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Immunization: It is Now Time to Make it Unclear: Reconciling Differences between Public Health Vaccine Recommendations and FDA Product Labeling-RECORDED WEBINAR

About this Course

This course is a recorded (home study version) of the CE Finale Encore Webinars.

 

Learning Objectives

Upon completion of this application based CE Activity, a pharmacist will be able to:

1. Compare and contrast the roles & activities of the Center for Biologics Evaluations and Research (CBER), US Food & Drug Administration (FDA), Centers for Disease Control & Prevention (CDC), and the Advisory Committee on Immunization Practices (ACIP) during the development and clinical use of vaccines in the United States.
2. Describe one specific example where the routine clinical use of a vaccine may differ from FDA-approved product prescribing information due to the following:

(a) costs, (b) disease epidemiology, (c) public acceptance, (d) vaccine supplies.

Release and Expiration Dates

Released:  December 15, 2023
Expires:  December 15, 2026

Course Fee

$17 Pharmacist

ACPE UAN

0009-0000-23-042-H06-P

Session Code

23RW42-KXV39

Accreditation Hours

1.0 hours of CE

Additional Information

 

How to Complete Evaluation:  When you are ready to submit quiz answers, go to the BLUE take test/evaluation button.

Accreditation Statement

The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Pharmacists and Pharmacy Technicians are eligible to participate in this application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-23-042-H06-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

Grant Funding

There is no grant funding for this activity.

Faculty

Jeffery Aeschlimann, PharmD
Associate Clinical Professor-Infectious Disease Specialty
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.

  • Dr. Aeschlimann consults with F2G, Inc. but there is no crossover in the topics, so all issues have been mitigated.

Disclaimer

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.

Content

Handouts

Post Test

 

    Immunizations (Aeschlimann) – Post-Test Questions

     

     

    1. If asked, which of the following activities would the Food and Drug Administration decline to do and send to another agency?

     

    1. Verify appropriate vaccine manufacturing processes
    2. Approve advertising for vaccine products Reporting System (VAERS)
    3. Determine the strategy for public use of vaccines in the U.S.

     

     

    2.) Which of the following items would you expect to always/very-commonly see in the FDA-Approved product labeling for a vaccine product?

     

    1. Instructions for preparation of the product and route of administration
    2. Comparative effectiveness data for people taking chronic steroid therapy
    3. Recommendations for use of lower doses in case of product shortages

     

     

    3.) Which of the following is a correct example of a vaccination situation for which ACIP has issued “Shared Clinical Decision-making” (SCDM) guidance?

     

    1. Intranasal influenza vaccine administration in immunocompromised persons
    2. Respiratory syncytial virus vaccination for adults aged 60 years and older
    3. Human papillomavirus vaccination for persons aged 16-21 years

     

     

    4.) Which entity ultimately approves the content for FDA vaccine product labeling?

     

    1. The Vaccines and Related Biological Products Advisory Committee
    2. The Center for Biologic Evaluation & Research
    3. The Center for Drug Evaluation and Research

     

     

    5.) Which of the following people would be allowed to sit in the CDC’s Advisory Committee on Immunization Practices (ACIP)?

     

    1. A member of a vaccine manufacturer’s current Board of Directors
    2. A college professor whose expertise is mechanical engineering
    3. A practicing physician who is an expert in virology and vaccine safety

     

     

    6.) What does ACIP recommend after healthcare providers receive a full series of hepatitis B immunizations?

     

    1. Serologic testing for all healthcare providers at high risk for occupational percutaneous or mucosal exposure to blood or body fluids.
    2. Serologic testing for immunocomproised healthcare providers at high risk for occupational percutaneous of any type.
    3. Molecular testing for all healthcare providers at high risk for occupational percutaneous or mucosal exposure to blood or body fluids.

    VIDEO

    Antipsychotic Utilization in a Pediatric Population-RECORDED WEBINAR

    About this Course

    This course is a recorded (home study version) of the CE Finale Encore Webinars.

     

    Learning Objectives

    Upon completion of this application based CE Activity, a pharmacist will be able to:

    1. Describe current practice guidelines regarding the use of antipsychotic medications in a pediatric population.
    2.  Outline adverse effects associated with the use of antipsychotic medication in a pediatric population.
    3.  Discuss when to initiate an antipsychotic medication in a pediatric patient.

    Release and Expiration Dates

    Released:  December 15, 2023
    Expires:  December 15, 2026

    Course Fee

    $17 Pharmacist

    ACPE UAN

    0009-0000-23-043-H01-P

    Session Code

    23RW43-XYW84

    Accreditation Hours

    1.0 hours of CE

    Additional Information

     

    How to Complete Evaluation:  When you are ready to submit quiz answers, go to the BLUE take test/evaluation button.

    Accreditation Statement

    The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

    Pharmacists and Pharmacy Technicians are eligible to participate in this application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-23-043-H01-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

    Grant Funding

    There is no grant funding for this activity.

    Faculty

    Megan J. Ehret PharmD, MS, BCPP
    Professor, Co-Director of Mental Health Program
    University of Maryland School of Pharmacy
    Baltimore, MD

    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.

    • Dr. Ehret is a consultant with Saladex Biomedical

    Disclaimer

    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.

    Content

    Post Test

    Post Test

    Antipsychotic Utilization in a Pediatric Population

    Megan Ehret, PharmD

     
    1. Which medication is a first-line treatment option for a 14-year-old patient with newly diagnosed schizophrenia?
    a. Divalproex Sodium
    b. Haloperidol
    C. Risperidone

    2. Which medication is a first-line treatment option for a 16-year-old patient with bipolar disorder, most recent episode depressed?
    A. Aripiprazole
    B. Divalproex Sodium
    C. Lurasidone

    3. Which medication can cause the most substantial weight gain?
    A. Cariprazine
    B. Lumateperone
    C. Olanzapine

    4. Which rating scale should be used to screen patients for tardive dyskinesia?

    A. Extrapyramidal Symptom Rating Scale
    B. Barnes Akathisia Rating Scale
    C. Abnormal Involuntary Movement Scale

    5. In which disease state would it be appropriate to initiate an antipsychotic medication in a pediatric patient?
    A. Autism
    B. Conduct Disorder
    C. Intellectual Disability

    Handouts

    VIDEO

    Treating Gout without Doubt

    Learning Objectives

     

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

    1. Describe gout's pathogenesis, relationship to hyperuricemia, and complications of untreated gout
    2. Describe the diagnosis and goals of therapy for gout
    3. Recall nonpharmacologic therapy for the management of gout and medications that can increase serum uric acid level
    4. Discuss the appropriate approach to gout therapy (acute attack treatment, prevention of future gout attacks, "medication-in-pocket," and "treat-to-target") and its timing

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

    1. Describe gout's pathogenesis, relationship to hyperuricemia, and complications of untreated gout
    2. Recall nonpharmacologic therapy for the management of gout and medications that can increase serum uric acid level
    3. Recognize different pharmacological classes and regimens for urate-lowering therapy (ULT) and target serum uric acid level
    4. Define the "treat-to-target" and "medication-in-pocket" approaches in gout therapy

       

      Release Date: January 10, 2024

      Expiration Date: January 10, 2027

      Course Fee

      Pharmacists:  $7

      Pharmacy Technicians: $4

      There is no funding for this CE.

      ACPE UANs

      Pharmacist: 0009-0000-24-006-H01-P

      Pharmacy Technician:  0009-0000-24-006-H01-T

      Session Codes

      Pharmacist:  24YC06-JBX39

      Pharmacy Technician: 24YC06-XJB44

      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 0009-0000-24-006-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

      Samar Nicolas, RPh, PharmD, CPPS
      Assistant Professor of Pharmacy Practice
      MCPHS University
      Worcester/Manchester, MA

      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.

      Samar Nicolas has no relationships with ineligible companies.

       

      ABSTRACT

      Gout is the most common form of inflammatory arthritis affecting about 9.2 million adults in the United States (US) and is the result of hyperurice-mia. Gout results from the chronic deposition and crystallization of urate in the joints and tissues. Although gout can affect any joint, initial attacks usually in-volve the big toe joint. The most recent guideline for the management of gout recommends colchicine, nonsteroidal anti-inflammatory drugs, or glucocorticoids (oral, intraarticular, intramuscular) as first-line agents for the treatment of gout flares. Patient-specific factors guide the drug choice among the first-line agents. Interleukin-1 inhibitors or adrenocorticotropic hormone are alternative agents. Pharmacists are well-positioned to assess adherence to ULT and educate patients about the importance of urate lowering therapy. Pharmacy technicians can ensure that patients have refills on their medication-in-pocket prescription to facilitate early initiation.

      CONTENT

      Content

      INTRODUCTION

      “I’ve been shot, and I’ve been stabbed; nothing compares to gout pain.”

      This is how Jim, a 77 year old man, describes his pain as he hobbles into the pharmacy to refill his prescription for colchicine. Jim complains that colchicine is not controlling his gout. He is wearing slippers that show his red swollen joint around his right big toe that is warm and painful to touch. Jim says his physician explained that these symptoms are due to podagra, uric acid crystallization and settling in the joint between his foot and big toe.1 As Jim speaks, his breath projects a strong alcohol smell.

      Gout is the most common form of inflammatory arthritis affecting about 9.2 million adults in the United States (US) and is the result of hyperuricemia.2,3 Men are at higher risk of developing gout than women.4 Other risk factors include post-menopause, genetics, end-stage renal disease, and major organ transplant.

      Uric acid overproduction, under-excretion, or both, elevate serum uric acid levels.5 Underexcretion of uric acid accounts for about 90% of gout cases.6 Human bodies produce uric acid as they break down dying tissues.4 Other sources of uric acid are foods high in purines, such as meats, seafood, and alcoholic beverages.7, 8 Ancient Greek history states that only rich people, who could afford these expensive foods, experience gout.9 Therefore, in the 5th century before Christmas (B.C.), people referred to gout as “the disease of kings.”10

      PATHOGENESIS

      Uric acid circulates in the blood as monosodium urate.11 In the kidneys, uric acid and urate undergo filtration and secretion into the filtrate followed by about 90% reabsorption into the blood.12 The American College of Rheumatology (ACR) guideline defines hyperuricemia as serum uric acid of 6.8 mg/dL or greater, the level above which urate becomes insoluble in the blood.4

      Gout results from the chronic deposition and crystallization of urate in the joints and tissues.4,13 Insoluble monosodium urate crystals form stone-like deposits, known as tophi, in soft tissues, synovial tissues, or bones.14,15 Tophi trigger an inflammatory response, which presents as an acute gout attack.15,16 However, hyperuricemia does not always result in gout.4

      Although gout can affect any joint, initial attacks usually involve the big toe joint. Gout attacks are sudden and very painful.17 Acute gout attacks reach maximum pain level in 12 to 24 hours and may last 3 to 14 days if patients do not seek therapy.18 For this reason, all healthcare providers including those on pharmacy teams need to educate patients to seek medical care. Effective gout management reduces the risk of long-term complications like degenerative arthritis, urate nephropathy, infections, renal stones, joint fractures, and nerve or spinal cord impingement.19

       

      DIAGNOSIS OF GOUT

      Clinicians diagnose gout by collecting patient history, examining the patient, laboratory workup, and imaging.19 Uric acid crystals in the synovial fluid or tophi in tissues and/or bones confirm gout diagnosis regardless of the uric acid level.4

      TREATMENT OF GOUT

      The ACR guideline describes 3 treatment goals for patients with gout20:

      1. Terminating the acute gout attack
      2. Preventing future attacks
      3. Lowering the serum uric acid level

      Terminating the Acute Gout Attack

      The ACR published the most recent guideline for the management of gout in 2020. The ACR guideline recommends colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs), or glucocorticoids (oral, intraarticular, intramuscular) as first-line agents for the treatment of gout flares.20  Patient-specific factors guide the drug choice among the first-line agents. Interleukin-1 (IL-1) inhibitors or adrenocorticotropic hormone (ACTH) are alternative agents.20  If a first-line agent is ineffective, intolerable, or contraindicated, the ACR guideline recommends switching to another first-line agent before trying alternative agents. Topical ice is an adjunct to pharmacologic therapy. The severity of the gout flare guides the treatment duration.

       

      Colchicine

      Colchicine exerts its anti-inflammatory effects by binding to free tubulin dimers leading to microtubule polymerization inhibition, which affects cellular function.21, 22 Colchine has had an interesting history, as the SIDEBAR explains. Common side effects of colchicine are dose-dependent and include diarrhea, nausea, and vomiting.  Because of its mechanism of action, toxic levels of colchicine inhibit cellular division leading to failure of multiple organs .22 Colchicine doses of 0.8 mg/kg are lethal.23 Colchicine undergoes extensive tissue distribution and therefore, a lower dose can be toxic in patients with liver or renal failure. Some unchanged colchicine undergoes renal excretion through glomerular filtration and therefore, requires dosage adjustment for renal dysfunction.21, 24  Cytochrome P450 3A4 hepatic enzymes metabolize colchicine.21, 25 P-glycoprotein facilitates colchicine removal from the body.26 Co-administration of medications that inhibit CYP3A4 enzyme activity (example: grapefruit juice, azole antifungals, erythromycin, verapamil) increase the risk of colchicine toxicity.21, 25 In addition, co-administration of colchicine with P-glycoprotein inhibitors (example: digoxin) increases the risk of colchicine toxicity.26 Toxic symptoms are dose-dependent with increasing severity.27 Patients with toxicity may present with gastrointestinal symptoms (nausea, vomiting, diarrhea), hypotension, lactic acidosis, or acute kidney injury.22, 27 To decrease the risk of toxicity, colchicine’s prescribing information recommends avoiding its co-administration with P-glycoprotein inhibitors or CYP3A4 inhibitors in patients with renal or hepatic impairment.28 For other patients, the prescribing information recommends weighing risks versus benefits before co-administering colchicine with medications that pose a significant drug interaction.

       

      SIDEBAR: HISTORY OF COLCHICINE

      Colchicine is derived from a plant, Colchicum automnale.29 Other names for this plant include Autumn Crocus, meadow saffron, naked lady, and colchicum.30 Ebers Papyrus, an Egyptian medical document on herbs dating back to 1500 BC, indicates the use of C. automnale for joint pain.31 In 1833, a German pharmacist analyzed the substance and gave it the name colchicine.29 In France, in 1819, a chemist and a pharmacist isolated colchicine from the plant. In 1884, a French pharmacist produced and sold colchicine as 1 mg granules, which is still available in some countries.29,32 Colchicine accounts for about 0.1-0.6% of the plant content.33 Non-surprisingly, the C. automnale plant is poisonous. Humans should not ingest the plant. Symptoms of C. automnale toxicity resemble the side effects or toxicity of colchicine.34 These symptoms range from diarrhea, nausea, and vomiting to organ failure and death.

      Colchicine was available for decades in the US without a U.S. Food and Drug Administration (FDA) approved labeling.35 Despite the Food, Drug, and Cosmetics Act requiring the FDA to approve medications based on efficacy and safety data, colchicine was grandfathered in. Grandfathered drugs were medications available on market before the Food, Drug, and Cosmetics Act of 1938 or its amendments in 1962.

      In 2006, the FDA initiated the unapproved drug initiative (UDI).36 The goal of the UDI program was to decrease the number of medications in the United States that do not carry FDA approval. Under the UDI program, the FDA allowed exclusive marketing to manufacturers who obtain FDA approval. Some pharmacists and pharmacy technicians may recall colchicine shortage as manufacturers of colchicine received warning letters from the FDA to stop selling colchicine.37 Mutual Pharmaceutical Company submitted a new drug application (NDA) for colchicine in November 2008.38 The UDI did not require manufacturers to conduct new clinical trials to obtain FDA approval. Mutual Pharmaceutical Company’s NDA included data from randomized controlled trials in 1974 and 2004 that proved the safety and efficacy of colchicine. As a result, in July 2009 the FDA approved colchicine for the treatment of gout and familial Mediterranean fever. Colchicine came back to the US market under brand name Colcrys.39

       

      Colchicine is light sensitive. Pharmacies should protect colchicine from light and dispense it in a light-resistant container.28 The FDA requires pharmacies to distribute a medication guide to patients when dispensing colchicine.40 Medication guides inform patients of potential serious adverse reactions and harm mitigation strategies. The Institute for Safe Medical Practices (ISMP) lists colchicine on the look-alike sound-alike (LASA) list due to potential for confusion with Cortrosyn, which is the brand name for cosyntropin.41  Of note, cosyntropin is a synthetic adrenocorticotropin hormone that has anti-inflammatory properties and is an alternative agent for gout attacks.42 In patients with a history of gout, the ACR guideline recommends a “medication-in-pocket” (discussed below) approach to allow early initiation of an anti-inflammatory drug at the onset of a gout flare.20 Since colchicine has anti-inflammatory properties, it is an option for the “medication-in-pocket” approach.

      The pharmacist takes a close look at Jim’s prescription refill history to figure out why colchicine is not working for Jim. The pharmacist explores several possibilities:

      • Is Jim adhering to his urate-lowering therapy (ULT)?
      • Is Jim refilling his colchicine as part of a gout flare prophylactic therapy upon initiating ULT?
      • Is Jim asking for colchicine as a “medication-in-pocket” approach?
      • Is Jim consuming excessive alcohol?
      • Is Jim eating foods rich in purines?
      • Is Jim taking any prescription or over-the-counter medications that may increase his uric acid level?

      NSAIDs

      The FDA has approved indomethacin, naproxen, and sulindac for the treatment of acute gout flare.43,44, 45 However, the guideline does not recommend a specific NSAID.20 Choice of agent depends on patient-specific factors including cardiovascular (CV) risk, gastrointestinal (GI) risk, cost, and availability without a prescription.46 Celecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor and therefore carries a low GI risk but is associated with a dose-dependent increase in CV risk.47, 48 Ibuprofen carries a low GI risk. Indomethacin, naproxen, diclofenac, and sulindac carry a moderate GI risk.49, 50 Among the nonselective NSAIDs, CV risk is highest with diclofenac and lowest with naproxen.51 Despite differences in CV risk among nonselective NSAIDs, the FDA mandates a boxed warning for all NSAIDs about increased  risk of thrombosis, myocardial infarction (MI), and stroke.52, 53 In addition, the FDA requires pharmacies to distribute a medication guide to patients when dispensing a prescription for NSAIDs.54 Any NSAID is an option for the “medication-in-pocket” approach.20

      Glucocorticoids

      The ACR guideline does not recommend a specific oral glucocorticoid.20 Parenteral glucocorticoids (intramuscular, intravenous, or intraarticular) are alternative options for patients who cannot tolerate oral therapy. Glucocorticoids (example: prednisone, methylprednisolone) are an attractive option for patients with chronic kidney disease (CKD) or those who cannot tolerate colchicine or NSAIDs.1,55 Short-term glucocorticoids do not cause significant side effects.56, 57 Glucocorticoids are an additional option for the “medication-in-pocket” approach, including injectable formulations for patients who cannot take oral medications.20 Methylprednisolone is available in different dosage forms such as oral, intramuscular (as acetate or succinate), intravenous (as acetate), and intraarticular (as acetate).58

      Anakinra

      Anakinra is an IL-1 receptor antagonist.59 It blocks the activity of the inflammatory mediatory IL-1. Anakinra has an off-label indication for gout attacks at a dose of 100 mg subcutaneously daily for 3 to 5 days.60, 61 The ACR guideline classifies anakinra as an alternative agent, particularly due to cost.20 The manufacturer recommends storing anakinra in the refrigerator and protecting from light until ready for administration.62 Patients can self-administer anakinra after demonstrating proper administration technique.59

      ACTH

      Adrenocorticotropic hormone (ACTH) binds to melanocortin receptors, which triggers the release of endogenous steroids, thus decreasing inflammation.63 The ACR guideline recommends ACTH as an alternative agent.20,63 ACTH is available as an intramuscular or subcutaneous injection.64 The purified cortrophin formulation carries an indication for acute gouty arthritis.65 The manufacturer does not provide a dosing recommendation specific for gout and recommends caution in patients with renal insufficiency.64-66 The manufacturer recommends storing ACTH in the refrigerator until ready for administration and warming to room temperature before injecting.67

      Table 1 summarizes the first-line agents for the treatment of gout flares.

      Table 1. First-line Agents for the Treatment of Gout Flares20, 24, 44-46, 56, 68-71 
      Therapy Dose Comment Monitoring parameters
      Colchicine ·        Day 1 of therapy: Use treatment dose of 1.2 mg by mouth (PO) as soon as possible then 0.6 mg after one hour. Maximum dose 1.8 mg/day.

      ·        Day 2 and until flare resolves, use prophylactic dose of 0.6 mg PO once or twice daily.

      If creatinine clearance (CrCl) < 30 mL/min:

       

      ·        Use 1.2 mg PO as soon as possible then single dose of 0.6 mg after one hour. Avoid repeating therapy within a 14-day period.

      ·        Alternatively, use 0.3 mg PO as soon as possible as a single dose. Avoid repeating therapy within 3-7 days.

       

      If patient is on dialysis:

      ·        Use 0.6 mg PO as a single dose. Avoid repeating therapy within a 14-day period.

      Monitor patients with CrCl ≤ 80 mL/min closely for adverse effects.
      NSAIDs

       

      ·        Indomethacin: 50 mg three time daily until pain is tolerable (usually, 3 to 5 days).

      ·        Sulindac: 200 mg twice daily until attack resolves (usually, 7 days).

      ·        Naproxen: 750 mg x 1 dose then 250 mg every 8 hours until attack resolves (usually, 2 days).

      ·        The manufacturer does not provide recommendations for renal dosage adjustment.

      ·        The Kidney Disease Improving Global Outcomes (KDIGO) guidelines recommends avoiding use of NSAIDs If CrCl < 30 mL/minute.

      Monitor GI, renal, and CV toxicity in elderly patients.

      Prescribe lowest effective dose for the shortest duration possible.

      Glucocorticoids ·        Follow specific glucocorticoid dosing recommendation. Safest option in patients with CKD. Monitor serum glucose, blood pressure, electrolytes, mood changes, and recurrent infections.

       

      Interestingly, a panel consisting of eight patients with gout participated in the development of the 2020 ACR guidelines.20 The patient panel provided valuable input from a patient perspective regarding therapy preference for patients with an established gout diagnosis. The patient panel strongly favored a medication-in-pocket approach for the treatment of acute gout flares. With this approach, the clinician prescribes an anti-inflammatory medication that the patient keeps on hand for use as needed.72 Moreover, the patient panel favored an injectable dosage form for the medication-in-pocket to control the pain faster in patients who can take nothing by mouth. The medication-in-pocket approach ensures that patients have quick access to an anti-inflammatory medication at the first onset of gout attack symptoms.20

      Jim’s colchicine regimen is consistent with the “medication-in-pocket” to treat an acute gout flare.

      MANAGEMENT OF CHRONIC GOUT

      The goal of chronic gout management is to lower the serum uric acid level with ULT, if indicated, and to prevent future attacks.20 ULT includes medications that decrease uric acid production or promote uric acid excretion.73 The ACR 2020 guideline recommends a “treat-to-target” approach that guides ULT dose titration and maintenance to achieve serum uric acid of less than 6 mg/dL.20 Lower ULT initial dosing with subsequent titration decreases the risk of gout flare associated with ULT initiation.20

      Pause and Ponder: What patient factors determine eligibility for urate lowering therapy (ULT)?

      Table 2 provides recommendation on initiation of ULT based on patient-specific factors.

      Table 2 - Indication for ULT 20
      Patient factors 2020 ACR guideline recommendation Comment
      ≥1 subcutaneous tophi ACR guideline strongly recommends initiating ULT Moderate or high certainty of evidence that benefits of ULT consistently outweigh the risks
      Gout-attributable radiographic damage
      ≥2 gout flares per year
      > 1 flare but < 2 flares per year ACR guideline conditionally recommends initiating ULT Low certainty of evidence or no data available and/or benefits and risks closely balanced
      First flare and any of the following:

      ·        Chronic kidney disease (CKD) stage ≥ 3

      ·        Serum uric acid > 9 mg/dL

      ·        Urolithiasis

      First gout flare ACR guideline conditionally recommends against initiating ULT
      Asymptomatic hyperuricemia*

      *Serum uric acid > 6.8 mg/dL

      Pause and Ponder: Which urate-lowering agent is first-line therapy?

      Table 3 summarizes urate-lowering medications.

      Table 3 - Urate Lowering Medications 20,74-76
      Pharmacological class Mechanism of action Medication Comments
      Xanthine Oxidase Inhibitors Inhibition of xanthine oxidase resulting in decreased conversion of hypoxanthine to xanthine and xanthine to uric acid. Allopurinol

      Febuxostat

      ·        Allopurinol is first-line agent.

      ·        Start allopurinol at ≤ 100 mg/day in normal kidney function and ≤ 50 mg/day in CKD stage ≥ 3 then titrate.

      ·        Start febuxostat at ≤ 40 mg/day then titrate.

       

      Uricosuric Agents Inhibition of urate reabsorption in the renal tubules resulting in increased excretion of uric acid in the urine. Probenecid ·        ACR guideline strongly recommends XOI over probenecid for patients with CKD stage ≥ 3

      ·        Start probenecid at 500 mg PO once or twice daily then titrate.

      Urate Oxidase Enzyme Catalysis of uric acid oxidation to water-soluble allantoin resulting in increased excretion of the allantoin in the urine. Pegloticase ·        ACR guideline strongly recommends against use of pegloticase as a first-line agent

      ·        Administer pegloticase 8 mg IV infusion every 2 weeks along with methotrexate 15 mg PO once a week with a folic acid supplement.

      ·        Start weekly methotrexate and folic acid supplementation 4 weeks before initiating pegloticase and continue while on pegloticase.

       

      Clinicians usually determine eligibility for ULT when patients present with an acute gout attack.20 Some experts favor initiating ULT two to four weeks after the resolution of a gout attack.77 One reason for this practice stems from the fear of gout attack worsening with ULT initiation. The other reason is the perception that during a gout attack, patients are in too much pain to process information regarding chronic therapy. However, the ACR guideline favors initiating ULT during a gout flare as patients may not return for a follow-up visit to initiate ULT after the flare resolves.20

      XANTHINE OXIDASE INHIBITORS (XOIs)

      XOI include allopurinol and febuxostat.20 XOI are first-line among urate-lowering agents, and the guideline recommends allopurinol as a first-line agent for all patients with gout, unless contraindicated.

      Allopurinol

      Allopurinol is associated with an increased risk of allopurinol hypersensitivity syndrome (AHS), a rare but severe, and potentially life-threatening adverse reaction.78 AHS presents as fever, severe rash, eosinophilia, hepatitis, and acute kidney injury.79 AHS is more common in patients who are African Americans or of Southeast Asian descent.78 Pharmacogenetic studies show that these patients have a gene on their human leukocyte antigen (HLA) system that increases the risk of developing AHS. This gene is the HLA-B*5801 allele.80 The interaction of allopurinol with the HLA-B*5801 allele triggers an immune reaction characterized by T-cell activation.81 Not all patients who are positive for HLA-B*5801 allele develop AHS.82 Risk of AHS increases in HLA-B*5801 allele positive patients who have elevated allopurinol serum level due to dose increase or renal dysfunction.81

      In the US, testing for HLA-B*5801 in Caucasians or Hispanics is not cost-effective.83 The 2020 ACR guideline recommends genetic testing for the HLA-B*5801 allele before starting allopurinol for patients who are African Americans or of Southeast Asian descent.20 The guideline recommends starting allopurinol at a low dose of 100 mg daily for normal renal function and a lower dose in case of renal dysfunction.

      The prescribing information recommends protecting allopurinol from light.74 ISMP lists the brand name of allopurinol, Zyloprim, on the look-alike sound-alike (LASA) list due to potential for confusion with zolpidem.42

       

      SIDEBAR: DID YOU KNOW THAT THE DISCOVERY OF ALLOPURINOL LED TO A NOBEL PRIZE AWARD?

      Gertrude Elion, who earned a master’s degree in chemistry from New York University in 1941, worked as a lab assistant for George Hitchings. Up until the 1950s, scientists produced medications by screening and modifying naturally existing substances.84 However, Elion and Hitchings’ contribution to medicine was groundbreaking to drug development as they introduced drug therapy that was targeted to specific cells. In 1963, Elion and Hutchings discovered that allopurinol blocked the synthesis of uric acid. In 1988, the Nobel Prize Committee awarded Gertrude Elion and George Hitchings the Nobel Prize in Physiology or Medicine for the discovery of allopurinol and other medications.85

       

      Febuxostat

      Febuxostat carries a boxed warning for increased risk of CV death in patients with cardiovascular disease (CVD), when compared to allopurinol.86 Therefore, the 2020 ACR guideline recommends selecting another ULT medication in patients with established CVD.20 For patients who experience a CV event while on febuxostat, the ACR guideline recommends switching to a different ULT medication.20 The FDA requires pharmacies to distribute a medication guide when dispensing febuxostat to patients.86

      URICOSURICS

      Probenecid

      Probenecid is the only uricosuric drug approved in the United States.87,88 Probenecid may cause nephrolithiasis (uric acid stones in the kidneys).89 These uric acid stones form as the uric acid crystallizes in an acidic urine. The prescribing information for probenecid recommends adequate hydration and adjunct urine alkalinizing agents (example: sodium bicarbonate or potassium citrate).89 However, the 2020 ACR guideline determined insufficient evidence to recommend the routine use of alkalinizing agents with probenecid.20 Probenecid is usually an add-on therapy in patients with partial response to an XOI. Remember to counsel patients on adequate hydration to decrease the risk of nephrolithiasis.

      ISMP lists probenecid on the LASA list due to potential for confusion with Procanbid, the brand name for procainamide, an antiarrhythmic drug.42 Probenecid also has some interesting abuse potential (see the SIDEBAR).

       

      SIDEBAR: CAN PROBENECID HELP ATHLETES IMPROVE PERFORMANCE?

      Random drug testing in sports led athletes to misuse probenecid to mask the unlawful use of performance-enhancing drugs such as anabolic-androgenic steroids.90 Probenecid inhibits the tubular secretion of anabolic-androgenic steroids in the kidneys, thus inhibiting their excretion in the urine. As a result, urine drug testing will not detect the use of these illegal substance, and athletes can pass the random drug testing successfully. In 1986, a doping control officer traveled from Norway and collected 6 urine samples from 6 Norwegian athletes who were training in the US. The athletes showed up at least 1.5 hours late probably to allow time for onset of action of the masking agent. Five of the samples showed an unusually dilute urine with low specific gravity. In addition, the concentration of endogenous androgenic-anabolic steroids in the urine samples was at least 100 times below normal.90 These unusual findings along with suspicious behaviors projected by the athletes during the testing process, triggered further analysis of the urine samples. The lab identified a “new masking agent”, probenecid and its metabolite, in these urine samples. Today, probenecid appears on the World Anti Doping Agency (WADA) prohibited list.91 The WADA list serves as a standard for identifying substances that athletes may illegally use to enhance performance in sports.91

       

      URATE OXIDASE ENZYME

      Pegloticase

      The FDA approved pegloticase for adults with chronic gout refractory to conventional therapy.92 The 2020 ACR guidelines recommends switching to pegloticase when XOIs, probenecid, and other interventions fail.20 In clinical trials, administering methotrexate with pegloticase increased the chance of tophi resolution by 22.8% compared to pegloticase monotherapy.76 Therefore, pegloticase’s prescribing information recommends co-administration with methotrexate, unless contraindicated. Folic acid supplementation decreases the risk of hepatotoxicity and GI side effects associated with methotrexate.93 Pharmacists should counsel patients about the importance of adherence to folic acid while on methotrexate.

      The manufacturer recommends storing pegloticase in the refrigerator and protecting it from light before dispensing.76 After diluting pegloticase for IV infusion in an institutional setting, healthcare workers should protect the solution from light.

       

      Pause and Ponder: When does the guideline recommend switching urate-lowering agents?

      The 2020 ACR guideline recommends using the maximum tolerated or recommended dose of a ULT.20  Figure 1 outlines the management of patients taking a XOI requiring adjustment to therapy:

      Figure 1. Switching ULT

      Jim’s medication profile reveals that he has been taking allopurinol for little over a year now.

       

      DURATION OF THERAPY

      For patients tolerating ULT, the 2020 ACR guideline recommends indefinite therapy to avoid worsening gout and its associated complications.20 Patients may not adhere to therapy due to cost, pill burden, and low health literacy.94 Remember to counsel patient on adherence and goals of ULT as patients may think they do not need to take ULT if they have no symptoms.

      PREVENTING GOUT FLARE UPON INITIATION OF ULT

      Initiation of ULT may trigger a gout flare due to activation of crystals precipitated in joints.95, 96 The risk of gout flare increases with higher reduction in serum uric acid levels. Studies suggest that gout attacks associated with ULT may decrease patient adherence to ULT.97 Prophylaxis with anti-inflammatory medications decreases the risk of gout flare upon ULT initiation. The 2020 ACR guideline recommends prophylactic therapy upon initiating ULT and for at least three to six months. Patients who continue to experience flares may require a longer duration of prophylactic therapy.20 Experts recommend colchicine or NSAIDs as first-line prophylactic therapy.98 Table 4 summarizes prophylactic medications and recommendations.

      Table 4 – Medications that Prevent Gout Attack with ULT Initiation
      Medication Recommendation
      Low-dose colchicine Use 0.6 mg once or twice daily
      Low-dose NSAIDs Use naproxen 250 mg or equivalent dose of different NSAID

      Add proton pump inhibitor if indicated

      Low-dose prednisone or prednisolone Use less than or equal to 10 mg per day

      Reserve corticosteroids for patients who cannot tolerate colchicine and NSAIDs

       

      NONPHARMACOLOGIC THERAPY AND LIFESTYLE MODIFICATIONS

      Serum uric acid levels decrease only slightly with dietary modifications.20 In addition, certain diets may trigger a gout flare. To decrease the risk of flares, the 2020 ACR guideline conditionally recommends the following approaches:

      • Limiting alcohol intake
      • Limiting purine intake. Some examples of high-purine foods include seafood like sardines, tuna, haddock, and meats like bacon, turkey, veal, and liver.99, 100
      • Limiting high-fructose corn syrup intake
      • Following a weight loss program if the patient is overweight or obese

      Jim projected an alcohol breath when speaking. Jim may be consuming excessive amounts of alcohol. He may be consuming a non-gout friendly diet.

      DIGITAL HEALTH AND GOUT MANAGEMENT

      Digitalization of health care is rapidly evolving and involves the use of technology to manage health conditions, ameliorate modifiable risk factors, and promote health and wellness.101 Wearable devices such as fitness trackers, patient portals, and mobile apps are only few examples of digital health tools. Investigators suggest that gout mobile health apps may improve patient perception of the disease, clarify beliefs, and benefit self-care.102 However, further studies are essential to prove these mobile applications beneficial. As of this writing, several gout-related mobile health applications are available. Target users for these applications can be clinicians or patients. For example, a physician developed a mobile application called Gout Diagnosis. The application includes an evidence-based algorithm to facilitate an accurate diagnosis of gout.103 On the other hand, patients can download from a variety of existing gout mobile applications at little or no cost.104 The National Kidney Foundation developed a mobile application called Gout Central. This application comes from a reputable foundation and provides patient education on symptoms and risk factors for gout, nonpharmacologic recommendations such as diet and lifestyle modifications, and medications to treat gout and prevent flares.104 The FDA does not regulate mobile medical applications.105 Therefore, the choice of mobile health application depends on patient preference such as cost, ease of use, compatibility, security, and type of content.106

      A mobile application may help Jim learn about foods and drinks that may trigger gout attacks.

      PHARMACY TEAM IMPACT ON GOUT MANAGEMENT

      Pharmacists are the most accessible healthcare professionals. Patients with a gout flare may seek pharmacists for recommendations on pain management. When patients without a previous gout diagnosis present to the pharmacy, pharmacists may recognize signs of gout and refer them to their primary care clinician. Pharmacists can educate patients who have a diagnosis for gout about the phases and goals of gout therapy, including the likelihood that ULT will be a lifelong therapy.

      Pharmacists are well-positioned to assess adherence to ULT and educate patients about the importance of ULT.107 Pharmacists can assess patient understanding of various therapies and remind them that anti-inflammatory medications treat acute gout attack or prevent gout flare upon initiating ULT. Pharmacists should empower patients to request from their clinician a medication-in-pocket prescription. Pharmacists should counsel patients on the proper use of medication-in-pocket by reminding them to take the anti-inflammatory medication as soon as possible, ideally within 12 hours of onset of a gout attack.108 In addition, patients may need a reminder about continuing their ULT while taking the medication-in-pocket for acute flares.109

      Pharmacy technicians can ensure that patients have refills on their medication-in-pocket prescription to facilitate early initiation. Updating the patient’s records in the pharmacy software with the gout diagnosis can facilitate this continuity of care. The pharmacy team should encourage patients to fill all their prescriptions at the same pharmacy. Through access to all the patient’s medications, pharmacists and pharmacy technicians can play a crucial role in optimizing gout management by identifying medications that increase serum uric acid levels.110

      In addition, the pharmacy team can identify potential drug-drug interactions. This is particularly important with colchicine as it is a substrate for CYP3A4 and P-gp and has a narrow therapeutic window.111 In addition, some medications are known to increase serum uric acid levels.20 Advising patients to check with the pharmacy team before purchasing an over-the-counter (OTC) medication can decrease the use of inappropriate medications. When completing transactions at the register, pharmacy technicians are well positioned to identify OTC products that can worsen gout, such as vitamin A or niacin.112 On the other hand, frequent purchase of OTC anti-inflammatory medications like naproxen or ibuprofen may imply uncontrolled gout.

      Patients can find educational videos on YouTube to learn more about gout therapy and appropriate diet.113 Additional resources are available to patients on goutalliance.org. These include videos, podcasts, guides, and awareness events.114 Some patients may like to learn about their condition using gout-related mobile applications.

      Pharmacy interns may benefit in hearing from patients about their experience with gout, especially the debilitating pain. This may help future pharmacists empathize and develop better relationships with patients, which can improve patient outcomes.115

      The entire pharmacy team could engage in alleviating misconceptions about gout. Some patients with gout have reported stigma regarding their condition from friends, family members, and healthcare workers.116 Some patients with gout have even reported an internalized stigma. Stigmatization may be due to the misbelief that gout is benign, preventable, or self-inflicted.

      Did you know that May 22 is National Gout Awareness Day?

      Jim states that he feels embarrassed about wearing slippers that expose his swollen toe. The pain is so intense that he is unable to tolerate a close-toe shoe.

      Table 5 summarizes some medications that may increase serum uric acid level.

      Table 5 – Managing Medications that Increase Serum Uric Acid Level and Risk of Gout Attack20,110,117-119
      Medication Mechanism Recommendation
      Loop and thiazide diuretics

      Use: hypertension, edema

       

      Decrease urate excretion The guideline recommends switching to a different antihypertensive and suggests losartan when feasible.

       

      Aspirin (low-dose, 81 mg)

      Use: prevention of CVD

      Increases uric acid renal reabsorption and decreases secretion The guideline conditionally recommends against discontinuing low-dose aspirin with appropriate indication.
      Niacin

      Use: dietary supplement

      Inhibits the enzyme uricase, thus inhibiting the oxidation of uric acid, or decreases uric acid excretion The guideline does not provide a specific recommendation for niacin-induced hyperuricemia. Experts recommend adequate hydration.

       

      After looking into Jim’s medication profile and inquiring about his OTC products, the pharmacist does not identify any medication that may be increasing his serum uric acid level.

      CONCLUSION

      Gout is the most common type of inflammatory arthritis. Untreated gout can lead to complications such as degenerative arthritis, urate nephropathy, infections, renal stones, joint fractures, and nerve or spinal cord impingement. ULT is indicated for chronic gout management. Allopurinol is the first-line urate-lowering agent. Colchicine, NSAIDs, and corticosteroids are indicated for acute flares, and, in lower doses, for gout flare prophylaxis upon initiating ULT. Diet and lifestyle modifications complement the pharmacologic therapy. The pharmacy team plays a crucial role in identifying drug-induced hyperuricemia and educating patients about the importance of adherence to ULT. Gout flares are painful and debilitating. Pharmacists can recommend initiation of anti-inflammatory therapy for acute gout flares. Pharmacy technicians can ensure patients have refills for their anti-inflammatory medication to facilitate the medication-in-pocket approach.

      Jim’s uncontrolled gout may be due to various reasons that pharmacy team can investigate. Inquiring about Jim’s drinking habits and educating him about the negative impact of alcohol on gout management is a necessary first step in his therapy. If an adequate trial of dietary changes does not control his symptoms, then switching to a different XOI or adding probenecid, depending on what he has tried so far, would be appropriate.

       

       

      Pharmacist Post Test (for viewing only)

      Treating Gout without Doubt

      Pharmacist POST-TEST
      1. Which of the following patient factors accounts for about 90% of gout cases?
      a) Overproduction of uric acid
      b) Underexcretion of uric acid
      c) Liver dysfunction

      2. Why does the American College of Rheumatology (ACR) define hyperuricemia as serum uric acid level greater than or equal to 6.8 mg/dL?

      a) All patients with serum uric acid level ≥ 6.8 mg/dL experience gout
      b) Serum uric acid level ≥ 6.8 mg/dL is insoluble in the blood
      c) Patients with serum uric acid level ≥ 6.8 mg/dL experience urate kidney stones

      3. Which of the following is involved in the pathogenesis of gout?

      a) Chronic deposition and crystallization of urate in the joints and tissues
      b) Chronic deposition and crystallization of calcium in the joints and tissues
      c) Increased glomerular filtration rate of uric acid due to caffeine intake

      4. Which of the following is a complication of untreated gout?

      a) Renal stones
      b) Congestive heart failure
      c) Visual changes

      5. Which of the following findings confirms a diagnosis of gout?
      a) Elevated uric acid
      b) Tophi in tissues and/or bones
      c) Burning upon urination

      6. According to the American College of Rheumatology (ACR) guideline, which one of the following is a goal of chronic gout therapy?
      a) Limiting gout attacks to a maximum of 2 attacks per year
      b) Preventing future gout attacks
      c) Decreasing the renal excretion of uric acid

      7. A 55 year-old-man presents with his first acute gout attack. In the absence of contraindications, which of the following medications is an appropriate first-line therapy for this patient?

      a) Colchicine
      b) Intramuscular methylprednisolone
      c) Anakinra

      8. Which one of the following statements is accurate about colchicine drug interactions?
      a) Co-administration of colchicine with P-glycoprotein inhibitors increases the risk of colchicine toxicity
      b) Co-administration of colchicine with P-glycoprotein inhibitors decreases colchicine efficacy
      c) Co-administration of colchicine with CYP 450 3A4 inhibitors decreases colchicine efficacy

      9. In the absence of contraindications, which one of the following medications is the first-line urate-lowering therapy?
      a) Allopurinol
      b) Febuxostat
      c) Probenecid

      10. A patient presents to fill his first prescription for allopurinol. Which one of the following is an appropriate counseling point for this patient?
      a) Start taking allopurinol today and continue indefinitely
      b) Discontinue allopurinol once you achieve uric acid level of < 6 mg/dL c) Keep allopurinol on hand and start taking at the first sign of a gout attack 11. A patient experiences an acute attack of gout. You review his medication profile. Which of the following medications may be aggravating his gout? a. atorvastatin b. niacin c. losartan 12. Which of the following is an appropriate nonpharmacologic intervention for gout? a. Increasing intake of purine-containing foods b. Switching from beer or wine to hard alcohol c. Applying ice to sore joints if tolerable

      Pharmacy Technician Post Test (for viewing only)

      Treating Gout without Doubt
      Technician POST TEST question

      1. According to the American College of Rheumatology (ACR), what is the definition of hyperuricemia?

      a) uric acid level > 6 mg/dL
      b) uric acid level ≥ 6.5 mg/dL
      c) uric acid level ≥ 6.8 mg/dL

      2. Which of the following statements is accurate about gout attacks?

      a) Gout attacks happen only in the big toe joint
      b) Gout attacks happen only in the morning
      c) Gout attacks happen in any joint

      3. When should patients with a first gout attack seek medical care?
      a) Only if the pain is unbearable
      b) Only if the pain lasts more than 10 days
      c) Anytime patients experience their first gout attack

      4. A patient calls the pharmacy saying that he is starting to experience a gout attack. The patient asks the pharmacy technician to refill his medication-in-pocket prescription. Which one of the following medications can the patient use for medication-in pocket approach?
      a) Allopurinol
      b) Naproxen
      c) Probenecid

      5. A pharmacy technician is refilling a patient’s medication-in pocket prescription for colchicine. The technician notices that after this fill, the prescription has no more refills. The patient’s next appointment is in eight months. What is the best next step?

      a) Send a refill request to the clinician’s office
      b) Inactivate the prescription
      c) Tell the patient to request a prescription during their next visit

      6. What is the goal of therapy for a patient taking allopurinol as part of a gout regimen?
      a) Achieving a serum uric acid level < 6 mg/dL b) Terminating an acute gout attack c) Decreasing the intensity of pain during an acute gout attack 7. Which one of the following nonpharmacologic therapy is beneficial for patients with gout? a) Decreasing the intake of foods high in purines b) Increasing alcoholic beverages consumption c) Decreasing the intake of caffeine 8. A patient visits the pharmacy counter frequently to check-out some OTC products. In the past three months, the patient has purchased the same product four times. Which one of the following OTC products may imply uncontrolled gout? a) Vitamin C b) Ibuprofen c) Dextromethorphan 9. A medication guide should accompany which of the following medications? a) NSAIDs b) Allopurinol c) Probenecid 10. Which one of the following medications Is a urate oxidase enzyme? a) Pegloticase b) Colchicine c) Probenecid 11. A patient experiences an acute attack of gout. You review his medication profile. Which of the following medications may be aggravating his gout? a. atorvastatin b. niacin c. losartan 12. Which of the following is an appropriate nonpharmacologic intervention for gout? a. Increasing intake of purine-containing foods b. Switching from beer or wine to hard alcohol c. Applying ice to sore joints if tolerable

      References

      Full List of References

      References

         

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        Immunization: A Quick Refresher: Perfect Intramuscular Injection Technique

        Learning Objectives

         

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

        Review basic intramuscular technique for vaccine administration
        List changes in administration technique that increase safety and decrease patient pain
        Describe the "clean as you go" process that saves time and reduces error

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

        Review basic intramuscular technique for vaccine administration
        List changes in administration technique that increase safety and decrease patient pain
        Describe the "clean as you go" process that saves time and reduces error

           

          Release Date: January 9, 2024

          Expiration Date: January 9, 2027

          Course Fee

          FREE

          There is no funding for this CE.

          ACPE UANs

          Pharmacist: 0009-0000-24-005-H06-P

          Pharmacy Technician:  0009-0000-24-005-H06-T

          Session Codes

          Pharmacist:  21YC03-ABC28

          Pharmacy Technician: 21YC03-CBA24

          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 0009-0000-24-005-H06-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

          Jill M. Fitzgerald, PharmD
          Emeritus Associate Professor of Clinical Pharmacy
          University of Connecticut School of Pharmacy
          Storrs, CT

          Jeannette Y. Wick, RPh, MBA
          Director, Office of Pharmacy Professsional Development
          University of Connecticut School of Pharmacy
          Storrs, CT

          Gabriella Scala
          PharmD Candidate 2022
          University of Connecticut School of Pharmacy
          Storrs, CT

          Samuel Breiner
          PharmD Candidate 2021
          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.

          Jill Fitzgerald, Samuel Breiner,  Gabriela Scala and Jeannette Wick have no relationships with ineligible companies.

           

          ABSTRACT

          Over the next months, we expect that more people will receive intramuscular vaccines than ever before. Many pharmacists and in some cases, pharmacy technicians, will mobilize to help with the immunization efforts. Some will take training for the first time, and others will have been trained but rusty. This activity reviews the best practices associated with intramuscular injection. UConn School of Pharmacy is providing this continuing education activity free as a public service.

          CONTENT

          Content

          INTRODUCTION

          As the healthcare community mobilizes and begins vaccinating to prevent the spread of coronavirus-SARS-19, pharmacists and in many places pharmacy technicians will be called to assist. In an effort to engage Americans in the program and encourage vaccination, the media is full of stories and videos of people receiving vaccinations. We at the University of Connecticut School of Pharmacy have watched with great interest, reading national newspapers and watching television clips about vaccination. One comment posted in response to an article in the New York Times caught our attention. Someone who dubbed herself “Retired Nurse” wrote the following comments1:

          “As for sore arms, I am not surprised. The wide variation in injection techniques displayed on television have been horrendous: Slow, tentative needle insertions, not stabilizing the site, too high up in the shoulder, exceptionally large needle lengths in tiny arms, etc. make me cringe. Hilariously, they showed doctors ceremoniously giving some of them on television but let's be honest, most physicians do not routinely administer shots. That task is delegated to a nurse or even a medical assistant in doctors' offices in many states. A vaccination can be a lot less painful, if not virtually painless, with good injection training.”

          We could not agree more, and as we prepare to train people from a number of professions in our state, we decided to create this short continuing education homestudy to help you review injection technique and stay abreast of the most recent developments.

          Intramuscular Injections

          Vaccines administered in pharmacies are generally given by one of two routes: (1) intramuscularly, or (2) subcutaneously. Most (but not all) immunizations are given intramuscularly. Most inactivated vaccines are administered intramuscularly in the deltoid, whereas all live-attenuated injectable vaccines are administered subcutaneously in the anterior arm (midway between the elbow and armpit).2 An exception of a common inactivated vaccine given subcutaneously would be meningococcal vaccine. To date, the available COVID-19 vaccines are all given intramuscularly. Intramuscular (IM) injections are exactly what the name implies – they are injections given into a muscle using a syringe.

          Let’s review the parts of the syringe very quickly. A syringe has three primary parts. The needle, the barrel, and the plunger (see Figure 1). The needle is also called the “sharp,” and for vaccines, it’s a very fine needle. This is the distal part of the syringe that penetrates the skin. The barrel is the tube that holds the vaccine, and it has markings similar to that on a ruler. In most cases, the barrel measures milliliters (mL). The plunger is the plastic device used to pull the vaccine into and push the vaccine out of the syringe.

          Cartoon showing the sections of a syringe, including needle, hub, barrel, and plunger

          An important area of the syringe is called the hub or the hilt. This is the place where the needle meets the barrel. When penetrating the skin, you will push the needle all the way to the hub or the hilt. Before you inject, the entire needle will be in the skin and the muscle – you won’t be able to see any of the metal needle. Many people worry that they will hit the patient’s bone. It’s a comfort to know that if you hit the bone, you will feel it. The patient will not. This is a word-for-word explanation that our peer reviewer and authors like3:

          "Needle length should be chosen based on the body habitus and weight of the patient. A needle that is too long can penetrate the deltoid muscle, hitting the bone. Although patients will not feel their bones being hit, the vaccine might not fully absorb into the muscle, leading to a reduced immune response. Furthermore, if the needle is too short the vaccine might be administered subcutaneously, which might result in decreased immune response and the development of nodules or cellulitus."

          Good Technique

          Good technique starts with preparation. Before you start administering vaccines, it’s essential that you prepare and anticipate how many patients you’ll see and what their needs will be. A cornerstone of good technique is knowing exactly how you will document. Especially with the COVID-19 vaccine, knowing how to document will be essential. Our understanding is that a new Vaccine Administration Management System has been developed to capture that data. When you arrive at your site, and eventually when the vaccine is available in your pharmacy, someone should train you on how to use the Vaccine Administration Management System. As with all vaccines, you’ll need to document the patient’s name, the vaccine’s lot number and expiration date, and where you gave the vaccine (left deltoid, right deltoid, etc.).4 And here is a quick aside: Many pharmacies don’t do a good job of documenting vaccines they give in their medication systems. Be certain to know what documentation is necessary, either in addition to or instead of Vaccine Administration Management System. For instance, health systems will require documentation in their electronic medical records or pharmacy system.

          Before you start, survey your area and ensure that the station at which you vaccinate has a sufficient amount of supplies. Table 1 lists items that you need at your station at all times and items you have to have ready for each patient. One thing we wish to emphasize is a technique that one of our students taught us. When you have gloves on, it’s very difficult to open a Band-Aid and apply it. In anticipation of needing it, if you peel back the outer wrapper before you start, it will be much easier to use the Band-Aid should you need it after vaccination.  Some people even place the small opened section of the bandage on the patient’s skin right next to where they will inject, so it’s easy access. And note that often, if you have good technique, the patient will not bleed. But use a Band-aid in case they “spring a leak” later.

          Table 1. Necessary Supplies for Immunization4,5

          Always at Your Station Have Ready for Each Patient
          •        A sharps container

          •        A handy trash can

          •        Band-Aids

          •        Cleaning solution

          •        Your personal protective equipment (mask, face shield, gloves)

          •        A box of tissues

           

          •        One alcohol wipe

          •        One sterile 2 x 2 gauze pad

          •        A new needle and syringe that are the correct size

          •        A clean pair of disposable gloves (for you to wear) for each patient

          •        A Band-Aid, partially open

           

          Next, commit to cleaning as you go. Have you ever noticed that when you go to any fast food restaurant, it is always clean and organized? That’s because they teach their staff to clean as they go. This lesson, when employed in our homes and in our workplaces, is extremely useful. It’s especially useful when you are immunizing many people. You don’t accumulate trash that has to be picked up later. This process has three key points when it comes to immunization4,5:

          • Throw paper and miscellaneous trash away immediately. What this means is if you take the cap off the needle, throw it in the trash immediately. You won’t be using the cap because we don’t recap needles any longer. Throwing it in the trash ensures you won’t be tempted to recap the needle. Similarly, any paper trash generated from anything that you open should go into the trash can immediately.
          • After you inject and withdraw the needle from the muscle, activate the safety device on the needle using a hands-free method immediately.
          • Place used needles or sharps in the sharps container as soon as you finish with them. Do not place the used syringe on your work area even for a moment. Put it in the sharps container. (Yes, we are stressing this point!)

          Have a Seat, Please

          It’s critical for patients to be seated when you give injections. Ideally, you should be seated also and we will discuss why below. Ask patients to relax their arms. They can place their palms on their legs or dangle their arms at the sides. Completely expose the upper arm and find your upside-down triangle target area of the deltoid muscle. If administering more than one vaccine in the same arm, separate the injection sites by one inch so that any local reactions can be differentiated.6

          As we implied above, for most adults, we administer the COVID-19 and most other IM vaccines in the upper arm. This is the location of the deltoid muscle. You will give the injection in the center of an upside-down triangle. To give the vaccine, completely expose the patient’s upper arm, and feel for the bone that goes across the top of the upper arm. This is the acromion process. The bottom of the acromion process is the flat edge of the inverted triangle (see Figures 2 and 3).5 The triangle points down. It ends at about the level of the armpit. You will inject into the lower two thirds of the deltoid. Note that giving injections in the upper third of the deltoid can damage the muscle and cause inordinate pain.7-9

          Graphic showing the bones of the shoulder, including acromion

           

          Drawing of person showing the deltoid injection area, which is an upside-down triangle in the mid-shoulder

          Shoulder injury related to vaccine administration (SIRVA) is an emerging concern. 3,7-9 This occurs when immunizers inject vaccines into the subdeltoid bursa or within the joint space. SIRVA causes shoulder pain and limited range of motion within 48 hours after IM vaccine administration.10,11 Experts advise immunizers to avoid administering vaccines in the top one-third of the deltoid. Studies show that immunizers who sit and administer vaccines to seated patients, using needles of the appropriate length, reduce the risk of SIRVA.7,8,12

          Let’s get more specific. The correct area to give an injection is in the center of the triangle. You would inject one to two inches or two to three finger widths below the lower edge of the acromion process.5,14 Gently stretch the skin around the injection site with your non-dominant hand. This displaces the subcutaneous tissue, aids needle entry and reduces pain. Insert the needle at a 90 degree angle, all the way to the hub. Depress the plunger at a rate of 1 second for every 0.1 ml of fluid.13 Again, avoid injecting too close to the top of the arm. Don’t use this site if a person is very thin or the muscle is very small. In these cases, it’s better to inject into the anterolateral thigh.4 The SIDEBAR describes considerations when selecting needles size and length.

          A final word before we go to the actual injection process. Please don’t say, “This will not hurt a bit!” People have very different thresholds for pain and it’s impossible to predict whether it will hurt. Develop some language that you are comfortable with, and use it. A good response of people who ask if it will hurt is to say, “It may hurt or sting a little but just for a minute or two.”

          Prepare yourself before you give an injection by using personal protective equipment, and using it correctly.4 During the pandemic, we advise covering your nose and your eyes, keeping your hands away from your face, and washing your hands often. Practice good hygiene before and after immunizing each patient. Do not wear the same set of gloves for more than one patient. Change gloves between patients and wash your hands and sanitize (and let dry) before putting on a new pair of gloves.4,5

          SIDEBAR: Choosing the Right Needle4,5,14-17

          Immunizers will administer current COVID-19 vaccine from Pfizer and Moderna using needles that fall in the ranges of 22-25 gauge and 1-1.5 inches in length. Remember, the higher the gauge, the finer the needle! The Pfizer COVID vaccine is currently approved for ages 16 and older while the Moderna vaccination has approval for ages 18 and older. CDC vaccination recommendations on needle gauge and length are consistent with current Pfizer and Moderna recommendations. The table below summarizes CDC recommendations on general needle gauges and lengths for IM injections based on age.

          Chart showing CDC recommendations on needle gauge and length based on age and weight

          Although we may be injecting 1 to 1.5-inch needles into patients' deltoids now, our near future will consist of younger and frail patients. This may require use of shorter needles (i.e., 5/8 inch) and a different injection site - that being the vastus lateralis (a muscle on the outer thigh).

          Ready, Set, Go

          Let’s go through the process twice and review first the general procedure, then some specifics.

          Here are the steps4,14:

          • First, open the alcohol wipe. Wipe the area where you plan to give the injection.
          • Prepare the needle.
          • Hold (stretch) the skin around where you will give the injection.
          • Insert the needle into the muscle at a 90° angle, all the way to the hub.
          • Inject the vaccine at a rate of 0.1 ml per second.
          • Remove the needle at the same 90 degree angle.

          Now let’s review some nuances.4,5,14

          • First, open the alcohol wipe. Wipe the area where you plan to give the injection. Wiping in a circular motion from the center out sometimes increases circulation and desensitizes the area. However, there’s no need to scrub. Just wipe firmly and dispose of the used alcohol wipe and its wrapper. Let the area dry (approximately 30 seconds) and do not blow on or touch the area until you give the injection.
          • Prepare the needle. Hold the syringe with your dominant hand and pull the cover off with your other hand. Throw the cover in the trashcan immediately so you are not tempted to recap. Place the syringe between your thumb and first finger (like a dart). Let the barrel of the syringe rest on your finger.
          • Hold the skin around where you will give the injection. With your free hand, which is also your non-dominant hand, gently press on the skin and pull it so that it’s slightly tight. Experts recommend two different ways of doing this. One is to make a “C” with your nondominant hand and stretch the skin between your first finger in your thumb. The second is to use the outer edge of you hand below the pinkie finger and pull the patient’s skin taut by pushing toward the outer edge of the arm (toward your non-dominant hand).
          • Insert the needle into the muscle. Hold the syringe barrel tightly and inject the needle through the skin and into the muscle at a 90° angle.
          • Inject the vaccine. Push down on the plunger and inject the medicine using your index finger. Push firmly and steadily at a rate of about 0.1 mL per second. Note that the Pfizer COVID-19 vaccine is only 0.3 mL, so you can inject it in about three seconds. The Moderna COVID-19 vaccine is a 0.5 mL volume, so it will take five seconds to inject.
          • Remove the needle. Once you have injected the vaccine, remove the needle at exactly the same angle as you used for it to go in – that is, 90°. Activate the safety device and dispose of the entire syringe in your sharps container. You can place gauze over the area where you give the injection or cover the injection site with a Band-Aid (do not massage the area).

          SIDEBAR: Needle Safety4,18

          Now let's quickly discuss how we can keep ourselves safe while immunizing. The CDC estimates that 590,194 needlestick injuries occur annually in all healthcare settings. Immunizing exposes pharmacists to an increased risk of needlestick injury and transmission of bloodborne disease, with the most dangerous being hepatitis B, hepatitis C, and HIV. Therefore, if we are to know the perfect technique to immunize we must also know the perfect technique to keep ourselves safe.

          Prevention is key to avoiding needlestick injury. Prevention includes:

          • NEVER recapping needles by hand (if you absolutely must recap a syringe by hand, use a one-handed method and scoop the cap onto the needle. That is, place cap on a flat surface, remove your hand from the cap, insert the syringe needle tip deep into the cap, and press the tip of the cap against an inanimate object to secure it in place)
          • Disposing of used needles in sharps containers
          • Use needles with safety features, called "engineered injury protection"
          • NEVER handing a syringe with an uncapped needle to someone else

          If a needlestick injury should occur, you must be equipped with the knowledge of what to do next.

          • Needlestick/cut: wash with soap and water
          • Splashed on skin or in nose or mouth: flush with water (soap if possible)
          • Splashed in eyes: irrigate with clean water, saline, or sterile irrigants

          Be sure to report the incident to your supervisor and seek medical treatment to discuss possible risk of exposure or need for post-exposure treatment. Keeping ourselves safe is just as important as keeping our patients safe.

          Refining Technique

          So now we’ve reviewed the step-by-step process for giving an IM vaccine. Let’s talk about a few points that will refine your technique and make you a real pro.

          As we prepare to vaccinate an entire nation, pharmacists will be working side-by-side with people from many different healthcare disciplines. In fact, we may be working with people who are not healthcare providers but have simply been trained to administer immunizations. From our experience, we have learned that conflict sometimes arises because healthcare practitioners trained in different disciplines have different ways of doing things. Our intent is to follow the most recent expert advice and use best practices. For that reason, we want to point out a few things that are either so new that others may not be aware of them or different from what you may see or hear at immunization sites.

          First, some helpful observers may tell you that you need to aspirate before you inject. For many years, many healthcare professionals were trained to aspirate – meaning after the needle is in the muscle, the immunizer will pull back on the plunger and see if they draw up any blood. This is an outdated practice.14 The Centers for Disease Control and Prevention indicates that aspiration is unnecessary and unwarranted when administering vaccines. They indicate, “Aspiration before injection of vaccines or toxoids (i.e., pulling back on the syringe plunger after needle insertion but before injection) is not necessary because no large blood vessels are present at the recommended injection sites, and a process that includes aspiration might be more painful for infants.”4,19  Should another provider approach you and criticize your technique, telling you that you need to aspirate, feel free to educate them about the proper way to give a vaccine!

          Second, while you are going through the immunization steps, you can help patients relax and build some confidence if you talk to the patient. A little chitchat will help patients feel comfortable. We probably don’t need to say this but we will: Stick with safe topics. Some good questions are things like, “Do you have a pet?” or “It’s really cold today, isn’t it?” Remember that it’s best to use open-ended questions once you get the conversation started, with open-ended questions being those that cannot be answered with a yes or a no. For example, if the patient responds affirmatively to your question about pets, keep the ball rolling by saying “What kind of pet do you have?” If you’re talking about the weather, you can ask the patient what his or her favorite season is, or what they like about rainy days. Asking, “What’s for dinner tonight?” is also of great conversation starter. It will also give you some ideas for your own supper!

          Next, let’s talk about skin that is not clear or is discolored. Ideally, we would want to inject into an area of the skin that is clear. You should never inject into broken skin, moles, or rashy areas. While you can inject into tattooed skin, we advise against it. The reason for this is the same as the reason that we inject into the clear areas of the skin: we want to be able to see a local reaction if it develops.4

          Finishing Up

          Finally, we are ready to finish the process. Once you’ve administer the vaccine, you’ll need to direct patients about their next steps and what they need to do. With the current COVID-19 vaccines at the current time, patients need to stay at the immunization site for 15 minutes for observation or as directed by your site’s specific policy.20 This may change as we administer significantly larger numbers of vaccinations. Older pharmacists were trained to provide a vaccine fact sheet to every patient they immunize. That practice seems to be site-specific at this point, so if your site requires a vaccine fact sheet be given to patients, do that.

          Review your documentation, and make sure that you have completed it entirely. This is critical for the COVID-19 vaccines because at some point, patients may need to prove that they were vaccinated to engage in certain activities. Take a few minutes to ensure that you have completed the documentation and submitted it appropriately.20

          A last PRO TIP is to take a minute to look at your station. Ensure that you have enough supplies to continue immunizing patients. Do not overfill your sharps containers. Know where the “FULL” line is. When they are close to full ask for or retrieve an empty container as a backup. Sanitize the area as directed by your site in preparation for the next patient.

          CONCLUSION

          Even the most proficient immunizer sometimes faces dilemmas in the immunization clinic. A final PRO TIP is indispensable: If at any time you encounter a problem and you are unsure or uncomfortable, find a more experienced immunizer and ask for help. We see all kinds of issues when we immunize—people who experience vasovagal syndrome (faint at the sight or thought of needles), people who are very thin or obese, people who have latex allergies and need to know if the vial’s stopper contains latex (neither the Pfizer or Moderna vaccine vials do). Finding someone with more expertise or simply collaborating with others to plan an approach is smart. It important to do your best to ensure the patient receives the vaccine; if you turn a patient away, he or she may not return.

           

           

           

           

           

           

          Pharmacist and Pharmacy Technician Post Test (for viewing only)

          Post Test

          Immunization: A Quick Refresher: Perfect Intramuscular Injection Technique

          1. When injecting a vaccine into the deltoid muscle, which area should you be certain to AVOID?
          A. The lower 1/3 of the upside-down triangle in which the acromion process is the top edge
          B. The middle 1/3 of the upside-down triangle in which the acromion process is the top edge
          C. The upper 1/3 of the upside-down triangle in which the acromion process is the top edge
          2. You have completed the steps necessary to prepare for injecting a vaccine. You are almost ready to insert the needle into the patient’s arm. What is the LAST STEP before inserting the needle?
          A. Pinch the skin on both sides so it makes a “mountain” and inject into the scrunched skin
          B. Use your non-dominant hand to pull the skin in one direction away from the injection site
          C. Tell the patient that it will not hurt and inject in whatever way is most comfortable for you

          3. After injecting the vaccine, removing the needle, activating the safety mechanism, and discarding the syringe in the sharps container, what should you do to ensure the medication is absorbed?
          A. Nothing. If you have used good injection technique, your job is done!
          B. Massage the area for approximately one or two minutes.
          C. Apply a hot compress and have the patient hold it there for 15 minutes.

          4. How quickly do most guidelines recommend to inject vaccines?
          A. 1 mL/second
          B. 0.1 mL/second
          C. 0.01 mL/second

          5. Why does the Advisory Committee for Immunization Practices recommend AGAINST aspiration when injecting vaccines?
          A. It increases risk of bleeding that will be difficult to stop
          B. It causes vaccine to leak from the muscle and decreases effectiveness
          C. No large blood vessels are present at the recommended injection sites

          6. Which of the following are the MOST COMMON bloodborne pathogens?
          A. Hepatitis B, hepatitis C, and HIV
          B. Influenza, coronavirus, and HIV
          C. Pneumonia, pinkeye, and staphylococcus

          7. Which of the following statements is TRUE?
          A. Always recap needles by hand
          B. Dispose of used needles in trash receptacles
          C. Use needles with safety features

          8. If you absolutely must recap a syringe by hand, how many hands should you use?
          A. One
          B. Two
          C. Three (get someone else to help)

          9. You are prepared to inject a vaccine and have uncapped the needle, and thrown away the cap. Your team leader enters the room and says she needs you immediately to answer some questions about your last patient. She has brought another immunizer to take over your station for 15 minutes. Which of the following is the BEST way to proceed?
          A. Hand the syringe with the uncapped needle to your replacement so he can finish this patient’s vaccination and leave with the team leader.
          B. Fish around in the trash can, find the cap, and recap the needle, and give the now-capped needle to your replacement to finish with this patient.
          C. Tell the team leader that you have discarded the cap, and suggest you finish with your current patient since it will only be a few seconds.

          10. You inadvertently squirt something from a used syringe into your eye. What do you do?
          A. Irrigate with clean water, saline, or sterile irrigants
          B. Wash with soap and water
          C. Flush with detergent and water

          11. Which of the following would be considered an “engineered injury protection”?
          A. Syringes with sliding sheath that shields the attached needle after use
          B. Using an open container in which to dispose used needles
          C. Asking employees for input on what needles they prefer

          12. Select the statement that is TRUE for the current Pfizer and Moderna vaccines:
          A. Both vaccines do not come with administration devices
          B. Both must be stored in the refrigerator until 15 minutes before use
          C. Both require needles that are 22-25 gauge and 1-1.5 inches in length

          13. You greet a patient and ask him to uncover his deltoid. As you assess him, you notice that he must weigh at least 350 pounds. Which factor needs to be adjusted before you administer the vaccine?
          A. The dose
          B. The needle gauge
          C. The needle length

          14. Your patient looks at the syringe, pales, and begins to shake. She tells you that she has a “vasovagal” reaction to needles. You do not know what this means. What is the BEST way to proceed?
          A. Distract her with idle chit-chat
          B. Find a more experienced immunizer
          C. Tell her she will have reschedule

          15. Patients can be quirky. Your current patient wants to stand to receive the vaccination. What is the BEST explanation for why both of you should sit?
          A. Immunizers who sit and administer vaccines to seated patients reduce the risk of injury to the patient’s shoulder.
          B. Immunizers who sit and administer vaccines to seated patients reduce the risk of needlestick injury to the immunizer.
          C. Immunizers who stand and administer vaccines to seated patients reduce the risk of the patient fainting.

          16. Your patient is heavily tattooed. In this training, we emphasized the importance of finding the area of clearest skin. Why?
          A. We want to be able to see a local reaction if it develops.
          B. Injecting into tattooed skin is more painful for the patient.
          C. Current COVID vaccines cannot be given in a tattooed area.

          17. What is the proper angle to give an IM injection?
          A. 45o
          B. 90o
          C. Inject at 45o, withdraw at 90o.

          18. Which of the following questions should you be prepared to answer in case a patient asks?
          A. Does the vaccine’s vial have plastic in the stopper?
          B. Does the vaccine’s vial have latex in the stopper?
          C. Does the vaccine come in a multidose vial?

          19. What is the BEST position for a patient’s arm while you are giving an IM injection?
          A. Relaxed with palms on legs or arm dangling at sides
          B. Taut with the patient squeezing a rubber ball
          C. Flexed as if they were showing you the size of their deltoid

          20. You’ve vaccinated a patient with a COVID vaccine, disposed of the sharp, and finished your task. What is the BEST thing to tell the patient?
          A. Thanks for doing this, your nation appreciates you.
          B. See you for the follow-up dose in six weeks!
          C. Please remain in the clinic for 15 minutes.

          References

          Full List of References

          References

             
            1. Harmon A. What the Vaccine Side Effects Feel Like, According to Those Who’ve Gotten It. Available at https://www.nytimes.com/2020/12/28/us/vaccine-first-patients-covid.html. Accessed December 30, 2020.
            2. Wick JY. Immunization: Tips, tools, and total success. Available at https://www.pharmacytimes.com/publications/issue/2016/August2016/Immunization-Tips-Tools-and-Total-Succes. Accessed January 2, 2020.
            3. Bancsi A, Houle SKD, Grindrod KA. Getting it in the right spot: Shoulder injury related to vaccine administration (SIRVA) and other injection site events. Can Pharm J (Ott). 2018;151(5):295-299.
            4. Centers for Disease Control and Prevention. Vaccine administration. Available at https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/administration.html. Accessed December 30, 2020.
            5. Centers for Disease Control and Prevention. Vaccine Administration: Intramuscular (IM) Injection Children 7 through 18 years of age. Available at https://www.cdc.gov/vaccines/hcp/admin/downloads/IM-Injection-children.pdf. Accessed December 30, 2020.
            6. Centers for Disease Control and Prevention. Adminster the vaccines. Available at https://www.cdc.gov/vaccines/hcp/admin/administer-vaccines.html. Accessed January 3, 2021.
            7. Bodor M, Montalvo E. Vaccination-related shoulder dysfunction. Vaccine. 2007;25(4):585-587.
            8. Atanasoff S, Ryan T. Lightfoot R, Johann-Liang R. Shoulder injury related to vaccine administration (SIRVA). Vaccine. 2010;28(51):8049-8052. doi: 10.1016/j.vaccine.2010.10.005.
            9. Cook IF. Subdeltoid/subacromial bursitis associated with influenza vaccination. Hum Vaccin Immunother. 2014;10(3):605-606. doi:10.4161/hv.27232.
            10, National Vaccine Injury Compensation Program (VICP). Prevention of SIRVA. Health Resources and Services Administration website. Available at hrsa.gov/advisorycommittees/childhoodvaccines/meetings/20150604/sirva.pdf. Accessed December 30, 2020.
            11. Cross GB, Moghaddas J, Buttery J, Ayoub S, Korman TM. Don’t aim too high: avoiding shoulder injury related to vaccine administration. Aust Fam Physician. 2016;45(5):303-306.
            12. Kroger AT, Sumaya CV, Pickering LK, Atkinson WL. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2011;60(RR02):1-60.
            13. : Dougherty L, Lister S (2015) The Royal Marsden Hospital Manual of Clinical Nursing Procedures. Oxford: Wiley-Blackwell.
            14. Immunize.org. How to administer intramuscular and subcutaneous vaccine injections. Avaialble at https://www.immunize.org/catg.d/p2020.pdf. Accessed January 3, 2021.
            15. Centers for Disease Control and Prevention. Moderna COVID-19 vaccine. Available at https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/downloads/standing-orders.pdf. Accessed January 3, 2021.
            16. Centers for Disease Control and Prevention. Pfizer-BioNTech COVID-19 Vaccine. Available at https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/prep-and-admin-summary.pdf. Accessed January 3, 2021.
            17. Centers for Disease Control and Prevention. Vaccine administration: Needle gauge and length. Available at https://www.cdc.gov/vaccines/hcp/admin/downloads/vaccine-administration-needle-length.pdf. Accessed January 3, 2021.
            18. U.S. Government Printing Office. Needlestick Safety and Prevention Act. Available at http://www.gpo.gov/fdsys/pkg/PLAW-106publ430/html/PLAW-106publ430.htm. Accessed January 3, 2021.
            19. Ipp M, Taddio A, Sam J, Gladbach M, Parkin PC. Vaccine-related pain: randomised controlled trial of two injection techniques. Arch Dis Child. 2007;92(12):1105-1108. DOI: 10.1136/adc.2007.118695
            20. Centers for Disease Control and Prevention. Resource library. Available at https://www.cdc.gov/vaccines/hcp/admin/resource-library.html. Accessed January 3, 2021.

            Vaccine Hesitancy: Management Strategies for Pharmacy Teams

            Learning Objectives

             

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

            ·       Describe vaccine hesitancy and barriers to vaccination
            ·       Recognize the how determinants of vaccine hesitancy contribute to behavioral outcomes
            ·       Recall anti-vaccine claims and rebuttals
            ·       Discuss situation-appropriate intervention strategies

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

            ·       Recall the benefits of vaccination
            ·       Recognize the various determinants of vaccine hesitancy
            ·       List ways to promote vaccine acceptance

               

              Release Date: August 21, 2023

              Expiration Date: August 21, 2026

              Course Fee

              Pharmacists: $4

              Pharmacy Technicians: $2

              There is no funding for this CE.

              ACPE UANs

              Pharmacist: 0009-0000-23-025-H06-P

              Pharmacy Technician:  0009-0000-23-025-H06-T

              Session Codes

              Pharmacist:  20YC61-VXK39

              Pharmacy Technician: 20YC61-KVT93

              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 0009-0000-23-025-H06-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

              Katharine E. MacDonald, PharmD Candidate 2021
              University of Connecticut School of Pharmacy
              Storrs, CT                                  

              Jeannette Y. Wick, RPh, MBA, FASCP
              Assistant 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.

              Katherine McDonald and Jeannette Wick have no relationships with ineligible companies.

               

              ABSTRACT

              Vaccines are responsible for reducing the incidence of vaccine-preventable diseases. While most people receive routine recommended vaccinations, a small portion of the population does not. Vaccine hesitancy and refusal are complex behaviors and the consequences of choosing not to vaccinate jeopardize both individual and societal health and safety. Pharmacists and pharmacy technicians must know the determinants and factors that contribute to vaccine hesitancy before they address and manage it appropriately. A comprehensive understanding of such influences can help pharmacists and pharmacy technicians identify and communicate with hesitant individuals better. Pharmacists and technicians are also able to screen patients for missing immunizations, provide patient education and support, and offer guidance.

              CONTENT

              Content

              INTRODUCTION

               

              Pharmacist Post Test (for viewing only)

              Pharmacist Post-test

              Pharmacist Learning Objectives:
              1. Describe vaccine hesitancy and barriers to vaccination
              2. Recognize the how determinants of vaccine hesitancy contribute to behavioral outcomes
              3. Recall anti-vaccine claims and rebuttals
              4. Discuss situation-appropriate intervention strategies

              1. Which of the following MOST CLOSELY corresponds to the WHO definition of vaccine hesitancy?
              A. Simple vaccine refusal in any context including lack of available vaccination services
              B. Acceptance of any vaccine if the ability to access vaccination is convenient
              C. Delay in acceptance or refusal of vaccines despite availability of vaccinations services

              2. Select the influence category, source of influence, and determinants that are paired correctly.
              A. Contextual influence—peer environment--costs
              B. Vaccine-specific issues—specific vaccine—mode of administration
              C. Group influences—political factors—reliability of vaccine supply

              3. A mother indicates she does not and will not vaccinate her children. You use motivational interviewing and learn that she believes natural immunity is safer than vaccine-induced immunity. What is an appropriate rebuttal if she consents to listen?
              A. Infection-induced immunity may elicit a superior immune response. However, the risks and complications associated with infection are significantly greater than those of vaccines.
              B. A panel of experts from the Institute of Medicine reviewed more than 12,000 published reports and several high-quality studies; none indicate natural immunity is stronger.
              C. The CDC’s system to track natural immunity vs. vaccine-induced immunity is called VAERS; you can examine the data in VAERS and see that your assumptions are wrong.

              4. Susan comes to the pharmacy and your technician reminds her she is due for her second HPV vaccination. Susan glances to the pharmacist’s workstation and quickly says, “Ummm, not today.” The technician gently says, “You’re here, and we’re not busy. Why don’t we get it done?” Susan replies, “No, not today. That guy gave me the last one and left a huge bruise. Not today.” What type of barrier is keeping Susan from her second shot?
              A. Vaccine accessibility
              B. Distrust of provider
              C. Gaps in knowledge

              5. Dave arrives at the pharmacy to pick up his “sugar meds” and you notice that he hasn’t received his flu shot yet. After providing him with a clinical recommendation for the vaccine, Dave replies, “Why do I need to? I work from home and have never gotten the flu before. What’s the point?!” Which barrier is preventing Dave from getting the flu shot?
              A. Distrust of vaccine
              B. Misinformation
              C. Perceived need for vaccine

              6. Manny is a regular customer who appears to be up to date on all of his vaccines except for the shingles vaccination. When you ask him why, he states that it’s for religious reasons, but says “I’d give it a try if there’s a shot without any pork in it.” Which intervention strategy would be most appropriate for Manny’s situation?
              A. Motivational interviewing about worldview
              B. Debiasing techniques to address overkill
              C. Offering Shingrix as an alternative

              Pharmacy Technician Post Test (for viewing only)

              Pharmacy Technician Post-test

              Pharmacy Technician Objectives:
              1. Recall the benefits of vaccination
              2. Recognize the various determinants of vaccine hesitancy
              3. List ways to promote vaccine acceptance

              1. Which of the following is a benefit of vaccination?
              A. Vaccines reduce the incidence of some diseases
              B. Vaccines completely eradicate vaccine-preventable diseases
              C. Vaccines only benefit vaccinated infants and children

              2. Which of the following types of vaccine coverage ensure the success of a vaccination program?
              A. Only high-risk people receive recommended vaccines
              B. Most people receive recommended vaccines on schedule
              C. Most infants and children receive some vaccines

              3. Mary tells you that she has not been vaccinated because the only place that is covered by her insurance requires a subway ride and then a taxi ride. Which of the following is the most likely determinant of Mary’s vaccine hesitancy?
              A. Geographic restrictions imposed by insurance
              B. Poor communication with her healthcare provider
              C. A bad attitude about necessary health care

              4. Joe lives in a rural area, and your pharmacist suggests he receive a flu shot. Joe says that his own doctor said that flu shots are fine, but not necessary for healthy folks. (The doctor said he hasn’t gotten one, and isn’t worried about it.) Which of the following is the most likely influence category to explain Joe’s vaccine hesitancy?
              A. Vaccine/ vaccination-specific issues
              B. Individual and group influences
              C. Contextual influences

              5. Which of the following is a way to promote vaccination in hesitant individuals?
              A. Ask the pharmacist to increase motivation using pressure
              B. Debunk any misinformation an individual may reference
              C. Listen to the individual’s concerns before taking action

              References

              Full List of References

              References

                 
                1. Meko H. School Will Pay $9.1 Million to Settle Lawsuit Over a Student’s Suicide. The New York Times. July 29, 2023. Accessed August 20, 2023. https://www.nytimes.com/2023/07/29/nyregion/new-jersey-student-suicide-settlement.html?searchResultPosition=1
                2. Murphy B. Why bullying happens in health care and how to stop it. American Medical Association. Published April 2, 2021. Accessed August 4, 2023. https://www.ama-assn.org/practice-management/physician-health/why-bullying-happens-health-care-and-how-stop-it
                3. Survey Suggests Disrespectful Behaviors Persist in Healthcare: Practitioners Speak Up (Yet Again) – Part I. Institute for Safe Medication Practices. February 24, 2022. https://www.ismp.org/resources/survey-suggests-disrespectful-behaviors-persist-healthcare-practitioners-speak-yet-again
                4. Intimidation: Practitioners Speak Up About This Unresolved Problem (Part I). Institute For Safe Medication Practices. Published March 11, 2004. https://www.ismp.org/resources/intimidation-practitioners-speak-about-unresolved-problem-part-i
                5. Disrespectful Behaviors: Their Impact, Why They Arise and Persist, and How to Address Them (Part II). Institute for Safe Medication Practices. April 14, 2024. Accessed August 4, 2022. https://www.ismp.org/resources/disrespectful-behaviors-their-impact-why-they-arise-and-persist-and-how-address-them-part
                6. Knapp K, Shane P, Sasaki-Hill D, Yoshizuka K, Chan P, Vo T. Bullying in the clinical training of pharmacy students. Am J Pharm Educ. 2014;78(6):117. doi:10.5688/ajpe786117
                7. Calvello M. Constructive vs. Destructive Feedback: Examples + Template | Fellow. Fellow.app. Published April 25, 2023. https://fellow.app/blog/feedback/constructive-vs-destructive-feedback-examples-template/
                8. Ryan M. Besting the Workplace Bully. Reference & User Services Quarterly. 2016;55(4):267-269.
                9. The Joint Commission. Bullying has no place in health care. www.jointcommission.org. Published June 2021. https://www.jointcommission.org/resources/news-and-multimedia/newsletters/newsletters/quick-safety/quick-safety-issue-24-bullying-has-no-place-in-health-care/bullying-has-no-place-in-health-care/
                10. Manzoni JF, Barsoux JL. The Set-Up-To-Fail Syndrome. Harvard Business Review. Published March 1998. https://hbr.org/1998/03/the-set-up-to-fail-syndrome
                11. Stein M, Vincent-Höper S, Schümann M, Gregersen S. Beyond Mistreatment at the Relationship Level: Abusive Supervision and Illegitimate Tasks. Int J Environ Res Public Health. 2020;17(8):2722. doi:10.3390/ijerph17082722
                12. Caring for Our Caregivers Caring for Our Caregivers Workplace Violence in Healthcare. https://www.osha.gov/sites/default/files/OSHA3826.pdf
                13. Infrontadmin. The 6 Stages of Bullying. https://truesport.org/bullying-prevention/stages-of-bullying/
                14. “Disruptive” doctors rattle nurses, increase safety risks. USA TODAY. Accessed August 3, 2023. https://www.usatoday.com/story/news/2015/09/20/disruptive-doctors-rattle-nurses-increase-safety-risks/71706858/
                15. Bullying in the workplace. www.independentpharmacist.co.uk. Accessed August 3, 2023. https://www.independentpharmacist.co.uk/services/bullying-in-the-workplace
                16. Ariza-Montes A, Muniz N, Montero-Simó M, Araque-Padilla R. Workplace Bullying among Healthcare Workers. International Journal of Environmental Research and Public Health. 2013;10(8):3121-3139. doi:https://doi.org/10.3390/ijerph10083121
                17. Glenn R. Grantner, PharmD, BCPS Clinical Pharmacist Sacred Heart Hospital Pensacola. Pharmacist Burnout and Stress. www.uspharmacist.com. Published May 15, 2020. https://www.uspharmacist.com/article/pharmacist-burnout-and-stress
                18. Medscape: Medscape Access. Medscape.com. Published 2023. Accessed August 9, 2023. https://www.medscape.com/slideshow/2022-physicians-misbehaving-6015583?icd=login_success_email_match_norm#13
                19. Staff B. Customer Harassment, Bullying Affecting Pharmacists’ Ability to Do Their Jobs. www.uspharmacist.com. https://www.uspharmacist.com/article/customer-harassment-bullying-affecting-pharmacists-ability-to-do-their-jobs
                20. Lamia M. The psychology of a workplace bully. the Guardian. Published March 28, 2017. https://www.theguardian.com/careers/2017/mar/28/the-psychology-of-a-workplace-bully
                21. Smith PK. Commentary III: Bullying in Life‐Span Perspective: What Can Studies of School Bullying and Workplace Bullying Learn from Each Other? J Community Appl Soc Psychol. 1997;7:249-255.
                22. Vramjes I, Elst TV. Griep Y, De Witte H, Baillen E. What Goes Around Comes Around: How Perpetrators of Workplace Bullying Become Targets Themselves. Group Organ Manag. 2023;48(4):1135-1172.
                23. Bullying and harassment. Pharmacist Support. Accessed August 3, 2023. https://pharmacistsupport.org/i-need-help-managing-my/work-life/bullyin-fact-sheet/
                24. Harassment | U.S. Equal Employment Opportunity Commission. www.eeoc.gov. https://www.eeoc.gov/harassment#:~:text=Harassment%20becomes%20unlawful%20where%201
                25. Anti-Harassment Policy Requirements By State. getimpactly.com. Accessed August 9, 2023. https://www.getimpactly.com/resources/anti-harassment-policy-requirements-by-state
                26. United States Department of Labor. The Whistleblower Protection Programs | Whistleblower Protection Program. Whistleblowers.gov. Published 2019. https://www.whistleblowers.gov/
                27. Koelmeyer S. An elbow in the waist: What is and isn’t bullying in the workplace. SmartCompany. Published May 20, 2019. Accessed August 3, 2023. https://www.smartcompany.com.au/business-advice/legal/bullying-workplace/
                28. Harassment Training Requirements by State. Project WHEN (Workplace Harassment Ends Now). Accessed August 4, 2023.
                29. Building positive workplace relationships. Pharmacist Support. https://pharmacistsupport.org/i-need-help-managing-my/work-life/building-positive-workplace-relationships/

                Accommodating Disabilities in Experiential Education: Easier Than it Seems, Full of Reward

                Learning Objectives

                 

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

                • DEFINE types of learning disabilities that preceptors are likely to encounter
                • LIST the information the school of pharmacy should provide to preceptors
                • IDENTIFY accommodation that are appropriate for specific students
                • DESCRIBE reasonable accommodation in experiential education

                  Education for disabled children. Handicapped kid on wheelchair in kindergarten. Equal opportunities, preschool program, special needs. Vector isolated concept metaphor illustration

                   

                  Release Date: December 10, 2023

                  Expiration Date: December 10, 2026

                  Course Fee

                  Pharmacists: $5

                  UConn Faculty & Adjuncts:  FREE

                  There is no grant funding for this CE activity

                  ACPE UANs

                  Pharmacist: 0009-0000-23-059-H04-P

                  Session Code

                  Pharmacist:  23PC59-ACA37

                  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 0009-0000-23-059-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

                  Neha Patel
                  2025 PharmD Candidate
                  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.

                  Jeannette Wick, Neha Patel, and Jennifer Luciano do not have any relationships with ineligible companies

                   

                  ABSTRACT

                  From time to time, preceptors need to address the needs of students who have disabilities, be they visible or invisible. Students’ disabilities may include chronic diseases, physical limitations, or difficulty with processing information. This continuing education activity introduces various types of disabilities that preceptors may encounter and suggests a stepwise process to develop accommodation plans. It discusses information that preceptors will need or want to have on hand, and potential sources to obtain the information. It also describes the various stakeholders and the accommodation process and the potential benefits for the entire workplace.

                  CONTENT

                  Content

                  INTRODUCTION

                  Some pharmacy students have visible or invisible disabilities that require accommodation (a change or adaptation to adjust a situation to meet the student’s unique needs). Anecdotally, faculty at the University of Connecticut School of Pharmacy report that between 5% and 12% of students in a typical class in the last 10 years need accommodation. In terms of physical disabilities, institutions of higher learning have almost always built or altered existing buildings to accommodate students with disabilities with ramps, elevators, wide doors, and similar structural changes. Preceptors who work in larger organizations may have support teams that address or have already addressed physical disabilities. Those who work in smaller organizations or older buildings may be intimidated by the need to accommodate but will find that the law requires “reasonable” accommodation.

                   

                  Pharmacy preceptors are more likely to encounter students who have chronic disease (e.g., asthma, autoimmune syndromes, diabetes, etc.) or learning disabilities, including those who are neurodivergent (the SIDEBAR explains the concept of neurodiversity). While taking classes, pharmacy schools often (and are legally required to) provide accommodation for students with learning disabilities (see Table 1). They may provide double time or access to a quiet room during exams, permission to take breaks during class, or notetakers to help them depending on the disability type. Students with learning disabilities acquire, organize, retain, comprehend, or use verbal or nonverbal information differently than others. They have impaired perception, thinking, remembering, or learning processes.1

                  Table 1. Types of Learning Disabilities1-7

                   

                  Learning disability Description
                  Anxiety disorder Anxiety that does not go away and can worsen over time. Symptoms can interfere with daily activities such as job performance, schoolwork, and relationships. Subtypes of anxiety disorders include generalized anxiety disorder, panic disorder, social anxiety disorder, and various phobia-related disorders.
                  Attention deficit hyperactivity disorder Causes an ongoing pattern of inattention and/or hyperactivity that interferes with functioning and/or development.
                  • Inattention may manifest as difficulty staying on task, sustaining focus, and staying organized; these problems are not due to insubordination or lack of comprehension.
                  • Hyperactivity manifests as involuntary constant movement, even when it is inappropriate, or excessive fidgeting, tapping, or talking. Adults with ADHD are often extremely restless or talkative.
                  • Impulsivity is acting without thinking or difficulty with self-control. It may include a desire for immediate reward or inability to delay gratification. It may manifest as interrupting others or making key decisions while ignoring long-term consequences.
                  Autism spectrum disorder (ASD) A neurologic and developmental disorder that affects how people interact with others, communicate, learn, and behave. Autism is known as a “spectrum” disorder because its wide variation in presentation and symptom severity.

                  People with ASD often have:

                  ·       Difficulty with communication and interaction with other people

                  ·       Restricted interests and repetitive behaviors

                  ·       Symptoms that affect their ability to function in school, work, and other areas of life

                  Dysgraphia A neurological disorder characterized by writing disabilities that appear as distorted or incorrect writing (inappropriately sized and spaced letters, or wrong or misspelled words despite focused instruction).
                  Dyscalculia Causes consistent failure to achieve in mathematics marked by difficulties with counting, working memory, visualization; visuospatial, directional, and sequential perception and processing; retrieval of learned facts and procedures; quantitative reasoning speed; motor sequencing; perception of time; and the accurate interpretation and representation of numbers when reading, copying, writing, reasoning, speaking, and recalling.
                  Dyslexia Impairs a person’s ability to read. Although varies by individual, common characteristics include difficulty with
                  • Phonological processing (the manipulation of sounds)
                  • Rapid visual-verbal responding
                  • Spelling

                   

                  SIDEBAR: Emerging Terminology and Necessary Understanding: Neurodiversity8-11

                   

                  Neurodiversity refers to the diversity of all people, but is often used in the context of autism spectrum disorder (ASD), neurological or developmental conditions, and learning disabilities. It is neither a medical term nor a diagnosis; it’s a descriptor used to replace the tendency to think of behaviors as normal or abnormal or to marginalize certain people based on their behaviors. When thinking about neurodiversity, it’s critical to remember that there is no one right way of thinking, learning, and behaving, and all differences are not necessarily deficits. Neurodiversity is not preventable, treatable, or curable. It’s the result of normal variation in the human genome. The term is used to promote equity and social justice for people who are members of a neurologic minority.

                   

                  Students who are neurodivergent experience and interact with the world around them in many different ways. Common characteristics among students who are neurodivergent include eye contact, facial expressions, and body language that are different than many other people’s.

                   

                  Students may or may not disclose (or even know) they are neurodivergent. When students do, it is important for preceptors to acknowledge neurodiversity and ask directly about a person’s preferred communication style and accommodations, many of which are described in the text of this continuing education activity. Many of the accommodations for people who are neurodiverse also help other students and employees who do not fall into neurologic minority categories, including

                  • Offering or allowing individuals to make small adjustments to the workspace
                  • Avoiding sarcasm, idioms, euphemisms, and implications
                  • Providing concise instructions
                  • Posting information about due dates and meetings as far in advance as possible
                  • Treating all people with respect

                   

                  Preceptors should foster environments that are conductive to neurodiversity, and to recognize and emphasize each person’s individual strengths and talents while also providing support for their differences and needs. It’s also helpful to know that many large companies are now adjusting their hiring processes to attract people who are neurodivergent. They’ve found that although some people have trouble navigating the hiring process, their unique abilities are valuable, increase the company’s productivity, and often lead to remarkable product and process improvements.

                   

                   

                  This continuing education activity is designed to help preceptors who encounter pharmacy students with disabilities develop workable plans. Preceptors should start by acknowledging a critical fact: accommodation isn’t special treatment. Accommodation levels the playing field so student pharmacists (and employees) can learn and do their best work.

                   

                   

                  PAUSE AND PONDER: You’re a preceptor for your state university. In April, the experiential education office notifies that you have one student per month from June through April. Shortly after, a staff member from the experiential education office calls and tells you that the student scheduled for August needs accommodation. What should you expect going forward, and what is the best time to plan?

                   

                  Providing Reasonable Accommodation

                  Institutions of higher learning usually have entire departments that develop policies, document the student’s type and degree of disability, and develop student-specific accommodation plans. When students who have disabilities go on clinical rotations, rotation sites may have no processes or policies to provide the same accommodation. Preceptors may not know how to cater to their needs. Often, practice sites need only to make minor adjustments to their environments, policies, and procedures. Once the organization makes the changes, the policies will be ready for future students! A PRO TIP is that an astute student who has disabilities may be willing to help edit and adjust policies; this insight can be valuable. However, the student may not want to help as this can be an added burden that other students don’t have.

                   

                  Five basic principles help schools ensure that clinical rotation sites provide reasonable accommodation for students on clinical rotations1,11,12:

                   

                  • Before going on rotation, it is critical for the school to document the student’s disability with a reliable diagnosis. The school’s department for students with disabilities usually does this.
                  • All parties will need to work together to identify elements of the student’s disability that would cloud the preceptor’s ability to assess the student’s competence. Any accommodation should mitigate those elements.
                  • Preceptors should work with the school to develop accommodation tailored to the specific rotation site and tasks to be accomplished at that site.
                  • Three hundred sixty-degree communication is essential. Preceptors, students, school and rotation site administration, and disability service staff must collaborate and communicate.
                  • Throughout the whole process, all parties must protect the student’s privacy.

                   

                  Students with disabilities are subject to a great deal of stigma not only from the outside world but also from preceptors. Ideally, schools should match these students with rotation sites and preceptors with prior experience accommodating students with disabilities.13 However, this may not always be possible. In ideal situations, preceptors are sympathetic and the relationship between the student and preceptor is open, non-judgmental, friendly, and relaxed. These characteristics set the stage for students to disclose their learning needs without fear of discrimination.14

                   

                  The school, however, must identify sites and preceptors based on the student’s accommodation needs without disclosing student-specific accommodation descriptions. Open and honest communication between students, the experiential education team, and representative(s) of the school’s disabilities office before they develop the rotation schedule can prevent problems later.13 Once the school confirms the student’s sites, it can share very basic student-specific details with the preceptor but only the student can share specific health information.1 In other words, the school can communicate the accommodation the student needs, but not the underlying diagnosis; that is private and only the student may disclose it.

                   

                  A challenge for students with physical disabilities is needing accommodation through multiple sites, which requires significant coordination and planning. A solution is providing multiple rotations at a single site where accommodation is available. When this solution is available, students can acclimate once.13 This can provide the best possible experience for the student, providing a level of comfort in the environment; conversely, this solution may force disabled students to stay at one site while their peers rotate from site to site and experience different healthcare teams. In institutions without pre-existing policies, schools would benefit by working with preceptors and the sites to develop guidelines for accommodating students. For students with physical disabilities, guidelines should address different types of mobility devices, physical dimensions of hospital facilities, safety requirements of the pharmacies, and access to particular areas.13 The preceptor should do this before the student begins working at the site. It would be unfortunate if a student arrived at a site only to find it was inaccessible.

                   

                  Step-by-Step to Accommodation

                  Using a stepwise approach on site helps preceptors ensure that they provide reasonable accommodation to students.

                   

                  1. Raising awareness among the clinical team regarding disabilities, accommodation, and inclusive learning environments is a prudent first step. The team is able to do this by reviewing the literature, laws, and regulations. The Americans with Disabilities Act (ADA) Titles I, II, and III and the Rehabilitation Act (see Table 2) are the constellation of laws that prohibit discrimination and govern accommodation in pharmacy experiential education.15 Individual states may also have additional laws that protect disabled students.

                   

                  Table 2. Federal Laws and Regulations that Protect Students with Disabilties15

                  Law/regulation Description
                  Americans with Disabilities Act (ADA)
                  Title 1: Employment ·       Prohibits discrimination in recruitment, hiring, promotions, training, pay, social activities, and other privileges of employment.

                  ·       Restricts questions that can be asked about an applicant’s disability before a job offer is made

                  ·       Requires that employers make reasonable accommodation for known physical or mental limitations of otherwise qualified individuals with disabilities, unless it results in undue hardship.

                   

                  Title II: Public sector ·       Requires state and local governments to give people with disabilities an equal opportunity to benefit from their programs, services, and activities

                  ·       Requires reasonable modifications to policies, practices, and procedures where necessary to avoid discrimination, unless doing so would fundamentally alter the nature of their service

                  ·       Does not require actions that would result in undue financial and administrative burdens

                  ·       Indicates governmental agencies must communicate effectively

                  Title III: Private sector ·       Explains public accommodation in businesses and nonprofits must not discriminate, exclude, segregate, or provide unequal treatment

                  ·       Requires businesses and nonprofits to make  reasonable modifications to polices, practices and procedures and communicate effectively with people with hearing, vision, or speech disabilities

                  ·       Requires employers to remove barriers and meet other access requirements.

                  Rehabilitation Act of 1973
                  Section 504 Prohibits programs or activities that receive federal funding from discriminating against disabled people.

                   

                  One area that all employers and employees need to understand is that accommodation can include variations on the workspace or equipment needed to complete various tasks, how work is assigned and communicated, the specific tasks, and the time and place that the work is done.16

                   

                  1. Establishing essential learning activities and outcomes for students helps all students, not just those with learning or physical disabilities. This means specifying essential functions, minimum competencies, expectations, and procedures that all students must be able to perform by the end of the rotation.15 Preceptors should note that accommodating a student’s needs does not mean lowering expectations.1 A PRO TIP here is that sometimes a student can meet the expectation with only small changes in the preceptor’s style. For students who have information processing issues, asking questions and then pausing for five seconds to allow the student to answer is better than rapid fire questions.1 (This is actually an approach that all preceptors and teachers need to use more in all situations. Pausing benefits everyone, including people who are not native English speakers.)

                   

                  1. The rotation site should make reasonable accommodation based on a reliable diagnosis that the student has documented via the school’s office of student disabilities. The pharmacy school’s office will also provide documentation of the requested accommodation to preceptors; students who have disabilities should not make the requests to preceptors on their own; they may, however, provide the accommodation letter and any information they want to share with the preceptor and copy the school’s director of experiential education if that is the school’s policy. One area that can be difficult for preceptors is the student’s healthcare appointments.1 A PRO TIP is to ask the student at the beginning of the rotation if you need to be aware of any scheduled appointments. Preceptors should also be very clear that the student must notify them of unanticipated appointments as soon as possible (or even before they call to schedule the appointment). If students miss time at rotations, they are responsible for making up the time.

                   

                  Documenting and discussing reasonable accommodation with the individual student who has a disability may be an uncomfortable or unfamiliar task for preceptors but will avoid problems later. Preceptors should meet with students to discuss exactly what they need in relation to their experiential outcomes (using the aforementioned list of specifying essential functions, minimum competencies, expectations, and procedures), asking questions such as1,15

                  • What limitations do you anticipate experiencing on the rotation?
                  • What tasks will you find problematic?
                  • What have you done in the past to reduce or eliminate these limitations?
                  • Do you anticipate needing us to make any modifications while you are here?
                  • What will you do if you encounter an unanticipated obstacle?

                   

                  Here’s another PRO TIP: Knowing a few ways to accommodate disabilities will help preceptors help the student. For example, a student who has severe anxiety will find many rotations difficult and threatening. A preceptor can suggest that the student observe or “preview” activities before requiring interaction, especially if the site is fast-paced or chaotic. Allowing the student to arrive early may also help. Students who are challenged organizationally may benefit from one (not multiple) outline of what to expect every day.1

                   

                  1. The student should self-assess and document how the disability affects each general competency and how accommodation could mitigate each concern.1 Figure 1 describes the process of preceptors choosing accommodation.

                   

                   

                   

                  The preceptor and student should develop an accommodation plan together and document it in writing. An ideal plan would list the intervention or accommodation and how it supports the student, those involved in creating the accommodation, and the parties responsible for any financial costs (discussed below). 11 For example, in a pharmacy setting where a great deal of business is conducted over the phone using headphones, a student who has difficulty hearing may need a phone amplifier. If the student wears hearing aids, headphones may interfere with her ability to hear. The plan should also include specific days/times for periodic check-ins so the student and preceptor can assess whether the intervention/accommodation meets the students’ needs and is still reasonable for the site.11

                   

                  A PRO TIP for preceptors is to stay abreast of technology changes.16 If students have difficulty reading or writing—these are students with dyslexia or dysgraphia—many programs now have read-aloud or voice-to-text programs that are remarkably accurate. Some calculators will talk. Encourage students to use them. Asking students to listen to their work using a read-aloud program will also help them catch errors.

                   

                  PAUSE AND PONDER: You meet with your new APPE student and learn that he has serious visual impairment. He indicates he needs to use assistive devices (supplemental lighting, a magnifier). How would you initiate a discussion about who will secure these devices?

                   

                  The last step, which overlaps with the previous steps to some extent, is providing reasonable accommodation. Readers may read the term “reasonable accommodation” and wonder what is considered reasonable. Accommodation should not pose an undue financial or administrative hardship to the practice site.15 The law would not consider an accommodation reasonable if it decreased quality or posed safety issues to patients or imposed undue financial or administrative burden on the institution. It would also be unreasonable to change curricular elements or alter course objectives substantially. Preceptors might reach out to the school’s experiential education office who can contact the university’s legal department to determine whether a specific accommodation is reasonable. Or, preceptors can contact their own legal representatives. Preceptors and students need to communicate openly and honestly to determine reasonable accommodation together. Table 3 describes some examples of reasonable accommodation.

                   

                  Table 3. Examples of Reasonable Accommodation in Clinical Experiential Learning8,15-17

                   

                  Student Limitation Accommodation
                  Anxiety ·       Embrace the learning experience and don’t be too hard on students when they make an error. Provide feedback and guidance for them to improve.

                  ·       Plan the days and weeks, setting achievable goals, and prioritizing tasks.

                  ·       Offer counseling services and other resources to support the student.

                  Concentration difficulties ·       Use organization techniques that help students manage time and stay on track.

                  ·       Ask students if using a highlighter to emphasize assignments that are priorities will help.

                  ·       Step away from busy workplaces to provide directions in a quieter location.

                  ·       Develop or have the student develop checklists for common tasks.

                  Distractibility ·       Provide or allow students to use their own noise-canceling headphones or give them a private room to work.

                  ·       Provide a quiet space away from noise and busy office traffic and a “Do Not Disturb” sign so students can work without interruption.

                  ·       Avoid allowing or encouraging multitasking. Have students complete one thing at a time.

                  Dyslexia ·       Encourage use of appropriate read-aloud and voice-to-text software.

                  ·       Explain and provide a list of common or site-specific acronyms and other jargon.

                  Neurodiversity ·       Sound sensitivity: offer a quiet break space, communicate expected loud noises (like fire drills), offer noise-canceling headphones.

                  ·       Tactile: allow modifications to the usual work uniform

                  ·       Movement: allow the use of fidget toys, allow extra movement breaks, offer flexible seating

                  ·       Use a clear communication style:

                  o   Avoid sarcasm, euphemisms, and implied messages.

                  o   Provide concise verbal and written instructions for tasks, and break tasks down into small steps.

                  ·       Inform people about workplace etiquette, and don’t assume someone is deliberately breaking the rules or being rude.

                  ·       Try to give advance notice if plans are changing and provide a reason for the change

                  ·       Don’t make assumptions – ask a person’s individual preferences, needs, and goals.

                  ·       Be kind, be patient

                  Poor organization ·       Set aside 15 minutes at the end of the day to plan the next day’s work.

                  ·       Have students and all employees return important shared items to the same place each time they use them.

                  ·       Consider a color-coding system for assignments or shelving.

                  ·       Keep things visible on shelves, bulletin boards, or other places; avoid storage in drawers or closets.

                  ·       Attach important objects physically to the place they belong.

                  Processing disorders ·       Provide both written and oral instructions.

                  ·       Follow-up important conversations with a brief e-mail

                  ·       Ask the student to make notes and provide them to you for review.

                  ·       Use the teach-back method; ask the student to repeat the information back so you can be sure you covered everything (and they heard the key messages)

                   

                  Emphasis on Planning Ahead

                   

                  Before rotations start, students with disabilities and preceptors should complete a practice walk-through at the rotation site to identify, modify, and make necessary adjustments.13 The experiential team must also understand the student’s career aspirations. Frank discussion will help all involved with rotation planning. The experiential team and the preceptor can address the students’ and preceptors’ concerns, needs, and goals in advance. Also, the person coordinating this process should identify and discuss costs and financial resources for the accommodation plan with all parties involved and determine who is responsible for the costs. This creates clear expectations. 13

                   

                  If during the check-in or at any time a situation changes, the plan needs revision to find a more acceptable or effective reasonable accommodation or an urgent concern arises, the student or the preceptor should contact the school immediately.13

                   

                  CONCLUSION

                  Preparing and executing accommodation can be challenging. Preceptors who develop skills in this area help student pharmacists develop communication, collaboration, and planning skills they will use and improve all during their careers. Preceptors also assess the actual barriers associated with the student’s disability in a controlled environment and help students learn how to mitigate the challenges associated with their disabilities in future employment. A PRO TIP is to keep in mind that many employees have disabilities or have slightly different learning styles. Learning how to accommodate them from students and schools of pharmacy will benefit your entire work force. It may even help you!

                   

                   

                   

                   

                  Pharmacist Post Test (for viewing only)

                  1. A student has been diagnosed with attention deficit hyperactivity disorder (ADHD), a type of learning disorder. Which of the following BEST describes ADHD?
                  A. A disorder characterized by writing disabilities that appear as distorted or incorrect writing
                  B. A disorder that affects how people interact with others, communicate, learn, and behave
                  C. A disorder that causes ongoing patterns of inattention and/or hyperactivity that interferes with functioning and/or development

                  2. You observe that a student has difficulties counting, putting documents in numerical order, and calculating doses when the order specifies a mg/kg dosing. What type of disability is this MOST LIKELY to be?
                  A. Dyslexia
                  B. Dyscalculia
                  C. Dysgraphia

                  3. Once the school confirms a student’s site, what information can the school share with the preceptor?
                  A. The required accommodation
                  B. The student’s diagnosis
                  C. The student’s health information

                  4. How can the school of pharmacy help students with disabilities to be comfortable and meet their needs at various clinical sites?
                  A. Informing the site that the student will be doing all their clinical rotations at that site
                  B. Providing policies and student-specific accommodation plans that can be adjusted
                  C. Only using preceptors who have experience accommodating students with disabilities

                  5. Mary, a preceptor, is preparing for Elwin to start a rotation at her site. Elwin told the preceptor that he struggles with organization. They are identifying accommodation and exploring if they need to make any changes to the site. Which of the following is the most appropriate accommodation to keep the site organized for the student?
                  A. Color-code the shelving system in the pharmacy
                  B. Provide both written and oral instructions
                  C. Provide directions away from the workplace

                  6. A pharmacy student, Sarah, has attention deficit hyperactivity disorder (ADHD) and will be going on her clinical rotation. She has been in communication with the school and the preceptor about accommodation, indicating her key limitation is distractibility. Which of the following is the is the BEST accommodation the preceptor can provide?
                  A. Encourage use of appropriate read aloud and voice to text software
                  B. Plan the days and weeks, setting achievable goals, and prioritizing tasks.
                  C. Provide a quiet space away and a “Do Not Disturb” sign

                  7. Which of the following factors would a preceptor consider when providing a reasonable accommodation?
                  A. The accommodation’s feasibility and financial cost
                  B. The student’s academic grade point average
                  C. The student’s specific diagnosis

                  8. Which answer correctly lists the steps when choosing an accommodation for a student?
                  A. Lower your expectations, assess whether the accommodation is meeting the student’s needs, analyze the required tasks
                  B. Maintain your expectations, analyze the required tasks, periodically assess whether the accommodation is meeting the student’s needs
                  C. Meet with the student, ask about the specific diagnosis of neurodiversity, develop a plan you think is suitable for the student

                  References

                  Full List of References

                  REFERENCES
                  1. Vos S, Kooyman C, Feudo D, et al. When Experiential Education Intersects with Learning Disabilities. Am J Pharm Educ. 2019;83(8):7468.
                  2. Anxiety Disorders. National Institutes of Mental Health. Accessed August 9, 2023. https://www.nimh.nih.gov/health/topics/anxiety-disorders
                  3. Autism Spectrum Disorder. National Institutes of Mental Health. Accessed August 14, 2023. https://www.nimh.nih.gov/health/topics/autism-spectrum-disorders-asd
                  4. Attention-Deficit/Hyperactivity Disorder. National Institute of Mental Health. Accessed August 5, 2023. https://www.nimh.nih.gov/health/topics/attention-deficit-hyperactivity-disorder-adhd
                  5. Dysgraphia. National Institutes of Neurological Disorders and Stroke. Accessed August 5, 2023. https://www.ninds.nih.gov/health-information/disorders/dysgraphia
                  6. Dyscalculia. Dycalculia.org. Accessed August 5, 2023. https://www.dyscalculia.org/
                  7. Dyslexia. National Institutes of Neurological Disorders and Stroke. Accessed August 5, 2023. https://www.ninds.nih.gov/health-information/disorders/dyslexia
                  8. Baumer N. What is Neurodiversity? Accessed August 14, 2023. https://www.health.harvard.edu/blog/what-is-neurodiversity-202111232645
                  9. Neurodivergent. The Cleveland Clinic. Accessed August 15, 2023. https://my.clevelandclinic.org/health/symptoms/23154-neurodivergent
                  10. Austin RD, Pisano GP. Neurodiversity as a Competitive Advantage. Harvard Business Review. May-June 2017. Accessed August 15, 2023. https://hbr.org/2017/05/neurodiversity-as-a-competitive-advantage
                  11. Elliott HW, Arnold EM, Brenes GA, et al. Attention deficit hyperactivity disorder accommodations for psychiatry residents. Acad Psychiatry. 2007;31(4):290-296.
                  12. Shrewsbury D. Dyslexia in general practice education considerations for recognition and support. Educ Prim Care. 2016;27(4):267-270.
                  13. Kieser M, Feudo D, Legg J, et al. Accommodating Pharmacy Students with Physical Disabilities During the Experiential Learning Curricula. Amer J Pharm Ed. Published online April 2, 2021:8426.
                  14. L’Ecuyer KM. Clinical education of nursing students with learning difficulties: An integrative review (part 1). Nurse Educ Pract. 2019;34:173-184.
                  15. Vos SS, Sandler LA, Chavez R. Help! Accommodating learners with disabilities during practice‐based activities. 2021;4(6):730-737.
                  16. Job Accommodation Ideas for People with Learning Disabilities. Learning Disabilities Association of American. Accessed August 5, 2023. https://ldaamerica.org/info/job-accommodation-ideas-for-people-with-learning-disabilities/
                  17. Horesh A. Conquer Anxiety in Clinical Rotations: A Guide for Medical Students. Accessed August 9, 2023. https://futuredoctor.ai/anxiety-in-clinical-rotations/

                  Patient Safety: Workplace Bullying

                  Learning Objectives

                   

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

                  1. Define workplace bullying in the healthcare setting
                  1. Explain the impact of workplace bullying on individuals, organizations, and patient care
                  1. Differentiate workplace bullying from harassment and workplace dysfunction
                  1. Describe the necessary steps to address and counteract workplace bullying

                    Individuals talking to each other behind another individual's back

                     

                    Release Date: November 20, 2023

                    Expiration Date: November 20, 2026

                    Course Fee

                    Pharmacists: $7

                    FREE FOR UConn Preceptors

                    Pharmacy Technicians: $4

                    There is no funding for this CE.

                    ACPE UANs

                    Pharmacist: 0009-0000-23-058-H05-P

                    Pharmacy Technician:  0009-0000-23-058-H05-T

                    Session Codes

                    Pharmacist:  23YC58-ABC28

                    Pharmacy Technician: 23YC58-BCA49

                    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 0009-0000-23-058-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

                    Giovanni Fretes, PharmD Candidate 2025
                    UConn School of Pharmacy
                    Storrs, CT

                                                       

                    Jeannette Y. Wick, RPh, MBA, FASCP
                    Director OPPD, 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.

                    Giovanni Fretes and Jeannette Wick have no relationships with ineligible companies.

                     

                    ABSTRACT

                    Several healthcare professional organizations have identified workplace bullying as a problem. Workplace bullying can decrease morale, but additionally, it can also compromise patient safety. Some studies have found that physicians tend to be identified most often as workplace bullies, but additional studies indicate that bullying in pharmacy is present and under reported. The most likely type of workplace bullying in pharmacy is verbal bullying, which includes mocking, name-calling, teasing, or intimidating a target. In some instances, physical or nonverbal bullying may occur. Unaddressed bullying can lead to diminished morale, strained employee relations, loss of respect for management, and increased absenteeism or tarnished reputation of the workplace. Establishing a reasonable definition of bullying, differentiating it from harassment, and training employees in bystander intervention can help improve the workplace and decrease the likelihood of damage from bullying.

                    CONTENT

                    Content

                    INTRODUCTION

                    Bullying is a popular topic these days. Hardly a day goes by without a story in the media about school bullies, social media bullies, celebrity bullies, political bullies, and even chef bullies. In addition, lawsuits have found people and organizations liable for suicides when they bullied the victim (called the target) or failed to address bullying.1 And many times, serial killers or individuals who conduct mass shootings are later identified as having been bullied. Clearly, the United States (U.S.) has a bullying problem. Does healthcare and, on a smaller scale, pharmacy, have a bullying problem?

                    This continuing education activity discusses bullying in the workplace because healthcare and on a smaller scale, pharmacy, do have bullying problems and students sometimes experience bullying as they are introduced to the profession on rotations or in residencies. Unlike harassment, bullying isn’t illegal in the U.S., but it has serious repercussions to individuals and organizations. Recognizing and addressing workplace bullying is essential to foster healthy and supportive work environments in healthcare settings, ultimately benefiting both staff and patients. Although the authors drafted this activity to address the bullying that students sometimes experience in experiential rotations, during extensive peer review, reviewers indicated this topic is of interest to all pharmacy personnel, not just preceptors.

                    Mock, Taunt, Intimidate

                    Workplace bullying is a widespread issue that affects various industries, including pharmacies and other healthcare settings. Most of the data in healthcare comes from studies of physicians’ interactions with other disciplines, and the American Medical Association (AMA) recognizes the problem. AMA defines workplace bullying as “repeated, emotionally or physically abusive, disrespectful, disruptive, inappropriate, insulting, intimidating or threatening behavior targeted at a specific individual.”2 Bullying’s purpose is to control, embarrass, undermine, threaten, or cause harm toward an individual. Various factors at the individual, organizational, and health system level can contribute to creation of an unprofessional workplace climate or culture.2

                    Workplace bullying is important to address because it can impact patient care, resulting in preventable mistakes. In a 2021 survey, roughly 35% of healthcare providers had concerns about medication orders but chose to assume correctness to avoid engaging with specific providers. One pharmacist was shamed by a colleague after seeking an independent double check for a vancomycin order with incorrect timing. Multiple errors like this occur annually because of the culture of shaming.3 Some data about how bullying affects the medication prescribing and administration process demonstrates this subject’s importance.

                    Every few years, the Institute for Safe Medication Practices (ISMP) surveys healthcare professionals about disrespectful behaviors and intimidation in the workplace.4,5 ISMP conducted its most recent survey in September 2021.3 Among the 1,047 respondents, 26% worked in the pharmacy, suggesting that bullying is a problem in pharmacies since a disproportionate number of pharmacy employees responded compared to more populous health care providers like physicians and nurses. A full 37% of respondents were pharmacists and 6% were pharmacy technicians.3

                    Disrespectful behaviors were clearly linked to medication concerns3:

                    • 40% of respondents said past disrespectful behaviors had altered the way they handled order clarifications or questions about medication orders.
                    • Roughly half of respondents said that they had relied on colleagues to interpret or validate an order rather than contact the prescriber in the past year; the reason was to avoid contact with the disrespectful prescriber.
                    • 11% of respondents indicated they avoided talking to a prescriber to interpret or validate an order’s safety more than ten times in the previous year.
                    • 7% said that they had been pressured to accept an order, dispense a product, or administer a drug despite safety
                    • Slightly more than one-third reported having concerns about a medication order but assumed it was correct rather than interact with a specific prescriber; roughly the same number of respondents said that a prescriber’s stellar clinical reputation often made them reluctant to question or clarify orders even if they had concerns.

                    TYPES OF WORKPLACE BULLYING IN HEALTHCARE

                    In the limited research that addresses workplace bullying in pharmacies and other health care settings, researchers frequently bemoan the fact that, the AMA’s definition aside, we have no consensus definition of bullying. It would be ideal if we could provide a concise definition of bullying or a checklist that would help managers, supervisors, coworkers, and preceptors ascertain when bullying is occurring. In fact, bullying occurs in many different forms.

                     

                    Verbal Bullying

                    Verbal bullying encompasses various forms of harmful language and communication. Examples of verbal bullying include mocking, name-calling, teasing, or intimidating someone to belittle or demean them. Insults and derogatory comments can degrade a person's self-esteem, creating a hostile working environment. Fans of the television show NCIS may recall that the section supervisor, Leroy Jethro Gibbs, always dubbed the newest hire “Probie,” which appears to have been short for probationary employee. People watching this show who are familiar with human resources regulations often shuddered when Gibbs did this, as it could be perceived as a form of bullying. Especially in government organization where the rules are very clear, such behavior would be dangerous. In pharmacies, calling people by unwelcome nicknames could be perceived as bullying.

                    Public humiliation is another form of verbal bullying that aims to embarrass the person who is being bullied in front of others. Trainees commonly report persistent attempts from their preceptors or trainers to humiliate them in front of colleagues. According to a study, “The abuse of students is ingrained in medical education and has shown little amelioration despite numerous publications and righteous declarations by the academic community over the past decade.”6

                    PAUSE AND PONDER: A preceptor asked a student a question in front of the rounding team. The student, who was unable to answer, blushed and stuttered. The preceptor said, “What school of pharmacy did you go to again? I need to call them and ask them what they're teaching because you clearly should have known the answer to this question.” The student reddened even more, and the preceptor said, “Oh! So, you're a blusher are you?” Was this teasing, was this misplaced humor, or was it bullying?

                    The term bullying does not appear in the Accreditation Council for Pharmacy Education (ACPE) standards. Researchers reviewed the professional literature and American Association of Colleges of Pharmacy (AACP) survey data collected from student evaluations of preceptors (N = 2087); students provided low evaluations for preceptors in at least one area in 119 evaluations.6 When the researchers scanned the comments for words or phrases closely associated with bullying, they found respondents reported 34 instances indicating bullying. Figure 1 shows the distribution of comments and includes examples of troublesome comments.6

                    Comments related to workplace bullying involve offensive behavior, humiliation, intimidation, exclusion or denial to opportunities, and excessive criticisms.

                    Figure 1. Comments Related to Bullying from Pharmacy Survey Data6

                    This data came from one college of pharmacy, but the researchers compared their data to that of a national study.6 It was similar. Although the rates of bullying seemed low, the researchers believed that bullying is seriously underreported in pharmacy. Some reasons may include the small number of pharmacists compared to physicians and nurses, the use of assessment tools that are not intended to identify bullying (asking the wrong questions), and students’ reluctance to complain because it may be perceived as unprofessional. Students may also be afraid that reporting bullying may affect their grades. The researchers recommend ACPE place more emphasis on bullying and develop of a consensus definition.6

                    Intimidation and threats instill fear and anxiety, leaving the target feeling vulnerable and powerless. Intimidating behaviors in the healthcare workplace are far from isolated incidents. A survey conducted with more than 2,000 healthcare providers revealed that subtle, yet effective forms of intimidation were more common than explicit forms.4 Respondents reported encountering behaviors such as condescending language, impatience with questions, and reluctance to answer or return calls. Physicians and prescribers were identified as the primary perpetrators of intimidation, exhibiting behaviors such as condescension, reluctance to answer questions, and verbal abuse more frequently than other healthcare providers.4

                    Additionally, destructive criticism is another unjustified way in which someone can wear down the target emotionally and psychologically. Constructive criticism and destructive criticism differ based on their delivery and the ways in which they impact individuals and their work.7 Constructive criticism uplifts people by providing suggestions and potential solutions while highlighting both positive aspects of someone's work and identifying areas for improvement. Destructive criticism undermines confidence, belittles efforts, and focuses on ridicule, leading to decreased morale and performance. It creates a hostile atmosphere and restrains productivity.7

                    Constructive feedback begins and ends with positive comments and present information in a supportive way, as this “compliment sandwich” exemplifies:

                    “Jacob, I appreciate your dedication and commitment to our pharmacy team. However, I've observed a higher number of medication errors when you’re dispensing prescriptions, which is unusual based on your work history. I know how dedicated you are to the team, so if you're facing any challenges that may be impacting your performance, please don't hesitate to reach out to me or any team member. We are here to support you and provide the best patient care possible."

                    Destructive feedback is replete with negativity:

                    "Jacob, your work recently in the pharmacy has been extremely disappointing. Why are you making so many mistakes? It's causing a lot of problems for the team, and frankly, I don't have the time or patience to fix everything for you. You really need to step up and improve your performance because it's negatively impacting our overall productivity."

                    It’s not always possible to use a compliment sandwich when addressing issues in the pharmacy. It is always possible to be kind.

                    Verbal bullying is usually easy to spot if the bully conducts the browbeating in public. In one pharmacy, a seasoned technician seemed to have a bias against students who were accruing IPPE or APPE hours. She would frequently tell students loudly, “If you can’t work any faster, it would be lovely if you would just get out of the way.” Her colleagues would turn a blind eye, but the section supervisor eventually took action and referred her to employee assistance. However, many bullies are adept at mounting their campaigns of terror when no one is looking. (Remember that the most likely place for bullying is schools is in the most difficult place to supervise: the playground.8)

                     

                    Non-Verbal Bullying

                    Non-verbal bullying in healthcare manifests through actions that undermine and harm the target without using explicit words.9 Bullies use exclusion and social isolation to insulate targets from their colleagues, fostering a sense of loneliness and alienation. Undermining and sabotage minimize the target's work and efforts, eliminating a culture of safety.9

                     

                    PAUSE AND PONDER: A preceptor assigned one pharmacy student to sort and file a large backload of paperwork. She also assigned a technician to explain what needed to be done and how. The technician was frustrated by the student’s questions, but two hours later, the student finished sorting. He asked the technician to check his work before he filed it. The technician riffled through the pile, said, “This is correct,” and then said, “Oops!” and intentionally dropped the entire pile on the floor. Was that bullying?

                     

                    Ignoring and dismissing ideas invalidates targets’ contributions and suggestions which diminishes their confidence and ability to perform well.10 Additionally, intentionally withholding information deprives targets of essential knowledge needed to perform their assigned tasks effectively.9 Individuals who use “the silent treatment” (refusing to engage in discussion and making no eye contact) are also bullies. Researchers have found that people in positions of power who use the silent treatment also frequently assign unreasonable or unnecessary tasks.11

                     

                    Finally, bullies may also use noise in subtle ways to intimidate or disturb targets. In one situation, students were assigned to work in an office across from a pharmacist who did not like to precept but did so because he was assigned the task. He kept his door closed most of the time but would slam it hard when coming and going. He’d watch to see if the students reacted.

                     

                    Physical Bullying

                    While less common in healthcare, physical bullying involves direct aggression towards the target.12 This can include pushing or shoving, which poses a threat to the target’s safety and well-being. Damaging personal belongings is another form of physical bullying, violating the target's personal space and property. Also forcing physical exertion on the target, such as excessive workloads or tasks beyond their capacity, can cause physical harm and exhaustion.12

                    Healthcare workers are already at risk for physical violence, and four times more likely to experience violence requiring an absence from work than people employed in other industries.12 According to 2013 Bureau of Labor Statistics (BLS) data, 80% of serious violent incidents were a result of interactions with patients. The remaining incidents were attributed to visitors, coworkers, or individuals outside of the healthcare facility with 3% of the incidents from coworkers.12

                    BLS found one fact of particular note: Employees were significantly less likely to report bullying and other forms of verbal abuse. They cited three contributing reasons: (1) lack of a reporting policy, (2) lack of faith in the reporting system, and (3) fear of retaliation, which is discussed below.12 Although healthcare workers appear to be more likely to be bullied by patients than coworkers, concerns about reporting flaws and retaliation may skew the data.12

                    SIGNS AND EFFECTS OF BULLYING

                    Absent a clear definition, healthcare managers and workers may struggle to identify bullying or differentiate it from harassment. Signs may be obvious—as in the example of the technician who tells students to get out of the way—or subtle.

                    Signs of Workplace Bullying

                    Recognizing the signs of workplace bullying is crucial for early intervention. Behavioral changes in targets, such as increased irritability, anxiety, or withdrawal, may indicate they are experiencing bullying.13

                    Effect on Workers and Patients

                    Workplace bullying has detrimental effects on both healthcare professionals and the quality of patient care.9 The emotional and psychological impact on targets can lead to heightened levels of stress, anxiety, and depression. This affects their well-being and their ability to provide optimal care to patients. Bullying can contribute to higher rates of medication errors, increased infections, and other negative patient outcomes. This is partly due to staff members' fear of speaking up against physicians or prescribers who are bullies.14 Physician Alan Rosenstein, an expert in disruptive behavior, highlights the existence of a "hidden code of silence" that keeps coworkers or colleagues from reporting or appropriately addressing many incidents.14

                    Rosenstein has collected anecdotes from his work. He doesn’t report any from situations involving pharmacists or technicians, some examples of disparaging remarks/actions may feel somewhat familiar to pharmacy workers who have had unfortunate interactions with prescribers14:

                    • During a tense operation, a surgeon insulted a male nurse, who had a special needs son, by saying, "You're a [r-word] just like your boy." The nurse filed a written complaint because of the insulting, disrespectful remark.
                    • At Vanderbilt University Medical Center in Nashville, a surgeon proceeded with an operation without washing his hands. Instead of openly addressing the issue, a nurse discreetly offered the surgeon gloves, but he simply discarded them into the trash.
                    • An OB/GYN patient was experiencing excruciating pain while the doctor sutured without providing sufficient anesthetic. When questioned by a medical student, the doctor made a joke saying that the patient could be given memory-erasing ketamine to forget about the experience.

                    It is essential for pharmacy owners to recognize the consequences of workplace bullying on their businesses. Table 1 lists negative consequences of unaddressed bullying and provides examples. Preceptors, supervisors, mentors, and organizations must address factors that promote bullying (like power imbalances, addressed below) and provide employees with support to maintain healthy, successful pharmacy settings.

                    Table 1. Negative Consequent of Unaddressed Bullying15

                    Consequences Examples
                    Diminished morale A seasoned pharmacy technician (whose pronouns = they/them), who has been working diligently for years, consistently faces belittling comments and criticism from the pharmacist. As a result, their overall enthusiasm for their work decreases, affecting their productivity and leading to a sense of resignation or disengagement. The rest of the staff will also feel disengaged and resigned.
                    Strained employee relations One pharmacist consistently questions another pharmacist’s decisions and recommendations in front of colleagues and patients leading to tension and hostility between them. This strained relationship might extend beyond work-related matters, making collaboration difficult and creating an uncomfortable atmosphere for other team members.
                    Loss of respect for management Employees witness a manager ignoring complaints, failing to provide a safe and supportive environment. The affected employees lose respect for the management team as they perceive the lack of intervention as a sign of management’s incompetence, leading to a diminished view of their leadership abilities.
                    Increased absenteeism/

                    tarnished reputation

                    Over time, employees are subjected to behaviors of bullying and begin to experience high levels of stress and anxiety due to the hostile environment. So, the employees start taking more sick days or even extended leaves of absence to cope with bullying’s emotional toll. The toxic work environment spreads through word of mouth among colleagues, potential hires, and even patients. The pharmacy’s reputation suffers as news of the toxic work environment and unaddressed bullying gets around.

                    Ultimately, workplace bullying may reduce everyone’s job satisfaction and productivity resulting from the negative work environment created by workplace bullying.16 Extensive studies have confirmed the association between workplace bullying and perceptions of organizational settings, including job satisfaction and commitment. Job dissatisfaction, which leads to emotional distress, can be regarded as a factor that influences employees’ commitment to their work.16

                     

                    CAUSES AND RISK FACTORS

                    To effectively address workplace bullying, preceptors—and all staff—need to understand the underlying causes and risk factors contributing to its occurrence in healthcare settings.

                     

                    Power Imbalances

                    Power imbalances can contribute to disruptive behavior in healthcare settings, leading to a range of negative consequences. (Yes, this means the bully might be the boss!8) While some may associate disruptive behavior with overt bullying and intimidation, the broader definition preferred by experts includes any actions that undermines safety culture.14

                    The issue of power imbalances in pharmacy is a growing concern, as evidenced by a 2015 report from the United Kingdom’s Advisory, Conciliation, and Arbitration Service (ACAS).15 Workplace bullying has been on the rise in the U.K., with a staggering 20,000 calls annually reporting bullying incidents to ACAS. Disturbingly, this problem extends to community pharmacies, where staff members face bullying from pharmacy owners, managers, supervisors, and colleagues.15 The level of labor stability also has a significant impact on vulnerability to bullying because lower-status employees often hold the most unstable and temporary jobs. An empirical study (a study that uses observation, measured phenomena, and participant’s experience rather than theory or belief) conducted among university employees in an academic center aimed to demonstrate that flexible working arrangements contribute to the prevalence of bullying.16 One reason for the increase in bullying within organizations is the restructuring processes and higher levels of outsourcing, which have widened the power gap between managers and employees.16

                    High Stress Levels and Demanding Work Environment

                    The demanding nature of healthcare work, coupled with high stress levels, can create an environment prone to workplace bullying.16 Healthcare professionals often face intense pressure, long working hours, and challenging situations that may increase tension and exacerbate conflicts. Stress can amplify negative behaviors and create a breeding ground for bullying. Bullying within a stressful environment can lead to burnout and cause talented, compassionate individuals to leave the healthcare profession.17,16

                     

                    Do pharmacy employees experience stress? In a recent survey, 61.2% of pharmacists reported experiencing significant burnout in their practices.17 This trend is prevalent among hospital pharmacists, with consistent rates across various practice settings and areas. The study reveals that those most affected by burnout were often unmarried, had no children, and worked extended hours, surpassing 40 hours per week. Pharmacists can be impacted by stress and burnout in all practice settings. Thus establishing support systems with family, friends, and coworkers is vital to enhancing morale and alleviating feelings of burnout.17

                     

                    High Expectations from Society

                    Healthcare professionals are entrusted with caring for the health and well-being of individuals, and society places high expectations on them. The pressure to meet these expectations, combined with limited resources and time constraints, can contribute to stressful work environments that may foster workplace bullying.18 Most healthcare workers feel like they are held to higher standards than the general public. This feeling is rooted in centuries of traditions and most medical organizations emphasize respect in personal interactions.18

                     

                    Healthcare workers also believe that the general public’s expectations of them outside the healthcare setting are set too high.12 The demanding and high-stress nature of healthcare work can make it challenging for professionals to enjoy their personal lives. The constant feeling of being at work and the fear that their actions could be scrutinized even during off-hours creates additional stress and anxiety. This work-life imbalance can have a significant impact on well-being and overall quality of life.18

                     

                    Lack of Policies and Procedures to Address Bullying

                    The absence of comprehensive policies and procedures specifically targeting workplace bullying in healthcare settings can perpetuate its occurrence.19 Without clear guidelines and protocols in place, both targets and bystanders may feel powerless and unsure of how to address and report bullying. Instances of bullying and verbal abuse are often under-reported for various reasons. As revealed by the 2022 National Pharmacy Workplace Survey by industry experts, the lack of robust policies and procedures to address bullying in the pharmacy profession is a pressing concern.19 The study highlights the absence of a formal mechanism for pharmacists and pharmacy personnel to discuss workplace issues with supervisors and management. This leads to an unwelcoming atmosphere, resulting in heightened stress and eventual burnout. Over 60% of respondents indicated that their employers did not actively seek their opinions, nor did employers respect or value employee input.19 Employers, insurers, lawmakers, and the public must come together to ensure ample resources, address patient safety concerns, and promote the well-being of pharmacy personnel.

                     

                    One topic also needs more attention: the bullying individual. The SIDEBAR provides information about people who tend to bully others.

                     

                    SIDEBAR: Some People are Simply Bullies20,8,21,22

                     

                    Bullies Unveiled: Bullies are individuals who employ intimidation and control tactics to further their own objectives. While they might appear cooperative when their goals align with the team’s or the employer’s, their methods are unfair and dishonest. In the workplace, bullies often target coworkers in lateral or lower responsibility positions, resorting to manipulation and terrorizing behaviors. They may even intimidate superiors, using tactics like threats of resignation during crises.

                     

                    The Hidden Shame: Some psychologists attribute bullying to ingrained shame, although others cite insecurities, disparate socioeconomic backgrounds, personality traits that make them outliers, and basic insecurities. Some theories indicate that targets of bullying are more likely to become bullies. Contrary to common belief, bullies don't necessarily suffer from low self-esteem. Instead, their behavior can stem from internalized shame. While some individuals who harbor shame may have low self-esteem, those who engage in bullying tend to have high self-esteem, and hubristic (overbearing or presumptuous) pride. Bullies may also be quite clever. Their attacks on others are defense mechanisms to alleviate their own feelings and ignore their real emotions.

                     

                    Shame's Impact on Coping: Early in life, people develop various responses to shame, which solidify into personality traits by adulthood. These coping mechanisms can be categorized by attacking others, self-attacking, avoidance, and withdrawal. For those who bully, the fear of shame, such as being perceived as inadequate at work, drives them to target others. Bullies exploit others' vulnerabilities—and especially others’ insecurities—and redirect their own shame onto their targets. The bully’s ultimate feeling is power.

                     

                    Narcissism and Withdrawal: Some bullies ultimately develop narcissistic traits, continually attacking others as a means to cope with deeply rooted shame. Conversely, targets are often sensitive individuals who respond to shame by self-blame. This response might maintain a connection with the bully and perpetuates a victim or target mentality. Withdrawal, another reaction to shame, involves concealing one's emotions and can lead to depression. Prolonged exposure to workplace bullying often triggers this response, proving just as harmful as self-attacking.

                     

                    Seeking Solutions: Bullying deflects a bully's shame and also provides a sense of power. However, many bullies remain unaware of their own inadequacies. The key to dealing with workplace bullies is solidarity among coworkers. Banding together against a bully offers support, as targets of bullying often face isolation and by confronting the bully's behavior collectively, coworkers can neutralize their power. Banding together does not mean ganging up on the bully. It means using the principles of bystander intervention (discussed below) and firmly calling out bullying when one sees it in a respectful but direct manner. Documenting repeated episodes of bullying is also critical.

                     

                    Readers should note, however, that when the bully’s target is someone that others tend to dislike or find little sympathy for, the team may not coalesce to support the target. Supervisors, managers, or observers who are leaders need to jump in and remind staff that bullying is unacceptable, and if the target leaves, who knows who will be next. Further, some research indicates that bullies may eventually become targets; backlash is not an ideal solution.

                     

                    A Path Forward: Ultimately, bullies can change their behavior by developing better coping mechanisms and learning to process their feelings constructively. Recognizing that bullies are driven by a response to shame or other factors, rather than consciously acknowledging it, is essential for devising effective strategies to address this issue. Supervisors and managers should refer employees with bullying tendencies to their employee assistance programs or similar programs.

                     

                    DIFFERENTIATING WORKPLACE BULLYING, HARASSMENT, AND DYSFUNCTION

                    To address workplace bullying effectively, healthcare workers and managers must differentiate it from harassment and dysfunction within the healthcare setting.

                     

                    Key Differences in Behaviors and Intent

                    While workplace bullying and harassment share similarities, such as the creation of a hostile work environment, they differ in terms of intent and behaviors. Again, bullying is often described as offensive, intimidating, malicious, or insulting behavior intended to undermine, humiliate, denigrate, or injure the recipient, and it may involve individuals or groups.23 It can take various forms, including spreading rumors, excluding someone, giving unachievable tasks, and more.

                     

                    Harassment, as defined by U.S. employment discrimination laws, involves unwelcome conduct based on various protected characteristics including race, color, religion, sex, national origin, age, disability, or genetic information. Title VII of the Civil Rights Act of 1964, the Age Discrimination in Employment Act of 1967 (ADEA), and the Americans with Disabilities Act of 1990 (ADA) all prohibit harassment as a form of employment discrimination.24 The difference between bullying and harassment is subtle. For example, calling a coworker or a student a skinny witch is bullying. Calling a coworker or a student a skinny Catholic witch introduces the element of religion. While neither is acceptable, the introduction of religion crosses the line to harassment. While bullying is not necessarily illegal, harassment based on protected characteristics is unlawful.

                     

                    PAUSE AND PONDER: Consider a technician who announces to all who are on duty that the new student smells terrible. Is that bullying or harassment? If he follows it up with, “It’s because people from his culture cook all that stinky food!” Is that bullying or harassment?

                     

                    Laws and Regulations against Workplace Harassment

                    Various laws and regulations protect employees against workplace harassment. Title VII, ADEA, and ADA prohibit harassment on a federal level, while individual states also have laws that require employers to enact anti-harassment policies.24,25  Harassment is illegal and someone—meaning anyone who is harassed or observes harassment—should report it when it creates a work environment that a reasonable person would find intimidating, hostile, or abusive. It is crucial to prevent harassment, and employers should establish clear anti-harassment policies, provide training, and address complaints appropriately.

                     

                    Supervisors, co-workers, or non-employees may harass others, and the employer may be liable for harassment by supervisors resulting in disciplinary actions.24,25 For non-supervisory harassment, employers can be liable if they knew or should have known about the harassment and failed to take corrective action. The Equal Employment Opportunity Commission (EEOC) assesses each case of harassment individually by considering the nature and context of the conduct. Overall, addressing harassment requires proactive measures and a commitment to maintaining a respectful work environment. 24,25

                     

                    Protection of Whistleblowers

                    Whistleblowers are protected under OSHA’s Whistleblower Protection Program, which enforces provisions from more than 20 whistleblower statutes safeguarding employees from retaliation for reporting violations.26 Retaliation is strictly prohibited under these laws and encompasses actions such as firing, demoting, denying benefits, intimidation, harassment, and other adverse actions. Retaliative actions may dissuade an employee from raising concerns about potential violations. Subtle actions like exclusion from important meetings or false accusations of poor performance can be considered retaliation. Temporary workers supplied by staffing agencies are also protected from retaliation. OSHA's program not only safeguards whistleblowers reporting violations, but also shows some similarities between retaliation and workplace bullying. Exclusion and intimidation are shared tactics in both retaliation and bullying, mainly differing in the employer's intent.26 Many experts in bullying indicate that given these parallels, employees who are targets of bullying should be protected in the same manner that whistleblowers are safeguarded. This approach would foster a work environment where all individuals can voice concerns and engage in their roles without fear of adverse consequences.

                     

                    PREVENTION AND INTERVENTION STRATEGIES

                    Although the U.S. hadn’t yet addressed workplace bullying formally, Australia has.27 Its Fair Work Act 2009 (Cth), allows its Fair Work Commission to hear bullying claims and order any corrective action other than monetary compensation) to stop bullying from continuing. In 2019, the Fair Work Commission heard a claim from a pharmacist. The SIDEBAR summarized the case, which ended in a ruling in favor of the employer but raised many questions. It highlights the complexities of these kinds of cases and the fact that some people have little insight into their behaviors.

                     

                    SIDEBAR: Who’s Bullying Who?27

                    A pharmacist alleged the pharmacy’s management was bullying him by scheduling him to work on Saturdays without adequate assistance. The employer had replaced a dispensing technician with an intern pharmacist who he considered incompetent. The pharmacist claimed it created unnecessary stress, doubling his work. He alleged that the pharmacy’s Saturday workload was similar to weekday workloads and required more staff.

                     

                    The employer demonstrated successfully that its Saturday workflow was significantly lower than weekdays. CCTV footage revealed that the pharmacist spent considerable time on Saturdays looking at his phone rather than working. The employer also indicated the pharmacist engaged in aggressive and intimidating conduct, even reducing the intern to tears on one occasion. His hostile behavior extended to other employees, leading two of them to seek counseling. The employer stated that the pharmacist's inability to work cooperatively with colleagues was the root of the problem, not the intern's competence.

                    The deciding official ruled no one acted unreasonably towards the pharmacist. He acknowledged the pharmacist's unacceptable behavior that involved mistreating several other employees. Some readers are no doubt reading this and nodding their heads, having seen, been subject to, or accused of bullying rightly or wrongly. Others are thinking, “Why is this guy still employed?”

                    To combat workplace bullying effectively in healthcare, a multi-faceted approach involving various strategies is necessary.

                     

                    Policy Development and Enforcement

                    It is essential to develop policies to combat workplace bullying in all pharmacy settings. Drawing from the AMA's report, pharmacy management can adopt key steps to create an effective anti-bullying policy and cultivate a positive work environment.2 Everyone involved needs to realize that developing a policy takes time, and implementing it requires an endless, consistent effort on the part of managers, supervisors, and staff. People from every level of the organization should have input into the draft and the review process. Putting the issue on the department’s staff meeting agenda will ensure that it doesn’t fall through the cracks.8

                     

                    First, management must ensure that the administration is fully aware of the impact of unprofessional behavior. The team can create strategies proactively to address and prevent bullying by recognizing the problem. One strategy might be to identify when and where the bullying occurs. Changes to the workflow, the schedule, or the supervision can improve the situations.8

                     

                    Second, management can arrange to educate the entire pharmacy staff about the harmful consequences of unprofessional or hostile conduct. When employees perceive that their leaders are committed to addressing bullying, they are more likely to report incidents or even intervene when witnessing inappropriate behavior among colleagues. Two types of education can help28:

                    • Federal law requires certain organizations to provide compliance training on harassment and discrimination. The U.S. Equal Employment Opportunity Commission also recommends (but does not require) workplace civility training. Workplace civility training promotes workplace respect and civility. Good training would include workplace norms, appropriate and inappropriate behaviors in the workplace, and possibly interpersonal skills, conflict resolution, and effective supervisory techniques.
                    • Bystander intervention training, usually associated with sexual harassment in schools, is increasingly recognized as a critical element of efforts to decrease harassment and inappropriate behaviors. Its goal is to refine employees’ sensitivity to harassment or bullying and empower them act. This training would need to identify offensive behaviors, describe employment non-discrimination laws, and explain how bystanders should respond upon witnessing a harassment incident.

                     

                    These crucial management steps and well-structured anti-bullying policies can foster a respectful and supportive workplace, promoting the well-being of all employees and enhancing overall patient care.

                     

                    Promoting a Supportive and Respectful Workplace Culture

                    Healthy working relationships are crucial to promoting a supportive and respectful workplace culture in the pharmacy. The most important characteristics that build good working relationships include29

                    • mutual respect
                    • open communication
                    • empathy
                    • building rapport with every member of the team.

                    Table 2 defines these terms. Practicing mindfulness (awareness of one’s feelings and the impact they have on themselves and others) can further improve relationships by reducing stress and anxiety, increasing emotional intelligence, and improving communication. It is essential to address inappropriate behavior promptly to prevent escalation, with support and guidance available to deal with bullying or harassment.

                     

                    Table 2. Key Characteristics of Healthy Working Relationships29

                    Characteristic Definition
                    Mutual respect The foundation of a healthy workplace where all members of the pharmacy team are valued and their views are acknowledged.
                    Open communication Free expression of ideas without fear of criticism, fostering trust and understanding
                    Empathy Compassionate comprehension of others’ states when connecting with colleagues and patients so effective communication, negotiation, problem-solving, and assertiveness to enhance collaboration and conflict resolution is possible.
                    Building rapport Fostering a positive dynamic with every team member to enhance workplace happiness

                     

                    PAUSE AND PONDER: Janine supervises three employees, Mary, Alice, and Siobhan. Mary and Alice are very close and tend to gossip. They dislike Siobhan, speak badly of her to others, and often fail to provide the information Siobhan needs to complete her work. They criticize her work cruelly in the weekly staff meeting. Siobhan’s name is pronounced shi-VON, but Mary and Alice consistently mispronounce it and misspell it. What should Janine do, and how can she support Siobhan?

                     

                    Encouraging Reporting and Providing Confidential Channels

                    Managers, supervisors, and preceptors should encourage healthcare workers to report incidents of bullying without fear of retaliation.14 They should establish confidential reporting channels to protect the identities of those who come forward.14

                     

                    When addressing bullying within the pharmacy setting, it is essential to establish a comprehensive reporting system that includes confidential channels for employees to voice their concerns.14 Vanderbilt University uses a slowly escalating corrective approach, where trained professionals engage in open discussions with alleged offenders, fostering an environment of respect and mutual understanding. Second offenses are met with warnings, followed by formal letters outlining the issues and potential interventions such as mental and physical screening (in case a health condition is causing symptoms of anger, frustration, and lack of patience). Repeat offenders may face the consequence of losing staff privileges.14

                     

                    Apart from corrective measures, effective strategies can also focus on providing help and support to offenders, such as anger management classes, counseling, or assistance with medical or addiction issues.14 Creating a reporting system that ensures confidentiality empowers pharmacy staff to come forward with their concerns, enabling prompt intervention.

                     

                    CONCLUSION

                    Workplace bullying in healthcare is a pressing issue that requires attention and action. It negatively impacts healthcare professionals’ well-being and compromises patient care. It is crucial to define and emphasize workplace bullying so we can shed light on the significance of addressing this problem. To reiterate

                    • Understanding the types, signs, and effects of workplace bullying allows us to recognize its presence and take appropriate measures.
                    • Identifying the causes and risk factors helps us understand the underlying factors contributing to its persistence in healthcare settings.
                    • Differentiating workplace bullying from harassment and dysfunction clarifies the specific behaviors and intent involved, leading to more effective interventions.
                    • Upholding laws and ethical obligations, along with whistleblower protection, ensures legal and ethical accountability.
                    • Creating prevention and intervention strategies, such as developing policy and promoting a supportive culture, provide a framework for addressing workplace bullying.
                    • Reporting incidences through mechanisms and confidential channels empower individuals to seek help and create a safer environment.

                    In conclusion, by recognizing, preventing, and intervening in cases of workplace bullying, healthcare organizations can create a better work environment that supports their employees and promotes optimal patient outcomes.

                    Pharmacist Post Test (for viewing only)

                    Patient Safety: Workplace Bullying
                    Post-test
                    Learning objectives
                    After completing this continuing education activity, pharmacists and pharmacy technicians will be able to
                    1. Define workplace bullying in the healthcare setting
                    2. Explain the impact of workplace bullying on individuals, organizations, and patient care
                    3. Differentiate workplace bullying from harassment and workplace dysfunction
                    4. Describe the necessary steps to address and counteract workplace bullying
                    1. Which of the following statements correctly describes findings about bullying in pharmacies?
                    A. Researchers have a consistent definition to identify bullying in pharmacy and it includes behaviors that are mocking, taunting, or intimidating.
                    B. Leading pharmacy organizations have embraced the AMA's definition of workplace bullying and apply it consistently.
                    C. One study found several comments related to bullying, but the study wasn't designed to identify bullying and rates are probably higher.

                    2. What is the focus of the Institute for Safe Medication Practices periodic survey of health care professionals?
                    A. Disrespectful behaviors and intimidation
                    B. Causes of medication errors
                    C. Harassment as defined by the US government

                    3. Which of the following did approximately half of ISMP survey respondents report?
                    A. Respondents said that they had been pressured to accept an order or administer a drug despite safety concerns.
                    B. Respondents said they had avoided talking to a prescriber to validate an order about a safety concern more than ten times in the previous year.
                    C. Respondents said they relied on colleagues to interpret or validate an order rather than contact the prescriber.

                    4. A competent floating pharmacist is occasionally assigned to a store where a technician consistently calls out, “How many times do I have to tell you this? You've worked here before! You should know where these things are!” every time he asks her a question. Which of the following might the staff experience when observing this behavior?
                    A. Decreased absenteeism
                    B. Diminished morale
                    C. Relief that they are not targets

                    5. A prescriber who works in a hospital is notorious for his disrespectful treatment of nurses and pharmacists. He frequently scolds nurses if they call to clarify orders, and he often hangs up by slamming the phone in pharmacists’ ears. Which of the following potential negative patient outcomes have studies associated with this type of behavior?
                    A. Higher medication error rates and increased infections
                    B. Increased rates of falls and hip fracture
                    C. Strained employee relations reducing collaboration

                    6. Aadhil is a practicing Muslim who steps away from the work site to pray a couple of times a day. He's also a new father and has been up all night. He mentions this fact to his coworkers during the morning huddle, and asks for their support during the day. The pharmacist on duty finds that Aadhil has made two mistakes in filling a physician's order within the first three hours of work. He calls out, “Hey Aadhil, maybe next time you go to pray you could pray for better accuracy!” Aahil laughs uncomfortably. How would you classify this behavior?
                    A. The pharmacist is bullying Aadhil but it's OK because Aadhil laughed.
                    B. The pharmacist is bullying Aadhil and this behavior is never OK.
                    C. The pharmacist is harassing Aadhil and the pharmacist’s behavior is illegal.

                    7. Two technicians, Maria and Dolores don't get along. Maria develops a sinus infection and presents a prescription to be filled late in the day when Dolores is the only technician on duty. Maria is unable to come to work for a week because of her illness, and Delores whispers to anyone who will listen that Maria had a prescription filled to treat a sexually transmitted disease. In addition to the fact that Dolores has violated HIPAA rules, what kind of behavior is this?
                    A. Harassment; Maria is a member of a protected class
                    B. Bullying; Spreading false rumors is unacceptable behavior
                    C. Neither harassment nor bullying; it's just gossip

                    8. What is the best way to combat workplace bullying effectively in healthcare?
                    A. Use a multifaceted approach that employs different strategies concurrently
                    B. Have management and supervisors develop and enforce a policy against bullying
                    C. Advise everyone in the workplace including the target to ignore the bully

                    9. It's a busy day in the pharmacy and the pharmacy’s resident bully is in great form this morning. She has called several technicians names including Dumbo, Idiot, and Sweet Cheeks. She has also made fun of one of the pharmacist’s pants, remarking on how poorly they fit him. How can the seven people who were on duty and have witnessed these attacks best address this issue?
                    A. Ignore it, because giving her any attention will increase her attacks
                    B. Use bystander intervention and ask the bully to stop the name calling
                    C. Make a note to ask the manager to refer the targets to the employee assistance program (EAP)

                    10. Janine supervises Mary, Alice, and Siobhan. Janine witnesses Mary and Alice treating Siobhan very badly at a staff meeting. They consistently mispronounce Siobhan’s name. How should Janine approach this situation after she has corrected them several times in previous meetings and also corrected the spelling of Siobhan’s name on several documents that Mary and Alice have prepared? HINT: What process has Vanderbilt university used?

                    A. Janine should meet with Mary and Alice privately and warn them that their behavior constitutes bullying and it needs to stop. She should say that she will pursue corrective and disciplinary action if the bullying behavior continues.
                    B. Janine should continue to correct Mary and Alice each and every time that they mispronounce Siobhan’s name and send any documents with misspellings back to Mary and Alice for correction. Reinforcement is the key to success!
                    C. Janine should meet with Mary, Alice, and Siobhan and try to get to the bottom of the problem. It's clear that Siobhan has done something to irritate Mary and Alice and correcting Siobhan’s behavior will fix the entire problem.

                    Pharmacy Technician Post Test (for viewing only)

                    Patient Safety: Workplace Bullying
                    Post-test
                    Learning objectives
                    After completing this continuing education activity, pharmacists and pharmacy technicians will be able to
                    1. Define workplace bullying in the healthcare setting
                    2. Explain the impact of workplace bullying on individuals, organizations, and patient care
                    3. Differentiate workplace bullying from harassment and workplace dysfunction
                    4. Describe the necessary steps to address and counteract workplace bullying
                    1. Which of the following statements correctly describes findings about bullying in pharmacies?
                    A. Researchers have a consistent definition to identify bullying in pharmacy and it includes behaviors that are mocking, taunting, or intimidating.
                    B. Leading pharmacy organizations have embraced the AMA's definition of workplace bullying and apply it consistently.
                    C. One study found several comments related to bullying, but the study wasn't designed to identify bullying and rates are probably higher.

                    2. What is the focus of the Institute for Safe Medication Practices periodic survey of health care professionals?
                    A. Disrespectful behaviors and intimidation
                    B. Causes of medication errors
                    C. Harassment as defined by the US government

                    3. Which of the following did approximately half of ISMP survey respondents report?
                    A. Respondents said that they had been pressured to accept an order or administer a drug despite safety concerns.
                    B. Respondents said they had avoided talking to a prescriber to validate an order about a safety concern more than ten times in the previous year.
                    C. Respondents said they relied on colleagues to interpret or validate an order rather than contact the prescriber.

                    4. A competent floating pharmacist is occasionally assigned to a store where a technician consistently calls out, “How many times do I have to tell you this? You've worked here before! You should know where these things are!” every time he asks her a question. Which of the following might the staff experience when observing this behavior?
                    A. Decreased absenteeism
                    B. Diminished morale
                    C. Relief that they are not targets

                    5. A prescriber who works in a hospital is notorious for his disrespectful treatment of nurses and pharmacists. He frequently scolds nurses if they call to clarify orders, and he often hangs up by slamming the phone in pharmacists’ ears. Which of the following potential negative patient outcomes have studies associated with this type of behavior?
                    A. Higher medication error rates and increased infections
                    B. Increased rates of falls and hip fracture
                    C. Strained employee relations reducing collaboration

                    6. Aadhil is a practicing Muslim who steps away from the work site to pray a couple of times a day. He's also a new father and has been up all night. He mentions this fact to his coworkers during the morning huddle, and asks for their support during the day. The pharmacist on duty finds that Aadhil has made two mistakes in filling a physician's order within the first three hours of work. He calls out, “Hey Aadhil, maybe next time you go to pray you could pray for better accuracy!” Aahil laughs uncomfortably. How would you classify this behavior?
                    A. The pharmacist is bullying Aadhil but it's OK because Aadhil laughed.
                    B. The pharmacist is bullying Aadhil and this behavior is never OK.
                    C. The pharmacist is harassing Aadhil and the pharmacist’s behavior is illegal.

                    7. Two technicians, Maria and Dolores don't get along. Maria develops a sinus infection and presents a prescription to be filled late in the day when Dolores is the only technician on duty. Maria is unable to come to work for a week because of her illness, and Delores whispers to anyone who will listen that Maria had a prescription filled to treat a sexually transmitted disease. In addition to the fact that Dolores has violated HIPAA rules, what kind of behavior is this?
                    A. Harassment; Maria is a member of a protected class
                    B. Bullying; Spreading false rumors is unacceptable behavior
                    C. Neither harassment nor bullying; it's just gossip

                    8. What is the best way to combat workplace bullying effectively in healthcare?
                    A. Use a multifaceted approach that employs different strategies concurrently
                    B. Have management and supervisors develop and enforce a policy against bullying
                    C. Advise everyone in the workplace including the target to ignore the bully

                    9. It's a busy day in the pharmacy and the pharmacy’s resident bully is in great form this morning. She has called several technicians names including Dumbo, Idiot, and Sweet Cheeks. She has also made fun of one of the pharmacist’s pants, remarking on how poorly they fit him. How can the seven people who were on duty and have witnessed these attacks best address this issue?
                    A. Ignore it, because giving her any attention will increase her attacks
                    B. Use bystander intervention and ask the bully to stop the name calling
                    C. Make a note to ask the manager to refer the targets to the employee assistance program (EAP)

                    10. Janine supervises Mary, Alice, and Siobhan. Janine witnesses Mary and Alice treating Siobhan very badly at a staff meeting. They consistently mispronounce Siobhan’s name. How should Janine approach this situation after she has corrected them several times in previous meetings and also corrected the spelling of Siobhan’s name on several documents that Mary and Alice have prepared? HINT: What process has Vanderbilt university used?

                    A. Janine should meet with Mary and Alice privately and warn them that their behavior constitutes bullying and it needs to stop. She should say that she will pursue corrective and disciplinary action if the bullying behavior continues.
                    B. Janine should continue to correct Mary and Alice each and every time that they mispronounce Siobhan’s name and send any documents with misspellings back to Mary and Alice for correction. Reinforcement is the key to success!
                    C. Janine should meet with Mary, Alice, and Siobhan and try to get to the bottom of the problem. It's clear that Siobhan has done something to irritate Mary and Alice and correcting Siobhan’s behavior will fix the entire problem.

                    References

                    Full List of References

                    References

                       
                      1. Meko H. School Will Pay $9.1 Million to Settle Lawsuit Over a Student’s Suicide. The New York Times. July 29, 2023. Accessed August 20, 2023. https://www.nytimes.com/2023/07/29/nyregion/new-jersey-student-suicide-settlement.html?searchResultPosition=1
                      2. Murphy B. Why bullying happens in health care and how to stop it. American Medical Association. Published April 2, 2021. Accessed August 4, 2023. https://www.ama-assn.org/practice-management/physician-health/why-bullying-happens-health-care-and-how-stop-it
                      3. Survey Suggests Disrespectful Behaviors Persist in Healthcare: Practitioners Speak Up (Yet Again) – Part I. Institute for Safe Medication Practices. February 24, 2022. https://www.ismp.org/resources/survey-suggests-disrespectful-behaviors-persist-healthcare-practitioners-speak-yet-again
                      4. Intimidation: Practitioners Speak Up About This Unresolved Problem (Part I). Institute For Safe Medication Practices. Published March 11, 2004. https://www.ismp.org/resources/intimidation-practitioners-speak-about-unresolved-problem-part-i
                      5. Disrespectful Behaviors: Their Impact, Why They Arise and Persist, and How to Address Them (Part II). Institute for Safe Medication Practices. April 14, 2024. Accessed August 4, 2022. https://www.ismp.org/resources/disrespectful-behaviors-their-impact-why-they-arise-and-persist-and-how-address-them-part
                      6. Knapp K, Shane P, Sasaki-Hill D, Yoshizuka K, Chan P, Vo T. Bullying in the clinical training of pharmacy students. Am J Pharm Educ. 2014;78(6):117. doi:10.5688/ajpe786117
                      7. Calvello M. Constructive vs. Destructive Feedback: Examples + Template | Fellow. Fellow.app. Published April 25, 2023. https://fellow.app/blog/feedback/constructive-vs-destructive-feedback-examples-template/
                      8. Ryan M. Besting the Workplace Bully. Reference & User Services Quarterly. 2016;55(4):267-269.
                      9. The Joint Commission. Bullying has no place in health care. www.jointcommission.org. Published June 2021. https://www.jointcommission.org/resources/news-and-multimedia/newsletters/newsletters/quick-safety/quick-safety-issue-24-bullying-has-no-place-in-health-care/bullying-has-no-place-in-health-care/
                      10. Manzoni JF, Barsoux JL. The Set-Up-To-Fail Syndrome. Harvard Business Review. Published March 1998. https://hbr.org/1998/03/the-set-up-to-fail-syndrome
                      11. Stein M, Vincent-Höper S, Schümann M, Gregersen S. Beyond Mistreatment at the Relationship Level: Abusive Supervision and Illegitimate Tasks. Int J Environ Res Public Health. 2020;17(8):2722. doi:10.3390/ijerph17082722
                      12. Caring for Our Caregivers Caring for Our Caregivers Workplace Violence in Healthcare. https://www.osha.gov/sites/default/files/OSHA3826.pdf
                      13. Infrontadmin. The 6 Stages of Bullying. https://truesport.org/bullying-prevention/stages-of-bullying/
                      14. “Disruptive” doctors rattle nurses, increase safety risks. USA TODAY. Accessed August 3, 2023. https://www.usatoday.com/story/news/2015/09/20/disruptive-doctors-rattle-nurses-increase-safety-risks/71706858/
                      15. Bullying in the workplace. www.independentpharmacist.co.uk. Accessed August 3, 2023. https://www.independentpharmacist.co.uk/services/bullying-in-the-workplace
                      16. Ariza-Montes A, Muniz N, Montero-Simó M, Araque-Padilla R. Workplace Bullying among Healthcare Workers. International Journal of Environmental Research and Public Health. 2013;10(8):3121-3139. doi:https://doi.org/10.3390/ijerph10083121
                      17. Glenn R. Grantner, PharmD, BCPS Clinical Pharmacist Sacred Heart Hospital Pensacola. Pharmacist Burnout and Stress. www.uspharmacist.com. Published May 15, 2020. https://www.uspharmacist.com/article/pharmacist-burnout-and-stress
                      18. Medscape: Medscape Access. Medscape.com. Published 2023. Accessed August 9, 2023. https://www.medscape.com/slideshow/2022-physicians-misbehaving-6015583?icd=login_success_email_match_norm#13
                      19. Staff B. Customer Harassment, Bullying Affecting Pharmacists’ Ability to Do Their Jobs. www.uspharmacist.com. https://www.uspharmacist.com/article/customer-harassment-bullying-affecting-pharmacists-ability-to-do-their-jobs
                      20. Lamia M. The psychology of a workplace bully. the Guardian. Published March 28, 2017. https://www.theguardian.com/careers/2017/mar/28/the-psychology-of-a-workplace-bully
                      21. Smith PK. Commentary III: Bullying in Life‐Span Perspective: What Can Studies of School Bullying and Workplace Bullying Learn from Each Other? J Community Appl Soc Psychol. 1997;7:249-255.
                      22. Vramjes I, Elst TV. Griep Y, De Witte H, Baillen E. What Goes Around Comes Around: How Perpetrators of Workplace Bullying Become Targets Themselves. Group Organ Manag. 2023;48(4):1135-1172.
                      23. Bullying and harassment. Pharmacist Support. Accessed August 3, 2023. https://pharmacistsupport.org/i-need-help-managing-my/work-life/bullyin-fact-sheet/
                      24. Harassment | U.S. Equal Employment Opportunity Commission. www.eeoc.gov. https://www.eeoc.gov/harassment#:~:text=Harassment%20becomes%20unlawful%20where%201
                      25. Anti-Harassment Policy Requirements By State. getimpactly.com. Accessed August 9, 2023. https://www.getimpactly.com/resources/anti-harassment-policy-requirements-by-state
                      26. United States Department of Labor. The Whistleblower Protection Programs | Whistleblower Protection Program. Whistleblowers.gov. Published 2019. https://www.whistleblowers.gov/
                      27. Koelmeyer S. An elbow in the waist: What is and isn’t bullying in the workplace. SmartCompany. Published May 20, 2019. Accessed August 3, 2023. https://www.smartcompany.com.au/business-advice/legal/bullying-workplace/
                      28. Harassment Training Requirements by State. Project WHEN (Workplace Harassment Ends Now). Accessed August 4, 2023.
                      29. Building positive workplace relationships. Pharmacist Support. https://pharmacistsupport.org/i-need-help-managing-my/work-life/building-positive-workplace-relationships/

                      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
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                                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
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                                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