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The Scoop on Pharmacy Burnout: Description and Management Strategies

Learning Objectives

 

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

  • Describe burnout and its effects in the pharmacy
  • Discuss risk factors and possible causes of burnout in the pharmacy
  • Differentiate between different burnout subscales
  • Identify strategies to manage burnout

man knocked down by burnout

Release Date:

Release Date: February 20, 2025

Expiration Date: February 20, 2028

Course Fee

Pharmacist:  $7

Pharmacy Technician: $4

ACPE UANs

Pharmacist: 0009-0000-25-009-H04-P

Pharmacy Technician: 0009-0000-25-009-H04-T

Session Codes

Pharmacist: 22YC01-JXX46

Pharmacy Technician: 22YC01-XWK93

Accreditation Hours

2.0 hours of CE

Accreditation Statements

The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-25-009-H04-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

 

Disclosure of Discussions of Off-label and Investigational Drug Use

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

Faculty

Yvonne Riley-Poku, PharmD
Medical Writer
Storrs, CT

Faculty Disclosure

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

Yvonne Riley-Poku, PharmD, has no relationship with an ineligible company and therefore has nothing to disclose.

ABSTRACT

Burnout is a response to prolonged work-related stress that has not been managed adequately. Although burnout is present in other professions, researchers have found it to be more prevalent in health services professions. In the pharmacy profession, increasing workload, staffing shortages, and hard-to meet company performance metrics are among the factors that contribute to burnout. The consequences of burnout in the pharmacy are substantial and range from low morale and employee turnover to serious dispensing errors. The onus for addressing burnout lies with employers and companies, although employees have a role to play as well. Several states are enacting new laws to address working conditions in pharmacies. Recently passed laws include mandating breaks for pharmacists, capping shift lengths, and disallowing excessive metrics.

CONTENT

Content

INTRODUCTION

Burnout is a response to prolonged work-related stress that can impair physical health and psychological wellbeing.1,2 Interest in burnout is growing. Employers and employees alike would like to understand burnout and determine a solution that will keep employees engaged and enthusiastic about work. For healthcare professionals and the pharmacy team to carry out their roles in improving the health of the population optimally, they must pay attention to their physical and psychological wellbeing. Consequences of burnout adversely affect both providers and patients in their care.

People who experience burnout feel emotional exhaustion, depersonalization, and reduced personal accomplishment.1 The Maslach Burnout Inventory (MBI) is the most widely used research measure on burnout.1 The Maslach Burnout Inventory Human Services Survey (MBI-HSS) is an assessment tool for burnout syndrome in human services occupations such as healthcare.1 Christina Maslach, a psychology professor at the University of California, Berkeley, is one of the pioneering researchers on burnout and its definition, predictors, and measurement.3 She is the architect of the Maslach Burnout Inventory and based on her work, the World Health Organization (WHO) included burnout as an occupational phenomenon in the International Classification of Diseases (ICD).3 Maslach and her colleagues’ initial research into burnout included surveys, interviews, and field observations of workers in human services professions such as health care, social services, mental health, criminal justice, and education. Their findings indicated that burnout could reduce the quality of care or service provided by the worker.1 Their findings also found a link between burnout and negative health outcomes for the worker such as headaches, muscle tension, hypertension, sleep disturbances, and cold and flu episodes.2 Burnout also seemed to be associated with personal dysfunction such as physical exhaustion, insomnia, increased use of substances, and poor interpersonal relationships.1

The Agency for Healthcare Research and Quality estimates that 30% to 50% of physicians, nurse practitioners, and physician assistants may be affected by burnout.4 Various professional organizations and studies have extensively reported on burnout in physicians. While more research is needed, researchers have conducted some studies to identify occupational burnout’s prevalence and risk factors in pharmacists and pharmacy technicians. These studies detail the existence of burnout among pharmacy staff.

Health care providers’ well-being impacts patient safety and patient care quality. It is essential that pharmacy team members understand burnout syndrome, and stakeholders in the profession must take steps to improve employee well-being.

Pause and Ponder: How would you describe the working conditions at your workplace?

Burnout Definition and Description

In the early 1970s, psychologist Herbert Freudenberger was one of the first to describe professional exhaustion and is credited with introducing the concept of burnout.4,5   Freudenberger did his burnout research observing staff working in a free medical clinic.4,5 After he completed his normal workday, he worked at a free clinic that he had helped organize during the Free Clinic Movement—a movement that involved healthcare providers in work that required almost endless effort and empathy. During these work shifts, he recognized the syndrome. He described burnout as putting a great deal of yourself into your work, with the staff and population you serve demanding this of you, while you also demand it of yourself. He further described it as eventually finding yourself in a state of exhaustion.5

Similar to Freudenberger’s description, the WHO defines burnout as a syndrome conceptualized as resulting from chronic workplace stress that has been poorly managed.6 Burnout can develop in employees such as healthcare professionals who work with other people in some capacity.1 Note that burnout is limited to work environments, an occupational hazard, if you will, and the ICD does not classify it as medical condition.6

Indicators of Burnout

Burnout has three subscales (scales used to obtain a rating or measurement that contributes to a rating or measurement on a larger scale). The terms that describe burnout’s three components may be familiar to pharmacists and technicians, but they have specific meaning when used to describe burnout. If pharmacists and technicians recognize how burnout presents, they will be better prepared to intervene early if they or their colleagues exhibit any of the feelings or attitudes described in the subscales.

The following are burnout’s subscales1:

  • Emotional exhaustion: Presents as feelings of energy depletion or exhaustion attributed to one’s work. As emotional resources are depleted, workers feel they are no longer able to give more of themselves on a psychological level.1 Other descriptions of emotional exhaustion are being worn out, having a loss of energy and enthusiasm for work, or feeling drained and fatigued.7
  • Depersonalization: Increased mental distance from one’s job, or feelings of negativity or cynicism related to one’s job. Other descriptions of this state are negative and cynical attitudes and feelings about one’s clients or negative, inappropriate, and irritable attitude toward clients.1 This perception of others may lead staff to view clients or patients as somehow deserving of their troubles.1
  • Decreased sense of personal accomplishment: Reduced professional efficacy, or feelings of reduced personal accomplishment. Workers may evaluate themselves negatively regarding their work and may also feel dissatisfied with their accomplishments on the job.1 Some words used to describe this condition include reduced productivity or capability, and low morale.

 

Table 1 describes studies and research on burnout in different pharmacy practice settings and their findings.

Table 1. Burnout Studies in Different Pharmacy Practice Settings8-12

Target Population Study Design and Description Result
Community pharmacists ·       Anonymous electronic surveys including the MBI-HSS and a work-factors-based questionnaire

·       To identify the prevalence and risk factors for occupational burnout in community pharmacists

74.9% of respondents reported burnout in at least one MBI-HSS subscale, most owing to emotional exhaustion (68.9%).
Health system pharmacists ·       Multi-center cross-sectional cohort survey study

·       Used MBI-HSS

·       To determine levels of, and risk factors for professional burnout among health system pharmacists

53.2% of study participants reported a high level in at least one MBI-HSS subscale.

 

8.5% of study participants had scores that indicated burnout on all 3 MBI-HSS subscales.

Clinical pharmacists in a hospital inpatient setting ·       Prospective, cross-sectional pilot study

·       Online survey

·       To characterize the level of and identify factors independently associated with burnout among clinical pharmacists practicing in an inpatient hospital setting within the United States

Low response rate. However, 61.2% of respondents reported burnout, largely driven by high emotional exhaustion.
Pharmacy residents ·       Electronic anonymous survey

·       To quantify burnout status of pharmacy residents and to correlate burnout to professional conduct and career outlook

74.4% burnout rate was reported among respondents.
Pharmacy technicians ·       Used MBI-HSS

·       To assess burnout among pharmacy technicians working in a hospital or health system setting

69.1% of respondents were experiencing burnout.
ABBREVIATIONS: MBI-HSS = Maslach Burnout Inventory-Human Services Survey

 

Risk Factors and Causes of Burnout

Across many occupations, common risk factors contribute to burnout. Table 2 describes those risk factors.

Table 2. Risk Factors for Burnout2

Risk Factor Description
Workload ·       Job demands exceeds human limits

·       Workload is unsustainable

·       No opportunity to recover from, or have a restful period after a particularly demanding event such as meeting a deadline or addressing a crisis resulting in acute fatigue

·       Prolonged overload becomes a chronic job condition leading to exhaustion

Control ·       Employees have no personal control in the workplace

·       Role conflict

·       Lack of opportunity to contribute to or participate in organizational decision-making

Reward ·       Insufficient reward be it financial, institutional, or social

·       Lack of recognition from managers, workers, and stakeholders devalues the work and leaves the worker with a sense of inefficacy

Community ·       The overall quality of social interaction at work and the ability to work as a team is inadequate.

·       Lack of a supportive and positive work environment

Fairness ·       Decisions at work are perceived as unfair or inequitable

·       Employees perceive an imbalance between their inputs (time, effort, expertise) and outputs (reward, recognition)

Values ·       A conflict exists between individual and organizational values

o   Values are the ideals or principles that originally draw people to a particular job.

·       Individual values unaligned with organizational goals could lead to burnout

Although employees in other professions experience burnout, workers in the human services professions such as healthcare, social services, mental health, criminal justice, and education are more prone to burnout.4 Workers in human services professions spend considerable amounts of time with other people. Their relationships often involve addressing a patient’s or a client’s health needs (medical, psychological, physical).1 Patients and clients have continuous health needs and challenges and frequently require ongoing, lengthy, or chronic support and care. In an effort to make a positive impact on the lives of others, healthcare workers can become overwhelmed.1 The nature of healthcare work coupled with stressful working conditions can be emotionally draining and lead to burnout.

Pharmacy professionals like other healthcare professionals are prone to burnout due to common risk factors and profession specific factors.

The following risk factors contribute to burnout among the pharmacy team4,10,13

  • Long professional work hours
  • Workload and inability to meet company specified performance metrics
  • Staffing shortages
  • Incompatibility between skills and actual daily tasks

Because the pharmacy profession is highly regulated, the pharmacy team must remain up to date with regulatory requirements.4 Everyone on the team must document extensively with no room for error. Attention to detail is a required skill for the pharmacy team because errors could lead to injury or potentially death.

An increasing workload, long working hours, and day-to-day tasks that may sometimes be incongruent with employees’ actual skills may lead to burnout at some point.4 A fear of retribution from speaking up about working conditions further exacerbates the risk of burnout.14

In a March 2021 NBC news story “Overworked, understaffed: Pharmacists say industry in crisis puts patient safety at risk” that aired, NBC news interviewed 31 retail pharmacists and technicians from 15 states.14 These pharmacists and technicians described extremely busy 12-hour shifts during which they were unable to take lunch or bathroom breaks. The interviewees further described crying in their cars after work and enduring sleepless nights from worrying about mistakes they may have made while working under such busy and rushed conditions.14 For a common daily scenario in a busy community pharmacy, see the SIDEBAR.

SIDEBAR: Does this busy community pharmacy sounds familiar?14

  • Long lines while short-staffed
  • Ringing phones
  • Busy drive-through
  • Weekly order that still needs to be put away on shelves
  • Patients waiting for vaccines

 

The story described working conditions in community pharmacies where pharmacists were being “pushed to do more with less.”14 Pharmacists described working faster to fill more orders, while juggling a wider range of tasks with fewer staff members at a rate that compromised patient safety.

A 2019 national pharmacist workforce study found two-thirds of pharmacists experienced increased workload in the past year. A high percentage of retail chain pharmacists in this survey rated their workloads as high or excessively high.15

Burnout rates among pharmacy employees may differ depending on practice setting.4 Community pharmacists report higher rates of burnout than employees in other practice settings like hospitals and independent pharmacies.9

Pause and Ponder: Do you dread your upcoming shift and live for your day off? Why or why not?

BURNOUT ASSESSMENT

Assessing burnout in the pharmacy profession is necessary for research and most importantly for interventions. With the MBI-HSS specifically, employers can design interventions to address the specific burnout subscale that their employees may report.1 Interventions addressing emotional exhaustion will differ from those addressing a reduced sense of personal accomplishment. Organizations or employers can focus strategies to address employee burnout.1 Finally, the assessment of burnout and the subsequent awareness that a problem exists can be the initial step in preventing or alleviating full blown job burnout.

The Maslach Burnout Inventory

The MBI is an assessment tool for the three components of burnout syndrome: emotional exhaustion, depersonalization, and a reduced sense of personal accomplishment.1 Although other measurements for burnout exist, the MBI is largely considered the gold standard for assessing burnout in a group of workers in a profession. The MBI is not an individual diagnostic instrument.1 This assessment tool was designed originally to measure burnout in human services professions such as healthcare, social work, and criminal justice.1 Maslach has since developed alternate forms of the MBI: the MBI-Educators Survey (MBI-ES) for the teaching profession, and the MBI-General Survey (MBI-GS) for other occupational groups.1 The MBI-HSS distinguishes burnout in health services occupations from burnout in other professions.1 This questionnaire is a self-administered tool and takes approximately 15 minutes to complete.1

The MBI is copyrighted.1 Researchers and individuals can purchase and administer it either as an online survey or as a paper and pencil survey.16 For the online surveys, score reports are generated online.16

The MBI is divided into three components, each of which includes personal statements that the respondent must rank.1 Examples of such personal statements are “I feel burned out from my work” and “I don’t really care what happens to some recipients.” MBI-HSS administrators score the items on the questionnaire on a seven-point scale. The scale ranges from a 0 response for “never,” to a 6 response for “every day.” Below are the three components1:

  • Emotional exhaustion – nine statements on this subscale assess “feelings of being emotionally overextended and exhausted by one’s work.”
  • Depersonalization – five statements on this subscale assesses an unfeeling and impersonal response the employee has towards their patients or clients.
  • Personal accomplishments – eight statements on this subscale assess “feelings of competence and achievements in one’s work with people.”

Each subscale is scored separately as low, average, or high using directions from the scoring key. There is not a total combined score. Respondents receive three separate scores—one score for each subscale. Receiving a score for each subscale benefits the assessment-taker because interventions to reduce burnout can be designed based on the specific component of burnout that needs to be addressed.1

For the emotional exhaustion and depersonalization subscales, a higher score corresponds to a higher degree of burnout. For the personal accomplishment subscale, however, a lower scale corresponds to a higher degree of burnout.1

The MBI has several drawbacks. Everyone has a different view of burnout and because the questionnaire is self-administered, respondents’ answers may be influenced by talking to other people such as friends and coworkers. For this reason, respondents should complete the MBI privately without knowing how other respondents are answering. The survey has also been labeled “MBI Human Services Survey” rather than “Maslach Burnout Inventory.” This reduces the chances of respondents linking the survey specifically to burnout; rather, the questionnaire’s title suggests it measures job-related attitudes and issues.1 Once all respondents have completed the survey, an open discussion of burnout is then appropriate. MBI administrators require no special qualifications. However, as a best practice, managers or supervisors should not administer the survey since this would affect how employees respond, i.e., employees may not be candid about their feelings.1

Although the MBI cannot be used as an individual diagnostic tool, it can be used as a self-assessment tool.1 Employees can compare their scores to those of others in their occupational group so they can recognize potential problems.1

ICD-11 Codes for Burnout

The ICD is the international standard for reporting diseases and health conditions and is the diagnostic classification standard for all clinical and research purposes.17 ICD-11 is the global standard for health data, clinical documentation, and statistical aggregation. It is scientifically up to date with multiple uses including use in primary care. The ICD defines diseases, disorders, injuries, and other related health conditions.17 The WHO maintains the ICD.17

The WHO’s 11th revision of the International Classification of Diseases (ICD-11) includes burnout, defining it as “a syndrome conceptualized as resulting from workplace stress that has not been successfully managed.”6 The previous revision, ICD-10, also included burnout. The definition in the 11th revision is now more detailed. According to this classification, burnout is work-related and does not apply to experiences in other areas of life.6

Alternative Measures to Assess Burnout

While experts consider the MBI to be the gold standard for burnout assessment, other measures exist that are not copyrighted, require no payment to use, and are publicly available.18

  • The Oldenburg Burnout Inventory – developed in Germany, this 16-item survey measures burnout in any occupational group. It covers two areas: exhaustion (physical, cognitive, and affective aspects) and disengagement from work (negative attitudes toward work objects, work content or work in general). It treats each burnout dimension separately.18
  • Single Item Burnout Measure – developed in the U.S., it measures burnout in any occupational group. The single question on the measure asks users to rate their burnout level based on their own definition of burnout. Users pick from five response options and receive scores that suggest no burnout symptoms, or one or more burnout symptoms.18
  • Copenhagen Burnout Inventory – developed in Denmark, this 19-item survey measures burnout in any occupational group and covers personal-, work-, and client-related burnout. It treats each burnout dimension separately.18

Recognizing Burnout’s Effects

Burnout influences quality of life and the team’s ability to perform optimally in their personal and professional capacities. In addition to negative health outcomes for employees such as muscle tension, headaches, sleep disturbances, hypertension, and cold and flu episodes,2 burnout’s consequences in the workplace include1,13,14,19

  • A decline in the quality of patient care
  • Dispensing errors
  • Low morale
  • Employee turnover
  • Missed days

 

Pause and Ponder: Do you feel rushed daily at work? How might that contribute to dispensing errors?

Dispensing Errors

We have described how an unsustainable workload is a risk factor for burnout (see Table 2). The costly effects of burnout include dispensing errors. Staff shortages, increasing workload, and long professional work hours contribute to dispensing errors in pharmacies.14,19 Community pharmacists and technicians, for example, work to fill prescriptions, give vaccinations, counsel patients, answer phones, tend to the drive-through and the register, and call insurance companies. They do all this while trying to meet their company’s specified performance metrics. The likelihood of a dispensing error is increased when working conditions in the pharmacy are rushed and chaotic.14,19

In 2006, in a comprehensive study of medication errors, the Institute of Medicine estimated that medication errors harmed at least 1.5 million Americans annually.20 Indirect costs of such errors include loss of productivity, emotional stress and suffering, and additional healthcare costs.20 A recent New York Times article tells the story of working conditions in pharmacies and metrics set by companies that pharmacists find hard to meet.19 The article reports several examples of dispensing errors. In one instance, an 85-year-old woman died after receiving the chemotherapy drug methotrexate instead of an antidepressant refill. Another patient went to the emergency room after receiving ear drops instead of eye drops, which caused eye swelling and burning. In another medication mix up, a patient received a blood pressure medication instead of her asthma medication, resulting in a pounding headache, nausea, and dizziness.19

Some states including Illinois and California are trying to change pharmacy practice. In Illinois, a new law requires pharmacists to have scheduled breaks. The state could also impose penalties on companies that do not provide a safe working environment.14 California’s new law requires that pharmacists not work alone.14 Changes from state boards of pharmacy could play an important role in improving the working conditions in pharmacies.

Employee Turnover

Employee turnover is the voluntary or involuntary loss of employees and the act of replacing them. Employees may leave their jobs voluntarily for many reasons including retirement or moving on to other opportunities. Others may leave due to lack of growth opportunities in their current roles, a hostile work environment, or a feeling of not fitting the company culture. Job-seekers and applicants view an unusually high turnover negatively, making turnover costly for employers. Companies must then put great efforts into recruiting, training, and onboarding. It also takes time for employers to train new employees adequately. Others may also view the company as having problems with their working conditions. Most importantly, high turnover diminishes productivity and the chance to build a cohesive team is lost.21

In 2004 in the U.S., researchers conducted a study to examine the relationship between organizational and individual factors, and pharmacists’ future work plans.13 The study sought to determine factors that contributed to pharmacists either leaving or staying with their current employer.13 Researchers in this cross-sectional study mailed surveys to licensed U.S. pharmacists. Respondents were asked to state whether they would leave or stay with their current employers during the next year. The researchers also asked respondents to rate their top five reasons for leaving or staying from a predetermined list. “Leavers” were those planning to leave their employer, and “stayers” were those planning to stay.

For leavers, 35% cited high stress levels as their exit reason, 31.1% cited excessive workload, and 25% cited poor salary or insufficient staffing.13

Stayers’ top reasons were good salary (50%), relationships with coworkers (46.6%), and good benefits (42%).13

Researchers also asked respondents to identify one main factor that influenced their decision to leave or to stay. A majority of these factors were under the employer’s control. Flexible schedules, ability to use skills, and salary/benefits influenced the stayers, while insufficient or unqualified staffing, poor scheduling and salary, and workload influenced the leavers.13

COVID-19 and Burnout in Healthcare Workers

In March 2020, the WHO declared the novel coronavirus disease (COVID-19) a global pandemic. COVID-19 is a highly contagious respiratory illness. As of January 4, 2022, COVID-19 had affected more than 54 million Americans and claimed the lives of more than 820,000.22 Factors such as preparedness for a pandemic, political leadership, availability of personal protective equipment (PPE), and the fear of infection and infecting others have played a role in the nation’s response to the pandemic. At the forefront of these crises were healthcare workers. The pandemic increased the levels of burnout among healthcare workers who have additionally had to witness patient suffering.

Before the pandemic, several studies across various pharmacy practice settings reported burnout among pharmacists. The 2019 national pharmacists’ workforce study reported 71% of practicing pharmacists characterizing their workload as either high or excessively high.15 During the COVID-19 pandemic however, studies showed that burnout has increased among healthcare workers, pharmacists included.23,24 Healthcare visits to hospitals and doctors’ offices are sometimes limited during the pandemic, however, community pharmacists are available for face-to face consults. While this is beneficial for patients, pharmacists and technicians face an increased risk of exposure to the virus. Additionally, pharmacists have had to take on new roles and responsibilities during the pandemic.25 The U.S. Department of Health and Human Services (DHS) authorized pharmacists to procure, dispense, and administer COVID-19 vaccines when they became available.25 DHS also authorized pharmacists to order and administer COVID-19 tests to aid in testing expansion in response to the COVID-19 pandemic.26

In the U.S., researchers studied the impact of COVID-19 on pharmacist workload, employment status, feelings of burnout, and overall emotional health.23 The Wisconsin Pharmacist Workforce Study was a cross-sectional study conducted before the COVID-19 vaccine was available but after the Department of Health and Human Services made the decision to permit pharmacists to administer it.23 Researchers focused on questions related to burnout domains and emotional health. For the reward domain, questions focused on changes in personal employment, while questions for the workload domain focused on exhaustion. Researchers used questions to measure depersonalization for the social interaction domain and developed questions about pharmacists’ social and emotional health. The study focused on the 2 largest pharmacist populations – community and hospital pharmacists – and had a 33% response rate. Study results are shown in Table 3.

Table 3. The Wisconsin Pharmacist Workforce Study Results23

Domain Questions Percentage of Community Pharmacists Reporting Percentage of Hospital Pharmacists Reporting
Hours Reduced 13 36
Hours Increased 19 8
Reduction in Wages 1 6
Temporary Furloughs 2 6
Concern About Being Furloughed or Losing Job 26 14
Increase in Workload or Work-Related responsibilities 41 42
Reduced interest in talking with patients 26 22
Social/emotional health Approximately 40% reported increased anxiety. Approximately 25% experienced increased sadness or depression.

 

The Wisconsin Pharmacist Workforce Study had imitations. Researchers only studied Wisconsin pharmacists, which makes generalization difficult. A non-response bias was also present; pharmacists with the highest workload would have had the least amount of time to respond to the survey. Despite these limitations, the study suggested that although pharmacists rose to the challenge during the pandemic, they experienced increased burnout as a result of COVID-19.23

Another study conducted across pharmacy practice settings in Australia to measure burnout in pharmacists during the coronavirus pandemic showed that burnout had increased.24 The study, an online survey, consisted of three parts. Researchers collected demographic information such as age, sex, primary practice area, and years of practice. They also used the MBI-HSS to measure burnout, and then asked questions pertaining to psychosocial issues. The questions focused on the pharmacists’ degree of concern for personal and family health, whether duties such as working overtime and workloads changed, and if precautionary measures in the workplace (e.g., PPE and infection control) were appropriate.24

Although only 17.8% of respondents reported caring for COVID-positive patients, an overwhelming 96.3% of pharmacists reported a change in their roles during the pandemic. These changes included increased workload (35.9%) and working overtime (52.2%). The pharmacists reported challenges they faced during the pandemic ranging from medication supply (40.9%) to patient incivility (24%). Regarding precautionary measures however, 71.1% of pharmacists reported that their workplace had sufficient precautionary measures.24

With regards to psychosocial factors, 36% of pharmacists were “very to extremely concerned” about their family’s health and 87.2% reported that their lives had been affected most by isolation from friends and family.24

With the arrival of the COVID-19 pandemic, pharmacy teams have been stretched even further with additional duties such as COVID- 19 testing, deep cleaning, and giving COVID vaccinations. COVID-19 has compounded burnout among the pharmacy team.

The federal government in the U.S. has not yet comprehensively tracked data on healthcare worker deaths, but according to “Lost on the Frontline,” a 12-month investigation by The Guardian, a British newspaper, and Kaiser Health News, more than 3600 healthcare workers in the U.S. died from the coronavirus disease in the pandemic’s first year.27

BURNOUT MANAGEMENT

The responsibility of addressing burnout among the pharmacy team does not only lie with employees but also with employers. In a study to assess burnout among pharmacy technicians working in a hospital or health-system settings in North Carolina, employees’ awareness of burnout resources at their institution was associated with lower odds of burnout, whether employees used those resources or not.11

Employers

The pharmacy profession as a whole must address burnout, and employers’ goals should be to identify and address factors that contribute to burnout.

Prevention strategies for burnout include2

  • Ensuring a sustainable workload at the workplace, while allowing for periods of rest and recovery
  • Encouraging active participation in organizational decision making
  • Providing appropriate rewards for employee achievement
  • Fostering a positive and supportive environment at the workplace
  • Promoting fairness, impartiality, or equity in decisions at work
  • Aligning employees’ personal expectations with the organization’s

Federal and State Legislation

Payment Reform

Pharmacists are generally only paid for filling prescriptions and do not bill for clinical services such as counseling and giving vaccinations. A proposed federal bill if passed, would grant pharmacists “provider status.” The Pharmacy and Medically Underserved Areas Enhancement Act (H.R. 2759/S.1362) was introduced in both the U.S. House of Representatives and the U.S. Senate in April 2021. This bill proposes pharmacist recognition as health care providers and allows compensation for their services to Medicare patients in medically underserved areas.28,29 With this status, pharmacists could bill insurers for clinical services for Medicare patients under Medicare Part B.28

At the state level, several states already assign some form of provider status to pharmacists. The National Alliance of State Pharmacy Associations (NASPA) identifies state provider status-related bills as those that apply to pharmacist scope of practice, payment for pharmacist provided patient care services, and/or the designation of pharmacists as providers. NASPA’s 2021 mid-year update on state provider status reports that in 18 states, 32 such bills have been signed into law. These laws include pharmacist immunization authority, broad prescriptive authority, contraceptive prescribing authority, and payment for services among others.30 In response to the NBC news story “Overworked, understaffed: Pharmacists say industry in crisis puts patient safety at risk,” the American Pharmacists Association (APhA), called for payment reform in pharmacy in a press release. 31 The APhA went on to say that the broken model of paying for the filling of prescriptions has led to a proliferation of productivity and efficiency metrics that have created a situation that compromises patient safety. The press release further stated that the APhA continues to fight for payment reform at both the federal and state levels.31

Burnout can occur when an incompatibility exists between employees’ skills and actual daily tasks. Giving pharmacists the opportunity to consult, provide, and bill for clinical services while spending less time in dispensing activities could be a remedy.13,31

Legislation

States like California, Illinois, and Virginia have passed new laws that will cap shift lengths for pharmacists. These laws also seek to ensure safe staffing levels and prohibit excessive metrics.14 According to the National Association of Boards of Pharmacy, about a third of all states now have some regulation that address working conditions in the pharmacy.14

Assessing Well-Being

Employees in other human services professions experience burnout as well, and it could be beneficial to look to other professions to see what initiatives they have in place to address burnout. The American Medical Association (AMA) for example, has a STEPS Forward program that seeks to prevent provider burnout.32 The program has interactive online educational modules with strategies to confront common challenges in a busy medical practice. The program is physician-developed and physicians can earn continuing medical education credit while learning about practice efficiency and patient care, patient health, physician health, and technology and innovation.32 Programs that improve resilience and well-being among employees might be beneficial to the pharmacy profession.

In an effort to address well-being, the APhA has launched the Well-Being Index, a validated screening tool invented by the Mayo Clinic, to help pharmacists assess their well-being.33 Respondents to the anonymous online survey that evaluates fatigue, depression, burnout, anxiety/stress, and mental/physical quality of life, receive immediate individualized feedback. This allows pharmacists to compare their well-being with their professional peers’ and directs them to tools and resources that can help promote well-being. Participants can also track their scores over time so they can be proactive in making self-care adjustments.33

Authors of a commentary on burnout syndrome among healthcare professionals suggest actions that pharmacy organizations can take to recognize and reduce burnout among their employees. These include4

  • Establishing a panel to evaluate burnout in the profession of pharmacy
  • Conducting further research into the prevalence prevention and effectiveness of treatment strategies of burnout across all practice settings of pharmacy
  • Incorporating strategies that promote mental health wellness and resiliency into pharmacists’ training.

Employees

“You can’t pour from an empty cup” - Unknown

Employees can adopt strategies to guard against burnout. The following strategies guard against burnout and promote wellbeing in the employee.

  • Continue to speak up about workplace conditions that affect patient safety and employee well-being.
  • Adopt self-care habits and foster hobbies outside of work. Ensure adequate sleep, nutrition, and exercise.
  • Be sure to take your vacation time or paid time off to recharge.
  • Foster a supportive and positive work environment by communicating and collaborating with teammates.
  • Keep up with continuing education and join a professional pharmacy organization. This enhances self-esteem and promotes a sense of purpose.

CONCLUSION

The importance of high-quality healthcare cannot be stressed enough. Healthcare professionals including pharmacists and pharmacy technicians play an important role in improving the overall population’s health. Clearly, burnout’s consequences among pharmacy workers could be detrimental for employees, patients, organizations, and society as a whole. It is important to recognize the indicators and risk factors for burnout to be able to address them and improve health care provider well-being. Employers and institutions must implement strategies to combat burnout in their employees. Some state boards of pharmacy are beginning to make changes and institute new laws that will cater to appropriate work environments and employee well-being.

 

Pharmacist & Pharmacy Technician Post Test (for viewing only)

1. Which of the following measures assesses burnout among pharmacy professionals?

A. The Maslach Burnout Inventory
B. DSM-V
C. ICD-11 diagnostic guidelines for anxiety

2. Turnover resulting from burnout in the pharmacy profession can be described as

A. Employees tend to retire immediately after reaching retirement age
B. Employees leave because they don’t fit in with the work culture
C. Employee with good salary/benefits leave due to relocation of spouse’s job

3. Which of the following is a risk factor for burnout among pharmacy professionals?

A. Employees receive hardly any raises or recognition after favorable end-of-year performance reviews
B. Employee is included from decision making in the workplace
C. Employees find the level of social interaction and collaboration at work adequate

4. Which of the following scenarios is a risk factor for burnout among pharmacy professionals?

A. During the COVID-19 pandemic, some pharmacies hired additional staff to help administer covid shots
B. During the COVID-19 pandemic, some pharmacy staff worked overtime, while administering COVID-tests, and consulting face-to-face with patients
C. An extremely busy pharmacy has qualified staffing and flexible scheduling for their employees

5. XY has been a pharmacy technician for 5 years and works at a busy community pharmacy. XY often feels overwhelmed, stressed, and burdened by keeping up with prescription numbers, prior authorizations and patients’ health needs and challenges. What is XY experiencing?

A. Depersonalization
B. Emotional exhaustion
C. A decreased sense of personal accomplishment

6. XY usually lies awake at night dreading the next shift. Pharmacy practice now feels like a chore and XY finds patients at drop-off and pick-up very irritating. What is XY experiencing?

A. Depersonalization
B. Emotional exhaustion
C. A decreased sense of personal accomplishment
7. XY now finds pharmacy practice unmotivating and often questions having accomplished anything worthwhile, or having had a positive impact on patients. What is XY experiencing?

A. Depersonalization
B. Emotional exhaustion
C. A decreased sense of personal accomplishment

8. Which of the following would be considered a good strategy to combat burnout among the pharmacy team?

A. States must mandate more continuing education requirements for pharmacy technicians
B. Employees must seek medications from their healthcare providers

C. States should pass laws that place caps on pharmacy shift lengths and reduce excessive performance metrics

9. Which of the following is best practice for the employee to prevent full blown burnout?

A. Limit hobbies outside of work as they are distracting and hinders job focus
B. Limit communication and collaboration with team mates to help avoid dispensing errors
C. Use vacation times or restful periods to recharge and avoid fatigue

10. Coworker relationships at XY’s workplace are somewhat cordial. XY however feels blind-sided by recent company decisions about technician break times. What is the BEST way for XY’s employer to ensure that XY avoids burnout?

A. Pharmacy technicians understand that management usually makes workplace decisions without employee input.
B. Pharmacy technicians have more continuing education hour requirements within the organization
C. Pharmacy technicians must be actively involved in making certain workplace decisions

References

Full List of References

References

  1. Maslach C, Jackson S, Leiter M. Maslach burnout inventory manual. 3rd Consulting Psychologists Press; 1996.
  2. Maslach C, Leiter MP. Early predictors of job burnout and engagement. J Appl Psychol. 2008;93:498-512.
  3. Berkeley University of California. Psychology. Christina Maslach. Accessed January 3, 2022. https://psychology.berkeley.edu/people/christina-maslach
  4. Bridgeman PJ, Bridgeman MB, Barone, J. Burnout syndrome among healthcare professionals. Am J Health-Syst Pharm. 2018;75:147-152.
  5. Fontes, F. Herbert J. Freudenberger and the making of burnout as a psychopathological syndrome. Accessed January 3, 2022. https://www.researchgate.net/publication/346586006_
  6. World Health Organization. Burn-out an “occupational phenomenon”: International classification of diseases. May 28, 2019. Accessed January 3, 2022.

https://www.who.int/news/item/28-05-2019-burn-out-an-occupational-phenomenon-international-classification-of-diseases

  1. Shrijver I. Pathology in the medical profession? Taking the pulse of physician wellness and burnout. Arch Pathol Lab Med. 2016;140:976-982.
  2. Durham ME, Bush PW, Ball AM. Evidence of burnout in health-system pharmacists. Am J Health-Syst Pharm. 2018;75:S93-S100.
  3. Patel SK, Kelm MJ, Lee HJ, et al. Prevalence and risk factors of burnout in community pharmacists. J Am Pharm Assoc. 2021;61:145-150.
  4. Jones GM, Roe NA, Louden L, Tubbs C. Factors associated with burnout among US hospital clinical practitioners: Results of a nationwide pilot study. Hosp Pharm. 2017;52:742-751.
  5. Kang K, Absher R, Granko RP. Evaluation of burnout among hospital and health-system pharmacy technicians in North Carolina. Am J Health Syst Pharm. 2020;77(24):2041-2042.
  6. Gonzalez J, Brunetti L. Assessment of burnout among postgraduate pharmacy residents: A pilot study. Curr Pharm Teach Learn. 2021;13(1):42-48.
  7. Gaither CA, Nadkarni A, Mott DA, et al. Should I stay or should I go? The influence of individual and organizational factors on pharmacists’ future work plans. J Am Pharm Assoc. 2007;47:165-173.
  8. Kaplan A, Nguyen V, Godie M. Overworked, understaffed: Pharmacists say industry in crisis puts patient safety at risk. NBC News. March 16, 2021. Accessed January 3, 2022.

https://www.nbcnews.com/health/health-care/overworked-understaffed-pharmacists-say-industry-crisis-puts-patient-safety-risk-n1261151

  1. American Association of Colleges of Pharmacy. National pharmacist workforce studies. Accessed January 3, 2022. https://www.aacp.org/article/national-pharmacist-workforce-studies

 

  1. Mind Garden. MBI: Human Services Survey. Accessed January 3, 2022.

https://www.mindgarden.com/314-mbi-human-services-survey

  1. World Health Organization. International Statistical Classification of Diseases and Related Health Problems (ICD). Accessed at https://www.who.int/standards/classifications/classification-of-diseases, January 3, 2022.
  2. National Academy of Medicine. Valid and reliable survey instruments to measure burnout, well-being, and other work-related dimensions. Accessed January 3, 2022. https://nam.edu/valid-reliable-survey-instruments-measure-burnout-well-work-related-dimensions/
  3. Gabler E. How chaos at chain pharmacies is putting patients at risk. New York Times. January 31, 2020. Accessed January 3, 2022.

https://www.nytimes.com/2020/01/31/health/pharmacists-medication-errors.html

  1. Eastman, P. IOM Report. Medication errors injure millions. Emergency Medicine News. 2006;28(9):44-46.
  2. Dik, B. Staff attrition vs staff turnover: What’s the difference? March 28, 2018. Accessed at https://jobzology.com/staff-attrition-vs-staff-turnover-whats-the-difference/, June 22, 2021.
  3. Centers for Disease Control and Prevention. Covid data tracker. Accessed January 3, 2022. https:// COVID.cdc.gov/ COVID-data-tracker/#datatracker-home
  4. Bakken BK, Winn AN. Clinician burnout during the COVID-19 pandemic before vaccine administration. J Am Pharm Assoc. 2021;S1544-3191(21)00164-3. doi:10.1016/j.japh.2021.04.009
  5. Johnston K, O'Reilly CL, Scholz B, et al. Burnout and the challenges facing pharmacists during COVID-19: results of a national survey. Int J Clin Pharm. 2021;1-10.
  6. S. Department of Health and Human Services. Trump administration takes action to expand access to COVID-19 vaccines. Accessed June 20,2021. https://www.hhs.gov/about/news/2020/09/09trump-administration-takes-action-to-expand-access-to- COVID-19-vaccines.html
  7. S. Department of Health and Human Services. Guidance for licensed pharmacists, COVID-19 testing, and immunity under the PREP Act. April 8, 2020. Accessed January 3, 2022. https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf
  8. Spencer J. KHN. Lost on the frontline. 12 months of trauma: More than 3600 US health workers died in Covid’s first year. April 8, 2021. Accessed January 3, 2022. https://khn.org/news/article/us-health-workers-deaths- COVID-lost-on-the-frontline/
  9. Press Release. Pharmacy associations applaud introduction of bill expanding Medicare patients’ access to pharmacist services. April 21, 2021. Accessed at Accessed January 3, 2022. https://www.ashp.org/News/2021/04/22/ASHP-APHA-Applaud-Introduction-of-Bill-Expanding-Medicare-Patients-Access-to-Pharmacist-Services
  10. APhA Action Center. Provider status for pharmacists.  Accessed January 3, 2022. ttps://actioncenter.pharmacist.com/campaign/provider-status-for-pharmacists/, September 10, 2021.
  11. News. 2021 State provider status mid-year legislative update. June 7, 2021. Accessed January 3, 2022.  https://naspa.us/2021/06/2021-state-provider-status-mid-year-legislative-update/
  12. Chinthamalla K. APhA: NBC news story illustrates the need for fundamental pharmacy payment reform. APhA Press Releases. March 17, 2021. Accessed at Accessed January 3, 2022. https://www.pharmacist.com/About/Newsroom/apha-nbc-news-story-illustrates-the-need-for-fundamental-pharmacy-payment-reform
  13. Mills, RJ. AMA launches Steps Forward to address physician burnout. AMA Press Releases. June 8, 2015. Accessed January 3, 2022. https://www.ama-assn.org/press-center/press-releases/ama-launches-steps-forward-address-physician-burnout
  14. Well-Being Index. Pharmacist Well-Being Index. Accessed January 3, 2022. https://www.mywellbeingindex.org/versions/pharmacist-well-being-index

Are You Curious about Pharmacoeconomics?

Learning Objectives

  After completing this application-based continuing education activity, pharmacists will be able to
  • Define common pharmacoeconomic terms used for economic evaluations.
  • Recall the advantages of pharmacoeconomic analysis for formulary management.
  • Compare and contrast different types of pharmacoeconomic analyses.
  • List the pharmacoeconomic tools a pharmacy benefit manager uses to lower drug costs.
After completing this application-based continuing education activity, pharmacy technicians will be able to:
  • Define common pharmacoeconomic terms used for economic evaluations.
  • Recall the advantages of pharmacoeconomic analysis for formulary management.
  • Compare and contrast different types of pharmacoeconomic analyses.
  • List the pharmacoeconomic tools a pharmacy benefit manager uses to lower drug costs.

Person wearing a white coat surrounded by one dollar bills holding two vials marked with dollar signs

 

Release Date:

Release Date:  February 15, 2025

Expiration Date: February 15, 2028

Course Fee

Pharmacist $7

Pharmacy Technician $4

There is no funding for this CPE activity.

ACPE UANs

Pharmacist: 0009-0000-25-003-H04-P

Pharmacy Technician: 0009-0000-25-003-H04-T

Session Codes

Pharmacist: 25YC03-QPL37

Pharmacy Technician: 25YC03-LPQ73

Accreditation Hours

2.0 hours of CE

Accreditation Statements

The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-25-003-H04-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

 

Disclosure of Discussions of Off-label and Investigational Drug Use

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

Faculty

Peter Gordinier Jr.
2025 PharmD Candidate
UConn School of Pharmacy
Storrs, CT

Jack Vinciguerra, PharmD.
Freelance Medical Writer
East Hartford, CT

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


 

Faculty Disclosure

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

Dr. Vinciguerra, Mr. Gordinier Jr., and Ms. Wick have no financial relationships with ineligible companies.

ABSTRACT

Many pharmacy practitioners have heard of pharmacoeconomics, but don't have a clear understanding of what that term means. This field of study has a unique vocabulary associated with it and compares different aspects of drugs to determine which drug will produce the best clinical and economic outcomes. Many Pharmacy and Therapeutics Committees are now requiring pharmacoeconomic analysis when they consider formulary changes, but these analysis come in several different forms. Depending on the type and quantity of information available, people preparing reports for Pharmacy and Therapeutics Committee meetings will need to decide which model or studies to use. The foundation for several of the models is quality adjusted life years or QALYs, which have advantages and limitations.  Pharmacy benefit managers use cost control tools and pharmacoeconomic analysis to control costs. Some tools that they may use are negotiated price, generic substitution, rebates, and patient copayments. Not all pharmacoeconomic studies are perfect, and this continuing education activity points out some of the ways in which they may be flawed.

CONTENT

Content

INTRODUCTION

Let’s start with an old joke. An economics student once asked her professor how much his shoes cost. The professor responded with “I don’t know, I haven’t finished wearing them yet.” Drugs are just like shoes because their sticker price does not reflect their true cost or value.

 

PHARMACOECONOMICS BACKGROUND

The term pharmacoeconomics dates back to 1986.1 Dr. Raymond Townsend used the term in a presentation for pharmacists in Canada.2 Dr. Townsend earned his PharmD at the University of California, San Francisco and developed the pharmacoeconomic research department at the Upjohn Company.3 The Upjohn team developed pharmacoeconomics to address payment concerns as the healthcare system transitioned from a cash-based system to a third-party payer system. Its goal was to ensure drug spending was efficient and effective.4 Pharmacoeconomics has evolved over the ensuing 30-plus years to become a subbranch of economics.

 

Pharmacoeconomics compares different aspects of drugs to determine which drug will produce the best clinical and economic outcomes.1 Pharmacists who work for pharmacy benefits managers (PBMs) or prepare for Pharmacy and Therapeutics (P&T) committee meetings are most likely to use pharmacoeconomic tools. But all healthcare personnel should understand pharmacoeconomics so they can use these tools as part of their efforts to optimize patient care or explain how health systems select medications to include on a formulary.

 

While these tools are useful, many pharmacists will avoid using pharmacoeconomics. In preparing to write this continuing education activity (CE), we asked faculty from two Schools of Pharmacy to identify pharmacoeconomic studies that have had significant clinical impact. One university pharmacy professor said, “Most pharmacoeconomics studies are ignored in clinical practice because practitioners don’t understand them or use other reasons to select a drug.” This CE activity should address both of those barriers—lack of understanding and the other considerations when selecting drugs.

 

MEET GEORGE

In this CE, George will join you. George just graduated from pharmacy school. He was hired at Man with the Yellow Hat Hospital and was put in charge of a presentation for the P&T Committee meeting. George is tasked with presenting a proposal to add a new drug, Monkeydex, to the formulary. If the Committee adds Monkeydex, he also needs to make a recommendation about the similar drug that is already on the formulary, Curiosan: should it remain on the formulary or be removed? The U.S. Food and Drug Administration (FDA) has approved both drugs for adventure-induced curiosity overload (AICO). Ted, another pharmacist, suggested George use pharmacoeconomic tools to analyze each drug’s effectiveness and cost.

 

PAUSE AND PONDER: Before reading further, write down as many pharmacoeconomic terms as you can!

 

Common Pharmacoeconomic Terms

George figured that common pharmacoeconomic terms are the best spot to begin his learning. George found these terms most helpful 5,6:

 

  • Comparators: the interventions being compared (and it’s possible to have two or more comparators)
  • Costs
    • Direct costs: paid by the health system (salary costs, drug acquisition costs)
    • Indirect costs: experienced by the patient (including decreased productivity, loss of earnings, hospital travel costs)
    • Intangible costs: costs of patient/family’s feelings (worry, distress)
  • Economic evaluation: comparing two different interventions and assessing their costs and outcomes
  • Opportunity cost: the loss of benefit from the option not chosen; for example, if you decide to spend two hours on a Friday night paying bills, the opportunity cost is that you cannot spend two hours pursuing leisure activities
  • Outcomes: the expected results from an intervention
  • Perspective: the different viewpoint from which an intervention can be assessed (patient, provider, payor, or just a population in general)
  • Target population: the group of patients who will benefit from the intervention
  • Willingness to pay: the maximum amount an individual, a system, an organization, or a payor will pay for an intervention

 

George compared the two interventions (Curiosan vs. Monkeydex) in Table 1. George used the new terms he learned.

 

PAUSE AND PONDER: Why is it necessary for a health system to consider indirect and intangible costs when entertaining the possibility of adding a medication to the formulary?

 

Table 1. George’s Use of Pharmacoeconomic Terms to Compare Two Interventions

Term Intervention Comparison
Economic Evaluation George will compare Curiosan vs. Monkeydex with the terms provided below
Target Population Curiosan: Treatment of AICO

Monkeydex: Treatment of AICO

Comparators Curiosan and Monkeydex
Opportunity Cost The hospital won’t be able to benefit from the drug not chosen
Outcomes Curiosan Pivotal Trial

-       Participants: 400 Patients aged 18-40 with AICO

-       Endpoints: reduction of AICO events per year

-       Results: patients experienced a 55% reduction in AICO events over a year

-       Adverse Effects: 15% of patients reported minor adverse effects from the drug such as nausea, infusion site pain, and light headedness

 

Monkeydex Pivotal Trial

-       Participants: 650 Patients aged 25-45 with AICO

-       Endpoints: reduction of AICO events per year

-       Results: patients experienced a 45% reduction in AICO events over a year

-       Adverse Effects: 20% of patients reported minor adverse effects such as headaches, constipation, and mild weight gain

Willingness to Pay The hospital is willing to pay up to $4500 for either medication
Perspective Each intervention will be assessed from the hospital’s viewpoint
Direct Costs Curiosan (TOTAL - $3900)

-       Administration - infusion once a month for six months ($400/month) plus each infusion costs $100 in medical service fees

-       Monitoring - monthly blood tests ($100)

-       Adverse Effect Treatment - requires OTC products ($50/month)

 

Monkeydex (TOTAL - $4200)

-       Administration - oral tablet taken once daily for twelve months ($300/month)

-       Monitoring - monthly blood tests ($25)

-       Adverse Effect Treatment - requires OTC products ($25/month)

Indirect Costs Curiosan

-       Patients may lose productivity time due to travel to the infusion center and medication administration times (~2-3 hour/day)

-       Transportation costs for gas (~$10 each visit)

 

Monkeydex

-       Patients may lose productivity time due to adverse effects of drug interrupting the day (~1 hour/day)

-       Hospital offers free mail deliver for Monkeydex

Intangible Costs Curiosan

-       Patients may feel stressed about injections and possible adverse effects

-       Monthly infusions can take a toll on a patient’s life and having to take off work for monthly injections can be stressful

-       After six months the patient will be cured

 

Monkeydex

-       Patients may feel calmer when taking a tablet

-       Patient receives the medication monthly and does not need to make any appointments

-       Patient needs to be on the medication for one year and they will be cured

ABBREVIATIONS: AICO = Adventure-Induced Curiosity Overload

 

 

ADVANTAGE OF PHARMACOECONOMIC TOOLS FOR FORMULARY DECISIONS

George learned a ton of new pharmacoeconomic terms and understands how they will be useful for his presentation on Curiosan and Monkeydex. George’s curiosity about formularies and the advantages of pharmacoeconomic information prompted him to look for additional material.

 

What is a formulary?

A drug formulary is a continuously updated list of safe and effective medications approved by a healthcare institution or insurer. The P&T committee is responsible for adding, keeping, or removing medications from the formulary. Although the P&T committee deals heavily with issues related to medications, it has representation from many departments: administrative people, nurses, pharmacists, physicians, and others. The broad membership reflects the fact that medication use is a transdisciplinary function. The P&T committee meets regularly to discuss new FDA drug approvals, revised and updated guidelines, firsthand patient drug experiences, institution policy, and new clinical trials.7 (See the SIDEBAR.)

 

SIDEBAR: P&T Committee Duties8

  • Manage the formulary including any changes and the addition of new drugs
    • Evaluate any candidate for the formulary using current evidence and clinical studies to either support or refute a drug’s addition
    • Conduct periodic drug use evaluation for all classes of medication
  • Consider patient safety in all decision processes
  • Ensure the electronic health record (EHR) integrates strategies to support drug selection
    • Specifically, the EHR should help with dosing and monitoring of patients to prevent errors
  • Develop strategies during drug shortages. The P&T committee finds bioequivalent drugs and decides how to ration the available drugs
  • Implement medication use policies. Medication use policies guide the use of a medication through prescriber education, pharmacist communication, or team rounds/meetings
  • Understand the reimbursement process for health systems concerning which insurances will pay for medications

 

Most formularies are based on a tiered system. A medication’s tier in the formulary reflects the plan’s coverage. Generic medications usually have a preferred tier and lower out of pocket costs, while brand name medications would be placed on a higher tier unless the PBM, healthcare system, or payer has negotiated a better price for a specific product (discussed below). Two types of formularies exist7:

  • Open Formulary – the plan provides coverage for all medications, even if they are not on the formulary. Certain medication classes, such as over-the-counter medications, are not covered.
  • Closed Formulary – the plan covers only medications that are on the formulary. Non-formulary medications may be covered when a healthcare practitioner deems it necessary, but the prescriber may need to submit a nonformulary drug request or paperwork for prior authorization. Typically, hospitals operate with a closed formulary.

 

Decision Analysis in Formulary Management

Pharmacoeconomics employs decision analysis to pool data related to medication to determine if one medication is more cost effective than a comparator. It’s easy to determine if a drug costs less than another based sheerly on acquisition price. But it can be a challenge to determine if a more or less expensive drug is a better, more effective choice.9 It is important to note that a drug’s effectiveness refers to how it performs in the real world. A drug’s effectiveness differs from its efficacy, which reflects how well a drug performs in clinical trials. Once the trials are over, drugs rarely perform as well in the real world where people who take the drug don’t receive that same support and may have characteristics that study participants did not have.10 Pharmacoeconomic researchers take into account a multitude of factors including cost, outcomes, and adverse events when analyzing two comparators.9

 

Many people, like the professor quoted at the start of this CE, wonder if pharmacoeconomics is useful. To highlight the effectiveness of decision analysis in the pharmacy profession, the University of Cincinnati James L. Winkle School of Pharmacy added a collaborative decision analysis project to its curriculum.11 Its purpose was for students to evaluate a drug based on multiple factors, not just cost. Students used a decision analysis model in Microsoft Excel to compare two antibiotics, using the model to recommend the better option. Professors released a student survey at the end of the project. The survey found that more than 90% of students felt the project was useful and said it widened their thinking skills about what a drug’s cost involves. Sticker price is not the only consideration.11

 

While decision analysis incorporates a medication’s cost and clinical outcomes, some organizations take a different approach, eschewing pharmacoeconomics entirely. The United States Preventive Services Task Force (USPSTF) makes education-based medication recommendations.12 It does not consider a medication’s cost at all when it makes a recommendation for its use. The USPSTF made this decision to focus solely on a medication’s clinical effectiveness because it does not want to limit a patient’s healthcare options based on cost.12

 

Overall, pharmacoeconomic analysis offers tools for formulary management including enhanced decision making, cost savings, and overcoming barriers. Using pharmacoeconomic analyses in formulary decision-making evaluates changes comprehensively and helps select the best intervention.9 Additionally, decision makers can select a more informed approach to keep a drug on a formulary by analyzing a drug’s effects in addition to its cost. Last, by using pharmacoeconomic tools more often, it can become more mainstream in formulary decision making.9

 

PAUSE AND PONDER: What drugs or drug classes used in your pharmacy would benefit from pharmacoeconomic analysis?

 

Common Types of Pharmacoeconomic Analyses

George learned a considerable amount of new information about decision analysis. He sees his error in only considering these medications’ acquisition prices in the past. George was curious about the methods pharmacoeconomic professionals use in their studies to report a medication’s overall effectiveness. He decided to look at the types of analyses.

 

The four types of analysis in pharmacoeconomic studies are cost benefit analysis (CBA), cost effectiveness analysis (CEA), cost minimization analysis (CMA), and cost utility analysis (CUA). Table 2 provides more information about each type of analysis.6

 

Table 2. Overview of Different Analyses6

  CBA CEA CMA CUA
Purpose -Calculates the cost benefit of an intervention

 

-Both the intervention and its benefits are converted to monetary values

Measures the health benefit in natural units (ex. ulcers healed) and monetary units -Focuses only on costs to a health service

 

-Used when two interventions have an identical benefit

-Interventions compared based on their impact on a patient’s life

 

-Measured in QALYs

 

Advantages Helps to compare the costs of different interventions in completely different therapeutic areas Compares two or more different drugs with similar outcomes, but different success rates Great tool to use when comparing a generic drug with its brand name counterpart Outcomes do not need to be measured on a monetary scale
Disadvantages May ignore benefits that cannot be measured by money value (ex. anxiety relief) Cannot compare drugs that treat different conditions Both interventions need to have identical benefits, besides cost Measurements in QALYs may differ in different disease states
ABBREVIATIONS: CBA = cost benefit analysis; CEA = cost effectiveness analysis; CMA = cost minimization analysis; CUA = cost utility analysis; QALYs = Quality Adjusted Life Years

 

George acquired a great basic knowledge of the analyses. He was curious to learn more about some new concepts he found in his research. Specifically, he wanted to know more about calculating outcomes costs for interventions, incremental cost-effectiveness ratio calculations, and how to determine quality-adjusted life years (QALYs). As a basis to understand the different analyses, it’s critical to look at QALY first.

 

Health economists calculate quantity of and quality of years, which are combined into QALYs.13 To calculate a QALY, begin with the utility score, which is scaled from 0 to 1. A chronic condition may have a utility score of 0.6. The Health Utilities Index Mark 3 (HUI3) is used to measure utility scores. The HUI3 asks a serious of questions about eight attributes (e.g., ambulation, cognition, dexterity, emotion, hearing, pain, speech, vision) and combines them into a score that ranges from 0 to 1. The numeral 1 means perfect health and 0 represents death.14 To calculate QALY, the utility score is multiplied by the time spent in each state, which translates into the number of years of life the typical patient gains on a treatment. For example, consider patients with a chronic condition (utility score of 0.6) receiving a treatment that will add seven years to their life. To calculate the QALY, multiply 0.6 x 7, which equals 4.2 QALYs gained.15

 

While QALYs can effectively determine how many life years are gained in many situations, they have some downsides.16 QALYs are blind to health conditions and personal characteristics such as age, disease severity, residence location, and sex. Additionally, the QALY does not encompass all aspects of an intervention’s benefit. For example, if a single mother takes a medication that rapidly improves her health, it can also improve the health of her kids and allow her to return to work quicker.16

 

Cost Benefit Analysis. The main purpose is to compare interventions with different outcomes. Typically, a CBA involves adding all the costs of an intervention and subtracting that figure from the expected benefits of the intervention. A CBA helps an organization to see an intervention’s return on investment. When doing a CBA, it’s important to identify an intervention’s direct, indirect, and intangible costs to compare against the intervention’s benefits.17 George found this explanation straightforward but had to ask Ted how he would estimate the expected benefits. To calculate the expected benefits, Ted told George to list the indirect and intangible benefits of the interventions and make educated guesses about monetary values for each, looking first to see if any studies have assigned or estimated costs. George can then subtract the intervention’s costs from these expected benefits to equal the net benefits.18

 

Cost Effectiveness Analysis compares the cost and outcomes for two or more interventions for the same condition. A CEA is centered around the incremental cost-effectiveness ratio (ICER). This explanation had George scratching his head, and he had to review it several times to really understand it. The ICER is the ratio of cost differences to outcomes differences between interventions.19 The ICER is useful because it shows the added cost per unit of health outcome gained from a new intervention.19 The ICER is calculated using the equation ICER = costs1 minus costs2 divided by effect1 minus effect2. For example, intervention 1 costs $200 with an 8 QALY benefit and intervention 2 costs $100 with a 4 QALY benefit. Plug these numbers into the equation and the ICER = 25. This means $25 per QALY for intervention 1 over intervention 2.20

 

Cost Minimization Analysis considers only half of an economic evaluation because it does not consider the outcomes of interventions. It simply looks at cost. For a CMA to be considered a full evaluation, health economists would need to consider the outcomes of interventions, such as how many life years are saved. If the interventions’ outcomes are equal, then the CMA can be useful.21

 

Cost utility analysis helps compare costs and benefits from different interventions. CUA takes into account benefits in terms of how many years are saved and quality of life.13 CUA is helpful to quantify how much an intervention can extend and improve someone’s life. QALYs are used in a CUA to display quality and quantity of years saved for a patient’s life. The best time to use a CUA is when someone wants to determine the cost-effectiveness of a product that is a high cost for the payer. A CUA study plans to show where resources should be allocated for maximum health benefit.13

 

George decided to put together his own CEA after learning more about the pharmacoeconomic analyses. He chose this approach since he was able to acquire the most information about how to properly perform a CEA. Table 3 shows George’s CEA for Curiosan compared with Monkeydex.

 

Table 3. CEA for Curiosan and Monkeydex

Curiosan Monkeydex
Total Cost (Both direct and indirect/intangible) $3900 (direct costs) + $200 (indirect/intangible costs) $4200 (direct costs) + $100 (indirect/intangible costs)
Effect (Reduction in Curiosity Overload Events per Year) 3 events prevented 5 events prevented
ICER

($4100 - $4300) / (3 - 5)
Outcome of ICER $100 from each episode prevented by using Curiosan over Monkeydex
ABBREVIATIONS: ICER = Incremental Cost-Effectiveness Ratio

 

George analyzed both costs and outcomes from the two interventions. He concluded $100 from each adventure-induced curiosity overload episode was saved by using Curiosan over Monkeydex. The CEA shows Curiosan’s effectiveness over Monkeydex when considering costs and outcomes. Let’s re-examine the pharmacy professor’s quote in which he said, “Most pharmacoeconomic studies are ignored in clinical practice because practitioners don’t understand them or use other reasons to select a drug to use.” What factors is he referring to? One other factor might be patient volume. This hospital generally sees about five AICO patients per day and they are treated in the emergency department. The P&T Committee knows that Man with the Yellow Hat Hospital has an emergency department with 20 available beds that can usually accommodate all these patients. If the emergency room experiences overflow, hospital management has designated the adjacent hallway to hold up to five excess patients. If the hospital only had a total of five beds available, however, or it was having difficulty staffing the ED, the P&T committee’s deliberations might be different.

 

PHARMACOECONOMIC TOOLS IN PHARMACY BENEFIT MANAGEMENT

George checked the major dailies—the most reliable newspapers across the country that fact-check before they publish—to see if any recent articles talked about the impact of pharmacoeconomics while doing his research. George checked these publications because he wanted to identify any recent major developments in the healthcare industry. He found multiple feature articles and opinion pieces on the function of PBMs. George read that PBMs contribute to formulary decision making for payors or employers and use different pharmacoeconomic tools to support their choices. George wanted to find out more about the PBM’s role and how they contribute to the formulary, so he delved into the topic again.

 

PBM History

PBMs surfaced in the 1950s due to a demand for special management of drug benefits.22 Pharmacists started the first PBMs, founding Prescription Services, Inc in Canada in 1958 and PAID Prescriptions in the United States (U.S.) in 1965. Through the years, health systems and payors began to collaborate with PBMs more often and they grew in size and scope. Now, PBMs handle a wide variety of tasks including formulary maintenance, pharmacy networks, mail order pharmacy operations, and contracts with wholesalers and manufacturers. A PBM’s most important service is maintaining a drug formulary. Most PBMs will handle multiple formularies for different clients. PBMs cover certain drugs on a formulary and some drugs require patients to pay a portion of the costs.22

 

George learned from his reading of current events that the Federal Trade Commission (FTC) is looking into PBMs and considering preventing them from combining. 22 The FTC often refers to PBMs as the prescription drug middleman industry and has launched inquiries into their operations and practices.23 It theorizes that if PBMs continue to combine and integrate, they could possibly have unprecedented control over drug prices, blocking competition. Their concern of market concentration is based on the oligopoly theory which states that if five firms in an industry account for more than 60% of the market, competition is stifled. The FTC alleges that the three largest PBMs processed almost 80% of prescriptions dispensed by U.S. pharmacies in 2023, and the top six processed more than 90%. Describing PBM operations as opaque, the FTC reported in July 2024 that despite their efforts to obtain records from six PBMs, several have refused to comply. A significant concern is that the current PBM structure may disadvantage small pharmacies that are not in the PBM network and the patients they serve.23,24 The FTC’s efforts are focused on promoting fair competition and protecting consumers from high medication prices.25

 

PAUSE AND PONDER: What are some cost control tools used lower drug costs in your pharmacy?

 

PBM Cost Control Tools

PBMs use an assortment of cost control tools to control costs26,27,28:

  • Negotiated prices. PBMs work on securing a specific price for drugs. PBMs that purchase drugs at a high volume can negotiate discounted prices. The price paid by the PBM is often much lower than other plans’ prices, such as Medicaid. PBMs will apply this discount to the pharmacies in its network, guaranteeing access for pharmacies that contract exclusively with the PBM.
  • Generic substitution. Here, the goal is to increase the use of generic medication whenever possible. Generally, generic drugs cost 80% to 85% less than their brand name equivalents. Pharmacists may receive an incentive for dispensing a higher number of generics.
  • Rebates. A rebate is money returned by the seller to the drug purchaser under certain conditions. The seller gives rebates to incentivize higher volume purchases and to stay competitive without directly lowering costs. The PBM often negotiates a rebate and reaches an agreement with the drug manufacturers. A rebate program may stimulate the PBM to increase its use of rebated drugs; on the flip side, rebates may cause the PBM to place high-priced drugs in better tiers than drugs that are more cost-effective, which creates higher out-of-pocket costs for some patients.
  • Copayments. A copayment is a fixed amount that patients, insureds, or beneficiaries pay for their prescriptions. PBMs use copayments as a cost-sharing mechanism to reduce the insurer’s or employer’s overall medication costs. PBMs adjust copayments depending on the plan they are managing. Generic medications generally have lower copayments, but brand and some generic medications may require a higher copayment.

 

Do PBMs Create Value in Healthcare?

PBMs have had many significant impacts on the drug distribution system. At their inception, they created systems to replace the manual claims filing process that was dependent on paper with electronic systems that communicated among stakeholders quickly. Today’s systems operate in real-time, which is advantageous to all stakeholders.29

 

Controversy surrounds PBMs (See the SIDEBAR). PBMs add value to their stakeholders (e.g., insurers, health systems, payors), but it is uncertain whether PBMs contribute significant value to the U.S. healthcare system. PBMs have proprietary contracts that prevent open discussion of the terms they negotiate and tools they use. Some experts allege that PBMs engage in “spread pricing,” meaning they charge health plans and employers more for generic drugs than what they reimburse pharmacies for these drugs, keeping the difference. Again, a lack of transparency allows this to happen: PBMs’ operations are proprietary and confidential. They often lack transparency and it’s possible to conclude they may take value from healthcare. Some evidence exists indicating that agreements with manufacturers agreements require PBMs to exclude generic drugs and biosimilars from their formularies in exchange for higher rebates.24,27,30

 

SIDEBAR: Have PBMs Abused the Drug Rebate System?

The 3 major PBMs—Caremark Rx, Express Scripts (ESI), and OptumRX—are currently in the FTC’s crosshairs for allegedly artificially inflating insulin drug prices. The FTC has filed an administrative complaint citing that 3 PBMs have developed and abused a drug rebate system that prioritizes high rebates from drug manufacturers, forcing consumers to spend more on life-saving medication.25

 

The crux of the issue centers on PBMs ability to establish discounts on the manufacturer’s initial sticker price of brand name drugs. Drug companies will agree to these discounts in exchange for preference and availability on the PBM’s formularies. As the discounts grew larger over time, pharmaceutical companies were forced to raise their initial sticker prices to maintain profits. Therefore, while PBMs have cut prices in half for their clients, patients have suffered because the price at point of service often reflects the initial sticker price.31 Even if less expensive insulins become available, PBMs are able to design their formularies strategically to exclude those options in favor of equivalent high list price, highly rebated products.32

 

The PBMs’ “chase-the-rebate” strategy has shifted the burden of high insulin prices directly to patients.25 Take, for example, one insulin product that was listed at $122.59 in 2012. Also in 2012, PBMs introduced exclusionary drug formularies, a tactic weaponized to demand higher rebates in exchange for a desirable spot on the formulary. By 2018, the list price of that specific insulin more than doubled to $289.36. Patients with deductibles or coinsurance do not benefit from rebates at the pharmacy counter. These out-of-pocket expenses for insulin drugs are sometimes even higher than total cost of the drug to the commercial payor.25

 

All three PBMs have pushed back on the allegations from the FTC, claiming the lawsuit “demonstrates a profound misunderstanding of how drug pricing works.”32 The FTC has also acknowledged that PBMs likely did not act alone, and actions against drug manufacturers may be on the horizon. Over the last year, Eli Lily, Novo Nordisk, and Sanofi all promised significant cuts to the list price of their insulins due to public and political pressure. The recently passed Inflation Reduction Act also has chipped away at insulin prices by establishing a $35 per month cap for Medicare Part D patients.32

 

Implications for Pharmacy Teams

Pharmacoeconomics is helpful for pharmacy teams because in a healthcare setting pharmacists need to be able to determine if a drug’s value can be justified by its cost. George learned that a good way to think about cost and value is this: “Value is the results you get divided by the cost. Value is what works, not how cheap it is.”33 Pharmacy employees, especially those who work in procurement or with the P&T Committee, should understand how to differentiate between the four types of pharmacoeconomic analyses. The different analyses help engage in informed decision making between two or more interventions. Pharmacoeconomics can guide clinical and policy decision making. Today, pharmacists in community and hospital settings provide a wide variety of services including vaccinations and medication use counseling. A health economist might perform a pharmacoeconomic analysis to determine if a pharmacist’s services are adding value to the healthcare system. Additionally, a payment model needs to be established to ensure pharmacists are compensated for their non-dispensing work.34

 

Red Flags in Pharmacoeconomic Studies

Pharmacy staff must recognize that pharmacoeconomic studies, like all studies, can be flawed. Certain red flags decrease a study’s validity. Below are some common questions to ask after reading a pharmacoeconomic study. These questions help identify the study’s limitations35:

  • Does the title accurately represent the study’s goals?
  • Did the researchers clearly state the study’s objective?
  • Did the researchers use a large enough data sample? Remember that larger sample sizes lead to more reliable results.
  • If the researchers compared interventions, did they use appropriate comparators?
    • If the researchers were reporting on a new treatment, did they compare it to the current standard of care or the most popular marketed options? Or did the authors compare the treatment to a less popular, less effective, or older (and retired) alternative?
  • Did the researchers provide a description of the competing alternatives’ use in clinical practice?
  • Did the researchers identify which perspective they employed to measure the costs?
  • Did the researchers indicate the study structure (retrospective, prospective, etc.)?
  • Were all the costs of the interventions included?
  • Did the researchers include all important clinical outcomes from various studies?
  • Were the study’s conclusions appropriate for the study? Or did the conclusions go beyond the scope of the target population?
  • Is it possible to extrapolate the findings to your population, or are the populations too different?
  • Did the researchers present the conclusions in an unbiased manner?

 

CONCLUSION

George was able to learn so much about pharmacoeconomics. He feels confident about the different pharmacoeconomics terms used for economic evaluations. George also recalls the advantages of pharmacoeconomic analysis and can compare the different types of analyses. Last, he better understands the PBM’s role and the tools a PBM uses to lower drug costs.

 

 

Pharmacist Post Test (for viewing only)

Are You Curious about Pharmacoeconomics?

Pharmacist Post-test

After completing this continuing education activity, pharmacists and pharmacy technicians will be able to
• Define common pharmacoeconomic terms used for economic evaluations.
• Recall the advantages of pharmacoeconomic analysis for formulary management.
• Compare and contrast different types of pharmacoeconomic analyses.
• List the pharmacoeconomic tools a pharmacy benefit manager uses to lower drug costs.

1. The P&T Committee at Queens Hospital is considering the addition of Fixitall, a new bi-weekly intravenous infusion drug for the treatment of rheumatoid arthritis, to the hospital formulary. Which of the following describe the direct costs of the proposed intervention?

A. Monthly administration, monitoring, and adverse effect OTC treatment costs.
B. Transportation costs to and from the hospital for each treatment.
C. Loss of wages from missing work during bi-weekly infusion center visits.

2. Which of the following best describes an opportunity cost?
A. The amount of money saved by acquiring drug A instead of drug B.
B. The loss of benefit of drug A if drug B is the preferred choice.
C. The negotiation of a rebate for either drug A or drug B.

3. Which of the following defines the pharmacoeconomic term “willingness to pay”?

A. The amount a drug manufacturer will rebate a PBM to indirectly lower drug costs.
B. The calculated ratio of cost differences to outcomes differences between interventions.
C. The maximum amount an individual, system, organization, or payer will pay for an intervention.

4. Which of the following is an advantage of using pharmacoeconomic analysis to inform formulary decisions?

A. Pharmacoeconomic analysis focuses solely on the medication’s cost in an effort to save payers the most money.
B. Pharmacoeconomic analysis considers drug efficacy rather than drug effectiveness to accurately predict real world implications.
C. Pharmacoeconomic analysis considers cost, outcomes, and adverse events when analyzing two or more comparators.

5. Which of the following describes an advantage associated with a cost benefit analysis?

A. Does not require the intervention and its benefits to be converted to monetary values.
B. Compares the cost of different interventions in completely different therapeutic areas.
C. Analyzes the difference in cost of a generic drug compared to its brand name equivalent.

6. Which of the following pharmacoeconomic analyses is measured in QALYs?

A. Cost benefit analysis
B. Cost minimization analysis
C. Cost utility analysis

7. Which of the following strategies do pharmacy benefit managers implement to lower drug costs?

A. Negotiating rebates with drug manufacturers that incentivize higher volume purchases.
B. Limiting the substitution of generic medications due to the lack of incentive provided.
C. Discouraging the use of copayments due to their tendency to increase overall medication costs.

8. Which of the following is an example of an intangible cost?

A. Transportation costs for gas to and from the infusion center.
B. Copayment costs that occur with every infusion treatment.
C. Cost of patient/family’s anxiety over recurrent injections and adverse effects.

9. You are conducting a cost effectiveness analysis of two new ulcerative colitis drugs. Drug A costs $400 with a 6 QALY benefit and Drug B costs $200 with a 4 QALY benefit. Which of the following is the correctly calculated incremental cost-effectiveness ratio (ICER)?

A. $20 per QALY for Drug A over Drug B.
B. $100 per QALY for Drug A over Drug B.
C. $60 per QALY for Drug A over Drug B.

10. Which of the following describes a disadvantage of a cost minimization analysis?

A. Compared interventions must have identical benefits other than cost.
B. Calculated measurements in QALYs may differ in different disease states.
C. Cannot compare a generic drug with its brand name counterpart.

Pharmacy Technician Post Test (for viewing only)

Are You Curious about Pharmacoeconomics?

Pharmacy Technician Post-test

After completing this continuing education activity, pharmacists and pharmacy technicians will be able to
• Define common pharmacoeconomic terms used for economic evaluations.
• Recall the advantages of pharmacoeconomic analysis for formulary management.
• Compare and contrast different types of pharmacoeconomic analyses.
• List the pharmacoeconomic tools a pharmacy benefit manager uses to lower drug costs.

1. The P&T Committee at Queens Hospital is considering the addition of Fixitall, a new bi-weekly intravenous infusion drug for the treatment of rheumatoid arthritis, to the hospital formulary. Which of the following describe the direct costs of the proposed intervention?

A. Monthly administration, monitoring, and adverse effect OTC treatment costs.
B. Transportation costs to and from the hospital for each treatment.
C. Loss of wages from missing work during bi-weekly infusion center visits.

2. Which of the following best describes an opportunity cost?
A. The amount of money saved by acquiring drug A instead of drug B.
B. The loss of benefit of drug A if drug B is the preferred choice.
C. The negotiation of a rebate for either drug A or drug B.

3. Which of the following defines the pharmacoeconomic term “willingness to pay”?

A. The amount a drug manufacturer will rebate a PBM to indirectly lower drug costs.
B. The calculated ratio of cost differences to outcomes differences between interventions.
C. The maximum amount an individual, system, organization, or payer will pay for an intervention.

4. Which of the following is an advantage of using pharmacoeconomic analysis to inform formulary decisions?

A. Pharmacoeconomic analysis focuses solely on the medication’s cost in an effort to save payers the most money.
B. Pharmacoeconomic analysis considers drug efficacy rather than drug effectiveness to accurately predict real world implications.
C. Pharmacoeconomic analysis considers cost, outcomes, and adverse events when analyzing two or more comparators.

5. Which of the following describes an advantage associated with a cost benefit analysis?

A. Does not require the intervention and its benefits to be converted to monetary values.
B. Compares the cost of different interventions in completely different therapeutic areas.
C. Analyzes the difference in cost of a generic drug compared to its brand name equivalent.

6. Which of the following pharmacoeconomic analyses is measured in QALYs?

A. Cost benefit analysis
B. Cost minimization analysis
C. Cost utility analysis

7. Which of the following strategies do pharmacy benefit managers implement to lower drug costs?

A. Negotiating rebates with drug manufacturers that incentivize higher volume purchases.
B. Limiting the substitution of generic medications due to the lack of incentive provided.
C. Discouraging the use of copayments due to their tendency to increase overall medication costs.

8. Which of the following is an example of an intangible cost?

A. Transportation costs for gas to and from the infusion center.
B. Copayment costs that occur with every infusion treatment.
C. Cost of patient/family’s anxiety over recurrent injections and adverse effects.

9. You are conducting a cost effectiveness analysis of two new ulcerative colitis drugs. Drug A costs $400 with a 6 QALY benefit and Drug B costs $200 with a 4 QALY benefit. Which of the following is the correctly calculated incremental cost-effectiveness ratio (ICER)?

A. $20 per QALY for Drug A over Drug B.
B. $100 per QALY for Drug A over Drug B.
C. $60 per QALY for Drug A over Drug B.

10. Which of the following describes a disadvantage of a cost minimization analysis?

A. Compared interventions must have identical benefits other than cost.
B. Calculated measurements in QALYs may differ in different disease states.
C. Cannot compare a generic drug with its brand name counterpart.

References

Full List of References

 

REFERENCES

  1. KurhekarJV. Chapter 4 - Ancient and modern practices in phytomedicine. Editor(s): Egbuna C, Mishra AP, Goyal MR. Preparation of Phytopharmaceuticals for the Management of Disorders, Academic Press, 2021, Pages 55-75, ISBN 9780128202845, https://doi.org/10.1016/B978-0-12-820284-5.00019-8.
  1. Mauskopf JA. Why study pharmacoeconomics?. Expert Rev Pharmacoecon Outcomes Res. 2001;1(1):1-3. doi:10.1586/14737167.1.1.1
  2. Raymond Townsend General Information. Profile previews: Company, investor and advisor profiles | Pitchbook. Accessed August 22, 2024. https://pitchbook.com/profiles.
  3. Wildeman RA. Pharmacoeconomic Challenges in Canada. Vol 29. Drug Info J. Accessed November 10, 2024. https://journals.sagepub.com/doi/abs/10.1177/009286159502900425
  4. Tonin FS, Aznar-Lou I, Pontinha VM, Pontarolo R, Fernandez-Llimos F. Principles of pharmacoeconomic analysis: the case of pharmacist-led interventions. Pharm Pract (Granada). 2021;19(1):2302. doi:10.18549/PharmPract.2021.1.2302
  5. Walley T, Haycox A. Pharmacoeconomics: basic concepts and terminology. Br J Clin Pharmacol. 1997;43(4):343-348. doi:10.1046/j.1365-2125.1997.00574.x
  6. [No author.] Formulary Management. AMCP.org. Accessed August 16, 2024. https://www.amcp.org/concepts-managed-care-pharmacy/formulary-management
  7. Ciccarello C, Billstein Leber M, Leonard MC, Nesbit T. ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System. 2021. Accessed August 27, 2024. https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/gdl-pharmacy-therapeutics-committee-formulary-system.ashx?la=en&hash=EF1E4214CC91C65097AEEECE91BF6EC985AE3E56
  8. Suh DC, Okpara IR, Agnese WB, Toscani M. Application of pharmacoeconomics to formulary decision making in managed care organizations. Am J Manag Care. 2002;8(2):161-169.
  9. Kim SY. Efficacy versus Effectiveness. Korean J Fam Med. 2013;34(4):227. doi:10.4082/kjfm.2013.34.4.227
  10. Cavanaugh TM, Buring S, Cluxton R. A pharmacoeconomics and formulary management collaborative project to teach decision analysis principles. Am J Pharm Educ. 2012;76(6):115. doi:10.5688/ajpe766115
  11. USPSTF and Cost Considerations. United States Preventive Services Taskforce. Accessed August 16, 2024. https://www.uspreventiveservicestaskforce.org/uspstf/about-uspstf/task-force-resources/uspstf-and-cost-considerations.
  12. Cost utility analysis: Health economic studies. GOV.UK. Accessed August 23, 2024. https://www.gov.uk/guidance/cost-utility-analysis-health-economic-studies.
  13. Horsman JR. Multi-Attribute Health Status Classification System: Health Utilities Index Mark 3 (HUI3). Health Utilities Inc. “Hui3.” Accessed August 29, 2024. http://www.healthutilities.com/hui3.htm
  14. Prieto L, Sacristán JA. Problems and solutions in calculating quality-adjusted life years (QALYs). Health Qual Life Outcomes. 2003;1:80. doi:10.1186/1477-7525-1-80
  15. Whitehead SJ, Ali S. Health outcomes in economic evaluation: the QALY and utilities, Brit Medl Bul. 2010; 96 (21): 5–21.
  16. Cost-benefit analysis: What it is & how to do it. Business Insights Blog. September 5, 2019. Accessed August 16, 2024. https://online.hbs.edu/blog/post/cost-benefit-analysis
  17. Donnelly S. Cost-benefit analysis: 5 steps to turn data into Smarter Choices. Finance Alliance. May 14, 2024. Accessed August 29, 2024. https://www.financealliance.io/cost-benefit-analysis/
  18. Bang H, Zhao H. Cost-effectiveness analysis: a proposal of new reporting standards in statistical analysis. J Biopharm Stat. 2014;24(2):443-460. doi:10.1080/10543406.2013.860157
  19. Paulden M. Calculating and Interpreting ICERs and Net Benefit [published correction appears in Pharmacoeconomics. 2020 Oct;38(10):1147. doi: 10.1007/s40273-020-00950-2]. Pharmacoeconomics. 2020;38(8):785-807. doi:10.1007/s40273-020-00914-6
  20. Wailoo A, Dixon S. The use of cost minimisation analysis for the appraisal of health technologies. NICE Decision Support Unit; 2019.
  21. Mattingly TJHyman DABai G. Pharmacy Benefit ManagersHistory, Business Practices, Economics, and PolicyJAMA Health Forum.2023;4(11):e233804. doi:10.1001/jamahealthforum.2023.3804
  22. Chen JP. FTC Accuses Drug Managers of Squeezing Patients and Pharmacies. July 29, 2024. Accessed September 2, 2024. https://www.forbes.com/sites/joshuacohen/2024/07/11/ftc-report-accuses-pbms-of-negatively-impacting-patients-and-pharmacies/
  23. Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies. Interim Staff Report. Federal Trade Commission. Accessed September 2, 2024. https://www.ftc.gov/system/files/ftc_gov/pdf/pharmacy-benefit-managers-staff-report.pdf
  24. FTC launches inquiry into prescription drug middlemen industry. Federal Trade Commission. August 20, 2024. Accessed August 29, 2024. https://www.ftc.gov/news-events/news/press-releases/2022/06/ftc-launches-inquiry-prescription-drug-middlemen-industry
  25. Kreling DH. Cost control for prescription drug programs: Pharmacy benefit manager (PBM) efforts, effects, and implications. ASPE. Accessed August 16, 2024. https://aspe.hhs.gov/cost-control-prescription-drug-programs-pharmacy-benefit-manager-pbm-efforts-effects-implications.
  26. Pharmacy Benefit Managers and Their Role in Drug Spending. Commonwealth Funds. April 22, 2019. Accessed September 2, 2024. https://www.commonwealthfund.org/publications/explainer/2019/apr/pharmacy-benefit-managers-and-their-role-drug-spending
  27. UHBlog. Generic vs. brand-name drugs: Is there a difference? University Hospitals. July 21, 2022. Accessed August 27, 2024. https://www.uhhospitals.org/blog/articles/2022/07/generic-vs-brand-name-drugs-is-there-a-difference
  28. Ginder-Vogel K. Alumni Brett Eberle, Nancy Gilbride, and Pat Cory weigh in on the news-making industry’s trends. University of Wisconsin-Madison School of Pharmacy. March 13, 2024. Accessed September 2, 2024. https://pharmacy.wisc.edu/2024/03/13/the-evolution-and-future-of-pharmacy-benefits-managers/
  29. Lyles A. Pharmacy Benefit Management Companies: Do They Create Value in the US Healthcare System?. Pharmacoeconomics. 2017;35(5):493-500. doi:10.1007/s40273-017-0489-1
  30. 31. Abelson R, Robbins R. F.T.C. Accuses Drug Middlemen of Inflating Insulin Prices. Nytimes.com. Published September 20, 2024. https://www.nytimes.com/2024/09/20/health/ftc-drug-price-inflation-insulin.html
  31. 32. Gilbert D. FTC sues pharmacy insurance managers, alleging unfair drug prices. Washington Post. Published September 20, 2024. Accessed September 29, 2024. https://www.washingtonpost.com/business/2024/09/20/prescription-drugs-insurance-ftc-pbm/
  32. Webb K. The Difference Between Cost and Value. Accessed August 20, 2024. https://keithwebb.com/difference-between-cost-value/
  33. Tonin FS, Aznar-Lou I, Pontinha VM, Pontarolo R, Fernandez-Llimos F. Principles of pharmacoeconomic analysis: The case of pharmacist-led interventions. Pharmacy Practice (Granada). Accessed August 28, 2024. https://scielo.isciii.es/scielo.php?pid=S1885-642X2021000100021&script=sci_arttext.
  34. Rascati KL. Essentials of Pharmacoeconomics: Health Economics and Outcomes Research. 3rd edition. Lippincott Williams & Wilkins; 2021.

Contraceptive Conversations: Pharmacists as Partners in Birth Control Prescribing

Learning Objectives

  After completing this application-based continuing education activity, pharmacists will be able to
Explain the benefits to women, children, and society when contraceptives are easily accessible
  • Compare available hormonal contraception by pharmacology, efficacy, clinical use, and patient variables
  • Paraphrase the CDC’s United States Medical Eligibility Criteria (MEC) for Contraceptive Use to guide prescribing for women with various medical conditions and other characteristics
  • Customize a prescription for appropriate hormonal contraceptive products based on each patient's medical status, age, and medications
  • Describe necessary counseling points when prescribing pharmacist-prescribed hormonal contraceptives in Connecticut
  • Identify situations in which pharmacist prescribing of hormonal contraceptives is not allowed in Connecticut
  • Review the hormonal contraceptive screening and prescribing process required by Connecticut law

Release Date:

Release Date:  November 27, 2024

Expiration Date: November 27, 2027

Course Fee

Pharmacist $40

There is no funding for this CPE activity.

ACPE UANs

Pharmacist: 0009-0000-24-054-H01-P

Session Code

Pharmacist:  24BC54-CBA36

Accreditation Hours

4.0 hours of CE

Accreditation Statements

The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-24-054-H01-P  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

 

Disclosure of Discussions of Off-label and Investigational Drug Use

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

Faculty

 

Kelsey Giara, Pharm.D.
UConn Adjunct Faculty
University of Connecticut
Storrs, CT

 

Faculty Disclosure

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

Dr. Giara has no financial relationships with ineligible companies.

ABSTRACT

This continuing education module was developed to meet the State of Connecticut pharmacist contraceptive prescribing requirements. Pharmacists who wish to prescribe contraceptives in this state can complete this activity. They should note that after reading the content, they must take an 80-question post-test and pass with a score of at least 80%. They should be prepared to use the materials included as Appendices. They should also visit the state’s web page on this topic (https://portal.ct.gov/dcp/drug-control-division/drug-control/drug-control---pharmacist-contraceptive-prescribing?language=en_US) where they will find additional documents, including the link to the questionnaires for prescribing hormonal contraceptives and emergency contraceptives.

CONTENT

Content

INTRODUCTION

More than 72 million individuals of reproductive age (15 to 49 years old) live in the United States (U.S.), and about 43 million of them are at risk of unintended pregnancy.1 This means they are sexually active and could experience unwanted pregnancy if they and their partners fail to use contraceptives consistently and correctly.

Here is a striking but under-reported fact: about one in two pregnancies in the U.S. is unintended (i.e., mistimed or unwanted at the time of conception).2 Compared to intentional pregnancies, people experiencing unintended pregnancy experience more mental health problems, have less stable romantic relationships, and sometimes delay initiation of prenatal care.3 Ideally, those who unintentionally conceive should ideally be in good health and ready to care for a new child, but sometimes that is not the case.

Children born as a result of unintended pregnancies are at an elevated risk of experiencing both mental and physical health challenges and are more likely to struggle in school.3 While the overall rate of unintended pregnancies is on the decline, disparities based on factors such as race/ethnicity, age, income, and education level persist.3

It is crucial to implement interventions that promote the use of contraception methods to prevent unintended pregnancies. While over the counter (OTC) options for pregnancy prevention exist, hormonal methods requiring a prescription (pill, patch, ring, and injection) are more effective than OTC products, withdrawal, or fertility-awareness methods for pregnancy prevention.4 Recent laws make it possible for pharmacists to prescribe hormonal contraceptives in some states, increasing access to these more effective therapies.

Note that this activity will employ the terms "woman/women" to align with the biological expectations of ovulation.

 

Understanding the Menstrual Cycle

The length of a woman’s menstrual cycle is a commonly misunderstood concept. While most people consider a natural 28-day cycle “normal,” this is only true for about 13% of women.5 The first day of menstrual bleeding is considered cycle day 1 and cycles range from about 21 to 40 days in length.

Hormone levels regulate the menstrual cycle. The pituitary gland produces luteinizing hormone (LH) and follicle-stimulating hormone (FSH), which promote ovulation and release of estrogen and progesterone from the ovaries.6 This hormone fluctuation splits the menstrual cycle into three phases; note that the timeframes described below are approximate length based on a 28-day cycle6:

  • Follicular phase (before egg release)
    • Lasts from cycle day 1 to ovulation
    • FSH levels rise to recruit a small group of follicles for growth and development
    • Between days 5 to 7, one follicle dominates and secretes estradiol to stop menstrual flow
  • Ovulatory phase (egg release)
    • Occurs on or around day 14
    • Sustained FSH levels cause an LH surge about 28 to 32 hours before the dominant follicle ruptures, also known as ovulation, releasing the mature oocyte (egg)
  • Luteal phase (after egg release)
    • Lasts from ovulation to the last day of the cycle
    • Remaining luteinized (matured) follicles become the corpus luteum, which produces progesterone to prepare the uterus for embryo (fertilized egg) implantation

 

Following the luteal phase, if no egg is fertilized or the egg does not implant, the corpus luteum degenerates after 14 days, estrogen and progesterone levels drop, and a new menstrual cycle begins.6 However, if a fertilized embryo is implanted, the cells around the embryo produce human chorionic gonadotropin (HCG). HCG maintains the corpus luteum, which continues to produce progesterone until the fetus can produce its own hormones. Pregnancy tests detect an increase in HCG in the blood or urine, indicating a fertilized embryo is present.6

PHARMACY-BASED HORMONAL AND EMERGENCY CONTRACEPTIVES

Contraception refers to the strategies employed to prevent pregnancy after sexual intercourse, which can be categorized into two main approaches7:

  1. Inhibiting the encounter of viable sperm with a mature ovum, achieved through methods such as barriers or ovulation prevention
  2. Preventing the implantation of a fertilized ovum in the endometrium, accomplished through methods that create an unfavorable uterine environment

It is crucial for sexually active individuals to be well-informed about the various contraceptive options available. This knowledge is essential in assisting patients in effectively preventing unintended pregnancies.

This activity will only discuss the birth control methods that pharmacists are directly involved in prescribing.

 

Hormonal Contraceptive Basics

As the name implies, hormonal contraceptives employ hormones—specifically, progestins and estrogens—to prevent pregnancy.7 Hormonal contraceptives do not protect patients from sexually transmitted infections, including human immunodeficiency virus, and this is a point that pharmacists need to stress at every visit. Estrogens’ role in birth control is to stabilize the endometrial lining and provide cycle control. However, estrogens also suppress FSH release from the pituitary gland to help block the LH surge and prevent ovulation. Progestins provide most contraceptive effect. They block the LH surge, which inhibits ovulation. Progestins also thicken cervical mucus to7

  • prevent sperm penetration
  • slow tubal motility
  • delay sperm transport
  • induce endometrial atrophy (thinning), reducing its receptivity to embryo implantation

Achieving the right balance between progestogens and estrogens is vital in hormonal contraceptives. Some hormonal contraceptives contain only a progestin, while others combine an estrogen and a progestin.7 Importantly, estrogen alone—or “unopposed estrogen”—does not protect against pregnancy and pose significant safety concerns. Patients with an intact uterus who take unopposed estrogen are at risk of cancer, endometrial hyperplasia, polyps, endometriosis, and adenomyosis.8

 

PAUSE AND PONDER: What is the difference between a CHC, a COC, and a POP?

 

Combined hormonal contraceptives (CHCs)—any contraceptive containing both an estrogen and progestin—are not appropriate for women7

  • older than 35 years who smoke
  • with obesity (body mass index 30 or greater)
  • with untreated hypertension (greater than 160/100 mm Hg)
  • with migraines (especially with aura)
  • at risk for deep vein thrombosis

The estrogen component of most CHCs is ethinyl estradiol.7 Many different progestins of differing androgenicity and similarity to testosterone exist, but no evidence suggests that a particular progestin is superior to others. Traditionally, experts classified progestins into “generations” based on parent compound and decade of development, but data shows this is not clinically useful.7

A woman can start CHCs at any time during her cycle if it is reasonably certain that she is not pregnant.9 If a patient starts CHCs within the first five days of menstrual bleeding, no additional protection is needed, but if it has been longer than five days from the start of menses, she should abstain from intercourse or use backup contraception for the next seven days.9 Table 1 outlines missed dose guidance for all contraceptive types.

 

Table 1. Missed Dose Guidance for Contraceptives7,10,11

Missed Dose/Failure Guidance
COCs: 1 pill late (< 24 hours overdue) or missed (24 to < 48 hours overdue) ·  Take the late/missed pill ASAP

·  Continue taking remaining pills at the same time (even if 2 doses in 1 day)

·  No back-up contraception needed

·  Consider emergency contraception if previous late/missed dose in same cycle or in the last week of the previous cycle

COCs: ≥ 2 consecutive pills missed (≥ 48 hours have passed since last pill) ·  Take the most recently missed pill ASAP

·  Discard any other missed pills

·  Continue therapy as usual

·  Use back-up contraception (e.g., condoms) or remain abstinent until they’ve taken hormonal pills for 7 consecutive days

·  If in last week of hormonal pills, skip placebo interval and start new pack immediately

·  Consider emergency contraception if pills missed in 1st week and unprotected intercourse occurred

POP: more than 3 hours late ·  Take missed pill ASAP, then go back to regularly scheduled time

·  Use back-up contraception until POP taken consistently for at least 48 hours

·  If vomiting occurs soon after taking, use back-up contraceptive for at least 48 hours

Transdermal patch: partially or completely detached ·  Reapply ASAP

·  If no longer sticky or becomes dirty, use a new patch (do not use supplemental wraps or adhesives)

·  If detached ≥ 24 hours, may no longer be protected from pregnancy; stop the current contraceptive cycle and start a new one (use back-up contraception for at least 1 week)

·  If unsure how long it was detached, treat it as if it was ≥ 24 hours

Transdermal patch: forget to change patch ·  At start of a patch cycle (week 1/day 1), apply a patch as soon as possible; this becomes the new “patch change day” and back-up contraception is needed for 1st week

·  In middle of a patch cycle (week 2/day 8 or week 3/day 15) < 48 hours late, apply new patch immediately; no change in “patch change day” and no back-up needed

·  In middle of a patch cycle (week 2/day 8 or week 3/day 15) ≥ 48 hours late, stop current cycle and start a new one with a new patch; this is new “patch change day” and should use back-up for 1 week

EE/E vaginal ring: falls out or removed ≥ 3 hours ·  Weeks 1 or 2: use back-up contraception until ring is in place for 7 consecutive days

·  Week 3: discard ring and either (1) insert new ring immediately to start next 3-week use or (2) insert a new ring ≤ 7 days from removal (only if ring was in for 7 consecutive days before removal)

·  Always use back-up contraception until the ring has been placed for 7 consecutive days

·  If removed < 3 hours, efficacy is not affected; rinse ring with cool/lukewarm water and reinsert ASAP

SAEE vaginal ring: falls out or removed ≥ 2 hours ·  Rinse ring with cool/lukewarm water and reinsert ASAP

·  Use back-up contraception until the ring has been placed for 7 consecutive days

·  If removed < 2 hours, efficacy is not affected

ASAP, as soon as possible; COC, combined oral contraceptive; EE/E, ethinyl estradiol/etonogestrel; POP, progestin-only pill; SAEE, segesterone acetate/ethinyl estradiol.

 

Combined Oral Contraceptives

Combined oral contraceptives (COCs)—meaning oral products containing both an estrogen (e.g., ethinyl estradiol) and a progestin (e.g., norethindrone, levonorgestrel, norgestimate)—come in many forms. COCs are about 91% effective, meaning that 9 of 100 women will become pregnant in a year with typical use.12 A major distinction in product selection is monophasic versus multiphasic7:

  • Monophasic COCs contain the same amounts of estrogen and progestin for 21 days, followed by seven days of placebo
  • Multiphasic COCs—including bi- and triphasic regimens—contain variable amounts of estrogen and progestin for 21 days, also followed by a 7-day placebo phase

 

Monophasic and multiphasic COCs boast similar safety and efficacy profiles, so product selection relies on hormonal content, patient-preference, and coexisting conditions.7 Women should typically initiate a COC containing 35 mcg or less of ethinyl estradiol and less than 0.5 mg of norethindrone (or an equivalent).7 Estradiol levels control the incidence of breakthrough bleeding. Few patients require doses of ethinyl estradiol greater than 35 mcg daily to prevent breakthrough bleeding. While some clinicians advocate for starting patients at the lowest possible estradiol dose to minimize risks, data suggests that 10 to 20 mcg of ethinyl estradiol daily is no safer than the 35-mcg dose and lower doses are associated with more breakthrough bleeding.7

 

Monophasic COCs are preferred over multiphasic upon initiation, as adverse effects (AEs) are easier to identify and manage. Monophasic COCs also allow for easy cycle extension (continuing the active moiety to bypass a period, an indication for which pharmacists are not authorized to prescribe) by simply skipping the placebo week and starting the next pack of active pills. When attempting this with multiphasic regimens, the variation in drug levels between phases often leads to breakthrough bleeding.7

 

Extended- and continuous-cycle COCs contain 84 days of active hormone tablets followed by seven days of inactive tablets, which may be more convenient with fewer AEs.7 Extended-cycle COCs are commercially available. Of note, some patients skip the 7-day placebo week of monophasic 28-day COCs to mimic extended-cycle products, but pharmacists are only legally authorized to prescribe hormonal contraceptives as indicated. Continuous-cycle COCs shorten the pill-free interval (e.g., two to four days versus seven days), thus reducing period-related symptoms. Patients using extended- and continuous-cycle regimens have fewer menstrual cycles annually, which is helpful for women with severe premenstrual syndrome (PMS), dysmenorrhea (menstrual cramps), and menstrual migraines.

 

Progestin-Only Pills

Progestin-only pills (POPs)—“minipills”—contain 28 days of active hormone (norethindrone or drospirenone) per cycle.7 They are generally less effective than COCs and associated with irregular, unpredictable menstrual bleeding. Patients must take POPs at approximately the same time (within three hours) every day for effective pregnancy prevention. The progestin dose in POPs is about one-third of that in COCs, resulting is less consistent suppression of ovulation. This leaves women at greater risk of breakthrough bleeding and ectopic pregnancy—pregnancy outside the uterus—because women on POPs often continue to ovulate regularly.7

 

Despite being less effective, POPs are appropriate for certain women. Postpartum women, for example, can experience hypercoagulability, and should avoid CHCs for at least 30 to 42 days postpartum due to risk of venous thromboembolism. Therefore, those who take contraceptives commonly take POPs.7 Women who breastfeed should also avoid CHCs, as the estrogen component can affect lactation, making POPs a better option.

 

POPs can be started at any time during a woman’s cycle if it is reasonably certain she is not pregnant.9 If a patient starts POPs within the first five days of menstrual bleeding, she need not use additional protection , but if it has been longer than five days from the start of menses, she should abstain from intercourse or use backup contraception for the next two days.9

 

ORAL CONTRACEPTIVE TAKEAWAYS:

  • COCs: Initiating a monophasic formulation containing 30 to 35 mcg of ethinyl estradiol and less than 0.5 mg of norethindrone (or an equivalent) offers the best chance of establishing a consistent menstrual pattern without raising AE risk. If patients experience estrogen- or progesterone-related AEs (listed in Table 2), dose adjustment is warranted.
  • Extended- or continuous cycle: Patients have fewer menstrual cycles each year, making them ideal for patients with severe PMS, dysmenorrhea, or menstrual migraines.
  • POPs: Less effective than COCs, but appropriate for patients within 42 days postpartum and women who breastfeed, as estrogen can affect lactation.

 

Table 2. Hormone-Related Adverse Effects13

Too Much Not Enough
Estrogen ·  Nausea

·  Breast tenderness

·  Weight gain

·  Headaches

·  Menstruation changes

·  Vasomotor symptoms (night sweats, hot flashes)

·  Early cycle (days 1-9) breakthrough bleeding or spotting

·  Amenorrhea

Progestins ·  Breast tenderness

·  Headache

·  Fatigue

·  Mood changes (depression, irritability)

·  Weight gain

·  Acne/oily skin

·  Hirsutism

·  Dysmenorrhea (painful periods)

·  Menorrhagia (heavy menstrual bleeding)

·  Late cycle (days 10-21) breakthrough bleeding or spotting

 

 

Non-Oral Hormonal Contraceptives

Some patients—particularly those who struggle with daily adherence to oral therapies—may benefit from alternative delivery mechanisms administered less frequently, including transdermal patch, vaginal ring, and injectable contraceptives.

 

The only transdermal CHC patch available in the U.S. contains ethinyl estradiol and norelgestromin (norgestimate’s active metabolite). The transdermal patch has comparable efficacy to COCs.12 It may be less effective, however, for patients weighing more than 198 lbs (90 kg).14 Patients apply the patch to the abdomen, buttocks, upper torso, or upper arm at the beginning of the menstrual cycle, avoiding areas where the patch could be rubbed by tight clothing.14 Patients replace the patch once weekly for 3 weeks, followed by a patch-free week. The patch is formulated to release hormones for nine days, allowing a 48-hour grace period for adherence.14

 

The CHC patch’s adverse effects are similar to those of COCs, but some patients experience application-site reactions. Patients can prevent these reactions by rotating application sites. Dysmenorrhea and breast discomfort are also possible, as the patch causes higher estrogen exposure compared to COCs.14

 

Vaginal ring contraceptives offer excellent cycle control, as patients can insert and remove them, and fertility returns rapidly after removal.15 Two vaginal ring contraceptives are available:

  • an ethinyl estradiol/etonogestrel (EE/E) ring that patients replace monthly
  • a segesterone acetate/ethinyl estradiol (SAEE) ring that patients replace yearly

 

The EE/E vaginal ring delivers 0.015 mg of ethinyl estradiol and 12 mcg of etonogestrel (desogestrel’s active metabolite) every 24 hours.16 Estrogen exposure with the EE/E ring is lower than that associated with COCs, so incidence of estrogen-related adverse effects is also decreased. Local reactions, like vaginal irritation and discharge, are more common.16 The SAEE vaginal system is slightly larger in diameter than the EE/E ring and contains two drug reservoirs delivering 0.15 mg and 13 mcg of segesterone and ethinyl estradiol, respectively, every 24 hours.15,10 The SAEE ring’s most common adverse effects are headache/migraine, nausea, vomiting, vaginal infections, abdominal pain, dysmenorrhea, vaginal discharge, urinary tract infection, breast discomfort, bleeding irregularities, diarrhea, and genital itching.10

 

To insert a vaginal contraceptive ring, patients should compress the ring between the thumb and index finger, then push the ring into the vagina.16,10 There is no danger of inserting too far; the cervix will prevent the ring from traveling up the genital tract. Additionally, precise ring placement is not an issue, as the hormones are absorbed anywhere in the vagina. Patients should leave the ring in place for three weeks, then remove it for one week.

 

If using the EE/E monthly ring, patients should discard the ring (but not flush it down the toilet) after removal and insert a new one on the same day of the week as the previous cycle.16 Alternatively, the same SAEE ring can be used for up to one year. During the ring-free week, patients should store the SAEE ring only in the provided case away from children, pets, and extreme temperatures.15,10 They should also wash the ring after removal and again before reinsertion using mild soap and water and pat dry with a clean cloth or paper towel. Patients should never use the same SAEE ring for more than 13 menstrual cycles.15,10

 

If a vaginal contraceptive ring is removed from the vagina, intentionally or otherwise, no backup contraception is needed if the patient reinserts the ring within three hours for the EE/E ring and two hours for the SAEE ring.16,10 If the ring remains out of the vagina for longer than these recommended time periods, backup contraception (e.g., male condoms, spermicide) is recommended for seven days after ring reinsertion. Patients should also avoid oil-based lubricants, as these can decrease the effectiveness of vaginal contraceptive rings.

 

Both vaginal ring systems carry risks for toxic shock syndrome (TSS), a rare, potentially life-threatening vital organ failure caused by bacterial infection.16,10 Items that remain in the vagina for an extended period of time are implicated in TSS because bacteria can be trapped in the vagina and enter the uterus via the cervix or objects in the vagina can also cause tiny cuts through which bacteria can enter the bloodstream. Advise patients to seek medical attention if they experience signs/symptoms of TSS17:

  • nausea or vomiting
  • sudden high fever and chills
  • watery diarrhea
  • rash resembling a bad sunburn or red dots
  • dizziness, light-headedness, or fainting
  • hypotension
  • red eyes (conjunctivitis)
  • peeling on the soles of feet or palms of hands

 

Depo-medroxyprogesterone acetate (DMPA) is a longer-lasting injectable contraceptive injected every three months either intramuscularly into the gluteal or deltoid muscle or subcutaneously into the abdomen or thigh.18 This eliminates daily adherence concerns. DMPA is about 94% effective with typical use.9 Note that Connecticut law prohibits pharmacists from administering DMPA injections without a collaborative practice agreement, but patients may self-administer DMPA subcutaneously if desired and indicated.

 

Injection timing is somewhat flexible. Early DMPA injection is safe if women cannot follow routine intervals, and patients can inject up to two weeks late without requiring back-up contraception.18 Women who are more than two weeks late, however, should use back-up contraception for seven days after receiving the injection. Return to fertility may be delayed six to 12 months after discontinuation, so DMPA is not recommended for women desiring pregnancy in the near future.18

 

DMPA’s most common adverse effects are weight gain, decreased bone mineral density, and bleeding irregularities (e.g., spotting, prolonged bleeding, amenorrhea).18 DMPA carries a Boxed Warning indicating patients should not use the drug for more than two years due to bone mineral density loss, which may be irreversible.18 Patients should only use DMPA for more than two years if all other contraceptive methods are inadequate. Ensure patients are adequately trained to self-inject DMPA before leaving the pharmacy.

 

Emergency Contraceptives

Two oral emergency contraceptives (ECs) are currently available: a single dose of progestin (levonorgestrel 1.5 mg) or an anti-progestin (ulipristal acetate 30 mg).7 Levonorgestrel is available over the counter, while ulipristal requires a prescription.19,20 Neither of these is abortifacient (i.e., they do not end an existing pregnancy), rather they work by blocking or delaying ovulation.

 

Women should take oral EC as soon as possible following unprotected intercourse, levonorgestrel within 72 hours and ulipristal acetate within five days.19,20 Repeat levonorgestrel use shows no serious adverse effects, but studies have not examined repeat use of ulipristal acetate.7 Upon prescribing emergency contraception, pharmacists should evaluate women for long-term contraceptive eligibility to prevent repeat use of EC.

 

EC may alter the next expected menses.19,20 Patients whose cycles are delayed more than one week should test for pregnancy. Additionally, women who become pregnant after using EC who experience lower abdominal pain should be evaluated for ectopic pregnancy (pregnancy occurring outside the uterus, most often in the fallopian tube).19,20

 

PAUSE AND PONDER: Where can you find the living document called the United States Medical Eligibility Criteria (U.S. MEC) for Contraceptive Use and how often should you review its contents? (Note that some questions in the post-test will require you to access this document, so you must review it thoroughly.)

 

ELIGIBILITY AND PRESCRIBING

 

CDC Eligibility Criteria

The CDC publishes the United States Medical Eligibility Criteria (U.S. MEC) for Contraceptive Use to guide safe use of contraceptive methods for women with various medical conditions and other characteristics.21 The most current version of these guidelines (as of February 2024) can be found at https://www.cdc.gov/reproductivehealth/contraception/mmwr/mec/summary.html. Appendix A of this activity includes the entire U.S. MEC and the 2020 update. The CDC has also created a summary chart, included in Appendix B, and pharmacists should note that the summary chart is a convenience that does not replace a responsibility to access the entire document when necessary. Pharmacists actively prescribing hormonal contraceptives should regularly monitor for updates to this living document.

 

The U.S. MEC includes recommendations for contraceptive use based on patient characteristics or medical conditions.21 While many off label uses exist for contraceptives, these CDC recommendations apply only to these products’ indicated use to prevent pregnancy.

 

Four categories of medical eligibility criteria for contraceptive use exist within the U.S. MEC:

  • Category 1: conditions for which no restrictions exist for use of the contraceptive method
  • Category 2: conditions for which the advantages of using the method generally outweigh the theoretical or proven risks; the method can generally be used, but careful follow-up might be required
  • Category 3: conditions for which the theoretical or proven risks usually outweigh the advantages of using the method; use is not recommended unless other more appropriate methods are not available or acceptable, so condition severity and the availability, practicality, and acceptability of alternative methods should be considered, and careful follow-up is required
  • Category 4: conditions that represent an unacceptable health risk if the contraceptive method is used

 

Be mindful that provision of a contraceptive method to a woman with a condition classified as category 3 requires careful clinical judgement and access to clinical services that may be unavailable to pharmacists. Referral may be needed. Pharmacists should never prescribe a hormonal contraceptive method to a patient with a category 4 health condition related to its use.

 

Pharmacists should also take note of whether continuation criteria exist for the product prescribed.21 Continuation criteria is clinically relevant when a medical condition develops or worsens during use of a contraceptive method. When risk categories differ for initiation and continuation, the differences are noted in the Initiation and Continuation columns. When these distinctions are not indicated, the category is the same for initiation and continuation of use.21

 

Additionally, these categories only concern safety, but many other factors must be considered when choosing a contraceptive method. Classification as a category 1 means that the method can be used with no regard to safety but does not necessarily mean that method is the best choice for that patient. Consider other factors, including effectiveness, availability, and acceptability.

 

Determining Pregnancy Status

The Centers for Disease Control and Prevention (CDC) recognizes that routine pregnancy testing for women is not necessary before the initiation of contraception in all cases. Based on clinical judgment, healthcare providers can omit a pregnancy test if a woman has no signs or symptoms of pregnancy and meets any of the following criteria21:

  • Is fewer than seven days after the start of normal menses
  • Has not had sexual intercourse since the start of last normal menses
  • Has correctly and consistently used a reliable contraception method
  • Is fewer than seven days after spontaneous or induced abortion
  • Is within four weeks postpartum
  • Is fully or nearly-fully breastfeeding (exclusively or at least 85% of feeds), amenorrhoeic, and less than six months postpartum

 

Screening Documents Simplify the Process

A prescribing pharmacist must assist the patient in completing a screening document for hormonal contraceptives or emergency contraceptives, as applicable. These and all documents related to prescribing of hormonal contraceptives by pharmacists in the state of Connecticut are available at the Department of Consumer Protection’s (DCP) website: https://portal.ct.gov/DCP/Drug-Control-Division/Drug-Control/Drug-Control---Pharmacist-Contraceptive-Prescribing. Prescribing pharmacists are responsible for ensuring their pharmacies use the most current version of all screening documents at all times.

 

When an individual requests a hormonal contraceptive, pharmacists must first determine the patient’s age. If the patient is 18 years or older, the pharmacist may continue to prescribe with this guidance, but if the patient is younger than 18 years, the pharmacist may only issue a prescription upon confirming the patient has previously been prescribed a contraceptive by another provider through one of the following means:

  • With the patient’s permission, contact the office or clinic where the patient visited a healthcare provider via telephone, facsimile, or shared health record system
  • With the patient’s permission, contact the pharmacy that previously dispensed a contraceptive prescription to the patient via telephone, facsimile, or shared health record system
  • Other acceptable documentation or evidence that demonstrates the patient has received prescription contraceptives (e.g., visit summary from the clinic that prescribed it, old prescription package/label)

 

The pharmacist must keep an electronic or written record of the action taken to confirm prior prescription for a minimum of 3 years. Whether prescribing a continuation of hormonal contraceptive therapy or initiating a new one, confirm the patient has been seen by a provider within the last 3 years either through written documentation (e.g., a visit summary) or contacting the office or clinic with the patient’s permission. Without this confirmation, pharmacists may not prescribe hormonal contraception.

 

Individuals with obesity (body mass index 30 kg/m2 or greater) and patients using drugs that inhibit CYP3A4 (e.g., bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John’s wort, topiramate, efavirenz, lumacaftor) may experience decreased efficacy with EC.21 Patients ineligible for EC prescribing include those who

  • are confirmed pregnant (though no harm to the woman, the course of her pregnancy, or the fetus if EC is inadvertently used is known to exist)
  • have undergone bariatric surgery that may affect EC absorption (e.g., Roux-en-Y gastric bypass, biliopancreatic diversion); an emergency intrauterine device may be more appropriate

 

If a patient seeking EC is deemed ineligible for prescribing, the pharmacist should not prescribe the EC, refer the individual to a primary care provider (PCP), and document the reason(s) for refusal on the screening documents. If the patient has no PCP, the pharmacist should provide information regarding local providers.

 

Hormonal Contraceptive Screening and Prescribing

Upon determining patient eligibility, have the patient complete the Connecticut Hormonal Contraceptive Self- Screening Questionnaire found on the DCP website. The questionnaire addresses

  • patient demographics (e.g., insurance status, allergies, preferences)
  • background information (e.g., last menstrual period, history of contraceptive use)
  • medical history (e.g., smoking status, preexisting conditions)
  • pregnancy status

 

Review this screening tool with the patient and clarify responses if needed. If a patient is requesting CHCs or they are recommended, measure and record the patient’s seated blood pressure. If the patient does not complete the questionnaire, a pharmacist cannot issue the prescription. Pharmacists should keep the completed questionnaire on file for at least three years. Patients must fill out a new questionnaire at least once every 12 months, but pharmacists can request this more frequently if desired.

 

Pharmacists should then use patient questionnaire responses to follow the Standard Procedures Algorithm for Connecticut Pharmacist Prescribing of Contraceptives found on the DCP website. This algorithm, with its clinical assessment sections summarized in Figure 1, assists in screening for red flags requiring provider referral. Pharmacists should access the complete document on the DCP website before attempting to take the post-test.

 

Figure 1. Simplified Assessment Sections of the Algorithm for Contraceptive Prescribing

*Anticonvulsants, antiretrovirals, antimicrobials, barbiturates, herbs and supplements, including but not limited to: carbamazepine, felbamate, phenobarbital, lamotrigine, oxcarbazepine, ritonavir, primidone, griseofulvin, St. Jonh’s wort, topiramate, phenytoin, lumacaftor/ivacaftor, and rifampin/rifabutin.

 

Pharmacists should pay special attention to steps 6 and 7 of the Standard Procedures Algorithm (and take a moment to access it now). It describes counseling points on starting hormonal contraception, managing expected and unexpected side effects, and appropriate adherence. Not that Step 7 is critical! Women need to be reminded about routine healthcare and sexually transmitted infection prevention. And the pharmacist’s job isn’t done until the paperwork is filed.

 

If hormonal contraceptives are not clinically appropriate based on the treatment algorithm, the pharmacist should refer the patient to a practitioner, not prescribe the hormonal contraceptive, and document the reason(s) for refusal on the screening documents. The State of Connecticut provides a Pharmacist Referral and Visit Summary template that may be used for this purpose. If hormonal contraceptives are clinically appropriate, pharmacists may prescribe a total of no more than 12 months including initial filling of the prescription along with refills. Refills may be transferred to another pharmacy if desired, as a pharmacy that does not have a prescribing pharmacist may dispense a prescription written by a prescribing pharmacist. Pharmacies may not, however, fill prescriptions written by pharmacists authorized to prescribe in other states but not in Connecticut.

 

Emergency Contraceptive Screening and Prescribing

To be eligible for a self-administered EC prescription, an individual must complete the Connecticut Emergency Contraception Self-Screening Questionnaire found on the DCP website indicating that the last day of unprotected intercourse was within the previous five days (120 hours). Pharmacies may create and use an electronic version of this self-screening tool if the collection of patient information and assessment process is at minimum identical to the state-provided questionnaire. The pharmacist must review the screening tool with the patient, clarify responses if needed, and measure and record the patient’s seated blood pressure.

 

Pharmacists should consider the following when choosing between levonorgestrel and ulipristal acetate for EC:

  • Levonorgestrel may be less effective than ulipristal acetate for women who weigh more than 165 lbs
  • Levonorgestrel may be preferable for patients who need EC due to missed or late administration of existing hormonal contraception
  • Starting hormonal contraceptives immediately after taking ulipristal acetate (within 5 days) may make it ineffective
  • Insurance may still cover OTC levonorgestrel if a pharmacist prescribes the product
  • Ulipristal acetate is more effective than levonorgestrel if more than 72 hours have passed since the last day of unprotected intercourse

 

Prescriptions for EC may not have any refills. Upon prescribing EC, counsel patients on the product’s proper use and potential adverse effects and provide written educational materials. The pharmacist must also notify the patient’s PCP and obstetrician/gynecologist (OB/GYN) with the patient's consent. If the patient does not have a PCP, the pharmacist should counsel the patient regarding the benefits of establishing such a relationship and, upon request, provide information regarding local providers. The pharmacist should also counsel the patient regarding the importance of preventive care, including routine well-woman visits, testing for sexually transmitted infections, and pap smears. Additionally, consider whether patients should also be evaluated for ongoing hormonal contraception, especially if they visit the pharmacy repeatedly for EC.

 

STICKING TO THE LAW

 

PAUSE AND PONDER: Are you ready for pharmacy-based contraceptive prescribing? Where will you maintain your documentation?

 

Documentation and Recordkeeping

Pharmacies must maintain appropriate records of hormonal contraceptive and EC prescribing:

  • All completed screening documents must be maintained at the prescribing pharmacy in the same manner as the prescription itself for at least three years.
  • All records created as part of the prescribing process must be maintained for at least three years and be readable retrievable and provided to DCP within 48 hours

 

Prohibited Acts

A prescribing pharmacist shall not

  • prescribe any hormonal contraceptive or EC in an instance where the screening document for hormonal contraceptive or screening document emergency contraceptives indicates that referral to a practitioner is clinically appropriate
  • prescribe any hormonal contraceptive or EC without a completed screening document for hormonal contraceptive or completed screening document for emergency contraceptive, as applicable
  • issue a prescription for a total supply period exceeding 12 months based on the directions of use provided on the prescription
  • prescribe any hormonal contraceptive or EC outside of the approved use stated in the product’s FDA-approved package insert
  • prescribe a medical device, with or without hormonal contraceptives, that is implanted by a practitioner for the purpose of preventing pregnancy, including intrauterine and implantable devices

 

Pharmacy Technician and Intern Involvement

Pharmacy technicians who have completed an approved training course for prescribing of hormonal contraceptives may, at the pharmacist's request, assist the pharmacist in prescribing a hormonal contraceptive by:

  • providing the screening document to the patient
  • taking and recording the patient's blood pressure
  • documenting the patient's medical history

 

A registered pharmacist intern may prepare a prescription for a hormonal contraceptive under the direct supervision of a trained prescribing pharmacist, but a pharmacist authorized to prescribe under this protocol must review, approve, and sign the prescription before the prescription is processed or dispensed.

 

CONCLUSION

Pharmacist prescribing removes significant barriers to patient access and use of hormonal contraceptives and EC to prevent pregnancy especially for those with limited access to healthcare services or busy schedules. More than 90% of Americans live within five miles of a pharmacy, making pharmacists the most accessible healthcare professionals and perfectly positioned to improve contraceptive access.22 Pharmacist involvement can lead to better education and counseling on contraceptive options, promoting informed decision-making and improving therapy uptake and adherence.

APPENDIX A – CDC US Medical Eligibility Criteria for Contraceptive Use, 2016

 

APPENDIX B – CDC US Medical Eligibility Criteria for Contraceptive Use, 2016, SUMMARY CHART

 

 

APPENDIX A-U.S. MEC 2024_UPDATE full text pdf

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APPENDIX B-U.S. MEC 2024 Summary Chart

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Pharmacist Post Test (for viewing only)

Pharmacist Post-test

1. What is the rate of unintended (mistimed or unwanted at the time of conception) pregnancy in the United States?
A. It's about 30%
B. It's about 50%
C. It's about 65%

2. Compared to intentional pregnancy, which of the following conditions is more likely to occur with unintentional pregnancy?
A. Women who experience unintended pregnancy also experience more mental health problems.
B. Women who experience unintended pregnancy also experience higher rates of iron deficiency.
C. Women who experience unintended pregnancy are more likely to be married or in stable relationships.

3. When researchers looked at children born as the result of an unintended pregnancy, what did they find?
A. Their mental and physical challenges are similar to other children's.
B. They are more likely to have mental challenges than physical challenges.
C. They are more likely than other children to struggle in school.

4. Which of the following approaches to contraception prevents implantation of a fertilized ovum in the endometrium?
A. Using a barrier method of contraception
B. Creating an unfavorable uterine environment
C. Preventing ovulation from occurring

5. Hormonal contraceptives use two hormones to prevent pregnancy. What are they?
A. Testosterone and estrogens
B. Progestins and testosterone
C. Progestins and estrogens

6. Which of the following correctly identifies estrogen’s role in birth control?
A. Promote the LH surge, which inhibits ovulation
B. Stabilize the endometrial lining and provide cycle control
C. Increase endometrial thickness to delay implantation

7. Which of the following correctly identifies progestin’s role in birth control?
A. Block the LH surge, which inhibits ovulation
B. Stabilize the endometrial lining and provide cycle control
C. Increase endometrial thickness to delay implementation

8. Why is estrogen never used alone as a contraceptive?
A. This is a trick question. Several FDA approved contraceptives employ estrogen alone to prevent contraception.
B. Unopposed estrogen increases the risk of hormonal imbalance and subsequently, the risk of pregnancy.
C. Unopposed estrogen increases risk of cancer, endometrial hyperplasia, polyps, endometriosis, and adenomyosis in women who have an intact uterus.

9. Anne Marie is 42-year-old woman who comes to the pharmacy seeking hormonal contraception. Your technician takes her blood pressure and records it as 152/93. Anne Marie smells like she has recently smoked a cigarette. Which of the following would be an appropriate choice of contraceptives?
A. A progestin only contraceptive
B. A combined hormonal contraceptive
C. Any hormonal contraceptive would be inappropriate

10. A primary care provider calls the pharmacy and asks you which progestin is the best in terms of contraceptive efficacy. What do you say?
A. No evidence indicates that a particular progestin is superior to others
B. Some evidence indicates any oral progestin is better than injectable forms
C. Norgestimate is more effective than any other progestin

11. When discussing possible hormonal contraceptives, the patient asks about the efficacy of combined oral contraceptives. What do you tell her?
A. With typical use, COCs are about 91% effective, meaning that 9 of 100 women will become pregnant in a year with typical use.
B. With typical use, COCs are about 95% effective, meaning that 5 of 100 women will become pregnant in a year with typical use.
C. With typical use, COCs are about 99% effective, meaning that 1 of 100 women will become pregnant in a year with typical use.

12. You are considering a combined hormonal contraceptive for a patient whose last menstrual period started seven days ago. She will start taking the contraceptive today. What should you tell her about intercourse?
A. She needs no additional protection and can have unprotected intercourse.
B. She should abstain or use backup contraception until her next menses.
C. She should abstain or use backup contraception for the next seven days.

13. Which of the following contains 84 days of active hormone tablets followed by 7 days of inactive tablets?
A. Extended- and continuous-cycle COCs
B. Extended- and continuous-cycle POPs
C. No hormonal contraception is formulated like this

14. A patient expresses a preference for a combined oral contraceptive pill that contains 40 mcg of ethinyl estradiol daily because her friend takes such a pill. She is new to hormonal contraceptives. What do you tell her?
A. You should start a COC containing 35 mcg or less of ethinyl estradiol.
B. You should start a COC containing 20 mcg or less of ethinyl estradiol.
C. You should start a COC containing 50 mcg or more of ethinyl estradiol.

15. The patient in the previous question asks why you selected the answer you did. What do you say?
A. Estradiol levels affect the incidence of blood clotting.
B. Estradiol levels affect the incidence of migraine headache.
C. Estradiol levels affect the incidence of breakthrough bleeding.

16. Why do the guidelines prefer monophasic COCs over multiphasic COCs when women start contraception?
A. Adverse effects are considerably less likely to occur.
B. Monophasic COCs always contain low estradiol doses.
C. Adverse effects are easier to identify and manage.

17. After discussing various options with a patient, she mentions that she works swing shifts in the same week and will sometimes have to take her pill before her night shift and sometimes after her evening shift. She asks if that will be a problem if she prefers the “minipill.” What is the MOST APPROPRIATE question for you to ask?
A. Will that keep you from taking it in the same 3-hour window every day?
B. How long does it take you to drive to and from work?
C. What about the “minipill” do you find so attractive?

18. In which populations of women are progestin-only pills preferred?
A. Postpartum women who have delivered in the last 30 to 42 days and breastfeeding women
B. Women who are older than 42 and smokers and women with body weights less than 127 lbs
C. Women who experience breakthrough bleeding and those with adherence challenges

20. Why do vaginal ring systems carry a risk of toxic shock syndrome?
A. They can trap bacteria on the cervix, allowing it to enter the fallopian tubes via the uterus.
B. The patient handles them multiple times during use, posing a risk of bacterial contamination.
C. They can trap bacteria in the vagina or create tiny cuts, allowing bacteria to enter the uterus via the cervix.

21. What warning is included in depo-medroxyprogesterone acetate’s labeling as a Boxed Warning?
A. Patients should not use the drug for more than two years due to bone mineral density loss, which may be irreversible
B. Return to fertility may be delayed six to 12 months after discontinuation, so DMPA is not recommended for women desiring pregnancy in the near future
C. DMPA is about 89% effective with typical use so women should use a backup method of contraception.

22. Which of the following emergency contraceptives requires a prescription?
A. Levonorgestrel 1.5 mg
B. Ulipristal acetate 30 mg
C. Neither

23. The CDC’s MEC uses “categories” based on evidence to describe its recommendation. Which of the following is paired correctly?
A. 1 = Theoretical or proven risks usually outweigh the advantages
B. 2 = Advantages generally outweigh theoretical or proven risks
C. 4 = No restriction (method can be used)

24. Your patient has sickle cell disease. According to the CDC’s MEC, what category do POPs fall into?
A. 1
B. 2
C. 3

25. Your patient has a history of gallbladder disease and had a cholecystectomy six months ago. Which of the following contraceptive methods are considered appropriate for this patient?
A. Any IUD, implants, or CHCs
B. DMPA, POPs, and CHCs
C. Benefits generally outweigh the risks for all methods

26. You look at the CDC’s MEC summary chart and you find that the category you are considering is marked with an asterisk (*). What does that mean?
A. Condition that exposes a woman to increased risk as a result of pregnancy.
B. See the complete guidance for a clarification to this classification.
C. Advantages generally outweigh theoretical or proven risks.

27. You look at the CDC’s MEC summary chart and you find that the category you are considering is marked with a dagger (‡). What does that mean?
A. Condition that exposes a woman to increased risk as a result of pregnancy.
B. See the complete guidance for a clarification to this classification.
C. Advantages generally outweigh theoretical or proven risks.

28. In the CDC’s MEC, what is the daily threshold for number of cigarettes at which the risk of using a CHC increases to “Unacceptable health risk (method not to be used)” for women age 35 and older?
A. 15
B. 20
C. 30

29. What does the CDC’s MEC say about the evidence to support the use of progestin-only injectable contraceptives in women at high risk for HIV?
A. Eleven observational studies suggested no association between their use and HIV acquisition
B. Eleven observational studies suggested their use increased risk for HIV acquisition 3-fold
C. Insufficient evidence exists to conclude that they increase the risk of HIV acquisition

30. In a woman who has rheumatoid arthritis and takes immunosuppressives, which of the following poses the highest risk?
A. DMPA
B. POP
C. CHC

31. What is the U.S. MEC’s reason for classifying the class of drugs referred to in the previous question as they did?
A. Risk for breakthrough bleeding increases
B. Risk for osteoporosis increases
C. Risk for drug interactions increases

32. What does the U.S. MEC, indicate about the use of emergency contraceptive pills (ECPs) in women who have experienced sexual assault?
A. ECPs might be less effective among women with BMI < 25 kg/m2 than among women with BMI > 30 kg/m2.
B. Frequently repeated ECP use might be harmful for women with conditions classified as 1, 2, or 3 for CHC or POP use.
C. Women with obesity might experience an increased risk for pregnancy after use of ulipristal acetate compared with women of healthy weight.

33. Carmen is a 44-year-old mother of four. She recently experienced a pulmonary embolism. Which hormonal contraceptive is LEAST appropriate for her?
A. Depo-medroxyprogesterone acetate
B. Combined hormonal contraceptives
C. Progestin-only pills

34. Alexis is on a COC and is experiencing early cycle (days 1-9) breakthrough bleeding. What change to her COC might resolve this issue?
A. Using a COC with more progestin
B. Using a COC with more estrogen
C. Changing her to a POP

35. Justine has been using DMPA for two years, and really likes it for its convenience. She asks you to renew the prescription. What do you do?
A. Screen her for adverse effects and renew the prescription if she has none.
B. Renew the prescription and advise her to increase her calcium and vitamin D intake.
C. Explain why it’s necessary to find an alternative birth control at this point.

36. Rory comes to the pharmacy requesting a prescription for emergency contraception following unprotected sex 48 hours ago. She weighs 150 lbs and has missed the first three doses of her COC because she forgot to refill it on time. Which of the following is the BEST choice for Rory?
A. Prescribe levonorgestrel
B. Prescribe ulipristal acetate
C. Referral for an emergency IUD

37. Tina is a 27-year-old woman who is six months postpartum and requesting a prescription for hormonal contraceptives. Her baby is formula-fed, she weighs 205 lbs, and she takes sertraline (an SSRI) for postpartum depression. She explains that she has had trouble with daily medication adherence in the past and expresses concerns about intolerable adverse effects. Which of the following hormonal contraceptives is MOST appropriate for Tina?
A. Continuous-cycle COCs
B. Transdermal CHC patch
C. EE/E vaginal ring system

38. In addition to verbal counseling, what must a pharmacist provide when prescribing hormonal contraception?
A. A document describing storage
B. A fact sheet specific to the drug
C. A receipt indicating the drug’s cost

39. In addition to the document described in the previous question, what else should the patient have in her possession before leaving the pharmacy?
A. A copy of documentation that the pharmacist passed this test
B. The pharmacist’s business card that includes a phone number
C. A written record of the contraceptive prescribed

40. Which of the following is a critical counseling point when counseling a woman who is starting hormonal contraception after using ECP?
A. Hormonal contraceptives do not protect against sexually transmitted diseases.
B. Using hormonal contraceptives routinely is less expensive than using ECPs.
C. Once you start hormonal contraception, you cannot use ECPs again.

41. You are prescribing POPs to a patient who started her last menstrual period 10 days ago. The last time she had sexual intercourse was 14 days ago. Which of the following counseling points is appropriate?
A. Start this medication today, and no backup contraception is needed.
B. Start this medication today and use backup contraception for 2 days.
C. Do not start this medication until after you’ve taken a pregnancy test.

42. You are prescribing transdermal CHCs to a patient who was previously on COCs but had poor adherence. Which of the following counseling points is appropriate?
A. If the patch detaches for three or more hours, use backup contraception for seven days
B. If you plan to exercise, use medical tape to reinforce the patch and prevent detachment
C. You may experience more adverse effects due to higher estrogen exposure

43. A patient consults with you for emergency contraception. You decide that ulipristal acetate is the best choice. The patient asks you to give her four refills. What do you tell her?
A. Yes, I can give you four refills but you must use them within a year.
B. Ulipristal is an OTC drug; you don’t need a prescription or refills.
C. The law doesn’t allow refills, so let’s discuss a better contraceptive plan.

44. Your patient is interested in hormonal contraception. She indicates that she doesn’t remember when she last saw a healthcare provider for a women’s health visit. Under what circumstance can you prescribe hormonal contraception?
A. She has an empty package of oral contraceptives and the last refill was expended this month.
B. She is younger than 18 years of age and accompanied by her mother who says it’s OK to prescribe to her.
C. She has a package of ECPs prescribed by a pharmacist in another state about two and a half years ago.

45. It’s August and a college student visits and asks for a prescription for a hormonal contraceptive. She’s excited because she is going to study abroad for one year starting in October. She asks for 14 months of an OCP. What do you do?
A. Write a prescription with 14 one-month refills and tell her to have her parent refill it and mail it as necessary
B. Issue a prescription for three months, and ask her to return before she leaves for a new 1-year prescription
C. Fill it in bulk for 14 months and make a note in the record indicating this is an exception to policy allowed by law
46. A 16-year-old high school student asks for a prescription for a hormonal contraceptive. In what way is this situation different than handling a prescription for a patient older than 18?
A. The patient must have previously been prescribed a contraceptive by another provider.
B. The patient needs permission from a parent or guardian before a pharmacist can prescribe.
C. The patient must take an OTC pregnancy test before a pharmacist can prescribe.

47. A woman comes to the pharmacy with a prescription for hormonal contraception written by another pharmacist. Can you fill it?
A. Yes, if I know the pharmacist.
B. No, she needs to go back to the pharmacy where the prescribing pharmacist works.
C. Yes, if the prescribing pharmacist is authorized to write for hormonal contraception.

48. Which of the following is a red flag requiring pharmacist referral to a practitioner for evaluation before prescribing DMPA?
A. Blood pressure > 140/90 mmHg
B. Taking escitalopram for depression
C. Gave birth 3 weeks ago

49. After prescribing hormonal contraceptives, which of the following is required?
A. Maintain completed screening documents at the prescribing pharmacy for 1 year
B. Transmit dispensing information to the electronic prescription drug monitoring program within 72 hours
C. Maintain all records created as part of the prescribing process for three years

50. Your pharmacy is located in a college town, and you are inundated with requests for hormonal contraceptive prescriptions. One of the pharmacy technicians completed an approved training course and would like to help. Which of the following is an appropriate way for the technician to contribute?
A. Provide screening documents and take and record the patient’s blood pressure
B. Take and record the patient’s blood pressure and review screening documents for contraindications
C. Supervise patients performing OTC pregnancy tests and provide educational materials about contraceptives

References

Full List of References

REFERENCES

    1. Guttmacher Institute. Contraceptive use in the United States by demographics. May 2021. Accessed October 18, 2023. https://www.guttmacher.org/fact-sheet/contraceptive-use-united-states
    2. Office on Women’s Health. Unplanned pregnancy. Updated February 22, 2021. Accessed October 18, 2023. https://www.womenshealth.gov/pregnancy/you-get-pregnant/unplanned-pregnancy
    3. Office of Disease Prevention and Health Promotion. Healthy People 2030: Reduce the proportion of unintended pregnancies — FP‑01. Accessed October 18, 2023. https://health.gov/healthypeople/objectives-and-data/browse-objectives/family-planning/reduce-proportion-unintended-pregnancies-fp-01
    4. Centers for Disease Control and Prevention. Contraception. Updated May 1, 2023. Accessed October 18, 2023. https://www.cdc.gov/reproductivehealth/contraception/index.htm
    5. Bull JR, Rowland SP, Scherwitzl EB, Scherwitzl R, Danielsson KG, Harper J. Real-world menstrual cycle characteristics of more than 600,000 menstrual cycles. NPJ Digit Med. 2019;2:83. doi:10.1038/s41746-019-0152-7
    6. Reed BG, Carr BR. The normal menstrual cycle and the control of ovulation. In: Feingold KR, Anawalt B, Blackman MR, et al., eds. Endotext. South Dartmouth (MA): MDText.com, Inc.; August 5, 2018.
    7. Teal S, Edelman A. Contraception selection, effectiveness, and adverse effects: A Review. JAMA. 2021;326(24):2507-2518. doi:10.1001/jama.2021.21392
    8. Montanino Oliva M, Gambioli R, Forte G, Porcaro G, Aragona C, Unfer V. Unopposed estrogens: current and future perspectives. Eur Rev Med Pharmacol Sci. 2022;26(8):2975-2989. doi:10.26355/eurrev_202204_28629
    9. Curtis KM, Jatlaoui TC, Tepper NK, et al. U.S. Selected Practice Recommendations for Contraceptive Use, 2016. MMWR Recomm Rep. 2016;65(4):1-66. doi:10.15585/mmwr.rr6504a1
    10. Annovera (prescribing information). TherapeuticsMD, Inc.;2022.
    11. Centers for Disease Control and Prevention. Recommended Actions After Late or Missed Combined Oral Contraceptives. Accessed February 28, 2024. https://www.cdc.gov/reproductivehealth/contraception/pdf/recommended-actions-late-missed_508tagged.pdf
    12. American College of Obstetricians and Gynecologists. Effectiveness of birth control methods. April 2023. Accessed February 20, 2024. https://www.acog.org/womens-health/infographics/effectiveness-of-birth-control-methods
    13. Darney PD. OC practice guidelines: minimizing side effects. Int J Fertil Womens Med. 1997;Suppl 1:158-169.
    14. Ortho Evra (prescribing information). Janssen Pharmaceuticals, Inc.;2017.
    15. Annovera - a new contraceptive vaginal ring. Med Lett Drugs Ther. 2019;61(1587):197-198.
    16. NuvaRing (prescribing information). Organon & Co.; 2022.
    17. Cleveland Clinic. Toxic shock syndrome. Updated August 12, 2022. Accessed February 20, 2024. https://my.clevelandclinic.org/health/diseases/15437-toxic-shock-syndrome
    18. Depo-subQ Provera 104 (prescribing information). Pfizer Inc.; 2020.
    19. Plan B One-Step (prescribing information). Barr Laboratories; 2009. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021998lbl.pdf
    20. Ella (prescribing information). HRA Pharma America Inc.; 2021.
    21. Centers for Disease Control and Prevention. US Medical Eligibility Criteria for Contraceptive Use, 2016 (US MEC). Reviewed March 27, 2023. Accessed February 20, 2024. https://www.cdc.gov/reproductivehealth/contraception/mmwr/mec/summary.html22. National Association of Chain Drug Stores. Pharmacies - The Face of Neighborhood Health Care Since Well Before the Pandemic. Accessed March 1, 2024. https://www.nacds.org/pdfs/about/rximpact-leavebehind.pdf

    Patient Safety: Cheers to the Beers: Unpacking the Latest Updates for Safer Prescribing -RECORDED WEBINAR

    About this Course

    This course is a recorded (home study version) of the 2024 CE Finale Encore Webinars.

     

    Learning Objectives

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

    Review the role of the Beers Criteria in reducing potentially inappropriate medication (PIM) use and enhancing patient safety in older adults
    Identify recent updates to the Beers Criteria and their implications for medication management in geriatric care
    Apply the updated Beers Criteria to real-world scenarios, optimizing medication selection and minimizing risks in older adults

    Release and Expiration Dates

    Released:  December 13, 2024
    Expires:  December 13, 2027

    Course Fee

    $17 Pharmacist

    ACPE UAN

    0009-0000-24-045-H05-P

    Session Code

    24RW45-XTY89

    Accreditation Hours

    1.0 hours of CE

    Additional Information

     

    How to Complete Evaluation:  When you are ready to submit quiz answers, go to the BLUE take test/evaluation button.  Don't forget to use the session code above, or that was sent to you in your confirmation email NOT the one on the presentation!

    Accreditation Statement

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

    Pharmacists and Pharmacy Technicians are eligible to participate in this application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-24-045-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.

    Grant Funding

    There is no grant funding for this activity.

    Faculty

    Kelsey Giara, PharmD
    Freelance Medical Writer
    Adjunct Faculty
    University of Connecticut School of Pharmacy
    Pelham, NH

    Faculty Disclosure

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

    • Dr. Giara has no financial relationships with ineligible companies.

    Disclaimer

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

    Content

    Handouts

    Post Test

    Learning Objectives
    • Review the role of the Beers Criteria in reducing potentially inappropriate medication (PIM) use and enhancing patient safety in older adults
    • Identify recent updates to the Beers Criteria and their implications for medication management in geriatric care
    • Apply the updated Beers Criteria to real-world scenarios, optimizing medication selection and minimizing risks in older adults

    1. About how many older adults are prescribed potentially inappropriate medications?
    A. One in seven
    B. One in five
    C. One in three

    2. Which of the following describes how age-related physiologic changes affect older adults?
    A. Decreased renal and hepatic blood flow slows drug excretion, causing toxicity
    B. Frailty increases activity in drug metabolizing pathways, making drugs less effective
    C. Decreased body fat and dehydration affect drug distribution and cause toxicity

    3. Which of the following best describes a potentially inappropriate medication?
    A. A drug that is contraindicated in patients older than 65 years
    B. A drug for which risks outweigh benefits in older adults
    C. A drug that should only be used in hospice or end-of-life care

    4. Which of the following is TRUE?
    A. Older adults should always avoid SGLT2 inhibitors
    B. The updated criteria removes doxepin < 6 mg/day C. Dabigatran is the safest anticoagulant for older adults 5. Which of the following best describes Beers Criteria guidance on proton pump inhibitors (PPIs)? A. Deprescribe after 8 weeks of scheduled use, unless the patient is high-risk B. After 8 weeks of scheduled use, reevaluate risks and benefits and continue if tolerated C. Avoid scheduled use completely and advise patients to use intermittent antacids 6. Which of the following is a reason to deprescribe a medication found on the Beers Criteria? A. The drug is being used to treat cancer but carries a risk of acid reflux B. The drug is being used to treat two indications at once C. The drug was prescribed to address the adverse effect of another drug 7. Mrs. Taylor, a 78-year-old woman with a history of AFib and diabetes, is prescribed rivaroxaban for stroke prevention and glyburide for glycemic control. During a consultation, she reports episodes of dizziness and has a recent lab result showing a creatinine clearance of 35 mL/min. Which of the following is the BEST plan of action? A. Recommend switching glyburide to glipizide B. Advise switching rivaroxaban to warfarin C. Continue both medications with increased monitoring for AEs

    VIDEO

    Immunization: Our Best Shot – Tips and Tools to Vaccinate Older Adults – RECORDED WEBINAR

    About this Course

    This course is a recorded (home study version) of the 2024 CE Finale Encore Webinars.

     

    Learning Objectives

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

    1.     RECOGNIZE appropriate vaccine recommendations for the older adult population
    2.      IDENTIFY potential barriers to vaccinations
    3.     ANALYZE current methods used to improve vaccination rates
    4.     DISCUSS ways to improve vaccine compliance in your patient population

    Release and Expiration Dates

    Released:  December 13, 2024
    Expires:  December 13, 2027

    Course Fee

    $17 Pharmacist

    ACPE UAN

    0009-0000-24-047-H06-P

    Session Code

    24RW47-FXY23

    Accreditation Hours

    1.0 hours of CE

    Additional Information

     

    How to Complete Evaluation:  When you are ready to submit quiz answers, go to the BLUE take test/evaluation button.  Don't forget to use the session code above, or that was sent to you in your confirmation email NOT the one on the presentation!

    Accreditation Statement

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

    Pharmacists and Pharmacy Technicians are eligible to participate in this application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-24-047-H06-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

    Grant Funding

    There is no grant funding for this activity.

    Faculty

    Jack Vinciguerra, PharmD
    Express Scripts
    St Louis, MO

    Faculty Disclosure

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

    • Dr. Vinciguerra has no financial relationships with ineligible companies.

    Disclaimer

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

    Content

    Handouts

    Post Test

    Immunization: Our Best Shot - Tips and Tools to Vaccinate Older Adults

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

    • Recognize appropriate vaccine recommendations for the older adult population
    • Identify potential barriers to vaccinations
    • Analyze current methods used to improve vaccination rates
    • Discuss ways to improve vaccine compliance in your patient population

    1. How many vaccines does the CDC strongly recommend for older adults?
    a. Just two: influenza and COVID
    b. Three: influenza, COVID, and RSV
    c. Six-ish!!! (It depends)

    2. New patient, ES, age 60, has recently moved to Connecticut from Ontario, Canada. The patient reports receiving Zostavax 1 month ago. Which of the following recommendations regarding the administration of Shingrix is correct?
    a. Shingrix is contraindicated in those who have received Zostavax.
    b. It is recommended to administer the Shingrix vaccine immediately.
    c. It is recommended to wait at least 8 weeks after receiving Zostavax.

    3. Which of the following situations might act as a barrier to vaccine uptake in older adults?
    a. The nearest pharmacy and healthcare facilities are miles away and not on a bus route.
    b. Other people at the senior center have had COVID, the flu, or shingles recently and been quite ill.
    c. Pharmacy staff asks pleasantly and often if they might be ready to be vaccinated.

    4. Which of the following is an example of a contextual influence as defined by the Vaccine Hesitancy Determinants Matrix?
    a. Personal experience with vaccinations
    b. Communication and media environment
    c. Mode of vaccine administration

    5. Which of these programs is a federal program that uses digital outreach, television, print, and radio to decrease vaccine hesitancy among older adults?
    a. Risk Less, Do More
    b. It’s a Sure Shot
    c. No Shot in the Dark

    6. You’re monitoring vaccine uptake in your community and it is alarmingly low. You decide to use the S-H-A-R-E method of encouraging vaccine uptake. What does the R stand for?
    a. Remind patients that getting a vaccine-preventable disease is costly
    b. Remind patients that vaccines protect them and their loved ones
    c. Remind patients that you have the vaccines they need in stock

    Share the tailored reasons why the recommended vaccine is right for the patient
    Highlight positive experiences with vaccines (anecdotal or in practice) to strengthen confidence
    Address patient questions and concerns about the vaccine
    Remind patients that vaccines protect them and their loved ones
    Explain the potential costs of getting the disease

    VIDEO

    Beyond Memory Loss: Mastering the Management of Behavioral Symptoms in Dementia-RECORDED WEBINAR

    About this Course

    This course is a recorded (home study version) of the 2024 CE Finale Encore Webinars.

     

    Learning Objectives

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

    1.      Identify clinical characteristics of the behavioral symptoms of dementia (BSD) including agitation, psychosis, and sleep disturbances
    2.      Discuss medications currently used in the management of BSD along with emerging pharmacologic therapy options
    3.      Determine the most appropriate pharmacologic treatment option for a patient with behavioral symptoms of dementia based on patient-specific factors

    Release and Expiration Dates

    Released:  December 13, 2024
    Expires:  December 13, 2027

    Course Fee

    $17 Pharmacist

    ACPE UAN

    0009-0000-24-048-H01-P

    Session Code

    24RW48-YXF98

    Accreditation Hours

    1.0 hours of CE

    Additional Information

     

    How to Complete Evaluation:  When you are ready to submit quiz answers, go to the BLUE take test/evaluation button.  Don't forget to use the session code above, or that was sent to you in your confirmation email NOT the one on the presentation!

    Accreditation Statement

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

    Pharmacists and Pharmacy Technicians are eligible to participate in this application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-24-048-H01-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

    Grant Funding

    There is no grant funding for this activity.

    Faculty

    Kristin Waters, PharmD, BCPS, BCPP
    Assistant Clinical Professor
    UConn School of Pharmacy
    Storrs, CT

    Faculty Disclosure

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

    • Dr. Waters is on the Johnson and Johnson speakers' bureau, but the information discussed here has no overlap. All financial relationships with ineligible companies have been mitigated.

    Disclaimer

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

    Content

    Handouts

    Post Test

      Behavioral Symptoms of Dementia Assessment Questions

      1. Which of the following is a symptom of agitation in dementia?
      1. Hallucinations
      2. Restless leg syndrome
      3. Throwing objects

       

      1. A 64-year-old patient has a PMH of AD, hypertension, urinary incontinence, and insomnia. Recently, they have been increasingly agitated throughout both the day and night. Symptoms primarily include pacing and verbally repeating the same phrases many times. Non-pharmacologic intervention is mildly effective, but the patient’s caregiver is requesting pharmacologic intervention as well.

      Current medications:

      Amlodipine 10 mg po daily

      Oxybutynin 10 mg po daily

      Diphenhydramine 25 mg po nightly prn insomnia

      Cetirizine 10 mg po daily

      Melatonin 6 mg po nightly Which of the following is the best first step in managing the patient’s agitation?

      1. Discontinue melatonin
      2. Reduce anticholinergic load
      3. Reduce dose of amlodipine

       

      3. The patient and caregiver agree to discontinuation of the cetirizine and diphenhydramine. They feel strongly that the oxybutynin improves their quality of life by allowing them to not become incontinent of urine overnight. Unfortunately, several weeks later the agitation symptoms persist. Which of the following is the best recommendations at this time?

      a. Initiate citalopram

      b. Initiate haloperidol

      c. Initiate risperidone

      1. A 71-year-old patient with vascular dementia recently started insisting that unknown people were living in his attic. He says he can hear the intruders talking during the night but they hide whenever someone goes up to check. The patient is extremely distressed about this and is trying to obtain a firearm to protect his family from these intruders.

      Which of the following pharmacologic recommendations may be appropriate?

      1. Brexpiprazole
      2. Trazodone
      3. Haloperidol

       

      1. The patient’s symptoms improve significantly after starting brexpiprazole. However, he is still very restless at night and wakes up frequently. He reports being “exhausted” each day. Which of the following would be the best pharmacologic option?
      1. Melatonin
      2. Eszopiclone
      3. Suvorexant

       

      6. Which medication approved for Parkinson’s disease psychosis has demonstrated the ability to prolong time to relapse of psychosis in Alzheimer’s disease?

      a. Brexpiprazole

      b. Pimavanserin

      c. Dexmedetomidine

       

      7. Which of the following behavioral symptoms of dementia is the most common?

      a. Apathy

      b. Psychosis

      c. Anxiety

      VIDEO

      Law: Seniors Self-Diagnosing and Treating: A Brave (and scary) New World-RECORDED WEBINAR

      About this Course

      This course is a recorded (home study version) of the 2024 CE Finale Encore Webinars.

       

      Learning Objectives

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

      Describe the reasons seniors are increasingly diagnosing and treating themselves with therapies
      Describe the legal and regulatory pathways that provide seniors access to therapies outside the drug supply chain
      Describe the ways that pharmacists can recommend dietary supplements that are free of adulterants and contaminants
      Describe the risks associated with self-treatment with dietary supplements, “peptides”, and counterfeit drug

      Release and Expiration Dates

      Released:  December 13, 2024
      Expires:  December 13, 2027

      Course Fee

      $17 Pharmacist

      ACPE UAN

      0009-0000-24-044-H03-P

      Session Code

      24RW44-BVF28

      Accreditation Hours

      1.0 hours of CE

      Additional Information

       

      How to Complete Evaluation:  When you are ready to submit quiz answers, go to the BLUE take test/evaluation button.  Don't forget to use the session code above, or that was sent to you in your confirmation email NOT the one on the presentation!

      Accreditation Statement

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

      Pharmacists and Pharmacy Technicians are eligible to participate in this application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-24-044-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.

      Grant Funding

      There is no grant funding for this activity.

      Faculty

      C. Michael White, PharmD, FCCP, FCP
      BOT Distinguished Professor and Chair of Pharmacy Practice
      University of Connecticut School of Pharmacy
      Storrs, CT

      Faculty Disclosure

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

      • Dr. White has no financial relationships with ineligible companies.

      Disclaimer

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

      Content

      Handouts

      Post Test

        Pharmacist Post Test

         

        1. Don is a 72-year-old who is looking online for alternatives to self-manage his pain. His prescriber told him he would not write any other prescriptions for oxycodone with APAP. He is looking at kratom and for Canadian Pharmacies that don’t require a prescription. Which of the following is the motivator for Don to transcend the normal medication supply chain?
        1. Cost of prescription options
        2. Circumvent prescriber gatekeeping restrictions
        3. Embarrassment over his health issue

         

        1. You are a pharmacist at a community pharmacy and a patient asks you which supplements to buy. What is a validated way to assure the dietary supplement you recommend does not have excessive microbial or heavy metal contamination and has the ingredients in the tablets/capsules advertised on the label?
        1. USP certification
        2. Better Homes and Gardens Certification
        3. The most expensive one

         

        1. Sylvia is a 68-year-old woman who weighs 120 pounds but wants to weigh 108 pounds like she did when she was 40 years old. Which of the following is a good counseling point if she reveals she is using a “peptide” GLP-1 product?
        1. Her obesity is a disorder that requires a GLP-1 product, so the benefits outweigh the risks
        2. These products are known to contain lead and arsenic in too high a level
        3. The labeled dose could vary, and she could overdose or underdose as a result

         

        1. Don from question 1 finds a “pharmacy” willing to sell him oxycodone with APAP for $7 a pill without a prescription. The site says it is a best seller in Canada. What is the main risk of Don getting his opioids from the unlicensed online site?
        1. Fentanyl adulteration and dose variability could lead to respiratory depression
        2. It is more expensive than the brand name prescription version he now takes
        3. The company offers no certificate of analysis or money back guarantee

         

        1. A company says its melatonin supplement can “support a restful sleep” and that “this product is not intended to diagnose, evaluate, or treat any disease.” What would the FDA call this?
        1. A legitimate health claim
        2. A legitimate quasi health claim
        3. A legitimate semi-health claim

         

        1. A woman calls a company that sells “Energy Macha” to complain that her newborn has an extra arm with seven fingers. How long does the company have to alert the FDA about this serious potential adverse event?
        1. 1-day
        2. 5-days
        3. 15-days

         

        1. Which of the following common adulterants is matched with the type of dietary supplement it is associated with?
        1. Weight Loss – human growth hormone
        2. Muscle Building – sildenafil
        3. Sexual Enhancement – tadalafil

         

        1. What is the name of the law that controls FDA authority over dietary supplements?
        1. DSHEA 1994
        2. OBRA 1990
        3. FDCA 1927

         

        VIDEO

        LAW: Call 1-800-Get-Cash Fast: Drug-Related Advertisements about Litigation RECORDED WEBINAR

        About this Course

        This course is a recorded (home study version) of the 2024 CE Finale Encore Webinars.

         

        Learning Objectives

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

        1.      Explain common terminology associated with commercials targeting older Americans
        2.      Describe legal processes associated with lawsuits generated against companies that make products alleged to cause harm
        3.      Discuss generalities in potential lawsuits associated with media promotion campaigns
        4.      Identify areas where no information is available to provide good, valid answers for patients who ask questions

        Release and Expiration Dates

        Released:  December 13, 2024
        Expires:  December 13, 2027

        Course Fee

        $17 Pharmacist

        ACPE UAN

        0009-0000-24-049-H03-P

        Session Code

        24RW49-ABC84

        Accreditation Hours

        1.0 hours of CE

        Additional Information

         

        How to Complete Evaluation:  When you are ready to submit quiz answers, go to the BLUE take test/evaluation button.  Don't forget to use the session code above, or that was sent to you in your confirmation email NOT the one on the presentation!

        Accreditation Statement

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

        Pharmacists and Pharmacy Technicians are eligible to participate in this application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-24-049-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.

        Grant Funding

        There is no grant funding for this activity.

        Faculty

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

        Faculty Disclosure

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

        • Ms. Wick has no financial relationships with ineligible companies.

        Disclaimer

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

        Content

        Handouts

        Post Test

          LAW: Call  1-800-Get-Cash Fast

           

          After completing this continuing education activity, learners will be able to

          • Explain common terminology associated with commercials targeting older Americans
          • Describe legal processes associated with lawsuits generated against companies that make products alleged to cause harm
          • Discuss generalities in potential lawsuits associated with media promotion campaigns
          • Identify areas where no information is available to provide good, valid answers for patients who ask questions

           

           

          1. What is the legal lingo for cases that are solicited on television using 1-800 numbers?
          1. Class action suits
          2. Torte claims
          3. Product liability suits

           

          1. What groups have traditionally been represented in parens patriae suits?
          2. State residents who appeal to the state to represent them
          3. Smokers and people who have opioid or alcohol use disorder
          4. Children, the mentally ill, people who are legally incompetent

           

          1. What is usury law?
          1. Laws pertaining to the use of a commercial product that results in alleged harm to a group of people who become plaintiffs
          2. Laws pertaining to  lending money at an interest rate that is unreasonably high or higher than the rate permitted by law
          3. Laws pertaining to any claim that arises in civil court, with the exception of contractual disputes, property, or criminal activity

           

          1. When discussing multi-district litigation (MDL), what does the adjective “generic” mean?
          1. It means that most torte claims do not include generic drugs; they focus on brand names
          2. It means assets (documents, expert opinion, interviews, etc) that apply to all plaintiffs
          3. It means developing charts, timelines, and visuals that a judge and jury will understand

           

          1. A patient asks you if you can determine how much money he might get if he joins a multi-district litigation on ranitidine. What do you say?
          1. Call the 1-800 number advertised on TV; the operator can provide that information.
          2. Go to the local library and access LegalTrac; settlement amounts are tracked closely.
          3. That information is guarded closely by nondisclosure agreements; it’s hard to tell.

           

          1. What is the Texas Two-Step in the legal arena?
          2. A term describing division of assets and liabilities between two companies
          3. A term describing a non-opt-out settlement for mass tort liability
          4. A term describing companies’ tendency to declare bankruptcy swiftly

           

          1. In a case against a major pharmaceutical company that made a liquid cherry flavored gastroprokinetic drug for adults, who received the lion’s share of the settlement?
          1. The patients/plaintiff
          2. The attorneys
          3. Others

          VIDEO

          Opioids: Impact of Palliative Care on Total Pain in the Older Adult-RECORDED WEBINAR

          About this Course

          This course is a recorded (home study version) of the 2024 CE Finale Encore Webinars.

           

          Learning Objectives

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

          Describe Palliative Care and its importance in the healthcare system today
          Define the concept of “total pain” and the importance of whole person care in pain and symptom management
          Recognize the physiologic changes that occur with aging and how those impact pain and symptom management
          Determine the role of the pharmacist in total pain management in the older adult

          Release and Expiration Dates

          Released:  December 13, 2024
          Expires:  December 13, 2027

          Course Fee

          $17 Pharmacist

          ACPE UAN

          0009-0000-24-046-H08-P

          Session Code

          24RW46-TXV63

          Accreditation Hours

          1.0 hours of CE

          Additional Information

           

          How to Complete Evaluation:  When you are ready to submit quiz answers, go to the BLUE take test/evaluation button.  Don't forget to use the session code above, or that was sent to you in your confirmation email NOT the one on the presentation!

          Accreditation Statement

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

          Pharmacists and Pharmacy Technicians are eligible to participate in this application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-24-046-H08-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

          Grant Funding

          There is no grant funding for this activity.

          Faculty

          Megan Mitchell, PharmD, MS
          Pharmacy Clinical Coordinator Pain Management and Palliative Care
          University of Connecticut Healthcare
          Farmington, CT

          Faculty Disclosure

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

          • Dr. Mitchell has no financial relationships with ineligible companies.

          Disclaimer

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

          Content

          Handouts

          Post Test

          Opioids: Impact of Palliative Care on Total Pain in the Older Adult

          Post Test Questions

           

          1. Which of the following are goals of palliative care?
            1. Convince patients to enroll with hospice for end-of-life care
            2. Stop curative intent therapies to focus on comfort
            3. Improve quality of life for patients and families

           

          1. Which of the following is true regarding the differences between primary palliative care and specialty palliative care?
            1. Any individual healthcare provider can provide primary palliative care
            2. Primary palliative care always comes first
            3. Specialty palliative care always requires insurance prior authorization

           

          1. Which of the following is the IASP definition of pain?
            1. An unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage
            2. An unpleasant physical experience associated with, or resembling that associated with, actual or potential tissue damage
            3. An unpleasant emotional experience associated with, or resembling that associated with, actual tissue damage

           

          1. Approximately how much money is spent annually via direct medical costs, lost productivity and disability related to chronic pain in the United States?
            1. $5.6 billion
            2. $56 billion
            3. $560 billion

           

          1. Which of the following pain types is defined as maladaptive changes in pain processing and modulation without evidence of tissue or nerve damage?
            1. Nociceptive pain
            2. Nociplastic pain
            3. Neuropathic pain

           

          1. Which of the following is the correct definition of “total pain”?
            1. The total suffering of one’s physical, social, psychological and spiritual self that is experienced when dealing with serious illness
            2. The total suffering of one’s physical, social, psychological and spiritual self that is experienced with first time home buying
            3. The total suffering of one’s physical, social, psychological and spiritual self that is experienced when taking CE post-tests

           

          1. How does non-physical pain and suffering often manifest?
            1. Reports of worsening mood
            2. Reports of physical pain
            3. Reports of fear of dying

          VIDEO

          DON’T SKIP A BEAT: TAKING THE PULSE OF ATRIAL FIBRILLATION

          Learning Objectives

            After completing this application-based continuing education activity, pharmacists will be able to
          •        Explain the definition, clinical presentation, and types of atrial fibrillation
          •        Discuss pharmacologic and non-pharmacologic treatment options for atrial fibrillation
          •        Describe the role of anticoagulation in atrial fibrillation management
          •        Identify interventions that could improve outcomes in atrial fibrillation patients
          After completing this application-based continuing education activity, pharmacy technicians will be able to:
          •        Explain the definition, clinical presentation, and types of atrial fibrillation
          •        Discuss pharmacologic and non-pharmacologic treatment options for atrial fibrillation
          •        Describe the role of anticoagulation in atrial fibrillation management
          •        Identify programs designed to promote medication adherence in patients with atrial fibrillation

          Anatomical structure of the heart centered in front of multiple electrocardiogram readings.

          Release Date:

          Release Date:  January 15, 2025

          Expiration Date: January 15, 2028

          Course Fee

          Pharmacist $7

          Pharmacy Technician $4

          There is no funding for this CPE activity.

          ACPE UANs

          Pharmacist: 0009-0000-25-001-H01-P

          Pharmacy Technician: 0009-0000-25-001-H01-T

          Session Codes

          Pharmacist:  25YC01-DSB29

          Pharmacy Technician:  25YC01-BSD92

          Accreditation Hours

          2.0 hours of CE

          Accreditation Statements

          The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Statements of credit for the online activity ACPE UAN 0009-0000-25-001-H01-P/T  will be awarded when the post test and evaluation have been completed and passed with a 70% or better. Your CE credits will be uploaded to your CPE monitor profile within 2 weeks of completion of the program.

           

          Disclosure of Discussions of Off-label and Investigational Drug Use

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

          Faculty

          Brian L. Gaul, B.S., PharmD, RPh
          Freelance Medical Writer
          Gaul Communications
          Tomah, WI


           

          Faculty Disclosure

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

          Dr. Gaul has no financial relationships with ineligible companies.

          ABSTRACT

          Atrial fibrillation (AFib) is a growing problem in the United States and globally. AFib occurs when the electric impulses of the heart’s upper chambers become chaotic and irregular. The result is a fast heart rate, pooling of blood in the atria, and erratic pumping of blood by the ventricles. The treatments for AFib include rate-control medications, rhythm-control drugs, anticoagulants, and nonpharmacologic procedures. A standardized scoring system determines the need for anticoagulation, with direct oral anticoagulants preferred over warfarin in most cases. Providers choose rate-control medications like beta-blockers, calcium channel blockers, and digoxin in selected patients; however, they may opt for rhythm-control antiarrhythmics like flecainide, sotalol, and dofetilide for others. Nonpharmacologic options include cardiac ablation, Watchman LLA and AtriClip devices, and electrical cardioversion. Pharmacists are well-positioned to monitor therapy, adjust anticoagulant dosing, and assist in the diagnosis of patients with AFib. Pharmacy technicians can coordinate compliance mechanisms like medication synchronization and refill reminders.

          CONTENT

          Content

          INTRODUCTION

          “My heart feels like it is pounding out of my chest.”

          Dan Reeves, a 79-year-old white male, makes this statement to the pharmacy technician at the counter while waiting to pick up his prescriptions for flecainide and apixaban. He has his hand over his chest and states he feels tired and short of breath when doing any activity. The pharmacy technician requests help from the pharmacist, who notes that Daniel is showing signs of an arrhythmia. A check of his records shows that he is two weeks late for his refill of flecainide, a medicine to treat atrial fibrillation (AFib). Upon questioning by the pharmacist, Dan says the doctor has told him how important it is to take the medication properly. However, he admits that he sometimes forgets to take the second dose at bedtime.

           

          AFib is the most common type of sustained heart rhythm disorder, also called an arrhythmia.1 It occurs when the heart's electrical activity is abnormal or irregular, usually resulting in a fast heart rate.1 If the rate does not return to normal, it can lead to stroke, heart failure, or other medical problems.2 AFib is a leading cause of stroke.1

           

          An estimated 2.3 million people in the United States have AFib, according to the most recent data available.3 Given the association between advanced age and AFib occurrence, an estimated 5.6 million will experience AFib by the year 2050.3 It affects fewer than 1% of people under the age of 60 to 65 but 8% to 10% of those older than 80.3 It happens more often in males and Caucasians.1

           

          Risk factors for developing AFib include the following1:

          • Advancing age
          • Chronic Inflammation
          • Congenital heart disease
          • Endocrine disorders
          • Genetic factors
          • High blood pressure
          • Increased alcohol consumption
          • Neurological disorders
          • Obstructive sleep apnea
          • Underlying heart and lung disease.

           

          Athletes who overtrain in intense cardiovascular sports, like competitive bikers and marathon runners, also are at an increased risk of developing AFib (see SIDEBAR).

           

          SIDEBAR: IS OVERTRAINING TO BLAME FOR AFIB IN ATHLETES?

          According to studies, the prevalence of AFib in athletes is about 2 to 10 times higher than in the general population.4 Most cases occur in endurance athletes, such as marathoners, and may result from overtraining. In one study, a group of middle-aged men who ran marathons had a higher incidence of AFib than their sedentary counterparts.5 The disease also occurs five times more often in aging cyclists (average age of 66 years old) who continue training.6 The duration and intensity of exercise correlate to the development of paroxysmal AFib.4

           

          Reports cite “irrational” regimens involving overtraining as the primary factors, along with obesity and diabetes.4 Treatment consists of removing the physical stress and prescribing flecainide or propafenone.7 Athletes may return to training in four to six weeks but should remain on a beta-blocker to prevent recurrence.8,9 Providers should consider the cardioselectivity of the beta-blocker and the athlete’s sport when choosing a therapy.4 Prevention and treatment of future episodes may include a “pill-in-pocket” approach or cardiac ablation.7

           

          AFib occurs when electrical impulses in the heart’s upper chambers, called the atria, come from multiple foci, rather than just the sinoatrial (SA) node. The atrial and ventricular depolarization rate becomes rapid and chaotic rather than their normal, consistent firing and propagation (called normal sinus rhythm).10,11 When different atrial defibrillation waves collide, they cancel each other out meaning no one pacemaker exists. This causes the atrial chambers to quiver, or “fibrillate” instead of contracting in a normal manner from the top of the atria to the bottom. As a result, blood pools in the left atrial appendage (a tissue sack attached to the left atria) which can lead to blood clots. The clots may dislodge from the left atrial appendage, travel to the brain, and cause embolic strokes.11

           

          The atrial depolarizations bombard the atrioventricular (AV) node separating the atria from the ventricle with approximately 300 depolarization stimuli per minute. The AV node tries to prevent some of these depolarizations from reaching the ventricles, but the resulting ventricular contractions become faster than normal and irregularly spaced.11

           

          PATHOGENESIS

          In a normal heart, electrical impulses travel in a coordinated way through the heart’s pacemaker, the SA node, through the atrial tissue, and to the AV node.13 The AV node slows the impulse before it travels to and depolarizes the ventricles.14 When the SA node in a normal heart initiates a depolarization wave, it spreads across the atria from top to bottom. Once the cells depolarize, it cannot depolarize again for a while, and this is called the effective refractory period. Immediately after the refractory period, the tissue is in a vulnerable period because the electrical charge of the cells is normalized but the amount of sodium in the cell is too high and the potassium inside the cell is too low. If another depolarization stimuli hits tissue in the vulnerable period, fibrillation occurs. However, this is rare in normal hearts because it is impossible for the wave of depolarization to circle behind the effective refractory tissue to hit other tissue in the vulnerable period. However, when there is a mixing of electrically active and inactive cells together, the single wave of depolarization becomes fractionated into multiple wavelets in three-dimensional space and one of the wavelets can emerge and hit tissue in the vulnerable period.

           

          AFib originates in the pulmonary vein-atrial border 95% of the time because the pulmonary vein contains electrically active atrial cells and inactive pulmonary vein cells that are intermingled.12 However, in people with longstanding AFib, the stress kills atrial cells, which are replaced by electrically inactive connective tissue, and the anatomic milieu is created to have AFib generated in the body of the atria itself. Patients with AFib may present to healthcare providers with or without symptoms.1 Patients may experience chest pain, palpitations, a fast heart rate, shortness of breath, nausea, dizziness, sweating, or general fatigue when they have symptoms.1 The ventricular rate for a patient with AFib is 110 to 140 beats per minute (BPM).1

           

          When AFib occurs, the heart can usually quickly abolish it on its own but as periods of AFib continue to occur, subsequent AFib episodes last longer and longer until eventually AFib just continues.

           

          Providers classify AFib into five types1:

          • Paroxysmal AFib will revert to normal sinus rhythm in less than seven days with no antiarrhythmic medication or electrical cardioversion.
          • Persistent AFib occurs and then persists, requiring intervention with antiarrhythmic medication or electrical cardioversion.
          • Long-standing persistent AFib exists for longer than 12 months, either due to failure to attempt cardioversion or failure of cardioversion.
          • Permanent AFib is unresponsive to antiarrhythmic medication or electrical cardioversion and continues for the rest of the patient’s life.
          • Non-valvular occurs without rheumatic mitral valve disease, mitral valve repair, or prosthetic heart valves.

           

          AFib can be viewed on an electrocardiogram (ECG), which will show an “irregularly irregular” pattern with no discernable P-waves and irregular RR spacing during rest (see SIDEBAR).1 Failure to detect paroxysmal AFib on an ECG doesn’t preclude having the arrhythmia because normal sinus rhythm can intersperse between the arrhythmic episodes. In that case, a patient may wear a Holter monitor (a small portable ECG machine) continuously for a few days or a patch monitor with 30-day readouts to detect the arrhythmia.10,15

           

          SIDEBAR: ECG Interpretation 10116,17

          An ECG is a visual representation of the heart's electrical activity. For a 12 lead ECG, six electrodes are placed on the chest and four on the limbs before connecting them to an ECG machine, which produces a readout. A normal ECG consists of a small P-wave, a large and narrow QRS complex, and a T-wave. The P-wave is a small, positive, smooth wave that reflects atrial depolarization, which precedes contraction of the atria. The QRS complex represents depolarization of the ventricles which precedes ventricular contraction. The T-wave follows the QRS complex and reflects rapid repolarization.17 Abnormal results from an ECG are a sign of potential heart problems like arrhythmias, ischemia or infarction, or even ventricular hypertrophy.

           

          TREATMENT OF AFIB

          The goals for treating AFib include reducing symptoms, preventing clots, and reducing the risk of heart failure and other cardiac complications.10 According to the 2023 American Heart Association/American College of Cardiology/American College of Chest Physicians/Heart Rhythm Society (multi-society) guidelines, patient-specific factors direct the choice of antiarrhythmic agent.2 Among those factors is heart failure, cardiovascular disease, or other health conditions. Treatment also varies based on where providers discovered the AFib: in the inpatient or outpatient setting.2

           

          PHARMACOLOGIC AGENTS

          The multi-society guidelines divide the agents for treating AFib into rate control and rhythm control medications.2 Rate control agents control the ventricular rate when patients are in AFib for better symptom management.18 Rhythm control medications restore and maintain normal sinus rhythm.10

           

          PAUSE AND PONDER: What medications treat AFib symptoms most effectively?

           

          Providers may choose from a wide range of medications, with the treatment choice often determined by the patient’s clinical picture and the setting in which the AFib occurs.

           

          RATE CONTROL MEDICATIONS

          Rate control medications slow the impulses through the AV node, reducing the rate of contraction of the ventricles.18 While the number of ventricular contractions per minute decrease (allowing for better ventricular filling with blood during diastole), the RR spacing remains irregular. This irregularity coupled with the loss of atrial contraction in AFib reduces the cardiac output versus normal sinus rhythm. The goal is better symptom control with limited adverse effects. (See Table 1.)10

           

          Table 1. Rate Control Medications in AFib

          Class Drugs Notes
          Beta-blockers Atenolol

          Bisoprolol

          Carvedilol

          Metoprolol

          Nadolol

          Pindolol

          Propranolol

           

           

           

           

           

          l

          Metoprolol succinate (the XL form) and tartrate (the immediate release form), as well as bisoprolol are beta-1 selective; metoprolol succinate, bisoprolol, and carvedilol are preferred choices for patients with heart failure.
          Nondihydropyridine calcium channel blockers DilTIAZem

          Verapamil

          Dihydropyridine CCBs do not block the AV node.
          Cardiac glycosides Digoxin Not as effective as beta-blockers or non-DHP CCBs during exercise or stress and has a narrow therapeutic index; may use in combination with other rate control agents.
          Class III antiarrhythmic Amiodarone Has antiadrenergic effects similar to beta-blockers and non-DHP CCBs; many drug interactions and adverse effects; good choice in patients with heart failure.
          ABBREVIATIONS: CCBs = calcium channel blockers; DHP = dihydropyridine

           

          Beta-Blockers

          Beta-blockers inhibit the activity of the beta-1 adrenoceptor at the AV node, slowing conduction (negative dromotropic effect).18 Providers may choose from various options, including atenolol, bisoprolol, carvedilol, metoprolol (succinate and tartrate), and propranolol. Atenolol, bisoprolol, and metoprolol are the cardioselective beta-blockers, which means they less potently block the beta-2 adrenoceptors in the lungs.19 While all beta-blockers can cause drops in the Forced Expiratory Volume in 1-second (FEV-1) in asthmatic patients, the cardioselective agents do so to a lesser extent. Their effects are readily reversed with standard dosing of inhaled beta-2 agonists. All beta-blockers control the ventricular rate, and the multi-society guidelines consider them first-line therapy.2

           

          Non-Dihydropyridine Calcium Channel Blockers

          The multi-society guidelines also list non-dihydropyridine calcium channel blockers dilTIAZem and verapamil as first-line for treating AFib.2 They block the L-type calcium channel to produce their negative dromotropic effects and like the beta-blockers have negative chronotropic and inotropic effects, meaning they slow the SA nodal firing rate and decrease the force of muscle contraction, respectively.18 They provide reasonable rate control and improve AFib-related symptoms compared to beta-blockers.2 The multi-society guidelines note that dilTIAZem and verapamil are contraindicated in patients with pre-existing heart failure.18 However, if the signs and symptoms of heart failure are solely due to the AFib and no other underlying diseases, verapamil and dilTIAZem can be used.

           

          The Institute for Safe Medication Practices lists the generic name dilTIAZem on the look-alike sound-alike list due to the potential for confusion with diazePAM.20 The organization recommends the use of TALLman lettering to distinguish the two drugs.20

           

          Digoxin

          Digoxin provides a negative dromotropic and chronotropic effects but does not provide a negative inotropic effect. The inotropic effect can be neutral at serum concentration below 1.2 nanograms/mL but can be positive at higher concentrations.18 Since digoxin slows AV nodal conduction through enhancing the parasympathetic nervous system, it does not work as well in times of higher sympathetic outflow like exercise or stress. The multi-society guidelines indicate providers may use digoxin with other rate control medications because it will not augment the negative inotropic effects of beta-blockers or non-dihydropyridine calcium channel blockers.2 The guidelines also recommend digoxin in patients who do not tolerate or have an inadequate response from other rate control agents.2,18 It is a narrow therapeutic index medication, with the recommended serum digoxin level for AFib being <1.2 nanograms/mL.2 Providers should use digoxin cautiously with verapamil, since verapamil is a P-glycoprotein inhibitor and the combination may therefore increase digoxin levels (see SIDEBAR).18 However, digoxin may be a good initial choice for acute rate control in heart failure patients with AFib since the negative dromotropic effects of beta-blockers and nondihydropyridine calcium channel blockers could induce decompensated heart failure.2 If patients start with low dose beta-blockers and digoxin in heart failure patients, as the beta-blocker dose is increased to therapeutic levels (doubled every two weeks until therapeutic doses are achieved) the digoxin level can be reduced.  

           

          SIDEBAR: DIGOXIN IN AFIB: FRIEND OR FOE?

          Digoxin is the oldest medication used today in AFib, with records of its use as early as 1250 AD.21 Dr. William Withering first described its good and bad effects in 1785.22 Providers still prescribe it today; however, its use has decreased in the 21st century.23 In AFib, the multi-society guidelines recommend it as a rate control agent.2 The guidelines suggest using it with either beta-blockers or non-dihydropyridine calcium channel blockers or as a standalone medication if the other rate control options are not tolerated.2

           

          Digoxin has a wide variety of adverse effects triggered by toxicity. These include arrhythmias, GI symptoms like anorexia, fatigue, and nausea, and central nervous system issues like mental status changes and visual disturbances.24 Elevated drug levels cause the most toxic effects, often triggered by drug interactions. Other antiarrhythmics like amiodarone, dronedarone, flecainide, non-dihydropyridine calcium channel blockers, propafenone, and quinidine may block P-glycoprotein and increase digoxin blood levels as a result.25,26 Antibiotics like macrolides and tetracyclines may have similar effects.25

           

          According to reports, toxicity occurs in about 13 to 25 percent of digoxin patients.25 It happens more often with blood levels greater than 2.0 nanograms/milliliter.25 While providers may stop digoxin and provide supportive therapy in milder cases, severe cases require digoxin-specific antibody fragments (digoxin-fab).22 Derived from sheep, digoxin-fab is an intravenous medication that works in 30 to 45 minutes to reverse digoxin toxicity.27 According to reports, providers use it in about 20% of cases of digoxin toxicity.28

           

          Other Rate Control Options

          The multi-society guidelines recommend amiodarone, dronedarone, and sotalol for rate control, but only in extreme circumstances. Providers sometimes order amiodarone as a last resort in a hospital setting. Still, it should be used sparingly due to its many drug interactions and adverse effect profile.2 Dronedarone has a chemical structure similar to amiodarone, except that it does not contain iodine, making it safer.10 However, the guidelines do not recommend its use in patients with heart failure or permanent AFib due to the risk of death.2,18 Sotalol is both a beta-blocker and a potassium-channel blocker that also exerts rhythm control properties.18 While it is a negative dromotropic agent, it can also prolong the QTc interval on the ECG, which may lead to a life-threatening arrhythmia called Torsade de Pointes.18

           

          In Torsade de Pointes, the ventricles beat in a fast, irregular manner.29 Torsade de Pointes means “twisting of the points” in French. It refers to a characteristic twisting pattern of QRS complexes around the ECG baseline.29 QRS complexes are specific waves or deflections on the ECG, representing electrical activation of the ventricles.14 Symptoms of Torsade de Pointes may include dizziness, fainting, or palpitations, or it may not present with symptoms.29 The syndrome can be short-lived and self-limiting or life-threatening.29

           

          RHYTHM CONTROL MEDICATIONS

          The Vaughan Williams classification system divides commonly prescribed rhythm control agents into two classes.10 Miles Vaughan Williams, a British pharmacologist and fellow at Hertford College in Oxford, created the classification system in 1970.30 Medications in Class Ic block sodium channels in the heart.10 Class III medications alter potassium channels.10 (see Table 2.)

           

          Table 2. Rhythm Control Medications in AFib

          Agent Vaughan Williams

          Class

          Dose Notes
          Flecainide 1c 50-150 mg po q12h Not indicated in patients with structural heart disease* (may cause arrhythmias); pill-in-pocket dose: 300 mg
          Propafenone 1c 150-300 mg po q8h or 225-425 mg SR po q12h Weak calcium channel blocking and beta-blocking properties; not for use in patients with structural heart disease;* pill-in-pocket dose: 600 mg
          Amiodarone III 400-800 mg po daily for 3-4 weeks, then 100-400 mg daily Also has rate control action; toxicity and drug interactions a concern; IV dosing: 5-7 mg/kg up to 1500 mg every 24 hours
          Sotalol III 80-240 mg po q12h Also has beta-blocking action useful for rate control; requires dosing based on kidney function; potential for life-threatening arrhythmias
          Dofetilide III 125-500 mg po BID Strict dosing based on renal function, body size and age; started with patient in hospital on telemetry for 3 days
          Dronedarone III 400 mg po BID Contraindicated in patients with permanent AFib or decompensated heart failure
          ABBREVIATIONS: AFib = atrial fibrillation; BID = twice daily; IV = intravenous; SR = sustained release

          *Denotes heart failure, post-myocardial infarction, or left ventricular hypertrophy.

           

          Flecainide

          Flecainide, a Class 1c agent, is effective in treating paroxysmal AFib in patients without heart disease.10 However, it can trigger other arrhythmias; the multi-society guidelines recommend ECG monitoring at initiation and dose changes.2 Providers should avoid flecainide in patients with structural heart disease or enlarged left ventricles.10 Given twice daily for chronic use, it also may serve as a “pill-in-pocket” option at a larger, loading dose to convert an AFib episode to normal sinus rhythm.10

           

          Providers sometimes give patients “pill-in-pocket” prescriptions, which may be taken at the time of an acute AFib episode to return the heart rate to normal sinus rhythm.2 Typically, the approach is first tested under the supervision of a provider before the prescription is written for the patient. Providers instruct the patient to carry the dose with them and take it if and when symptoms occur.2

           

          Propafenone

          Providers use propafenone, another Class 1c agent, in paroxysmal and sustained AFib.10 It blocks sodium channels and has weak calcium channel-blocking and beta-blocking properties.10 Like flecainide, it can cause arrhythmias, and the multi-society guidelines recommend ECG monitoring at initiation, dosing changes, and periodically during treatment.2 Providers prescribe propafenone every 8 to 12 hours as a chronic medication. They may prescribe larger doses in a “pill-in-pocket” approach to convert recent-onset AFib to normal sinus rhythm.10

           

          Dofetilide

          Dofetilide is a Class III agent that blocks IKr, a key potassium channel in the heart.10 It limits the maximum frequency of electrical impulses without slowing conduction through the AV node.10 It can cause dangerous arrhythmias, including Torsade de Pointes.2 As a result, the multi-society guidelines recommend providers place patients under observation with ECG monitoring for three days when starting this medication.2 The initial period requires a hospitalization that lasts at least 12 hours after the patient converts to normal sinus rhythm.2 The guidelines indicate providers should monitor potassium and magnesium blood levels due to the risk of arrhythmia.2 Providers must dose dofetilide based on kidney function.10

           

          Sotalol

          Sotalol, another Class III antiarrhythmic, is a beta-1 and beta-2 blocker.10 It prolongs the length of electrical impulses to control heart rhythm.10 Like dofetilide, it can cause dangerous arrhythmias, including Torsade de Pointes.2 The multi-society guidelines recommend three days of inpatient ECG monitoring for patients who start sotalol. The guidelines also suggest regular monitoring of potassium and magnesium levels.2 Providers must dose sotalol based on renal function.10

           

          Amiodarone

          While amiodarone is more effective at preventing recurrent AFib episodes than sotalol, dotetilide, and dronedarone, the multi-society guidelines recommend these other options preferably for most patients, although it is a first line option (along with dofetilide) in heart failure.2 Amiodarone is a Class III drug that blocks both IKr and IKs potassium channels and exhibits rate control properties.10 It blocks sodium and calcium channels and displays antiadrenergic properties as well.10 The multi-society guidelines note that amiodarone has a long list of adverse effects and drug interactions, making it a poor choice for chronic therapy.2 The adverse effects include thyroid disorders (see SIDEBAR), lung toxicity, liver toxicity, photosensitivity, blue-green skin discoloration, corneal microdeposits, peripheral neuropathy, and the potential for Torsade de Pointes.16 However, the balance of IKr and IKs potassium channel blockade means it is less likely to cause Torsade de Pointes than Class III antiarrhythmics like dofetilide and sotalol.2 Amiodarone (like dronedarone) blocks many CYP P450 isoenzymes and P-glycoprotein. Notable drug interactions include atorvastatin, calcium-channel blockers, beta-blockers, digoxin, fluoroquinolone and macrolide antibiotics, phenytoin, simvastatin, and warfarin.35

           

          SIDEBAR: THE TROUBLESOME ‘I’ IN AMIODARONE

          The antiarrhythmic amiodarone comprises 37% iodine (element ‘I’ on the periodic chart) by weight.31 The iodine content and the molecule's shape can cause problems for patients prone to thyroid disorders.31 Depending on the patient’s susceptibility, amiodarone may cause low thyroid, called hypothyroidism, or a high thyroid condition, called thyrotoxicosis.31

           

          Each 200 mg of amiodarone contains 75 mg of iodine, with 7 mg of free iodine released when enzymes process the medicine.31 The free iodine is much more than the recommended daily requirement of 0.15-0.3 mg, which leads to iodine overload.31

           

          Iodine is critical in creating and processing thyroid hormones T3 and T4. Excess iodine in patients may lead to an overproduction of thyroid hormone, especially in the short to moderate term. Thyrotoxicosis may also occur due to direct damage to the thyroid, which is called thyroiditis.33 The consequences of thyrotoxicosis may be severe, including arrhythmias.33 Treatment of thyrotoxicosis depends on its subtype but may include methimazole, prednisone, or propylthiouracil.31,34

           

          With longer term use of amiodarone, the thyroid produces similar or slightly higher levels of T4 hormone but this T4 is shunted to reverse T3 (rT3) which is biologically inactive, instead of to T3 which is more potent than T4. It is this reduction in T3 that drives signs and symptoms of hypothyroidism in susceptible patients.31 The treatment of hypothyroidism is the use of levothyroxine, following guidelines for its use in low thyroid conditions.33 In cases in which providers stop amiodarone, thyroid function may return to normal.31

           

          Dronedarone

          Like amiodarone, dronedarone is a Class III antiarrhythmic that blocks sodium and calcium channels and features beta-blocking properties.10 It resembles amiodarone in chemical structure but lacks iodine. The absence of iodine makes it safer, removing or reducing thyroid, lung, and liver effects.10 Dronedarone has shown modest benefits for patients with non-permanent AFib.10 It is contraindicated in permanent AFib or New York Heart Association Class III to IV heart failure.2,10,18

           

          CONSIDERATIONS IN CHOICE OF RATE OR RHYTHM CONTROL

          Prescribers sometimes face difficult choices between rate control or rhythm control. Many factors affect the decision, including the patient’s clinical picture. How old is the patient? How severe are the symptoms? Does the patient have heart disease?

           

          PAUSE AND PONDER: In what situations would prescribers use rate and rhythm control?

           

          The goals of rate control include treating symptoms, preserving heart function, and improving quality of life.18 Providers prefer this strategy in older patients (age greater than 80 years) with no or mild symptoms.18 Rate control also may be the only option if rhythm control fails or the risks of it outweigh the benefits.18 Finally, rate control is more cost-effective due to the medications' wide availability and low cost.36

           

          However, the correct degree of rate control has been debated. Previous sources have recommended a goal ventricular rate of less than 80 bpm at rest in symptomatic patients, but newer recommendations suggest a more lenient approach of less than 110 bpm.2 A recent study showed no difference in outcomes with the more lenient strategy, which the multi-society guidelines currently favor.2,37 As a general rule, all AFib patients should have a ventricular rate less than 110 bpm; those who can tolerate lower heart rates should get the opportunity to see if this reduces their hemodynamic symptoms during AFib. Once a patient’s ventricular rate is below 80 bpm though, further heart rate reductions are unlikely to provide additional value and they should consider a rhythm control strategy.

           

          Rhythm control is preferred in most cases, even though it hasn’t shown an advantage over rate control in risk of death.1,10 It prevents stroke and improves quality of life but might increase the risk of hospitalization, especially due to ventricular arrhythmias such as Torsade de Pointes.38,39 Rhythm control is also the best option in patients with a recent diagnosis and in the case of AFib combined with heart failure.2 It reduces symptoms and slows disease progress from paroxysmal AFib to more sustained forms of the arrhythmia.2 Remember that rhythm control medication is overlaid upon rate control medication, one does not replace the other.

           

          ANTICOAGULANTS

          To reduce the risk of stroke in patients with AFib, the multi-society guidelines recommend the use of anticoagulation in select cases.2 Determining the need for anticoagulation involves a risk assessment using a scoring system – the CHA2D2-Vasc (see Table 3).2 In men, a score of 0 indicates low risk, 1 low-moderate risk, and 2 or more is moderate-high risk.1 In women, a score of 0 or 1 is low risk, a score of 2 is low-moderate risk, and a score of 3 or more is moderate-high risk.2 Providers should start anticoagulation in patients with moderate-high risk and consider it in patients with low-moderate risk.1 When uncertain about whether the benefits of anticoagulation are greater than the risk of bleeding, providers may use the HAS-BLED scoring system; however, the multi-society guidelines indicate it should not replace clinical judgment.2 HAS-BLED considers age, renal and kidney function, stroke history, and other factors to determine the risk of bleeding events with anticoagulation.40

           

          Table 3. CHA2DS2-VASc Scoring Considerations

          Condition Score
          Congestive Heart Failure 1
          Hypertension 1
          Age > 75 2
          Diabetes 1
          Stroke/TIA 2
          Vascular Disease 1
          Age 65-74 1
          Sex category (female sex) 1

           

          Providers prescribe direct oral anticoagulants (DOACs) and warfarin for anticoagulation (see Table 4).1,2 In patients with AFib and no signs of stroke, providers should start anticoagulation immediately.2 The standard for patients with a transient ischemic attack or stroke is the “1-3-6-12” rule. Providers should start anticoagulation in 1 day after a transient ischemic attack and 3, 6, and 12 days after mild, moderate, or severe strokes, respectively.41 This is because there is an increased risk of cerebral bleeding after a stroke for a short period of time and anticoagulation would exacerbate it.

           

          Table 4. Anticoagulants

          Class Agents Dosing Notes
          Vitamin K antagonists Warfarin Dependent on INR Frequent monitoring and dosing changes; drug and food interactions; required anticoagulant if patient has mitral stenosis or mechanical valves
          Direct oral anticoagulants (DOACs) Apixaban 5 mg po BID Renal dosing: 2.5 mg po BID in patients with > 2 of the following: age > 80 yr, body weight < 60 kg, creatinine level > 1.5 mg/dl
          Dabigatran 150 mg po BID Renal dosing: 75 mg po BID in patients with CrCl of 15-30 mL/min
          Edoxaban 60 mg po daily Renal dosing: 30 mg po daily in patients with CrCl of 15-50 mL/min
          Rivaroxaban 20 mg po daily Take with food; renal dosing: 15 mg po daily in patients with CrCl of 15-50 mL/min
          ABBREVIATIONS: BID = twice daily; CrCl = creatinine clearance; DOACs = direct oral anticoagulants; INR = international normalized ratio

           

          DOACs

          In most cases, providers prescribe DOACs, including apixaban, dabigatran, edoxaban, and rivaroxaban.2 Studies show that each is equal to, if not superior to, warfarin in preventing stroke and has less bleeding.2 DOACs have fewer drug and food adverse effects, cost more than warfarin, but do not have INR laboratory costs. Dabigatran binds to thrombin (Factor IIa) in the coagulation cascade, and prevents it from activating coagulation factors.42 Apixaban, edoxaban, and rivaroxaban are Factor Xa inhibitors and prevent the cleavage of prothrombin to thrombin.43-45

           

          Warfarin

          Warfarin is a Vitamin K antagonist.2 Researchers believe it competitively inhibits the vitamin K epoxide reductase complex 1 (VKORC1), which is important for activating Vitamin K in the body.46 Without active Vitamin K, Factors VII, IX, X, and II cannot be activated. Warfarin has long been a standard of anticoagulant therapy, although its many drug and food interactions and the need for regular monitoring make its use challenging for clinicians and patients alike.2 However, providers still use warfarin for the treatment of AFib in patients with mechanical heart valves or mitral stenosis.2 The goal international normalized ratio (INR) for AFib is 2.0 to 3.0 in most cases, except in the presence of certain mechanical heart valves where the INR is 2.5 to 3.5.10

           

          CONSIDERATIONS IN THE SELECTION OF ANTICOAGULANTS

          The choice of anticoagulant depends on several factors. Despite their high costs, the multi-society guidelines consider DOACs first-line therapy due to their advantages over warfarin.2 Compared to warfarin, DOACs have lower bleeding risks, fewer drug and food interactions, no dietary restrictions, and require less therapeutic monitoring.2 Providers must adjust DOACs based on renal function.2 However, warfarin is the only anticoagulant indicated for patients with mitral stenosis or mechanical heart valves.2 Multi-society guidelines do not recommend antiplatelet drugs such as aspirin or P2Y12 inhibitors as a substitute for anticoagulants in treating AFib.2

          In patients with both AFib and coronary artery disease, the use of an oral anticoagulant can be used alone to treat both. If the patient requires dual antiplatelet therapy (DAPT), after an acute coronary syndrome or the use of a drug eluting stent, but also has AFib, there is a new recommendation. Instead of 6-12 months of DAPT plus an anticoagulant, they recommend a single month of triple therapy, and then 5 months of the P2Y12 inhibitor + oral anticoagulant followed by the oral anticoagulant alone.

           

          PAUSE AND PONDER: What are the recommendations for reversing anticoagulation with warfarin and DOACs?

           

          Providers must also consider reversal of anticoagulation in the case of bleeding. Removal of the offending drug works in some cases, but providers have options in life-threatening instances. They may reverse warfarin by administering Vitamin K and 4-factor proprotein complex concentrate (PCC) in an acute setting.2 Reversal of DOACs occurs in only 2% to 4% of cases.2 Providers reverse dabigatran using idarucizumab.2 Andexanet-α reverses apixaban, edoxaban, and rivaroxaban.2 Providers administer PCC, idarucizumab, and andexanet-α intravenously.

           

          NONPHARMACOLOGIC INTERVENTIONS

          Electrical Cardioversion

          Providers may attempt electrical cardioversion in emergencies or when medications fail to treat AFib adequately.2 The procedure is completed in an outpatient facility. Providers place electrode pads on the patient’s chest and back and connect them to a cardioversion machine.47 The patient receives anesthesia, and providers administer a high-voltage shock. The shock resets the heart to its normal sinus rhythm. Providers monitor patients for several hours and then patients may go home if they experience no complications.47

          The multi-society guidelines recommend anticoagulation therapy three weeks before and four weeks after electrical cardioversion if AFib has been present for more than 48 hours (or an unknown period).2 The anticoagulant reduces the risk that a clot may be formed during or after the procedure that can be dislodged and cause medical problems.48 Even after the AFib is shocked to normal sinus rhythm, it takes a few weeks for the atria to fully start contracting normally again.

           

          Catheter Ablation

          Catheter ablation involves the insertion of small tubes directed through the veins to the heart. The ends of the tubes contain electrodes that damage the diseased heart tissue that is causing abnormal electrical pulses.49 Heat (radiofrequency ablation) or cold (cryoablation) from the electrodes destroy the tissue.50 As a result, ectopic foci or re-entry circuits are eliminated, and normal electrical conduction resumes. Young, healthy patients are good candidates for catheter ablation and the procedure is much more effective in patients with paroxysmal AFib.10 The multi-society guidelines recommend catheter abation when antiarrhythmic therapy is ineffective, not tolerated, or non-preferred.2 Catheter ablation can be curative of AFib in 70% of cases but may take as many as three attempts to fully resolve the arrhythmia.10 Providers should continue anticoagulation during and after the procedure unless it is clear that the procedure was curative months down the line.2

           

          Watchman LAA Device and AtriClip

          In patients who require anticoagulation, but the risk of bleeding outpaces the potential benefits, there are devices that occlude the left atrial appendage (LAA, the pouch on the left atria where most of the clots form in AFib). The Watchman LAA device is placed inside the atria and then opens like an umbrella to block off the LAA. The AtriClip is a clamp that is applied to close off the LAA from the outside of the heart during open heart surgery. In this case, the clots still form in the LAA but cannot get out in the circulation. If a patient is having nonadherence to oral anticoagulation due to bleeding, this is a potential option that a pharmacist could recommend a patient discuss with their cardiologist.

           

          TREATMENT IN THE ACUTE SETTING

          Providers in an acute setting order beta-blockers or non-dihydropyridine calcium channel blockers as the first-line treatment.2 If ineffective, digoxin is the next choice. Amiodarone is also an option, but only if the previous treatments fail. Providers should not use dilTIAZem and verapamil in patients with poor left ventricular function or heart failure.2

           

          Providers may attempt electrical or pharmacologic cardioversion in the acute setting, especially in unstable patients.2 Providers use one of three intravenous medications in pharmacologic conversion. The multi-society guidelines recommend ordering ibutilide if patients do not have reduced ventricular function or risk for Torsade de Pointes.2 Ibutilide is a Class III antiarrhythmic available only in an intravenous form that quickly restores normal sinus rhythm.10 Providers may also order amiodarone; however, converting to sinus rhythm takes longer than other antiarrhythmics (8 to 12 hours).2 The multi-society guidelines suggest procainamide as another option.2 It is a Class 1a antiarrhythmic that quickly restores normal sinus rhythm; however, the multi-society guidelines discourage its long-term use due to its many adverse effects.2,10 Procainamide may cause low blood pressure, nausea, vomiting, and a Lupus-like syndrome.10 Providers should avoid using it in patients with heart failure, and it can prolong the QTc interval, potentially leading to Torsade de Pointes.10

           

          LIFESTYLE MODIFICATIONS

          The multi-society guidelines recommend lifestyle modifications for patients with factors that may influence the disease course.2 Providers should recommend weight loss in overweight and obese patients and moderate to vigorous exercise for all AFib patients. The guidelines also recommend screening for sleep apnea with appropriate treatment if it is found. Finally, providers should counsel patients to reduce or eliminate alcohol and tobacco use.2

           

          AFIB AND HEART FAILURE

          Several factors complicate the management of AFib in the presence of heart failure.2 Providers should consider the degree of left ventricular dysfunction, which determines the type of heart failure and limits the choice of antiarrhythmic.2,51

           

          The multi-society guidelines recommend rhythm control over rate control in AFib with heart failure.2 However, the multi-society guidelines recommend against certain rhythm control agents—namely, flecainide, dronedarone, and propafenone—in patients with heart failure.2 Digoxin may be an appropriate choice for rate control, as it has a role in treating both diseases while non-dihydropyridine calcium channel blockers should not be used.2 Beta-blockers can be used, and actually provide enhanced survival in heart failure patients, but need to be started with low doses and then slowly titrated up to therapeutic doses.

           

          Besides treating AFib, an evaluation of the patient should reveal whether their profile meets guideline-directed medical therapy for heart failure.2 In the case of heart failure with reduced ejection fraction, this includes one of three approved beta-blockers: bisoprolol, metoprolol, or carvedilol.51 It also includes mineralocorticoid antagonists like spironolactone, a sodium-glucose cotransporter-2 inhibitor, and either an angiotensin-converting enzyme inhibitor, angiotensin II receptor blocker, or sacubitril/valsartan.51

           

          DIGITAL HEALTH AND AFIB

          Smartphones, smartwatches, and handheld devices show promise for uncovering asymptomatic AFib.52 In approximately one-quarter of patients with asymptomatic disease, providers do not discover AFib until patients suffer a stroke.53 In recent years, smart devices have provided a solution – ECG monitors. The devices use a technology called photoplethysmography (PPG) sensor technology.52 Reflected light from the device measures changes in blood flow from the irregular heart rate.52

           

          Specific versions of the Apple Watch, the Garmin Venu, and the Samsung Galaxy all use PPG technology to look for irregular heart rhythms.52 Fitbit also has PPG capabilities in its Charge and Sense models.52 A meta-analysis showed that smartphones detect AFib with a sensitivity of 94% and a specificity of 96%.54 Sensitivity means that if a patient is having AFib, the device will detect it 94% of the time. Specificity means that in 4% of cases, when AFib is found, it is due to something other than AFib. PPG technology is equally as effective at detecting AFib as a single-lead ECG.54 Another meta-analysis confirmed that smartwatches were not inferior to medical-grade devices.55

           

          Some limitations of using smart devices in ECG monitoring include the potential for false positives, disparities in access, and the possibility patients will overload providers with consumer data. ECG monitors may incorrectly indicate positives, especially for young, healthy patients.53 AFib patients older than 65 with a low educational and socioeconomic status often do not own smart devices.56 Experts also worry about the possibility of consumer data overwhelming the overworked healthcare system.52

           

          Investigators are examining the possibility that mobile ECG monitoring can reduce stroke risk?52. A large initial trial of 75-year-old patients using a Zenicor-ECG device twice daily for two weeks revealed a small but significant reduction in endpoints, which included strokes, at five-year follow-up.57

           

          Application stores feature digital apps to help manage AFib.58 The apps allow patients to record appointments, feelings, symptoms, and questions for their doctors, among other things. App quality varies, and providers should advise patients to check ratings and reviews and provide recommendations.58

           

          PHARMACY TEAM IMPACT ON AFIB MANAGEMENT

          Nearly 90% of Americans live within five miles of a community pharmacy.59 That fact makes pharmacists one of the most accessible healthcare providers.60 Pharmacists and technicians can leverage their familiarity with their customers in several ways.

           

          For pharmacists, managing and monitoring anticoagulation is the most obvious intervention that can improve outcomes. Providers and administrators often ask pharmacists to dose INRs for warfarin patients in clinics, hospitals, and outpatient settings. Pharmacists may monitor for bleeding complications, both with warfarin and DOACs.

           

          Pharmacist medication review activities may catch meaningful drug-drug and drug-food interactions in AFib patients. Pharmacists can also monitor for the toxic effects of medications like digoxin and amiodarone and report any observations to providers. Even common agents like beta-blockers and calcium channel blockers may cause troublesome interactions in patients with complicated clinical pictures. Pharmacists may catch these problems and intervene with the prescriber.

           

          Pharmacists can collaborate with pharmacy technicians to improve patient adherence to medications. While technicians may coordinate the adherence programs, pharmacists counsel patients on the importance of following providers’ medication orders and communicate nonadherence to the prescriber.

           

          Pharmacists also may counsel patients on lifestyle modifications. If a pharmacy has a smoking cessation program, for example, the pharmacist may refer AFib patients to it. The pharmacist may also counsel on the need for weight loss or exercise and help the patient set goals.

           

          Finally, the advent of portable ECG monitors allows pharmacists to set up screening programs for asymptomatic or suspected AFib. The AliveCor KardiaMobile is a single-lead ECG that connects through a smartphone. Pharmacists may use it to collect ECGs and triage patients. A cardiologist then confirms any positive result and refers the patient for treatment.61

           

          Pharmacy technicians may also help manage AFib. Technicians often coordinate medication adherence programs, such as automated refill reminders, medication synchronization, and compliance packaging. Pharmacy technicians can then inform the pharmacist of cases of nonadherence.

           

          Technicians may also coordinate filling pill-in-pocket prescriptions for medications like flecainide or propafenone. They can also use TALLman lettering for sound-alike look-alike medications and place dosing labels on shelving for narrow therapeutic index medications like warfarin or digoxin.20

           

          Finally, technicians can inform pharmacists when AFib patients try to purchase inappropriate over-the-counter or herbal medications. Decongestants like pseudoephedrine can increase heart rate, and herbals like St. John's wort and hawthorn can interact with antiarrhythmics.62,63 Medications like non-steroidal anti-inflammatory medications, aspirin, and herbals like vitamin E supplements, ginseng, and ginkgo biloba may interfere with anticoagulation.62,631

           

          Finally, pharmacies can foster knowledge and understanding of the disease by hosting community events in coordination with local healthcare providers. For example, a pharmacy could hold an event during AFib awareness month in September. Pharmacy staff could invite representatives from local clinics and cardiologists’ offices.

           

          CONCLUSION

          AFib is the most common type of heart rhythm disorder or arrhythmia, and its incidence and prevalence continue to grow as the population ages. Goals for AFib patients include prevention of stroke, control of heart failure symptoms, and improvement in quality of life. Rate and rhythm control antiarrhythmics can treat AFib. The rate control strategies help with symptoms by controlling the ventricular rate. Rhythm control medications restore the normal sinus rhythm, but providers must carefully choose and monitor them due to their side effects and contraindications. Providers prefer rhythm control agents in many patients due to their ability to reduce the risk of stroke and improve quality of life. Anticoagulation is indicated in cases of higher stroke risk; providers should choose DOACs over warfarin in most cases, except for patients with mitral stenosis or mechanical heart valves.

           

          Beta-blockers and calcium channel blockers are the first choices in the acute setting, followed by digoxin. Providers have limited options in both rate and rhythm control in patients with heart failure. Beta-blockers, digoxin, dofetilide, sotalol, and amiodarone provide options. Pharmacists can play essential roles in managing and monitoring anticoagulation, performing drug use reviews and adherence monitoring, and screening patients for asymptomatic cases. Pharmacy technicians can aid pharmacists by coordinating adherence mechanisms, filling pill-in-pocket refills, and notifying the pharmacist of patients' improper OTC or herbal selections.

           

          Now let’s return to our patient case. Dan’s uncontrolled AFib requires a quick call to his cardiologist, who suggests he go to a local emergency room for examination. The pharmacy staff offers to put his apixaban, flecainide, and other medications on a medication synchronization program with refill reminders. They also suggest that he invest in a digital device that monitors ECG. He promises to go straight to the emergency room.

          Pharmacist Post Test (for viewing only)

          Pharmacist Post-Test
          After completing this education activity, pharmacists will be able to
          1. Explain the definition, clinical presentation, and types of atrial fibrillation
          2. Discuss pharmacologic and non-pharmacologic treatment options for atrial fibrillation
          3. Describe the role of anticoagulation in atrial fibrillation management
          4. Identify interventions that could improve outcomes in atrial fibrillation patients

          1. What symptoms do patients experience from the heart's abnormal or irregular electrical activity that is seen in atrial fibrillation?
          A. slow heart rate
          B. fast heart rate
          C. fewer clots

          2. What is the type of atrial fibrillation that recurs and persists, requiring intervention with medications or procedures?
          A. persistent
          B. paroxysmal
          C. permanent

          3. Beta-blockers and non-dihydropyridine calcium channel blockers like dilTIAZem and verapamil are first-line rate control medications for atrial fibrillation. If they fail or are contraindicated, what is the next best choice for rate control?
          A. digoxin
          B. flecainide
          C. amlodipine

          4. Which Class III antiarrhythmic blocks a key potassium channel and requires 3 days of observation with ECG monitoring when it is started?
          A. flecainide
          B. propafenone
          C. dofetilide

          5. What Class III antiarrhythmic is considered a last resort despite its rate and rhythm-control properties due to its drug interactions and adverse effects, including triggering thyroid disease?
          A. metoprolol succinate
          B. dronedarone
          C. amiodarone

          6. What does the CHA2D2-VASc scoring system measure?
          A. Risk of heart failure with atrial fibrillation
          B. Proper starting dose of warfarin
          C. Risk of stroke in atrial fibrillation

          7. You are a pharmacist dosing and monitoring warfarin in an anticoagulation clinic. Alfred Pennington arrives for his international normalized ratio (INR) test and warfarin dosing adjustment. You notice that he has atrial fibrillation, but he does not have mitral stenosis or mechanical heart valves. What is the next step?
          A. Contact his provider and suggest switching to a DOAC like apixaban
          B. Do nothing special; check his INR and change the dose if necessary
          C. Counsel Alfred on the drug and food interactions with warfarin without calling his provider

          8. Which of the following is an advantage of direct oral anticoagulants over warfarin in atrial fibrillation patients?
          A. fewer drug and food interactions
          B. lower cost
          C. more therapeutic monitoring

          9. Which medication quickly restores normal sinus rhythm during a pharmacological cardioversion in the acute setting?
          A. Digoxin
          B. Ibutilide
          C. Verapamil

          10. Judy James is in the pharmacy to pick up her prescription for Verapamil when she asks for the pharmacist. She states that she has been feeling nauseated (nauseous?) and fatigued lately and that her vision “isn’t right.” You check her profile and note that she is an atrial fibrillation patient who is also on digoxin. What do you do next?
          A. You tell her to discontinue the digoxin as it may be causing an interaction with the verapamil.
          B. Since you suspect digoxin toxicity, you call Judy’s provider and suggest that they do a digoxin level test (?)
          C. You tell Judy that these are normal side effects of her medications and that she shouldn’t worry about them

          Pharmacy Technician Post Test (for viewing only)

          Pharmacy Technician Post-Test
          After completing this education activity, pharmacy technicians will be able to
          1. Explain the definition, clinical presentation, and types of atrial fibrillation
          2. Discuss pharmacological and non-pharmacological treatment options for atrial fibrillation
          3. Describe the role of anticoagulation in atrial fibrillation management
          4. Identify programs designed to promote medication adherence in patients with atrial fibrillation
          1. What symptoms do patients experience from the heart's abnormal or irregular electrical activity that is seen in atrial fibrillation?
          A. slow heart rate
          B. fast heart rate
          C. fewer clots

          2. What is the type of atrial fibrillation that recurs and persists, requiring intervention with medications or procedures?
          A. persistent
          B. paroxysmal
          C. permanent

          3. Beta-blockers and non-dihydropyridine calcium channel blockers like dilTIAZem and verapamil are first-line rate control medications for atrial fibrillation. If they fail or are contraindicated, what is the next best choice for rate control?
          A. digoxin
          B. flecainide
          C. amlodipine

          4. Which Class III antiarrhythmic blocks a key potassium channel and requires 3 days of observation with ECG monitoring when it is started?
          A. flecainide
          B. propafenone
          C. dofetilide

          5. What Class III antiarrhythmic is considered a last resort due to its drug interactions and adverse effects, including triggering thyroid disease?
          A. metoprolol succinate
          B. dronedarone
          C. amiodarone

          6. What does the CHA2D2-VASc scoring system measure?
          A. Risk of heart failure with atrial fibrillation
          B. Proper starting dose of warfarin
          C. Risk of stroke in atrial fibrillation

          7. Wayne Peters comes to the pharmacy counter to pick up his prescription for apixaban. You know that Wayne has had problems with atrial fibrillation in the past, and the pharmacist has told you that apixaban reduces his risk of stroke. Wayne mentions that he occasionally forgets to take the second dose of apixaban. What can you suggest to help him remember?
          A. Ask his wife to remind him to take his second daily dose
          B. Suggest he enroll in the pharmacy’s compliance packaging system
          C. Tell him to set a reminder on his phone

          8. Which of the following is an advantage of direct oral anticoagulants over warfarin in atrial fibrillation patients?
          A. fewer drug and food interactions
          B. lower cost
          C. more therapeutic monitoring
          9. Which medication quickly restores normal sinus rhythm during a pharmacological cardioversion in the acute setting?
          A. Digoxin
          B. Ibutilide
          C. Verapamil

          10. You are coordinating the week’s medication synchronization patients, and you notice that John Denner’s dofetilide is not synced with his other medications. The pharmacist has told you he has both atrial fibrillation and heart failure. The pharmacist said the dofetilide controls his heart rhythm and prevents his heart failure from worsening. What is the next step?
          A. Coordinate with the pharmacist on next steps to determine if he should be taking the medication
          B. Assume he should be on the dofetilide and sync with his other medications
          C. Assume the medication has been discontinued and don’t include it in the sync

          References

          Full List of References

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