can be easily picked up by another person and administered in error.

                      Why would prefilled flushes be used for compounding? First, among the many recent drug shortages, normal saline topped the list for a very long time. Second, they are quick and easy to use, and third, healthcare professionals cling to many misconceptions. Some professionals believe that a syringe does not need to be labeled. There is also a myth that a 10 mL syringe must be used to administer IV push medications. Perhaps it is due to “telephone tag” teaching, where one procedure is passed from one to another.

                      So, how do we fix this? Clear procedures need to be established for compounding each medication. Staff training is a must, and a simple roll of blank labels in the compounding area can go a long way to avoiding errors.

                       

                      Table 2. Sample Immediate Use Compounding Evaluation

                      Name of person assessed: Jonathan the Husky Dog  Location:

                       

                      Husky Clinic

                       Evaluation of Handwashing, Garbing, Gloving and Aseptic technique:

                      In left-hand boxes, indicate for each activity

                       P = acceptable completion of the described activity in the correct order,

                      X = the order is incorrect or the activity is performed incorrectly or

                      N/O = the activity was not observed.

                      Notes/

                      Comments on any of the activities.

                      Removes all jewelry and outer garments
                      Uses nail pick under running water
                      Washes hands with soap and water for 30 seconds
                      Dries hands with approved wipe
                      Dons required garb
                      Applies alcohol-based hand sanitizer, allows to air dry
                      Selects the correct pair of gloves
                      Correctly dons sterile gloves
                      Applies sterile alcohol to gloves, allows to air dry
                      Disinfects compounding area with facility approved agent
                      Selects proper components
                      Disinfects critical sites with 70% alcohol wipe

                       

                      Punctures vial at a 45-degree angle to avoid coring
                      Withdraws the correct amount of fluid from vial
                      Disposes waste in proper container
                      Visually inspects final product
                      Demonstrates proper labeling
                      Applies correct 4-hour BUD
                      Name of evaluator________________________Date:_____ Pass   /   Fail

                       

                      CONCLUSION

                      Whether you are the designated pharmacist or just a team member, it is important for you to recognize immediate use medications and locations where they may be compounded. With the implementation of USP<797> commencing on November 1, 2023, now is the time to look at the pharmacy clean room and all areas in your facility where compounding may be occurring. Huge changes in workflow as well and policies and procedures may need to be adopted. Create a well-balanced team of professionals and get to work!

                       

                      Pharmacist Post Test (for viewing only)

                      The Upcoming USP<797> Changes: Impact on Immediate Use Medications
                      Post-test Pharmacists and Technicians
                      After completing this continuing education activity, pharmacists and pharmacy technicians will be able to:
                      1. Point out an immediate use medication
                      2. Recognize locations where immediate use medications may be compounded
                      3. Investigate the designated person’s responsibilities
                      4. Identify core competencies required for immediate use compounding

                      1. Jerry is the designated person for a large health system. He is preparing to implement the new USP<797> changes. Today, he is making a list of potential immediate use situations. Which of the following situations should he add to his list?
                      a. A technician docking ten vials onto proprietary bags
                      b. A pharmacist reconstituting TPA in the emergency department
                      c. An anesthesiologist using a premade fentanyl syringe

                      2. Abdul and Allyssa are having coffee at break. Abdul says that he receives e-mail notifications from the FDA’s automated system. Alyssa asks, “have they reported anything interesting lately about compounding?” What does Abdul report?
                      a. The FDA has seen an uptick in community-based clinics compounding under unsanitary conditions
                      b. The MedWatch Adverse Event Reporting reports more errors caused by choosing the wrong syringe
                      c. The FDA indicates that they are having trouble tracking problems when patients pay cash for infusions

                      3. A veterinarian works in a veterinary practice that employs a certified veterinary technician and has taken all necessary steps to be USP<797> compliant. She needs to prepare and administer an injection of an analgesic immediately for a dog that was hit by a car. Can she do this?
                      a. Yes, because veterinary medications do not need to comply with USP <797>
                      b. Yes, if the certified veterinary technician prepares the dose in the medication room
                      c. Yes, because the practice has taken steps to comply completely with USP<797>

                      4. Clara applies for a job as a “designated person” at a naturopathic clinic. The person interviewing indicates that the facility’s staff seems to prepare immediate use medications in many different (and USP<797> noncompliant) ways. She asks Clara how she would solve this problem. What is the BEST answer?
                      a. Training all staff personally and documenting the training in the facility’s SOPs
                      b. Purchasing medications from a wholesaler that is licensed by the federal government
                      c. Establishing, monitoring, and documenting procedures for CSP handling and storage

                      5. It’s October 31, 2023, at 10:22 PM and Andy needs to prepare an immediate use medication that will probably be given in the emergency department shortly after midnight. The facility’s SOPs are compliant with the revised USP<797> chapter that becomes effective on November 1, 2023. He determines that he can prepare the medication now for its administration after midnight. What do you think?
                      a. Since the USP <797> is not effective until tomorrow, the facility needs to use the maximum BUD allowed in the previous version (2 hours)
                      b. Since the facility is already USP <797> compliant and its SOPs have been updated, 4 hours is the maximum BUD
                      c. Andy needs to wait until midnight and prepare the immediate use medication closer to the time it will be administered.

                      6. Sally’s supervisor is checking her competencies as required by the USP<797>. She asks, “Which of the following represents an appropriate situation that would be considered an immediate use medication?”
                      a. Using a premixed normal saline syringe for reconstituting vial contents
                      b. Completing a compounding record for more than one patient
                      c. Using a single dose vial for two patients within four hours

                      7. Maria considers herself a responsible healthcare professional. She hasn’t needed to prepare an immediate use medication in several months, but today, she needs to compound an antibiotic on site. What should she do before compounding this medication?
                      a. Ensure the designated pharmacist has evaluated the facility’s training procedures
                      b. Complete a standard USP form that is a declaration that she knows how to compound.
                      c. Schedule a media fill test and thumb and fingertip test using an agar plate

                      8. What information is the designated person responsible for updating in the SOPs?
                      a. Training and competency procedures
                      b. Names of personnel who have been trained
                      c. The cost of training to the hospital

                      9. When must immediate use compounders have their training completed?
                      a. Initially and then annually
                      b. Initially and every 6 months
                      c. As required by the facilities SOPs

                      10. Which core competencies apply to immediate use compounding?
                      a. Hand hygiene and sterile filtration
                      b. Hand hygiene, measuring and mixing
                      c. Measuring, mixing and principles of high-efficiency filters

                      Pharmacy Technician Post Test (for viewing only)

                      The Upcoming USP<797> Changes: Impact on Immediate Use Medications
                      Post-test Pharmacists and Technicians
                      After completing this continuing education activity, pharmacists and pharmacy technicians will be able to:
                      1. Point out an immediate use medication
                      2. Recognize locations where immediate use medications may be compounded
                      3. Investigate the designated person’s responsibilities
                      4. Identify core competencies required for immediate use compounding

                      1. Jerry is the designated person for a large health system. He is preparing to implement the new USP<797> changes. Today, he is making a list of potential immediate use situations. Which of the following situations should he add to his list?
                      a. A technician docking ten vials onto proprietary bags
                      b. A pharmacist reconstituting TPA in the emergency department
                      c. An anesthesiologist using a premade fentanyl syringe

                      2. Abdul and Allyssa are having coffee at break. Abdul says that he receives e-mail notifications from the FDA’s automated system. Alyssa asks, “have they reported anything interesting lately about compounding?” What does Abdul report?
                      a. The FDA has seen an uptick in community-based clinics compounding under unsanitary conditions
                      b. The MedWatch Adverse Event Reporting reports more errors caused by choosing the wrong syringe
                      c. The FDA indicates that they are having trouble tracking problems when patients pay cash for infusions

                      3. A veterinarian works in a veterinary practice that employs a certified veterinary technician and has taken all necessary steps to be USP<797> compliant. She needs to prepare and administer an injection of an analgesic immediately for a dog that was hit by a car. Can she do this?
                      a. Yes, because veterinary medications do not need to comply with USP <797>
                      b. Yes, if the certified veterinary technician prepares the dose in the medication room
                      c. Yes, because the practice has taken steps to comply completely with USP<797>

                      4. Clara applies for a job as a “designated person” at a naturopathic clinic. The person interviewing indicates that the facility’s staff seems to prepare immediate use medications in many different (and USP<797> noncompliant) ways. She asks Clara how she would solve this problem. What is the BEST answer?
                      a. Training all staff personally and documenting the training in the facility’s SOPs
                      b. Purchasing medications from a wholesaler that is licensed by the federal government
                      c. Establishing, monitoring, and documenting procedures for CSP handling and storage

                      5. It’s October 31, 2023, at 10:22 PM and Andy needs to prepare an immediate use medication that will probably be given in the emergency department shortly after midnight. The facility’s SOPs are compliant with the revised USP<797> chapter that becomes effective on November 1, 2023. He determines that he can prepare the medication now for its administration after midnight. What do you think?
                      a. Since the USP <797> is not effective until tomorrow, the facility needs to use the maximum BUD allowed in the previous version (2 hours)
                      b. Since the facility is already USP <797> compliant and its SOPs have been updated, 4 hours is the maximum BUD
                      c. Andy needs to wait until midnight and prepare the immediate use medication closer to the time it will be administered.

                      6. Sally’s supervisor is checking her competencies as required by the USP<797>. She asks, “Which of the following represents an appropriate situation that would be considered an immediate use medication?”
                      a. Using a premixed normal saline syringe for reconstituting vial contents
                      b. Completing a compounding record for more than one patient
                      c. Using a single dose vial for two patients within four hours

                      7. Maria considers herself a responsible healthcare professional. She hasn’t needed to prepare an immediate use medication in several months, but today, she needs to compound an antibiotic on site. What should she do before compounding this medication?
                      a. Ensure the designated pharmacist has evaluated the facility’s training procedures
                      b. Complete a standard USP form that is a declaration that she knows how to compound.
                      c. Schedule a media fill test and thumb and fingertip test using an agar plate

                      8. What information is the designated person responsible for updating in the SOPs?
                      a. Training and competency procedures
                      b. Names of personnel who have been trained
                      c. The cost of training to the hospital

                      9. When must immediate use compounders have their training completed?
                      a. Initially and then annually
                      b. Initially and every 6 months
                      c. As required by the facilities SOPs

                      10. Which core competencies apply to immediate use compounding?
                      a. Hand hygiene and sterile filtration
                      b. Hand hygiene, measuring and mixing
                      c. Measuring, mixing and principles of high-efficiency filters

                      References

                      Full List of References

                      References

                         
                        REFERENCES:
                        1. United States Pharmacopeia (USP). General Chapter, <797> Pharmaceutical Compounding—Sterile Preparations. (2023) USP-NF. Rockville, MD: United States Pharmacopeia. Accessed June 19, 2023.
                        2. FDA highlights concerns with compounding of drug products by medical offices and clinics under insanitary conditions. Oct. 25,2021. https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-compounding-drug-products-medical-offices-and-clinics-under-insanitary
                        3. Scales BS, Dickson RP, LiPuma JJ, Huffnagle GB. Microbiology, genomics, and clinical significance of the Pseudomonas fluorescens species complex, an unappreciated colonizer of humans. Clin Microbiol Rev. 2014 Oct;27(4):927-48. doi: 10.1128/CMR.00044-14. PMID: 25278578; PMCID: PMC4187640.
                        4. ASHP, The sterile compounding answer book. Chapter 8, Immediate use and preparation for administration. page 33-34
                        5. Pedersen CA, Schneider PJ, Ganio MC, Scheckelhoff DJ. ASHP National survey of pharmacy practice in hospital settings: Dispensing and administration- 2020. Am J Health Syst Pharm. 2021;78(12):1074–93.
                        6. National Assessment of State Oversight of Sterile Drug Compounding. The Pew Charitable Trust. February 2016. Accessed August 7, 2023. https://www.pewtrusts.org/~/media/assets/2016/02/national_assessment_of_state_oversight_of_sterile_drug_compounding.pdf
                        7. Mind Tools, Gap Analysis. Accessed Jun18,2023. https://www.mindtools.com/afv9hac/gap-analysis

                        8. Pharmacy Purchasing & Products Magazine, USP <797> Immediate-Use CSPs: Small Changes, Big Impact. Feb.2023 Vol.20 No.2, page 10. Kevin N. Hansen, PharmD, MS, BCPS, BCSCP Amanda M. Choi, PharmD, MBA Annie Lambert, PharmD, BCSCP February 2023 - Vol.20 No. 2

                        9. United States Pharmacopeia (USP). General Chapter, <797> Pharmaceutical Compounding—Sterile Preparations. (2008) USP-NF. Rockville, MD: United States Pharmacopeia. Accessed June 20, 2023.

                        10. Institute of Safe Medical Practices. Part II Survey results suggest action is needed to improve safety with adult IV push medications. Dec. 2018, Vol.16, Issue 12. Accessed June 22, 2023.https://www.ismp.org/sites/default/files/attachments/201812/NurseAdviseERR201812.pdf

                        Set Your Ascites on Improving Patient Care: The Pharmacy Team’s Role in Hepatorenal Syndrome Management

                        Learning Objectives

                         

                        After completing this application-based continuing education activity, pharmacists and technicians will be able to

                        1. Describe the prevalence, pathophysiology, and prognosis of hepatorenal syndrome (HRS)
                        2. Explain updated guidelines for diagnosis and treatment of HRS
                        3. Discuss current and emerging therapies for HRS
                        4. Identify the role of pharmacists and pharmacy technicians in HRS treatment

                          Cartoon image depicting a person with ascites.

                           

                          Release Date: August 15, 2023

                          Expiration Date: August 15, 2025

                          Course Fee

                          Pharmacists: FREE

                          Pharmacy Technicians: FREE

                          This CE was funded by:  Mallinckrodt

                          ACPE UANs

                          Pharmacist: 0009-0000-23-029-H01-P

                          Pharmacy Technician: 0009-0000-23-029-H01-T

                          Session Codes

                          Pharmacist:  23YC29-HPX34

                          Pharmacy Technician:  23YC29-XPX38

                          Accreditation Hours

                          2.0 hours of CE

                          Accreditation Statements

                          The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-029-H01-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

                           

                          Disclosure of Discussions of Off-label and Investigational Drug Use

                          The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

                          Faculty

                          Rachel Eyeler, PharmD, BCPS
                          Adjunct Clinical Professor
                          UConn School of Pharmacy
                          Storrs, CT

                                                     

                          Nicole A. Pilch, PharmD, BCPS
                          Associate Professor Department of Pharmacy and Clinical Sciences
                          Medical University of South Carolina
                          Charleston, SC

                          Faculty Disclosure

                          In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

                          Drs. Eyeler and Pilch do not have any relationships with ineligible companies.

                           

                          ABSTRACT

                          Hepatorenal syndrome (HRS) is a specific type of kidney injury unique to patients with end stage liver disease, also known as cirrhosis. Patients with cirrhosis have scarred, stiff livers in which blood cannot flow through easily. Portal hypertension changes blood flow resulting in several consequences: ascites, esophageal varices, and HRS. The American Association for the Study of Liver Diseases guidelines describe two distinct forms of HRS. Therapies such as volume resuscitation (e.g., with crystalloids or albumin) and vasoconstrictors (e.g., norepinephrine or terlipressin) focus on restoring blood flow to the kidneys before they are irreparably injured. Sometimes, clinicians must select therapies based on availability of intensive care unit beds and monitoring equipment. Clinicians also need to consider factors when patients leave the hospital and are discharged to home. Pharmacists and pharmacy technicians who are familiar with the basics of HRS can help clinicians make appropriate choices, counsel patients thoroughly, and contribute to better patient outcomes.

                          CONTENT

                          Content

                          INTRODUCTION

                          Hepatorenal syndrome (HRS), a type of kidney injury unique to patients with advanced liver disease, carries a grim prognosis. Therapies such as volume resuscitation (e.g., crystalloids or albumin) and vasoconstrictors (e.g., norepinephrine or terlipressin) focus on restoring blood flow to the kidneys before they are irreparably injured. Pharmacists and pharmacy technicians can play a crucial role in helping select and monitor therapies for treatment of this syndrome, and perhaps more importantly, by helping patients avoid developing HRS in the first place. By educating patients to avoid certain over the counter (OTC) medications that can worsen the condition (e.g., non-steroidal anti-inflammatory drugs [NSAIDs]), and teaching patients to monitor their diuretic use by weighing themselves daily and monitoring their blood pressure, engaged pharmacists and pharmacy technicians can make a large difference in their patients’ clinical outcomes.

                           

                          HRS: A Complication of Cirrhosis

                          Cirrhosis, an advanced state of liver disease, is increasingly common and an important cause of mortality.1 Globally, in 2017 the estimated incidence of people living with compensated cirrhosis was 112 million. In 2019, cirrhosis was associated with 2.4% of deaths worldwide.2 Classically, cirrhosis in developed countries is most commonly due to hepatitis C infection and alcohol misuse.1 However, over the past decade, the incidence of non-alcoholic fatty liver disease (NAFLD) has increased dramatically with improvement in diagnostic criteria and screening. At the same time, treatment improvements for hepatitis B and C infections have decreased viral hepatitis-related deaths in some areas of the world. The COVID-19 pandemic has also had significant impact, with data collected from multiple countries showing a substantial increase in alcohol consumption, and an increase in alcohol-associated cirrhosis deaths.2,3 Testing and treatment rates for hepatitis B and C declined internationally between January 2019 and December 2020,4 and treatment delays are predicted to lead to excess liver-related deaths.2,5

                          PAUSE AND PONDER: How will the new hepatitis C direct-acting antivirals (e.g., elbasvir, glecaprevir, ledipasvir, pibrentasvir, sofosbuvir, velpatasvir, and voxilaprevir) change the landscape of HRS?

                          Although the causes of cirrhosis may be shifting, the transition from chronic liver disease to cirrhosis is generally the same. Chronic inflammation of the liver leads to fibrosis and scarring, causing structural and hemodynamic changes within the liver (Figure 1). One of the main consequences is development of portal hypertension. Portal hypertension results because the scarring of the liver makes it more difficult for blood to flow through it, leading to increased blood pressure in the portal vein as blood is delivered from the splanchnic organs (stomach, small intestine, colon, pancreas, and spleen) (Figure 2). The obstruction of blood flow through the portal vein additionally results in dilation of the splanchnic circulation as a compensatory mechanism aimed at restoring blood flow. In turn, increased blood flow to the splanchnic circulation worsens portal hypertension.1  

                          Figure 1. Stages of Liver Disease.

                          Graphic showing the stages of liver disease, from healthy liver to cirrhosis.

                           

                          Figure 2. The splanchnic circulation. The splanchnic circulation describes blood flow to the abdominal organs. Blood from these “splanchnic” organs is delivered to the portal vein, and accounts for the majority of the blood flow to be processed by the liver.

                          Graphic showing the blood flow from the aorta, through organs and liver, and then finally to the inferior vena cava.

                           

                          Pathophysiology of HRS

                          Portal hypertension and the changes in blood flow that result are the main drivers of several consequences of cirrhosis. These complications include the development of ascites, espophageal varices, and HRS.

                           

                          Ascites is fluid accumulation in the peritoneal cavity that commonly appears as abdominal swelling or bloat. A patient with significant ascites will often test positive for a “fluid wave.” That is, when a patient is lying flat and someone applies pressure to the abdominal midline, a clinician can tap one flank sharply, and an impulse or “shock wave” will travel through the fluid in the abdomen. The clinician will be able to be feel the tap on the other side.

                           

                          Esophageal varices are enlarged veins in the esophagus that can lead to bleeding that commonly presents as “coffee ground” looking emesis (or vomitus) that is a result of the blood being digested in the stomach then regurgitated through the esophagus. In the case of HRS, the portal hypertension and splanchnic vessel dilation mean that blood tends to pool in the splanchnic circulation, decreasing effective arterial volume (i.e., a decreased amount of blood effectively perfusing organ tissue, including the kidneys). Additionally, the body activates various compensatory mechanisms aimed at increasing blood volume (e.g., the renin-angiotensin system and the sympathetic nervous system). This action is an attempt to restore effective blood volume, which leads to vasoconstriction of the kidney arterioles and further hypoperfusion of the kidney (Figure 3).6

                          Figure 3. Changes in blood flow with cirrhosis. The image on the left represents normal splanchnic and portal blood flow. The image on the right shows blood flow to a cirrhotic liver. Blood from the splanchnic organs meets increased resistance in the portal vein, leading to portal hypertension. The splanchnic arteries vasodilate which worsens portal hypertension and leads to decreased blood flow to the kidneys.

                          Cartoon showing the difference in blood flow between a normal liver and cirrhotic liver. The main difference is backup of blood flow, causing portal hypertension.

                          ABBREVIATIONS: ADH: antidiuretic hormone, IMA: inferior mesenteric artery, RAAS: renal angiotensin aldosterone system, RBF: renal blood flow, GFR: glomerular filtration rate, SMA: superior mesenteric artery

                          Prevalence and Prognosis

                          HRS is a type of acute kidney injury (AKI) that is unique to patients with decompensated cirrhosis. HRS occurs in the absence of hypovolemia or any structural changes to the kidney—in fact, the kidneys often function normally following liver transplantation.7 HRS is common in patients with cirrhosis, and risk of development increases as the severity of cirrhosis and the duration with which the patient has had it increase. In one study of patients with cirrhosis and ascites, the incidence of HRS increased from 18% at one year to 39% after five years.8 The development of HRS is unfortunately associated with a very poor prognosis, and often the only way to reverse the kidney failure is to receive a liver transplant.7

                           

                          Classification and Diagnosis

                          Two distinct forms of HRS have been described. According to the American Association for the Study of Liver Diseases (AASLD) guidelines9

                          • Type 1 HRS is a rapid increase in creatinine (0.3 mg/dL or greater) within 48 hours or an increase in serum creatinine to levels that are at least 50% higher than the most recent baseline value measured within three months. It often has a precipitating factor, such as a bacterial infection, gastrointestinal bleeding, or over-diuresis. This type of HRS is more common and more severe, making up 75% of cases and having a median survival of one month.
                          • Type 2 HRS takes a longer time to develop and is defined as an estimated glomerular filtration rate of less than 60 mL/minute/1.73m2 for three months or more in the absence of other (structural) causes. This is the same definition used for all patients with chronic kidney disease (CKD). Type 2 HRS often co-occurs with other complications of cirrhosis (i.e., refractory ascites) and has a median survival of about seven months.8

                           

                          In recent years the nomenclature has been updated so that type 1 HRS is referred to as HRS-AKI and type 2 is called HRS-CKD.6,9

                           

                          Sometimes it is hard to know that a patient with end-stage liver disease is in kidney failure. These patients may have decreased muscle mass, are prone to malnutrition, and may take diuretics to control volume status. All three of those factors make serum creatinine an unreliable surrogate measure of kidney function.10

                          In patients with cirrhosis and ascites who meet the criteria for AKI, the diagnosis of HRS-AKI becomes one of exclusion. Clinicians must attempt to rule out hypovolemia, shock, medication-induced AKI, and structural kidney injury. In the absence of these alternative causes for AKI, a diagnosis of HRS-AKI can be made, and treatment commenced as soon as possible, as early intervention is key to decreasing mortality.9

                           

                          Sidebar: Why is serum creatinine unreliable in advanced liver disease?

                          In clinical practice, clinicians often estimate kidney function by measuring a patient’s serum creatinine and inputting the value into a kidney function estimating equation. Creatinine is a byproduct of creatine, an amino acid produced by the liver and released into the circulation to reach target tissues, such as muscle. Creatinine is released during normal muscle metabolism. It is used in kidney function estimates because the glomerulus filters it freely, and so theoretically the rate at which the kidneys clear creatinine should be similar to the glomerular filtration rate itself.

                           

                          However, a patient’s serum creatinine value is not affected by glomerular filtration rate alone. A malfunctioning liver may produce lower amounts of creatinine’s precursor, creatine. Additionally, patients with cirrhosis may have decreased oral intake due to nausea, ascites, and/or ongoing alcohol use. This means they consume less creatine is consumed from the diet as well. Finally, since creatinine is a product of muscle tissue breakdown and patients with cirrhosis tend to have significantly reduced muscle mass, they may generate less creatinine from the creatine. The end result is a serum creatinine that is normal or even lower than that seen in healthy individuals.

                           

                          Hence, kidney function estimates that rely on creatinine tend to overestimate kidney function in these patients and even small absolute increases in creatinine could represent an acute kidney injury.

                          PAUSE AND PONDER: Is there a better way to measure true kidney function in patients with end-stage liver disease?

                           

                          Current and Emerging Therapies for HRS

                          Therapies used to treat HRS aim at removing the precipitating factor and increasing blood flow to the kidneys. First, clinicians must identify and treat the potential etiology leading to the decline in kidney function (e.g., antibiotic therapy in the treatment of an infection of ascites fluid called spontaneous bacterial peritonitis [SBP], proton pump inhibitors, and endoscopic intervention to stop a gastrointestinal bleed). Removing the cause is one of the most important factors in ensuring that the change in kidney function is not permanent.

                           

                          Fundamentally the kidney receives insufficient blood flow secondary to a decrease in effective arterial blood flow, so initial therapy’s main goal is to improve the patient’s mean arterial pressure as soon as possible. The most common goal cited is to increase the patient’s mean arterial pressure (MAP) to greater than 65 mmHg to improve perfusion to target end organs, specifically the kidney.11,12 The goal is to improve kidney function and give the patient additional time to secure a liver transplant or stabilize the end stage disease and decrease mortality. This continuing education activity will review the agents used to improve kidney function in the setting of HRS. Table 1 summarizes guideline recommendations for initial management of patients with HRS-AKI.

                           

                          Table 1. Summary of Society Guidelines for Initial Management of HRS-AKI in the ICU9,22,23,32,33
                          Society HRS-AKI Definition Volume expander Vasopressor of choice Target
                          American Association for the Surgery of Trauma 2022 Increase in SCr > 0.3 mg/dL within 48 hours or > 50% increase in SCr in preceding 7 days in patients with cirrhosis/ascites without another cause Lactate ringers or Plasmalyte over Normal Saline; albumin 20-25% 1 gm/kg/day x 48 hours Norepinephrine, Terlipressin MAP > 65 mmHg, increased urine output
                          American Association for the Study of Liver Disease 2021 Increase in SCr > 0.3 mg/dL within 48 hours or > 50% increase in SCr in preceding 7 days in patients with cirrhosis/ascites without another cause; use SCr values for the last 3 months prior to event to evaluate baseline Albumin 1 gm/kg on day 1, then 40 to 50 gm daily while receiving vasopressor therapy Terlipressin,* Norepinephrine 0.5 mg/h ; max 3 mg/h Increase MAP by at least 10 mmHg above pre-treatment baseline or urine output >200 mL over 4 hours; albumin to maintain CVP between 4-10 mmHg;

                          Continue treatment until SCr back to baseline up to 14 days; if SCr remains at or above pre-treatment values after 96 hours stop vasopressor therapy

                          European Association for the Study of the Liver 2010 Kidney failure in the setting of liver disease unexplained by another cause Albumin 1 gm/kg/day (max 100 gm/day) Terlipressin 1 mg every 4 to 6 hours in combination with albumin, if SCr does not improve by at least 30% in 72 hours increase dose to 2 mg every 4 hours Increase in MAP by at least 5 mmHg by day 3
                          American Gastroenterological Association 2022 Increase in SCr > 0.3 mg/dL within 48 hours or > 50% from baseline or urine output is <0.5 mL/kg/hr for > 6 hours Albumin 1 gm/kg/day x 48 hours, if no improvement continue 1 gm/kg x 1 day then 20 to 40 gm daily while receiving vasopressor therapy Terlipressin 1 mg every 4 to 6 hours; increase to 2 mg every 4 to 6 hours if reduction in SCr < 25% by day 3 if available up to 14 days, alternative norepinephrine or midodrine/octreotide Increase MAP by at least 10 mmHg or urine output by at least 50 mL/h for at least 2 hours, maintain priority for liver transplant if survive
                          *not approved in US at the time of guideline construction

                           

                          ABBREVIATIONS: CVP = central venous pressure; MAP = mean arterial pressure; SCr = serum creatinine

                           

                           

                           

                          PAUSE AND PONDER: When might these interventions be considered “too late?” What would you do then?

                           

                          Crystalloids

                          Initial evaluation of patients includes an assessment of their effective arterial blood volume status. Early cessation of home medications that impact blood pressure or volume status, such as diuretics (e.g., spironolactone, furosemide) will allow a more accurate determination. If the patient’s effective arterial blood volume is not optimized, inadequate blood flow to the kidney can precipitate acute kidney injury in the setting of cirrhosis.

                           

                          Crystalloids, such as normal saline and Lactated Ringer’s, stay within the intravascular space and provide appropriate initial fluid replacement. However, clinicians must provide fluid replacement (also referred to in this case as fluid resuscitation) carefully and with appropriate monitoring as patients can become volume overloaded. Patients with end stage liver disease have low albumin levels and tend to lack the oncotic pressure (a type of osmotic pressure induced by plasma proteins, especially albumin) required to keep crystalloids within the intravascular space. Even minimal resuscitation can produce significant peripheral edema and pulmonary edema, and worsen ascites.13

                          Pharmacists should provide support in appropriate monitoring of volume status and ensuring serum electrolytes are frequently obtained. Fluids may need to be stopped abruptly in response to volume overload to prevent hypervolemic hyponatremia (low sodium levels).14 Appropriate understanding of the patient’s intravascular volume status will determine if using albumin during resuscitation is appropriate.

                           

                          Albumin

                          Patients with end-stage liver disease typically have reduced or low albumin levels because the liver is no longer able to manufacture these proteins. Reduced albumin decreases the circulating oncotic pressure which yields fluid leakage from blood vessels into other areas of the body (e.g., peritoneal space), reducing the arterial blood volume going to the kidney. This becomes especially apparent when a precipitating event such as a hemorrhage or infection occurs, which further decreases circulating blood volume. Clinicians often administer concentrated albumin (e.g., 25% or 25 grams/100 mL) every six to eight hours to increase the intravascular circulating blood volume. Albumin allows fluid to move from the interstitial spaces back into the blood stream and keeps exogenously administered crystalloids in the vessels, thereby increasing blood flow to the kidneys.12 Clinicians should reserve concentrated albumin for patients with baseline low serum albumin (e.g., less than 3 mg/dL) who are also volume overloaded and limit them to just the amount that restores hemodynamic stability.15

                           

                          Patients who have inadequate total body volume or those who have capillary leak (e.g., septic shock) may benefit from less concentrated (e.g., 5%) albumin infusions. A recent single center open-label, randomized study evaluated hypotensive patients with end-stage liver disease and compared volume replacement with albumin to normal saline.16 The primary outcome was to determine which approach could reverse a mean arterial pressure less than 65 mmHg more effectively within the first hours of resuscitation. Of note this trial excluded patients who needed immediate interventions, such as variceal bleed or vasopressor agents.17 The researchers randomized patients to receive 250 mL of 5% albumin over 30 minutes followed by 50 mL/hr for three hours or normal saline 30 mL/kg over 15 to 30 minutes followed by 100 mL/h over three hours. Albumin was more effective than normal saline in improving mean arterial pressure above 65 mmHg in the first hour (25.3% albumin vs 14.9% normal saline, p = 0.03) of resuscitation. The benefit continued over the next three hours (p < 0.001) and survival was also better in patients resuscitated with albumin than those treated with saline (43.5% vs 38.3%).16,18 The researchers note that results are predicated on appropriate management of the underlying causes of hypotension (i.e., sepsis).

                           

                          Albumin is expensive, can be and has been subject to shortages. It should be used with stewardship in end stage liver disease and HRS; however, the evidence for benefit is robust especially when combined with other modalities.16 It is important to understand the patient’s volume status and hemodynamic goals to select the appropriate concentration and frequency.19,20 The AASLD Guidelines for the Diagnosis, Evaluation and Management of Ascites, Spontaneous Bacterial Peritonitis and HRS suggest that patients who present with HRS should receive 1 gram/kg albumin on day 1 and then 40 to 50 grams per day until kidney function improves and other therapies are no longer needed.9,15 The daily dose may be reduced (e.g., 20 to 40 grams/day) if given in combination with vasopressor agents with a goal to maintain adequate volume. Clinicians sometimes use a surrogate measure of volume using a central venous catheter to measure central venous pressure (CVP), which reflects the amount of blood in the patient’s anterior vena cava and venous tone. In this case, a CVP goal between 10 and 15 mmHg is targeted.10,21 Unfortunately CVP can be unreliable when ascites is present and clinicians may need to employ other invasive methods along with close monitoring for the development of pulmonary edema.9,22,23

                           

                          Ensuring albumin is available for patients with HRS is necessary. Some ways to aid centers in managing their supplies when shortages occur include limiting scheduled orders to 24 hours (e.g., 1 gram of 25% every 8 hours for 24 hours). Limiting “evergreen” orders to 24 hours will ensure clinicians assess patients appropriately before administering additional albumin and may prevent unappreciated volume overload. Also, standardized order sets will prevent use of partial vials, larger than needed vials (e.g., 250 mL or 500 mL) and inappropriate ordering of the incorrect concentration (e.g., 5% versus 25%). Teaching hospitals may also benefit from limiting albumin orders to certain clinical situations or diagnoses to avoid ubiquitous use for volume resuscitation in patients (e.g., trauma) who can be resuscitated with crystalloid.

                           

                          Vasopressors

                          Vasopressors are given in combination with resuscitation, specifically albumin. The exogenous albumin facilitates adequate oncotic pressure to keep fluid in the vasculature, allowing vasopressors to constrict the vessels, increase mean arterial pressure, and supply fluid to the kidney. Vasopressors will be ineffective and can make kidney function worse if fluid in the vasculature is insufficient. Therefore, prescribers should only institute vasopressors along with or after volume resuscitation. The main adverse effects associated with any vasopressor therapy are related to ischemia (poor blood flow) in the peripheral limbs/tissues (e.g., fingertips, skin), gastrointestinal tract, or heart.9 Limited head-to-head trials exist to identify which agent or combination is the most effective in reversing HRS beyond early implementation of therapy in combination with albumin volume expansion. Table 2 summarizes the pros, cons, and considerations related to vasopressor agents used in the treatment of HRS.

                           

                          Table 2. Vasopressor Agents Pros, Cons and Considerations
                          Medication Pros Cons Considerations
                          Norepinephrine Frequently used in the ICU setting, team comfort with monitoring for adverse effects and ease/experience with titration May be less effective in hypothermia, pH dysregulation, continuous infusion May require ICU setting, especially for acute titration; may require a central line
                          Terlipressin Does not require a central line, or continuous infusion Requires additional monitoring for ischemia which may require ICU level care to ensure safety Requires monitoring for ischemic events
                          Octreotide Can be given outside the ICU Slow response, IV or subcutaneous administration May be continued as an outpatient
                          Midodrine Available as an oral agent, can be given outside the ICU Slow response, only available as an oral agent; frequency of dosing May be provided on discharge to help maintain blood pressure in the setting of hypotension

                          ABBREVIATIONS: ICU = intensive care unit; IV = intravenous

                           

                          Norepinephrine

                          Norepinephrine is an exogenous catecholamine that targets alpha-1-adrenergic receptors which helps improve peripheral vascular resistance.24 Norepinephrine has been used consistently in the United States (U.S.) for many years and has been the agent of choice until the recent approval of terlipressin. Norepinephrine’s limitation is that it can be less effective, as are other catecholamines, if patients have temperature or pH dysregulation. Appropriate resuscitation and correction of these variables can improve norepinephrine’s efficacy. A meta-analysis comparing the effectiveness of norepinephrine and terlipressin suggests that norepinephrine is as effective in increasing mean arterial pressure and reversal of kidney dysfunction.24 The most frequent doses of norepinephrine cited in terlipressin head-to-head trials were between 0.5 to 3 mg/hour and/or 0.05 to 0.7 mcg/kg/minute titrated to increase mean arterial pressure 10 mmHg above baseline or increasing urine output to more than 200 mL/hour.24 Clinicians must monitor norepinephrine administration carefully to prevent complications of vasoconstriction, such as cardiac or digital ischemia and therefore it is often restricted to the intensive care unit (ICU).24

                           

                          Terlipressin

                          Terlipressin is a prohormone of lysine-vasopressin, causing extended release of lysine-vasopressin and activation of V1 and V2 receptors allowing intermittent administration.24 V1 receptors are predominantly located in the smooth muscles of the arterial vasculature in the splanchnic region. Activating V1 receptors constricts the splanchnic vessels (reducing delivery of blood flow to the portal vein, lowering portal pressure) which subsequently may improve blood flow to kidneys. Additionally, activation of the V2 receptors causes reabsorption of water in the kidney.24,25 Terlipressin has been evaluated in several prospective, placebo-controlled clinical trials evaluating its efficacy in improving kidney function in HRS.18 Specifically, a recent prospective, randomized, double-blind controlled trial evaluated the effectiveness of terlipressin against placebo in combination with albumin in reversing HRS-AKI.25 Terlipressin was more effective than placebo in reversing HRS (32% vs 17%, p < 0.006), but did yield more respiratory failure.25 This trial was an impetus for U.S. Food and Drug Administration (FDA) approval of terlipressin in 2023.

                           

                          The FDA approved terlipressin for rapid reduction in kidney function in the setting of cirrhosis with no other etiology, or reversal of HRS at a dose of 1 mg administered by intravenous bolus every six hours.10 If the patient’s serum creatinine fails to improve or increases within the first 96 hours then prescribers should discontinue terlipressin. If improvement is marginal (e.g., less than 30% from baseline) the dose can be increased to 2 mg every six hours.10 Therapy should be continued until the patient’s serum creatinine is 1.5 mg/dL or less for two days or a maximum of 14 days. Prescribers should use terlipressin with caution in patients with a history of ischemic conditions (e.g., cardiac, mesenteric).10 Terlipressin should not be used in patients who have a serum creatinine exceeding 5 mg/dL, in patients who are hypoxic (SpO2 less than 90%), or in patients who develop ischemia.10,23

                           

                          Terlipressin is often given outside the ICU and does not need continuous cardiac monitoring, which may make it desirable for longer term administration.10 Initial clinical trials compared norepinephrine continuous infusion (1 mcg/kg/minute increased every four hours to increase MAP by 10 mmHg) to terlipressin (1 mg every four hours; increased to 2 mg every four hours after three days) combined with albumin to maintain a CVP between 10 and 15 mmHg. These trials defined a complete response as an improvement in serum creatinine by at least 30% from baseline within 14 days of therapy. There was no difference in responders between norepinephrine and terlipressin (70% and 83%).21,26,27 Therefore terlipressin’s benefit may lie in its intermittent dosing and ability to be administered outside the ICU.

                           

                          Terlipressin’s most common adverse reactions (≥10%) include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea. Terlipressin does have some additional considerations. It also has a boxed warning for possible serious or fatal respiratory failure, and clinicians need to monitor patients’ oxygen saturation carefully.28

                           

                          Terlipressin is supplied as a single dose 0.85 mg vial that must be stored under refrigeration and protected from light. Vials are reconstituted with 5 mL of sodium chloride and if not used, must be refrigerated and expire after 48 hours. The initial dose based on the approved labeling is one vial (0.85 mg) every six hours; which can be increased to two vials (1.7 mg) every six hours.28

                           

                          Midodrine and Octreotide

                          Midodrine and octreotide in combination have been a staple in the treatment of acute HRS for the last two decades in the U.S. Midodrine, an oral tablet, is like norepinephrine and produces vasoconstriction through alpha-1-adrenergic receptors.24 Octreotide injection is a somatostatin analogue that decreases the release of vasodilatory substances and glucagon leading to vasoconstriction of the splanchnic circulation.24 Because norepinephrine must be administered in the ICU, some healthcare facilities favor the combination of midodrine and octreotide. They also use midodrine/octreotide if they have not added terlipressin to their formularies.23 Unfortunately, patients tend to respond slowly to the combination and the combination requires an extended duration for full benefit.23 Octreotide cannot be given without midodrine but midodrine may be continued long-term (e.g., post-discharge) to maintain blood pressure in patients who are persistently hypotensive.23,29

                           

                          Researchers recently published a single center experience with standardizing administration of midodrine and octreotide for treatment of HRS at their center.29 They wanted to standardize the use and dosing of albumin in combination with midodrine dosed at 2.5 to 10 mg three times daily and octreotide 50 to 100 mcg subcutaneously three times daily for 14 days and compare it to previous unstandardized prescribing. The goal was to obtain a full response: a serum creatinine within 0.3 mg/dL of baseline within seven to 14 days. Use of the standardized protocol was more effective in producing a full response than the historical unstandardized practice (25% vs 10%, p = 0.07).29 Additionally, the researchers also found that fewer patients in the protocol group required kidney replacement therapy. Guidelines suggest initiating midodrine at a dose of 7.5 mg three times daily and titrating it to 12.5 mg three times daily in combination with octreotide.23 The combination may still be in favor because it is a cost-effective alternative to terlipressin outside the ICU.

                           

                          Midodrine is supplied in three tablet strengths which include 2.5 mg, 5 mg and 10 mg.30 This allows outpatient tapering or adjustment if the patient experiences tachycardia. Unfortunately, it is short acting and requires three times daily dosing initially. In practice, dropping the middle of the day dose without reducing the strength allows improved adherence once the patient’s blood pressure is stable. Midodrine’s labeling includes a boxed warning for possible marked elevation of supine blood pressure, and clinicians should monitor supine and standing blood pressure regularly.30

                           

                          Octreotide is supplied in single dose ampules or multidose vials that must be stored in the refrigerator and protected from light; multidose vials must be discarded within 14 days. Octreotide is stable for 14 days at room temperature.31 Doses of 50 mcg to 100 mcg are administered every eight hours around the clock during the inpatient stay. If patients continue on octreotide as outpatients, the hospital pharmacy often needs to supply the doses. Patients and caregivers need appropriate education on subcutaneous injections and disposal of injection materials. In practice, the dose used in the hospital with success is often continued and not reduced to allow for the shortest duration possible. Octreotide subcutaneous injections on the outpatient side typically require additional insurance approval and preparation so discharge planning early is important.31

                           

                          The Role of Pharmacists and Pharmacy Technicians in the Treatment of HRS

                          Pharmacists and pharmacy technicians can play an integral role in improving outcomes for patients presenting with or who have a history of HRS. Prevention is the key! Patients with end-stage liver disease should avoid medications that can precipitate HRS such as non-steroidal anti-inflammatory drugs and will require appropriate adjustment or discontinuation (if possible) of potential nephrotoxic agents (e.g., certain antimicrobials).

                           

                          Ensuring patients with a history of spontaneous bacterial peritonitis (SBP) are on appropriate antibiotic prophylaxis can prevent subsequent SBP events that decrease blood flow to the kidneys. In the ambulatory setting, careful blood pressure monitoring and adjustment of blood pressure medications commonly used to treat portal hypertension (e.g., carvedilol), can ward off hypotensive events that can precipitate HRS.

                           

                          Table 3 summarizes some lifestyle counseling tips that can help empower patients to play an active role in optimizing their care and preventing HRS episodes. Additionally, general management of concurrent disease states, such as heart failure and diabetes, can aid in maintaining optimal hemodynamics.

                          Table 3. Lifestyle Counseling Points for Patients with Cirrhosis at risk for HRS35-37
                          Avoid alcohol Even if the cause of liver damage isn’t drinking, alcohol use can increase the amount of damage. Patients who cease alcohol can experience dramatic improvements in some of the complications of cirrhosis.
                          Low sodium diet (especially in patients with ascites) Limit sodium intake. This can be quite difficult, but if it can be done will help quite a bit with volume management. Patients with ascites are often asked to target ≤2 g/day. (For reference, 1 teaspoon of salt contains 2.3 g!)
                          Weight loss in patients who are overweight Even a small amount of weight loss (e.g., a few pounds) can have a beneficial effect in patients with NAFLD or chronic HCV.
                          Protect yourself from infections Patients need to stay up to date on vaccinations, wash their hands frequently, and avoid people who are sick.
                          Organize medication schedule Patients with liver impairment can take seven to 10 medications a day—some administered multiple times a day. Investing in a strong adherence-enhancing system with alarm reminders or reminders from caregivers can be key.
                          Use OTC medications carefully NSAIDs, such as ibuprofen and naproxen, can precipitate acute kidney injury.
                          Monitor weight daily (if on diuretic treatment) Patients need to weigh themselves first thing in the morning after urinating. They should report significant weight changes to their providers (e.g., losing 1 pound or more a day or gaining more than 5 pounds in a week).

                           

                           

                          SIDEBAR: Did you know…acetaminophen can be a great choice for patient with HRS?34

                          Imagine a situation where a medical intern is cross-covering in the medical intensive care unit and receives a call from a nurse about a patient with HRS. The patient is experiencing some mild pain and the nurse would like an as-needed medication to help.

                           

                          Or…

                           

                          You are working in the pharmacy and receive an order for oxycodone 5 mg every six hours as needed for mild pain. You are very concerned that this patient has both kidney and liver insufficiency and oxycodone is not a good choice but what else can you recommend?

                           

                          What about acetaminophen?!?

                           

                          Acetaminophen tends to have a bad rap mainly because it is in so many prescription and OTC products. It’s often in the news for causing liver toxicity. Oftentimes patients and providers do not think about the total acetaminophen exposure (the total daily dose of acetaminophen) and that is where the danger can come in. When the amount of acetaminophen’s toxic intermediary N-acetyl-p-benzoquinone imine (NAPQI) exceeds the liver’s glutathione stores, NAPQI starts to stick to hepatocytes (the liver’s main structural component). NAPQI acts like an antigen and stimulates the immune system to attack the liver.

                           

                          Fortunately, it takes a significant amount administered at one time or consistently over several days to expend the glutathione stores. Doses up to 2,000 mg per day are safe and effective in most patients with severe liver insufficiency. (The maximum daily dose in healthy adults is 3900 mg.) Pharmacists and pharmacy technicians can ensure providers and patients with liver disease know they have alternative options. They can also help patients avoid reaching for a NSAID, especially if the patient has had a recent bout of HRS or if the patient is taking other medications that would suggest the presence of liver insufficiency (e.g., lactulose, rifaximin, norfloxacin). Remember prevention of HRS is the key!

                           

                          When a hospital admits a patient, healthcare providers need to understand what the patient was taking at home and stop or continue the appropriate medications at the right doses. For example, prescribers should discontinue medications that could be reducing blood pressure (e.g., beta blockers and alpha beta blockers) on admission.11,16 They need to consider adjusting home medications for kidney dysfunction and restarting medications needed to manage other complications of end-stage liver disease (e.g., lactulose for encephalopathy).

                           

                          When prompt administration of resuscitation with albumin is needed, the team may need help selecting the appropriate concentration. Patients who are significantly volume overloaded but have fluid in the extravascular space (e.g., in the abdominal cavity) would likely benefit from concentrated (25%) albumin. With the multidisciplinary team, the pharmacy team needs to understand the patient’s volume status and goals of therapy. Helping teams develop protocols to treat HRS can aid in goal-directed therapy and allow quick implementation of pharmacologic interventions to improve blood flow to the kidneys.

                           

                          At discharge pharmacists and pharmacy technicians must ensure that medications are appropriately adjusted for the patient’s current kidney and liver function after the acute event has resolved or stabilized. The pharmacy team should be involved in educating patients on how to organize their new medication regimens, how to monitor their responses to therapy and recognize common adverse effects, and how appropriate lifestyle changes can increase the effectiveness of therapy and help avoid the advanced complications of liver disease.

                           

                          CONCLUSION

                          HRS is a common complication for patients with advanced liver disease and ascites. Patients are in a state of decreased effective arterial blood flow to the kidneys and other end organs, and kidney injury is easily precipitated by nephrotoxic agents, over-diuresis, or bacterial infection. Acute treatment is aimed at restoring blood flow to the kidneys with the use of volume resuscitation and splanchnic vasoconstrictors. Pharmacists and pharmacy technicians can identify medications that may worsen kidney function, and assist in the appropriate prescribing, monitoring, and stewardship of these agents. Additionally, appropriate patient education—empowering patients to monitor their fluid/blood pressure status and avoiding OTC medications that can worsen their condition or precipitate HRS—is key in optimizing patient outcomes.

                          Pharmacist Post Test (for viewing only)

                          Set Your Ascites on Improving Patient Care: The Pharmacy Team’s Role in HRS Management
                          Pharmacist post-test
                          JC is a 56-year-old patient with end-stage liver disease secondary to non-alcoholic steatohepatitis (NASH) who presents to the emergency department with her caregiver after she was found disoriented in the backyard overnight. An arterial line is placed and the initial mean arterial pressure is 40 mmHg with a central venous pressure of 3 mmHg.

                          Past Medical History:
                          • Type 2 diabetes
                          • NAFLD, biopsy proven six years ago
                          • variceal bleed last year
                          • ascites and recent worsening encephalopathy.
                          Vital signs:
                          • blood pressure 72/30 mmHg
                          • temperature 102.3 F (39 C)
                          • weight 56 kg, last weight 58 kg one week ago
                          • no urine output
                          Labs:
                          • Scr 3.8 mg/dL (Scr 0.7 mg/dL last week).
                          No signs of edema or ascites.
                          Current medications: pantoprazole 40 mg daily, furosemide 40 mg every other day, carvedilol 6.25 mg twice daily, lactulose 30 mL TID, glipizide 10 mg daily, citalopram 10 mg daily.

                          Please use the case above to answer the next 5 questions.

                          1. JC’s blood pressure is 80/50 mmHg in triage, an arterial line is placed and CVP is initially 3 mmHg. What is the most appropriate immediate intervention given this information?
                          A. Normal saline 500 mL bolus
                          B. Vasopressin 0.04 units/min continuous infusion
                          C. Midodrine 10 mg three times daily

                          2. During JC’s admission the team requests your evaluation of the patient’s home medications. Which home medication would you discontinue on admission?
                          A. Carvedilol
                          B. Lactulose
                          C. Citalopram

                          3. What should the patient’s goal mean arterial pressure (MAP) be?
                          A. Increase MAP by 30%
                          B. Decrease MAP to 30 mmHg
                          C. MAP of at least 65 mmHg

                          4. The team is trying to determine what dose and concentration of albumin to administer. Based on only the information in the case, which initial dose and concentration is the most appropriate?
                          A. 100 grams of 5% albumin
                          B. 60 grams of 25% albumin
                          C. 60 grams of 5% albumin

                          5. The hospital is currently on ICU diversion and no critical care beds are available, so she must be cared for on the internal medicine unit. That unit cannot manage central lines. What is the most appropriate regimen to improve the patient’s MAP in addition to the currently infusing albumin?
                          A. Terlipressin
                          B. Norepineprhine
                          C. Octreotide

                          6. A patient has received terlipressin 1 mg every 6 hours for the past four days and the patient’s serum creatinine has increased from 3.5 mg/dL to 5 mg/dL. How should terlipressin be adjusted?
                          A. Stop terlipressin
                          B. Increase terlipressin dose to 1 mg every four hours
                          C. Increase terlipression dose to 2 mg every six hours

                          7. Which of the following medications should be avoided in patient with hepatorenal syndrome and/or liver cirrhosis?
                          A. Acetaminophen
                          B. Naproxen
                          C. Guaifenesin

                          8. HR is a 53-year-old Hispanic male who presents from hepatology clinic with an acute rise in serum creatinine. Admission medication reconciliation notes that his primary care doctor recently started him on losartan, and his blood pressure was 74/52 mmHg on admission. Following hydration with normal saline and stopping all other offending medications, the doctor prescribes midodrine and octreotide. What hemodynamic change can you expect following initiation of midodrine?

                          A. Decrease in blood pressure
                          B. Increase in portal pressure
                          C. Increased blood pressure

                          9. Which of the following is the most accurate rationale for combining albumin with other agents that cause vasoconstriction to manage hepatorenal syndrome?

                          A. Exogenous albumin administration decreases intravascular oncotic pressure and allows for a decrease in mean arterial pressure when combined with vasoconstricting agents
                          B. When specifically used in the setting of infection, exogenous albumin administration allows for enhanced delivery of protein bound antimicrobials to their required site of action
                          C. Use of intravenous concentrated albumin allows fluid from the extravascular space to be pulled into the blood stream and increases blood volume and delivery to the kidney

                          10. Which of the following best describes the pathophysiology of HRS?
                          A. Increased blood flow to the kidney in the setting of splenic vasodilation
                          B. Decreased blood flow to the kidney in the setting of portal hypertension
                          C. Decreased blood flow to the kidney in the setting of splenic vasoconstriction

                          11. Which of the following is a definitive treatment required to resolve HRS?
                          A. Liver transplant
                          B. Kidney transplant
                          C. Portal vein transplant

                          12. Which of the following best describes the main difference between Type I HRS and Type II HRS?
                          A. Type 1 HRS is associated with a higher rise in serum creatinine (at least 0.3 mg/dL from baseline).
                          B. Type 1 HRS happens more quickly (increase in serum creatinine over the most recent baseline taken within the past three months).
                          C. Type 1 HRS shows the presence of structural kidney disease (e.g., polycystic kidney disease or glomerular, interstitial, or vascular diseases).

                          Pharmacy Technician Post Test (for viewing only)

                          Set Your Ascites on Improving Patient Care: The Pharmacy Team’s Role in HRS Management
                          Pharmacy technician post-test
                          1. Which of the following is a reason that liver disease affects the kidneys?
                          A. Toxins that are cleared by the liver are toxic to the kidneys
                          B. The treatments for liver disease release nephrotoxins
                          C. Liver disease affects blood flow to the kidneys

                          2. Which of the following best describes main difference between Type I HRS and Type II HRS?
                          A. Type 1 HRS is associated with a higher rise in serum creatinine (at least 0.3 mg/dL from baseline) over any time period.
                          B. Type 1 HRS happens more quickly (increase in serum creatinine over most recent baseline taken within the past three months).
                          C. Type 1 HRS shows the presence of structural kidney disease (e.g., polycystic kidney disease or glomerular, interstitial, or vascular diseases).

                          3. A patient with a past medical history of cirrhosis and ascites comes into the pharmacy complaining of mild to moderate knee pain and asks for help picking an over-the-counter analgesic. Which of the following will the pharmacist most likely recommend because of safety concerns?
                          a. Naproxen
                          b. Low dose acetaminophen
                          c. Ibuprofen

                          4. A patient is picking up prescriptions for furosemide and spironolactone. Which of the following should the patient remember to do to prevent an over-diuresis that can precipitate HRS?
                          a. Weigh himself daily in the morning after he urinates; record his weights
                          b. Eat a high sodium diet; read labels carefully and aim for more than 2 grams/day
                          c. Practice good sleep hygiene; aim for an average 7 hours/night

                          5. JC is a 55-year-old patient admitted to the intensive care unit with worsening ascites and hepatorenal syndrome. His mean arterial pressure is 50 mmHg, and the ICU doctor orders IV crystalloids. Which home medication might the team want to discontinue?
                          A. Carvedilol
                          B. Lactulose
                          C. Citalopram

                          6. Which of the following is a definitive treatment required to resolve HRS?
                          A. Liver transplant
                          B. Kidney transplant
                          C. Portal vein transplant

                          7. Which of the following is a vasopressor of the splanchnic circulation?
                          A. Lactated ringers
                          B. Terlipressin
                          C. Albumin

                          8. Which of the following is the most accurate rationale for combining albumin with other agents that cause vasoconstriction in the management of hepatorenal syndrome?
                          A. Exogenous albumin administration decreases intravascular oncotic pressure and allows for a decrease in mean arterial pressure when combined with vasoconstricting medications
                          B. When specifically used in the setting of infection, albumin allows for enhanced delivery of protein bound antimicrobials to their required site of action
                          C. Use of intravenous concentrated albumin pulls fluid from the extravascular space into the blood stream and increases blood volume and delivery to the kidney

                          9. What is a drawback to the use of midodrine and octreotide in the treatment of HRS?
                          A. It constricts the splanchnic circulation.
                          B. It was not available in the United States until 2023.
                          C. It takes an extended number of days for full benefit.

                          10. Which of the following medications needs to be administered in the intensive care unit?
                          A. Albumin
                          B. Norepinephrine
                          C. Octreotide

                          References

                          Full List of References

                          References

                             
                            1. Tsochatzis EA, Bosch J, Burroughs AK. Liver cirrhosis. Lancet. 2014 May 17;383(9930):1749-61.
                            2. Huang DQ, Terrault NA, Tacke F, Gluud LL, Arrese M, Bugianesi E, Loomba R. Global epidemiology of cirrhosis - aetiology, trends and predictions. Nat Rev Gastroenterol Hepatol. 2023 Jun;20(6):388-398.
                            3. Kim D, Alshuwaykh O, Dennis BB, Cholankeril G, Ahmed A. Trends in Etiology-based Mortality From Chronic Liver Disease Before and During COVID-19 Pandemic in the United States. Clin Gastroenterol Hepatol. 2022 Oct;20(10):2307-2316.e3.
                            4. Kondili LA, Buti M, Riveiro-Barciela M, Maticic M, Negro F, Berg T, Craxì A. Impact of the COVID-19 pandemic on hepatitis B and C elimination: An EASL survey. JHEP Rep. 2022 Sep;4(9):100531.
                            5. Blach S, Kondili LA, Aghemo A, Cai Z, Dugan E, Estes C, Gamkrelidze I, Ma S, Pawlotsky JM, Razavi-Shearer D, Razavi H, Waked I, Zeuzem S, Craxi A. Impact of COVID-19 on global HCV elimination efforts. J Hepatol. 2021 Jan;74(1):31-36.
                            6. Tariq R, Singal AK. Management of Hepatorenal Syndrome: A Review. J Clin Transl Hepatol. 2020 Jun 28;8(2):192-199.
                            7. Arroyo V. The liver and the kidney: mutual clearance or mixed intoxication. Contrib Nephrol. 2007;156:17-23.
                            8. Ginès A, Escorsell A, Ginès P, Saló J, Jiménez W, Inglada L, Navasa M, Clària J, Rimola A, Arroyo V, et al. Incidence, predictive factors, and prognosis of the hepatorenal syndrome in cirrhosis with ascites. Gastroenterology. 1993 Jul;105(1):229-36.
                            9. Biggins SW, Angeli P, Garcia-Tsao G, Ginès P, Ling SC, Nadim MK, Wong F, Kim WR. Diagnosis, Evaluation, and Management of Ascites, Spontaneous Bacterial Peritonitis and Hepatorenal Syndrome: 2021 Practice Guidance by the American Association for the Study of Liver Diseases. Hepatology. 2021 Aug;74(2):1014-1048.
                            10. Wong F, Kwo P. Practical Management of HRS-AKI in the Era of Terlipressin: What the Gastroenterologist Needs to Know. Am J Gastroenterol 2023 Jun 1;118(6):915-920.
                            11. Chandna S, Zarate ER, Gallegos-Orozco JF. Management of Decompensated Cirrhosis and Associated Syndromes. Surg Clin North Am. 2022 Feb;102(1):117-137.
                            12. Patidar KR, Peng JL, Pike F, et al. Associations Between Mean Arterial Pressure and Poor ICU Outcomes in Critically Ill Patients With Cirrhosis: Is 65 The Sweet Spot? Crit Care Med. 2020 Sep;48(9):e753-e760.
                            13. Francoz C, Durand F, Kahn JA, Genyk YS, Nadim MK. Hepatorenal Syndrome. Clin J Am Soc Nephrol. 2019 May 7;14(5):774-781.
                            14. Maynard E. Decompensated Cirrhosis and Fluid Resuscitation. Surg Clin North Am. 2017 Dec;97(6):1419-1424.
                            15. Nanchal R, Subramanian R, Karvellas CJ, et al. Guidelines for the Management of Adult Acute and Acute-on-Chronic Liver Failure in the ICU: Cardiovascular, Endocrine, Hematologic, Pulmonary, and Renal Considerations. Crit Care Med. 2020 Mar;48(3):e173-e191.
                            16. Philips CA, Maiwall R, Sharma MK, et al. Comparison of 5% human albumin and normal saline for fluid resuscitation in sepsis induced hypotension among patients with cirrhosis (FRISC study): a randomized controlled trial. Hepatol Int. 2021 Aug;15(4):983-994.
                            17. Cullaro G, Kanduri SR, Velez JCQ. Acute Kidney Injury in Patients with Liver Disease. Clin J Am Soc Nephrol. 2022 Nov;17(11):1674-1684.
                            18. Mujtaba MA, Gamilla-Crudo AK, Merwat SN, Hussain SA, Kueht M, Karim A, Khattak MW, Rooney PJ, Jamil K. Terlipressin in combination with albumin as a therapy for hepatorenal syndrome in patients aged 65 years or older. Ann Hepatol. 2023, Vol. 28, p. 101126.
                            19. Kugelmas M, Loftus M, Owen EJ, Wadei H, Saab S. Expert perspectives for the pharmacist on facilitating and improving the use of albumin in cirrhosis. Am J Health Syst Pharm. 2023, Vol. epub.
                            20. Zheng X, Bai Z, Wang T, et al. Human Albumin Infusion for the Management of Liver Cirrhosis and Its Complications: An Overview of Major Findings from Meta-analyses. Adv Ther. 2023, Vol. 40, pp. 1494-1529.
                            21. Nassar Junior AP, Farias AQ, D' Albuquerque LA, Carrilho FJ, Malbouisson LM. Terlipressin versus norepinephrine in the treatment of hepatorenal syndrome: a systematic review and meta-analysis. PLoS One. 2014, Vol. 9, p. e107466.
                            22. Seshadri A, Appelbaum R, Carmichael SP 2nd, et al. Management of Decompensated Cirrhosis in the Surgical ICU: an American Association for the Surgery of Trauma Critical Care Committee Clinical Consensus Document. Trauma Surg Acute Care Open. 2022, Vol. 7, p. e000936.
                            23. Flamm SL, Wong F, Ahn J, Kamath PS. AGA Clinical Practice Update on the Evaluation and Management of Acute Kidney Injury in Patients With Cirrhosis: Expert Review. Clin Gastroenterol Hepatol. 2022, Vol. 20, pp. 2702-2716.
                            24. Flamm SL, Brown K, Wadei HM, Brown RS, Kugelmas M, et al. The Current Management of Hepatorenal Syndrome–Acute Kidney Injury in the United States and the Potential of Terlipressin. Liver Transplantation . 2021, Vol. 27, pp. 1191-1202.
                            25. Wong F, Curry MP, Reddy KR, Rubin RA, Porayko MK, Gonzalez SA, et al. Terlipressin plus albumin for the treatment of hepatorenal syndrome type 1. N Engl J Med 2021;384:818-828. N Engl J Med. 2021, Vol. 384, pp. 818-828.
                            26. Alessandria C, Ottobrelli A, Debernardi-Venon W, Todros L, Cerenzia MT, Martini S, Balzola F, Morgando A, Rizzetto M, Marzano A. Noradrenalin vs terlipressin in patients with hepatorenal syndrome: a prospective, randomized, unblinded, pilot study. J Hepatol. 2007, Vol. 47, pp. 499-505.
                            27. Martín-Llahí M, Pépin MN, Guevara M, Díaz F, Torre A, Monescillo A, Soriano G, Terra C, Fábrega E, Arroyo V, Rodés J, Ginès P and Investigators, TAHRS. Terlipressin and albumin vs albumin in patients with cirrhosis and hepatorenal syndrome: a randomized study. Gastroenterology. 2008, Vol. 134, pp. 1352-1359.
                            28. Terlivaz [package insert]. Mallinckrodt Pharmaceuticals;2023.
                            29. Hiruy A, Nelson J, Zori A, et al. Standardized approach of albumin, midodrine and octreotide on hepatorenal syndrome treatment response rate. Eur J Gastroenterol Hepatol. 2021, Vol. 33, pp. 102-106.
                            30. Midodrine [package insert]. Upsher-Smith Laboratories; 2020.
                            31. Octreotide Acetate Inejction [package insert]. Fresenius Kabi; 2022.
                            32. European Association for the Study of the Liver. EASL clinical practice guidelines on the management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome in cirrhosis. J Hepatol. 2010 Sep;53(3):397-417.
                            33. Pitre T, Kiflen M, Helmeczi W, et al. The Comparative Effectiveness of Vasoactive Treatments for Hepatorenal Syndrome: A Systematic Review and Network Meta-Analysis. Crit Care Med. 2022 Oct 1;50(10):1419-1429.
                            34. Rogal SS, Hansen L, Patel A, Ufere NN, Verma M, Woodrell CD, Kanwal F. AASLD Practice Guidance: Palliative care and symptom-based management in decompensated cirrhosis. Hepatology. 2022 Sep;76(3):819-853.
                            35. Nobili V, Carter-Kent C, Feldstein AE. The role of lifestyle changes in the management of chronic liver disease. BMC Med. 2011 Jun 6;9:70.
                            36. Saleh ZM, Bloom PP, Grzyb K, Tapper EB. How Do Patients With Cirrhosis and Their Caregivers Learn About and Manage Their Health? A Review and Qualitative Study. Hepatol Commun. 2020 Nov 17;5(2):168-176.
                            37. US Department of Veterans Affairs. Ascites due to Cirrhosis. 2018. https://www.hepatitis.va.gov/pdf/ascites-fact-sheet.pdf Accessed 6/30/2023.

                            Prepping Pharmacist Preceptors on the Pharmacists’ Patient Care Process (PPCP)

                            Learning Objectives

                             

                            After completing this application-based continuing education activity, pharmacists will be able to

                              • Describe the PPCP model and its uses
                              • Apply the PPCP when students address clinical problems in the workplace
                              • Identify areas where pharmacy students need the most guidance when using the PPCP

                              Two healthcare professionals talking while looking at a vial filled with medication capsules

                               

                              Release Date: July 21, 2023

                              Expiration Date: July 21, 2026

                              Course Fee

                              Pharmacists: $7

                              UConn Faculty & Adjuncts:  FREE

                              There is no grant funding for this CE activity

                              ACPE UANs

                              Pharmacist: 0009-0000-23-028-H04-P

                              Session Code

                              Pharmacist:  23PC28-XPK68

                              Accreditation Hours

                              2.0 hours of CE

                              Accreditation Statements

                              The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-028-H04-P  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

                               

                              Disclosure of Discussions of Off-label and Investigational Drug Use

                              The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

                              Faculty

                              Kimberly Ma
                              PharmD Candidate 2024
                              UConn School of Pharmacy
                              Storrs, CT

                              Jeannette Y. Wick, RPh, MBA, FASCP
                              Director, Office of Pharmacy Professional Development
                              UConn School of Pharmacy
                              Storrs, CT

                              Faculty Disclosure

                              In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

                              Kimberly Ma and Jeannette Wick do not have any relationships with ineligible companies

                               

                              ABSTRACT

                              Preceptors often work with students to review patient cases in an organized way. Experts developed the Pharmacists’ Patient Care Process (PPCP) in 2014 to provide a template that is consistent and concise, but also comprehensive. Using this process, students and licensed pharmacists develop SOAP notes to document the subjective and objective data they need to complete an assessment, and ultimately make a plan. PPCP stresses an important point: follow-up is critical and a well-written SOAP note can be extremely helpful in the follow-up process. This continuing education activity uses a case study to demonstrate how the PPCP process should work and emphasize areas where preceptors can provide tangential learning. It includes PRO TIPS for preceptors when they supervise students who are attempting to complete PPCP. It highlights the most common errors and suggest ways that preceptors can work with students to improve their experiential education.

                              CONTENT

                              Content

                              INTRODUCTION: A PATIENT CASE

                              JM, an 8-year-old white male presents to your clinic. It’s a pediatric care clinic located in an area where many financially challenged families live. After talking with his parents, you learn he was recently diagnosed with central precocious puberty (CPP). His endocrinologist recommends initiating therapy and would like to know what treatment you recommend. His parents also have questions.

                              Your spry pharmacy student jumps at the opportunity to write a SOAP note using the “PPCP.” To you, PPCP sounds like an illegal drug that was abused in the 1980s. She explains that the Pharmacists’ Patient Care Process (PPCP) is a standardized model for collaborative medication management. She clarifies what it entails and how to apply the process in a clinical setting.

                              PPCP’s Importance

                              Schools of pharmacy have taught the PPCP for the past few years. Preceptors who are unfamiliar with the process may find it helpful to review the PPCP as many students will take this approach when addressing clinical problems in the workplace.

                              PPCP: THE DETAILS

                              Teamwork in healthcare has achieved major goals for many patients (although we have room for improvement): accessible, affordable, and high-quality care. In addition to the many healthcare team members, pharmacists are critical contributors to care plans. Medication expertise equips pharmacists with the knowledge to reduce drug adverse events, prevent medication errors, and provide invaluable input for decision-making.1

                              In 2014, the Joint Commission of Pharmacy Practitioners (JCPP) developed a standardized process for medication management that could be used across interdisciplinary teams and dubbed it PPCP. JCPP’s members developed the approach using principles of evidence-based practice. The five steps—collect, assess, plan, implement, and follow-up—are tied together with careful communication and documentation.2 Pharmacists can remember the steps as the pneumonic “CAP-IF.”

                              SOAP Notes

                              The subjective, objective, assessment, and plan (SOAP) note provides a method of documentation for the collect, assess, and plan steps of the PPCP. SOAP notes are probably familiar to most preceptors, as clinicians have used them for roughly 50 years.3 Table 1 highlights the key components of SOAP notes.

                              Table 1. Components of a SOAP Note1

                               

                              Objective Information Subjective Information
                              ·       Current medication list (prescription and nonprescription)

                              ·       Medical history

                              ·       Physical assessments (i.e., blood pressure, heart rate, weight, height, respiratory rate, etc.)

                              ·       Laboratory results

                              ·       Chief complaint

                              ·       Symptoms

                              ·       Patient lifestyle habits, preferences, and beliefs

                              ·       Patient goals for care

                              ·       Socioeconomic factors

                              Assessment
                              ·       Problem: statement highlighting the chief complaint or main medication-related problem

                              ·       Rationale: the reasoning for the intervention cited from guidelines and supporting evidence from the collected information

                              ·       Goals of care: possible barriers to adherence, socioeconomic considerations, and desired outcome of intervention

                              Plan
                              ·       Specific recommendation or intervention based on practice guidelines (i.e., initiation of drug therapy, referral to another provider, or non-pharmacologic lifestyle modifications)

                              ·       Plan for upcoming sessions, specific monitoring parameters, and progress indicators

                               

                              Collect

                              Thorough collection of the right information supplies pharmacists with tools to make safe, effective decisions. A combination of objective and subjective information paints a more complete picture of a patient’s clinical status. If possible, pharmacists should obtain and verify their information across multiple sources. Past medical records, active medication lists, and laboratory results are great places to start.

                              When soliciting subjective information, pharmacists should use open-ended questions. Prompting patients with questions formatted to avoid “yes” or “no” answers allow providers to obtain more information in less time, prioritize chief complaints better, and minimize implicit assumptions.4

                              Back to the Case

                              Your head is spinning trying to sort all the “P’s” in PPCP, CPP, and JCPP, but your student assures you that she will start with collecting relevant clinical information. First, you and your student perform a physical assessment of JM including taking his height and weight. JM takes no medication except an occasional antihistamine, but if he took other chronic medications, this would be the time to direct your student to perform a medication reconciliation. Next, you prompt JM’s parents with open ended questions, and they recall JM’s past medical history. You should ask your student if JM needs to be involved in the discussion (see SIDEBAR). After meeting with JM and his parents, here is the relevant information your student jots down:

                              Subjective information

                              • At age 5, JM frequently soaked through his underarm clothing with pungent perspiration, so since then, he uses a strong deodorant
                              • He is starting to develop pubic and underarm hair
                              • He has some acne on his face and upper back
                              • JM occasionally tells his parents he feels “different” than his classmates because he is so much bigger and taller
                              • He has no past surgeries or hospitalizations
                              • Takes OTC multivitamins daily and loratadine for allergies in the spring

                              Objective Information

                              • Height = 4’8” inches
                              • Weight = 102 pounds
                              • DHEA Sulfate = Tanner stage III - 60 ug/dL (N = < 28 ug/dL)
                              • Clinical exam findings = testicle size indicates puberty
                              • X-ray bone age hand and wrist = greater than 2 standard deviations, 156 months (expected = 108.9 months)
                              • Luteinizing hormone (LH) = 0.4 units/L (N = < 0.3 units/L)

                              SIDEBAR: Pediatric Involvement in Healthcare Decisions5,6

                              In pediatric cases, clinicians may choose to consult only parents when making decisions regarding their child’s medical care. However, this practice, which is rooted in legal precedence, should shift to involve affected children to some extent. The American Academy of Pediatrics advocates that adolescents actively participate in decisions based on their ability and maturity. 5 While research is lacking on how exactly to assess a child’s aptitude to participate in decision making, some studies show that children can participate as young as age 5.6 Regardless, it doesn’t hurt to ask children if they have questions or concerns. In the case, JM is 8 and has voiced his concern previously about his height and size. Therefore, including him in the conversation is a possibility if his parents agree.

                              Preceptors can and should provide tangential learning when working with special populations. Reminding students that adolescents, older adults, people who have cognitive decline or dementia, and people for whom English is a second language will need careful counseling. Pharmacists and pharmacy staff will also need to select their words carefully and accommodate these patients’ needs. Assigning students to do some research on the various needs in these populations is an excellent way to help them develop skills and a professional identity.

                              Upon looking at your student’s notes so far, you assure her she has done well. However, you still have some questions. You remind her that sometimes information like height and weight requires additional evaluation and ask her to calculate JM’s BMI; she finds that it’s 22.9. You ask your student, “How does JM’s height and weight compare to the expected height and weight of boys his age?” To which she replies, “Pediatric growth charts will give us a better idea!” After consulting the growth charts, she determined and documented that JM falls within the 112th percentile for both measurements.

                              To make learning comprehensive, you could ask the student if the only kind of precocious puberty is central in nature. This will help your student learn to differentiate among different forms of similar diagnoses.

                              Assessment

                              An assessment of comprehensive patient information helps prioritize the problems that require attention. Pharmacists should consider all information when identifying the problem, the rationale, and the goals of therapy. Some example questions pharmacists can consider include1

                              Medication appropriateness

                              • What is the indication for each medication?
                              • What is the correct dosing?
                              • What are the common adverse effects?
                              • What are the possible drug interactions?

                              Factors that impact access to care

                              • What cultural factors create barriers to care?
                              • What socioeconomic factors impact the patient?
                              • What is the patient’s level of healthcare literacy?
                              • What goals does the patient or his parents have?
                              • What barriers impact patient adherence?

                              Additional services

                              • What preventive care measures does the patient qualify for?
                              • Which immunizations has the patient received?
                              • What other concerns does the patient have?

                              THE CASE RESUMED...

                              After compiling the objective and subjective information on JM, the student finds guidelines in the Journal of Clinical Endocrinology for the management of CPP.7 Due to JM’s symptoms and lab values showing consistencies with CPP, the guidelines recommend initiating a gonadotropin releasing hormone (GnRH) analog. Depending on JM’s and his parents' preferences, the endocrinologist can choose either an injectable (leuprolide) or long-acting implantable device (histrelin) provided the insurance covers it or the cost is manageable.

                              Once again, you should have some questions for your student. For example, asking the student to list the search terms and search engines she employed can shed light on her process. Another question might be, “Are these the only guidelines available?” You can show her that you used PubMed, as she did, but when you used Google Scholar, you found an excellent review article that lists five other publications. You suggest she look at them since expert recommendations can vary. She might also contact the endocrinologist and ask if he plans to follow the guidelines she identified, and if not, why not.

                              The endocrinologist messages back saying he agrees leuprolide and histrelin are both reasonable options to consider for first-line therapy. However, he also cites a 2019 update published on Hormone Research in Paediatrics. These guidelines recommend a third U.S. Food and Drug Administration (FDA)-approved option for the treatment of CPP, triptorelin.8 He says the student should consider this choice as a potential treatment for JM as well.

                              After reading the endocrinologist’s note, you emphasize to your student the importance of citing multiple guidelines when drafting an assessment. In this case, the FDA approved an additional treatment, triptorelin, in 2022. You walk through your student’s process of finding clinical information to identify more ways she can improve next time. Furthermore, you point out how the endocrinologist’s insight exemplifies the importance of interdisciplinary care.

                              Simultaneously, you and your student read through all three monographs and discuss the major differences you’d like to share with his parents. You ask the student to practice her delivery of the information, and she says, “Leuprolide is a long acting injectable administered intramuscularly (IM) or subcutaneously. Your doctor will administer the IM formulation every month, three months, or six months. “Triptorelin is similar to leuprolide, but is only available as a six month IM formulation. The other option is for your doctor to administer the subcutaneous formulation every six-months.9 On the other hand, histrelin comes as a long-acting 1¼ inch implant surgically placed into the upper arm every 12 to 24 months. For the first 24 hours after the surgery, JM should avoid swimming or bathing. As long as JM avoids heavy play or exercise for the first week, he will not have to worry about any further restrictions after that. The implant also requires surgical removal.”10

                              Now, you prompt the student to recall that JM’s parents expressed concern about what would happen if JM experienced an adverse reaction to the long-acting implantable device. They asked, “What is the procedure like?” and “If JM has a reaction to the implant, must he continue to wear it for 12 months or can the doctor remove it easily before then?”

                              The student does more research and says she will assure JM’s parents that this outpatient procedure lasts only 10 minutes, though the appointment may last 60 to 90 minutes. Most surgeons will just numb the area; however, children may undergo sedation if necessary. The surgeon will insert the narrow implant into a small approximately 5 mm opening made in the skin on the inner surface of the arm. With this option, JM can return to school the same day. The student plans to mention that complications don’t commonly occur, but minor discomfort and bruising may.11 The student plans to continue, “The implant may be removed immediately if JM presents at any time a severe allergic reaction or adverse effect. However, this is not common.”

                              Before you and the student document the assessment section of your SOAP note, the student indicates she will ask JM if he has questions. He shares that he “HATES needles” but is also scared of the surgery hurting.” The student plans to tell him not to worry because he won’t feel any pain during the operation. He can also choose to sleep during the surgery if he prefers.

                              Here, the preceptor should step in with gentle corrections about patient-appropriate language. First, most Americans have no idea what a 5 mm incision will look like. You ask her to calculate its length in inches and explain it by comparing it to something the child will recognize, like the size of small dice or a stack of 20 playing cards. Next, it’s critical to remind the student that we must never tell patients that something won’t hurt. This is a lesson students should learn during immunization training and creates an opportunity for cross training (applying this principle to other areas of pharmacy) that applies regardless of patient age. Healthcare professionals should never say, “This will not hurt a bit!” or anything similar. People have different pain thresholds making it impossible to predict whether it will hurt. Student pharmacists need to develop language they are comfortable with and use it. A good response if people ask if it will hurt is, “It may hurt or sting a little but just for a minute or two.” In this case, the preceptor suggests saying, “The doctor will numb the area.”

                              Finally, the preceptor may point out that “operation” can be a scary word for children. The student needs to use a word like “procedure” or find a way to avoid either of those words.

                              The preceptor should also point out that JM’s parents had also said they were worried about two things: (1) potential side effects and (2) the cost of care. They heard on the news that expenses associated with these medications can add up quickly. The cost of care and determining what the patient’s insurance will cover is probably foremost in the endocrinologist’s mind, too.

                              In terms of potential side effects, your student says that both GnRH analogs have similar side effect profiles. From the pediatric studies she read on GnRH adverse effects, she shares that signs of puberty may increase transiently with therapy before growth velocity eventually slows down. Some children experience weight gain, changes in appetite, body aches, headaches, gastrointestinal (GI) symptoms, or signs of a common cold. Parameters like physical growth and bone mass density may decrease during treatment but usually return to normal one year after treatment discontinuation.9, 10

                              Before selecting JM’s treatment option, it’s critical to evaluate insurance coverage since it’s on the forefront of everyone’s concerns. The student needs to determine if they have insurance and what the plan covers. She starts by finding information on ballpark cost. She reports a histrelin implant costs around $40,000. If the patient requires mild sedation when the doctor inserts the implant, the cost may increase. However, in some cases, the implant may be used for up to two years. Leuprolide’s median annual cost ranges from $20,000-$40,000 depending on the formulation.12 A single injection of triptorelin costs roughly $19,000, making the annual cost nearly $40,000 as well. Then says she will remind JM’s parents that while this may give them an idea, the cost may vary outside of that range.

                              Plan

                              Following the assessment, pharmacists work to develop a personalized patient care plan in collaboration with other healthcare professionals. The plan should reflect recommendations from the most recent evidence-based clinical practice guidelines. Pharmacists should focus on optimization of care in a safe, effective, and cost-effective manner.

                              1. Address medication-related problems and optimize medication therapy
                              2. Set specific, measurable, achievable, realistic, and timed (SMART) goals in the context of the patient’s healthcare goals and access to care
                              3. Involve patients to engage in education, empowerment, and self-management
                              4. Support non-pharmacologic interventions as appropriate

                              SMART Goals. When creating an action plan for patients, pharmacists should aim to set goals that are SMART.

                              • Specific instructions provide other clinicians with accurate information about the patient.
                              • Measurable outcomes provide clinicians the ability to evaluate the patient’s progress and whether the plan requires adjustments
                              • Achievable and realistic goals
                              • A timeline for the plan ensures healthcare providers routinely follow up with their patient

                              A PLAN FOR JM

                              After you document JM’s main problem, rationale, and goals for care in the assessment section, you move on to create his plan. Following careful consideration of the assessment, you and your student decide to recommend starting histrelin to treat his CPP since his insurance will cover it once the endocrinologist completes prior authorization forms. (Here, you suggest that the student find the prior authorization forms and volunteer to complete as many sections as she can for the endocrinologist. You explain that she can expedite the process and this is a skill she can apply to many different pharmacy practice locations.) Choosing histrelin is also a needle-free option, which may make JM happy. You remind your student that the plan should also include scheduling necessary appointments and follow-ups with JM’s other providers in addition to counseling on the specific adverse effects of the medication detailed in Table 2.

                              Table 2. Example SOAP note for JM 7

                              Name: JM

                              Age: 8    

                              DOB: 10/02/14

                              Allergies: Seasonal allergies, NKDA

                              Chief Complaint: Patient referred to clinic by endocrinologist for medication therapy; patient was recently diagnosed with central precocious puberty (CPP)
                              Subjective Information

                              JM is an 8-year old white male presenting to the clinic. He recently met with his endocrinologist on 6/28/23 and has been referred to the clinic for drug therapy to treat CPP. His parents confirm JM’s use of deodorant to combat excessive perspiration and body odor since the age of 5. He has also developed pubic and underarm hair in addition to acne on his face and upper back. His parents are concerned regarding JM’s reported insecurities at school due to his larger size.

                              PMH: no surgeries or hospitalizations Medications: daily multivitamin, OTC loratadine (prn for allergies)
                              Objective Information

                              Clinical exam findings = testicle size indicates puberty

                              112th percentile for weight and height

                              Relevant Labs: Bone age of 13, LH 0.4 units/L, DHEA sulfate 60 ug/dL

                              Height: 55 in Weight: 102 lbs BMI: 22.9 BP: 110/61 mmHg HR: 75 bpm Temp: 98.6 ℉ RR: 15
                              Assessment

                              Problem: Patient requires medication therapy for untreated indication.

                              Rationale: According to the Journal of Clinical Endocrinology Practice Guidelines for Central Precocious Puberty, JM requires hormone suppression therapy. Symptoms of rapid linear growth, advanced skeletal maturation, and basal LH levels > 0.3 units/L require treatment with GnRH analogs until the normal age of puberty.

                              Goals of Care: The goal of treatment is to reduce signs of premature pubertal progression while ensuring therapy is well tolerated and medication side effects are minimized. Patient’s parents would like to choose an option that is cost effective and safe.

                              Plan

                              Initiate histrelin 50mg SQ implant to be administered by JM’s surgeon every 12-24 months depending on safety and efficacy parameters evaluated at follow up appointments

                              Schedule surgery appointment with JM’s surgeon at earliest convenience

                              Schedule follow up in 3 months to evaluate pubertal progression, growth velocity, skeletal maturation, and tolerability

                              Counsel JM/JM’s parents on possible adverse effects including weight gain, changes in appetite, initial flare of puberty symptoms, GI symptoms, body aches/pains, and signs of common cold

                              Counsel JM’s parents on providing support to make JM feel good about himself. Children who are undergoing rapid development at this age may feel different when comparing themselves to other children their age.

                              Implement

                              During the implementation phase, pharmacists set the action plan into motion. This may include the administration of vaccines, initiating or discontinuing a medication, or scheduling the next follow-up appointment. Pharmacists, primary care physicians, or caregivers work together to provide care based on the goals made in the planning step.1

                              Follow-up and Monitor

                              The pharmacist in collaboration with other health care providers should follow-up with the patient as recommended in practice guidelines and referring back to the SOAP note. Continuous monitoring of medication appropriateness, adherence, safety, laboratory results, and patient concerns will indicate if the plan requires revision. Routine medication reconciliations, check-ups, or conversations with patients improve outcomes and help to achieve goals of therapy.

                              Putting it All Together

                              Upon completion of the SOAP note, you send the endocrinologist your recommendations. You contact JM’s parents to discuss scheduling a follow-up appointment in three months with the endocrinologist and counsel on histrelin.

                              IMPLICATIONS FOR PRECEPTORS

                              The Benefits. The PPCP model creates a reproducible framework that demonstrates clinical pharmacists’ contributions to medication-related outcomes.13 In addition to improving the quality and completeness of patient medical records, SOAP notes give pharmacists a place to start when working up a new patient. As students practice developing SOAP notes, preceptors should emphasize how the lessons they learn in one case can apply to future cases.

                              The Drawbacks. As more pharmacy programs integrate PPCP into their curriculum, new students will have access to courses that teach the model. But because the PPCP model is relatively new, many licensed pharmacists have not yet familiarized themselves with the process. Extracting the necessary information to write quality SOAP notes can also be time consuming. Depending on the setting, pharmacists may not have enough time to walk through every step with students. Finally, the PPCP method does not encompass all clinical situations. The framework relies on pharmacists to exercise clinical judgment and reasoning to modify the model as needed.

                              Uncomfortable Topics. Students often have little exposure to difficult topics. These may include end-of-life issues, psychiatric diagnoses, cultural or ethnic differences, drug abuse/misuse, and gender-related topics. In this case, students may feel strong discomfort in discussing matters related to sex and sexual development. Preceptors need to help students reduce their hesitancy when communicating with you and the patient because improper communication can lead to poor collection of relevant information. Keep in mind strong note-writing skills facilitate good care. Two things help: (1) practice, and (2) finding resources designed to help with difficult topics. The Conversation Project (https://theconversationproject.org/resources/healthcare/) is one such resource that can help students become more comfortable with difficult topics.

                              In addition, students may have implicit and explicit biases for uncomfortable topics such as the use of hormone blockers, which may bring to mind their use in transgender children. Creating a safe place for your student to share opinions provides a great opportunity for you to teach students how to avoid these biases. Preceptors need to remember that learning—especially if it changes a student's perspective or points out a student's mistake—can be threatening, and students can feel vulnerable while learning. It’s an emotional experience.6

                              To help guide students through these experiences, the SIDEBAR provides 10 additional tips preceptors can use when supervising the PPCP.

                              SIDEBAR: PRO TIPS for Preceptors Who Supervise the PPCP

                              (1) Don't let the acronym scare you! This is a new name for a process you've probably used knowingly or unknowingly for years.

                              (2) Encourage independence. Hand over the problem to the student once you've described the problem and fielded the student's questions. Establish a time for the student to be prepared to discuss it but check in periodically to see if the student is having trouble.

                              (3) Rescue when necessary. Some students will need more support than others. If a student is clearly flummoxed, spend more time and provide more direction.

                              (4) Promote interdisciplinary communication. Having students discuss a clinical problem with another clinician, either with you or on their own, fosters interdisciplinary care. Students will also learn from the other clinicians, which will lighten your load!

                              (5) When students present findings, always ask them to describe things like the search terms and search engines they used or the obstacles they encountered. Help them refine their processes to reduce barriers or find more appropriate resources.

                              (6) Consistently prompt students to determine if the case is typical or unusual. Asking questions based on a modification of the case can help students learn more globally.

                              (7) Don't "stay in your lane"! In this CE, the practice site is an ambulatory care location specific to pediatrics. The lessons a student learns in this rotation, if they go beyond pediatrics, will be invaluable. Helping students develop communication skills or analyze how disease states present or are treated in adults or other special populations will increase their clinical acumen in future rotations.

                              (8) Address implicit biases or misconceptions. Students may not know that an attitude or opinion is biased, incorrect, or simply rude.

                              (9) Debrief. After the PPCP is done, provide feedback, ask others who may have been involved to provide feedback, and ask the student to perform a self-assessment.

                              (10) Appreciate reverse mentoring. Remember that students often teach us new things!

                               

                              Common Sources of Error

                              Collecting too little information. Not all the information pharmacists need to collect will be obvious. In the patient case, the student collected important objective information like height and weight. However, without something like growth charts to evaluate JM’s height/weight compared to other kids his age, the information does not help in the assessment. Preceptors can aid students who are new to documenting SOAP notes when they are required to dive deeper into collected information. Students should not make assumptions as to what other clinicians know off the top of their heads. In this case, other areas where the preceptor helped the student included directing her to seek other expert opinions like the endocrinologist. That puts the “inter” in “interdisciplinary” care!

                              Collecting too much information. Pharmacists and students should collect information worthy of appraisal. In other words, only collect the necessary information that will contribute to the identification, prevention, and resolution of either the chief complaint or medication-related problems. If pharmacists/students do not actively use collected information to make the assessment or plan, they should omit it in the note. Documenting more information does not equate to better information. This leads to overly lengthy or confusing SOAP notes. Here, as in the previous error, preceptors should ask students to examine and explain their processes.

                              Not verifying information. All information should be verified across multiple sources like when performing traditional medication reconciliations. This prevents possible errors in note-taking that may arise from outdated documentation.

                              Sourcing one guideline. Depending on the disease state, the frequency in which guidelines are updated can vary. Preceptors should emphasize the importance of looking for multiple guidelines and paying attention to their publication dates. Occasionally, the FDA may approve new treatment options after the release of clinical guidelines or updates. In this case, the student completely missed an additional treatment option as a result of sourcing a single guideline from 2013. Similar to how preceptors should encourage students to verify collected information across multiple sources, preceptors should also encourage students to cross-check sources that aid in their assessment.

                              The assessment lacks evidence. As mentioned above, the assessment should communicate the assessor’s thought process. The information collected by the pharmacist/student should justify why the problem is a problem. If there is no subjective or objective information to back up the assessment, the assessment has no basis.

                              Forgetting recommendations on current medications. Pharmacists/students should not forget to include instructions for the patient’s current medications, not just the newly prescribed medications.

                              Forgetting non-pharmacologic recommendations. The plan section also encompasses non-pharmacologic interventions such as referral to another provider, ordering additional laboratory tests, education, or counseling on lifestyle interventions. Pharmacists/students should remember that not all patients require initiation of a new medication.

                              Being vague. When initiating new therapy appropriately, pharmacists/students should always provide specific recommendations with the drug name, dose, and frequency. Vague instructions such as “Initiate hormone blocker therapy” are unhelpful. Similarly, instead of “monitor for side effects,” pharmacists/students can list the specific symptoms that present most commonly.

                              Poor communication. Errors due to poor communication directly hinder the PPCP. Furthermore, clinicians with experience are not necessarily better communicators. Therefore, pharmacists should engage in education/training to constantly improve communication skills. SOAP notes should effectively communicate the pertinent information used to create a plan and document important details for the patient’s medical record.

                              Setting it and forgetting it. The PPCP is not a linear process. While this framework provides clinicians a place to start and a checklist of sections to complete in order, pharmacists should remember to review and revise all sections at any given time. For example, pharmacists may identify new information they should go back to collect as they work on their assessments. Preceptors should encourage their students to occasionally step back and evaluate the completeness and coherence of the SOAP note. Sometimes patient cases will require students to revise sections of the SOAP note they already completed.

                              And a New Case

                              Just before the end of the month, the endocrinologist sends yet another patient with precocious puberty to you. The patient LD is a 9-year old Hispanic female. Her endocrinologist recently diagnosed her with idiopathic precocious puberty and wants to know which treatment you recommend. Her parents also want to know why this is happening to their daughter. Before taking LD’s family from the clinic waiting room, you decide to let your student take charge of this case while you supervise. You ask your student “Now that you have practiced writing SOAP notes and know a little about this disease state, how will you approach the PPCP this time?”

                              The student says to you...

                              “I stored all my notes from the last case on precocious puberty from earlier this month. I have a document containing the guidelines from the Journal of Clinical Endocrinology along with several updated publications that cite all additional first-line medications approved after the original guideline’s release. I will start with the collection of subjective information such as LD’s symptoms and medical history followed by objective information, specifically pertaining to her growth statistics. I should calculate BMI and her height/weight percentiles since precocious puberty is usually associated with accelerated growth. Next, I will examine her relevant lab values. Since the patient is female, I will be looking out for progesterone levels this time. If possible, I shall cross-reference all of the information I collect across multiple sources.”

                              “Before I move onto making an assessment, I understand LD’s parents may feel very concerned about their daughter's condition. I don’t want to forget to address their question. I will explain that idiopathic precocious puberty does not have a definitive cause. To help them better understand, I’ll mention that idiopathic cases may result from anything ranging from a head injury in childhood to exposure to certain chemicals. Regardless of the cause, I will assure them there are several treatment options that may be appropriate for LD at this time. I can walk them through the pros and cons of all the available options.”

                              “Next, I would prompt LD’s parents with open-ended questions to learn more about their major concerns, potential barriers to medication therapy, and insurance eligibility. I know these are important considerations for my assessment. It would also be appropriate for me to engage with LD using appropriate language for a 9-year-old girl. I realize the topic may be uncomfortable to discuss, but without taking initiative of the discussion I may forget to include pertinent details in my SOAP note.”

                              “Finally, using the information I collected about the family’s preferences and LD’s medical history, I will draft the chief complaint, rationale for treatment, goals of therapy, and eventually a completed plan. The plan will include which treatment I recommend along with the dose, frequency, and which adverse effects are most common. I will write when I recommend a follow-up with her endocrinologist and make note of which lifestyle modifications may support her specific treatment. If the endocrinologist is on board, then we can collaboratively implement and follow-up with the patient as appropriate.”

                              You are overjoyed to hear that your student has taken what she learned from the previous case and applied it to this case as well. Although some of the parameters were different, such as the patient’s sex, she was able to anticipate how the changes may impact her SOAP note this time. While you identify a few areas in which she can improve, you are happy that she is continuing to expand her clinical pharmacy knowledge.

                              Conclusion

                              The PPCP model can be applied to any healthcare setting in which pharmacists practice. This comprehensive approach to patient-centered care has established a streamlined method of documenting patient information to be shared among healthcare teams. As the PPCP continues to grow in clinical settings, practicing pharmacists should become familiar with its methods and applications.

                              Pharmacist Post Test (for viewing only)

                              Prepping Pharmacist Preceptors on the Pharmacists’ Patient Care Process (PPCP)
                              Post-test
                              Learning Objectives
                              After completing this continuing education activity, preceptor-pharmacist will be able to
                              • Describe the PPCP model and its uses
                              • Apply the PPCP when students address clinical problems in the workplace
                              • Identify areas where pharmacy students need the most guidance when using the PPCP
                              POST TEST
                              1. Which of the following correctly lists the steps of the PPCP process in order?
                              A. Collect, plan, assess, follow-up, implement
                              B. Collect, assess, plan, implement, follow-up
                              C. Plan, collect, assess, follow-up, implement
                              2. Which of the following best describes the JCPP’s reason for developing the PPCP?
                              A. To establish a more efficient method of medical documentation
                              B. To provide an opportunity for pharmacists to expand their clinical role
                              C. To create a reproducible method of managing patient medications

                              3. Which of the following examples is a common error pharmacy students make when using the PPCP?
                              A. Avoiding discussion involving uncomfortable topics such as those sexual in nature
                              B. Spending too long counseling the patient as opposed to documenting the SOAP note
                              C. Omitting recommendations to follow up with the patient’s primary care provider
                              4. Which of the following is a common source of error with the PPCP?
                              A. Using a single clinical guideline for recommendations
                              B. Spending the most time documenting the assessment section
                              C. Cross-referencing medication lists against too many sources
                              5. A nurse practitioner calls your clinic and would like you and your student to work up a patient with stage II hypertension. The patient is a 64-year-old African American male who is currently taking amlodipine 2.5 mg and chlorthalidone 6.25 mg. His blood pressure was 150/90 mmHg at his last doctors appointment. Which of the following would be an appropriate first step?
                              A. Increase the dose of his medications. The SOAP note does not need to be performed as his blood pressure remains elevated due to subtherapeutic dosing.
                              B. Ask the patient about his/her medication adherence recently. This information will dictate how you decide to approach the patient.
                              C. Contact the patient’s local pharmacy for a complete list of active medications. This will be valuable information to collect prior to assessing the patient.
                              6. A student working on a SOAP note cites a 2012 guideline from Europe. The preceptor notices the student forgets to consider a first-line treatment option that was approved in 2022. What should the preceptor do at this point?
                              A. Call the physician to get his/her opinion on the newly approved medication
                              B. Discuss the importance of citing multiple sources with the student
                              C. When the student finishes the note, add in the missing information
                              7. Laboratory values belong under which of the following sections of the PPCP?
                              A. Assessment
                              B. Objective information
                              C. Subjective information
                              8. Your student is counseling a patient who has dementia. When you ask him to practice how he would counsel the patient, he looks puzzled and asks “What for? He has dementia and he won’t understand anyway.” How do you proceed?
                              A. Ask the student to find guidelines on how to determine when and how dementia patients should be counseled.
                              B. Tell him it was a trick question and that he is correct that dementia patients should never be counseled.
                              C. Explain pharmacists are legally required to offer counseling and he should be prepared if the patient requests it.
                              9. A preceptor and student are working in an ambulatory care clinic. A patient presents to the counter and says she has been experiencing terrible adverse effects from one of her medications. The patient places a bottle of sertraline on the counter. She believes this is the medication causing her persistent insomnia. After talking with the doctor, she has switched to taking it in the morning, but she claims it does not help. How should the preceptor advise the student to continue?
                              A. Advise the student to counsel the patient on ways to manage this adverse effect of sertraline. The student may consult the monograph or other recent guidelines.
                              B. Remind the student that persistent insomnia is a flag to contact the provider. The psychiatrist can handle this as it isn’t in the scope of the preceptor’s practice.
                              C. Advise the student to start by evaluating the patient’s past medical history and evaluating her medications before sending her back to see her doctor.
                              10. A general practitioner refers a patient with mild asthma to your clinic. He has recommended the patient to start SMART therapy and would like you to supply your recommendations through a SOAP note. Under your supervision, the student finishes collecting the necessary objective and subjective information and has begun a draft of the assessment as follows:
                              “The patient needs medication therapy for an untreated indication. According to the GINA guidelines, the patient should initiate a low dose inhaled corticosteroid plus a long-acting beta agonist combination in low doses as needed.”
                              Which of the following best describes the feedback the preceptor should give the student when applying the PPCP model?
                              A. The student has done a good job so far. However, the assessment should also consider patient concerns such as insurance coverage.
                              B. The student has done a good job so far. The student should provide specific doses and monitoring parameters for completeness.
                              C. The student has done a good job so far. The student should call the provider to check if they follow the GINA guidelines, and if not, why.

                              References

                              Full List of References

                              References

                                 
                                REFERENCES
                                1. Joint Commission of Pharmacy Practitioners. Pharmacists’ Patient Care Process. Published May 29, 2014. Accessed June 21, 2023. https://jcpp.net/patient-care-process/
                                2. Cooley J, Lee J. Implementing the Pharmacists' Patient Care Process at a Public Pharmacy School. Am J Pharm Educ. 2018;82(2):6301. doi:10.5688/ajpe6301
                                3. Podder V, Lew V, Ghassemzadeh S. SOAP Notes. [Updated 2022 Aug 29]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 January. https://www.ncbi.nlm.nih.gov/books/NBK482263/
                                4. Takemura Y, Sakurai Y, Yokoya S, et al. Open-ended questions: are they really beneficial for gathering medical information from patients?. Tohoku J Exp Med. 2005;206(2):151-154. doi:10.1620/tjem.206.151
                                5. Taub S. Learning to Decide: Involving Children in their Health Care Decisions. Virtual Mentor. 2003;5(8): virtualmentor.2003.5.8. pfor3-0308. Published 2003 Aug 1. doi: 10.1001/virtualmentor.2003.5.8.pfor3-0308
                                6. Elnicki DM. Learning with emotion: which emotions and learning what?. Acad Med. 2010;85(7):1111. doi:10.1097/ACM.0b013e3181e20205
                                7. Fuqua JS. Treatment and outcomes of precocious puberty: an update. J Clin Endocrinol Metab. 2013;98(6):2198-2207. doi:10.1210/jc.2013-1024
                                8. Bangalore Krishna K, Fuqua JS, Rogol AD, et al. Use of Gonadotropin-Releasing Hormone Analogs in Children: Update by an International Consortium. Horm Res Paediatr. 2019;91(6):357-372. doi:10.1159/000501336
                                9. Lexicomp. Wolters Kluwer Health, Inc. Updated June 20, 2023. Accessed June 21, 2023. https://online-lexi-com.ezproxy.lib.uconn.edu/lco/action/doc/retrieve/docid/pdh_f/129683?cesid=afdPrd0aazi&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Dleuprolide%26t%3Dname%26acs%3Dfalse%26acq%3Dleuprolide#rfs
                                10. Lexicomp. Wolters Kluwer Health, Inc. Updated June 6, 2023. Accessed June 21, 2023. https://online-lexi-com.ezproxy.lib.uconn.edu/lco/action/doc/retrieve/docid/pdh_f/128793?cesid=4Ds6TlNfgKm&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Dhistrelin%26t%3Dname%26acs%3Dfalse%26acq%3Dhistrelin
                                11. Supprelin LA (Histrelin) Subcutaneous Implant Procedure. Children’s Hospital of Philidelphia. Published May 4, 2021. Accessed June 21, 2023. https://www.chop.edu/treatments/supprelin-la-histrelin-subcutaneous-implant-procedure
                                12. Kaplowitz P, Hoffman, R. Precocious Puberty Medication. Medscape. Updated January 24, 2022. Accessed June 21, 2023. https://emedicine.medscape.com/article/924002-medication
                                13. Harris IM, Phillips B, Boyce E, et al. Clinical pharmacy should adopt a consistent process of direct patient care. Pharmacotherapy. 2014;34(8):e133-e148. doi:10.1002/phar.1459
                                14. Silverman LA, Han X, Huang H, Near AM, Hu Y. Clinical characteristics and treatment patterns with histrelin acetate subcutaneous implants vs. leuprolide injections in children with precocious puberty: a real-world study using a US claims database. J Pediatr Endocrinol Metab. 2021;34(8):961-969. Published 2021 Jun 21. doi:10.1515/jpem-2020-0721

                                Patient Safety: Fad Diets: Do They Deserve the Hype?

                                Learning Objectives

                                 

                                After completing this application-based continuing education activity, pharmacists will be able to

                                1. Describe the prevalence of fad diets in society
                                2. Outline the components of different types of fad diets
                                3. Explain the effect different fad diets can have on the body
                                4. Recognize situations in which fad diets present safety concerns for patients

                                  After completing this application-based continuing education activity, pharmacy technicians will be able to

                                  1. Describe the prevalence of fad diets in society
                                  2. Outline the components of different types of fad diets
                                  3. Explain the effect different fad diets can have on the body
                                  4. Recognize situations in which fad diets present safety concerns for patients

                                  Obese individual standing in front of words relating to food.

                                   

                                  Release Date: July 15, 2023

                                  Expiration Date: July 15, 2026

                                  Course Fee

                                  Pharmacists: $7

                                  Pharmacy Technicians: $4

                                  There is no grant funding for this CE activity

                                  ACPE UANs

                                  Pharmacist: 0009-0000-23-022-H05-P

                                  Pharmacy Technician: 0009-0000-23-022-H05-T

                                  Session Codes

                                  Pharmacist:  23YC22-XPK68

                                  Pharmacy Technician:  23YC22-KPX83

                                  Accreditation Hours

                                  2.0 hours of CE

                                  Accreditation Statements

                                  The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-23-022-H05-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

                                   

                                  Disclosure of Discussions of Off-label and Investigational Drug Use

                                  The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

                                  Faculty

                                  Abigail R. Johnson, BS
                                  Senior US FDA Regulatory Affairs/Medical Writing Intern
                                  Arciel LLC, Stratford, CT

                                             

                                  Faculty Disclosure

                                  In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

                                  Ms. Johnson has no financial relationships with ineligibile companies.

                                   

                                  ABSTRACT

                                  In the United States, being overweight or having obesity are two leading causes of health issues, and these rates have increased in recent years. Enter the concept of fad diets. People often turn to diets or tools advertised as promoting quick weight loss without considering the diet’s sustainability and their bodies’ reaction. Fad diets’ one-size-fits-all approach is usually not the cure-all solution people hope it will be. Overall healthy nutrition and lifestyle choices are more beneficial. Due to fad diets’ popularity, it is essential to understand their components and their affect within the body to reduce health risks. This continuing education activity discusses intermittent fasting, ketogenic (“keto”) diets, pay-for-food systems, paleolithic (“paleo”) diets, and the Atkins diet. It identifies patients for whom fad dieting can be dangerous.

                                  CONTENT

                                  Content

                                  INTRODUCTION

                                  Fad diets have always existed but have been on the rise in recent years due to the explosion of social media in the 21st Century. A fad diet is a popular diet followed to achieve fast results or fix long-term problems associated with eating, specifically weight.1 Fad diets are labeled as fads for a reason. These short-lived trends with wide popularity disregard for the rationale behind or quality of the approach itself.3,4

                                  People who choose fad diets are often trying to fix ongoing problems including overweight or obesity, inadequate nutrition, sedentary behaviors, and failure to maintain overall healthy habits.2 Individuals who follow fad diets adhere to a mainstream concept of dieting without acknowledging individual health needs and restrictions. Health consequences may arise as a result of adhering to a diet ill-suited to an individual's nutritional needs and ability to sustain the associated effort. In addition, certain diets may influence medication interactions and disease outcomes. For this reason, fad diets can undermine patient safety.

                                   

                                  This continuing education activity summarizes popular fad diets to inform pharmacy teams of their benefits and risks. It will allow teams to make recommendations for patients, understand how medications interact with the diets, and help prevent health complications.

                                   

                                  The History of Fad Diets

                                  Fad diets have existed throughout history in different forms. For example, in the 1920s, the Cigarette Diet was popular. Lucky Strike, a cigarette company, promoted the cigarette diet. They claimed that cigarettes would suppress appetite to boost sales using the tagline “Reach for a Lucky instead of a sweet.” Promoters advertised that people would lose weight successfully while following the diet.6 The 1940s saw the rise of the Master Cleanse. This juice cleanse consisted of a meal replacement drink consisting of hot water, lemon juice, maple syrup, and cayenne pepper. Its popularity stemmed from promises of cleansing the body of toxins while providing very few calories. It reached new levels of popularity in 2006, when superstar Beyoncé claimed to lose 20 pounds in two weeks using this method 6 In the 1960s, The Drinking Man’s Diet made an appearance. The recommendation was to consume high-protein and low-carbohydrate foods while drinking as much alcohol as desired. An example meal may have included a large serving of steak, salad or vegetables, and several alcoholic beverages. The Drinking Man’s Diet’s supporters considered alcohol a good carbohydrate and allowed indulgence. This diet was marketed toward the male population.6

                                   

                                  People have always been interested in quick fixes for weight loss and appearance without considering how they will feel or how to keep the weight off indefinitely.1 This approach to choosing a diet or making nutrition decisions ignores tactics that sustain weight loss. Fad diets are inherently unsustainable options that often lead to weight regain. These outcomes prove many fad diets are unreliable (if not dangerous).

                                   

                                  With the creation and explosion of modern social media in the early 2000s, fad diets surged in popularity. Social media often fosters a community of misinformation regarding fad diet composition, how to follow the specific diet, and the diet’s benefits.5 Much of the information on social media regarding fad diets lacks reputable, verifiable sources. Fad diet promoters use scientific jargon loosely and inappropriately to make information convincing when describing seemingly miraculous diets. However, the information could just be the opinion of an individual or a promotional company sponsorship.5 Unless diet information is published by a credible source, it should be regarded as untrustworthy.

                                   

                                  Pause and Ponder: How many times a week do you see diet-related content on social media?

                                   

                                  Fad Diet Prevalence

                                  Approximately 45 million Americans (about 14% of the total population) go on a diet each year.7 Of these diets, 50% are fad diets.7 According to the United States (U.S.) Weight Loss & Diet Control Market, the weight loss industry is one of the most advertised with investors spending $66 billion annually.7 More people than ever are overweight or obese and using diets as a solution. Table 1 summarizes obesity’s prevalence, which is rising each year in the U.S.

                                   

                                  Table 1. Obesity Prevalence in the U.S. Population8

                                  Age (years) % of Population
                                  Adults aged 20 and up 41.9%
                                  Adolescents aged 12-19 22.9%
                                  Children aged 6-11 20.7%
                                  Children aged 2-5 12.7%

                                   

                                  According to the Centers for Disease Control and Prevention (CDC), individuals who are overweight or have obesity are at elevated risk for many health issues. These include elevated cholesterol, stroke, heart disease, hypertension, cancer, type 2 diabetes, mental illness, low quality of life, and mortality, among others.9 While many factors can influence weight, individuals can adapt their diets to meet nutritional needs and make long-term differences to improve health outcomes.

                                   

                                  TYPES OF FAD DIETS

                                  As the definition implies, fad diets’ popularity increases and decreases with current trends. This section discusses some of the most popular current fad diets.

                                   

                                  Intermittent Fasting

                                  Individuals following an intermittent fasting diet alternate eating and fasting (not eating or drinking anything) on a cyclic schedule. This diet focuses more on eating during specific periods of time than restricting meal components. Various intermittent fasting schedules exist, but popular versions include alternate-day and time-restricted fasting.10,11 Alternate-day fasting means fasting every other day, while time-restricted fasting involves eating within set time windows during the day. Individuals should consult a doctor and choose the type of intermittent fasting that best fits their health needs (but most do not). Studies show following intermittent fasting schedules leads to decreased body weight, body mass index (BMI), and waist circumference.11 Studies also show improved blood glucose and triglyceride levels following this diet.10

                                   

                                  The body uses ingested calories—specifically carbohydrates, sugars, and nutrients—as fuel.10 If people eat continuously throughout the day, the body uses ingested calories as fuel to perform necessary bodily functions. The body stores unused ingested calories in the form of fat where they become an energy reserve.10,12

                                   

                                  When the period between meals lengthens and the body lacks a constant supply of calories for fuel, it turns to the fat reserve to burn fat stored in the body. The theory is that the longer a person goes without eating, the more the body will use its fuel reserve. The more reserve is used, the more fat is burned.10 As more of the reserve is used for energy while intermittent fasting, more weight is lost through fat burn.

                                   

                                  Intermittent fasting regulates eating times without restricting foods or food groups. Dieters must make conscious choices to include foods beneficial to health. This includes fruits, vegetables, plant proteins or lean meats, whole grains, superfoods (see Sidebar: Superfoods), and low-fat dairy options.12 Healthy choices also include limiting processed foods and sugars.

                                   

                                  Sidebar: Superfoods13

                                  Superfoods are nutrient-rich and high in important dietary components including antioxidants, vitamins, minerals, fiber, and healthy fats. These help keep the body functioning, reduce disease risk, and improve well-being. Some examples of superfoods are

                                  • Avocados → These include potassium and healthy fats to lower the risk of heart disease.
                                  • Chia seeds → These include fiber, protein, antioxidants, vitamins, and minerals. They are also easy to add to recipes.
                                  • Dark and leafy greens → All greens are good greens, but these are especially nutrient dense, including vitamins A, C, and E. They also contain vitamin K, which promotes bone health.
                                  • Ginger → This includes vitamin C, magnesium, and potassium. It also helps reduce pain and aid nausea.
                                  • Salmon → Fish is high in omega-3 fatty acids, which can help reduce heart disease.
                                  • Yogurt → This includes calcium and protein to help with bone health, cancer prevention, and immune health. It is also a good source of probiotics to support gut health.

                                   

                                  Pause and Ponder: Do patients ask about superfoods when discussing dietary information or supplements? Do you know which to recommend?

                                   

                                  Pros and Cons

                                  Like most diets, intermittent fasting has benefits and drawbacks. Following intermittent fasting correctly boosts memory, improves blood pressure, induces fat loss while maintaining muscle mass, helps prevent obesity, improves type 2 diabetes by reducing insulin resistance, and improves tissue health.12,14 Intermittent fasting also regulates the body’s 24-hour cycle to improve physiological functioning and metabolic health. As a result, gastrointestinal (GI) microbiomes, energy levels, and sleep may improve.15

                                   

                                  Drawbacks of this diet include issues with long-term maintenance/adherence, leading to regaining weight.10 It is difficult and tiring for individuals to maintain fasting for extended periods. In addition, until the body is accustomed to fasting periods, symptoms such as headaches, nausea, or dizziness may occur. Some individuals may feel an initial decrease in energy levels when starting this diet.10

                                   

                                  Keto Diet

                                  The keto diet, also known as the ketogenic diet, is centered around depriving the body of carbohydrates.16 Researchers originally developed the ketogenic or keto diet in the 1920s as an epilepsy treatment, especially for resistant pediatric cases.17 The rise of effective antiepileptic drugs and treatments decreased use of the ketogenic diet for this purpose. As originally designed, total daily calories were composed of high fat intake (70% to 80%), moderate amounts of protein (10% to 20%), and low carbohydrate intake (5% to 10%).16 An iteration of this diet has gained more traction since the 1990s, as people realized its effectiveness for quick weight loss.16

                                   

                                  The keto diet helps with weight loss through the processes of gluconeogenesis and ketogenesis. Under normal circumstances, carbohydrates produce energy for the body.16 When insufficient carbohydrates are available, insulin secretion is reduced and glucose is less available. The body then exploits gluconeogenesis, using lactic acid, glycerol, and amino acids to produce glucose as an energy source.16

                                   

                                  If carbohydrate levels drop further, the body enters ketogenesis and secretes ketone bodies as an alternative energy source.16 As insulin secretion levels remain low and ketone bodies are used for energy, fat and glucose storage falls significantly. This can cause other fats to break down, leading to bodily fat loss.16

                                   

                                  To remain in ketogenesis, the body needs constant carbohydrate deprivation.16 The longer it is deprived of carbohydrates, the more fat is burned in the ketotic state. This is known as nutritional ketosis and is considered safe, as opposed to the metabolic state of ketoacidosis (an accumulation of ketones that increases the blood’s acidity), which can be life-threatening.16

                                   

                                  During ketoacidosis, ketone bodies are produced in large amounts and can acidify the blood pH.16 Acidic blood pH reduces the amount of oxygen blood delivers to cells leading to cell death and life-threatening complications. Insulin keeps the production of ketone bodies at bay, so sometimes people with type 1 diabetes develop ketoacidosis due to decreased insulin production. Taking diabetes-related medication correctly reduces the risk of ketoacidosis in people with diabetes. Following a low carbohydrate diet for a prolonged amount of time can also lead to ketoacidosis.17 To reiterate, ketogenesis is the production of ketone bodies in response to carbohydrate and glucose depletion. Low concentrations of ketone bodies are generally regarded as a safe, as opposed to high concentrations caused by ketoacidosis (which is a medical emergency).16

                                   

                                  What to Eat and Avoid

                                  Given the strong emphasis on high-fat foods, healthy fats comprise the largest part of this diet.16 Foods such as seeds and nuts, coconut, avocados, poultry fat, and plant fats (e.g., olive or coconut oils) are encouraged. In addition, some dairy products—including butter, hard cheese, and yogurt—are allowed, but people on a ketogenic diet should avoid cream, ice cream, and full-fat milk given their natural sugar content.17 Individuals following this diet should consume a moderate amount of protein, ideally meats high in omega-3 fats.16 This includes grass-fed beef, free-range poultry, wild-caught fish, and pork. Nuts, seeds, tofu, and eggs are also acceptable protein sources.17

                                   

                                  Adhering to a diet with less than 10% of calories from carbohydrates can be challenging, especially since this diet requires individuals to calculate “net carbs” (See Sidebar: What are “Net Carbs”?).16 Vegetables lacking high starch contents (e.g., cauliflower, broccoli, onions, leafy greens, bell peppers, garlic, mushrooms, cucumber, summer squash) are encouraged. Small portions of fruit are also allowed, and fruits with a lower net carb content (e.g., berries) are preferred. Other acceptable carbohydrates include dark chocolate, herbs, spices, unsweetened tea, coffee, vinegars, and mustards.17

                                   

                                   

                                  Sidebar: What are “Net Carbs”? 17

                                  The body cannot digest or metabolize some carbohydrates because of their molecular structures. For example, fruits, vegetables, whole grains, and sugar alcohols contain insoluble fibers that are indigestible. Insoluble carbs have no energy value or blood sugar impact, so they are allowed when following the keto diet. The keto diet requires dieters to calculate “net carbs,” the amount of carbohydrates taken in by the body that are digested and metabolized and thus contribute to calories. However, it is important to note that the total calorie level does not change even when “net carbs” are calculated.

                                   

                                  Individuals calculate net carbs by subtracting the number of ingestible carbohydrates from the food’s total amount of carbohydrates. For example, food containing 24 total carbohydrates and 21 ingestible carbohydrates equals 3 net carbs. Ingestible carbohydrates can typically be found by subtracting the amount of fiber from the amount of carbohydrates in the food item, but it can be more complicated. A number on online net carb calculators are available to help.

                                   

                                  Net carbs are also known as “impact carbs.” Food manufacturers use both terms as marketing strategies, but governing bodies do not regulate use of these phrases.

                                   

                                  Foods containing added sugar, whole or refined grains, and flour products are restricted.17 Starchy foods are also not allowed, including some high-starch vegetables such as corn, potatoes, and winter squash. Fruits with a high net carb content and fruit juices are restricted. Most keto programs also advise against alcoholic beverages due to their carbohydrate content and added sweeteners.17

                                   

                                  Pros and Cons

                                  The keto diet may be beneficial for weight loss, as it uses ketone bodies for energy to deplete glucose and fat storage abilities. Decreasing sugar intake lowers the risk of developing diabetes, obesity, and metabolic syndrome.16 Following this diet may reduce cholesterol, blood sugar, and blood pressure, and decrease insulin resistance.17

                                   

                                  Diet restrictions may cause short-term adverse effects such as nausea and vomiting, fatigue, headaches, dizziness, and insomnia.16 This is known as the “keto flu.” Symptoms usually resolve once the body adjusts to the diet after a few weeks. Fluids and electrolyte replenishment can help alleviate discomfort during this period.16

                                   

                                  Documented long-term adverse effects include increased uric acid levels in the blood, increased risk of kidney stones, and osteoporosis.17 This is due to the diet’s restrictive nature and omission of necessary components to sustain a healthy diet. Nutrient deficiencies can occur as a result of following this diet.17

                                   

                                  People struggle to adhere to the ketogenic diet due to strict regulation of fat, protein, and carbohydrates.17 Dieters must carefully monitor their adherence to intake limits and meet target levels. This can be difficult for individuals to maintain long-term and lead to low adherence to the diet.17

                                   

                                  Pay-for-Food Systems

                                  Pay-for-food diets are meal prep services or meal delivery services with pre-portioned ingredients, pre-cooked meals, or meal replacement options. Diets focus on weight loss and are designed for convenience. These options take the guesswork out of planning meals and make it easier to track eating.

                                   

                                  Nutrisystem

                                  The Nutrisystem meal service claims its diets help with weight loss through a high-protein and low glycemic approach.18 Nutrisystem expects users to lose one to two pounds a week by managing blood sugar and controlling hunger to avoid overindulgence. Dietitians design meals to include healthy options and relieve the stress of planning.18

                                   

                                  Meals are pre-portioned to fit an individual’s needs and tastes.18 The meals’ composition of lean protein, healthy fat, and smart carbohydrate ingredients is supposed to curb hunger. Protein shakes and bars are options to supplement plans. Nutrisystem claims deprivation is too restrictive and allows for some deviation from the plan or healthy alternatives to “bad foods.” In addition, dieters can track their progress and calories using Nutrisystem’s app. This system promotes prizes and special offers to keep individuals motivated.18

                                   

                                  Prices vary by plan type but can range from $9.99 to $15.18 a day. Nutrisystem has plans designed specifically for men, women, partners, and people with diabetes.18

                                   

                                  SlimFast

                                  When SlimFast originated, the system promoted meal replacement shakes to lose weight.19 The company has since expanded to include drink mixes, snacks, and meal replacement bars. The products are grouped into categories such as calorie control, high protein, keto, and intermittent fasting. The website also contains a recipe section for dieters to use in their meal planning.19

                                   

                                  SlimFast plans are based on individuals’ goals and preferences, including the Favorite Foods Plan, Keto Plan, High Protein/Low Carb Plan, Original Plan, and Intermittent Fasting.19 Dieters purchase SlimFast products to supplement or replace parts of their current diet. Plans themselves are not priced because individuals buy their own groceries and supplement with SlimFast products associated with the plan of their choice. The company also has an app to use for weight management tracking and a private Facebook group to communicate with other individuals on the diet to offer support or guidance.19 SlimFast claims their plans and products promote and maintain weight loss and encourage people to make better food choices.19

                                   

                                  Jenny Craig

                                  The Jenny Craig company has recently gone out of business after 40 years in the industry. Some experts indicates that one reason has been the availability of weight loss medications and increased competition in this market space. This system emphasized one-on-one coaching mixed with healthy foods to lose weight quickly.20 The company claimed dieters could lose up to 18 pounds in the first four weeks. Coaches designed meal plans to be unrestrictive and included an individual’s favorite foods. Meals focused on low-fat foods with high fiber and protein. This program also emphasized physical activity and occasional intermittent fasting to aid the weight loss process.20

                                   

                                  Plans consisted of meals from the program, two snacks, and supplemental grocery items daily to promote weight loss and increase metabolism.20 One snack included Jenny Craig’s Recharge Bar, used when intermittent fasting. The program claimed the Recharge Bar helped dieters lose weight faster, feel less hungry, and maintain fasting. Jenny Craig coaches designed plans and provided guidance for the duration of the program.20

                                   

                                  Food was delivered weekly or biweekly. Depending on the type of plan, individuals paid $13.99 to $21.99 per day. Prices were based on the number of meals, membership length, and amount of coaching support included. Promotional offers and meal bundles were available.20

                                   

                                  Pros and Cons

                                  Pay-for-food diets can be intriguing as they promote healthy choices, weight loss, and convenience.18-20  They reduce mental load and stress surrounding dieting by making the choices easier or eliminating the need to choose altogether. Some services also provide support groups or coaches for accountability and guidance. In addition, if dieters can adhere to these plans, meal kits promote portion control and reduce overeating.18-20

                                   

                                  A major con associated with these diets and meal kits is adherence. As people lose weight on these diets, they may stop using them, gain weight back, and become discouraged about trying again. This can reverse improved health outcomes.18-20 Another con is cost. Individuals may be discouraged by the prices associated with pay-for-food systems. The cost may not be viable or sustainable options for all individuals.18-20  

                                   

                                  Studies have shown these diets to be ineffective. Attrition rates (percentages of people leaving a program) are 30% or greater, and 37% of dieters who complete programs lose less than 5% of their initial body weight.21 Other studies failed to produce significant results for how these pay-for-food diets affect weight loss when compared to educating or counseling individuals on weight.22 High attrition rates and insignificant weight loss results suggest these diets are unsustainable and unreliable.21

                                   

                                  Paleo Diet

                                  The paleo diet goes by many names, including the Paleolithic, caveman, or Stone-Age diet. It consists of (allegedly) eating like humans of the Paleolithic era did, mixed with modern components to supplement the diet. The Paleolithic era occurred from roughly 2.5 million years ago to 1,200 B.C. Diet supporters believe current body function is similar to how it functioned during this era and eating foods available or comparable to this time will improve health.23 Introduced in 2002 by Dr. Loren Cordain, a scientist specializing in nutrition, this diet has surged in popularity in recent years due to weight loss claims.24

                                   

                                  Due to disagreements about which foods were available in the Paleolithic era compared with today, many diet plans are dubbed “paleo.” They differ in specific foods allowed. All plans emphasize high protein, healthy fats, low or moderate carbohydrates, low sugar and sodium, and high fiber to meet weight loss goals.23 The term “paleo” will be used to describe this model. The paleo diet consists of consuming mostly lean meats, fruits, vegetables, nuts, seeds, and fish, in line with what researchers believe was consumed during the Paleolithic age.23 It also emphasizes reducing intake of dairy, grains, and carbohydrates.25

                                   

                                  Weight loss can occur through several pathways using the paleo diet. 23 Like the keto diet, ingesting fewer carbohydrates forces the body to use fat for fuel. In addition, replacing highly processed foods, added sugars, and large amounts of carbohydrates with healthier options can aid weight loss. Eating more protein and less calorically dense food (i.e., few calories in a large volume of food) also helps curb hunger and leave individuals more satisfied.23

                                   

                                  Less calorically dense foods—including vegetables, fruits, low-fat or fat-free dairy, and egg whites—can be eaten in larger quantities. These foods help with weight loss as they allow individuals to eat a larger volume and feel full, without ingesting large numbers of calories.26 This reduces snacking and overall food intake.23

                                   

                                  Conversely, calorically dense foods are high in calories and eaten in small amounts. These contribute weight gain as individuals who eat a small volume consume high numbers of calories.27 Examples of calorically dense foods include27

                                  • Proteins: fish, beans, eggs, cheese, yogurt, fats including nuts, avocados, nut butters
                                  • Carbohydrates: potatoes, brown rice, whole grains

                                   

                                  Overall, the paleo diet works by breaking down the diet into basic components and making healthier choices. Cutting out foods leading to high glucose or carbohydrate storage also aids in eating healthier and inducing weight loss.28

                                   

                                  What to Eat and Avoid

                                  Allowed foods emphasize fresh and healthy choices to remain consistent with foods found in the Paleolithic age.23 This includes lean meats, fish or shellfish, fruit, vegetables, honey, nuts or seeds, and olive or coconut oils. Frozen fruits and vegetables are allowed as they contain the same nutrients as the fresh variety and may be more convenient. Omega-3 fats are important for the body and can be found in fish, grass-fed beef, avocado, olive oil, some nuts (e.g., walnuts, almonds, pistachios), and seeds. Root vegetables such as cassava and sweet potatoes are highly nutritious and are allowed in moderation.23

                                   

                                  Restricted foods have little nutritional value or a high glycemic index unsuitable for the paleo diet.23 For example, white potatoes and processed foods are off limits. Other restricted foods include whole or refined grains, cereals, refined sugar, refined vegetable oil, legumes, dairy products, alcohol, coffee, and salt. Canola is a refined vegetable oil and is not allowed. Restricted legumes include peanuts, beans, and lentils.23

                                   

                                  This diet emphasizes eating healthy and portioning fats, proteins, and carbohydrates to enhance health.23 Calorie counting and general portion control are deemphasized in this diet. Some plans also allow for “cheat meals” (those consisting of food not beneficial to health) in the early stages of the diet to increase adherence.23

                                   

                                  Pros and Cons

                                  Components of this diet including fiber, potassium, and antioxidants aid bodily functions and reduce disease risk. Reducing the intake of highly processed foods with little nutritional value also helps improve overall health.25 Short-term benefits may include weight loss, improved blood pressure and cholesterol levels, and increased insulin sensitivity.23 One study documented improvements in metabolic levels, specifically glucose control and lipids, in people with diabetes.28

                                   

                                  Unfortunately, restricting or excluding foods altogether for long periods of time can lead to nutritional deficiencies and health complications. For example, limiting dairy intake leads to deficiencies of calcium, vitamin D, and B vitamins.23 These deficiencies can increase risk of osteoporosis and bone injuries.24 Dairy-related nutrient deficiencies are not specific to the paleo diet, but can occur due to its food restrictions. Restricting grains in the diet also deprives the body of nutrients, which increases risks of diabetes and heart disease. In addition, increased meat consumption (especially red meat) contributes to saturated fat intake and increases risks of cardiovascular problems and diabetes.23 It may also be difficult for people to adhere to a diet that restricts certain categories of foods.

                                   

                                  Atkins Diet

                                  The Atkins diet promotes low carbohydrate intake while allowing as much protein and fat as desired. Robert C. Atkins, a heart specialist, developed this diet in the 1960s as a method for weight loss and maintenance.30 Although it is a low-carb diet, the Atkins program acknowledges that eating right is always better than eating less.31 This diet is ever evolving to be current with updated nutritional expertise.30

                                   

                                  Like the keto diet, Atkins emphasizes low carbohydrate intake of less than 20 g per day to start.30 Unlike the keto diet, consumption of fat and protein is less restricted. Carbohydrates are claimed as the problem without regulating the intake of other food groups. Diet supporters believe the sugars found in carbohydrates cause health issues such as blood sugar imbalances and weight gain.30

                                   

                                  Hypothetically, eating fewer carbohydrates lowers dietary sugar leading to greater satiety, increased energy, less stored fat, and higher metabolism.31 When the body lacks glucose and carbohydrates to use as energy, it turns to fat to keep the body functioning through ketogenesis. The more fat a person burns, the more weight they lose.

                                   

                                  Fat and protein comprise the remainder of the diet. As carbohydrates are viewed as the source of health issues, intake levels of fat and protein are less restricted. Calorie counting and portion control are unnecessary, besides keeping track of carbohydrate intake to stay below the allowable limit.30

                                   

                                  The Atkins diet is split into phases with specific allowable limits of carbohydrates (see Table 2). The diet’s phases adjust to reflect changes in body function and weight. As carbohydrate levels fluctuate in each phase, protein and fat levels change to achieve satiety.

                                   

                                   

                                  Table 2. Atkins Diet Phases31

                                  Phase Instructions
                                  Phase 1:

                                  Induction

                                  3 regular sized meals or 4-5 small meals, vitamins/supplements, 8 oz. glasses of water, 20 g net carbs per day
                                  Phase 2:

                                  Ongoing weight loss

                                  Can add net carbs in 5 g increments weekly, vitamins/supplements, 8 oz. glasses of water, no more than 40 g a day after adding extra carbs, introduce Atkins food products
                                  Phase 3:

                                  Pre-Maintenance

                                  Maintaining previous stages, can add net carbs in 10 g increments weekly to find the perfect balance until the goal weight is reached, maintain carb intake of goal weight
                                  Phase 4:

                                  Maintenance

                                  Maintaining Phase 3 carb level, reducing fat intake as carb intake increases, managing cravings and weight

                                   

                                   

                                  While phases differ in carbohydrate intake levels, they include similar food groups overall.30 Allowed foods include vegetables, oils, fats, and protein (e.g., eggs, cheese, fish, meat and poultry). Dieters can introduce berries, nuts, seeds, starchy vegetables, and whole grains in the third phase, provided they are still losing weight. Dieters can also eat Atkins’ commercial selection of products during and after phase two. Most fruits, alcohol, baked goods high in sugar, bread, pasta, and nuts are restricted in phase one. Some fruits and grains are added by phase three.30

                                   

                                  Pros and Cons

                                  Benefits of the Atkins diet include weight loss; decreased blood pressure; and lower incidence of heart disease, metabolic syndrome, and diabetes.30 This diet can also improve blood sugar and cholesterol levels. These benefits are attributed to low carbohydrate intake and subsequent weight loss.30

                                   

                                  Reducing carbohydrate intake may initially cause symptoms such as headache, weakness, fatigue, and dizziness.30 Unrestricted fat intake can be unhealthy. In addition, using fat as the body’s energy source for too long may lead to ketoacidosis if dieters misuse the plan.29 Nutrient deficiency can also occur on this diet as a result of restrictions.30

                                   

                                  Weight loss pursuant to this diet is difficult to maintain due to its deficiencies and restrictive nature. Following the carbohydrate limit for long periods of time is difficult and unsustainable for some people.30 Cardiologists warn this diet puts oxidative stress (disproportionate levels of oxygen reactive species overwhelming the ability of body systems to detoxify them) on organs and can cause serious heart problems or fatal complications.29 Some long-term studies have shown the Atkins diet is no more effective than other fad diets. In addition, these studies show that most people who lost weight while following the Atkins diet regained it.30

                                   

                                  IMPLICATIONS FOR PHARMACY TEAM

                                  Fad dieting can compromise patient safety, and certain patients are at elevated risk for problems. Pharmacy teams are responsible for advising patients about drug-diet interactions and concerns. Table 3 describes conditions and their associated medications that impact the use of fad diets.

                                   

                                  Table 3. Implications for Pharmacy Teams10,16,23,30,32-40

                                  Diet Patient Conditions and Associated Medications That Can Be Contraindications with Diets
                                  Intermittent Fasting ·       Age younger than 18 years

                                  ·       Pregnancy or breastfeeding

                                  ·       Type 1 diabetes

                                  o   Insulin, blood pressure medication, cholesterol-lowering medication

                                  ·       History of eating disorder

                                  Keto ·       Diabetes

                                  o   Insulin, blood pressure medication, cholesterol-lowering medication

                                  ·       Hypoglycemia

                                  o   Glucagon or other forms of glucose

                                  ·       Pancreatitis

                                  o   Pain medication

                                  ·       Liver failure

                                  ·       Fat metabolism disorders

                                  o   Cholesterol-lowering medication

                                  ·       Primary carnitine deficiency

                                  o   L-carnitine supplements

                                  ·       Carnitine palmitoyltransferase deficiency

                                  ·       Carnitine translocase deficiency

                                  ·       Porphyrias

                                  o   Hemin

                                  ·       Pyruvate kinase deficiency

                                  o   Mitapivat (Pyrukynd), folic acid supplements, iron chelators

                                  Pay-For-Food Systems ·       Contraindications and associated medication will depend if it is an individually designed plan or the service’s version of intermittent fasting, keto, etc.
                                  Paleo ·       Cardiovascular related issues

                                  o   Anticoagulants, ACE inhibitors, cholesterol-lowering medications, diuretics, etc.

                                  ·       Diabetes

                                  o   Insulin, blood pressure medication, cholesterol-lowering medication

                                  ·       Nutrient deficiency disorders

                                  Atkins ·       Diabetes

                                  o   Insulin, blood pressure medication, cholesterol-lowering medication

                                  ·       Taking diuretics

                                  o   Thiazide, loop, potassium-sparing diuretics or a mix of types

                                  ·       Severe kidney disease

                                  o   Blood pressure medication, anemia medication, cholesterol-lowering medication, supplements

                                  ·       Pregnancy or breastfeeding

                                   

                                  Nutritional Myths

                                  As mentioned, misinformation surrounding diets has always existed, and social media has magnified the problem. Some myths are more harmful than others, but knowing the facts is essential to correctly informing others.32 Examples of nutritional myths that pharmacy teams can debunk for their patients are found in Figure 1.

                                   

                                   

                                  Dieting is not a one-size-fits-all solution. When pharmacy teams advise patients, they must work with patients to consider health factors . Factors to consider include a patient’s medications, lifestyle choices, and known health issues.33 Pharmacy teams should advise individuals that fad diets are not necessary and following a generally healthy diet is usually sufficient to lose weight. They should make healthy swaps and find strategies that work best for them as individuals. For example, they can cut back on processed foods, consume more fruits and vegetables, and be conscious of fat or carbohydrate intake to ensure healthy sources. These choices are effective ways to achieve the long-term goals without employing fad diets that promote quick fixes.33

                                   

                                  CONCLUSION

                                  Fad diets are undeserving of the positive hype they receive. They are short-term solutions that sometimes work for people looking to lose weight or make changes quickly. However, benefits are outweighed by their unsustainability and poor post-diet maintenance planning. Fad dieting also starts a cycle of yoyo dieting (see Sidebar: Yoyo Dieting). The best option for health is to find strategies that work individually and stick with them. Ditch the fad diets and make long-term healthy choices for better, lasting results.33

                                   

                                  Sidebar: Yoyo Dieting

                                  Yoyo dieting, or weight cycling, occurs when people achieve their goal weight through dieting, stop dieting and return to unhealthy habits, gain the weight back, diet again for a period, gain the weight back, and repeat the cycle. Yoyo dieting is not only a conscious choice. Physiological mechanisms related to energy intake and expenditure, genetics affecting weight control processes, and the interaction between genes and the environment also affect the cycle.34

                                   

                                  Yoyo dieting lacks substantial or sustainable changes to lifestyle or nutrition to keep weight off and instead focuses on quick fixes.34 These quick fixes ultimately fail when weight is regained, and the cycle continues. Most weight lost is gained back within the first two to three years after dieting ceases. However, if dieters keep weight off for two years, the likelihood of gaining it back decreases.35

                                   

                                  Pause and Ponder: Do you think fad diets are helpful or harmful?

                                  Resources for Pharmacists and Pharmacy Technicians

                                   

                                  Pharmacist Post Test (for viewing only)

                                  Fad Diets: Do They Deserve the Hype?

                                  Pharmacist Post-test

                                  After completing this continuing education activity, pharmacists will be able to

                                  ● Describe the prevalence of fad diets in society
                                  ● Outline the components of different types of fad diets
                                  ● Explain the effect different fad diets can have on the body
                                  ● Recognize the value of the pharmacist/pharmacist technician’s role in understanding this information

                                  1. Of the 45 million Americans who go on a diet each year, what percentage are fad diets?
                                  A. 66%
                                  B. 50%
                                  C. 14%

                                  2. What makes fad diets appealing to millions of dieters?
                                  A. They are a good way to stop the cycle of yoyo dieting
                                  B. They are considered safe for individuals with health complications
                                  C. They promote quick weight loss results

                                  3. Which of the following fad diets mainly focus on low carbohydrate intake?
                                  A. Keto and Atkins
                                  B. Keto and intermittent fasting
                                  C. SlimFast and Atkins

                                  4. Which types of fad diets claim to improve blood pressure?
                                  A. Intermittent fasting, pay-for-food diets, and Atkins
                                  B. Intermittent fasting, keto, paleo, and Atkins
                                  C. Paleo and Atkins

                                  5. What causes ketoacidosis?
                                  A. Prolonged extreme carbohydrate restriction***
                                  B. Prolonged extremely high carbohydrate intake
                                  C. Low-level ketone body production

                                  6. Why should individuals taking cardiovascular-related medications such as ACE inhibitors or cholesterol-lowering drugs avoid the Paleo diet?
                                  A. Nutrient deficiencies caused by the composition of the diet lead to increased risk of cardiovascular issues.
                                  B. Reduced grain intake and high meat or fat consumption leads to increased risk of cardiovascular issues.
                                  C. These medications cause sensitivity to foods included in the Paleo diet.

                                  7. A patient with type 1 diabetes mentions that she plans to start following the keto diet because she knows that carbohydrates spike her blood sugar. Which of the following is the BEST response?
                                  A. It is the best way for people with diabetes to lose weight quickly and keep it off long-term
                                  B. It will be difficult for you to follow long-term, so the Atkins diet is more appropriate
                                  C. It is not a safe option for you because you are at increased risk of ketoacidosis

                                  8. Why is it important for pharmacy teams to understand contraindications and health implications of fad diets?
                                  A. To identify signs of diabetes based on how the body reacts to certain fad diets
                                  B. To advise patients about drug-diet interactions and how fad diets can impact their health
                                  C. To direct patients to an appropriate fad diet based on their current medications

                                  9. What general nutrition information should people follow instead of fad diets?
                                  A. Cut all dairy, gluten, and fat from the diet and eat only protein and carbohydrates
                                  B. Decrease fats and carbohydrates in the diet and increase red meat intake
                                  C. Limit processed foods and make overall healthy choices like eating more superfoods

                                  10. A patient comes to the pharmacy to pick up medication and you advise him to avoid diets involving fasting and calorie restrictions. His condition and associated medication indicate fasting and restricting calories would be harmful to his health. Which fad diets does this warning pertain to?
                                  A. Intermittent Fasting, Keto, Atkins
                                  B. Keto, Paleo, Atkins,
                                  C. Intermittent Fasting, Paleo, Atkins

                                  Pharmacy Technician Post Test (for viewing only)

                                  Fad Diets: Do They Deserve the Hype?

                                  Pharmacy Technician Post-test

                                  After completing this continuing education activity, pharmacy technicians will be able to

                                  ● Describe the prevalence of fad diets in society
                                  ● Outline the components of different types of fad diets
                                  ● Explain the effect different fad diets can have on the body
                                  ● Recognize the value of the pharmacist/pharmacist technician’s role in understanding this information

                                  1. Of the 45 million Americans who go on a diet each year, what percentage are fad diets?
                                  A. 66%
                                  B. 50%
                                  C. 14%

                                  2. What makes fad diets appealing to millions of dieters?
                                  A. They are a good way to stop the cycle of yoyo dieting
                                  B. They are considered safe for individuals with health complications
                                  C. They promote quick weight loss results

                                  3. Which of the following fad diets mainly focus on low carbohydrate intake?
                                  A. Keto and Atkins
                                  B. Keto and intermittent fasting
                                  C. SlimFast and Atkins

                                  4. Which types of fad diets claim to improve blood pressure?
                                  A. Intermittent fasting, pay-for-food diets, and Atkins
                                  B. Intermittent fasting, keto, paleo, and Atkins
                                  C. Paleo and Atkins

                                  5. What causes ketoacidosis?
                                  A. Prolonged extreme carbohydrate restriction
                                  B. Prolonged extremely high carbohydrate intake
                                  C. Low-level ketone body production

                                  6. Why should individuals taking cardiovascular-related medications such as ACE inhibitors or cholesterol-lowering drugs not follow the Paleo diet?
                                  A. Nutrient deficiencies caused by the composition of the diet lead to increased risk of cardiovascular issues.
                                  B. Reduced grain intake and high meat or fat consumption leads to increased risk of cardiovascular issues.
                                  C. These medications cause sensitivity to foods included in the Paleo diet.

                                  7. A patient with type 1 diabetes mentions that she plans to start following the keto diet because she knows that carbohydrates spike her blood sugar. Which of the following is the BEST response?
                                  A. It is the best way for people with diabetes to lose weight quickly and keep it off long-term
                                  B. It will be difficult for you to follow long-term, so the Atkins diet is more appropriate
                                  C. It is not a safe option for you because you are at increased risk of ketoacidosis

                                  8. Why is it important for pharmacy teams to understand contraindications and health implications of fad diets?
                                  A. To identify signs of diabetes based on how the body reacts to certain fad diets
                                  B. To advise patients about drug-diet interactions and how fad diets can impact their health
                                  C. To direct patients to an appropriate fad diet based on their current medications

                                  9. What general nutrition information should people follow instead of fad diets?
                                  A. Cut all dairy, gluten, and fat from the diet and eat only protein and carbohydrates
                                  B. Decrease fats and carbohydrates in the diet and increase red meat intake
                                  C. Limit processed foods and make overall healthy choices like eating more superfoods

                                  10. You are checking out a customer at the pharmacy counter and notice she is picking up some over-the-counter items along with her prescriptions. Which of the following groups of items would prompt you to refer an individual to the pharmacist?
                                  A. Metformin (for diabetes), Atkins snack bars, and Dramamine (for dizziness)
                                  B. Sertraline (for depression), SlimFast shakes, and a bottle of water
                                  C. Lisinopril (for blood pressure), a gallon of ice cream, and a bottle of soda

                                  References

                                  Full List of References

                                  References

                                     
                                    REFERENCES
                                    1. Wdowik M. The long, strange history of dieting fads. Colorado State University. November 13, 2017. Accessed January 14, 2023. https://source.colostate.edu/the-long-strange-history-of-dieting-fads/
                                    2. Tahreem A, Rakha A, Rabail R, et al. Fad Diets: Facts and Fiction. Front Nutr. 2022;9:960922. Published 2022 Jul 5. doi:10.3389/fnut.2022.960922
                                    3. Foxcroft L. Introduction: 'The Price of a Boyish Form'. In: Calories and Corsets: A History of Dieting over Two Thousand Years. Profile Books; 2011:1-8.
                                    4. British Dietetic Association (BDA). Fad diets: Food fact sheet. September 2021. Accessed January 16, 2023. https://www.bda.uk.com/resource/fad-diets.html
                                    5. British Dietetic Association (BDA). Fad diets and Instagram – friend or Foe? March 2019. Accessed January 16, 2023. https://www.bda.uk.com/resource/fad-diets-and-instagram-friend-or-foe.html
                                    6. Gans, K. Fad diets through the decades. U.S. News. December 23, 2019. Accessed January 17, 2023. https://health.usnews.com/health-news/blogs/eat-run/articles/fad-diets
                                    7. Johnson J. Fad diets are bad diets. American Council on Science and Health. July 2, 2018. Accessed January 20, 2023. https://www.acsh.org/news/2018/07/02/fad-diets-are-bad-diets-13134
                                    8. Centers for Disease Control and Prevention. Obesity and overweight. Updated January 5, 2023. Accessed January 20, 2023. https://www.cdc.gov/nchs/fastats/obesity-overweight.htm
                                    9. Centers for Disease Control and Prevention. Health effects of overweight and obesity. Updated September 24, 2022. Accessed January 20, 2023. https://www.cdc.gov/healthyweight/effects/index.html
                                    10. Johns Hopkins Medicine. Intermittent fasting: What is it, and how does it work? Accessed January 23, 2023. https://www.hopkinsmedicine.org/health/wellness-and-prevention/intermittent-fasting-what-is-it-and-how-does-it-work
                                    11. Chair SY, Cai H, Cao X, Qin Y, Cheng HY, Ng MT. Intermittent fasting in weight loss and cardiometabolic risk reduction: A randomized controlled trial. J Nurs Res. 2022;30(1):e185. doi:10.1097/jnr.0000000000000469
                                    12. UC Davis Health. Intermittent fasting: Benefits, how it works, and is it right for you? February 4, 2022. Accessed January 23, 2023. https://health.ucdavis.edu/blog/good-food/intermittent-fasting-benefits-how-it-works-and-is-it-right-for-you/2022/02
                                    13. Cleveland Clinic. What is a superfood, anyway? November 10, 2021. Accessed January 23, 2023. https://health.clevelandclinic.org/what-is-a-superfood/
                                    14. de Cabo R, Mattson MP. Effects of intermittent fasting on health, aging, and disease [published correction appears in N Engl J Med. 2020 Jan 16;382(3):298] [published correction appears in N Engl J Med. 2020 Mar 5;382(10):978]. N Engl J Med. 2019;381(26):2541-2551. doi:10.1056/NEJMra1905136
                                    15. Patterson RE, Laughlin GA, LaCroix AZ, et al. Intermittent fasting and human metabolic health. J Acad Nutr Diet. 2015;115(8):1203-1212. doi:10.1016/j.jand.2015.02.018
                                    16. Masood W, Annamaraju P, Uppaluri KR. Ketogenic Diet. In: StatPearls. Treasure Island (FL): StatPearls Publishing; June 11, 2022. Updated June 11, 2022. Accessed January 24, 2023. https://www.ncbi.nlm.nih.gov/books/NBK499830/
                                    17. Harvard T.H. Chan School of Public Health. Diet Review: Ketogenic diet for weight loss. May 22, 2019. Accessed January 24, 2023. https://www.hsph.harvard.edu/nutritionsource/healthy-weight/diet-reviews/ketogenic-diet/
                                    18. Nutrisystem. Accessed January 25, 2023. https://www.nutrisystem.com
                                    19. SlimFast. Accessed March 9, 2023. https://slimfast.com
                                    20. Jenny Craig. Accessed January 25, 2023. https://www-prd.jennycraig.com/how-it-works
                                    21. McEvedy SM, Sullivan-Mort G, McLean SA, Pascoe MC, Paxton SJ. Ineffectiveness of commercial weight-loss programs for achieving modest but meaningful weight loss: Systematic review and meta-analysis. J Health Psychol. 2017;22(12):1614-1627. doi:10.1177/1359105317705983
                                    22. Chaudhry ZW, Doshi RS, Mehta AK, et al. A systematic review of commercial weight loss programmes' effect on glycemic outcomes among overweight and obese adults with and without type 2 diabetes mellitus. Obes Rev. 2016;17(8):758-769. doi:10.1111/obr.12423
                                    23. Harvard T.H. Chan School of Public Health. Diet Review: Paleo diet for weight loss. October 28, 2019. Accessed January 26, 2023. https://www.hsph.harvard.edu/nutritionsource/healthy-weight/diet-reviews/paleo-diet/
                                    24. The Paleo Diet. Accessed January 26, 2023. https://thepaleodiet.com/
                                    25. UC Davis Health. Paleo diet: What it is and why it's not for everyone. April 27, 2022. Accessed January 26, 2023. https://health.ucdavis.edu/blog/good-food/paleo-diet-what-it-is-and-why-its-not-for-everyone/2022/04
                                    26. Weight loss: Feel full on fewer calories. Mayo Clinic. March 22, 2022. Accessed January 26, 2023. https://www.mayoclinic.org/healthy-lifestyle/weight-loss/in-depth/weight-loss/art-20044318
                                    27. Cleveland Clinic. High calorie foods and snack ideas to gain weight. September 15, 2020. Accessed January 26, 2023. https://my.clevelandclinic.org/health/articles/16555-snack-ideas-for-weight-gain
                                    28. Masharani, U., Sherchan, P., Schloetter, M. et al. Metabolic and physiologic effects from consuming a hunter-gatherer (Paleolithic)-type diet in type 2 diabetes. Eur J Clin Nutr 69, 944–948 (2015). https://doi.org/10.1038/ejcn.2015.39
                                    29. Parmar RM, Can AS. Dietary Approaches To Obesity Treatment. In: StatPearls. Treasure Island (FL): StatPearls Publishing; October 3, 2022. Accessed January 27, 2023. https://www.ncbi.nlm.nih.gov/books/NBK574576/
                                    30. Atkins diet: What's behind the claims? Mayo Clinic. May 12, 2022. Accessed January 27, 2023. https://www.mayoclinic.org/healthy-lifestyle/weight-loss/in-depth/atkins-diet/art-20048485
                                    31. Atkins. Accessed January 27, 2023. https://www.atkins.com/how-it-works
                                    32. Type 1 diabetes. Mayo Clinic. Accessed March 10, 2023. https://www.mayoclinic.org/diseases-conditions/type-1-diabetes/diagnosis-treatment/drc-20353017
                                    33. American Diabetes Association. Hypoglycemia (low blood glucose). Accessed March 10, 2023. https://diabetes.org/healthy-living/medication-treatments/blood-glucose-testing-and-control/hypoglycemia
                                    34. Natesan V, Kim SJ. Lipid Metabolism, Disorders and Therapeutic Drugs - Review. Biomol Ther (Seoul). 2021;29(6):596-604. doi:10.4062/biomolther.2021.122
                                    35. Health Resources & Services Administration. Primary carnitine deficiency. Accessed March 10, 2023. https://newbornscreening.hrsa.gov/conditions/primary-carnitine-deficiency
                                    36. Porphyria. Mayo Clinic. Accessed March 10, 2023. https://www.mayoclinic.org/diseases-conditions/porphyria/diagnosis-treatment/drc-20356072
                                    37. Cleveland Clinic. Pyruvate kinase deficiency. Cleveland Clinic. Accessed March 10, 2023. https://my.clevelandclinic.org/health/diseases/23419-pyruvate-kinase-deficiency
                                    38. American Heart Association. Types of heart medications. Accessed March 10, 2023. https://www.heart.org/en/health-topics/heart-attack/treatment-of-a-heart-attack/cardiac-medications
                                    39. Cleveland Clinic. Diuretics. Accessed March 10, 2023. https://my.clevelandclinic.org/health/treatments/21826-diuretics
                                    40. Mayo Clinic. Chronic Kidney Disease. Accessed March 10, 2023. https://www.mayoclinic.org/diseases-conditions/chronic-kidney-disease/diagnosis-treatment/drc-20354527
                                    41. Egan S. 10 Nutrition myths experts wish would die. The New York Times. January 19, 2023. Accessed February 3, 2023. https://www.nytimes.com/2023/01/19/well/eat/nutrition-myths.html
                                    42. Haspel T. Weight-loss diets boil down to one thing, and it's not science jargon. The Washington Post. January 23, 2023. Accessed February 4, 2023. https://www.washingtonpost.com/food/2023/01/23/weight-loss-diets-fasting-keto/
                                    43. Contreras RE, Schriever SC, Pfluger PT. Physiological and epigenetic features of yoyo dieting and weight control. Front Genet. 2019;10:1015. Published 2019 Dec 11. doi:10.3389/fgene.2019.01015
                                    44. Johns Hopkins Medicine. Maintaining Weight Loss. August 8, 2021. Accessed February 6, 2023. https://www.hopkinsmedicine.org/health/wellness-and-prevention/maintaining-weight-loss
                                    45. Centers for Disease Control and Prevention. Weight Loss and Management. March 19, 2021. Accessed February 6, 2023. https://www.cdc.gov/healthyweight/tools/index.html
                                    46. USDA. Healthy Living and Weight. U.S Department of Agriculture. Accessed February 6, 2023. https://www.nutrition.gov/topics/healthy-living-and-weight

                                    Patient Safety: Ketogenic Diet: Fad Weight Loss or True Medical Benefits?

                                    Learning Objectives

                                     

                                    After completing this application-based continuing education activity, pharmacists will be able to

                                      • Describe the components and mechanisms of the ketogenic diet for medical purposes.
                                      • List disease states in which the ketogenic diet has been proven to help
                                      • Use this information to counsel patients who are interested in the ketogenic diet’s medical benefits

                                      After completing this application-based continuing education activity, pharmacy technicians will be able to

                                      • Describe the components of the ketogenic diet for medical purposes
                                      • List disease states in which the ketogenic diet has been proven to help
                                      • Identify situations in which patients need referral for additional information

                                       

                                      Release Date: December 1, 2022

                                      Expiration Date: December 1, 2025

                                      Course Fee

                                      Pharmacists: $7

                                      Pharmacy Technicians: $4

                                      There is no grant funding for this CE activity

                                      ACPE UANs

                                      Pharmacist: 0009-0000-22-065-H05-P

                                      Pharmacy Technician: 0009-0000-22-065-H05-T

                                      Session Codes

                                      Pharmacist:  22YC65-ABC23

                                      Pharmacy Technician:  22YC65-CBA32

                                      Accreditation Hours

                                      2.0 hours of CE

                                      Accreditation Statements

                                      The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-22-065-H05-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

                                       

                                      Disclosure of Discussions of Off-label and Investigational Drug Use

                                      The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

                                      Faculty

                                      Dylan DeCandia
                                      2023 PharmD Candidate
                                      University of Connecticut School of Pharmacy
                                      Storrs, CT

                                      Karisse T. Lora
                                      2023 PharmD Candidate
                                      University of Connecticut School of Pharmacy
                                      Storrs, CT

                                      Jeannette Y. Wick, RPh, MBA
                                      Director Office of Pharmacy Professional Development
                                      University of Connecticut School of Pharmacy
                                      Storrs, CT

                                                 

                                      Faculty Disclosure

                                      In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

                                      Dylan DeCandia, Karisse Lara and Jeannette Wick do not have any financial relationships with ineligibile companies.

                                       

                                      ABSTRACT

                                      The ketogenic diet, despite its current popularity, was initially developed to address seizure disorders. Its reliance on high fat, moderate protein, low carbohydrate intake can make it a challenge for patient adherence. By maintaining a constant state of ketogenesis from eating fatty foods, patients on the ketogenic diet change their natural fuel source from glucose to ketone bodies. Its medical uses include obesity, glaucoma, diabetes, seizures, and other neurode-
                                      generative disorders. A key concept is that patients must strive for ketosis (notketoacidosis) and monitor medical conditions closely. It is contraindicated in patients with liver failure, pancreatitis, inborn disorders of fat metabolism, primarycarnitine deficiency, carnitine palmitoyl transferase deficiency, carnitine translocase deficiency, porphyria, and pyruvate kinase deficiency. People who have type1 diabetes or who are pregnant should not follow this diet. Some people develop the “keto-flu,” a slang term for symptoms indicative of carbohydrate withdrawal. Numerous reliable resources are available for patients and healthcare providers.

                                      CONTENT

                                      Content

                                      INTRODUCTION

                                       

                                      Did you know that the ketogenic diet was NOT initially created for weight loss? Recently, the “keto” diet has become another fad diet for people trying to lose weight. Since 2000, more researchers have started to study the ketogenic diet, causing an increase in dieters who are employing this diet.1

                                       

                                      For decades, various entities have promoted fad diets as a way to lose weight and accrue other health benefits, with no data to back them up. The ketogenic diet began to reach the public’s consciousness in the 1970s, gained popularity in the early 2010s, and by 2017, it was a frequent topic in national news media. Google searches for the ketogenic diet (sometimes called the paleo diet, which is similar but not identical) quadrupled that year; questions about this diet were in the top 10 health questions.2 Many people started using the ketogenic diet without understanding how it works or its associated benefits and risks. In 2014, celebrities like Lebron James, Kim Kardashian, and Megan Fox started using the ketogenic diet during its fad weight loss phase. In 2020, around 6% of Americans were consuming a ketogenic, high fat diet.3

                                       

                                      In the 1920s, researchers noticed that some patients with epilepsy experienced benefits during fasting, so they discovered a way to mimic fasting to treat the disease.1 Soon, physicians began to use the ketogenic diet for its antiepileptic properties.1 However, in the next decades, researchers introduced antiepileptic medications and the ketogenic diet’s popularity faded. Treatment for epilepsy still includes some of the first antiepileptic medications: phenobarbital and phenytoin.4 Although physicians began using phenobarbital in 1912 for epilepsy, the U.S. Food and Drug Administration did not approve phenytoin for use in epilepsy until 1938.5 In the 1940s, clinicians used troxidone, but its toxicity profile was unacceptable. Ethosuximide, approved in 1958, replaced it. Approval of carbamazepine and valproic acid in the 1960s made the ketogenic diet unnecessary and obsolete for the most part.5

                                       

                                      Although pharmacists are the medication experts on the clinical team, they must understand all types of treatment, including nonpharmacologic interventions. During a ketogenic diet, patients eat a limited number of carbohydrates so the body will enter ketosis. Because of the diet’s intensity, pharmacists and technicians need to understand how the diet works to ensure patient safety. When patients start or are on the ketogenic diet, pharmacists need to counsel patients to ensure no drug interactions occur. Pharmacists also need to counsel patients who may have started the diet by themselves about its benefits and the risks. Also, remember interested dieters might embrace a New Year's resolution regarding ketogenic dieting, because National Keto Day is January 5th!

                                       

                                      This continuing education activity summarizes knowledge of the ketogenic diet, the diet’s mechanism and its positive and negative effects, current medical uses for patients with epilepsy, diabetes, polycystic ovary syndrome (PCOS), and others, and recommendations for patient education and counseling.

                                       

                                      KETOGENIC DIET

                                       

                                      The ketogenic diet alters how the body burns energy, from carbohydrates to lipids. The traditional food pyramid places fats in the smallest section at the top, with carbohydrates in the largest bottom section. The ketogenic diet flips the pyramid, so most recommended foods are fats and very few are carbohydrates.

                                       

                                      According to the Dietary Guidelines for Americans, 25% to 35% of an adult’s diet should come from fats, 45% to 65% from carbohydrates, and 10% to 30% from protein.6 In a 2000 calorie day for ketogenic diet patients, fat should account for 70% to 80% or 165 g of daily caloric intake.7

                                       

                                      Although an exact timeframe is unknown, researchers believe that it can take the body up to four weeks to adapt to the ketogenic diet and ketosis.8 Patients initiating the diet could try daily exercise to force the body to break down fats, but its efficacy for reducing time to ketosis is unknown.8

                                       

                                      Ketogenesis

                                       

                                      The ketogenic diet uses ketosis and ketogenesis. When people eat carbohydrates, the body uses cellular respiration to produce energy from breaking down glucose molecules. However, if no carbohydrates are available, which would be the case during extended exercise or fasting periods, the body will naturally enter ketosis. Ketosis is a state of elevated ketone bodies, which include beta-hydroxybutyric acid, acetoacetic acid, and acetone in the blood.9 When the body needs energy, ketogenesis occurs to produce these ketone bodies, which can be used as an alternative energy source.

                                       

                                      In normal cellular respiration, acetyl-CoA is condensed with oxaloacetate to begin the citric acid cycle. Beta-oxidation of fatty acids can produce acetyl-CoA, similar to the production of acetyl-CoA from glycolysis of glucose. In times of reduced glucose (i.e., fasting, extended exercise, ketogenic diet), the body diverts the acetyl-CoA produced from the fatty acids into ketogenesis.

                                       

                                      Ketosis begins with fatty acid oxidation and the production of acetyl-CoA. Using the enzyme 3-ketothiolase, acetyl-CoA is converted into acetoacetyl-CoA. Then, the enzyme HMG-CoA synthase converts acetoacetyl-CoA to HMG-CoA.9 Low glucose levels during starvation or a high fat diet—a signal that the body needs to produce an alternative energy source for the brain—trigger this step of ketogenesis.10

                                       

                                      The last step of energy production during ketosis is the conversion of HMG-CoA to the ketone bodies acetoacetate (AcAc) and 3-beta-hydroxybutyrate (3HB). Using HMG-CoA lyase, AcAc and 3HB are cleaved from HMG-CoA.9 By being in a constant state of ketogenesis from eating fatty foods, patients on the ketogenic diet change their natural fuel source from glucose to ketone bodies.

                                       

                                      Ketone Bodies

                                       

                                      The 3 main types of ketone bodies are AcAc, 3HB, and least commonly, acetone. The liver produces AcAc, 3HB, and acetone in a 78:20:2 ratio, respectively, during fatty acid oxidation.11 Acetone is produced the least because it’s the byproduct of the uncommon and spontaneous decarboxylation of 3HB.11 Ketone bodies are the only non-glucose derived energy source for the brain.10 The brain cannot process fatty acids, so they must be converted into ketone bodies first. They provide energy to the brain because both AcAc and 3HB can diffuse across blood brain barrier.9

                                       

                                      During a normal day, ketone bodies account for only 2% to 6% of an individual's energy requirements. However, after a three- to four-day fast, ketone bodies account for 30% to 40% of the body's energy source.9 The liver can produce 185 grams of ketone bodies daily, which is enough to satisfy a person’s daily energy needs.9

                                       

                                      By using ketone bodies, patients can avoid breaking down carbohydrates as an energy source, similar to how the body naturally functions during fasting. Ketone bodies are thought to have a direct beneficial mechanism, which will be discussed later, in disorders like epilepsy.

                                       

                                      Effects of Insulin and Glucagon

                                       

                                      Insulin and glucagon are important in ketosis and ketone bodies. Low insulin levels trigger steps in the ketosis process. Insulin, also called the antiketogenic hormone, decreases 3HB production, whereas glucagon, the ketogenic hormone, increases 3HB production.12

                                       

                                      When humans consume carbohydrates and blood glucose levels rise, the pancreas releases insulin to absorb the blood sugar for energy storage.13 Insulin inhibits hormone-sensitive lipase and HMG-CoA synthase, enzymes that take part in fatty acid breakdown. It also stimulates acetyl-CoA carboxylase, causing the conversion of acetyl-CoA to malonyl-CoA, and blocking fatty acid transport into the mitochondria.10 As a result, insulin decreases the need for fatty acid oxidation and ketone bodies are decreased. The ketogenic diet requires patients to avoid carbohydrates to diminish insulin production and promote these mechanisms.

                                       

                                      Glucagon does the opposite of insulin. The body uses epinephrine and glucagon to stimulate adipose (fat) tissue to produce more fatty acid.9 Glucagon triggers phosphorylation of hormone-sensitive lipase and HMG-CoA synthase, thus promoting ketogenesis.9 The body releases fatty acids from triglycerides, so they can be broken down by the newly activated enzymes.

                                       

                                      A successful ketogenic diet requires a high glucagon/insulin ratio, similar to that experienced during fasting and by patients with diabetes. The high ratio increases fatty acid production and oxidation. Ketogenesis will follow.

                                       

                                      Foods Consumed

                                       

                                      Most foods for a ketogenic diet will have moderate amounts of proteins, no carbohydrates, with many fats. To prevent heart disease, physicians and pharmacists can counsel patients to eat healthy fats. Table 1 describes some examples of foods that are common in the ketogenic diet.

                                       

                                      Table 1. Food Options Commonly Used in the Ketogenic Diet14

                                      Fish and Seafood -        Full of protein

                                      -        No carbs

                                      -        Associated with positive cardiovascular and health benefits

                                      Poultry and Meat

                                      (Chicken, beef)

                                      -        Rich in protein

                                      -        No carbs

                                      -        Limit processed meats

                                      Nuts

                                      (Almonds, walnuts, pecans, cashews)

                                      -        High in fiber, protein, and unsaturated fats

                                      -        Very low carbs

                                      -        Antioxidants

                                      Non-starchy Vegetables

                                      (Broccoli, green beans, bell peppers)

                                      -        Include other vitamins and nutrients

                                      -        Antioxidants

                                      Cheese -        No carbohydrates

                                      -        High in fats, protein, calcium

                                      -        Too many saturated fats

                                      Avocados -        Potassium, unsaturated fats

                                      -        Most carbohydrates in avocados are fiber

                                       

                                      Patients on the ketogenic diet must understand how to track their nutrition to diet properly, calculating proteins, carbohydrates, and fats daily. Patients must calculate carbohydrates to account for dietary fiber because fiber is not digested with other carbohydrates.14 When tracking nutrition, patients on the ketogenic diet must track net carbohydrates, which can be found by subtracting the dietary fiber content from the total carbohydrates. The total carbohydrate level reported on nutrition labels does not accurately reflect the carbohydrate content the patient has consumed.

                                       

                                      Most of the foods mentioned in Table 1 are high in fat. Fish, seafood, meat, poultry, and eggs are main staples. Processed meats, like bacon, should be eaten more sparingly compared to non-processed meats, like chicken and beef.14 Patients can eat chicken and fish more frequently because they promote cardiovascular health, unlike red meat. Many people believe that berries are not allowed on the ketogenic diet, but strawberries, raspberries, and blackberries have very low net carbohydrates. The total carbohydrates in berries may appear high, but their high fiber content allows berries to have a low net carbohydrate content.

                                       

                                      A vegetarian ketogenic diet is a possibility, even though options are more limited. Vegetarian options with high protein and low carbohydrates include nuts, tofu, and seitan (a meat substitute made from the gluten in wheat).15 These dieters can also enjoy peanut butter-based desserts for more proteins. Seeds are high in fat and have high dietary fiber. For higher calorie meals, eggs and dairy (hard cheeses and plain yogurt) are an important fat option. Eggs have many fats, but essentially no carbohydrates.15

                                       

                                      Any food that is high in net carbohydrates will disrupt the body's ketosis. These are foods like starchy vegetables, juices, syrup, chips, and crackers.14 Foods high in carbohydrates will give the body enough energy to not oxidize fatty acids and prevent the production of ketone bodies.14

                                       

                                      PAUSE AND PONDER: Would a fasting patient reach ketosis quicker than a patient who is not fasting?

                                      WHO BENEFITS FROM THE KETOGENIC DIET?

                                      Obesity

                                      Obesity, a leading risk factor for many chronic health conditions, continues to rise in the United States. According to the CDC, the prevalence of diabetes has increased to 41.9% from 2017 to 2020.16 Many have adopted low-carbohydrate, high fat lifestyles to lose weight. A 2016 meta-analysis of 11 randomized control trials assessed the efficacy of the ketogenic diet. Among the 1369 participants, those on the ketogenic diet experienced greater weight loss than those who participated in a low-fat diet.17 After six months to two years of intervention, patients experienced significant weight loss, HDL cholesterol increase, and triacylglycerol (TAG) reduction. The studies were limited by moderate to high heterogeneity and possible publication bias. A 2021 study evaluated the efficacy of the ketogenic diet using a mobile health application in comparison to a calorie restricted, low-fat application.18 Of the 155 participants, those using the ketogenic diet app experienced greater weight loss (12.3 pounds) at 12 weeks. Hemoglobin A1c (HbA1c) and liver enzymes also improved for the ketogenic diet group. This study was limited by operating fully remotely via the application. Patients could have benefited from in-person counseling or on-site visits to promote adherence.18

                                      Another meta-analysis of 13 randomized controlled trials showed that participants on the ketogenic diet benefited from greater weight loss than those on a low-fat diet proving that the ketogenic diet can be used for obese patients. The low-fat diet group consisted of 787 patients while the ketogenic diet group consisted of 790. Patients that were part of the keto group lost approximately 3.6 pounds (1.6 kilograms) more than the low-fat group.19 Patients saw a greater increase in HDL and a more significant reduction in TAG in the keto group.

                                      Type 2 Diabetes

                                      Patients with type 2 diabetes (T2D) sometimes benefit from the ketogenic diet through improved glycemia and reduced insulin resistance. A study of 28 patients with T2D following a ketogenic diet showed that blood glucose and HbA1c improved. The ketogenic diet could potentially help patients with T2D reduce the number or dose of medications.20 Another comparative study showed that obese patients with T2D had improvement in blood glucose profiles, insulin sensitivity, and HbA1c when adhering to the ketogenic diet for two consecutive weeks.21 However, the study was limited by short duration and small sample size.

                                      Polycystic Ovary Syndrome

                                      Similar benefits seem to apply to patients with polycystic ovarian syndrome (PCOS). Patients with PCOS experience hyperandrogenism, insulin resistance, and ovulatory dysfunction.22 Current treatment options include metformin, clomiphene, and letrozole; the ketogenic diet may provide good results for these women through insulin reduction.

                                      In addition to the symptoms listed above, women with PCOS tend to gain weight, develop acne, and experience hirsutism.23 Physicians recommend lifestyle modifications and hormonal contraceptives as first line interventions, but often, these interventions are insufficient, and symptoms persist.23

                                      Researchers have conducted many studies to evaluate the benefits of the ketogenic diet for women with PCOS, yet the studies are greatly limited by sample size. For example, a 2019 study consisting of 14 women with PCOS struggling with their weight assessed changes in body weight, BMI, fat body mass, lean body mass, HDL, and several other parameters. At 12 weeks, participants saw a 9.43-kilogram (20.7 pound) reduction in body weight, 3.35 reduction in BMI, and an 8.29-kilogram (18.2 pound) reduction in fat body mass.23

                                      A pilot study consisting of five women tested the ability of the ketogenic diet to reduce PCOS symptoms. Researchers provided the women with low-carbohydrate diet books and handouts alongside group meetings to test the ketogenic diet’s efficacy for PCOS. Participants consumed fewer than 20 grams of carbohydrates per day for six months. To test participants’ adherence, researchers measured ketones and body weight. Throughout the 24-week period, participants lost weight with a mean BMI decrease of four kilograms (approximately 8.8 pounds) which was a 14.3% total reduction in body weight.24 The study resulted with clear reductions in testosterone, fasting serum insulin, and an overall improvement of PCOS symptoms.

                                      Additionally, an eight-week crossover study involving 30 women with PCOS demonstrated various benefits. On average, weight loss ranged from 1.3 to 1.6 kg (2.8-3.5 pounds). When compared to baseline, the results of this study highlight the relationship between decreases in testosterone and fasting insulin.25 Overall, improvements in insulin resistance, testosterone levels, and weight loss, the ketogenic diet may help patients with PCOS.

                                      Epilepsy

                                      The original use for the ketogenic diet was as an antiepileptic therapy in children.1 After the discovery of antiepileptic medications, the need for the ketogenic diet diminished. However, researchers are bringing the ketogenic diet back to help treat patients who are refractory to modern antiepileptic medications.

                                      In combination with medications, researchers have seen up to a 50% reduction in the number of seizures patients are having, with 10% to 15% becoming seizure free.26 Co-administration with antiepileptics is possible for some medications. However, most patients are children and maintaining this strict diet is difficult.

                                      During a retrospective study, researchers compared the effects of the ketogenic diet to modern anticonvulsant medications in 150 children. At one year, 55% of patients remained on the diet, and 27% of the patients who remained in the trial had a greater than 90% decrease in seizure frequency.27 The diet allowed children to reduce their medication burden (patients averaged having 6.2 anticonvulsant medications before the trial), and proved to be more effective than many medications. More studies in larger patient populations are needed over longer periods of time to make stronger conclusions.

                                      Research attributes the ketogenic diet’s anticonvulsant properties to an increased seizure threshold. Mitochondria in the brain have healthier biogenesis and density, leading to increased resistance to metabolic stress.28 Another way the diet increases seizure threshold is through decreased glucose consumption and production of glycolytic ATP.28 Subsequently, potassium channels remain open and hyperpolarize the neuronal membrane.28

                                      Researchers have found that ketone bodies produced from fatty acid oxidation have their own anticonvulsant effects. Although different ketone bodies have different effects, researchers have found that they can alter various neuronal membrane transporters to decrease excitability. Ketone bodies can inhibit transporters like the vesicular glutamate transporter and neuronal potassium channels. Inhibition of these transporters prevents signal transmission and causes decreased excitability of neuronal cells.29

                                      Other Neurodegenerative Disorders

                                      In addition to epilepsy, promising evidence shows that the ketogenic diet has favorable effects for other neurodegenerative disorders. As the incidence of Alzheimer’s disease (AD) increases, few treatment options are available. The ketogenic diet may reduce deposition of amyloid beta (Aβ) plaques in patients with AD. With the addition of D-β-hydroxybutyrate (an enantiomer of the ketone body 3HB) to the ketogenic diet, ketones were able to increase neuron survival by reversing Aβ (1-42) toxicity. 30 By increasing ketone production in the liver, the ketogenic diet can reduce the production of reactive oxygen species.31 Ketone bodies also work to block histone hyper-acetylation initiated by histone deacetylases (HDACs), increasing antioxidant levels. The ketogenic diet can improve metabolic efficiency which improves ATP concentrations resulting in further protective effects.31

                                      Ketones’ neuroprotective effects can potentially help patients with Parkinson’s disease by reducing oxidative stress, maintaining energy supply, and modulating deacetylation and inflammatory responses.31,32 Because they can reduce inflammation and inhibit the glutamate excitatory synapse, infusions of ketone bodies like 3HB may lead to small improvements in Parkinson’s symptoms.32 The use of the ketogenic diet for Parkinson’s is still controversial, thus further research is necessary.

                                      Glaucoma

                                      Glaucoma is the second leading cause of vision loss in the world.33 Because ketone bodies are the major source of energy when participating in the ketogenic diet, mitochondrial dysfunction in the retina and optic nerves associated with glaucoma may be decreased.32,34 A 2020 observational study assessed the benefit of the ketogenic diet in 185,638 adults with glaucoma from three studies between 1976 and 2017. Results showed that following a low carbohydrate diet was associated with 20% lower risk of developing primary open-angle glaucoma with initial paracentral visual field loss.35 However, evidence is still lacking, and researchers need to investigate more to prove the ketogenic diet’s efficacy for glaucoma.

                                      Colorectal Cancer

                                      According to the American Cancer Society, colorectal cancer is the third leading cause of cancer-related deaths in men and women in the United States.36 A 2022 study suggests that the ketone body, 3HB, can suppress colorectal cancer.37 In one experiment, investigators evaluated the ability of the ketogenic diet to prevent tumor growth and development in mice.

                                      They discovered that 3HB could suppress tumor growth by reducing proliferation of colonic crypt cells.37 3HB induced positive changes in tumor growth through the upregulation of the homeodomain-only protein X (HOPX). The HOPX protein inhibits cancer organoid growth when overexpressed.37 Mice fed the ketogenic diet showed elevated levels of HOPX specific to the colonic tissue.

                                      Overall, mice assigned to the ketogenic diet experienced improved long-term survival rates. To test the efficacy of the ketogenic diet for existing tumors, after two cycles of dextran sodium sulfate, researchers introduced the diet to the mice. After exposure to the diet, tumor growth decreased. When researchers discontinued the ketogenic diet from the mice, tumor development proceeded.37

                                      This discovery led to further testing, this time in human organoids. Organoids are tissue cultures derived from stem cells.38 In the right environment, they are used to replicate organs. They are an essential tool to monitor disease development. Findings mimicked the results from the mice in 41 patients with colorectal cancer. This suggests that the ketogenic diet may be used for the prevention and treatment of colorectal cancer in the future.37

                                      PAUSE AND PONDER: How do you think patients would feel using the ketogenic diet as a primary treatment for neurodegenerative diseases in the future?

                                      Contraindications to the Ketogenic Diet

                                      Some patients should not follow the ketogenic diet. It is contraindicated in patients with liver failure, pancreatitis, inborn disorders of fat metabolism, primary carnitine deficiency, carnitine palmitoyl transferase deficiency, carnitine translocase deficiency, porphyria, and pyruvate kinase deficiency.39,40

                                      Because of the high risk of developing diabetic ketoacidosis (DKA), patients with type 1 diabetes on SGLT2 inhibitors should not participate in the ketogenic diet.41 DKA occurs when the body produces a dangerously high level of ketones at a rapid pace. Feeling extremely thirsty and frequent urination are early symptoms of DKA. Later symptoms of DKA include dry skin and mouth, flushing, fatigue, stomach upset, and pain. Another notable warning sign of DKA is a fruity odor on the patient’s breath. Acetone is responsible for the sweet scent and indicates high levels of ketones in the body.42 If left untreated, DKA can further develop, ultimately leading to death.

                                      Pregnancy is also a contraindication. The CDC recommends 340 additional calories per day during the second trimester of pregnancy and 450 additional calories per day during the third trimester.43 The CDC also recommends a well-balanced diet for women who are expecting. Losing weight during pregnancy is not safe and can be harmful to a patient’s baby.43 Folic acid and iron supplementation is pivotal in a fetus’ development. The World Health Organization recommends daily iron and folic acid supplements to reduce the risk of low birth weight.44 If a pregnant woman were to go on the ketogenic diet, she would need to ensure she consumes the suggested dose of 120 mg elemental iron and 2800 µg (2.8 mg) folic acid daily.44 Overall, no evidence indicates that the ketogenic diet is safe for pregnant women.

                                      KETOGENIC DIET SAFETY AND COUNSELING

                                      Although several studies suggest the ketogenic diet can be effective for weight loss, limited literature is available concerning its long-term effects. Long-term effects include hepatic steatosis, hypoproteinemia, kidney stones, and vitamin and mineral deficiencies.40

                                      Currently, no guidelines address the ketogenic diet specifically, and other guidelines do not include the ketogenic diet for the treatment of the previously mentioned diseases. Researchers must complete longer term studies with larger patient populations to prove the ketogenic diet’s benefits and elucidate any long-term risks. Pharmacists and other healthcare providers should keep this in mind when recommending the diet to patients.

                                      The Keto-Flu

                                      A common adverse effect of the ketogenic diet is the “keto-flu.” The symptoms are indicative of carbohydrate withdrawal that can create symptoms like brain fog, fatigue, nausea, vomiting, constipation, and muscle soreness.40, 39 Symptoms usually begin within one to two days and resolve within a week or less. Pharmacists can counsel patients on proper hydration, light exercise, rest, and starting the diet slowly to try to prevent the keto-flu.

                                      Cardiovascular Effects

                                      As research has previously shown, the ketogenic diet shows short-term benefits for obesity and cholesterol. Due to the overconsumption of fats, researchers wondered about the longer-term effects. In rodent studies, the ketogenic diet led to the development of hepatic inflammation and nonalcoholic fatty liver disease.45 Limited research has been done for nonalcoholic fatty liver disease in humans and more study is needed.

                                      Other Adverse Effects

                                      While on the ketogenic diet, patients may experience constipation. The healthcare team should implement a bowel regimen for the patient including an agent like polyethylene glycol 3350 (MiraLAX®) that’s sugar-free, meaning it adds no additional carbs. Other notable side effects are kidney stones and a decrease in bone density. To prevent kidney stone occurrence, pharmacists can counsel patients on drinking large amounts of liquids.. Patients can reach out to their providers to ensure they check bone health routinely. Several advisory groups recommend bone mineral density screening for women aged 65 and older and men aged 70 and older, and for other patients who are at high risk. Patients participating in the ketogenic diet are no exception, and could be considered high-risk if they do not consume enough calcium and vitamin D. Pharmacists can counsel patients to monitor their calcium and vitamin D intake and supplement it if necessary. Upon screening, providers may also recommend calcium and vitamin D supplementation for patients who experience a decline in bone mineral density.46

                                      What Can Health Professionals Do?

                                      Pharmacists can counsel patients on ketone testing to prevent occurrences of DKA. When a patient’s blood glucose exceeds 240 mg/dL, testing ketone levels every four to six hours is warranted.47 Ketones can be monitored through the urine and blood. A urine stick test is the most common and changes color depending on the ketone level. Although urine tests are convenient, blood ketone tests from finger sticks are more accurate because they measure 3HB and/or AcAc in the blood.48 If ketone tests indicate high levels, the patient is at moderate or high risk for ketoacidosis and patients should seek medical attention. Table 2 shows normal ketone levels, the optimal state of nutritional ketosis, and the level for ketoacidosis.

                                      Table 2. Ketone Levels48
                                      Normal Ketone ≤ 0.5 mmol/L
                                      Nutritional Ketosis 1 - 3 mmol/L
                                      Ketoacidosis ≥ 20 mmol/L

                                      Patient adherence to long-term regimens always becomes challenging. Counseling patients on the importance of sticking to their diet and other medications will increase the likelihood of desired results.

                                      PAUSE AND PONDER: On average, how long do you think a patient can remain adherent to the ketogenic diet lifestyle?

                                      Medication management is a vital component of patient safety. To ensure that starting the ketogenic diet is safe, a healthcare professional should perform a complete medication reconciliation. Pharmacists, with an interdisciplinary team, should then develop a plan for medication adjustments (including OTCs) and carbohydrate intake. The use of medication package inserts, institutional databases, and manufacturer helplines can assist the team in determining carbohydrate content of drugs to make the process more seamless.46 The following oral suspensions contain high carbohydrate contents:49    

                                      • Amoxicillin
                                      • Nystatin
                                      • Levetiracetam
                                      • Midazolam
                                      • Phenobarbital
                                      • Phenytoin
                                      • Baclofen
                                      • Ibuprofen

                                      Making patients aware that they must inform the healthcare team of any new medications is equally as important.

                                      Some medications are of concern with the ketogenic diet.

                                      • Patients taking SGLT2 inhibitors should not participate in nutritional ketosis due to the increased risk of diabetic ketoacidosis.
                                      • Clinicians need to monitor patients taking the anticonvulsant valproate (a fatty acid) and might need to adjust their doses since the ketogenic diet increases metabolic efficiency and valproate can be burned by cells for energy.50 Patients may feel as though valproate is not as effective after starting the ketogenic The dose, in this case, may need to be increased temporarily.
                                      • A case study showed that topiramate can increase blood pH, inducing metabolic acidosis and kidney stones.51 This may become hazardous if patients are already in nutritional ketosis.
                                      • Patients may experience hypotension while taking antihypertensive agents and following the ketogenic They should monitor blood pressure frequently.

                                      Pharmacists and other health professionals should inform patients to stay hydrated to reduce the risk for kidney stones and eat low salt food items.

                                      MYTHS AND FACTS

                                      The ketogenic diet has become increasingly popular over the years. Halle Berry, Vanessa Hudgens, Kourtney and Kim Kardashian are a few of many celebrities that have tried the ketogenic diet and have seen incredible results. MTV’s Jersey Shore star, Vinny Guadagnino, also known as the Keto Guido, is no stranger to the diet and has even written a keto cookbook. Seeing such drastic transformations all over tabloids and social media, without a doubt leaves people wondering “Why not? If they can do it, so can I,” while others think, “This can’t be real.”

                                       

                                      Many misconceptions create skepticism among patients from the abundance of information available on the internet. Pharmacists can alleviate patient worries by staying informed and referring patients to reliable resources. Table 3 below dispels common myths.

                                       

                                      Table 3. Myths and Facts About the Ketogenic Diet52
                                      MYTH FACT
                                      The ketogenic diet is bad for your health. The ketogenic diet has several health benefits including:

                                      ●      Weight loss

                                      ●      Improved brain function

                                      ●      Reduction of seizures

                                      ●      Blood sugar management

                                      ●      Improvement of PCOS symptoms

                                      Side effects may include nausea, vomiting, constipation, or other common side effects.

                                      All I have to do is consume any type of fat while going keto. Patients should eat healthy fats like avocados, nuts, seeds, and fish. Healthy fats lower LDL levels and raise HDL levels. Unhealthy fats saturated and trans fatty acids (e.g., fried foods, pastries, butter, and cream) raise LDL levels.
                                      If I go keto, I will get ketoacidosis. Ketosis and ketoacidosis are different conditions. The ketogenic diet induces ketosis.

                                      ●      In ketosis, the body burns fat since carbohydrates are unavailable. Nutritional ketosis is a normal response.

                                      ●      Ketoacidosis is a complication seen primarily in patients with T2D where the blood becomes acidic. It can be life-threatening.

                                      I will have no energy if I start a ketogenic diet. Some people may experience an adjustment period while beginning the ketogenic diet. They may experience temporary fatigue, brain fog, or the “keto-flu.” Eventual ketone production fuels the brain with energy and resolves symptoms.
                                      The ketogenic diet is only useful for weight management. The ketogenic diet has proven effective in patients with diabetes, PCOS, metabolic syndromes, Alzheimer’s disease, and obesity.
                                      I can’t drink any alcohol while on the ketogenic diet. Various low-carb alcoholic beverages can be substituted. Light beer, vodka, gin, and rum are a few examples, but patients should keep intake low-moderate. Patients should avoid sweet drinks and cocktails to prevent high sugar intake.

                                       

                                      Another common misinterpretation is that any low-carbohydrate food is considered keto. No food item has the same benefit as the other. The healthcare team must work with patients to create dietary plans that are more feasible for them. With a tailored diet plan, patients are more likely to feel structured and reach their goals. Overall, providers should conclude that patient education is necessary to certify patient trust and safety.

                                       

                                      PATIENT RESOURCES

                                       

                                      Reliable resources for patients are hard to find. Table 4 describes some resources that pharmacists can provide to patients for more information.

                                       

                                      Table 4. Resources About the Ketogenic Diet for Patients

                                      Cleveland Health Clinic -        Discusses what patients eat on the ketogenic diet

                                      -        Small tidbits on benefits and risks

                                      -        Includes information on populations that could benefit from the diet

                                      -        https://health.clevelandclinic.org/what-is-the-keto-diet-and-should-you-try-it/

                                      Harvard University Health -        Discusses key-takeaways from a ketogenic diet review

                                      -        Gives food examples

                                      -        Easy-to-understand

                                      -        Discusses health implications for certain patient populations

                                      -        https://www.health.harvard.edu/blog/ketogenic-diet-is-the-ultimate-low-carb-diet-good-for-you-2017072712089

                                      Academy of Nutrition and Dietetics -        Popular nutrition website that presents findings on various health topics

                                      -        Discusses populations that the ketogenic diet would not be safe in

                                      -        Gives background on the diet

                                      -        https://www.eatright.org/health/wellness/fad-diets/what-is-the-ketogenic-diet

                                      Everyday Health -        Discusses risks and benefits of the diet

                                      -        Provides food substitutions and daily meal plans

                                      -        Discussion potential supplements and vitamins that may be beneficial to dieters

                                      -        Discusses other nutrition techniques for other topics

                                      -        Articles are peer-reviewed

                                      -        https://www.everydayhealth.com/diet-nutrition/ketogenic-diet/comprehensive-ketogenic-diet-food-list-follow/

                                      EatingWell -        Brief explanation about the ketogenic diet

                                      -        Provides variety of food options for dieters

                                      -        Easy-to-understand and discusses other nutrition techniques

                                      -        Peer reviewed and gives background on all authors/editors

                                      -        https://www.eatingwell.com/article/290697/ketogenic-diet-101-a-beginners-guide/

                                       

                                       

                                      CONCLUSION

                                      Following a low-carbohydrate, high fat diet that uses ketone production to fuel the body requires a large selection of foods if patients are to maintain this diet. This is the challenge of the ketogenic diet. Pharmacists and technicians need a good understanding of what this diet is—and what it is not—so they know when prescribers are likely to use it for diseases. Pharmacists, as they screen for contraindications, should identify the signs of ketosis and counsel patients on managing safe ketone levels.

                                      Patient education is the key to reaching patient goals. Pharmacists must be ready to address patient questions and concerns regarding the ketogenic diet in conjunction with current medications. When pharmacists are a part of the care process, outcomes improve.

                                       

                                      Pharmacist Post Test (for viewing only)

                                      Ketogenic Diet: Fad Weight Loss or True Medical Benefits?

                                      PHARMACIST POST TEST QUESTIONS

                                      LEARNING OBJECTIVES
                                      After completing this continuing education activity, pharmacists will be able to:
                                      - Describe the components and mechanisms of the ketogenic diet for medical purposes.
                                      - List disease states in which the ketogenic diet has been proven to help
                                      - Use this information to counsel patients who are interested in the ketogenic diet’s medical benefits

                                      1. Which of the following statements is a MYTH regarding the ketogenic diet?
                                      a. The ketogenic diet benefits patients wanting to lose weight from PCOS.
                                      b. A patient starting the ketogenic diet will have ketoacidosis.
                                      c. The ketogenic diet does not prevent patients from alcohol consumption.

                                      2. James is a 46-year-old male with type 1 diabetes with a BMI of 28. His current medications include insulin-glargine, empagliflozin, and hydrochlorothiazide. He would like to start the ketogenic diet to lose weight. Would you recommend James start the ketogenic diet?
                                      a. Yes, James should start the ketogenic diet right away. It has proven to be efficacious in patients with type 1 diabetes.
                                      b. No, James is currently on an SGLT2 inhibitor. He is at an increased risk of developing DKA.
                                      c. James needs to contact his primary care physician for more information.

                                      3. Which of the following chronic conditions needs more information for the ketogenic diet to be a proven treatment?
                                      a. PCOS
                                      b. Epilepsy
                                      c. Glaucoma

                                      4. Mary is an obese 34-year-old female who comes into the pharmacy with a concern. She recently started the ketogenic diet and is experiencing fatigue, nausea, and brain fog. What advice can you give Maria?
                                      a. Inform Maria that she should stop the ketogenic diet immediately and contact her doctor.
                                      b. Inform Maria that this is completely normal, and she may be experiencing the keto-flu.
                                      c. Recommend Maria take over-the-counter acetaminophen for her nausea. Her symptoms will resolve in a few days.

                                      5. Which neurodegenerative disorder has substantial evidence that the ketogenic diet may be beneficial?
                                      a. Refractory epilepsy
                                      b. Dementia
                                      c. Parkinson’s Disease

                                      6. Which of the following best describes ketogenesis?
                                      a. The process of producing ketone bodies for energy, an alternative pathway to normal metabolism
                                      b. The last step in the creation of ketone bodies, when AcAc and 3HB are cleaved from HMG- CoA
                                      c. The process that breaks down fatty acids acetyl-CoA, so the body can enter the citric acid cycle

                                      7. Which of the following disorders was seen in animal models after long term use of the ketogenic diet?
                                      a. Hematoma
                                      b. Non-alcoholic fatty liver disease
                                      c. Major rashes

                                      8. What was the ketogenic diet originally created for?
                                      a. Weight loss
                                      b. Type 2 Diabetes
                                      c. Epilepsy

                                      9. Becky comes into the pharmacy and is asking for help for recommendations on starting a ketogenic diet. If she is consuming 2000 calories per day, how many fats should you recommend for Becky to consume each day?
                                      a. About 100g of fats daily, which is around 50% of her daily calories
                                      b. About 165g of fats daily, which is around 70% of her daily calories
                                      c. About 30g of fats daily, which is around 15% of her daily calories

                                      10. What are the general effects of insulin and glucagon on ketosis?
                                      a. Insulin and glucagon are both anti-ketogenic
                                      b. Insulin is pro-ketogenic, and glucagon is anti-ketogenic
                                      c. Insulin is anti-ketogenic, and glucagon is pro-ketogenic

                                      Pharmacy Technician Post Test (for viewing only)

                                      Ketogenic Diet: Fad Weight Loss or True Medical Benefits?

                                      TECHNICIAN POST TEST QUESTIONS

                                      LEARNING OBJECTIVES

                                      After completing this continuing education activity, pharmacy technicians will be able to:
                                      - Describe the components of the ketogenic diet for medical purposes
                                      - List disease states in which the ketogenic diet has been proven to help
                                      - Identify situations in which patients need referral for additional information

                                      1. Which of the following statements is a MYTH regarding the ketogenic diet?
                                      a. The ketogenic diet benefits patients wanting to lose weight from PCOS.
                                      b. A patient starting the ketogenic diet will have ketoacidosis.
                                      c. The ketogenic diet does not prevent patients from alcohol consumption.

                                      2. James is a 46-year-old male with type 1 diabetes and is 156 lbs. He is currently taking empagliflozin (an SGLT2 inhibitor). He would like to start the ketogenic diet to lose weight. From what you learned, why should James avoid the ketogenic diet?
                                      a. James is not overweight. He does not need the ketogenic diet to lose more weight.
                                      b. James is currently on an SGLT2 inhibitor. He is at an increased risk of developing DKA.
                                      c. James needs to contact his primary care physician to see if he is a candidate before starting the diet.

                                      3. Which of the following chronic conditions needs more information for the ketogenic diet to be a proven treatment?
                                      a. PCOS
                                      b. Epilepsy
                                      c. Glaucoma

                                      4. Mary is an obese 34-year-old female who comes into the pharmacy with a concern. She recently started the ketogenic diet and is experiencing fatigue, nausea, and brain fog. What is Maria experiencing?
                                      a. Maria is experiencing withdrawal from not being adherent to the diet. She should create a new care-plan with her provider.
                                      b. Maria is experiencing the “keto-flu.” Refer her to the pharmacist so she can further explain the adverse effect.
                                      c. Maria is ketoacidotic. Ask Maria if anyone has mentioned that her breath smells fruity.

                                      5. Which neurodegenerative disorder has substantial evidence that the ketogenic diet is beneficial for their condition?
                                      a. Epilepsy
                                      b. Parkinson’s Disease
                                      c. Dementia

                                      6. A patient comes into the pharmacy after beginning a new ketogenic diet. The patient is worried because she read online that long term effects of the diet could cause a “fat liver.” What is the best response to the patient?
                                      a. Refer the patient to the pharmacist for additional information.
                                      b. Describe the many long-term effects of the ketogenic diet
                                      c. Describe a study about non-alcoholic fatty liver with long term dieting

                                      7. What was the ketogenic diet originally created for?
                                      a. Weight loss
                                      b. Type 2 Diabetes
                                      c. Epilepsy

                                      8. Becky comes into the pharmacy and is asking for help for recommendations on starting a ketogenic diet. If she is consuming 2000 calories per day, how many fats should Becky consume each day?
                                      a. About 100g of fats daily, which is around 50% of her daily calories
                                      b. About 165g of fats daily, which is around 70% of her daily calories
                                      c. About 30g of fats daily, which is around 15% of her daily calories

                                      9. Which of the following best describes ketogenesis?
                                      a. The process of producing ketone bodies for energy, an alternative pathway to normal metabolism
                                      b. The last step in the creation of ketone bodies, when AcAc and 3HB are cleaved from HMG- CoA
                                      c. The process that breaks down fatty acids acetyl-CoA, so the body can enter the citric acid cycle

                                      10. What is the best response to a patient who is wondering how to count carbohydrates for her ketogenic diet?
                                      a. Use any carbohydrate counting app, all you must do is enter the amount of carbohydrates on the nutrition label.
                                      b. Subtract the fiber carbohydrates from the total carbohydrates to get net carbohydrates and record that number.
                                      c. Record only the carbohydrates from fiber. Other types of carbohydrates do not count because they are not digested the same.

                                      References

                                      Full List of References

                                      References

                                         
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