INTRODUCTION

Dolly is a pharmacist in an independent pharmacy working 9 to 5 (what a way to make a living!). Her technician, Miley, calls her to the front to talk with Carol, a 60-year-old woman who consistently wears her smartwatch. Miley tells Dolly, “You have to hear this!” Carol reports that while walking her dog, she tripped and landed face down on the pavement. Carol says her smartwatch called out, “It looks like you’ve taken a hard fall,” and asked if it should call 911. Carol didn’t need emergency services, but she was grateful that the watch detected her fall and could help if necessary. If Carol had been unresponsive, the watch would have called 911 automatically. When Carol left, Miley said, “You know Dolly, I am really concerned that artificial intelligence (AI) is going to replace me.” Dolly nodded and said, “I know. I have some concerns, too. It's enough to drive you crazy if you let it.” Dolly realizes she needs to look into AI and its possibilities.

AI is a technology that learns, reasons, and performs tasks to mimic humans.¹ A 2022 Pew Institute survey of 11,004 Americans found that while 55% use AI frequently, awareness of its presence and capabilities varies.² Only 30% of participants demonstrated high AI awareness, with factors such as education level, income, and Internet use influencing their familiarity.² Despite growing adoption, public engagement is mixed, with concerns about AI’s impact fueling debate.

Recently, many media outlets have published articles about AI, and many of those pieces have generated public debate and concern.^3-5 Public engagement in ethical debates about AI’s use and limitations is only reasonable and well advised if individuals understand its strengths and limitations. Despite the widespread adoption of AI technologies among Americans, another Pew Research Center survey reported that only 15% express more excitement than concern about its increased use in daily life, 38% express more concern than excitement, and 46% are mixed, containing both excitement and concern.⁶ Nonetheless, AI’s adoption and market value increases annually. Researchers estimated the AI market size at $40 billion in 2022 and expect it to grow to $1.3 trillion by 2032.⁷

Americans rely on AI in their everyday lives for web searches, task automation, and more—often without even realizing it. Engineers have seamlessly integrated AI into technologies like Siri, Alexa, and Google Home, making everyday tasks more convenient. With almost limitless possibilities, AI continues to evolve and grow, including in the healthcare field.

PAUSE AND PONDER: Take a moment and look at this list. Which of the following are AI powered? You can find the answers at the end of this activity (after the CONCLUSION).

• Air conditioners
• Automatic washing machines
• Basic calculators
• Customer service chatboxes
• Email services
• Facial recognition technology
• Media/playlist recommendations
• Purchase recommendations
• Refrigerators
• Social media
• Television remote controls
• Voice assistants
• Wearable fitness trackers

Defining AI

AI systems predict, recommend, and make decisions using machine-based algorithms. Programmers design these systems with a set of rules and human-defined objectives to accomplish a variety of tasks.^8,9 As Table 1 implies, no single definition fully captures AI’s complexity, and its applications are broad.¹

AI Models

AI system designs vary based on the AI model used. Common algorithms include machine learning, neural network, deep learning, natural language processing, and rule-based expert systems. Neural network and deep learning fall under the broader category of machine learning. Table 2 describes how developers tailor each model to accomplish specific tasks in unique ways.¹⁰ It also captures common AI models used in healthcare with examples for their application.

After some research, Dolly was ready to determine the model AI uses to detect falls. She found that smartwatches rely on machine learning models, including deep learning, to identify falls. Specifically, the technology uses accelerometer (an instrument that detects and measures speed and directional vibrations) and gyroscope (an instrument that detects and measures angular momentum) data from the watch to detect abrupt movements and shifts in motion that could signal a fall.¹⁶

PAUSE AND PONDER: How can healthcare professionals and leaders integrate AI models into healthcare?

AI IN DISEASE MANAGEMENT

Integrating AI into healthcare can transform patient care and streamline workflows.¹⁰ A recent survey reported that 80% to 90% of forecast panelists believe that AI will improve care, simplify patient referrals, and facilitate prior authorizations.⁸ Also, 63% of participants indicated that it is very or highly likely for health systems to adopt AI for pharmacist documentation. AI can specifically help document patient information in electronic health records (EHR).⁸ Some physicians and advanced practice providers are already using AI to improve patient documentation.⁸

Generative AI uses machine models to analyze data patterns and create content like images and text. In healthcare, it enhances patient care and supports whole-person health.⁸ This technology can assist with medical image interpretation, inform disease diagnosis, identify care gaps, personalize treatment plans, enable remote patient monitoring, and support early intervention and preventive care.^8,17 In her research, Dolly found a number of applications that could improve patient care.

Diabetes Management

By 2050, statisticians expect that 1.31 billion Americans will have diabetes.¹⁸ Diabetes management requires frequent follow-up and comprehensive examinations to monitor blood glucose levels and detect complications.¹⁹ Medical resources are unevenly distributed across the United States (U.S.). Physicians are often concentrated in wealthier and suburban areas, leaving rural regions with limited access to primary and specialty care. Yet, rural populations have a 16% higher prevalence of type 2 diabetes (T2DM) and a 20% higher T2DM-related hospital mortality rate compared to urban populations.²⁰

Effective diabetes management requires a collaborative approach involving endocrinology, nutrition, nephrology, ophthalmology, pharmacy, and podiatry. Since primary care alone is insufficient to handle this complex condition, rural areas face significant challenges in diabetes management.¹⁹ By 2034, researchers estimate a shortage of 124,000 doctors in the U.S., with the majority of loss in primary care.²¹ If this prediction is accurate, individuals in rural areas will face growing challenges accessing healthcare. Given the uneven distribution of healthcare resources across various regions, AI advancements may enhance efficiency in diabetes care while diminishing overall health expenditures.^10,19

To achieve better care for all people, clinicians may use predictive models to assess disease progression in T2DM, forecast blood glucose levels, and detect diabetic retinopathy.²²

AI technology may prevent diabetes onset in high-risk patients by ensuring early medical intervention.¹⁹ AI technologies may use non-invasive, cost-effective methods capable of early identification and classification of diabetes.

An emerging theory is that machine learning using facial texture features and tongue color analysis could predict diabetes onset and identify those at high risk. In patients with diabetes, skin manifestations are common.²³ These manifestations range from acanthosis nigricans (demarcated plaques with grey to brown pigmentation), to dermopathy (spots on the front of lower legs), to skin thickening.²³ The pathophysiology of these conditions is not entirely understood. However, aging and diabetes causes increased collagen interlinking. Consequentially, skin changes like thickening and hardening may occur.²³

In Chinese Medicine, practitioners believe face regions reflect the health of internal organs.²⁴ Asian researchers postulated that tongue discoloration, such as a yellow coating, is linked to diabetes, with studies showing a connection between tongue features and glucose metabolism.^25,26 In 2017, researchers conducted a study to determine which model analyzes facial texture and color to detect diabetes most accurately.²⁴ They took facial images, divided them into regions, characterized regions by textures, and analyzed them using eight different models.²⁴ In 2019, Chinese researchers collected tongue images from 570 patients and analyzed their color and texture using AI models. The results demonstrated that these models may effectively associate tongue images with diabetes, but these studies remain preliminary.²⁵

In 2024, 8.7 million Americans or 3.4% of all U.S. adults met laboratory criteria for diabetes but were not aware that they had this condition.²⁷ Delayed diagnosis is a common concern in diabetes, with about 45% of adults worldwide undiagnosed.¹⁸ Current diabetes diagnostic tests include hemoglobin A1C, fasting plasma glucose, 2-hour plasma glucose, and oral glucose tolerance test (OGTT). These four tests are invasive as they require venipuncture.²⁴ Non-invasive diagnostic methods, such as analyzing facial images and tongue color, could help identify diabetic patients who are unaware of their condition.

Dolly is fascinated by this information, but aware that these findings are very preliminary. Recently, one of her favorite patients, Lily, had gained weight rapidly in the early trimesters of pregnancy. Her obstetrician ordered an OGTT. Before the test, Lily fasted, then drank a sugary solution and had her blood sugar levels measured at specific intervals. This process was challenging for Lily, as the sight of blood and having her blood drawn nauseates her. Dolly wishes that non-invasive methods were currently available.

In primary care, AI technologies may create personalized diet and exercise plans for people with diabetes. These plans could align with clinician recommendations and contribute to effective diabetes management.¹⁸

Despite the promise of AI technology in diabetes management, predicting blood glucose levels remains challenging because food and subcutaneously administered insulin absorption rates vary. AI technologies are increasingly embedded into continuous glucose monitoring (CGM) systems to predict blood glucose levels. CGMs track patients’ blood glucose levels in real time and eliminate frequent finger pricks. CGMs provide regular and accurate blood glucose data, offering greater convenience than traditional finger sticks. Regardless, errors may still occur. CGM may report blood glucose levels that differ from actual values by roughly 9%. Differences in actual blood glucose level measurements may be an important consideration for individuals with diabetes and their healthcare providers. Soon, it’s likely that AI will also measure ketone levels; some systems will be integrated into CGMs.²⁹

Another obstacle is when clinicians’ recommendations differ from those generated using AI, as both may be correct. To resolve discrepancies, AI may serve as a tool to support human decision-making. Last, AI technology is designed based on the data it receives. Data quality is important for accurately predicting and managing diabetes.^19,22

Cardiac Care

Like diabetes, heart failure (HF)—the inability of an individual’s heart muscle to pump enough blood—is becoming more prevalent. Common symptoms include shortness of breath, fatigue, and swelling of the legs, ankles, or abdomen.³⁰ Worldwide, approximately 60 million individuals live with HF.³¹ Managing HF requires accurate diagnoses and treatments tailored to individual patients. AI technologies may help diagnose, predict outcomes, classify, and optimize treatment strategies in HF.³²

Researchers have published much information on HF, and information on the use of machine learning to analyze this data is increasing. AI algorithms address challenges like data noise (large amounts of unwanted data that make analysis difficult), false correlations (no relationship between two variables), and statistical power issues (a study’s inability to detect accurate results or effects). By streamlining data analysis, AI complements traditional statistical methods to gather insights into HF.³²

Researchers have created an AI-based diagnostic algorithm for HF. The study enrolled 600 patients with and without HF. The results demonstrated a diagnostic accuracy of 98% and surpassed non-specialist clinicians, who had an accuracy of 76%. In regions with limited access to HF specialists, these AI technologies could be beneficial.^32,33

Patients with HF also face high 30-day readmission rates. Decreasing HF hospital admissions and readmissions is important considering the financial penalties that the Centers for Medicare and Medicaid Services (CMS) impose. CMS reduces hospital payments by a percentage following unplanned 30-day readmissions for patients with HF.³⁴ The hospitalization rate has improved from about 367 hospitalizations per 100,000 adults in 2016 to 350 hospitalizations in 2020. However, Healthy People 2030’s target is 330 per 100,000, meaning more improvement is needed.³⁵

Deep learning AI models may help lower hospital readmissions for patients with HF. In a 900-patient cohort study, these technologies outperformed traditional techniques in predicting readmission rates. This AI algorithm used heart sounds, respiratory rate, tidal volume (the amount of air that moves in and out of the lungs during a normal breath), heart rate, and patient activity to make predictions.³²

The rising use of remote monitoring and wearable devices is likely to expand AI’s effectiveness in managing HF. AI-powered smartwatches programmed with electrocardiography features demonstrate acceptable accuracy in detecting HF with reduced ejection fraction. These technologies allow continuous data streams, better prediction in hospital readmission rates, and earlier HF identification.^31,32

Dolly finds that smartwatches can also be useful for patients who have or are at risk for atrial fibrillation (AFib). Carol, the patient whose smartwatch detected a fall, has been worried that she might develop AFib, which causes irregular heartbeats. Last week, the watch detected an episode of AFib. When Carol visited her provider, she brought the printed electrocardiogram showing the episode. This enabled the provider to make informed decisions about next steps, supported by AI technologies.

Sepsis Identification

Globally, sepsis—a life-threatening response to an infection—is a leading cause of illness and death.³⁶ Patients with sepsis present with varying degrees of severity, ranging from mild sepsis to septic shock. It can lead to tissue damage, organ failure, and death. Sepsis’s variable presentation makes early detection challenging. However, prompt recognition of sepsis is critical, as every hour without treatment increases the risk of death.³⁶

AI technologies may predict sepsis hours before its onset. Through machine learning and predictive algorithms, AI improves the accuracy of sepsis detection in a clinical setting.^36-38 Researchers conducted a prospective, multi-center study of 590,736 patients across five hospitals, with 6,877 included in the analysis.³⁸ During the study, researchers used the Targeted Real-time Early Warning System (TREWS) as a sepsis alert system for providers.³⁸ TREWS is a machine learning-based algorithm that notifies providers when a patient is at high risk for sepsis.

TREWS integration enabled early intervention from providers and reduced the hospital mortality rate by 5.1% when providers responded to the alert within three hours.³⁸ The TREWS intervention group also saw a 4.5% decrease in overall mortality compared to patients whose providers did not respond within three hours. Patients flagged as high risk also experienced reductions in organ failure severity.³⁸ A critical point is provider response time. It is possible that providers who responded more quickly simply had better resources or teams at their disposal.³⁹

This study’s major limitation was the predetermined alert settings, which may have influenced the alerts and their associations with clinical outcomes.³⁸ TREWS notified providers when patients exhibited significant findings related to sepsis. This constraint limits the study’s generalizability, as variations in alert settings may lead to significant differences in the timing of alerts and, potentially, patient outcomes. Future implementation may adopt a less restrictive model, allowing earlier warnings by identifying patients with fewer sepsis-related criteria.³⁸

Alert fatigue—healthcare provider desensitization to safety alerts—may also limit this study’s applicability to clinical practice.³⁸ Alert fatigue often causes individuals to not respond properly to safety alerts and warnings.⁴⁰ TREWS integration may contribute to the alert fatigue phenomenon that plagues the healthcare industry.

Despite this study’s promising results, few large, randomized controlled trials (RCTs) have evaluated AI-based alerts for patients with sepsis.³⁷

Acute Kidney Injury Alert

Acute kidney injury (AKI; a decline in the kidney filtrate rate) impacts approximately 18% of inpatients and greater than 50% of patients in intensive care units.⁴¹ Like managing HF and diabetes, early detection is critical.^41,42 Two studies have examined AI in AKI.

Chinese researchers led a double-blind RCT to evaluate the impact of electronic alerts on adults with AKI.⁴¹ They randomized more than 2,000 hospitalized patients to determine whether an AKI alert combined with management strategies improves care and clinical outcomes. The data showed that alerts did not improve kidney function or overall patient outcomes. However, the alerts influenced treatment approaches. Patients in the alerts group received more intravenous fluids (82.6% vs 61.8%), fewer nonsteroidal anti-inflammatory drugs (5% vs 11%), and more AKI documentation at discharge (49.9% vs 27.3%).⁴¹

Another double-blinded, multicenter RCT enrolled more than 6,000 patients. Researchers concluded that the AKI alerts did not reduce the risk of AKI progression, dialysis initiation, or death within 14 days of randomization.⁴²

Both studies found that integrating their specific AKI alert algorithms into EHR did not improve patient outcomes.^41-43 However, pairing these alerts with management strategies influenced providers’ treatment decisions. These findings suggest that while changes in treatment strategies may not directly benefit patients, they may help avoid medications that can contribute to AKI.^41,42

Image Interpretation

Beyond its use in facial recognition for social media and security, AI also has the proven potential to analyze medical images. Specifically, AI technologies show promise in oncology for identifying and categorizing cancers, and in managing diabetic retinopathy.

Oncology

Researchers are developing AI models for cancer imaging, aiming to improve tumor detection, characterization, and monitoring.^10,44 These tools identify various cancers and predict patient outcomes very accurately.⁴⁵ They can help minimize oversights and serve as an initial screen to reduce omission errors.

AI tumor characterization involves tumor segmentation (outlining and identifying boundaries of the tumor in images), diagnosis, and staging. AI-driven automated segmentation has the potential to enhance the efficiency, reproducibility, and quality of tumor measurements.⁴⁴ It may also improve the ability to monitor changes in tumors over time. Despite these promising advancements, challenges remain in ensuring accurate detection, characterization, and monitoring.⁴⁴

Diabetic Retinopathy

AI models can detect diabetic retinopathy, a complication of diabetes that progressively impairs vision over time. AI identification of diabetic retinopathy is facilitated through retinal fundus imaging, which has demonstrated high sensitivity and selectivity, as defined in the SIDEBAR.^22,46,47

In 2017, researchers enrolled 521 participants across 10 U.S. centers. Each patient underwent a dilated ophthalmoscopy (an eye exam). The AI algorithm accurately identified 36 of 37 positive cases (97% sensitivity) and 162 of 184 negative cases (88% specificity).⁴⁶ The researchers concluded that the AI system detects mild diabetic retinopathy more effectively than general ophthalmologists or retina specialists. This tool may offer a low-cost solution for diabetic retinopathy screening and help reduce the burden of diabetic eye screenings.⁴⁶

Electronic Health Records

Approximately 80% of clinically relevant healthcare information is unstructured data.⁴⁸ Applying a natural language processing (NLP)-based algorithm to the EHR may help hospitals identify patients who need a clinical pharmacist’s review. NLP models possess the ability to engage in speech recognition, text analysis, and translation, with goals centered around language processing. One example of its use is transcribing patient interactions, which may be helpful for medication reconciliation. Similarly, NLP-based systems can prepare reports, such as patient notes within the EHR, and analyze these notes.¹⁰ By analyzing notes, the system can also identify patients requiring extensive medication interventions and categorize them as high risk. This classification enables pharmacists to dedicate their efforts to patients most likely to benefit, ultimately enhancing their impact on patient care.⁴⁸

AI models may also detect and alert providers when an ordered medication deviates from its typical use pattern. AI captures information on standard dosages and indications, aiding drug selection, dose recommendations, drug-drug interaction detection, and order entry.⁴⁹ This tool supports pharmacists and other healthcare providers in clinical decision-making to minimize medication-related errors and improve patient outcomes.⁴⁹

Generative AI models may streamline providers’ documentation processes. Clinicians spend approximately 35% of their time documenting patient data and notes.⁵⁰ AI technologies may reduce this workload, allowing providers to focus more on patient care. However, before integrating AI into documentation, leaders must set clear guidelines. For effective use, these guidelines must address concerns such as data security, accuracy, reliability, ethical considerations, and the need for ongoing evaluation of AI programs to ensure regular maintenance and optimization.⁵¹

The possibilities for AI integration in EHR are endless. With proper use, these resources help streamline workflow and increase time providers spend on direct patient care.

PAUSE AND PONDER: What are the opportunities and challenges for AI integration into healthcare?

AI CHALLENGES

A major challenge is AI’s inability to explain how it arrives at its conclusions, referred to as model transparency. Predictive modeling and deep learning procedures are difficult to adopt in clinical environments. The algorithms behind these models often lack transparency and experimental context.^8,22

For clinicians to accept AI, they must understand how models generate recommendations. By detailing internal decisions, behaviors, and actions, AI’s developers can build trust among healthcare providers. Developers must equip clinicians with sufficient information to understand each event’s causes. Subsequently, providers can determine how to incorporate AI recommendations into their clinical decision-making processes.^8,22

Another barrier arises from EHRs’ limitations. Since EHR data is not publicly available, AI technologies may struggle to generate comprehensive recommendations. Also, healthcare organizations often restrict data access to internal use, leaving predictive modeling without sufficient information.²² To address this challenge, some experts propose federated learning. This allows institutions to contribute to a global model while keeping sensitive data within their respective systems.¹⁰ However, as AI processes large volumes of data, the risk of data breaches and unauthorized access increases. Protecting databases from security threats remains a challenge.⁸

Bias presents another obstacle. If data used in AI models is homogenous, the results may be skewed. Developers must ensure that training datasets include a wide range of patient demographics and conditions to prevent biased outcomes.⁸

Cost inhibits widespread adoption of AI. Institutions allocate resources for AI differently. Smaller, rural hospitals may struggle to implement these technologies due to financial constraints.⁸ Also, demonstrating a clear return on investment for AI integration is difficult. The limited cost avoidance data per intervention and impact on patient outcomes makes it challenging for hospital executives to justify AI investments.⁸

Legal and ethical considerations further complicate AI acceptance. Mistakes are inevitable with AI technologies. Who will be held accountable for errors, especially when they impact patient outcomes? Healthcare providers may be reluctant to adopt AI technologies if responsibility for potential AI errors is unclear.^8,10 This also calls into question regulatory compliance. If AI becomes the standard of care, providers who choose not to use these tools may face legal and regulatory consequences.^8,10

Before implementing AI in clinical practice, healthcare institutions must thoroughly test and validate each model. A designated committee containing diverse healthcare professionals should lead the approval process to ensure safe and effective implementation of AI models. This approval process and integration into daily practice may take years.¹⁰

After looking at how AI is used currently, the research underway, and AI’s challenges, Dolly feels confident that she can discuss changes in the workplace and pharmacy processes with Miley.

TAILORING AI TO PHARMACY PRACTICE

Many healthcare providers already recognize the implications of AI integration in healthcare. A recent survey asked pharmacists, “How likely is it the following will occur by the year 2029 in the geographic region where you work?”⁸ Table 3 displays the findings on AI integration in pharmacists’ documentation and medication histories.⁸

As healthcare professionals acknowledge AI’s expanding function, they must develop a strong understanding of these technologies. Pharmacists and pharmacy technicians, in particular, need a basic knowledge of AI.⁴⁸ With this foundation, pharmacists can assess AI models’ strengths and limitations and determine when and how to use them effectively.

To establish a baseline understanding of AI technologies, institutions must integrate education and didactic experiences into training for pharmacy technicians, pharmacy students, and pharmacists.^52,53 This will equip healthcare providers with the basic skills needed to evaluate AI models and understand its responsibility in improving patient care.

AI and the Pharmacy Workforce

Like Miley, may pharmacy personnel worry that AI may replace pharmacists and pharmacy technicians. In the United Kingdom, researchers estimate 35% of all jobs—including some pharmacy-related positions—could be automated in the next 10 to 20 years.¹⁰ However, they also predict job losses will amount to less than 5%. This is because of factors like cost of automation technologies, labor market dynamics, and regulatory and social acceptance. These circumstances create major barriers in the widespread adoption of AI across industries and may mitigate actual job loss.¹⁰

In healthcare, similar trends are expected. To date, AI has not eliminated jobs.¹⁰ Pharmacy student enrollment is unlikely to rise, and researchers predict that 20% of first year post-graduate residency spots will remain unfilled after the match. As a result, they anticipate the pharmacy workforce will decline.⁸ This projected reduction has led to expectations that AI will assist with repetitive pharmacy tasks, allowing pharmacists and technicians to focus on responsibilities that require human expertise.

With the integration of AI into healthcare, pharmacists are expected to expand their scope of practice into areas where they can use their skills more and influence outcomes.^8,10 These include managing high-cost medications, bridging gaps in primary care, applying empathy and persuasion, and taking a big-picture approach to patient care. While AI is designed to mimic certain human actions, it is not human. It lacks interpersonal skills and the ability to build relationships. Ultimately, AI will complement pharmacists by streamlining repetitive tasks, addressing workforce shortages, and enabling them to use their unique human intelligence abilities.^8,10

Adverse Drug Reactions

A primary responsibility for pharmacists in medication management is to mitigate patients’ risk of adverse drug reactions (ADRs). EHR systems use AI for ADR prediction and detection. For example, if a prescriber orders amiodarone for a patient who is already taking warfarin, the system is designed to alert healthcare providers that the combination leads to high bleeding risk. Current systems already deliver this alert, and an AI-assisted system may recommend providers decrease the patient’s warfarin dose empirically by 30% to 50%.⁵⁴ However, like any test or algorithm, false positives and negatives can occur, meaning these systems are not foolproof. It is crucial that clinicians and pharmacists do not rely solely on these alerts for detecting ADRs or sending notifications. Instead, they should apply clinical decision-making and rely on their expertise.

A recent study involving 412 patients used a machine learning algorithm to predict the likelihood of ADRs in neonates.⁵⁵ Researchers designed the algorithm to associate a risk score to predict and prevent ADRs, rather than simply display a warning as is done currently for certain medications. The model displayed high predictive accuracies, successfully detecting ADRs in patients with allergic, renal, central nervous system, and hepatic ADRs 78.9% to 90.2% of the time.^49,55 These models illustrate AI’s broad application in ADR detection which supports clinical decision-making.

AI also offers opportunities to improve patient adherence. It can trigger patient-specific message alerts, such as medication renewal reminders for both the pharmacist and the patient. This ensures timely prescription refills, helps maintain a consistent medication supply, and supports better medication adherence for improved health outcomes. Wearable devices like smartwatches and smartphones also integrate AI technology that may encourage behavioral changes and enhance adherence.¹⁰ For example, some smartwatches offer a time-to-stand reminder. If individuals have not moved within the first 50 minutes of an hour, the watch will remind them to stand. Simple alerts like these increase movement and encourage behavior changes.

Beyond clinical applications, AI has the potential to transform pharmacy operations. AI technology may request and process prior authorizations (something of great interest to Dolly and Miley), manage the supply chain, optimize pharmacy revenue cycles, and track financial performance.⁸

CONCLUSION

AI technologies are likely to revolutionize healthcare by enhancing clinical decision-making, improving patient outcomes, and streamlining workflows. Through automation of routine tasks and data analysis, AI can help healthcare providers deliver more efficient care. However, significant barriers including algorithm transparency, bias, cost, and accountability concerns must be addressed before AI is widely adopted. Overcoming these challenges requires collaboration among healthcare providers, policy makers, and AI developers. Establishing clear guidelines and validation procedures will help ensure AI technologies are safe and used properly. With proper implementation and education, AI is a powerful tool that enhances healthcare professionals’ abilities. Dolly and Miley now appreciate that it cannot replace human skills like empathy, critical thinking, and personalized communication.

PAUSE AND PONDER: Take a moment and look at this list. Which of the following are AI powered? These are the answers that we promised to provide!

• Air conditioner
• Automatic washing machine
• Basic calculators
• Customer service chat box
• Email services
• Facial recognition
• Media/playlist recommendations
• Purchase recommendations
• Refrigerators
• Social media
• Television remote control
• Voice assistants
• Wearable fitness trackers

Download CE Activity

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 Settings^8-12

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

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 team^4,10,13

• 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 11^th 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 11^th 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 include^1,13,14,19

• 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

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.

Download CE Activity

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

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

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

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 costs^26,27,28:

• 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.

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INTRODUCTION & BACKGROUND

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

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

Overview of the Medicare Prescription Payment Plan

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

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

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

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

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

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

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

Table 1. Anticipated M3P Claims Messaging Information

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

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

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

SIDEBAR: Part D Patient Costs Defined

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

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

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

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

Distribution of M3P responsibilities

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

M3P Resources

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

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

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

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

SUMMARY AND CONCLUSION

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

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

Good:

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

Better:

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

Best:

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

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