Demystifying the Medicare Prescription Payment Plan

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

Describe the benefits and features of the Medicare Prescription Payment Plan
Outline the responsibilities of Part D Sponsors and dispensing pharmacies under the Medicare Prescription Payment Plan
Discuss the characteristics of beneficiaries most likely to benefit from participating in the Medicare Prescription Payment Plan
Explain the resources available for Medicare Beneficiaries to learn more about the Medicare Prescription Payment Plan

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.

More than 1.4 million Americans paid drug costs of $2000 or more in 2020. Starting January 1, 2025, the M3P allows Medicare Part D members the option to pay for their Part D medications through a monthly invoice while paying nothing at the pharmacy counter. This change has operational and financial impacts for many areas of pharmacy. M3P claims processing requires coordination between Plans, PBMs, and dispensing pharmacies. Pharmacists and pharmacy technicians can help their patients benefit from the M3P by educating themselves and their patients about the program.

INTRODUCTION & BACKGROUND

The Inflation Reduction Act (IRA) of 2022 is a large piece of legislation that included a wide range of provisions, including clean energy, tax revenues, and healthcare costs. The Medicare Part D changes contained in the IRA aim to make prescription drugs more affordable for Medicare beneficiaries.¹

One of the Medicare Part D changes included in the IRA is the Medicare Prescription Payment Plan (M3P). Starting January 1, 2025, the M3P allows Medicare Part D members the option to pay for their Part D medications through a monthly invoice while paying nothing at the pharmacy counter.² This change has operational and financial impacts for many areas of pharmacy, including dispensing pharmacies, Medicare Part D Plans (Plans), and Pharmacy Benefit Managers (PBMs).

Overview of the Medicare Prescription Payment Plan

The Kaiser Family Foundation estimated that more than 1.4 million Americans paid drug costs of $2000 or more in 2020.³ While the IRA contains other provisions designed to lower prescription drug costs, the M3P does not change the amount that patients pay for their medications. Instead, the M3P (originally called “copay smoothing”) helps Medicare beneficiaries afford their prescriptions by “smoothing” the costs over monthly invoices instead of paying the full amount to their pharmacy. The IRA requires Plans to make the M3P available to any member who has out-of-pocket costs for Part D medications, regardless of their income or out-of-pocket amount. The M3P also requires Plans to⁴

Educate members about the availability of the M3P
Notify dispensing pharmacies when members are likely to benefit from participating in the M3P
Reflect $0 member payment for approved M3P claims
Allow multiple methods for members to opt-in to the M3P
Issue monthly M3P invoices to participating members
Include all prescriptions covered under Medicare Part D in the M3P
Pay the dispensing pharmacy for the member’s portion of the drug cost

Figure 1 illustrates the basic process for patients who choose to participate in M3P.

The Centers for Medicare & Medicaid Services (CMS) requires Plans to educate members about the availability of M3P through a variety of channels. Plans must include general M3P information on their websites, when issuing new member identification, and with annual plan document mailings. Plans and dispensing pharmacies must also provide M3P information to targeted members who are likely to benefit from participating in the program. CMS has determined that members with out-of-pocket costs of at least $2000 in the first three quarters of the year or $600 for a single prescription are the most likely to benefit from using the M3P.⁵

M3P claims processing starts January 1, 2025, and requires coordination between Plans, PBMs, and dispensing pharmacies. For members not participating in the M3P, Plans, through their PBMs, must indicate that the patient is likely to benefit from the M3P on approved Part D prescription claims with patient costs that are $600 or more. Receipt of this information from the claim requires the dispensing pharmacy to provide educational materials about the M3P to the patient. While CMS requires pharmacies to distribute M3P information to patients in response to claims messaging, CMS does not require them to provide additional counseling about the program. Pharmacists and pharmacy technicians may, however, choose to educate themselves and their patients about the M3P to provide an elevated patient experience.⁵

PAUSE AND PONDER: What quick talking points can you provide to your patients to help them understand the M3P?

Approved Part D claims for patients who have opted into the program will include instructions for the dispensing pharmacy to send a secondary M3P claim. The secondary M3P claim must use a different Bank Identification Number/Processor Control Number (which pharmacy staff usually refer to as BIN/PCN) combination than the corresponding primary Part D claim. The National Council for Prescription Drug Programs (NCPDP) creates and maintains the standardized format for prescription claims transmission. NCPDP is adding specific transmission codes for PBMs to transmit M3P information to dispensing pharmacies.⁴ Table 1 describes the types of M3P claims processing information that dispensing pharmacies should expect starting January 1, 2025. Pharmacists and technicians should consult their employer’s training materials for specific instructions on providing patients with information about the M3P, using NCPDP M3P transmission codes, and submitting secondary M3P claims.

Table 1. Anticipated M3P Claims Messaging Information

Patient Status	Claim Type	Message Type
Not participating in M3P	Approved Part D Claims with ≥ $600 patient cost	The member is likely to benefit from participating in the M3P; the pharmacy should provide M3P educational information.
Not participating in M3P	Secondary M3P Claims (if sent accidentally)	The member is not participating in the M3P program; the pharmacy should collect the member’s cost share based on the Part D claim.
Participating in M3P	Approved Part D Claims	The member is participating in the M3P; the pharmacy should send a secondary M3P claim.
Participating in M3P	Secondary M3P Claims	The corresponding Part D claim is not found. Transmission may have failed or the Part D claim has been reversed; the pharmacy should reprocess the Part D claim and then re-send the secondary M3P claim.
Participating in M3P	Secondary M3P Claims	The drug is not covered by Part D and therefore not eligible for M3P; the pharmacy should collect the member’s cost share based on the Part D claim.

Members can start signing up for the M3P as early as October 15, 2024, which is the beginning of open enrollment for 2025 Medicare Part D coverage. They can also sign up any time after their 2025 Part D coverage starts. CMS requires Plans to accept M3P participation requests by mail, telephone, or through a website application.⁴ CMS does not currently require dispensing pharmacies to process M3P election requests, and pharmacists and pharmacy technicians should direct patients to their Plan to sign up for the M3P.

Once a member opts into the program, their Plan will issue a monthly M3P invoice for all Part D prescription costs including the deductible and copay/coinsurance amounts. CMS requires Plans to issue M3P invoices separately from monthly premium invoices.⁴

Plans can remove members from M3P participation for failure to pay M3P invoices after a 2-month grace period but cannot disenroll members from Part D coverage for failure to pay M3P invoices. Members who are removed from M3P participation for falling behind on M3P payments can restore their M3P participation by paying their past-due M3P balance in full.⁴ Plans may disenroll members from Part D coverage for failure to pay monthly premium invoices after a 2-month grace period, even if their M3P invoices are paid in full.⁶ Pharmacists and pharmacy technicians can help M3P patients stay current with their payments by reminding them to pay both M3P and monthly Part D premium invoices. The SIDEBAR explains common terms.

SIDEBAR: Part D Patient Costs Defined

Monthly Premium: a monthly payment that maintains enrollment in the Plan; not impacted by deductible, copay, or coinsurance amounts

Annual Deductible: a yearly dollar amount the patient pays before their Plan starts to contribute to prescription costs

Copayment (or Copay): a specific, pre-determined dollar amount the patient pays for each prescription after satisfying the deductible

Coinsurance: an alternative to a copay, the percentage of the total cost the patient pays for each prescription after satisfying the deductible

Distribution of M3P responsibilities

CMS develops guidance and member-facing documents that Plans and PBMs use when building operational processes. For the M3P, CMS is providing Plans with⁵

Detailed guidance documents that provide M3P requirements and invoice calculation instructions
Content for plan mailings including the Annual Notice of Change, Evidence of Coverage, and Explanation of Benefits
A fact sheet with educational language for Plan websites and printed materials
An election request form
Letters to notify members of M3P election, failure to pay, and termination from the program
A targeted letter for members who are likely to benefit from participating in the M3P

CMS is also adding M3P information to the resources and educational materials that they provide directly to Medicare beneficiaries, including the annual Medicare & You Handbook, Medicare.gov, and Medicare Plan Finder.⁵

CMS assigns most of the responsibility for the M3P to Plans and holds Plans accountable for meeting all program requirements. Plans are responsible for delivering all aspects of the M3P but must rely on PBMs, vendors, and dispensing pharmacies for certain requirements. Table 2 provides an overview of the main activities that Plans must implement for M3P.^4,5

Table 2. Plan M3P Responsibilities^{4, 5}

Activity	Requirements
Member education	· General information during open enrollment, with annual plan mailings, and on their website · Targeted information prior to and during the plan year for members who are likely to benefit from the M3P
M3P participation processing	· Mail, telephone, and web-based options · Accept M3P elections during open enrollment, before the start of the plan year · Activate completed M3P elections received during the plan year within 24 hours · Outreach to gather missing information from incomplete M3P election requests · Communication to PBM for claims processing
M3P claims processing	· Coordination and oversight of their PBM for o Claims notification to pharmacies for members who are likely to benefit from M3P o Processing information and $0 copay/coinsurance for M3P participants o Payment to the dispensing pharmacy for the member’s portion of the drug cost
M3P Invoices and Payment Collections	· Monthly invoices based on CMS-required calculations · 60-day grace period, then removal from M3P for failure to pay
Other	· Customer service · Pharmacy and provider education · Data and reporting · Oversight of dispensing pharmacies

While Plans hold the most responsibility for M3P, dispensing pharmacies play a large part in the program’s success. CMS requires all pharmacies who accept Part D prescription drug coverage to participate in the M3P. Pharmacists and pharmacy technicians must act on M3P claim information to distribute M3P materials to members and process M3P claims.Pharmacies may need to adjust their claim reversals and reprocessing procedures to ensure that both the primary Part D and the secondary M3P claims are included. For example, if a patient decides to fill a prescription for less than the original quantity, the pharmacy would need to first reverse both the Part D and M3P claims and then resubmit both claims with the new quantity. CMS also requires pharmacies to re-process claims for members who sign up for M3P after filling but before picking up their prescriptions.^4,5

To benefit from the M3P, Medicare beneficiaries are responsible for reviewing the educational materials provided by CMS, their Plan, and their pharmacy. They also have the opportunity to use the tools provided by their Plan to determine if they would benefit from participating in the M3P. After signing up, members are obligated to pay their M3P invoices on a monthly basis to avoid being removed from the program. Members who sign up for the M3P may decide later to drop out of the program but are still responsible for paying invoices incurred during their M3P participation.^4,5

Monthly invoice calculations and members most likely to benefit from participating in the M3P

The monthly invoice calculations required by CMS are complex and typically do not result in equal monthly installments. Members can sign up for the M3P at any time during the year, and the monthly invoice calculation for their first month in the program is different from the invoice calculations for later months. Invoice amounts also vary based on when the member signs up for the M3P and prescriptions purchased at the pharmacy before they entered the program. CMS protects members who participate in the M3P by prohibiting Plans from adding service/late fees or charging interest on M3P balances.⁴

PAUSE AND PONDER: What can you tell a patient who asks how the M3P is different than using a credit card to pay for his prescriptions?

CMS holds Plans responsible for accurately calculating M3P invoice amounts and answering member questions. Dispensing pharmacies are not required to explain invoice details but may benefit from understanding why not all patients will benefit from participating in the M3P.⁴

Figures 2 and 3 provide examples of pharmacy copay/coinsurance amounts compared to M3P invoice amounts for members who sign up for M3P in January. Both example members have the same out-of-pocket prescription costs for the year. The member in Figure 2 is more likely to benefit financially from the M3P because the monthly M3P invoice amount is never higher than what they would have paid at the pharmacy counter. In general, the higher the member’s out-of-pocket prescription costs the earlier in the year, the more likely the member will benefit financially from using the M3P.⁴

All Part D members are entitled to sign up for the M3P, regardless of their drug costs or M3P invoice amounts. Members who do not benefit financially from the M3P, such as the member illustrated in Figure 3, may have personal reasons for signing up for the program. For example, patients who rely on caretakers to pick up their prescriptions from the pharmacy may prefer the convenience of having no cost at the pharmacy counter. Patients may also pay more than their MP3 invoice amounts earlier in the year to reduce invoice amounts later in the year as long as they do not pay more than their total year-to-date copay/coinsurance amounts.⁴

Alternatively, patients may have non-financial reasons for not signing up for the M3P. They may not want to receive another monthly bill or may feel that paying for their prescriptions at the pharmacy provides better visibility into their drug costs. Even patients who would benefit financially from using the M3P may be put off by the uneven monthly M3P payment amounts. Patients who sign up for the M3P have the option to leave at any time if they feel they are not benefiting from the program.

PAUSE AND PONDER: What other non-financial situations may members face where they could benefit from the M3P?

M3P Resources

CMS has a number of resources available for anyone looking for more information about the M3P. They provide access to detailed M3P guidance, technical, and related information at https://www.cms.gov/inflation-reduction-act-and-medicare/part-d-improvements/medicare-prescription-payment-plan

CMS also provides an annual handbook entitled “Medicare and You” designed to educate members about all aspects of Medicare. When the 2025 version of “Medicare and You” is released by CMS in late 2024, it will include educational information about the M3P.⁵ The “Medicare and You” handbook is available at https://www.medicare.gov/medicare-and-you.

At the time of this publication, CMS is still developing additional resources, but expects information about the M3P to be available at www.medicare.gov.⁵

CMS requires Plans to provide information about the M3P on their websites before October 15, 2024. While the general M3P information included on Plan websites will likely be similar to the information provided by CMS, it will also include Plan-specific instructions and contact information.⁵

SUMMARY AND CONCLUSION

The M3P provides flexibility for Medicare beneficiaries who prefer to receive a monthly invoice instead of paying for their prescriptions at the pharmacy counter. The program requires complex operational changes for Plans, PBMs, and dispensing pharmacies.

CMS holds Plans responsible for the overall administration of the M3P, but PBMs and dispensing pharmacies have important responsibilities. Pharmacists and pharmacy technicians can help their patients benefit from the M3P by educating themselves and their patients about the program.

Good:

Be familiar with your pharmacy’s procedures for processing M3P claims
Provide M3P information to patients when prompted by your pharmacy’s dispensing system
Refer patients to their Plan for additional information about the M3P

Better:

Discuss the overall benefits of the M3P
Answer patient questions about how the M3P works
Describe the characteristics of patients most likely to benefit from using the M3P

Best:

BE COMMUNITY CHAMPIONS! Stay abreast of upcoming changes and take the time to comment on proposed revisions to Medicare
Assist patients with decisions about M3P participation
Consider appointing one staff member to be your “M3P Expert” who deals with complex patient questions

Demystifying the Medicare Prescription Payment Plan
Educational Objectives for Pharmacists and Pharmacy Technicians:
1. Describe the benefits and features of the Medicare Prescription Payment Plan
2. Outline the responsibilities of Part D Sponsors and dispensing pharmacies under the Medicare Prescription Payment Plan
3. Discuss the characteristics of beneficiaries most likely to benefit from participating in the Medicare Prescription Payment Plan
4. Explain the resources available for Medicare Beneficiaries to learn more about the Medicare Prescription Payment Plan.

1. What can you tell patients who ask about the Medicare Prescription Payment Plan?
a. It will lower prescription drug costs for millions of Americans
b. It creates an option to pay for Part D prescriptions through a monthly invoice
c. The government will make this program available on January 1, 2026

2. What can members who participate in the Medicare Prescription Payment Plan expect?
a. They will pay $0 at the pharmacy for their Part D prescriptions
b. They must meet strict minimum income requirements
c. They will receive monthly invoices from their pharmacy

3. Which of the following is an M3P responsibility for dispensing pharmacies?
a. Provide counseling about the program
b. Distribute materials in response to claims messaging
c. Identify patients who are likely to benefit from the program

4. If a member fails to pay M3P invoices, what could happen?
a. They could be required to change pharmacies
b. They could be denied prescription drug coverage
c. They could be removed from the M3P program

5. Which of the following is a Medicare Part D Plan responsibility?
a. Processing M3P participation requests
b. Allowing a 90-day grace period for failure to pay M3P invoices
c. Developing guidance and member-facing documents

6. Which Medicare beneficiaries are most likely to benefit financially from using the M3P?
a. People who have high drug costs early in the year
b. People who have low drug costs throughout the year
c. People who have high drug costs late in the year

7. What advice can you offer to patients who do not benefit financially from the M3P?
a. They are not permitted to use the program
b. They must remain in the program until the end of the plan year
c. They may choose to join the program for non-financial reasons

8. Which of the following may patients consider a disadvantage to using the M3P, even for patients who may benefit financially from the program?
a. Invoice amounts that are not the same every month
b. Being required to change pharmacies to participate
c. Risk of losing their prescription coverage if they cannot pay their M3P invoices

9. Where can beneficiaries learn more about the M3P?
a. The 2024 “Medicare and You” Handbook
b. From their Plan Formulary
c. CMS and Plan websites

10. When will Medicare Part D Plans have M3P details available on their websites and start accepting M3P member elections?
a. After patients meet their annual deductible
b. No later than October 15, 2024
c. After January 1, 2025

References

Centers for Medicare & Medicaid Services. The Inflation Reduction Act Lowers Health Care Costs for Millions of Americans. Accessed April 27, 2024. https://www.cms.gov/priorities/legislation/inflation-reduction-act-and-medicare/lowers-health-care-costs-millions-americans

Centers for Medicare & Medicaid Services. Fact Sheet: Medicare Prescription Payment Plan. Accessed April 27, 2024. https://www.cms.gov/files/document/medicare-prescription-payment-plan-fact-sheet.pdf

Kaiser Family Foundation. Explaining the Prescription Drug Provisions in the Inflation Reduction Act. Accessed July 1, 2024. https://www.kff.org/medicare/issue-brief/explaining-the-prescription-drug-provisions-in-the-inflation-reduction-act/
Centers for Medicare & Medicaid Services. Medicare Prescription Payment Plan: Final Part One Guidance on Select Topics, Implementation of Section 1860D-2 of the Social Security Act for 2025, and Response to Relevant Comments. Accessed April 27, 2024. https://www.cms.gov/files/document/medicare-prescription-payment-plan-final-part-one-guidance.pdf

Centers for Medicare & Medicaid Services. Medicare Prescription Payment Plan: Final Part Two Guidance on Select Topics, Implementation of Section 1860D-2 of the Social Security Act for 2025, and Solicitation of Comments. Accessed July 17, 2024. https://www.cms.gov/files/document/medicare-prescription-payment-plan-final-part-two-guidance.pdf

Centers for Medicare & Medicaid Services. What Happens When a Plan Member Doesn’t Pay Their Medicare Plan Premiums? Accessed April 28, 2024. https://www.cms.gov/outreach-and-education/outreach/partnerships/downloads/11338-p.pdf

Management of Adults with Type 2 Diabetes: A Patient-Focused Approach

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

· Describe type 2 diabetes diagnostic criteria and glycemic targets

· Identify the components of diabetes self-management education and support

· Recognize the importance of an individualized treatment program

· List treatment recommendations for type 2 diabetes in the setting of common comorbidities

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

· Describe type 2 diabetes diagnostic criteria and glycemic targets

· Identify the components of diabetes self-management education and support

· Recognize the importance of an individualized treatment program

· List common comorbidities in type 2 diabetes

The diabetes epidemic is growing globally. Knowledge of current standards of care is essential for healthcare professionals. Understanding the importance of lifestyle recommendations and current pharmacologic therapies based on comorbidities is integral to improving diabetic patient outcomes. This continuing education activity follows a format similar to the Standards of Medical Care in Diabetes, focusing on the non-pregnant adult with T2DM. The current standards stress the importance of assessing each patient as an individual and emphasize a team care approach with patient involvement in monitoring diet, weight, physical exercise, and glycemic targets. This continuing education activity reviews the treatment of comorbid conditions, including obesity, hyperlipidemia, hypertension, heart disease, and chronic kidney disease, in addition to glycemic care. Using glucose-lowering therapy that decreases weight and slows cardiovascular disease progression is the new standard of care. Current medication therapy highlights incorporation of sodium-glucose cotransporter 2 inhibitors and glucagon-like peptide-1 agonists into therapeutic treatment plans.

INTRODUCTION

Many years ago, I dined with a large man who looked as if he had lost a substantial amount of weight. He ordered meat and vegetables and explained to me that he had eliminated most carbohydrates from his diet. As a result of dietary changes, he was able to discontinue his diabetes medication. As a pharmacist, this concept of treating a disease with lifestyle changes, rather than medication, left a profound impact.

Globally, diabetes mellites is the ninth major cause of death. This epidemic has quadrupled in the past 30 years, affecting about one in 11 adults.¹ Type 2 diabetes mellitus (T2DM) accounts for approximately 90% of diabetes mellitus diagnoses.¹ Traditionally, treatment goals focused on hemoglobin A1C (HbA1c) and blood glucose levels to treat T2DM. However, the incidence of diabetes and diabetic complications continues to rise despite the many hypoglycemic medications on the market.^2,3 Many older hypoglycemics can lead to weight gain, conflicting with the treatment goal of decreasing body mass.⁴ Optimizing diet, nutrition, and physical exercise are important treatment components, but patients may find this challenging. The healthcare team can supply the necessary support to optimize therapy. If lifestyle modifications and traditional treatments are ineffective, newer T2DM medications offer novel treatment approaches that potentially improve overall patient outcomes.

Prevalence and Risk Factors

The global adult prevalence of diabetes is significant and varies by several factors⁵:

Overall, approximately 6.1%
Males 6.5%
Females 5.8%
Older adults between the ages of 65 and 95 years, over 20%
Adults in their late 70’s (75 to 79 years) 24.4%.

In 76.5% of those with T2DM, research found risk factors were present, with high body mass index (BMI) being the primary risk factor for T2DM worldwide. Other risk factors included dietary risks, environmental or occupational risks, tobacco use, low physical activity, and alcohol use.⁵

According to the Centers for Disease Control and Prevention (CDC) National Diabetes Statistics Report (2023), in the United States in 2019, 8.7% of the population had diagnosed diabetes. Its prevalence also varied by ethnicity⁶:

Native Americans and Alaska Natives 14.5%
Non-Hispanic blacks 12.1%
Hispanics 11.8%
Non-Hispanic Asians 9.5%
Non-Hispanic whites 7.4%.

People with less than a high school education were more likely to have diabetes (13.4%) than those with a high school education (9.2%) and those with more than a high school education (7.1%). Below the federal poverty level, the prevalence was 13.7% for men and 14.4% for women. The percentages vary depending on the affected individuals’ eating and exercise habits, age, ethnicity, culture, location, education level, and economic status.⁶

Diagnosis

According to the American Diabetes Association (ADA) Professional Practice Committee Classification and Diagnosis of Diabetes, clinicians diagnose T2DM according to one of the following criteria⁷:

A fasting plasma glucose level of 126 mg/dL (7 mmol/L) or higher
A 2-hour plasma glucose level of 200 mg/dL (11.1 mmol/L) or higher during a 75-gram oral glucose tolerance test
A random plasma glucose of 200 mg/dL (11.1 mmol/L) or higher in a patient with classic symptoms of hyperglycemia or hyperglycemic crisis
A HbA1c level of 6.5% (48 mmol/mol) or higher.

Glycemic Goals

Clinicians in all walks of practice use guidelines to monitor glycemic status in patients with diabetes. Assessing glycemic status at least two times annually in patients who have stable glycemic control is sufficient. Assessment of glycemic status involves one or more of the following⁸:

Monitoring HbA1c status
Employing a continuous glucose monitoring device with time in range monitoring
Using a device containing a glucose management indicator.

The ADA recommends quarterly HbA1c monitoring for those with less stable glycemic control.^8,9 The HbA1c goal for most nonpregnant adults is 7% if the patient experiences no significant hypoglycemia. If the patient uses ambulatory glucose management, a target goal of 6.5% may be suitable. Less stringent HbA1c goals of up to 8% may be appropriate for patients with limited life expectancy or if treatment harm outweighs its benefits. When patients experience unexplained hypoglycemia, providing prompt hypoglycemia avoidance education or raising the glycemic targets are essential interventions, especially in patients with low cognition or declining cognition.⁹

COMMON COMORBIDITIES

Frequently, patients with T2DM have comorbidities. A review study analyzed patients with T2DM at varying times from diagnosis to identify the dominant multimorbidity cluster types. The study found that three condition clusters appeared consistently^10-13:

Cardiometabolic precursor conditions are common at diagnosis of T2DM
- Disorders of lipid metabolism (hyperlipidemia)
- Obesity
- Hypertension

Vascular conditions are usually associated with later stage T2DM
- Coronary artery disease (which can lead to heart failure)
- Chronic kidney disease
- Peripheral vascular disease (including peripheral arterial disease)
- Stroke (a manifestation of cerebrovascular disease)
- Atrial fibrillation

Mental health conditions occur regardless of diabetes duration
- Depression (the second most common condition in females after hypertension)
- Severe mental illness

DIABETES SELF-MANAGEMENT EDUCATION AND SUPPORT

Diabetes Self-Management Education and Support (DSMES) is an essential component of diabetes treatment. Support from the healthcare professional team augments patients’ necessary knowledge and skills. The four critical times to evaluate the need for DSMES are¹⁴:

at diagnosis
annually and/or when not meeting treatment targets
when compelling factors develop
when transitions in life or care occur.

Collaboration between patients and the healthcare team provides patient-centered DSMES. Thorough DSMES includes counselling on nutrition, physical activity, and psychosocial issues. Digital coaching and self-management interventions can be the means to deliver education and support.¹⁴

Diabetes self-management training (DSMT) is the reimbursable component of DSMES. A health care professional who is a certified Diabetes Care and Education Specialist (CDCES) —generally a dietitian, nurse or pharmacist— administers the DSMT. DSMT covers blood glucose monitoring, physical activity, healthy eating, medication, coping, problem solving.¹⁵

PAUSE AND PONDER: What lifestyle behaviors are fueling the diabetes epidemic?

Nutritional Therapy

Compelling evidence supports nutrition therapy’s efficacy and cost-effectiveness as a component of the medical management of T2DM.¹⁶According to the CDC, a registered dietitian or nutritional professional provides medical nutrition therapy (MNT). MNT focuses solely on diet. Education should encompass in-depth, individualized nutritional assessment and follow-up with repeated reinforcement to aid with behavior change.¹⁷ MNT encourages a diet rich in non-starchy vegetables, whole foods, and limited added sugars and refined grains. Increasing dietary fiber intake is beneficial, as diets high in fiber may lower HbA1c moderately. Minimizing carbohydrate intake improves glycemia. Diets higher in unsaturated fats than carbohydrates improve glycemia, triglycerides, HDL-C, and LDL-C in patients with cardiovascular disease and kidney disease.¹⁶

Caloric goals with an overall energy deficit (calories in are less than calories expected) promoting 5% weight loss have shown clinical benefit in reducing HbA1C. The goal for optimal outcomes in T2DM is to reduce body weight by 15%.¹⁶Dietary intervention can lead to disease remission, defined as sustained HbA1c levels below 6.5% for three months. Those diagnosed with type 2 diabetes for four years or fewer are more likely to achieve remission through diet. However, interventions accompanied by other lifestyle changes can be more effective than diet alone.¹⁸

Physical Activity

The World Health Organization (WHO) recommends adults engage in at least 150 to 300 minutes of moderate-intensity or 75 to 150 minutes of vigorous-intensity physical activity, or a combination of both, per week. Additionally, the WHO recommends reducing sedentary behaviors across all age groups and abilities.¹⁹

According to the CDC, moderate-intensity physical activity includes brisk walking, light yard work, light snow shoveling, biking, or playing with children. Ideally, patients’ heart rates will be 64% to 76% of their maximum. (To calculate actual beats per minute, patients subtract their age from 220, then multiply by 0.64 for the lower limit and by 0.76 for the upper limit.) Vigorous-intensity (high-intensity) exercise is jogging, swimming, rollerblading, cross country skiing, competitive sports, or jumping rope. Ideally, patients’ heart rate will be 77% to 93% of their maximum heart rate. (Calculation of the beats per minute is the same as above using 0.77 and 0.93 as the multipliers.)²⁰

Physical exercise has a positive effect on glycemic control. One study compared baseline glycemic levels with those measured after 30 minutes of moderate exercise before breakfast for three consecutive days. The study found that blood glucose levels were less variable throughout the day after morning exercise.²¹In patients with impaired fasting glucose, progression to diabetes is slower in those who chose leisure time physical activity over sedentary tasks.²² High intensity exercise improves HbA1c more than moderate- or mild-intensity exercise.²³

Researchers conducted an 8-year study of 30 patients with T2DM in which participants engaged in three 90-minute sessions of aerobic exercise per week. The exercise program included a 15-minute warm up and cool down period. During the aerobic period, participants’ exercise intensity gradual increased from 50% to 80% maximum heart rate. Study participants had significantly reduced HbA1c and BMI. Participants also had significantly improved oxygen utilization. The researchers reported a HbA1c significant decrease of 1.39% among the experiment group.²⁴

Physical activity may be the most underutilized tool in T2DM management. Physical activity improves cardiorespiratory fitness, reduces insulin resistance and insulin levels, improves lipid profiles, reduces visceral adipose tissue, and lowers blood pressure, decreasing cardiovascular risk.²⁵ Due to exercise’s overwhelming benefit, developing a structured exercise plan for patients diagnosed with T2DM is a key responsibility for healthcare teams. Ideally, the healthcare care team would include an exercise physiologist.²⁵

PAUSE AND PONDER: What self-care behaviors contribute to effective T2DM self-management?

Psychosocial Support

Up to 19% of patients with diabetes experience mental health symptoms. Depression is common, especially in women. Early detection and treatment of mental health comorbidities can reduce their impact on health outcomes. Mortality risk is higher in patients with mental health comorbidities, especially in those with substance use disorder and schizophrenia. Mental health comorbidities also increase the likelihood of all-cause hospitalization.²⁶

Experts agree that collaborative patient-centered approaches to psychosocial care are best; such approaches include assessing patients for depression, anxiety, disordered eating, and cognitive capacities. Psychosocial screening and follow-up may include attitudes about diabetes, expectations for medical management, and outcomes.⁸

The Association of Diabetes Care and Education Specialists has identified seven self-care behaviors that contribute to effective self-management of diabetes and related conditions through improved behavior²⁷:

being active
healthy coping
healthy eating
monitoring
problem solving
reducing risk
taking medication

Well-educated patients can contribute to their diabetes management with self-care behaviors. Monitoring health metrics like blood glucose, blood pressure, physical activity, diet, weight, medication adherence, mood, and sleep empower diabetes patients and improve outcomes.²⁷Higher medication adherence, as would be expected, is associated with improved glycemic control, fewer emergency department visits, decreased hospitalizations, and lower medical costs.²⁸Patients sharing data with the healthcare team can fuel discussion to find solutions, reduce risk, and improve personalized therapy plans.²⁷

PHARMACOLOGIC THERAPY

First line therapy for T2DM depends on comorbidities, patient-centered treatment factors, and management needs. It frequently includes metformin and comprehensive lifestyle modification. If the patient has atherosclerotic cardiovascular disease (ASCVD), heart failure (HF), and/or chronic kidney disease (CKD) then appropriate initial medical therapy may include glucagon-like peptide 1 (GLP-1) receptor agonists and sodium-glucose cotransporter 2 (SGLT-2) inhibitors with or without metformin. Prescribers may continue metformin upon initiation of insulin therapy for ongoing glycemic and metabolic benefits.⁸

Metformin

Apothecaries have used metformin medicinally for centuries. It is a guanidine derivative found in Galega officinalis, a plant called goat’s rue. Metformin was isolated and introduced in Europe in the 1950s and the United States in the 1990s.²⁹ Metformin decreases hepatic glucose production, decreases intestinal glucose absorption, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Metformin does not cause hypoglycemia and patients generally tolerate it well. The most common adverse effect is diarrhea, resulting in 6% of patients discontinuing therapy. Other common adverse effects include nausea/vomiting, flatulence, asthenia, indigestion, and abdominal discomfort. Precautions include the potential for lactic acidosis, especially in patients with the following risk factors³⁰:

Renal impairment
Hepatic impairment
Heart failure
Hypoxic states
Excessive alcohol intake
Radioactive dye studies
Restricted food and fluid intake

Metformin may interfere with vitamin B₁₂ absorption. Approximately 7% of patients become deficient. Supplementation with vitamin B₁₂ is appropriate if deficits develop.³⁰

Metformin can reduce HbA1c by 1.8% and lower the amount of insulin required to achieve glycemic targets by 19%.³¹ Initial dosing is 500 mg twice daily, or 850 mg daily, increasing as tolerated by 500 mg weekly to a maintenance dose of 1000 mg twice daily in patients with normal renal function. The maximum recommended dose is 2,550 mg per day. Monitoring fasting plasma glucose during initiation and dose titration aids in determining therapeutic response. Maintenance measurement of HbA1c levels should occur every three months.³⁰Renal function is an important factor in metformin use. The recommended eGFR threshold for initiation of metformin is 45 mL/min. If, during therapy, the eGFR falls below 45 mL/min, the team need to assess the benefit of continued therapy. Use is contraindicated in patients with an eGFR below 30 mL/min.³⁰

INSULIN THERAPY

ADA Standards of Care recommend early introduction of insulin if clinicians see evidence of ongoing weight loss, symptoms of hyperglycemia, HbA1c levels exceeding 10%, or blood glucose levels of 300 mg/dL or higher. The potential for over-basalization (titration of basal insulin beyond an appropriate dose in an attempt to achieve glycemic targets) exists with insulin therapy. Signs of over-basalization may include a basal dose exceeding 0.5 units/kg/day, high bedtime-morning or post-prandial glucose differential, hypoglycemia, and high glycemic variability.⁸

When caring for hospitalized patients with diabetes, basal insulin or a basal plus bolus correction insulin is the preferred treatment for noncritically ill patients with poor oral intake. The standards prefer an insulin regimen with basal, prandial, and correctional components in patients with good nutritional intake. In many hospital settings, the basal and prandial doses are weight-based, and a correctional scale is added to scheduled mealtime doses to correct for pre-meal hyperglycemia.

It’s critical to initiate insulin therapy for persistent hyperglycemia at a threshold of 180 mg/dL or more, confirmed on two occasions. After initiating insulin, the current Standards of Care recommend a target glucose range of 140 to 180 mg/dL for most patients. More stringent goals, such as 110 to 140 mg/dL, may be appropriate for select patients if they do not exhibit significant hypoglycemia. The ADA defines hyperglycemia as blood glucose levels over 140 mg/dL in the hospital, and hypoglycemia as blood glucose below 70 mg/dL. Monitoring glucose every four to six hours or every two hours for an insulin infusion is best. Each hospital or hospital system should implement hypoglycemic management protocols.⁸

TREATMENT RECOMMENDATIONS IN COMMON COMORBIDITIES

Obesity

High BMI is the primary risk factor for T2DM.⁵Diabetes was the second leading cause of BMI-related deaths in 2015 globally.³² The DIRECT trial showed a T2DM remission rate of 36% after 24 months in patients receiving structured support for initial weight loss and weight loss maintenance.³³The 2022 ADA Standards of Medical Care in Diabetes categorize obesity treatment options based on BMI⁸:

Nonpharmacologic strategies may be sufficient for those with BMI 25 to 26.9
Providers should consider adding pharmacotherapy for those with a BMI of 27 to 29.9
For those with a BMI exceeding 30 (or for Asian Americans with BMI 27.5 and over), patients and their treatment teams might consider metabolic surgery

The Standards of Care in Diabetes stress a minimum of 5% weight loss for most people with T2DM. It is important to include counseling with two to three monthly sessions focusing on dietary changes, physical activity, and behavioral strategies to achieve a 500 to 750 kcal/day energy deficit. Person-centered, nonjudgmental language, specifically “person with obesity” rather than “obese person,” fosters collaboration between patients and providers. Consideration of the medication’s effect on weight gain is important.⁸ Metformin, SGLT-2 inhibitors, GLP-1 receptor agonists, alpha-glucosidase inhibitors, and amylin mimetics promote weight loss.³⁴

As of November 2023, three FDA-approved obesity medications also have FDA approval for treating T2DM. These are the GLP-1 agonists liraglutide, semaglutide, and tirzepatide.^35,36Dosages are as follows^37-39:

Liraglutide (Saxenda) has an initial dose of 0.6 mg/day with a maintenance dose of 3 mg/day
Semaglutide (Wegovy) has an initial dose of 0.25 mg/week with a maintenance dose of 2.4 mg/week
Tirzepatide (Zepbound) has an initial dose of 2.5 mg/week with a maintenance dose of 5 to 15 mg/week

The FDA has approved these medications for weight loss in patients with a BMI of 30 or above or BMI of 27 or above with a comorbidity including hypertension, T2DM, or dyslipidemia.^37-39 These drugs lower glucose by stimulating insulin secretion from pancreatic islets in response to oral glucose load, like the natural hormone incretin. They delay gastric emptying, suppress appetite, increase satiety, decrease inappropriate glucagon secretion, and promote beta cell proliferation.^40,41

Clinical data for the GLP-1 medications in weight loss is impressive. The SCALE trial has shown that the absolute weight loss with liraglutide 3 mg daily in patients with T2DM is 5.6 kg (12.3 lbs) over 56 weeks.⁴²The absolute weight loss associated with semaglutide 2.4 mg weekly in obese patients or overweight patients with at least one risk factor is 12.7 kg (28 lbs) over 68 weeks.⁴³Diabetic patients treated with tirzepatide 5, 10 or 15 mg weekly for 72 weeks lost an average of 12% body weight compared to placebo.³⁹ These medications contain warnings and precautions for thyroid C-cell tumors, acute pancreatitis, acute gallbladder disease, hypoglycemia with some T2DM medications, kidney injury, hypersensitivity reactions, and suicidal ideation.^37-39 The labeling for semaglutide and tirzepatide carries a precaution for diabetic retinopathy.^38,39 A precaution for heart rate increase is included in the labeling for liraglutide and semaglutide.^37,38 Most patients find these drugs have overwhelming benefits with primarily gastrointestinal adverse effects.^36-38

Providers may consider metabolic surgery for T2DM treatment in adults with a BMI of 30 and over (or for Asian Americans with a BMI of 27.5 and greater). Metabolic surgery refers to surgical organ modification; bariatric surgery, for example, is metabolic surgery for treatment of obesity (commonly known as a gastric bypass). A high-volume surgical center with experienced multidisciplinary teams knowledgeable about obesity management, diabetes, and gastrointestinal surgery is the best choice. Access to long-term medical, nutritional, and behavioral support after the procedure optimizes recovery. Patients may benefit from continuous glucose monitoring as an important adjunct, especially for those with episodes of hypoglycemia. After surgery, the clinical team should provide patient support, including mental health services.⁴⁴

Bariatric surgery is an effective treatment option in T2DM patients with obesity. In a recent study, after a median follow-up of 19 months post-surgery, 68 of 105 obese patients achieved diabetes remission. Study participants had a median BMI of 42.4 and a diagnosis of T2DM before the procedure. Patients taking multiple glucose-lowering medications or dependent on insulin or SGLT2 inhibitors were less likely to undergo complete remission. A longer duration of T2DM pre-operatively was a negative predictor of remission.⁴⁵

PAUSE AND PONDER: Which classes of diabetes medications are best for patients with ASCVD?

Cardiovascular Disease

All diabetic patients require yearly assessment of HF and ASCVD (coronary artery disease, cerebrovascular disease, or peripheral arterial disease). Hypertension, dyslipidemia, and diabetes are risk factors for ASCVD. Controlling cardiovascular risk factors can prevent or slow ASCVD in people with diabetes.⁴⁶

Prescribers should consider the presence of coronary artery disease in patients exhibiting atypical cardiac symptoms, signs of vascular disease, or electrocardiogram abnormalities. Atypical cardiac symptoms include unexplained dyspnea or chest discomfort. Carotid artery stenosis, transient ischemic attack, stroke, and peripheral arterial disease are indicators of ASCVD.⁴⁶

In T2DM patients with established ASCVD or kidney disease, current ADA Standards of Medical Care suggest an SGLT-2 inhibitor or GLP-1 receptor agonist with demonstrated cardiovascular disease benefit (see Table 1 and Table 2). A quick review of FDA indications and landmark trials ensures the correct medication and dose have been chosen as newer agents continue to emerge with indications that may encompass weight loss and treatment of T2DM. To reduce the risk of adverse cardiovascular and kidney events, patients with T2DM and established ASCVD may benefit from combined therapy with an SGLT-2 inhibitor and a GLP-1 receptor agonist with demonstrated cardiovascular benefit.⁴⁶

Table 1. Landmark Trials for SGLT-2 Inhibitors Evaluating T2DM with Cardiovascular Disease^47-50

Trial	Drug	Outcome
EMPA-REG OUTCOME	Empagliflozin 10-25 mg daily	Reduction in major adverse cardiovascular events; Reduction in hospitalization for heart failure
CANVAS	Canagliflozin 300 mg daily goal	Reduction in major adverse cardiovascular events; Reduced hospitalization for heart failure and cardiovascular death
DECLARE-TIMI 58	Dapagliflozin 10 mg daily	Reduction in heart failure-related death and hospitalization; Reduction in renal events

The SGLT-2 inhibitors’ primary mechanism of action is reduction of renal tubular glucose reabsorption at the proximal tubule resulting in glucosuria.⁵¹ The SGLT-2 inhibitors’ glucose-lowering efficacy decreases with increasing renal impairment.⁵² Most patients tolerate these medications well, with mild adverse effects. The proposed cardiovascular benefits include improved, blood pressure reduction, inflammation reduction, diuresis, inhibition of nervous system, and prevention of cardiac remodeling (physical changes to heart).⁴⁷ Their adverse effects include genitourinary infections, intravascular volume depletion, increased risk of diabetic ketoacidosis, and potentially an increased risk of lower limb amputations.⁵² Prescribers need to hold SGLT-2 inhibitors during acute illness (hospitalization), when fluid intake is inadequate, or if acute kidney injury occurs.⁴⁷

Pancreatic hormones and incretin hormones regulate glycemic homeostasis. GLP-1 is an incretin hormone that increases pancreatic insulin release and decreases glucagon release.⁴¹ The GLP-1 receptors are located in the renal proximal convoluted tubular cells and preglomerular vascular smooth muscle cells in the kidneys.⁵³ The GLP-1 receptor agonists lower HbA1c, weight, and blood pressure.⁵⁴

GLP-1 receptor agonists promote natriuresis (increased sodium in the urine), lowering blood pressure.⁵⁵ GLP-1 receptor agonists also reduce reactive oxygen production, thereby reducing platelet activation, macrophages, and monocytes in the vascular wall. Stabilization of the endothelial cells occurs with less plaque hemorrhage and rupture.⁵⁶ Overall, GLP-1 enhancement results in a slower progression of atherosclerosis.⁵⁷

Table 2. Landmark Trials for GLP-1 Agonists: Evaluating T2DM with Cardiovascular Disease^57-60

Trial	Drug	Outcome
REWIND	Dulaglutide 1.5 mg once a week	Reductions in major adverse cardiovascular events
SUSTAIN-6	Semaglutide 0.5 or 1 mg once a week	Relative risk reduction in major adverse cardiovascular events
LEADER	Liraglutide 1.8 mg (or max dose tolerated) daily	Relative risk reduction in major adverse cardiac events and cardiovascular death

In T2DM patients with a history of ASCVD, aspirin 75 mg to 162 mg daily is a secondary prevention strategy. In patients with documented aspirin allergies, clopidogrel 75 mg daily is an alternative. Patients with stable coronary and or peripheral artery disease and a low bleeding risk should take dual antiplatelet therapy for at least one year following acute coronary syndrome. Aspirin and low dose rivaroxaban can prevent major adverse limb and cardiovascular events.⁶¹

Hypertension

Hypertension exacerbates cardiovascular disease, which is the major cause of morbidity and mortality in diabetes.⁶² In 2023, the ADA updated the hypertension criteria. According to the 2023 Standards of Care in Diabetes recommendations, patients are hypertensive if they exhibit a sustained blood pressure of 130/80 mm Hg or more, or a single level of 180/110 or more. The target goal is 130/80 mm Hg or less. Blood pressure targets below 120/80 mmHg are associated with hypotensive adverse events (such as falls). Patients with diabetes who are hypertensive should monitor their blood pressure at home. Patients with blood pressures exceeding 120/80 should implement lifestyle interventions including diet changes and weight loss, reduced sodium and increased potassium intake, moderation of alcohol, and increased physical activity.⁶¹ Treatment of hypertension reduces cardiovascular events and microvascular complications.^63,64

In patients with persistently elevated blood pressure, pharmacologic therapy in addition to lifestyle modifications improves outcomes. First-line pharmacologic therapy includes use of an angiotensin-converting enzyme inhibitor (ACEi), or an angiotensin receptor blocker (ARB). Clinical trials assessing these drugs demonstrate a reduction of cardiovascular events in T2DM patients with coronary artery disease. Prescribers should maximize doses for patients with a urine-to-creatinine ratio greater than 30 mg/g creatinine, as this is a sign of kidney damage. If the patient does not tolerate one drug class, the prescriber may switch to the other; however, the prescriber should not use them together. Annual monitoring of glomerular filtration rate (GFR) and serum potassium are needed.⁶¹

Prescribers should start their patients on two medications if they have a confirmed office blood pressure of 160/100 mm Hg or more.⁶¹ Common therapies include thiazide-like diuretics and dihydropyridine calcium channel blocker.⁶⁵ Patients on triple antihypertensive therapy including a diuretic with unmet blood pressure goals may require a mineralocorticoid receptor antagonist, such as spironolactone.⁶⁶ Adding a mineralocorticoid receptor antagonist may increase the risk of hyperkalemia. Regular monitoring of serum creatinine and potassium is prudent.⁴⁶

In the absence of albuminuria, ACEi and ARBs may not provide superior cardio-protection over thiazide-like diuretics or dihydropyridine calcium channel blockers.⁶⁷ Patients who have had a prior myocardial infarction, active angina, or HF with reduced ejection fraction (HFrEF) should be treated with a beta blocker. However, beta blockers do not reduce mortality when used as antihypertensives in the absence of these conditions.^54,68

Hyperlipidemia

Reduction of lipids and cholesterol is important because hyperlipidemia is a risk factor and common comorbidity for T2DM. Lifestyle modification focusing on weight loss is the first step of lipid management. Trained nutritionists can educate patients to eat a diet low in saturated fat and trans-fat. The goal is a diet that increases dietary n-3 fatty acids, viscous fiber, and plant stanols/sterols. Physical activity also helps improve lipid profiles. The importance of lifestyle therapy and glycemic optimization for triglycerides of 150 mg/dL or greater, and/or HDL equal to or less than 40 mg/dL for men and 50 mg/dL for women, cannot be understated. Lipid profiles at the time of diabetes diagnosis, at initiation of statin therapy or dose change, and annually thereafter are useful to monitor disease progression.⁶¹

Statin therapy has documented beneficial outcomes in patients with ASCVD.^69,70 The intensity of dosing is outlined below (see Table 3)⁶¹:

Patients with diabetes aged 40 to 75 without ASCVD should begin moderate-intensity statin therapy in addition to lifestyle therapy.
Patients with diabetes aged 40 to 75 years and multiple ASCVD risk factors should take high intensity statin therapy to reduce LDL cholesterol by at least 50% of baseline for an LDL target of less than 70 mg/dL.
Patients with diabetes and ASCVD should take high-intensity statin therapy. Prescribers may add ezetimibe or a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, such as alirocumab or evolocumab, to achieve a goal of LDL below 55 mg/dL and an LDL reduction of 50% or more.

Table 3. Once daily: High-intensity and Moderate-intensity Statin Therapy⁶¹

Moderate-intensity statin therapy	High-intensity statin therapy
Atorvastatin 10–20 mg	Atorvastatin 40–80 mg
Rosuvastatin 5–10 mg	Rosuvastatin 20–40 mg
Simvastatin 20–40 mg
Pravastatin 40–80 mg
Lovastatin 40 mg
Fluvastatin (extended release) 80 mg
Pitavastatin 1–4 mg

Heart Failure

HF is a major cause of morbidity and mortality from cardiovascular disease. Recent studies indicate that people with diabetes have twice the risk of hospitalization due to HF compared to those without, after adjusting for age and sex.^71,72 Patients with established T2DM have a 33% greater risk of hospitalization for HF.⁷¹

HF is staged as A to D. Stage A HF indicates risk for developing HF. All patients with established diabetes are in the stage A category and at heightened risk for progression to later stages of HF. Stage B HF is asymptomatic with structural heart disease, abnormal cardiac function, or elevated cardiac biomarkers. Prescribers should monitor biomarkers, natriuretic peptide (BNP), or high sensitivity cardiac troponin yearly to detect subclinical HF in individuals with diabetes. Monitoring helps identify those in stage A or B HF who are at the highest risk of progressing to symptomatic HF. Useful cutoff values for these indicators are a BNP of 50 pg/mL and a NT-proBNP of 125 pg/mL.⁷³

Individuals considered to be at stages C and D have had or are experiencing symptomatic HF. Common symptoms are exertional dyspnea (shortness of breath), fatigue and edema that reflect fluid retention, congestion, and low cardiac output. Laboratory evaluations for patients with HF include natriuretic peptide, complete blood count, urinalysis, serum electrolytes, blood urea nitrogen, serum creatinine, glucose, fasting lipid profile, liver function, and thyroid stimulating hormone. Additionally, prescribers should order a chest x-ray and 12 lead electrocardiogram.⁷³

In stage A or B HF patients with diabetes and hypertension, medical therapy includes an ACEi or ARB. Clinical trials have found that treatment with a thiazide-type diuretic or an ACEi is more effective than treatment with a calcium channel blocker in preventing progression to symptomatic HF. Patients with diabetes and diabetic kidney disease (DKD) without symptomatic HF may benefit from finerenone, a nonsteroidal mineralocorticoid receptor antagonist.⁷³

Standards of Care recommendations for those with HFrEF and diabetes include an angiotensin receptor/neprilysin inhibitor (ARNI) or ACEi or ARB, beta blockers, mineralocorticoid receptor antagonist, and SGLT-2 inhibitor. In individuals with diabetes and HFrEF, including an ARNI (sacubitril/valsartan) instead of ACEi or ARBs is prudent. It is reasonable to consider treatment with spironolactone among individuals with heart failure with preserved ejection fraction (HFpEF) as well. Clinical trials have shown that treatment with an SGLT-2 inhibitor reduces HF hospitalizations.⁷²Individuals with high cardiovascular risk, including those with stage B HF and those with symptomatic HF, should take an SGLT-2 inhibitor. Prescribers may consider statins based on age and background risk factors. Treatment for patients requiring additional glycemic control may include a GLP-1 agonist, metformin, or both, or insulin. Current Standards of Care do not recommend the use of dipeptidyl peptidase-4 (DPP) inhibitors or thiazolidinediones in T2DM patients with stage B, C or D HF.⁷³

In addition to drug therapy, participation in cardiac rehabilitation is associated with improved patient outcomes. Cardiac rehabilitation involves exercise training, education, and emotional support. Key counseling points for patient with diabetes and HF are to minimize alcohol intake and avoid smoking. Weight loss improves cardiometabolic risk factors. Metabolic surgery can improve risk factors for HF in obese patients.⁷³

Chronic Kidney Disease

Diabetes is the leading cause of kidney disease in the developed world.⁷⁴ The presence of CKD markedly increases cardiovascular risk and health care costs.⁷⁵ Practitioners diagnose CKD primarily by sustained elevation of urinary albumin excretion and low estimated glomerular filtration rate (eGFR).⁷⁶

Recommendations include yearly assessment of eGFR and urinary albumin in all T2DM patients. In patients with established DKD, monitoring up to four times yearly may be necessary.⁷⁶ Consistent eGFR values less than 60 mL/min, in conjunction with a urinary albumin value over 30 mg/g creatinine defines an abnormal eGFR.⁷⁷ The definition of stage 1 and 2 CKD is high albuminuria with eGFR 60 mL/min or above. CKD stages 3-5 have progressively lower eGFR ranges.⁷⁸ At any eGFR, the degree of albuminuria is associated with risk of cardiovascular disease, CVD progression, and mortality.⁷⁵

Current ADA Standards of Care emphasize optimization of blood pressure and blood glucose to reduce the risk of and slow CKD progression.⁷⁶ ACEi or ARBs are the preferred first-line agents for blood pressure treatment in T2DM patients with hypertension and decreased eGFR.^79,80 The healthcare team needs to continue renin-angiotensin system blockade for increases in serum creatinine of 30% or less in the absence of volume depletion. In addition, it needs to monitor serum potassium levels when patients take ACE inhibitors, ARBs, or diuretics.⁷⁶

Recent trials show SGLT-2 inhibitor therapy reduces CKD progression and cardiovascular events in patients with CKD, T2DM, and an eGFR of 20 mL/min/1.73m² or greater.⁷⁶ SGLT-2 inhibitors reduce renal tubular glucose reabsorption, weight, systemic blood pressure, intraglomerular pressure, albuminuria, and slow GFR loss through mechanisms that are independent of glycemia.⁸¹ To minimize cardiovascular events, addition of a glucagon-like peptide 1 agonist may help, or a nonsteroidal mineralocorticoid receptor antagonist (nsMRA) if eGFR is 20 mL/min/1.73m². For patients with urinary albumin of 300 mg/g or greater, reduction of at least 30% slows CKD progression.⁷⁶ Suggested daily protein intake in CKD stage 3 (non-dialysis) patients is 0.8 g/kg body weight per day. Higher levels of protein have been associated with increased albuminuria and more rapid kidney function loss.⁸² If the eGFR falls below 30, a nephrologist referral is needed.⁷⁶

Tables 4 and 5 list recent trials that support current ADA Standards of Care regarding treatment of diabetes in the presence of CKD.⁷⁶ In the CREDENCE trial, canagliflozin therapy reduced the development of ESRD by 32% in patients with CKD.⁸³ The DAPA-CKD trial studied dapagliflozin in CKD. Two thirds of the patients had a diabetes comorbidity. There was significant benefit for a decline in eGFR, ESRD or death from cardiovascular or renal causes.⁸⁴ The FIDELIO-DKD trial studied the nonsteroidal mineralocorticoid receptor antagonist, finerenone. The trial identified a significant reduction in DKD progression and cardiovascular events in people with advanced kidney disease. Participants took finerenone 10 to 20 mg daily. Evaluation after a mean of 3.4 years demonstrated a 23% reduction in the composite kidney outcome consisting of sustained decrease in eGFR of at least 57%.⁸⁵

Table 4. Landmark Trials for SGLT-2 inhibitors in renal disease^47,83,84,86

Trial	Drug	Outcome
CREDENCE	Canagliflozin 100 mg daily	Cardiovascular and renal protection
DAPA-CKD	Dapagliflozin 10 mg daily	Reduction of eGFR decline; Reduction of ESRD; Reduction of renal mortality
EMPA-KIDNEY	Empagliflozin 10 mg daily	Reduced progression of kidney disease; Reduced cardiovascular death

Table 5. Landmark Trials for GLP-1 Receptor Agonists in T2DM and Renal Disease^57,58,87,88

Trial	Drug	Outcome
AWARD-7	Dulaglutide 0.75 -1.5 mg once a week	Slower decline in eGFR. No change in urine albumin-creatine ratio
LEADER	Liraglutide 1.8 mg (or max dose tolerated) daily	Reduced the development and progression of diabetic kidney disease
REWIND (analysis)	Dulaglutide 1.5 mg once a week	Relative risk reduction in composite renal outcome

CONCLUSION

T2DM is indeed a growing epidemic fueled by an unhealthy diet and a sedentary lifestyle.¹ A prescription is only a partial answer to a multifactorial problem. This is why the ADA Standards of Care for diabetes incorporate a multidisciplinary approach focusing on individuals, their current disease states, and preventive measures for disease progression. Recommendations emphasize the importance of self-management, education, and support. Nutritional therapy, physical activity, and psychological support are key elements. Effective weight management is a powerful tool for managing or even reversing T2DM. Current therapy recommendations also incorporate the use of cardiovascular protective medications with demonstrated efficacy for ASCVD.⁸

Due to the high prevalence of comorbid conditions associated with T2DM, it is fortunate that the SGLT-2 inhibitors and GLP-1 receptor agonists are a resource for patients with T2DM comorbidities. These agents improve cardiovascular function and are compatible with guideline-based preventive recommendations for blood pressure, lipids, glycemia, and antiplatelet therapy.^51,89 Diabetes treatment has entered a new era of understanding. The overwhelming data favors addressing the whole patient including lifestyle, education, weight loss options, and cardiovascular related comorbidities. The new ADA Standards of Medical Care provide clinicians with the knowledge and tools to treat the growing diabetic epidemic.

Management of Adults with Type 2 Diabetes: A Patient-Focused Approach

Post-test Questions for Pharmacists

Learning Objectives (pharmacists)
● Describe type 2 diabetes diagnostic criteria and glycemic targets
● Identify the components of diabetes self-management education and support
● Recognize the importance of an individualized treatment program
● List treatment recommendations for diabetes type 2 in the setting of common comorbidities

1. Which of the following is TRUE about the incidence of the global diabetes epidemic?
a. The incidence has quadrupled in the past three decades with a current estimate of about 1 in 11 adults affected worldwide
b. The incidence has doubled in the past four decades with a current estimate of about 1 in 15 adults affected worldwide
c. The incidence has tripled in the past decade with a current estimate of about 1 in 8 adults affected worldwide

2. Which group of people is LEAST LIKELY to be diagnosed with diabetes in the US?
a. Those below the federal poverty level
b. Native Americans and Alaska natives
c. Non-Hispanic whites with college degrees

3. According to ADA Standards of Medical Care in Diabetes, pharmacologic therapy options for patients with HFrEF and diabetes may include all of the following drug classes EXCEPT?
a. ARNI
b. SGLT2 inhibitor
c. DPP-4 inhibitors

4. What is the focus of DSMES?
a. Nutrition, relaxation, and psychosocial issues
b. Nutrition, physical activity, and psychosocial issues
c. Physical therapy, psychotherapy, and natural dietary supplements

5. Which of the following statements about diet is TRUE?
a. Diet as a primary intervention for T2DM can achieve remission, defined as sustained HbA1c levels under 6.5% for 3 months
b. Diets low in fats and higher in carbohydrates are recommended for those with T2DM due to the risk of cardiovascular disease
c. Sustaining calorie intake and monitoring blood glucose levels is often the best course of action for those recently diagnosed with T2DM

6. Which statement is true regarding physical activity and diabetes?
a. The World Health Organization guidelines state that those with diabetes should exercise less than 75 minutes per week.
b. Aerobic exercise before breakfast increases blood glucose levels.
c. In patients with impaired fasting glucose progression to diabetes is slower in those who chose leisure time physical activity over sedentary tasks.

7. Which of the following self-care behaviors is an effective self-management tool for diabetes?

a. Healthy coping, healthy eating, being active, taking medication, monitoring, reducing risk, and problem solving
b. Healthy coping, healthy eating, resting, taking medication, monitoring, reducing risk, and spending time with family
c. Healthy coping, healthy eating, being active, taking medication, monitoring, reducing risk, and allowing your doctor to decide the best way for you to manage your diabetes independently

8. Which statement best defines the current ADA Standards of Medical Care in Diabetes recommendations?
a. All diabetic patients should follow a step-up drug therapy algorithm developed by the American Diabetes Association to meet glycemic targets.
b. Regardless of comorbidities, initial treatment of T2DM should include hypoglycemic agents such as sulfonylureas supplemented by insulin, if needed, to achieve a HgA1c of 7% or lower
c. First line therapy for T2DM depends on comorbidities, patient centered treatment factors and management needs.

9. Under what circumstances should initial treatment include insulin?
a. If there is ongoing weight loss, symptomatic hyperglycemia, A1C levels over 10%
b. If there is fluid overload, symptomatic hypoglycemia or A1C levels over 8%
c. If the patient has chronic kidney disease, heart failure or chronic obesity

10. For a patient with diabetes whose eGFR > 20, which comorbidity would benefit most from a medication regimen containing an ACEi, SGLT2 inhibitor, and a GLP-1 agonist or a nsMRA?

a. Chronic kidney disease
b. Hypertension
c. Hyperlipidemia

Management of Adults with Type 2 Diabetes: A Patient-Focused Approach

Post-test Questions for Pharmacy Technicians

Learning Objectives (technicians)
● Describe type 2 diabetes diagnostic criteria and glycemic targets
● Identify the components of diabetes self-management education and support
● Recognize the importance of an individualized treatment program
● List common comorbidities in type 2 diabetes

3. Which laboratory data would lead to a positive diagnosis of diabetes?
a. A hemoglobin A1c level of 6.0%
b. A 2-hour plasma glucose level of 200 mg/dL or higher during a 75 gram oral glucose tolerance test
c. A fasting plasma glucose level of 120 or higher

6. Which statement is true regarding physical activity and diabetes?
a. The World Health Organization guidelines state that those with diabetes should exercise less than 75 minutes per week.
b. Aerobic exercise before breakfast has increases blood glucose levels.
c. In patients with impaired fasting glucose progression to diabetes is slower in those who chose leisure time physical activity over sedentary tasks.

7. Which of the following self-care behaviors is an effective self-management tool for diabetes?

8. According to the new 2023 ADA Standards of Medical Care in Diabetes, patients are hypertensive if they exhibit a sustained blood pressure above which level?
a. 140/90 or more
b. 130/80 or more
c. 120/80 or more

9. Which of the following lists accurately describes the most common comorbidities in type 2 diabetes?

a. Cardiometabolic, vascular, and mental health conditions
b. Cardiometabolic, vascular, and dermatologic conditions
c. Cardiac, gastrointestinal, and mental health conditions

10. How much more is risk of heart failure hospitalization in people who have type 2 diabetes?

a. 33%
b. 50%
c. 77%

References

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3. Saeedi P, Petersohn I, Salpea P, et al. Global and regional diabetes prevalence and estimates for 2023 and 2045. Re-sults from the International Diabetes Atlas 9th Edition. Diabetes Res Clin Pract 2019;157:107843 doi: 10.1016/j.diabres.2019.107843
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7. American Diabetes Association Professional Practice Committee. 2.Classification and Diagnosis of Diabe-tes: Standards of Medical Care in Diabetes-2022. Diabetes Care 2022;45(Suppl 1):S17–S38. https://doi.org/10.2337/dc22-S002
8. American Diabetes Association. Standards of Medical Care in Diabetes-2022 Abridged for Primary Care Provid-ers. Clin Diabetes 2022;40(1):10–38. https://doi.org/10.2337/cd22-as01
9. American Diabetes Association. 6.Glycemic Targets: Standards of Medical Care in Diabetes-2021. Diabetes Care 2021;44(Suppl 1):S73–S84 https://doi.org/10.2337/dc21-S006
10. Cicek M, Buckley J, Pearson-Stuttard J, et al. Characterizing Multimorbidity from Type 2 Diabetes. Endocrinol Metab Clin North Am. 2021; 50(3): 531–558. doi: 10.1016/j.ecl.2021.05.012
11. Iglay K, Hannachi H, Howie JP. Prevalence and co-prevalence of comorbidities among patients with type 2 diabetes mellitus. Curr Med Res Opin. 2016;32(7):1243–1252. doi: 10.1185/03007995.2016.1168291
12. Roger V. Epidemiology of heart failure: A Contemporary Perspective. Circ Res 2021;128(10):1421-1434 https://doi.org/10.1161/CIRCRESAHA.121.318172
13. Nowakowska M., Zghebi S.S., Ashcroft D.M. The comorbidity burden of type 2 diabetes mellitus: patterns, clusters and predictions from a large English primary care cohort. BMC Med. 2019;17(1):145. doi: 10.1186/s12916-019-1373-y
14. American Diabetes Association Professional Practice Committee. 5. Facilitating Behavior Change and Well-being to Improve Health Outcomes: Standards of Medical Care in Diabetes-2022. Diabetes Care. 2022;45(Suppl 1):S60-S82. doi:10.2337/dc22-S005b
15. Davies J, Fischi A, Beck J, et al. National Standards for Diabetes Self Management and Support. Diabetes Care 2022; 45(2): 484-492 doi: 10.2337/dc21-2396
16. Evert AB, Dennison M, Gardner CD, et al. Nutrition Therapy for Adults with Diabetes or Prediabetes: A Consensus Report. Diabetes Care. 2019;42(5):731–754. https://doi.org/10.2337/dci19-0014
17. Centers for Disease Control and Prevention (CDC). Diabetes Self-Management Education and Support (DSMES) Toolkit: Medical Nutrition Therapy. https://www.cdc.gov/diabetes/dsmes-toolkit/reimbursement/medical-nutrition-therapy.html Accessed October 14, 2023
18. Rosenfeld RM, Kelly JH, Agarwal M, et al. Dietary Interventions to Treat Type 2 Diabetes in Adults with a Goal of Remission: An Expert Consensus Statement from the American College of Lifestyle Medicine. Am J Lifestyle Med. 2022;16(3):342-362. https//doi:10.1177/15598276221087624
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28.Capoccia K, Odegard PS, Letassy N. Medication Adherence with Diabetes Medication: A Systematic Review of the Literature. Diabetes Educ. 2016;42(1):34-71. doi: 10.1177/0145721715619038.
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41. Lee YS, Jun HS. Anti-diabetic actions of glucagon-like peptide-1 on pancreatic beta-cells. Metabolism. 2014;63(1):9-19. doi: 10.1016/j.metabol.2013.09.010
42. Pi-Sunyer X, Astrup A, Ken Fujioka, M.D., et al. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. N Engl J Med. 2015; 373(1):11-22. doi: 10.1056/NEJMoa1411892
43. Wilding JP, Batterham RL, Calanna Sl, et al. Once Weekly Semaglutide in in Adults with Overweight or Obesity. N Engl J Med. 2021;384(1):989-1002. doi: 10.1056/NEJMoa2032183
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45. Raja H, Ebrahim S, Mamidanna R, et al. Association between preoperative glucose-lowering medication agents and the status of type 2 diabetes mellitus after bariatric surgery. Br J Diabetes 2023;23:31-34. doi: https://doi.org/10.15277/bjd.2023.409
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47. Chan JC. SGLT2 Inhibitors: The Next Blockbuster Multifaceted Drug? Medicina. 2023;59(2):388. doi:10.3390/medicina59020388
48. Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015; 373(22):2117-2128. doi: 10.1056/NEJMoa1504720
49. Neal, B, Perkovic V, Mahaffey KW, et al. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med. 2017; 377:644-657. doi:10.1056/NEJMoa1611925
50. Wiviott, SD, Raz I, Bonaca MP. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019; 380(4):347-357. doi: 10.1056/NEJMoa1812389
51. Fonseca-Correa JI, Correa-Rotter, R. Sodium-Glucose Cotransporter 2 inhibitors Mechanisms of Action: A Review. Front Med (Lausanne). 2021:8:777861. doi: 10.3389/fmed.2021.777861
52. Chesterman T, Thynne TR. Harms and benefits of sodium-glucose co-transporter 2 inhibitors. Aust Prescr. 2020:43:168-171. doi: 10.18773/austprescr.2020.049
53. Pyke C, Heller RS, Kirk RK, et al. GLP-1 receptor localization in monkey and human tissue: Novel distribution re-vealed with extensively validated monoclonal antibody. Endocrinology. 2014; 155(4):1280–1290. doi: 10.1210/en.2013-1934
54. Sun F, Wu S, Guo S, et al. Impact of GLP-1 receptor agonists on blood pressure, heart rate and hypertension among patients with type 2 diabetes: a systematic review and network meta-analysis. Diabetes Res. Clin Pract. 2015;110(1):26-37. doi: 10.1016/j.diabres.2015.07.015
55. Gutzwiller JP, Tschopp S, Bock A., Drewe J, Beglinger C, Sieber CC. Glucagon-like peptide-1 induces natriuresis in healthy subjects and in insulin-resistant obese men. J Clin Endocrinol Metab. 2004;89(6):3055–3061. doi: 10.1210/jc.2003-031403
56. MA X, Liu Z, Ilyas I, et al. GLP-1 receptor agonists (GLP-1RAs): cardiovascular actions and therapeutic potential. Int J Biol Sci. 2021;17(8): 2050–2068. doi: 10.7150/ijbs.59965
57. Nachawi N, Rao PR, Makin V. The role of GLP-1 receptor agonists in managing type 2 diabetes. Clevel Clin J Med. 2022:89(8) 457-464. doi: https://doi.org/10.3949/ccjm.89a.21110
58. Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (RE-WIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019;394(10193):121-130. doi: 10.1016/S0140-6736(19)31149-3
59. Maroso SP, Bain SC, Consoli A, et al. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016; 375(19):1834-1844. doi: 10.1056/NEJMoa1607141
60. Maroso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016; 375(4):311-22. doi: 10.1056/NEJMoa1603827
61. ElSayed NA; Aleppo G; Aroda VR; on behalf of the American Diabetes Association. 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes-2023. Diabetes Care. 2023;46(Suppl 1):S158–S190. https://doi.org/10.2337/dc23-S010
62. Petrie JR, Guzik TJ, Touyz RM. Diabetes, Hypertension, and Cardiovascular Disease: Clinical Insights and Vascular Mechanisms. Can J Cardiol. 2018;34(5):575-584. doi: 10.1016/j.cjca.2017.12.005American Diabetes
63. Ettehad D, Emdin CA, Kiran A, et al. Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis. Lancet. 387(10022):957-967. doi: 10.1016/S0140-6736(15)01225-8
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65. De Boer IH, Bangalore S, Benetos A, et al. Diabetes and hypertension: a position statement by the Ameri-can Diabetes Association. Diabetes Care. 2017;40:1273–1284. https://doi.org/10.2337/dci17-0026
66. Iliescu R, Lohmeier TE, Tudorancea I, Laffin L, Bakris GL. Renal denervation for the treatment of resistant hyperten-sion: review and clinical perspective. Am J Physiol Renal Physiol. 2015;309(7): F583–F594. doi: 10.1152/ajprenal.00246.2015
67. Bangalore S, Fakheri R, Toklu B, Messerli FH. Diabetes mellitus as a compelling indication for use of renin angioten-sin system blockers: systematic review and meta-analysis of randomized trials. BMJ. 2016;11:352: i438. doi: 10.1136/bmj.i438
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72. McAllister DA, Read SH, Kerssens J, et al. Incidence of Hospitalization for Heart Failure and Case-Fatality Among 3.25 Million People With and Without Diabetes Mellitus. Circulation. 2018;138(24):2774–2786. https://doi.org/10.1161/CIRCULATIONAHA.118.034986
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74. De Boer IH, MD, MS; Rue TC, MS; Hall YN, MD; et al. Temporal Trends in the Prevalence of Diabetic Kidney Dis-ease in the United States. JAMA. 2011;305(24):2532-2539. doi:10.1001/jama.2011.861
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The Human-Animal Bond: How Close Is Too Close? – RECORDED WEBINAR

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 1.0 CE Hour for completing the activity (ACPE UAN 0009-0000-24-021-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.

The Human-Animal Bond: How Close is Too Close?

Recognize and describe different zoonotic diseases: Rabies, Lyme Disease, Ringworm (Dermatophytosis), Leptospirosis, Giardia, and Toxoplasmosis
Describe method of transmission of each disease
List the treatment of each disease (if possible)
Indicate the species of animal that can harbor the disease
Describe how to prevent the disease

1. At what age is the earliest a dog or cat can receive the rabies vaccination?
A. 8 weeks
B. 6 months
C. 12 weeks

2. What is the symptom of Lyme Disease in dogs that owners tend to notice first?
A. Shifting lameness
B. Vomiting
C. Increased thirst and urination (PUPD)

3. What is the best way to prevent most zoonotic infections?
A. Avoid wildlife
B. Use essential oils
C. Wash your hands

4. What antibiotic do veterinarians use most often to treat Spirochete bacterial infections?
A. Doxycycline
B. Clindamycin
C. Amoxicillin-clavulanic Acid

5. How are most zoonotic intestinal parasites are spread?
A. Aerosolized
B. Infection through break in the skin
C. Fecal-oral

6. What zoonotic disease causes an itchy, circular red lesion on the skin?
A. Lyme disease
B. Ringworm
C. Leptospirosis

7. What species most commonly carries toxoplasma?
A . Cats
B. Dogs
C. Ferrets

Law: People are not Cows and Off-label Prescribing is Utterly Different – RECORDED WEBINAR

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 1.0 CE Hour for completing the activity (ACPE UAN 0009-0000-24-018-H03-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.

1. Off label drug uses generally do not become on-label uses. What is a primary reason for this?
A. There is a financial disincentive to manufacturers.
B. The FDA has no easy mechanism to accomplish this.
C. Manufacturers want to emphasize their drug’s primary.

2. You have a sick cow. Which of the following is correct about the type of drug that can be used for treatment?
A. Any drug approved by the FDA for human use.
B. A drug approved for use in chickens if there is no comparable drug approved for cows.
C. A drug that can be compounded by a pharmacist and added to the cow's feed.

3. What category of drugs has the highest rate of off-label use? (Prior to the pandemic.)
A. Anti-seizure drugs
B. Anti-depressants
C. Antibiotics
4. Why does the FDA take a hands-off approach to off-label use?
A. The FDA is not permitted to prevent manufacturers from touting an unapproved use once a drug has been approved.
B. The FDA does not regulate the practice of medicine.
C. The FDA can only act after it receives information of unintended consequences from off-label use.

5. When may a pharmacist recommend an OTC human drug for an animal?
A. Under any circumstances so long as it is not a food animal.
B. When there is no comparable veterinary product available.
C. A pharmacist may not recommend a human OTC drug for use in an animal.

6. Which of the following is a notable risk associated with illicit use of xylazine?
A. Naloxone-resistant overdose
B. Whole body rash and desquamation
C. Respiratory depression

7. The FDA was sued for publishing a warning about the off-label use of ivermectin for COVID. What was the basis of the lawsuit?
A. The FDA cannot prevent physicians from prescribing a drug off-label and need not issue warnings.
B. The FDA's warning on ivermectin was erroneous and used misplaced humor to try to sway opinions.
C. In publishing warning overstepped the FDA’s authority and interfered with the doctor-patient relationship.

Compounding: Go Hog Wild: Creative (and Informed) Veterinary Compounding – RECORDED WEBINAR

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 1.0 CE Hour for completing the activity (ACPE UAN 0009-0000-24-019-H07-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.

1. Farmer Brown's large Maine Coon cat needs fluoxetine. Considering size, anatomy, and skin absorption, which animal would require a similar dose of fluoxetine transdermal gel?
A . A small terrier dog
B. A medium sized sphinx (hairless) cat
C. A large barn owl

2. Meow-Meow is a domestic American cat. She weighs 6.3 pounds, although she needs to gain at least 3 pounds. She needs medication for her heart condition, and the veterinarian wants to prescribe lisinopril 0.25 mg/kg once daily. YIKES! You calculate that Meow-Meow weighs 2.9 kg and needs a dose of 0.725 mg of lisinopril. Can you compound this dose?
A. No, the veterinarian needs to find a different medication
B. Yes, but it would be easier to give 1.5 mg every other day
C. Yes, because a commercial product is unavailable in this strength

3. Your 30-pound hound, Bosco, is begging to eat the food you left on your plate after dinner. In keeping with your house rule never to feed the dog from the table, you take your plate to the sink and get Bosco’s bowl. Which of the following things should you throw in the trash rather than feed to Bosco?
A. The piece of grilled, boned ribeye steak
B. The grapes and raisins on the salad
C. The plain baked potato with yogurt

4. Your client, Venice Marriot, needs to have a medication compounded for her teacup chihuahua Tokyo. She indicates that she and Tokyo prefer medications that are pink. After discussing the pros and cons of compounding with color, which food coloring should you use to make a pink oral solution?
A. Natural beet extract
B. FD&C Red No. 3
C. Neither

5. Which of these basic oral paste formulas would be best to use for Farmer Brown’s cat?
Ingredient Formula 1 Formula 2 Formula 3
Polyethylene glycol 300 65 grams 25 grams
Polyethylene glycol 3350 35 grams 25 grams 25 grams
Propylene glycol 50 grams 25 grams
Molasses (for horses) 50 grams

A. Formula 1
B. Formula 2
C. Formula 3

6. Which flavoring would be best suited for a picky Emperor penguin at Mystic Aquarium?
A. Orange or mango flavoring
B. Sardine or tuna flavors
C. Beef or liver flavoring

7. What Is the BEST way to improve pharmacy personnel’s knowledge of veterinary medications?
A. Pharmacies can be sure to have a veterinary drug handbook at the pharmacy and that the computer system flags veterinary precautions.
B. Pharmacists can complete a continuing education activity on veterinary pharmacy and require all other staff members to take it also.
C. Pharmacy owners and systems can take out extra liability insurance and pray that nothing happens to any animal that receives a prescription from their pharmacies.

Patient Safety: Teaching Old Dogs New Tricks: Dispensing for Companion Animals in Community Pharmacy – RECORDED WEBINAR

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 1.0 CE Hour for completing the activity (ACPE UAN 0009-0000-24-020-H05-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.

Animal Models of Disease: Barking up the Right Tree – RECORDED WEBINAR

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 1.0 CE Hour for completing the activity (ACPE UAN 0009-0000-24-022-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.

Acne Vulgaris Pathogenesis and Treatment

Acne vulgaris is common. It presents with inflammatory and non-inflammatory lesions primarily on the face and trunk. While acne vulgaris is not associated with mortality, it causes a great deal of physical and psychologic sequelae such as permanent scarring, poor self-image, depression, and anxiety due to the lesions’ prominence and appearance. Its direct costs including lost productivity exceed $3 billion annually in the United States. Patients may treat minor cases of acne vulgaris with topical therapies. The most used topical acne medications include retinoids, benzoyl peroxide, topical antibiotics, or a combination of two or all three of these drugs. Moderate to severe acne vulgaris often necessitates the addition of systemic therapies as an adjunct to existing topical regimens. Prescribers use oral antibiotics or hormonal medications to treat moderate to severe acne in conjunction with topical therapies, as tolerated. Isotretinoin is an oral systemic drug used for severe recalcitrant nodular acne. Isotretinoin is given as monotherapy and has a corresponding Risk Evaluation and Mitigation Strategy (REMS) program with which patients must comply due to the drug’s teratogenicity. Several other physical modalities and alternative medicines may be used for acne; however, the data is not robust enough to prioritize their use.

INTRODUCTION

Acne vulgaris is a chronic skin condition characterized by open or closed comedones (bumps) and the development of inflammatory papules, pustules, or nodules.¹ Papules are small, raised bumps; pustules are small, pus-filled bumps; and nodules are larger, solid lesions that extend into the deeper layers of the skin. Acne is among one of the most common skin disorders, frequently affecting adolescents and young adults. In the 2013 Global Burden of Disease study, acne vulgaris ranked second most burdensome skin disease among all skin diseases as measured by disability-adjusted life years.² Experts estimate acne’s prevalence in young adults to be between 35% to more than 90%, with males affected more often than females in this age category.³ Acne’s incidence generally declines with increasing age, and tends to exhibit a female predominance following adolescence, affecting up to 15% of women.⁴

While acne is not associated with mortality, several complications may arise such as hyperpigmentation, scarring, and negative psychosocial effects.³ A variety of treatment options are available for acne vulgaris, both over-the-counter (OTC) and prescription; product selection depends on lesion severity and patient-specific factors. Topical therapies are for milder cases, while systemic therapies are employed in more severe cases, typically in conjunction with topical treatments.

Pathogenesis of Acne

Acne vulgaris is a complex inflammatory disorder affecting the pilosebaceous unit of the skin, which is composed of the hair follicle and sebaceous gland (glands that secrete sebum, an oily substance that keeps skin from drying out).³ Acne’s pathogenesis involves several different host factors that lead to lesion formation. The four main contributing factors associated with acne development include hyperkeratinization of follicles, increased sebum production, Cutibacterium acnes bacteria, and inflammation.³

Increased sebum secretion from sebaceous glands, often stimulated by androgens, serves as a growth medium for C. acnes bacteria. This bacterium has the propensity to activate an immune response that subsequently triggers an inflammatory response. The inflammatory response results in the formation of inflammatory papules and pustules.

Acne vulgaris may have other etiologies aside from the four main biologic factors. Cutaneous lesions can occur by way of mechanical injury or skin trauma because of scrubbing, squeezing, or friction, referred to as acne mechanica.⁵ Additionally, an association exists between psychologic stress and increased acne severity. Genetics is another factor that may contribute to the development of acne. Studies have shown that individuals with close family members who have acne are at increased risk of developing the condition.³

Insulin resistance is also implicated in the formation of acne as it can stimulate androgen production and lead to increased serum levels of insulin-like growth factor-1 (IGF-1). Increased IGF-1 levels are linked to increased facial sebum excretion, which ultimately facilitates acne formation. Androgens contribute significantly in the development of acne as they stimulate the growth and secretory function of sebaceous glands, further increasing sebum production.³

Several dietary elements have been associated with acne, although the evidence is not robust. A reduced glycemic index or a glycemic load diet (i.e., a low carbohydrate diet with reduced intake of processed meats, added sugar, and refined grains) may reduce the quantity and severity of acne lesions by reducing free androgens and IGF-1 levels.⁶ Additionally, omega-3 fatty acids can decrease IGF-1 and inhibit pro-inflammatory leukotriene B₄, which potentially lessens the number of lesions. Conversely, milk and dairy products have been associated with an increase in acne lesions, likely due to their opposite effects on IGF-1 levels.³

In addition to dietary intake, the gut microbiome can impact acne development.⁶ A randomized, placebo-controlled double-blind study of 20 adult patients with acne showed promising results in acne improvements with probiotic supplementation over a 12-week period.⁷ While this preliminary data supports the use of probiotics for acne, more robust data is needed to confirm these findings.

Despite these dietary correlations, the relationship between acne and weight or body mass index (BMI) is uncertain. A large population-based study of about 600,000 adolescents in Israel found that obesity was inversely related to the development of acne.⁸Conversely, a smaller scale case-control study of adolescents with moderate to severe acne found a correlation between lower BMI and lower incidence of acne.⁹ As studies have yielded mixed results, a connection is unclear at this time.

Pretreatment Assessment

Prior to establishing a treatment plan, thorough assessment of the types of acne lesions and severity of those lesions is essential. Additionally, clinicians should consider potential contributing factors such as comedogenic skincare products (i.e., products that have a high likelihood of clogging pores), medications, or endocrine disorders. They should also consider the presence of complications such as scarring, hyperpigmentation, or presence and extent of psychologic distress when establishing treatment regimens and setting treatment goals.¹⁰ Anatomic location of the lesions is important to note as well.¹

Acne vulgaris lesions are either comedonal or papulopustular³:

Comedonal lesions are milder in severity and characterized by closed comedones, also known as “whiteheads,” or open comedones, also known as “blackheads.” Comedonal lesions are non-inflammatory and typically smaller than 5 mm in size, or smaller than the size of a pencil top eraser.
Papulopustular acne has a more inflamed presentation with relatively superficial papules or pustules, although still typically smaller than 5 mm in size.
Nodular acne is a more severe variation of papulopustular acne with deep-seated, inflamed and often tender, large papules or nodules.

While no universally accepted method of assessing acne grade or severity exists, several characteristics may differentiate between mild acne and more severe variants. Mild acne typically has limited skin involvement with scattered, small (less than 5 mm in size) comedonal lesions or inflamed papules. Mild acne also has an absence of near confluent skin involvement (defined as lesions that flow together) and no scarring or large nodules. Many visually prominent comedonal or inflammatory papulopustular lesions are characteristic of moderate to severe acne. Other features indicative of moderate to severe acne include the presence of large nodules, scarring, and involvement of multiple body areas.¹⁰

PAUSE AND PONDER: Since several treatments for acne are available over-the-counter (OTC), what is a reasonable regimen for mild acne using only OTC drugs?

Treatment for Mild Acne

The American Academy of Dermatology published guidelines for the management of acne vulgaris in 2016, and on January 30, 2024, the academy published an update to these guidelines in the form of a systematic review.^1,11 The updated guidelines offer evidence-based recommendations and several good practice statements for the management of acne vulgaris. The guidelines classify recommendations as strong, where the benefits clearly outweigh the risks, or conditional, where the benefits are closely balanced with risks and burden. Conditional recommendations apply to most patients, but the most appropriate action may differ depending on patient or other stakeholder values.¹¹

Topical medications—as monotherapy or in combination—are typically the initial treatment of choice for mild acne.¹¹For mild comedonal acne without inflammatory lesions, treatment with a topical retinoid is an appropriate choice.¹ Mild papulopustular and mixed acne may benefit from either a combination of a topical retinoid and topical antimicrobial or benzoyl peroxide and a topical antibiotic. Combining topical antibiotic treatment with benzoyl peroxide decreases the development of antibiotic resistance to C. acnes and improves treatment outcomes.¹⁰ The 2024 guidelines strongly recommend the following topical therapies for patients with acne based on moderate evidence: benzoyl peroxide, topical retinoids, and topical antibiotics (although not as monotherapy).¹¹

Topical Retinoids

Topical retinoids are routinely the initial treatment choice for mild comedonal acne. As vitamin A (retinol) derivatives, retinoids are important regulators of cell reproduction, proliferation (self-multiplication), and differentiation (specialization into specific cell types).¹² In comedonal acne, retinoids normalize follicular hyperkeratosis (excessive development of keratin in hair follicles which result in papules) and prevent formation of the microcomedo, the primary lesion of acne.¹⁰ Table 1 lists the four currently available topical retinoid therapies for acne vulgaris: adapalene, tazarotene, tretinoin, and trifarotene.

Table 1. Topical Retinoids for Acne Vulgaris^10,13

Medication	Usual Dosage	Available Dosage Forms	Common Adverse Effects
Adapalene	Apply to acne lesions once daily in the evening or before bedtime	Cream: 0.1% Gel: 0.1% (OTC), 0.3% Lotion: 0.1%	Local skin irritation: erythema (redness), skin scaling, xerosis (dryness), burning, and pruritus (itching); photosensitivity (light sensitivity)
Tazarotene		Cream: 0.05%, 0.1% Gel: 0.05%, 0.1% Foam: 0.1% Lotion: 0.045%	Local skin irritation: burning and stinging, contact dermatitis, erythema, pruritus, skin discoloration, skin inflammation, application site pain, and xerosis; photosensitivity
Tretinoin		Cream: 0.025% to 0.1% Gel: 0.01% to 0.05% Lotion: 0.05% Microsphere gel: 0.04% to 0.1%	Local skin irritation: peeling, xerosis, burning, stinging, erythema, and pruritus; photosensitivity
Trifarotene		Cream: 0.005%	Application site pruritus, skin irritation, and photosensitivity

OTC, over the counter.

Tretinoin, when used topically, reduces the likelihood of follicular epithelial cells from sticking together, and decreases microcomedone formation. Additionally, it can increase turnover of follicular epithelial cells and stimulates mitotic activity or cell division thereby causing expulsion of comedones.¹⁴ Tretinoin is available in various dosage forms including creams, gels, and lotions. Newer formulations of tretinoin such as microsphere gels release the medication more slowly and are generally less irritating.¹⁰

Patients should apply tretinoin to the affected area once daily at bedtime, 20 minutes following washing and drying of the face. Newer formulations are more stable, allowing patients to use them immediately following cleansing.¹⁴ Adverse effects of topical tretinoin, listed in Table 1, are typically most pronounced in the first month of therapy. Pharmacy teams should instruct patients to apply sunscreen in the morning to minimize photosensitivity (sensitivity to light), and guidelines recommend using sunscreen throughout the course of treatment with topical retinoids.¹

Adapalene is a retinoid-like drug that functions as a modulator of cell differentiation, keratinization (i.e., when the epithelial cells develop a hardened horn-like character), and inflammatory processes.¹⁵Adapalene is available as a cream, gel, and lotion applied topically at bedtime after cleansing. It is the only retinoid available without a prescription. Adapalene has demonstrated similar efficacy and superior tolerability compared to other retinoids.¹⁶

Tazarotene is a retinoid prodrug (i.e., inactive compound that turns into an active drug once metabolized) that reduces the number of inflammatory and non-inflammatory lesions in acne vulgaris.¹⁷ Patients apply tazarotene (a cream, gel, foam, or lotion) to the affected area once daily at bedtime after cleansing. The adverse effect profile is similar to that of other retinoids. While topical retinoid therapy is generally not recommended in pregnancy, this topical acne medication is contraindicated in pregnancy.

Trifarotene is a retinoic acid receptor (RAR) agonist with specific activity at the gamma subtype of RAR. RAR activation causes transcription of several genes that are responsible for cell differentiation and mediation of inflammation.¹⁸It is the first topical retinoid specifically studied in both facial and truncal acne, yielding favorable safety, tolerability, and efficacy data in patients with moderate acne.¹⁹ Trifarotene is available as a cream applied once daily in the evening or before bedtime.

Benzoyl Peroxide

Benzoyl peroxide is a topical oxidizing drug which kills the bacteria on the skin, halts the production of sebum, and breaks down the outermost layer of the skin. It has potential to improve both inflammatory and non-inflammatory acne lesions.²⁰ Benzoyl peroxide is available in a variety of dosage forms including creams, gels, washes, and foams and in several concentrations ranging from 2.5% to 10%, most of which are available OTC. Concentration-dependent irritation, staining, and bleaching of fabric and hair is a limiting factor in treatment with benzoyl peroxide. Pharmacists and technicians should inform patients that staining of towels and pillowcases is common when using this medication.

Irritation from benzoyl peroxide manifests as erythema, scaling, xerosis, or stinging, tightening, or burning sensations.¹⁰ Generally, lower concentrations (i.e., 2.5% to 5%), water-based, and wash-off products have better tolerability, particularly in patients with sensitive skin.¹ Presently, C. acnes shows no resistance to benzoyl peroxide, so addition of this medication to other regimens may further minimize development of antibiotic resistance.

Benzoyl peroxide is optimal for mild papulopustular acne with or without comedonal lesions. Patients may use benzoyl peroxide in conjunction with a retinoid or topical antibiotic, and several combination products are available by prescription only (described in Table 2). If using benzoyl peroxide in combination with tretinoin, patients should apply the medications at different times of the day to avoid oxidation or degradation of the tretinoin product (i.e., use benzoyl peroxide in the morning and tretinoin in the evening). Benzoyl peroxide application timing does not matter when co-administered with the tretinoin microsphere formulation or other retinoids.¹ The guidelines recommend using benzoyl peroxide one to three times daily, however, an increase in adverse effects such as dryness can occur with increased frequency of use. Usually, visible improvement occurs after about three weeks of benzoyl peroxide use, and maximal improvement is apparent after eight to 12 weeks.¹⁰

Table 2. Topical Combination Medications for Acne Vulgaris^10,13

Category	Medication	Usual Dosage
Benzoyl Peroxide and Topical Antibiotic	Benzoyl peroxide 5% / clindamycin 1% gel	Apply twice daily
	Benzoyl peroxide 5% / clindamycin 1.2% gel	Apply once daily in the evening
	Benzoyl peroxide 2.5% / clindamycin 1.2% gel	Apply once daily in the evening
	Benzoyl peroxide 3.75% / clindamycin 1.2% gel	Apply once daily in the evening
	Benzoyl peroxide 5% / erythromycin 3% gel	Apply twice daily
Antimicrobial and Retinoid	Clindamycin 1.2% / tretinoin 0.025% gel	Apply once daily in the evening
	Benzoyl peroxide 2.5% / adapalene 0.1% gel	Apply once daily in the evening
	Benzoyl peroxide 2.5% / adapalene 0.3% gel	Apply once daily in the evening
	Benzoyl peroxide 3% / tretinoin 0.1% cream	Apply once daily in the evening
Antimicrobial, Antibiotic and Retinoid	Benzoyl peroxide 3.1% / clindamycin 1.2% / adapalene 0.15% gel	Apply once daily

Topical Clindamycin

Clindamycin is an antibiotic used topically for acne vulgaris, most often in combination with benzoyl peroxide. The guidelines discourage monotherapy with topical antibiotics due to concerns for antibiotic resistance.¹¹ Clindamycin is available in numerous topical dosage forms including gels, solutions, lotions, foam, and pledgets (small cotton rounds with medication embedded) and comes co-formulated with several retinoid medications.

A meta-analysis comparing different topical treatments for acne demonstrated that gels containing benzoyl peroxide and clindamycin in combination were modestly more effective than benzoyl peroxide alone for the treatment of inflammatory acne lesions, superior to clindamycin alone, and resulted in faster improvement.²¹ Clindamycin is generally well tolerated when used topically, but irritation may occur as with any topical acne medication. Patients apply clindamycin to the affected area twice daily. Topical erythromycin is an alternative to clindamycin; however, reduced efficacy due to antibiotic resistance has limited its use.¹

Salicylic Acid and Azelaic Acid

Several alternative topical medications are available for patients with acne who are unable to tolerate retinoid therapy. Topical salicylic acid is a comedolytic medication (product which resolves papules and prevents formation of new ones) with mild anti-inflammatory properties that works by causing desquamation (shedding) of the horny layer of skin.²² It is available OTC in a variety of different gels, washes, pads, masks, lotions, and solutions. The guidelines conditionally recommend salicylic acid for patients with acne based on low certainty of evidence.¹¹Salicylic acid is typically dosed once daily, however patients may increase to two or three times daily if needed, as tolerated. Skin dryness and peeling may occur from using this medication, especially when used in excess.²³ For patients seeking an OTC resolution for acne, pharmacists can suggest salicylic acid in combination with benzoyl peroxide.

Azelaic acid is an effective treatment for acne due to its antimicrobial and antikeratinizing effects on the follicular epidermis and carries a conditional recommendation based on the guidelines.^24,11 Azelaic acid possesses mild anti-inflammatory properties and can improve acne-induced, post-inflammatory hyperpigmentation.¹⁰ Patients apply this medication to the affected area twice daily, and it comes formulated as a cream, gel, and foam. Studies have shown that azelaic acid’s efficacy is comparable to other topical acne treatments, and it is generally well tolerated. Azelaic acid’s most common adverse effect, as with other topical acne medications, is local skin irritation.^25,26

Alternative Therapies for Resistant Disease

In patients who report insufficient improvement with first line treatments, providers may consider several additional topical options before starting systemic therapy. For comedonal acne, providers may try an alternative concentration of the retinoid therapy if there is room to increase, or switch to another retinoid drug if the current medication is already maximally dosed. For papulopustular acne, providers may change the retinoid medication or add concomitant benzoyl peroxide and/or a topical antibiotic, if desired. Alternative approaches to managing papulopustular acne involve the addition of topical dapsone, clascoterone, or topical minocycline.¹⁰ Table 3 lists antimicrobial therapies and additional alternative topical medications available for the treatment of acne vulgaris.

Table 3. Antimicrobial Therapies and Alternative Topical Medications used for Acne Vulgaris^10,13

Category	Medication	Usual Dosage	Available Dosage Forms	Common Adverse Effects
Antimicrobial	Benzoyl Peroxide	Apply one to three times daily	2.5 to 10% gels, lotions, creams, pads, masks, cleansers, foam (most are OTC)	Local skin irritation
	Clindamycin	Apply twice daily	1% gel, lotion, pledget, solution, foam	Generally well tolerated, skin irritation may occur
	Dapsone	Apply once daily	Gel: 5%, 7,5%	Application site dryness and pruritus
	Erythromycin	Apply twice daily	2% gel, solution, pledget	Generally well tolerated, skin irritation may occur
	Minocycline	Apply once daily 1 hour prior to bed	Foam: 4%	Headache
Topical Androgen Receptor Inhibitor	Clascoterone	Apply twice daily	Cream: 1%	Scaling, dryness, edema, or irritation of skin; HPA axis suppression
Other	Azelaic acid	Apply twice daily	Cream: 20%	Local skin irritation
			Gel: 15%
			Foam: 15%
	Salicylic acid	Apply one to three times daily	0.5 to 2% creams, gels, pads, cleansers, solutions, soaps, pledget, foam (most are OTC)	Local skin irritation including transient stinging, burning, or pruritus; potential for salicylate absorption

HPA, hypothalamic-pituitary-adrenal; OTC, over the counter.

PAUSE AND PONDER: What factors could contribute to the higher prevalence of acne in males during adolescence?

Topical dapsone is an antimicrobial agent that shows modest to moderate efficacy, particularly in the reduction of inflammatory acne lesions in clinical trials.^27,28 While dapsone’s mechanism of action is poorly understood, it is thought to possess both anti-inflammatory and antimicrobial properties. Additionally, dapsone has demonstrated superior efficacy in females as opposed to males.²⁹ Dapsone may be used in combination with benzoyl peroxide, however due to the potential for oxidation, patients must apply the medications at different times. Temporary yellow or orange discoloration of the skin and hair may occur if patients apply dapsone and benzoyl peroxide simultaneously. Patients apply dapsone to the affected area once daily and generally tolerate it well. Unlike with oral dapsone therapy, testing for glucose-6-phosphate dehydrogenase is unnecessary.¹

Clascoterone is a first-in-class topical androgen receptor inhibitor indicated for the treatment of acne vulgaris in individuals aged 12 years and older.³⁰ This medication competes with dihydrotestosterone (DHT) for androgen receptors to block DHT from binding to these receptors. This in turn reduces the transcription of androgen-responsive genes that modulate inflammation and sebum production.³⁰ Two phase 3 randomized clinical trials demonstrated that clascoterone has a similar safety profile to placebo without any downstream systemic androgenic effects.³¹ Patients apply clascoterone to the affected area twice daily. Clascoterone’s most common adverse effects include scaling, dryness, edema, or irritation of skin. Another, more serious potential adverse effect is hypothalamic-pituitary-adrenal axis suppression (i.e., inadequate cortisol production leading to impaired stress response).¹⁰Currently, clascoterone carries a conditional recommendation for the treatment of acne; this is based on a high certainty of evidence, however, also considers cost and access to treatment.¹¹

Treatment for Moderate to Severe Acne

Patients with moderate to severe acne may benefit from topical therapy, but this disease severity often necessitates the addition of systemic medications to achieve optimal outcomes. The guidelines recommend several different oral medications for acne vulgaris including antibiotics, isotretinoin, and hormonal medications, listed in Table 4.¹ Prescribers usually employ systemic therapy in combination with topical medications, but they use oral isotretinoin as monotherapy. Drug selection is based on lesion severity and consideration of patient-specific factors.

Table 4. Systemic Therapies for Acne Vulgaris^10,13

Category	Medication	Usual Dosage	Common Adverse Effects
Tetracycline Antibiotics	Doxycycline	Immediate Release: 50 to 100 mg twice daily or 100 mg once daily Delayed Release: 100 mg every 12 hours for 1 day, then 100 mg once daily Sub-antimicrobial dosing: Immediate Release: 20 mg twice daily Delayed Release: 40 mg once daily	Photosensitivity, GI distress, pseudotumor cerebri; contraindicated in pregnancy and children < 8 years of age
	Minocycline	Immediate Release: 50 or 100 mg daily or twice daily Extended Release: 1 mg/kg/day (round to nearest available strength)	Dizziness, vertigo, serum sickness, drug-induced lupus, skin discoloration, pseudotumor cerebri; contraindicated in pregnancy and children <8 years of age
	Sarecycline	33 to 54 kg: 60 mg once daily 55 to 84 kg: 100 mg once daily 85 to 136 kg: 150 mg once daily	Photosensitivity, GI distress; contraindicated in pregnancy and children <8 years of age
Macrolide Antibiotics	Azithromycin	Pulse dosing due to long drug half-life; 500 mg 1–3 times per week or 4 times monthly was studied, optimal regimen unknown	GI distress
Macrolide Antibiotics	Erythromycin	250 to 500 mg twice daily initially, then decrease to once daily	GI distress
Aldosterone Receptor Antagonists	Spironolactone	50 to 100 mg/day in 1 or 2 equally divided doses	Menstrual irregularity, breast tenderness, minor GI symptoms, orthostatic hypotension, hyperkalemia, dizziness, headaches, fatigue; contraindicated in pregnancy
Oral Retinoids	Isotretinoin	0.5 mg/kg/day, increasing to 1 mg/kg/day in 1 or 2 equally divided doses; total dose 120 to 150 mg/kg over 20 weeks	Dry skin and mucous membranes, visual changes, myalgia, hypertriglyceridemia, elevation of hepatic enzymes; teratogenic (absolutely contraindicated in pregnancy)
Combination Oral Contraceptives	Various estrogen/progestin combinations	One tablet once daily	Nausea, breast tenderness, weight gain, thromboembolic events

GI, gastrointestinal.

Oral Antibiotics

Systemic antibiotics are indicated for moderate to severe inflammatory acne.¹ Antibiotics reduce inflammation by inhibiting the growth of C. acnes bacteria, with some antibiotics also exhibiting direct anti-inflammatory properties.When initiating oral antibiotic therapy for acne, prescribers should limit the duration of treatment to the shortest necessary interval to minimize antibiotic resistance; continuous therapy for three or four months is typically sufficient.³² The guidelines recommend simultaneous use of a topical retinoid with the oral antibiotic. Addition of topical benzoyl peroxide will further limit occurrence of antibiotic resistance.³²

Tetracycline antibiotics are first-line medications for the treatment of acne vulgaris.¹ While other antibiotics may be used when treatment fails or is not tolerated, treatment with non-antibiotic systemic medications (e.g., isotretinoin) is typically considered first.³² Tetracycline antibiotics inhibit protein synthesis by binding the 30S subunit of the bacterial ribosome, and they also possess anti-inflammatory properties.¹Children younger than eight years old and patients who are pregnant cannot use tetracyclines due to the potential for discoloration of developing permanent teeth. Doxycycline, minocycline, and sarecycline are the main tetracyclines used for acne in the United States (U.S.). Providers no longer use tetracycline itself for acne due to tolerability issues, antibiotic resistance, and limited availability.

The guidelines strongly recommend doxycycline for acne vulgaris based on moderate evidence.¹¹ The typical recommended dose of doxycycline for acne is 100 mg twice daily. Patients take delayed release tablets once daily after the initial loading dose.³³ Several studies have also shown that sub-antimicrobial dosing of doxycycline—either 20 mg twice daily or 40 mg once daily of the delayed-release formulation—is an effective strategy for acne vulgaris management.^34-36 This dosing strategy eliminates the drug’s antibacterial action while maintaining its anti-inflammatory effects. Data shows that once daily 40 mg delayed-release doxycycline reduced inflammatory lesions and was better tolerated than doxycycline 100 mg once daily.³⁴ Doxycycline’s most common adverse effects are gastrointestinal complaints, which patients can mitigate by taking the medication with food. Photosensitivity and benign increased intracranial pressure (pseudotumor cerebri) have also been associated with the use of tetracyclines, including doxycycline.³³

Minocycline is a tetracycline antibiotic that the guidelines conditionally recommended for the treatment of acne vulgaris based on moderate evidence.¹¹ Although minocycline is effective, it has been associated with greater toxicity than doxycycline, so it is not usually used first.³⁷ Typical minocycline dosing is 50 mg to 100 mg twice daily, or 1 mg/kg/day of the extended-release formulation. Minocycline may produce vestibular adverse effects such as headache, dizziness and vertigo, serum sickness, and pseudotumor cerebri. According to a systematic review, minocycline is the only tetracycline associated with the development of lupus erythematosus, although the risk is small.³⁷ Photosensitivity may also occur with minocycline but typically to a lesser extent than with doxycycline.³²

Sarecycline is a newer, narrow-spectrum tetracycline antibiotic indicated for inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.³⁸ The guidelines conditionally recommended this medication based on high certainty evidence.¹¹ A narrow-spectrum antibiotic targets specific types of bacteria, while a broad-spectrum antibiotic is effective against a wide range of bacteria. Using this narrow-spectrum drug reduces the potential for antibiotic resistance and gut microbiome disruption.³² Sarecycline dosing is weight-based ranging from 60 mg to 150 mg once daily.³⁸ Importantly, studies have not established sarecycline’s efficacy beyond 12 weeks or safety beyond 12 months. Sarecycline’s most common adverse effect in clinical trials was nausea.³⁸

Alternative antibiotics for acne vulgaris are reserved for patients who cannot tolerate or don’t respond well to tetracyclines and are not candidates for other systemic therapies.³² Clinical trials have evaluated macrolides—including erythromycin and azithromycin—for acne. A meta-analysis comparing the efficacy of azithromycin to doxycycline demonstrated that azithromycin pulse therapy (i.e., 500 mg one to three times per week or four times monthly) is equivalent to doxycycline 100 mg once or twice daily at 12 weeks in moderate to severe acne vulgaris.³⁹ While some data supports their efficacy, macrolides are rarely used for this indication due to concerns for antibiotic resistance.⁴⁰ Additionally, erythromycin is very poorly tolerated due to significant gastrointestinal adverse effects.

Other antibiotic regimens that may be effective for acne in adults are trimethoprim-sulfamethoxazole 160 mg/800 mg once to twice daily and cephalexin 500 mg twice daily, but data supporting their use is limited.⁴¹ The guidelines discourage using these antibiotics for acne due to increased risk of antibiotic resistance.¹

Topical Antibioitcs

Providers may consider topical minocycline as an alternative topical antibiotic for acne vulgaris in moderate to severe cases. Topical minocycline comes as a 4% foam and is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.⁴² Three large clinical trials have shown topical minocycline foam consistently reduces inflammatory acne lesions.^43,44 Patients apply the medication to the affected area at the same time each day at least one hour before bedtime. Pharmacists should inform patients that minocycline foam is well tolerated, with headache being the most notable adverse effect.⁴²

Isotretinoin

Isotretinoin is an oral retinoid that tackles all four major factors in acne pathogenesis: sebum production, follicular hyperkeratinization, inflammation, and C. acnes bacteria. Isotretinoin is U.S. Food and Drug Administration (FDA) approved for the treatment of severe recalcitrant (refractory) nodular acne vulgaris.³²This medication is also a good option for moderate acne resistant to other treatments or for the management of acne that has produced physical scarring or psychosocial distress.¹ Oral isotretinoin is the only medication that can permanently alter the natural course of acne vulgaris, and has the potential to induce long-term remission.³² Most patients experience long-term improvement in acne severity after just one course of isotretinoin. Additionally, continued improvement may occur for several months following completion of the treatment course, so patients must wait at least five months before considering additional isotretinoin therapy.⁴⁵

Patients take isotretinoin as monotherapy over the course of several weeks. Dosing is weight-based starting at 0.5 mg/kg/day in two divided doses, then titrated up to 1 mg/kg/day after the first month. The typical treatment duration is 15 to 20 weeks or until the total nodule count decreases by more than 70%, whichever occurs first.⁴⁶ Taking the medication with food improves absorption (an important counseling point). Isotretinoin is contraindicated in pregnancy due to its teratogenicity (causes birth defects), but it is unclear whether teratogenic effects occur in sperm from males using isotretinoin.⁴⁷ All patients who are prescribed the medication, prescribing providers, and pharmacies who dispense isotretinoin must enroll in the iPLEDGE REMS to receive the medication. Pharmacy teams play an integral part in ensuring patients can safely obtain this medication. They must verify that both the patient and provider are enrolled, obtain a Risk Management Authorization (RMA) number prior to filling and dispensing each prescription, and that no more than a 30-day supply is dispensed. Additionally, upon authorization, the iPLEDGE REMS website provides a “do not dispense to patient after” date. It is calculated as 30 days after the office visit for patients who cannot get pregnant, and seven days from the documented negative pregnancy test for patients who can.

Isotretinoin is associated with several potential adverse effects including dry skin and mucous membranes, visual changes, and myalgia. Additionally, patients, particularly those with severe disease, may see an initial transient worsening of acne that requires adjustment to therapy.⁴⁵ Isotretinoin is known to cause hyperlipidemia and elevation of hepatic transaminases (liver enzymes) necessitating lab monitoring.³² Some research suggests a possible link between depression and suicidal ideation, but the data is inadequate to establish causality at this time.^48,49 Researchers have also suggested a link between isotretinoin and inflammatory bowel disease, but several large cohort studies have not confirmed this.^50-52

PAUSE AND PONDER: What would be the best course of action for a pregnant patient with acne?

Oral Hormonal Therapies

Combination oral contraceptives (COC) and/or spironolactone may be reasonable therapeutic options for patients with acne vulgaris assigned female sex at birth. Both therapies carry a conditional recommendation for use in acne based on moderate evidence.¹¹ These hormonal therapies work by reducing the androgenic effects on sebaceous glands, reducing sebum production. This can ultimately diminish comedone development and minimize C. acnes bacteria growth.³²

COCs containing an estrogen and progestin are effective therapies for acne vulgaris in female patients. Although most progestins in oral contraceptives have androgenic properties, all low-dose COCs are estrogen dominant and produce an overall antiandrogenic effect.³² The four COCs with an FDA approval for the treatment of acne vulgaris are

drospirenone 3 mg/ethinyl estradiol 0.02 mg
drospirenone 3 mg/ethinyl estradiol 0.02 mg/levomefolate calcium 0.451 mg
norethindrone acetate/ethinyl estradiol/ferrous fumarate (triphasic formulation, meaning dose differs by the week)
norgestimate/ethinyl estradiol (triphasic formulation)

These are all approved for patients with acne vulgaris who also desire contraception.¹³

COCs for acne are not for use in patients who are younger than 14 years of age or within the first two years of starting menses unless it is clinically warranted.¹Other contraindications to COCs exist, including smokers aged 35 and older and patients with select cardiovascular and gastrointestinal comorbidities.¹¹ COCs may be used in combination with other oral acne medications, including the tetracyclines and spironolactone.¹ All COCs are associated with cardiovascular risks including thromboembolism and myocardial infarction, specifically in smokers. Additionally, they carry a potential risk of breast cancer and cervical cancer.¹³Providers do not use progestin-only contraceptives for acne vulgaris as their androgenic properties may exacerbate acne.³²

Spironolactone is an aldosterone receptor antagonist with potent antiandrogen activity. It decreases testosterone production and competitively inhibits binding of testosterone and DHT to androgen receptors. Spironolactone may also inhibit 5-alpha-reductase (the enzyme that converts testosterone to DHT) and increase steroid hormone binding globulin (a protein that binds to estrogens and androgens).¹While spironolactone is not FDA approved for acne, clinicians often use it off-label based on available evidence and expert opinion.^53-55 When used for acne, spironolactone is dosed at 50 mg to 100 mg in one or two equally divided doses. Patients generally tolerate it well, and the most common adverse effects include diuresis (increased urination), menstrual irregularities, breast tenderness, breast enlargement, fatigue, headache, and dizziness.¹ It is also important to note that spironolactone is a potassium-sparing diuretic and hyperkalemia (high potassium levels) may occur when given at high doses or in patients with comorbidities such as renal insufficiency or severe heart failure. Hyperkalemia can be serious, but young, healthy patients taking spironolactone for acne do not appear to be at significant risk for hyperkalemia and don’t require monitoring.^11,32

Rare, Severe Acne Variants

Acne Fulminans

Acne fulminans is a rare form of acne vulgaris characterized by the sudden development of large, inflammatory nodules and friable (fragile) plaques with erosions, ulcers, and hemorrhagic crusts. This may occur with or without systemic symptoms such as fever, malaise, bone pain, and arthralgias.³ These lesions typically present on the trunk; however, they may occur elsewhere. Isotretinoin can trigger acne fulminans, but some cases are idiopathic (no known cause). Acne fulminans typically occurs in adolescent males with preexisting acne vulgaris.³

Treatment for acne fulminans involves using oral corticosteroids, usually prednisone 0.5 mg to 1 mg/kg/day, in combination with isotretinoin. If isotretinoin precipitated acne fulminans, prescribers must stop this medication and proceed with corticosteroid monotherapy for four weeks in patients with systemic symptoms and for two weeks for patients without systemic symptoms. When acne fulminans resolves, patients may restart isotretinoin in conjunction with the oral corticosteroid for at least four weeks before gradually titrating isotretinoin up as tolerated and reducing the corticosteroid dose. Providers may consider combination therapy with oral corticosteroids and tetracyclines for acne fulminans, but it is less effective.³²

Acne Conglobata

Acne conglobata is a severe form of nodular acne that primarily affects males. Large draining lesions, sinus tracts (linear, burrowing lesions resulting when multiple nodules merge), and severe scarring are characteristic of acne conglobata. Unlike acne fulminans, acne conglobata is not associated with systemic symptoms.³The recommended treatment is oral isotretinoin, but isotretinoin may also occasionally cause severe flares at the start of therapy. Similar to the treatment for acne fulminans, low initial doses of isotretinoin (0.5 mg/kg per day or less) with oral corticosteroids before or during isotretinoin therapy are usually required.³² Intralesional glucocorticoid injections with triamcinolone acetonide have demonstrated efficacy as an adjunct treatment for severe nodular acne lesions.^1,11Additionally, tetracycline antibiotics have been used for severe nodular acne and may play a role in the treatment of acne conglobata, but they cannot be combined with isotretinoin due to the increased risk of pseudotumor cerebri.⁵⁶ Case reports supporting the use of tumor necrosis factor-alpha inhibitors (i.e., etanercept, adalimumab, and infliximab) have been documented, but more research is needed.^57-59

Physical Modalities and Complementary and Alternative Medicine

While various physical modalities have been employed to treat acne vulgaris, limited evidence supports these approaches in the peer-reviewed medical literature.¹ Comedeo extraction performed by a professional using pressure and excision when necessary to physically remove comedones may be beneficial in resistant cases and is often used in practice. Use of topical tretinoin cream for four to six weeks prior to extraction may be advantageous.²³

Several studies suggest that chemical peels may improve acne mildly, particularly in patients with non-inflammatory comedonal lesions.^60-62 However, more large-scale, high-quality double-blinded placebo-controlled trials are needed. Additionally, evidence suggests the need for multiple treatments, and the results may not be long-lasting.^23,60 Most chemical peels contain glycolic acid or salicylic acid.¹Patients who are taking isotretinoin are not candidates for a chemical peel due to the increased potential for irritation. Pharmacists should counsel patients using topical retinoids to pause therapy for several days prior to receiving a chemical peel.²³

Microdermabrasion is a non-invasive superficial peeling modality in which abrasive crystals are propelled onto the skin and subsequently suctioned with a vacuum device, resulting in exfoliation of the outermost layer of the epidermis.²³ A pilot study conducted in a cohort of 24 patients supports the use of microdermabrasion for acne, but these patients continued to take other acne medications throughout the study.⁶³High-quality evidence to support the effectiveness of microdermabrasion for acne is lacking.

Laser and light-based therapies have been used to treat acne, but additional studies are needed to evaluate their efficacy.⁶⁴ Dermatologists have used intense pulsed light, broad-spectrum continuous-wave visible light (i.e., blue light and red light), photodynamic therapy, photopneumatic technology, and laser sources such as potassium titanyl phosphate laser, pulsed dye laser, and infrared lasers.²³The guidelines conditionally recommend against adding pneumatic broadband light to adapalene 0.3% gel based on low certainty evidence, however available evidence is insufficient to establish recommendations for other light-based therapies.¹¹

Photodynamic therapy shows the most promise compared to the other laser and light therapies.⁶⁵With this modality, the dermatologist applies a photosensitizer, such as aminolevulinic acid, to the affected skin for 15 minutes to three hours.¹ The skin then absorbs the photosensitizer where sebocytes (sebum-producing epithelial cells) absorb it preferentially. Subsequently, a laser or light device activates the photosensitizer that generates singlet oxygen species, damaging the sebaceous glands and reducing C. acnes bacteria. While this treatment has great potential, additional research is necessary to determine the optimal photosensitizer, incubation time, and light source.¹

Complementary and Alternative Medicine

Tea tree oil, also known as melaleuca oil, is an essential oil produced by steaming the leaves of the Australian tea tree. Tea tree oil has been used for a variety of conditions and possesses both antimicrobial and anti-inflammatory properties.⁶⁶ Two clinical trials assessed tea tree oil’s effectiveness in acne vulgaris.^67,68 A placebo-controlled trial determined that topical 5% tea tree oil is effective for mild to moderate acne vulgaris.⁶⁷ A comparator trial compared tea tree oil to benzoyl peroxide for acne and demonstrated that tea tree oil is comparable to benzoyl peroxide with better tolerability but slower onset of action.⁶⁸ Pharmacists should note that tea tree oil may be a good option for patients seeking a more natural remedy for acne. While data supports its use, the guidelines state that available evidence is insufficient to develop a recommendation on the use of tea tree oil for acne.¹¹

Alpha hydroxy acids, such as glycolic acid and lactic acid, are weak organic acids that induce skin peeling to improve acne and hyperpigmentation among other dermatologic conditions. They are available over the counter in a variety of dosage forms (e.g., creams, washes, lotions) and are used in higher concentrations for in-office chemical peels.²³ Some preliminary evidence supports the use of alpha hydroxy acids for acne; however, they are thought to confer the most benefit when used synergistically as a component of a comprehensive acne regimen.⁶⁹

While conclusive studies supporting safety and efficacy are lacking, several marketed devices claim to improve acne using heat. These devices produce a pulse of heat directly to the lesion, which is thought to kill any C. acnes bacteria present and produce an anti-inflammatory effect. The FDA has cleared multiple devices for this purpose, meaning they have gone through a review process, but medical devices of this type do not undergo the rigorous FDA approval process that requires clinical trials.^{23, 70}

Conclusion

A variety of treatment options for acne vulgaris are available, and treatment selection is based on lesion severity and patient preference. Clinicians treat mild acne with topical medications, several of which are available OTC. Patients seeking OTC solutions may consider benzoyl peroxide, salicylic acid, or adapalene, and tea tree oil is an option for those seeking a more natural remedy. Topical therapies are often employed first for milder acne, however they are often beneficial as part of the treatment plan in more severe cases as well. Systemic medications such as antibiotics, hormonal medications, and isotretinoin treat moderate to severe acne. Pharmacy teams should ensure patients are aware of the potential for gastrointestinal symptoms with antibiotics and isotretinoin’s teratogenicity, among other potential adverse effects. Oral corticosteroids are appropriate for very severe cases involving relatively rare acne variants. Several other alternative therapies and physical modalities may be employed as part of the regimen for acne vulgaris, but more research is necessary to assess the safety and efficacy of these options.

Acne Vulgaris Pathogenesis and Treatment

Pharmacist Post-test

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

1) Describe the pathogenesis of acne, including the potential role of diet
2) Outline topical and systemic pharmacologic therapies used to treat acne
3) Identify physical modalities with utility in treating acne
4) Review available evidence supporting complementary and alternative medicine use for acne

1. What are the four main contributing factors implicated in the development of acne vulgaris?
A. Hypokeratinization of follicles, increased sebum production, C. acnes bacteria, and inflammation
B. Hyperkeratinization of follicles, increased sebum production, C. acnes bacteria, and inflammation
C. Hyperkeratinization of follicles, reduced sebum production, C. acnes bacteria, and inflammation

2. What dietary element is associated with an increase in acne lesions?
A. Dairy products
B. Omega-3-fatty acids
C. High fat diet

3. Jessica is a 14-year-old patient who presents with bothersome acne. She has primarily white heads and black heads and does not appear to have any inflammatory nodules. Which topical therapy would be MOST appropriate to start with as monotherapy?
A. Benzoyl Peroxide
B. Clindamycin
C. Tretinoin

4. What is the purpose of using benzoyl peroxide in addition to topical antibiotics for acne?
A. To reduce skin irritation
B. To improve the appearance of scarring
C. To reduce antibiotic resistance to C. acnes

5. Which topical retinoid is available over-the-counter without a prescription?
A. Adapalene
B. Tretinoin
C. Tazarotene

6. Which systemic medication is usually used as monotherapy for severe acne?
A. Tetracycline
B. Spironolactone
C. Isotretinoin

7. Matthew is a 17-year-old male who was taking minocycline for his moderate to severe acne. He experienced significant gastrointestinal symptoms, so he stopped taking it. What is the MOST reasonable option to consider next?
A. Doxycycline
B. Spironolactone
C. Isotretinoin

8. Which laser/light-based therapy shows the most promise for acne treatment?
A. Photodynamic therapy
B. Photopneumatic technology
C. Infrared lasers

9. Which of the following BEST describes acne conglobata?
A. A rare form of acne vulgaris characterized by sudden development of large, inflammatory nodules, and friable plaques
B. A severe form of nodular acne characterized by large draining lesions, sinus tracts, and severe scarring
C. A severe variation of papulopustular acne with deep-seated, inflamed, and often tender, large papules or nodules

10. Which alternative therapy originates from a plant source in Australia?
A. Tea tree oil
B. Glycolic acid
C. Lactic acid

Acne Vulgaris Pathogenesis and Treatment

Pharmacy Technician Post-test

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

2. What dietary element is associated with an increase in acne lesions?
A. Dairy products
B. Omega-3-fatty acids
C. High fat diet

3. Which topical acne treatment can cause bleaching of fabric and hair?
A. Tretinoin
B. Benzoyl peroxide
C. Adapalene

4. Which class of antibiotics is a first-line treatment for moderate to severe acne?
A. Penicillins (e.g., amoxicillin, ampicillin, dicloxacillin)
B. Tetracyclines (e.g., doxycycline, minocycline, sarecycline)
C. Macrolides (e.g., azithromycin, erythromycin)

5. Which topical retinoid is available over-the-counter without a prescription?
A. Adapalene
B. Tretinoin
C. Tazarotene

6. Which of the following is a non-invasive superficial peeling modality in which abrasive crystals are propelled onto the skin and subsequently suctioned within a vacuum device?
A. Photodynamic therapy
B. Chemical peel
C. Microdermabrasion

7. IPLEDGE is a Risk Evaluation and Mitigation Strategy (REMS) used for which acne medication, meaning this medication cannot be dispensed without the provider, patient, and pharmacy registering with this program?
A. Sarecycline
B. Isotretinoin
C. Trifarotene

8. Which laser/light-based therapy shows the most promise for acne treatment?
A. Photodynamic therapy
B. Photopneumatic technology
C. Infrared lasers

9. Which medications for moderate to severe acne can only be used to treat acne in individuals assigned female sex at birth?
A. Combined oral contraceptives and spironolactone
B. Combined oral contraceptives and isotretinoin
C. Spironolactone and isotretinoin

10. Which alternative therapy originates from a plant source in Australia?
A. Tea tree oil
B. Glycolic acid
C. Lactic acid

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62. Lee HS, Kim IH. Salicylic acid peels for the treatment of acne vulgaris in Asian patients. Dermatol Surg. 2003;29(12):1196-1199. doi:10.1111/j.1524-4725.2003.29384.x
63. Lloyd JR. The use of microdermabrasion for acne: a pilot study. Dermatol Surg. 2001;27(4):329-331. doi:10.1046/j.1524-4725.2001.00313.x
64. Barbaric J, Abbott R, Posadzki P, et al. Light therapies for acne. Cochrane Database Syst Rev. 2016;9(9):CD007917. Published 2016 Sep 27. doi:10.1002/14651858.CD007917.pub2
65. Boen M, Brownell J, Patel P, Tsoukas MM. The Role of Photodynamic Therapy in Acne: An Evidence-Based Review. Am J Clin Dermatol. 2017;18(3):311-321. doi:10.1007/s40257-017-0255-3
66. Carson CF, Hammer KA, Riley TV. Melaleuca alternifolia (Tea Tree) oil: a review of antimicrobial and other medicinal properties. Clin Microbiol Rev. 2006 Jan;19(1):50-62. doi: 10.1128/CMR.19.1.50-62.2006. PMID: 16418522; PMCID
67. Enshaieh S, Jooya A, Siadat AH, Iraji F. The efficacy of 5% topical tea tree oil gel in mild to moderate acne vulgaris: a randomized, double-blind placebo-controlled study. Indian J Dermatol Venereol Leprol. 2007;73(1):22-25. doi:10.4103/0378-6323.30646
68. Bassett IB, Pannowitz DL, Barnetson RS. A comparative study of tea-tree oil versus benzoylperoxide in the treatment of acne. Med J Aust. 1990;153(8):455-458. doi:10.5694/j.1326-5377.1990.tb126150.x
69. Tung RC, Bergfeld WF, Vidimos AT, Remzi BK. alpha-Hydroxy acid-based cosmetic procedures. Guidelines for patient management. Am J Clin Dermatol. 2000;1(2):81-88. doi:10.2165/00128071-200001020-00002
70. Badgwell Doherty C, Doherty SD, Rosen T. Thermotherapy in dermatologic infections. J Am Acad Dermatol. 2010;62(6):909-928. doi:10.1016/j.jaad.2009.09.055

Over-the-Counter (OTC) Medications and Devices Released within the Last Three Years

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

· Describe the significance of the availability of each recently released over-the-counter medication or device

· List the common uses or indications for each over-the-counter medication or device

· Explain the directions for use for each over-the-counter medication or device

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

· Describe the significance of the availability of each recently released over-the-counter medication or device

· List the common uses or indications for each over-the-counter medication or device

· Explain the directions for use for each over-the-counter medication or device

Demands on pharmacists have continued to increase over the past few years. Pharmacists feel confident about dispensing medications, but some do not feel equally as confident when recommending over-the-counter medications. It is important for pharmacists to stay informed about new over-the-counter medications and be able to counsel patients on the selection and use of these products. New over-the-counter medications released in the past few years include birth control, devices that detect heart arrhythmias, allergy remedies, and products to treat opioid overdoses.

INTRODUCTION

Self-care involves patients' ability to diagnose and treat their own illness without the help of a health care practitioner. Ninety-six percent of patients believe that over-the-counter (OTC) medications make it easy to care for these self-care conditions.¹Patients save $56.8 billion annually when they use OTC/nonprescription medications instead of prescription medications.² Pharmacists and pharmacy technicians are frequently consulted about different self-care conditions and the appropriate choice of OTC medications and devices.

PAUSE AND PONDER: Would you be able to recognize the symptoms of an overdose?

Naloxone Nasal Spray

The Center for Disease Control and Prevention (CDC) reported that there were 106,363 opioid-related deaths during a 12-month period ending in July 2023.³ The Food and Drug Administration (FDA) originally approved Naloxone to reverse an opioid overdose in 2015 as prescription only.⁴ It moved to OTC/nonprescription status in March 2023 through the FDA’s Rx-to-OTC switch process.^5,6 The manufacturer drove this change to nonprescription status by providing data showing that the drug is safe and effective and that consumers could understand how to use the product based on the proposed labeling.⁵

Naloxone (Narcan, Emergent BioSolutions) was the first OTC medication approved to reverse opioid overdose in community settings. Patients (who use prescription or illegal opioids), caregivers, family members, or friends can now purchase naloxone in community pharmacies, grocery stores, and online without a prescription.^5,7Based on Federal law, people of any age can purchase naloxone, but state laws may differ.⁷ Table 1 describes symptoms of an opioid overdose. The overdose can result from use of fentanyl, heroin, morphine, oxycodone, and other opioids. Naloxone works by blocking the opiate receptors in the brain so that the opiate cannot exert its effects. If it is not an overdose situation, patients will experience no effect.⁵

Table 1. Opioid Overdose Symptoms⁵

· Body aches

· Diarrhea

· Fever

· Goose bumps

· Increased blood pressure

· Increased heart rate

· Nausea or vomiting

· Restlessness or irritability

· Sweating

Naloxone nasal spray contains only one dose and is not reusable. It is available in a 4 mg dose. Observers or caregivers should administer naloxone as soon as possible when they suspect an overdose. The observer/caregiver should lay the patient down on his or her back with their neck supported and the head tilted back. The caregiver should remove the tab from the nasal spray. It does not need to be primed. Caregivers place their thumb on the bottom of the red plunger and the first and middle fingers around the nozzle. The caregiver then places the tip of the nasal spray inside the patient’s nose. They should press the red plunger to administer the medication. They can give additional doses every two to three minutes if needed. They should also call emergency services immediately.

During an overdose situation, the patient could experience withdrawal effects such as nausea, vomiting, sweating, tremors, shivering, or irritability.⁸ The cost is approximately $45 for two single doses.⁹

A Naloxone Nasal Spray Training Device is available for anyone that wants to learn how to administer the nasal spray. The kit contains instructions and two training devices. It does not contain active medication.¹⁰

In July 2023, the FDA approved a second OTC naloxone product. RiVive (Harm Reduction Therapeutics) contains 3 mg naloxone. This is also a Rx-to-OTC change supported by evidence demonstrating that the naloxone levels that reach the blood stream are similar in the prescription and nonprescription product.¹¹ The approximate cost is $36 for a twin pack.

PAUSE AND PONDER: How would you respond if a 13-year-old girl approached you and began asking questions about the norgestrel birth control? What questions would you ask?

Norgestrel 0.075 mg Tablets

In 2019, the CDC reported that 35.7% of pregnancies were unintended in women aged 15 to 44.¹²Unintended pregnancies may result in negative consequences due to a lack of early prenatal care and increased risk of preterm delivery.¹³Having norgestrel available without a prescription may help to reduce unintended pregnancies.¹⁴

Opill (Perrigo) is the first nonprescription oral contraceptive. Opill tablets contain norgestrel 0.075 mg, which is a progestin, or a form of progesterone. It is only used to prevent pregnancy; it does not protect against sexually transmitted diseases such as HIV. The American College and Obstetricians and Gynecologists and the American Medical Medication Association have endorsed this product. Women of any age can purchase Opill in community pharmacies, grocery stores, and online.^14,15

Norgestrel thickens the mucus in the cervix, preventing sperm from reaching the egg. The progestin may also inhibit ovulation, but not in all cases. Each pack contains 28 tablets, 24 active tablets that contain progestin and four inactive tablets that do not contain progestin. Norgestrel will begin working two days after the patient starts a pack and patients must take one tablet at the same time daily to be effective.

Missing tablets or not taking the tablets at the same time every day may reduce the birth control’s effectiveness and increase the chance of pregnancy. If a patient fails to take the tablet by three hours or more of her scheduled time, she should take the next tablet as soon as possible. In this case, she and her partner should also use condoms (or another backup method of birth control) or avoid sex (vaginal) for the next two days.¹⁵ Once a pack is completed, patients should start the next pack without any break in between.¹⁶ With typical use, the pregnancy rate is 9 in 100 during the first year of progestin-only tablets and for perfect use (never forgetting to take a tablet and taking the same time every day), the pregnancy rate is 1 in 100 women.¹⁵

Patients may experience side effects such as headache, dizziness, nausea, fatigue, cramps, or bloating.¹⁶ Progestin-only medications are contraindicated in women who have a history of lupus or breast cancer. Opill will be available on store shelves in March 2024. The suggested cost is $19.99 for a one month supply.¹⁷

OTC Hearing Aids

Approximately 30 million adults in the United States have some type of hearing loss.¹⁸ OTC hearing aids are credited for improving the quality of life in patients, according to a study in the Journal of the American Medication Association.¹⁹ The study used a previously validated model (Decision model of the Burden of Hearing Loss Across the Lifespan: DeciBHAL-US) and simulated the projected probability of hearing loss and the use of traditional and OTC hearing aids in 40- and 50-year old males and females. Use of OTC hearing aids resulted in a $70 to $200 savings over a lifetime. Patients also began using OTC hearing aids earlier in life compared to traditional hearing aids (77.6 versus 78.9 years respectively).¹⁹ The OTC Hearing Aid Act provided the opportunity for patients to purchase OTC hearing aid devices without a medical examination or the necessity of being fitted by a hearing aid specialist.

OTC hearing aids are approved for adults 18 years of age and older and can be purchased online or in stores.¹⁸OTC hearing aids are appropriate for patients with mild or moderate hearing loss. They are not appropriate for severe or profound hearing loss. OTC hearing devices have limits on the maximum output and would not treat severe hearing loss appropriately. Table 2 provides questions that a pharmacist might ask a patient regarding use of OTC hearing aids.

Table 2. Questions Pharmacists Should Ask Patient about OTC Hearing Aids²⁰

· Are you 18 years or older?

· Why do you think you need a hearing aid?

· Have you had your hearing tested either by a professional or by using an online tool?

· Do sounds appear muffled?

· Do you have trouble hearing in a group or a noisy area?

· Do you turn the television up to an excessively high level?

Patients wear OTC hearing aids behind or in the ear canal; implantation is not required. Sound is amplified in the ear canal and moved to the inner ear, where processing and transmission to the brain occurs.¹⁸

Patients should first test their hearing by using an online resource that is provided on the product’s website. Once the results are provided, patients can select the best product for their needs using online product selection tools, based on their brand name choice. Table 3 lists features of some OTC hearing devices.²¹

Table 3. Features of some OTC Hearing Devices²¹

· Advanced acoustics

· Bluetooth streaming

· Hands-free phone calling

· Rechargeable

· Water resistant

Brands include Jabra Enhance, Audicus, and MDHearing. Costs range from $200 to $1000 per pair.²² Some health insurance companies may provide coverage for OTC hearing devices based on specific brands.²³

Lidocaine 4% Patch

Lidocaine is a topical anesthetic and works by inhibiting nerve impulse conduction. It provides a numbing sensation and is used to treat minor pain. Areas that can be treated include the back, neck, shoulders, and knees/elbows.²⁴Lidocaine patches are not appropriate for areas of inflammation.²⁵

Lidocaine patches can be used on patients 12 years of age and older. Patients apply the patch to the affected area of the skin every six to eight hours and should not exceed three applications per day.¹The patch may fall off if exposed to water, so waiting until the patch is off is the best time to shower or swim. Patches should not be applied to damaged or broken skin.The patch should not be covered with a bandage or a heating pad because too much lidocaine may be absorbed through the skin.²⁵

After the patch is removed, it can be discarded in the trash after it’s folded in half (adhesive side in).²⁵ Common side effects include warmth or stinging.²⁶ This product should not be used longer than seven days.

Brand names include Salonpas (lidocaine 4%) Pain Relieving Gel Patch (approximate cost is $11 for 6 patches) and Aspercreme(lidocaine 4%) Lidocaine Pain Relief Patch (approximate cost is $10 for 3 patches).²⁴ Pharmacists and technicians should pay careful attention to brand name products with different ingredients. Salonpas Pain Relieving Patch contains camphor, methyl salicylate, and menthol.

Diclofenac Sodium 1% Gel

Diclofenac topical gel was also changed to nonprescription through the Rx-to-OTC switch process. The FDA approved it as a prescription in 2007 and approved the move to nonprescription status in 2020.²⁷

Voltaren (Haleon) is a nonsteroidal anti-inflammatory (NSAID) gel, which means that it reduces prostaglandins, which are often responsible for inflammation. It is approved for the treatment of arthritis pain in the hand, wrist, elbow, foot, ankle, or knee in adults older than 18 years. It is not approved for sprains, strains, or sport injuries.²⁷

Diclofenac relieves joint pain and stiffness.¹ Dosing is based on the area of application. Patients apply 2.25 inches to the upper body (hand, wrist, elbow) and apply 4.5 inches to the lower body (foot, ankle, knee). The dose is measured using an enclosed dosing card.

Diclofenac comes with an easy twist cap, which is helpful for patients with arthritis. The gel should be rubbed into the affected area up to four times a day for up to 21 days.²⁸ Voltaren does not feel greasy and has a clean scent, compared to other topical preparations used to treat joint pain and stiffness. Common side effects include mild skin irritation. Patients who are allergic to aspirin should not use diclofenac topical gel.²⁷Diclofenac has limited systemic absorption and provides pain relief at the site of application.²⁹Diclofenac topical gel does not work immediately. Patients may not notice relief for one week.²⁷

The cost is approximately $19 for a 3.5 oz tube.³⁰

PAUSE AND PONDER: What symptoms would patients experience if they thought they have atrial fibrillation?

KardiaMobile

KardiaMobile (Alivecor) is used as a personal electrocardiogram (ECG), which measures the electrical activity in the heart. It is FDA-cleared. KardiaMobile is a single-lead ECG used to detect common arrhythmias such as atrial fibrillation, bradycardia, and tachycardia in 30 seconds.³¹ More than 454,000 hospitalizations occur each year in the United States due to atrial fibrillation.³²

The KardiaMobile device is the size of a credit card and pairs or communicates with a smartphone. Patients open the Kardia app on their smartphone and press “Record now.” The patient should place the KardiaMobile device near the smartphone so that the two can connect. The patient places two fingers on each of the pads on the KardiaMobile device. After a few seconds, the results appear in the Kardia app. Patients can save the results or email them to a health care practitioner.³¹ Patients also have access for one year to KardiaCare, which is a service that includes ECG evaluations by cardiologists and monthly reports.³³

The sensitivity and specificity for atrial fibrillation are 92% and 95%, respectively, and 85% and 83% for normal sinus rhythm.³⁴

The Apple Watch also provides a similar service for the detection of heart arrhythmias. According to a study conducted in 2022, the Apple Watch and KardiaMobile can both detect rhythm and heart rate issues but the KardiaMobile had a nonsignificant trend toward better accuracy and rhythm detection.³²

The approximate cost for the KardiaMobile device is $79.³¹

Azelastine HCl 0.15% Nasal Spray

Azelastine (Astepro, Bayer) is approved for the temporary relief of nasal congestion, runny nose, and sneezing due to indoor and outdoor allergies. This is the first available OTC antihistamine nasal spray. It is steroid free and approved for adults and children 6 years of age and older.³⁵About 25.7% of adults and 18.9% of children have seasonal allergies.³⁶

Azelastine is an H₁-receptor antagonist that prevents histamine from activating the histamine receptor and producing symptoms such as nasal congestion, runny nose, and sneezing. Patients should prime the spray before using it by pumping the spray until a fine mist comes out.³⁷ Before using the spray, they must blow their nose to clear the nostrils. The patient may then tilt their head downward and insert the tip ¼” to ½” into the nostril. Patients then press the pump once and sniff gently.³⁸

Children 6 to 11 years of age should use one spray in each nostril twice daily. Children 12 years of age and older and adults should use one or two sprays in each nostril once or twice daily.Common adverse effects include runny nose, headache, and bitter taste. If patients experience drowsiness, they can use the spray at bedtime (and this is a good counseling point). The labeling recommends avoiding azelastine with alcohol or sedatives. Patients should experience relief within the first three hours of the dose.¹

If the nozzle is clogged, the patient should unscrew the spray pump unit. The patient should fill a bowl or container with warm water, soak the nozzle, and pump the nozzle several times under water to clear the clog. Finally, the patient should let the nozzle dry before putting it back on the bottle. The product will need to be primed again before the next use.³⁸

The cost is approximately $24 for 120 metered sprays.³⁹

Olopatadine Hydrochloride 0.1%

Olopatadine (Pataday, Alcon) is used to treat itchy, red eyes caused by ragweed, grass, animal hair, and pollen allergies.⁴⁰ Forty percent of the population has experienced itchy, red eyes due to allergies.⁴¹ Olopatadine is a mast cell stabilizer, which prevents histamine from forming during the allergic cascade.²⁷ Patients 2 years of age and older can use this product. The dose is one drop in the affected eye twice daily every six to eight hours. Reminding patients to remove contacts before use and wait 10 minutes after using the drops before reinserting them is a key counseling point.⁴²

Patients should stop using the product if they experience changes in vision, increased eye redness, or eye pain.²⁷The cost is approximately $20 for a 5 mL bottle.⁴²

Pataday (olopatadine 0.2%) Once Daily Relief and Pataday(olopatadine 0.7%) Once Daily Relief Extra Strength are also available as nonprescription products.⁴³

Mometasone Furoate 50 mcg Nasal Spray

Mometasone furoate (Nasonex, Perrigo) is used to treat allergies, such as hay fever, that produces symptoms such as nasal congestion, runny and itchy nose, and sneezing.⁴⁴ Mometasone is a corticosteroid.⁴⁰ It blocks the release of substances that produce inflammation in the body. Nasonex can be used in patients 2 years of age and older. It is the first nonprescription nasal steroid and is full prescription strength.⁴⁰

As with many other nasal products, the steps for administration start with shaking mometasone furoate before each use and executing a priming spray before the first use. The patient should

insert the tip of the bottle in the nostril using a finger to hold the other nostril closed
breathe in and spray at the same time
repeat the process in the other nostril
avoid blowing their nose right after using the nasal spray.⁴⁴

Patients 2 to 11 years of age should use one spray in each nostril once daily and patients 2 years of age and older should use two sprays in each nostril once daily. Stinging of the nasal passages is a common side effect. The product must be discarded after 75 days from the first use, even if product remains in the bottle.⁴⁴Pharmacists and pharmacy technicians can remind patients to note the day they start using the product and/or the day when it needs to be discarded on the label. The cost is approximately $15 for 60 sprays.⁴⁵

Ivermectin 0.5% Lotion

Approximately 6 to 12 million cases of head lice occur each year. Children between the ages of 3 and 11 years are most commonly affected.⁴⁶ Ivermectin was originally available by prescription only. In 2020, the manufacturer started the process to change the classification to nonprescription. Ivermectin lotion is no longer available as a prescription.⁴⁷

Head lice are parasites that survive by feeding on human blood. Lice are spread by person-to-person contact in close environments. Adult head lice are between 2 to 3 mm in length and move by crawling; they cannot hop or fly.⁴⁶Commons symptoms of head lice include itching on the head and scratching behind the ears.⁴⁸

Ivermectin 0.5% lotion (Sklice, Azurity Pharmaceuticals) is used to treat head lice and nits and is approved for children 6 months of age and older. Sklice is applied to dry hair and the scalp. The entire scalp and the hair nearest the scalp should be completely covered before the person applying the lotion pulls it through to the end of the hair. Patients may require the entire tube of product. Sklice is left on the hair for 10 minutes and then rinsed with water only. Patients should wait 24 hours before applying shampoo. Side effects include ocular irritation and a feeling of burning skin. These effects are rare.

Lice eradication is possible with one treatment. Treatment is effective for 94.9% of patients.⁴⁹ The approximate cost is $293 for 177 grams, which is a single treatment.⁵⁰ Generic alternatives are also available. Other therapies for head lice include permethrin (approximate cost is $39)⁵¹ and pyrethrin/piperonyl butoxide (approximate cost is $14)⁵².

CONCLUSION

More than 700 products have been changed to OTC status through the Rx-to-OTC switch process.⁵³ More are sure to come. It is very important that pharmacists and pharmacy technicians stay up-to-date with not only products on the market from the Rx-to-OTC switch process but also with entirely new product entities. Continuing education programs, product websites, and package information are an appropriate way to become familiar with all new product releases.

1. What is TRUE with regard to opioid overdose and the use of naloxone spray?
A. The person observing the possible overdose should place the patient on their side before administering the naloxone spray.
B. If an additional dose is needed, the caregiver should wait 2 or 3 minutes before administering the next dose.
C. The person observing the possible overdose will only ever need to give one spray to treat an opioid overdose.

2. A patient calls you on the phone and says that she is six hours late in taking her next dose of the norgestrel tablet pack. What do you tell her?
A. She should throw away the pack immediately and start a new pack.
B. She should just skip the dose and start again the next day at the usual time.
C. She should take the tablet and use a backup method of birth control.

3. What symptom does azelastine (Astepro) treat?
A. Cough
B. Headache
C. Runny nose

4. KardiaMobile is available for over-the-counter use. Why is this device important?
A. It allows patients to detect heart rhythm abnormalities that they may not know that they have.
B. Patients need fewer visits to healthcare providers and can self-monitor arrhythmias without follow-up.
C. Athletes can monitor their heart rates during workouts so they can maximize the benefit of exercise.

5. What is a TRUE statement relating to lice and its treatment?
A. Patients should apply Sklice (ivermectin) lotion to freshly shampooed wet hair.
B. Patients should always apply a second treatment within 24 to 48 hours.
C. Patients should leave Sklice on the hair for 10 minutes then rinse with water.

3. What symptom does azelastine (Astepro) treat?
A. Cough
B. Headache
C. Runny nose

References

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28. Voltaren Arthritis Pain Relief Gel. Accessed December 28, 2023. https://www.voltarengel.com/arthritis-pain-gel/
29. Topical NSAID therapy for musculoskeletal pain. March 2010. Accessed January 1, 2024. https://academic.oup.com/painmedicine/article/11/4/535/1893796
30. Voltaren Arthritis Pain Gel. Accessed December 28, 2023. https://www.walmart.com/ip/Voltaren-Topical-Arthritis-Medicine-Gel-Pain-Reliever-for-Arthritis-3-5-Oz/556463039?athbdg=L1103&adsRedirect=true
31. Kardia. Accessed December 28, 2023. https://store.kardia.com/products/kardiamobile
32. Atrial fibrillation. October 2022. Accessed January 1, 2024. https://www.cdc.gov/heartdisease/atrial_fibrillation.htm
33. FDA clears world’s first credit-card-sized personal ECG. February 2022. Accessed January 1, 2024. https://www.prnewswire.com/news-releases/fda-clears-worlds-first-credit-card-sized-personal-ecg-301472260.html
34. KardiaMobile for ECG monitoring and arrythmia diagnosis. November 2020. Accessed January 1, 2024.
https://www.aafp.org/pubs/afp/issues/2020/1101/p562.html#:~:text=The%20sensitivity%20and%20specificity%20of,premature%20atrial%20or%20ventricular%20contractions
35. FDA approves Astepro Allergy Nasal Spray for over-the-counter use in the United States. June 2021. Accessed December 28, 2023. https://www.businesswire.com/news/home/20210617005872/en/FDA-Approves-Astepro%C2%AE-Allergy-Nasal-Spray-for-Over-the-Counter-Use-in-the-United-States
36. More than a quarter of U.S. adults and children have at least one allergy. January 2023. Accessed January 1, 2024. https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2022/20220126.htm#:~:text=For%20Immediate%20Release%3A%20January%2026%2C%202023&text=Findings%20from%20the%20adults'%20report,6.2%25%20have%20a%20food%20allergy.
37. How to use nasal sprays correctly. December 30, 2022. Accessed March 16, 2024. https://www.news-medical.net/health/How-to-Use-Nasal-Sprays-Correctly.aspx#:~:text=If%20the%20patient%20is%20using,mist%20comes%20out%20when%20pumped.
38. Astepro Allergy. Accessed January 1, 2024. https://www.asteproallergy.com/products/astepro-allergy-nasal-spray
39. Astepro Allergy. Accessed December 28, 2023. https://www.walmart.com/ip/Astepro-Allergy-Medicine-Steroid-Free-Antihistamine-Nasal-Spray-120-Metered-Sprays/900785735?from=/search
40. FDA approves Rx-to-OTC switch for nasal allergy spray. March 2022. Accessed January 1, 2024. https://www.empr.com/home/news/fda-approves-rx-to-otc-switch-for-nasal-allergy-spray/
41. Allergic conjunctivitis. May 2022. Accessed January 1, 2024. https://www.ncbi.nlm.nih.gov/books/NBK448118/
42. Pataday. Accessed December 28, 2023. https://www.walgreens.com/store/c/pataday-eye-itch-relief/ID=300399614-product
43. Pataday. Accessed January 1, 2024. https://www.myalcon.com/professional/ocular-health/allergy-drops/pataday/#:~:text=Pataday%C2%AE%20Once%20Daily%20Relief,Available%20Without%20a%20Prescription.&text=The%20highest%20concentration%20of%20olopatadine,your%20patients%20without%20a%20prescription
44. Nasonex 24HR Allergy. Accessed December 28, 2023. https://www.drugs.com/nasonex.html
45. Nasonex. Accessed December 28, 2023. https://www.target.com/p/nasonex-24hr-non-drowsy-mometasone-furoate-allergy-medicine-nasal-spray-60-sprays/-/A-86065697?ref=tgt_adv_xsp&AFID=google&fndsrc=tgtao&DFA=71700000049427614&CPNG=PLA_Health_Priority%2BShopping_Local%7CHealth_Ecomm_Essentials&adgroup=Health_Priority+TCINs&LID=700000001170770pgs&LNM=PRODUCT_GROUP&network=g&device=c&location=9005861&targetid=pla-323070238464&gad_source=1&gclid=Cj0KCQiA1rSsBhDHARIsANB4EJbiey-yBHLXAeMjOJoCM5FdUr0QBYiy9gRQjLS2mNX3pvHhtZaCvd8aAhtYEALw_wcB&gclsrc=aw.ds
46. Epidemiology & risk factors. October 2019. Accessed January 1, 2024. https://www.cdc.gov/parasites/lice/index.html
47. FDA approves lotion for nonprescription use to treat head lice. October 27, 2020. Accessed March 16, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-lotion-nonprescription-use-treat-head-lice#:~:text=Sklice%20is%20for%20external%20use,available%20as%20a%20prescription%20drug
48. Sklice lotion. Accessed January 1, 2024. https://www.sklice.com/images/1.0-home/sklice-lotion-cil.pdf
49. Ivermectin lotion (Sklice) for head lice. June 2014. Accessed January 1, 2024. https://www.aafp.org/pubs/afp/issues/2014/0615/p984.html#:~:text=EFFECTIVENESS,31.3%25%20for%20placebo).
50. Sklice prices, coupons and patient assistance programs. Accessed December 28, 2023. https://www.drugs.com/price-guide/sklice
51. Nix Complete Treatment Kit. Accessed January 12, 2024. https://www.walmart.com/ip/Nix-Complete-Treatment-Kit-Permethrin-Cream-Rinse-1-for-Lice-Eggs-5-oz/772728163?from=/search
52. RID. Accessed January 12, 2024. https://www.walmart.com/ip/RID-Lice-Killing-Shampoo-2-oz/226676020?from=/search
53. FAQs about Rx-to-OTC switch. Accessed January 12, 2024. https://www.chpa.org/about-consumer-healthcare/faqs/faqs-about-rx-otc-switch#:~:text=106%20ingredients%2C%20indications%2C%20or%20dosage,been%20newly%20approved%20since%201976

Dealing with Difficult Students: Simple(ish) Solutions to Common Problems

Every student is different. Preceptors may encounter a student who has habits or behaviors that need adjustment. Often, these habits or behaviors are reflective of a lack of professionalism. Preceptors who anticipate certain behaviors and develop strategies to deal with them can usually help students navigate the rotation successfully. It's critical to address poor behaviors the first time they happen, document carefully if the behaviors persist, and involve the school of pharmacy if the behaviors continue. This continuing education activity will describe common challenges and propose effective solutions for dealing with difficult students. It will also discuss student centered learning and present case studies.

INTRODUCTION

Pharmacist preceptors shape the future of pharmacy by mentoring students during their experiential learning experiences. It is not uncommon for preceptors to encounter challenging situations and difficult student behaviors that can ultimately test a preceptor’s skills and patience. A faculty preceptor once said, “Students don’t usually fail rotations because they don’t know brand and generic drug names; they fail because of behaviors incompatible with the pharmacist’s professional identity. No one becomes a preceptor to hunt for students and force them to go to rounds!”

By addressing diverse behaviors and challenges that preceptors commonly encounter, this activity will empower preceptors to address troublesome behaviors effectively.

PAUSE AND PONDER: What types of difficult behavior have you encountered in the students you precept in the past?

TYPES OF DIFFICULT BEHAVIOR

Preceptors report a variety of challenging student behaviors during introductory pharmacy practice experiences (IPPE) or advanced pharmacy practice experiences (APPE) rotations. This continuing education activity explores the following behaviors as they relate to experiential education; failure to answer introductory emails, dressing inappropriately, cursing, poor language choices, disrespectful oral or written language, tardiness, and making excuses for unacceptable behaviors.

Failure to Send Introductory E-mail

Schools of pharmacy typically notify students about their IPPE or APPE rotations several months in advance, often in April for the latter. The timing for reaching out to preceptors may differ for IPPE and APPE students. For example, some schools require IPPE students to contact their preceptors shortly after receiving their site match notification. They may also expect APPE students to introduce themselves and address any site requirements approximately two weeks in advance of the first scheduled day unless the preceptor contacts them sooner. Students should take the initiative and reach out to their preceptors first. This communication serves multiple purposes, including introducing themselves, demonstrating awareness of the start date, confirming the student’s ability to fulfill the expected hourly commitment of the rotation, and addressing any scheduling adjustments. Students spend 120 to 160 valuable hours under the preceptor’s guidance. A student’s failure to initiate or answer introductory emails can significantly impact the student-preceptor relationship and hinder early establishment of effective communication channels.

When students fail to communicate, it opens the door to discuss the importance of good communication in the workplace. Preceptors can use a few techniques to encourage better communication from students^1,2:

Create an electronic reminder on your calendar that will notify you one week before a student is expected. If you haven’t heard from the student, use the contact information the school provided for the student and send a brief message. Something like, “My calendar indicates you are scheduled for your rotation at (INSERT LOCATION) starting Monday. I haven’t heard from you. Are you still scheduled or has your situation changed?”
Consider copying the school’s Office of Experiential Education (OEE) and asking if the preferred contact method has changed.
Know that 47% of e-mail is opened or deleted based on the subject line. Be sure to use a specific subject line, like “IMMEDIATE RESPONSE NEEDED: Your April 2024 rotation.” Experts recommend starting with a command and using seven or few words so the subject line will be visible on a phone. Using four or fewer words increases the likelihood e-mail will be opened, so a subject line of “TIME SENSITIVE: IPPE Rotation” might be even better.
When the student responds, reply promptly (modeling good communication), providing information like start time, hours, dress code, and other essential information as you would with any student. Ask for a reply confirming the student received the information.
If the student does not reply, resend the communication, and copy the OEE. Add a sentence at the start of the communication (and consider highlighting it) that says, “I haven’t heard from you. Is this your preferred method of communication?”
When the student reports, discuss the need for prompt responses, underscoring that preceptors are busy and do not have time to track students down.

Inappropriate Dress and Hygiene

Schools of pharmacy and preceptors expect students to adhere to professional dress standards during their experiential rotations. Dressing appropriately can improve the student’s self-perception and confidence and also improves the public’s confidence and perceptions of a pharmacist’s abilities.³ Preceptors can explain to students that dressing professionally also reflects the workplace institutional culture. Dressing appropriately can improve the likelihood of career advancement.^4,5 Table 1 lists examples of appropriate and inappropriate attire for pharmacy students.

Table 1. Professional Attire^3,6

Appropriate Attire

Inappropriate Attire

· A clean, ironed white lab coat with name tag

· Full length slacks with a collared dress shirts or skirts with blouses or dress shirts, or dresses

· Maintains good hygiene

· Blue jeans, shorts, overalls, sorority or fraternity jerseys, t-shirts, halter tops, tank tops

· Hats, caps

· Tennis shoes, sandals, bare feet

· Excessive jewelry

· May also include revealing clothing, unkept appearance, or lack of attention to personal hygiene

Consider the case of Ally, a P2 pharmacy student on her first IPPE rotation at a large, well-recognized health system. Ally always reported for her shifts wearing dress pants and a turtleneck of sorts under her white coat. One day, Ally joined her preceptor for a meeting with the organization’s medical directors and the room was quite warm. Ally removed her white coat, which revealed the fact that her top was a crop-top and exposed her torso. Ally had always appeared to dress professionally before but always kept her white coat on.

While conversations about dress are sensitive and may be uncomfortable, it’s important to address issues early when appropriate. Experiential rotations may be the first time a student has ever needed to dress professionally. It may take some students time to assimilate to professional dress standards.^4,5 Providing feedback supports the students ability to make a positive first impression and aids in overall career readiness.

After the meeting ended, the preceptor (who was also female) privately addressed Ally’s attire. She suggested that Ally dress professionally daily for any occasion with or without her white coat. If the preceptor had been male, he could ask another female pharmacist to speak with Ally. The key is to address these issues in private and with discretion.

Hygiene is often closely related to attire. Students who have poor hygiene and noticeable body odor often fail to launder, repair, or replace their clothes when they should. Talking with students about hygiene problems is embarrassing for everyone involved. Here, too, it’s often less embarrassing for the student if the person who addresses the issue is of the same gender. The discussion also needs to be conducted in private and with absolute discretion. Some students may have underlying medical conditions that contribute to the problem, like lack of smell or difficulty with executive functioning or organization.⁷ Preceptors can point out that a lack of proper hygiene can lead to social problems with peers and patients and sometimes increases the likelihood of illness. Clothing like white coats that aren’t washed often harbor bacteria and accumulate odors.⁸ Students may need very specific direction. For example, the preceptor may need to tell the student that white coats must be washed every week, or that showering and washing hair at least every other day is the expectation. They can also suggest that students establish routines and incorporate hygiene activities into their routines, like showering every evening if students tend to run late in the morning.⁷

A growing concern in workplaces is the use of fragrance.⁹ More than one-third of Americans report scent sensitivity.¹⁰The reason: artificial fragrances can be irritating to individuals who have allergies and asthma. Colognes and perfumes are not the only problem. Products like lotions, soaps, hairsprays, laundry detergent, and dryer sheets designed to reduce static can also trigger allergies and asthma. For individuals who have sensitivities to fragrances, exposure can lead to headache, respiratory distress, itching/burning eyes, runny nose or congestion, and nausea. The end result is presenteeism, meaning they are present in the workplace but unable to perform as well as they might.⁹ For this reason, some workplaces have policies indicating that employees may not wear any fragrances while on duty.

Here, too, the best intervention is to discuss the problem directly with the student as soon as it's noticed. Since about one-third of workplaces include individuals who have scent sensitivities, establishing a fragrance-free policy is prudent. Consistency is important. Site supervisors who ask one employee or student to stop wearing fragrance should make sure that the rule applies to everyone. Again, it’s often more comfortable for students if the person who approaches them is of the same gender.

PAUSE AND PONDER: What types of difficult behavior might stem from little exposure to professional environments and lack of experience?

Profane or Poor Language Choices

Patients often complain about profanity in healthcare, as they expect professionals to remove these words from professional discussions. But it’s a fact that people—all kinds of people—curse. Experts indicate that people use profane words in two ways: (1) in casual conversation, and (2) in anger.¹¹ Students sometimes use profanity or inappropriate language, and in some cases, they are unaware that the words or phrases they choose are offensive, unprofessional, or incomprehensible. Some students simply use words that they grew up hearing and using, and they believe the words are acceptable. These words usually refer to biologic functions. One pharmacist was surprised when she heard her technician talking to a patient about diarrhea using the *s*-word to describe feces. When she approached the technician, the technician said with all sincerity, “That’s what it is! (The *s*-word)!” And while the *s*-word is unprofessional, students will need to know patient-friendly terms because “feces” is too high level for many patients. (Suggest bowel movement, stool, or even poop.) Students may also be accustomed to using curse words in casual conversation and simply swear habitually. Unfortunately, others may overhear even casual conversations between coworkers and be offended, so using profanities at work (even in casual conversation) should be avoided.¹¹

Using profanity in anger is a different issue.¹¹Employees and students usually curse in angerwhen they are frustrated or arguing with someone. Usually, the person is in a heightened emotional state and the conversation is loud. The cursing affects everyone who hears the profanity, and patients are especially likely to be affected. Humans translate loud conflict as a survival threat and it activates the fight or flight response, raising others’ emotional states, too. Such a change can affect the performance of those involved in or witnessing the conflict for the next few hours. It’s possible that the incident could affect patient outcomes.¹¹

Preceptors should consider a “No Swearing Policy.” Such policies should be enforced with a well-defined managerial plan for disciplinary action or possible termination for employees and specific repercussions for students (discussed below). While swearing, in and of itself, may not constitute serious misconduct, understanding its context and the potential harm it can cause is crucial.

When preceptors observe a student breaching a no swearing policy, they should consider several factors¹²:

Intention: Determine whether the student accidentally used profanity as an outlet for frustration or used swear words to voice abuse or threats.
Delivery: Assess the specific words being used, the volume, and the student’s tone when swearing.
Context: Examine the circumstances in which an individual swore and the motivations behind it.
Workplace Environment: Consider the nature of your workplace, including the type of work being performed and the overall atmosphere.

With employees, the recourse is corrective or disciplinary action. With students, the recourse is documentation in the next evaluation and if the event is serious enough, failing the student in the professionalism section of the evaluation (which in some schools precipitates a failing grade for the entire rotation).

It's important for preceptors to recognize when a student’s behavior may be considered unsafe or harmful to themselves, to patients, or other health care personnel. In cases when a student displays behavior that endangers others, preceptors should

Involve the student’s school immediately.
Provide timely, constructive, and actionable feedback. Identifying and sharing concerns as soon as they arise offers students the opportunity to correct the behavior promptly. Students may not receive a tremendous amount of feedback on their professionalism. It’s important to be transparent about a student’s progress or standing in a rotation.
Inform students that they are breaching workplace policies and the types of disciplinary action that may follow.
Document the date, time, and specific details of any concerning behavior. For situations in which students are at risk of a low to failing grades, documenting behaviors with dates can help justify grading decisions and address concerns with the OEE.

Similar steps can be taken when students violate other polices like dress code, attendance, workplace harassment, cell phone use, etc.^13,14

Disrespectful Language

Another type of inappropriate communication is biased language. Clearly, abusive language, hate speech, and racist or sexist remarks are never appropriate, but biased language may occur without the student being cognizant of it.¹⁵ Preceptors should address the student immediately and explain why what the student said or how the student said it is inappropriate. Some students may come from environments at home or socially where inappropriate language is normalized. These students may voice opinions that reflect their cultural biases, political persuasion, or religious beliefs, or demean others who believe differently. They may also use language that has been common and accepted by society but has now fallen from favor.¹⁵ For example, referring to the technicians as “the girls who run the register,” needs gentle correction. Similarly, labeling patients crazy, drug addict, and senile should prompt preceptors to suggest kinder, gentler terms. These terms have been replaced by mentally ill, person who uses drugs, and person with dementia, respectively. Explaining why negative words may be hurtful can help students develop empathy. It’s also an opportunity to explain how these conditions, like all medical diagnoses, are not the patient’s fault.^16,17

Finally, elderspeak is something pharmacy staff often use unintentionally to demonstrate support for the elderly patient.¹⁸ Elderspeak may become obvious as students encounter older adults. It’s a kind of speech adjustment—often called “baby talk” or “pet talk”—that young people may use when talking with an elder. Table 2 provides some examples of elderspeak.¹⁸

Table 2. Examples of Elderspeak¹⁸

Changing the delivery of verbal information to
- Raise the pitch and tone
- Speak in a singsong tempo
- Exaggerate words
- Speak more slowly
Shortening sentence length
Simplifying sentence complexity by using limited (and sometimes condescending) vocabulary
Repeating or paraphrasing what the elder just said
Using terms like "dear," "honey," “old buddy,” or “young lady”
Using statements that sound like questions
- Ending sentences with a negative question (e.g., You want to take this medicine as directed, don’t you?”)

In short, elders often find elderspeak condescending and patronizing.¹⁸Elderspeak can have a significant impact on specific patient populations. For example, patients with dementia or Alzheimer’s may experience progressive symptoms of aphasia as they age. Many caretakers and healthcare providers resort to language that is simple and limited to alpha commands, or language that is concise, straightforward, and direct. While elderspeak may help compensate for natural changes in older adults’ cognitive abilities, it may consequently cause older people to question their abilities and reinforce negative stereotypes about aging. Because opportunities for communication using elderspeak are constrained (often can be answered with yes or no or the communication invites a “correct” answer or no answer at all), older adults may perceive elderspeak negatively. It may cause reduced self-esteem, depression, and withdrawal from social interactions.Pointing out the problem when students use elderspeak is often enough to correct the behavior. Some students, however, will need coaching. Some strategies to minimize elderspeak include repeating and paraphrasing what you are saying, simplifying phrases, actively listening, and asking appropriate questions.^18,19

It’s essential for students to communicate effectively, maintaining a professional and positive demeanor at all times. Rotations with patient interaction are excellent opportunities to help students communicate their thoughts and feelings effectively. Poor language choices reflect poorly on the student, the school of pharmacy, and the pharmaceutical profession.

Other Specific Behaviors

While the list of challenging student behaviors may be endless, this section touches on some of the other most common difficult behaviors preceptors encounter. This includes tardiness, boundary violations like practicing beyond one’s scope, inappropriate cell phone use, lacking accountability, lacking initiative and motivation, sloppy work practices, and gossiping. Employing effective strategies to manage these behaviors foster a more professional and productive educational experience.

Last to Arrive, First to Leave

Students are expected to be punctual and arrive at their rotations 15 minutes early. These standards are in place to replicate the pharmacist’s obligations and duties. While students aren’t responsible for opening a pharmacy at 8:00 AM, students must demonstrate their ability to be held accountable to such standards in the future. Students must adhere to their agreed scheduling commitments and communicate any delays or absences promptly. Tardiness creates lost productivity. Being 10 minutes late each day is equal to a week's paid vacation by year’s end! It can also inconvenience others if they need to delay meetings or events.

Students who have chronic tardiness problems usually have time management issues. It’s a habit that's difficult to defeat. Preceptors can use a number of interventions, described in Table 3.²⁰

Table 3. Dealing with Tardiness^20,21

Encourage punctuality with a clear policy. Communicate the policy to students when they arrive (and consider putting it in your introductory email) and enforce it consistently.
Send reminders of early meetings or events. Send an e-mail reminder the evening before or 30 minutes before every meeting. Remind participants to be on time. Do not backtrack to fill them in on missed discussions if they are late.
Deal with tardy individuals privately. Meet with the student, revisit company policies, and ask about extenuating circumstances or logistics problems. Clarify the consequences for being late, which may include asking the school to reassign the student.
Describe punctuality as a choice. Convey to students that attendance is not an option, but a critical component of their professional training. They have a choice: To be punctual or the school will have to be notified immediately.
Document, Document, Document. Keep written documentation of all incidents of tardiness, detailing the date and time. This will provide an accurate report to the OEE regarding the student’s behavior.
Keep the pharmacy school involved and aware.

Tardiness doesn’t just affect the student but the entire workplace dynamic. As one professor commented, “When you are late, it makes us ALL late. This is because, even if you think you’re just a student, you have a job here. When you don’t show up on time, you can’t do all the things we count on you.” This statement emphasizes the cascading effects of lateness and the importance of punctuality as just one way to demonstrate professionalism and teamwork.

Addressing Boundary Issues and Protocol Deviation

Students may fail to adhere to established procedures when the pharmacist is not present. For instance, students may provide patient counseling without the pharmacist present or verify medications without the pharmacist’s supervision to speed up workflow. This is called performing outside the scope of training or practice.²²

Some pharmacy employees are tempted to perform outside the scope of training or practice. Sometimes students feel pressured or justified to perform beyond their scope, but doing so violates professional guidelines, risks patient safety, and may violate state or national laws and regulations.²² Pharmacists might also choose to overlook or fail to confront boundary crossing. However, if allowed once, it sets a precedent for the future. Preceptors need to be clear that emergencies and staffing shortages happen, but all employees including students need to work within their scope of practice. Preceptors need to address mismatched expectations (i.e., that a student thinks it’s OK to counsel if the preceptor is busy) and ensure that the workplace has adequate supervision.²²

Preceptors can coach students that while they are on rotation and after they are licensed, they need to be aware of exactly what they can and can’t do. Students should watch for key phrases that signal danger which include

I’ll just do this first and then (show the pharmacist, call the doctor, convince the patient) later, I’m sure he won’t mind…
We do this all the time…
I know how to do this, it’s no big deal.

When they start thinking like that, they need to stop and make sure they are practicing within their scope of practice.

Practicing outside the scope aligns with another ethical concept known as incrementalism. Incrementalism suggests that as individuals repeatedly observe unethical behavior, they perceive it as less wrong, eventually normalizing it or deeming it acceptable. As the mind struggles to detect subtle changes over time, people may engage in unethical behavior more readily through a gradual process of minor infractions, ultimately escalating unethical behaviors. Unethical or challenging behavior typically doesn’t arise as a conscious decision to violate ethical standards; instead, it often occurs incrementally along a slippery slope, in tandem with peer interactions.

Using cell phones at inappropriate times

Cellphones, tablets, and other electronic devices can help students access pertinent information to better support their pharmacy practice experience. However, engaging with these devices in ways not related to their practice, such as unnecessary texting or browsing on social media, is inappropriate.

Social media encompasses Internet-based tools that facilitate networking and collaboration, and real-time sharing of information, photos, videos, and more. Social media can be referred to as “social networking” or “Web 2.0.”²³ These platforms can have positive and negative consequences on a student’s performance. While cell phones can be an indispensable tool for communicating and information access, misuse, or excessive use, can also be a source of distraction. When social media is excessive, it can lead to social media addiction (which is not yet a recognized medical condition). As with substance use, social media addiction can negatively impair physical and psychological health and cause behavioral disorders such as depression, anxiety, and mania. Researchers have not identified a threshold that would suggest what levels of social media use is considered to have poor outcomes. It’s clear poor management of social media use presents many concerning consequences on students’ academic performance and interpersonal relations ^24-26

As the technology landscape is always changing, consequences are unpredictable. Some practical solutions to supporting a student’s management of social media use can include:

Set clear expectations: Early on, practice settings need to communicate and enforce guidelines about cell phone use. A simple approach is to set parameters in the syllabus.
Suggest time management tools: Encourage students to use timers to manage their engagement with social media effectively. In the settings app on most phones, students can set a time limit that alerts the user when the time has been met.
Be informative: Preceptors can encourage students to join online medical communities to access news articles, expert insights, and stay up to date on research and trends. Some students may simply have never thought to do so. Examples of social networking sites available for pharmacists include the following:

ASHP Connect (connect.ashp.org )
APhA (www.pharmacist.com)
The Pharmacist Society (www.pharmacistsociety.com)
LinkedIn

Connect with students: Preceptors might also share readings, blogs, or podcasts that relate to the experiential rotation with students. As a supplement, following up on these materials can also exercise a student’s communication skills and their proficiency in relaying medical information.

Lack of accountability and dishonesty

At times, it may be necessary to address a student’s challenging behavior by discussing it privately. Many reactions can emerge from such conversations. Honesty and accountability should be prioritized – students should openly acknowledge their actions or lack thereof. As aspiring licensed pharmacists, they must uphold principles of integrity and accountability from the early stages of their advanced pharmacy practice experiences. Lack of accountability and dishonesty are character flaws that preceptors should consider quite serious.

Let's talk about a student, Jeff, who started his IPPE rotation in a chain pharmacy location. Jeff's school of pharmacy has experienced recurring issues with him. He often fails to respond to emails in a timely manner if at all. Staff in the experiential education office has to nag at him constantly to update records about vaccinations, license renewals, and similar necessary documentation. He is often flippant about why OEE needs any of this information. On the first day of his rotation, his preceptor asked if he was up to date with all of his vaccinations and licensure renewals, to which he responded, “Of course. I wouldn't be here if I wasn't!” Over the first few days that Jeff worked at the store, the preceptor noticed some incongruities in several of Jeff’s explanations. He had unusual explanations for tardiness, was very defensive when he didn't know the answer to a question, and he was caught using the photocopier for personal purposes even after he had been told not to.

Several days later, the person who was responsible for tracking documentation in the OEE called and asked to speak with Jeff. She had heard that Jeff reported to this site even though the school had told him not to until his vaccinations were current. Jeff took the phone off to a corner of the pharmacy and spoke in hushed tones. When he was done, he told the preceptor that unfortunately he had an emergency and had to leave, and he would let him know when he would return. When the preceptor expressed concern, Jeff said that he had not submitted his vaccination documentation. When pressed further, Jeff confessed that he actually had failed to receive his vaccinations.

Dishonesty is unacceptable in a professional setting. When encountering similar situations, the preceptor should consider the following:

Preceptors should report dishonesty to the OEE as soon as they notice it. Often, preceptors think that this may be a one-off instance of a student’s bad judgement, or preceptors think they may not understand something. Usually, however, this is a behavior that the school of pharmacy has been tracking and other people have noticed also.
Documentation is critical. It needs to be thorough and clear. Preceptors should document what they saw or heard, how they disproved or came to realize that the information was dishonest, and when exactly it happened. They should not wait till the final evaluation to make note of the problems. It should occur in the very first evaluation and it's acceptable to do an immediate interim evaluation.
If the preceptor decides to pass a student who showcased moments of dishonesty on a rotation, they should document in writing that they are passing the student, but they experienced professionalism problems during the rotation.
At some schools that use a pass-fail system, professionalism violations are an immediate “fail.” We don't want people who have this magnitude of dishonesty entering the profession.

PAUSE AND PONDER: What kinds of behaviors would improve with discussion and direction, and what kind of behaviors would improve with more practice?

Inability to take initiative and unwillingness to participate in activities

Some students may appear frustrated, bored, underprepared, and distracted. This lack of engagement may manifest in communication styles aimed at minimizing interactions or diverting attention away from meaningful conversations. An essential component of professional development is the student’s capacity to engage proactively in various learning activities.

A particularly concerning sign is a student’s lack of motivation, which may be evident in their reluctance to engage in self-directed learning or displaying disinterest in the rotation site, assigned activities, or patient care. To address this issue, Table 4 outlines several coaching strategies designed to re-engage students lacking motivation.

Table 4. Strategies to Engage Students Lacking Motivation^27,28

Discuss your observations regarding their disinterest and lack of motivation with the student.
Encourage the student to create a personal success plan, including:
Self-assessment of performance areas needing improvement, as identified by the preceptor
Development of a concrete, actionable plan for improvement
Engagement in critical reflection
Revisit the learner’s professional and rotational goals to realign the students focus
Consider setting mutual goals with the student, focusing on how to use discretionary time during the rotation to meet their unique needs and interests.

Students may distance themselves for several reasons. This could be due to finding a topic uninteresting, lacking understanding of situational expectations, or facing difficulties engaging with an interprofessional team or among cross-generational groups. By allowing students the opportunity to receive feedback and create their own success plan, they can incorporate a self-directed learning process. This approach provides a scaffold in developing essential self-awareness skills.

Consider Sally, who was two weeks in her rotation at Rosemary Hospital. Her preceptor, Dr. Unconfrontational (“Dr. U”), observed that Sally was unengaged, asked no questions, and kept disappearing in the break room for long stretches of time. Five days into the rotation, Dr. U asked Sally if she had read the assigned chapter the evening before. She said she did. When he asked questions about its content, she couldn’t answer. He needed to take a phone call, and she slipped away. He found her in the break room with the book open to the chapter (but she seemed to just stare at the pages). Dr. U was disappointed that Sally wasn’t interested in what he considered the most fascinating—but not the most difficult—part of his specialty. He decided that it was easier to stop assigning reading to Sally because she seemed uninterested. At the rotation’s end, he passed her with a C.

Cases like this demonstrate that precepting can be difficult and students can be puzzling. Although it’s hard to tell if Sally read the chapter, her behavior suggests she did not. The way that Dr. U interacted with Sally provides little information about the root of the problem. Dr. U could have done a number of things when he noticed Sally’s lack of enthusiasm^29-31:

He could have educated himself about disengagement. It’s usually not directed at the preceptor. It could be poor self-esteem, difficult home situations, or the need to work after hours to support oneself. It may be that the student doesn’t see the assignment as challenging. Or, the student may be bored and need more—rather than less—work.
He could have spent time asking Sally about her interests and what she hoped to learn in his rotation. While getting to know her, he could have asked if she had concerns or obligations outside of the rotation that he should know about. Ice-breaking activities are critical with students and should reveal students’ talents, passions, questions, and challenges. Asking questions like, “How do you learn best?” or “Would you rather read about a topic, watch a video, or do both?” can also provide good information.
He could have examined his own expectations to make sure they were SMART (specific, measurable, achievable, realistic, and time-tagged). Was he asking too much?
He could have asked her what she learned in pharmacy school related to his specialty, and what she liked and disliked about it.
He could provide “hooks” to start her thinking about what’s coming next. This is the practice of providing just a little bit of attention-grabbing information about a topic. Preceptors can make a controversial statement (“Some people believe that gargling with bleach kills COVID. We’ll talk about how to respond to that kind of talk next week.”), asking a provocative question (“Why do you think that more than half of patients don’t take their medication? Do you think that statistic is accurate?”), or telling a good story (“I keep this x-ray on the bulletin board because it reminds me of a child who had nausea, vomiting, diarrhea, and low copper levels. It all came down to those things you see in his gut! Anyway…think about that and we’ll talk about it next week)
He could have asked her to develop three goals for the rotation, and three sub-goals for each of the main goals so she could plan her own learning. If she couldn’t do this activity (which would explain much about why she is disengaged), he could work with her to develop goals.
He could have asked her to create a deliverable as she read the chapter. Asking her to write down 10 interesting facts or use sticky notes to mark the pages she found most interesting and least comprehensible would have added an interactive element to the assignment.
He could have asked her if she has had any experience with patients or family members who have diagnoses related to his field. This often provides some real-world relevance to learning.

Sloppiness

Health professionals including pharmacy students are held to rigorous standards of cleanliness, organization, and adherence to site-specific protocols. These protocols are not merely procedural formalities but are fundamental to maintaining quality standards and preventing pharmacy errors.

Pharmacy students, through their education and practical experiences, should be well-versed in these high standards. In compounding labs, for instance, faculty emphasize meticulous attention to detail and stringent adherence to procedures. As future pharmacists, they will prepare or verify medications that are often ingested orally, where the risk of contamination carries potentially severe consequences. Table 5 shares examples of how a student may exhibit sloppy behavior.

Table 5. Examples of the Sloppy, Disorganized, and Nonadherent Student

Poor medication management: This can include incorrect labeling, improper storage of drugs, or disorganized inventory management. These practices can lead to medication errors, altered drug metabolism, or even possible harm to patients.
Lack of attention to detail: This can manifest in several ways such as making calculation errors, misinterpreting prescriptions, or failing to recognize important patient information. Again, this is a patient safety issue.
Failure to clean up: Leaving behind clutter and the detritus of pharmacy work for others to clean not only disrupts workflow but also reflects a lack of professionalism and responsibility.
Improper waste disposal: Disregarding proper guidelines for drug disposal of expired or unused medications, sharps, and other waste can pose environmental and safety repercussions.
Improper recycling practices: In hospital and community pharmacy settings, waste bins are often color-sorted for proper disposal. For example, disposing patient information in a regular trash bin instead of its designated bin violates HIPAA regulations.

Addressing these issues in educational settings is imperative for students to be aware of their habits and actions. This involves reinforcing the importance of these standards early, modeling these behaviors, and holding students accountable when necessary.

Gossiping

During rotations, some students may seamlessly connect with other staff members. In some cases, students may observe instances when coworkers engage in gossip and complaints about the workplace and colleagues. While it might be tempting to indulge in such discussion, setting boundaries is crucial when displaying leadership. This includes no gossiping or destructive criticism, and showing empathy when other coworkers present difficult behaviors. Students should be embedded in the healthcare team with a healthy sense of belonging. As students practice mirroring the pharmacist’s actions, they learn to act as mediators in workplace conflict.

One way to discuss gossip with students is to ask them if they know what Socrates said about repeating information.³² This Greek philosopher said that before speaking, people need to ask themselves three questions about the information they plan to convey: Is it true, is it kind, and is it necessary? These questions are filters. Asking these questions guides the honest person to engage in ethical thinking and decision-making. Taking a few minutes to shift the discussion from the juicy tidbit of gossip to the related and more important topic of truth, kindness, and necessity can (but doesn’t always) help people who gossip develop some insight into their behavior. Emphasizing that these questions help individuals develop nurturing, trusting, empathetic relationships is key. This technique is useful with students and coworkers and can often start the process of reducing gossiping.³²

LEARNING THEORY TO ENHANCE ROTATIONS

Canadian psychologist Albert Bandura is widely recognized for introducing the concept of social cognitive theory.³³ He postulated that learning of any type occurs through observation, imitation, and modeling with influence from the learner’s attention, motivation, attitudes, and emotions. It means that the environment interacts with the individual’s cognitive makeup as learning occurs. Preceptors can use his tenets to help students engage and learn. Bandura’s observational learning theory moves through four key cognitive processes^33,34:

Attention: Learning starts with an individual’s engagement and focus on a particular behavior or task. The ability to imitate a behavior hinge on the accessibility of role models, behavior complexity, and perceived value of behavior. Ultimately, students need to perceive a model, or their preceptor, as someone worth imitating.
Retention: Students should register and retain information that they observe from their model preceptor. Learners retain information in a symbolic form of imagery and verbal elements. When preceptors perform actions repeatedly, they enhance the student’s retention.
Motor reproduction: As students are assigned to new tasks or behaviors associated with being a pharmacist, they will use clues from imagery and verbal elements to guide their actions. Frequent motor reproduction exposes students to new situational contexts and empowers them to adapt and refine their behaviors in future interactions. Role models who demonstrate positive behaviors subtly influence others’ actions and responses.
Motivation, reinforcement and punishment: Attention, retention, and motor reproduction all contribute to the ability to imitate a behavior. To stimulate positive reinforcement of behavior, the motivation and will to perform is often based on the rewards and punishment that result from modeling those actions.

Preceptors who understand another theory—that of unconscious learning—will also be able to assess students based on their past experiences and present materials appropriately. It describes the acquisition, access, and application of knowledge without deliberate and controlled attention. It’s the opposite of studying for an exam. It’s basically the “learn by doing” model, students are unaware it’s happening, and it, too, has four stages.^35,36

In the first stage, unconscious incompetence, students are unaware of how little they know about a subject. These are entry level students who have little experience. They may think they know more than they actually do.
In the second stage—conscious incompetence—students are able to recognize knowledge deficits. Preceptors can think of this as the point where students experience that AH-HA! moment of enlightenment.
Learning begins to accelerate and coalesce in the third stage—conscious competence. Students will begin to see patterns and store that information. An example would be learning the top 200 drugs after processing prescriptions or orders, rather than just memorizing them.
In the fourth stage, students develop unconscious competence. A task or process becomes second nature. Preceptors will not need to remind students to complete steps. Students will simply do the right thing.

Learning barriers can contribute to student difficulties, so understanding learning theory can assist preceptors to support students and reduce difficult behaviors. Exposure to a variety of situations in the workplace will help students learn unconsciously.³⁶ Fear and anxiety are barriers to unconscious learning (and contributors to difficult behaviors), so creating a learning environment that is comfortable (and maybe even fun) can speed the process. So can asking students to take a few moments and visualize processes and procedures before starting.³⁶

In the unconscious incompetence stage, preceptors will need to look for signs that students are recognizing they don’t know what they don’t know.³⁷ Having students repeat processes until they can do them without error is essential. Asking students how they think they are doing may stimulate some self-awareness. Encouraging them to periodically question what they think they know is also good.³⁷ These steps break down learning barriers gradually.

When students reach conscious incompetence, preceptors need to be observant. It’s the step where students, frustrated with their deficits, may want to give up. Preceptors who provide encouragement and additional practice can help them move on. Students need positive feedback to progress to the last step of unconscious competence, or mastery.

PAUSE AND PONDER: Think about a student whose behavior was difficult to address in the past. After taking this continuing education activity, how would you have addressed the issues differently?

CONCLUSION

When students are on rotations, they are in certain respects on their own and need oversight from preceptors and the preceptors’ team. Students benefit from preceptors who engage with their students. Oversight and feedback are needed consistently during this crucial time because preceptors want their students to succeed in the profession and the workplace. Pharmacy preceptors who explore the effectiveness of managing tardiness and use strategies to reinforce accountability and motivation will find the precepting experience more fulfilling. A thorough understanding and application of social cognitive theory and stages of learning will enhance a preceptors response to difficult student behaviors. They can use the interventions they develop to build better pharmacy student experiences. Before giving up on the student, they should ask for help from the pharmacy school’s OEE and reach out to people with good supervisory skills.

Why does early intervention on the preceptor’s part to correct difficult student behaviors matter? Developing good workplace behaviors is critical to prepare students for the rigors and responsibilities of the pharmacy workplace. Precepting students is a phenomenal opportunity to practice life-long learning and working mantras.

POST TEST QUESTIONS

Dealing with Difficult Students: Simple(ish) Solutions to Common Problems

Educational Objectives
1. DEFINE types of student behaviors and common challenges preceptor’s encounter
2. EXPLAIN the underlying factors and learning needs that contribute to difficult student behaviors
3. APPLY the principles of student-centered learning to develop appropriate responses to difficult students
4. ANALYZE case studies and develop strategies for difficult student behaviors

1. Why is dressing appropriately important for students on rotation in a community pharmacy setting?
A. Community pharmacies usually enforce dress codes strictly.
B. It can improve the student’s self-perception and confidence.
C. It ensures that students bathe and groom regularly.

2. Why should a preceptor intervene when a student addresses an older patient as “honey” or “sweetie”?
A. Elderspeak usually signals conflict and activates the fight or flight response, creating fear and anxiety among people who are nearby.
B. Elderspeak is demeaning to older people and may cause them to question their abilities and reinforce negative stereotypes about aging.
C. Elderspeak is usually reserved for speaking to children as it describes using endearments, so children feel more relaxed.

3. Why might a student use poor word choices that may be considered profane for biologic functions?
A. They may have grown up in a home where those words were used exclusively and not realize that most people consider the words profane.
B. The problem isn't the student; The problem is that the preceptor doesn't understand that English is changing and some words are more acceptable now.
C. The student probably perceives that the patient will be more comfortable with common slang and needs to be corrected.

4. A student is on his first rotation in a hospital setting. He has no experience other than a few weeks working in a chain pharmacy. The preceptor observes the student using a procedure that may be acceptable in a chain pharmacy but it's not acceptable in a hospital pharmacy. What step of unconscious learning does this reflect?
A. unconscious incompetence
B. conscious incompetence
C. conscious competence

5. A student reports for her rotation wearing a white coat that is clean and pressed but smells like a popular laundry additive that adds a strong scent to the fabric. Two employees at this location are extremely allergic to strong scents. Select the statement that is TRUE.
A. All health care facilities have policies that prohibit the use of scents.
B. The preceptor’s introductory e-mail should have said not to use fragrance.
C. More than one-third of Americans report scent sensitivity.

6. Why might a student be tempted to perform outside the scope of work appropriate for an intern?
A. The student might feel pressured to do more than she should.
B. The pharmacy school might not have explained scope of work.
C. State law might be vague about an intern’s scope of work.

7. A student has prepared inadequately on several occasions and presented work that is sloppy and incomplete. The preceptor asks the student to create a personal success plan. What is one possible component to such a plan?
A. A face-to-face discussion with the preceptor
B. Engagement in critical reflection about motivation
C. A letter to the pharmacy school documenting deficits

8. You overhear a student discussing information about one employee with one of your other employees. You know that the information is untrue and mean-spirited. You pull the student aside and counsel him about gossip. What question would help the student develop insight?
A. Is it true, is it kind, and is it necessary?
B. Where did you get that information?
C. Why would say something like that?

9. Which of the following is an example of a “hook” to increase student engagement?
A. Ensuring you make only uncontroversial statements
B. Asking questions that student will surely be able to answer
C. Telling a story about materials to be covered next week***

10. Your current APPE student tends to arrive 15 minutes late every day and seems to disappear about 10 minutes before the close of business. Which of the following is the BEST approach?
A. Clarify the store's hours and that the student needs to arrive and leave on time, explain why it's necessary to be on time, and document if the problem persists
B. Document the problem on the first offense, explain why it's necessary to be on time, clarify the store's hours and that only paid employees can arrive late
C. Notify the school of pharmacy immediately that the student is a problem and needs to be reassigned to a different rotation site because she is too difficult

11. Which of the following statements is the best strategy for dealing with difficult students?
A. Preceptors should address problems only if they reoccur since most times, students simply are ignorant of certain rules.
B. Preceptors should address problems as soon as they see them using kind corrective action and positive reinforcement.
C. Preceptors should realize that when they have difficult students, the problem is usually a mismatch with the rotation site.

REFERENCES
1. Non-Responders: How to Deal With Colleagues Who Don’t Answer Their Email. Walden University. Accessed March 19, 2024. https://www.waldenu.edu/online-masters-programs/ms-in-industrial-and-organizational-psychology/resource/non-responders-how-to-deal-with-colleagues-who-dont-answer-their-email
2. Zucker R. How to Follow Up with Someone Who’s Not Getting Back to You. Harvard Business Review. January 13, 2021. Accessed March 19, 2024. https://hbr.org/2021/01/how-to-follow-up-with-someone-whos-not-getting-back-to-you
3. Naughton CA, Schweiger TA, Angelo LB, Lea Bonner C, Dhing CW, Farley JF. Expanding Dress Code Requirements in the Doctor of Pharmacy Program. Am J Pharm Educ. 2016;80(5):74. doi:10.5688/ajpe80574
4. Cardon PW, Okoro EA. Professional characteristics communicated by formal versus casual workplace attire. Bus Comm Q. 2009;72(3): 355–360. doi: 10.1177/1080569909340682
5. Furnham A, Chan PS, Wilson E. What to wear? The influence of attire on the perceived professionalism of dentists and lawyers. J Appl Soc Psychol. 2013;43(9):1838-1850. doi:10.1111/jasp.12136
6. Rickles NM. UConn School of Pharmacy Student Handbook. University of Connecticut School of Pharmacy
7. McClure C. Autism and Poor Hygiene: The Smelly Truth to Overcome. My Autism Mind. July 13, 2023. Accesse March 19, 2024. https://myautismmind.com/poor-hygiene/
8. Chan CK, Lam TY, Mohanavel L, et al. Knowledge, attitude, and practice of white coat use among medical students during clinical practice (LAUNDERKAP): A cross-sectional study. Am J Infect Control. 2024;52(1):35-40. doi:10.1016/j.ajic.2023.06.022
9. Rádis-Baptista G. Do Synthetic Fragrances in Personal Care and Household Products Impact Indoor Air Quality and Pose Health Risks?. J Xenobiot. 2023;13(1):121-131. Published 2023 Mar 1. doi:10.3390/jox13010010
10. Steinemann A. International prevalence of fragrance sensitivity. Air Qual Atmos Health. 2019;12(8):891–897. doi: 10.1007/s11869-019-00699-4.
11. Thompson R. The Profanity Problem. January 24, 2022. Accessed August 27, 2023. https://www.workingnurse.com/articles/the-profanity-problem/
12. Raptis G. My Employee is Swearing in the Workplace. What can I do?. Updated April 11, 2022. Accessed February 15, 2024. https://legalvision.com.au/my-employee-is-swearing-in-the-workplace-what-can-i-do/
13. Chunta KS, Custer NR. Addressing unsafe student behavior. AJN, American Journal of Nursing. 2018;118(11):57-61. doi:10.1097/01.naj.0000547667.08087.51
14. Raptis G. My employee is swearing in the workplace. what can I do? LegalVision. April 11, 2022. Accessed September 9, 2023. https://legalvision.com.au/my-employee-is-swearing-in-the-workplace-what-can-i-do/.
15. Morgan K. Why swearing could have a place in the office. May 16, 2021. Accessed August 27, 2023. https://www.bbc.com/worklife/article/20210514-why-swearing-could-have-a-place-in-the-office
16. Szalavitz M. Why We Should Say Someone Is A 'Person With An Addiction,' Not An Addict. NPR. June 11, 2017. https://www.npr.org/sections/health-shots/2017/06/11/531931490/change-from-addict-to-person-with-an-addiction-is-long-overdue
17. Senile: Why Not to Use the Term and How You Can Age Well. Healthline. Accessed August 27, 2023. https://www.healthline.com/health/senior-health/senile
18. Simpson J. Elderspeak – Is it helpful or just baby talk? Merril Center. Accessed September 1, 2023.https://merrill.ku.edu/elderspeak-it-helpful-or-just-baby-talk
19. Torres-Soto K. The Effects of Elderspeak on the Mood of Older Adults with Dementia: A Preliminary Report. Order No. 13885707 ed. Minnesota State University, Mankato; 2019. Assessed August 31, 2023. https://www.proquest.com/dissertations-theses/effects-elderspeak-on-mood-older-adults-with/docview/2247140946/se-2
20. DeLonzor D. Taming Tardiness. SHRM. August 18, 2020. Accessed October 1, 2023. https://www.shrm.org/resourcesandtools/hr-topics/people-managers/pages/taming-tardiness.aspx
21. Edwards P. HR in Practice: Addressing Employee Tardiness. MedEsthetics. August 25, 2016. Accessed October 1, 2023. https://scholar.google.com/scholar?as_ylo=2019&q=tardiness+healthcare+worker+punctuality&hl=en&as_sdt=0,7
22. Doobay-Persaud A, Evert J, DeCamp M, et al. Extent, nature and consequences of performing outside scope of training in global health. Global Health. 2019;15(1):60. Published 2019 Nov 1. doi:10.1186/s12992-019-0506-6
23. Ventola CL. Social media and health care professionals: benefits, risks, and best practices. P T. 2014;39(7):491-520.
24. Azizi, S.M., Soroush, A. & Khatony, A. The relationship between social networking addiction and academic performance in Iranian students of medical sciences: a cross-sectional study. BMC Psychol 7, 28 (2019). https://doi.org/10.1186/s40359-019-0305-0
25. Bhandarkar AM, Pandey AK, Nayak R, Pujary K, Kumar A. Impact of social media on the academic performance of undergraduate medical students. Med J Armed Forces India. 2021;77(Suppl 1):S37-S41. doi:10.1016/j.mjafi.2020.10.021
26. Lahiry S, Choudhury S, Chatterjee S, Hazra A. Impact of social media on academic performance and interpersonal relation: A cross-sectional study among students at a tertiary medical center in East India. J Educ Health Promot. 2019;8:73. Published 2019 Apr 24. doi:10.4103/jehp.jehp_365_18
27.Davis LE, Miller ML, Raub JN, Gortney JS. Constructive ways to prevent, identify, and remediate deficiencies of "challenging trainees" in experiential education. Am J Health Syst Pharm. 2016;73(13):996-1009. doi:10.2146/ajhp150330
28. Briceland LL, Caimano RC, Rosa SQ, et al. Exlporing the impact of engaging student pharmacists in developing individualized experiential success plans
29. Barkley EF. 7 Ways to Use “The Hook” to Grab Students’ Attention. Wiley Network. Accessed January 16, 2024. https://www.wiley.com/en-us/network/education/instructors/teaching-strategies/7-ways-to-use-the-hook-to-grab-students-attention
30. Chipchase L, Davidson M, Blackstock F, et al. Conceptualising and measuring student disengagement in higher education: A synthesis of the literature. Int J Higher Ed. 2017;6(2):31-42.
31. [No author.] A Gentle Nudge: How Teachers Can Address Disinterested Students. Accessed January 15, 2024. https://blog.planbook.com/disinterested-students/
32. Is it True, Is It Kind, or Is It Necessary Quote: Origin and Explanation. QUOTELYFE. Accessed January 16, 2024. https://quotelyfe.com/is-it-true-is-it-kind-or-is-it-necessary-quote-origin-and-explanation/
33. Fuente J de la, Kauffman DF, Boruchovitch E. Editorial: Past, present and future contributions from the social cognitive theory (Albert Bandura). Frontiers in Psychology. Published online August 7, 2023. Accessed September 8, 2023.
34. Incrementalism. Ethics Unwrapped. November 5, 2022. Accessed September 7, 2023. https://ethicsunwrapped.utexas.edu/glossary/incrementalism.
35. Kuldas S, Ismail HN, Hashim S, Bakar ZA. Unconscious learning processes: mental integration of verbal and pictorial instructional materials. Springerplus. 2013;2(1):105. doi: 10.1186/2193-1801-2-105.
36. Griffen M. Unconscious Incompetence and the Four Stages of Learning. Medium. January 13, 2014. Accessed January 31, 2023. https://mattangriffel.medium.com/unconscious-incompetence-ad5583abf646
37. Cherry K. What Is the Dunning-Kruger Effect? A cognitive bias that causes an overestimation of capability. verywellMind. November 5, 2022. Accessed January 31, 2023. https://www.verywellmind.com/an-overview-of-the-dunning-kruger-effect-4160740

Learning Objectives

Accreditation Statements

Disclosure of Discussions of Off-label and Investigational Drug Use

Faculty

Faculty Disclosure

ABSTRACT

CONTENT

Content

Overview of the Medicare Prescription Payment Plan

Figure 1 illustrates the basic process for patients who choose to participate in M3P.

Table 1. Anticipated M3P Claims Messaging Information

Distribution of M3P responsibilities

Table 2. Plan M3P Responsibilities4, 5

Monthly invoice calculations and members most likely to benefit from participating in the M3P

M3P Resources

SUMMARY AND CONCLUSION

Pharmacist & Pharmacy Technician Post Test (for viewing only)

References

Full List of References

Learning Objectives

Accreditation Statements

Disclosure of Discussions of Off-label and Investigational Drug Use

Faculty

Faculty Disclosure

ABSTRACT

CONTENT

Content

Pharmacist Post Test (for viewing only)

Pharmacy Technician Post Test (for viewing only)

References

Full List of References

Learning Objectives

Accreditation Statement

Grant Funding

Faculty

Faculty Disclosure

Disclaimer

Content

Handouts

Post Test Pharmacist

Learning Objectives

Accreditation Statement

Grant Funding

Faculty

Faculty Disclosure

Disclaimer

Content

Handouts

Post Test Pharmacist

Learning Objectives

Accreditation Statement

Grant Funding

Faculty

Faculty Disclosure

Disclaimer

Content

Handouts

Post Test Pharmacist

Learning Objectives

Accreditation Statement

Grant Funding

Faculty

Faculty Disclosure

Disclaimer

Content

Handouts

Post Test Pharmacist

Learning Objectives

Accreditation Statement

Grant Funding

Faculty

Faculty Disclosure

Disclaimer

Content

Handouts

Post Test Pharmacist

Learning Objectives

Accreditation Statements

Disclosure of Discussions of Off-label and Investigational Drug Use

Faculty

Table 2. Plan M3P Responsibilities^{4, 5}