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Reaching for the 'Stars': Medication Nonadherence, Root Causes, and Methods for Intervention

INTRODUCTION

With baby boomers (Americans born between 1946 and 1964) now turning 65 years of age, the impact of the aging of the U.S. population on this country’s health care system is accelerating in unprecedented ways. Over the next 25 years, the population older than 65 will double.1 This generation is living longer than their parents, but with greater disease burden. Chronic conditions such as obesity, type 2 diabetes, hypertension, and hyperlipidemia will affect two-thirds of baby boomers, and long-term medication therapy will be a cornerstone of disease treatment and mitigation.

Despite the availability of effective agents, medication nonadherence is a growing challenge, with rates as high as 50% in chronic disease.2,3 As former Surgeon General C. Everett Koop famously noted, “Drugs don’t work in people who don’t take them.” Medication nonadherence contributes to poor outcomes and creates avoidable costs of $100 billion to $300 billion annually; it is the largest avoidable cost in health care.4,5 Thus, disease mitigation through appropriate medication prescribing and use are now central features of the government-funded Medicare and Medicaid programs and health care exchanges. Increasingly, health care quality is being measured using direct and indirect markers of chronic disease control, including medication adherence. Quality measures that reflect medication adherence in the treatment of cardiovascular disease, diabetes, and chronic obstructive pulmonary disease are linking medication persistence to quality reimbursement through the Five-Star Quality Rating System.6 As health care providers for a growing population of chronically ill patients, pharmacists must deliver patient-centric care that addresses disease goals and medication adherence at each patient encounter proactively.7

This module aims to equip the learner with the tools necessary to understand the basics of health care reform and measures of quality; engage patients in conversations about medication adherence; identify and resolve barriers to medication adherence; and deliver quality patient-centric care that improves Medicare star ratings through the use of a high-touch model.

THE NEED FOR HEALTH CARE REFORM

Statisticians and policy experts have observed a marked disparity between rising health care costs and lagging health care outcomes in the last 2 decades.8 Since the 1990s, the Institute of Medicine (IOM) has published several landmark studies that define and describe the scope of the U.S. health care problem, with recommendations on steps toward health care redesign/improvement.9-12 The purpose behind IOM’s research was to define factors that have contributed to the health care performance gap and to propose solutions that would slow this negative trend. The urgency for health care reform grew, creating the impetus for the Patient Protection and Affordable Care Act.13 Collective research indicated 4 broad opportunities for reform, including regulatory requirements around “quality”: expectations for continuous quality improvement; the support and design of programs that fostered marketplace competition; and payment incentives for high quality care.14

While a thorough review of the attributes of the Affordable Care Act are beyond the scope of this article, it is important for readers to appreciate the need, in fact, the absolute necessity for reform. The traditional “fee for service” model had failed to achieve desired outcomes and produced skyrocketing costs. A revolutionary change was necessary to control costs and improve health outcomes. Quality-based interventions became a central feature of reform, many of which focus on appropriate medication use and disease management. (See the case illustration on depression in the below patient-related factors section; it differentiates between fee-for-service and quality-based models of health care delivery.)

An important consideration when designing new models of care is perspective, as certainly patients, providers, and payers may all view “quality” through their unique lenses. In the design of quality-based measures, which serve as markers for health plan performance and reimbursement, each perspective must be considered thoughtfully. Traditional methodologies of patient care were challenged to identify opportunities to promote positive change. Additionally, reform prompted providers to become more patient-centric in their patient care activities, and to develop coordinated, team-based initiatives to achieve disease outcomes. Thought leaders developed recommendations around core principles of effective health care delivery, with patient-centric models that7

  • Promoted effective communication between patients and providers
  • Improved adherence to medications and self-care
  • Improved communication between providers
  • Encouraged the practice of evidence-based medicine

Pharmacists have to be effective members of the health care team and have established roles in team-based models such as the accountable care organization and the patient-centered medical home.13 This is critical to the success of effective models of care that aim to achieve disease management in a growing proportion of chronically ill individuals.

Why Medication Adherence Matters

Health care advances have enabled Americans to live longer than ever before. In the past 100 years, the main causes of death in older people have shifted from acute infections (pneumonia and tuberculosis) to chronic conditions (heart disease and cancer).15 While much credit is given to public health initiatives and vaccinations for alleviating early mortality, Americans’ sedentary lifestyle is the greatest risk to future health efforts.

Because of inactivity and excess calorie consumption, obesity has increased in the United States over the past 20 years. As a result, 1 in 3 adults (34%) and approximately 17% of children and adolescents are obese (body mass index of more than 30 kg/m2).16 Rising rates of obesity-related conditions such as hypertension, diabetes, heart disease, and stroke present a serious challenge to Americans’ longevity. Lifestyle modifications aimed at weight loss through diet and exercise are foundational interventions, proven to reverse, delay, or prevent complications of diabetes and high blood pressure.17 Central to care of chronic diseases is medication therapy management, which attempts to achieve desired endpoints, and evidence-based medicine, which has the potential to reduce morbidity, mortality, and health care expenditures.

Despite higher disease burden, baby boomers are expected to live longer than their parents because of availability of and advances in medicine. Delivery of evidence-based care by providers does not guarantee desired outcomes, however. As depicted in Figure 1, patient behavior plays a critical role in predicting outcomes. In fact, the success or failure of chronic disease management rests largely in the patient’s adherence to a prescribed treatment plan. The World Health Organization states that interventions to improve adherence may have a greater effect on health than improvements in specific medical therapy.18 This statement highlights the efforts placed on medication adherence as an indicator of quality.

Figure 1. Achieving outcomes in chronic disease management depends on selection of the optimal treatment and patients' adherence to the regimen

Addressing adherence is emphasized in the patient-centric care model. Historically, medication adherence in chronic disease has been poor and waned over time.2,19 About two-thirds of older Americans are living with chronic diseases that require medication management; only one-half of these patients take their medicines as prescribed.20,21 Reasons for medication nonadherence, discussed more thoroughly in later sections, fall into 3 categories:

  • Patient-related factors (lack of understanding about the disease, lack of involvement in the treatment-decision-making process, and suboptimal health literacy)
  • Prescriber-related factors (polypharmacy, explaining benefits and risks of medications ineffectively, and lack of consideration about financial burden to the patient)
  • Health-system/team-building–related factors (high drug costs or copayments, lack of health information technology for use by prescribers, and lack of time with patients)

Impact of Medication Adherence

Adherence is defined as “the extent to which a person’s behavior—taking a medication, following a diet, and/or executing lifestyle changes—corresponds with agreed-upon recommendations from a health care provider.”2 In terms of medications, adherence implies that a person will take his or her medications exactly as instructed, on an ongoing basis, for the specified duration—which is typically many years for treatment of chronic disease.

Human behavior, however, predicts otherwise. For even the most well-intentioned individuals, doses are missed, prescriptions are not refilled on time, or instructions are misunderstood. Simply put, nonadherence happens. While missing an occasional dose of a medicine may be acceptable/normal human behavior, frequent deviation from a prescribed regimen results in compromised outcomes.

Medication nonadherence contributes to poor therapeutic outcomes, disease progression, and billions of dollars in avoidable health care expenditures.2,22,23 The Centers for Medicare & Medicaid Services (CMS) is placing growing emphasis on medication adherence as an important quality indicator. Successful adherence interventions that produce disease-modifying outcomes result from a collaborative, patient-centric, high-touch model focused on identifying and resolving barriers.7,18 Standardized definitions of adherence have been developed to measure outcomes related to medication adherence in clinical practice.

Studies that evaluated adherence to statin regimens in older patients demonstrate adherence rates of 68% at 120 days and a significant decline in adherence after 6 months.24 The impact of adherence on clinical outcomes was evaluated in more than 4,000 patients who were placed on angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs), beta-blockers, and statins following myocardial infarction. Adherence to all medication classes gradually decreased over time, and 80%.25

This work is consistent with several other studies that demonstrate a loss of efficacy and an increase in disease-related complications with adherence below the 80% threshold. These studies and others have developed a standardized rate of “acceptable” adherence of 80% or greater, which has now been tied to reimbursement in chronic disease management.25-27

MEASURING MEDICATION ADHERENCE

Medication adherence can be measured using several methods. The most precise methods—such as direct observation and frequent laboratory measurements of blood levels—are time consuming and costly; these are barriers to widespread use.

One commonly used method of estimating adherence indirectly uses pharmacy claims data and calculates rates of adherence based on refill rates. In the proportion of days covered (PDC) method, the number of days between the first fill of the measurement period and the last day of the measurement period is the denominator in the calculation. For example, if the measurement period is a calendar year, and the first fill occurred on January 1, the denominator would be 365 days. The numerator is determined by the number of days covered by prescription fills during the denominator period.28

The PDC for a 30-day-supply, once-daily prescription that is filled 8 times (240 pills) in a 365-day period is 0.65, or 65%. Nau describes the PDC and its use in more detail.28 The PDC offers a standardized approach to calculate adherence. CMS uses PDC to calculate medication adherence in chronic disease as a star quality performance measure. CMS recognizes a PDC lower than 80% as a threshold for nonadherence.

Medicare Star Measures for Medication Adherence

Medicare is a government-sponsored, CMS-administered insurance plan that provides benefits to people who are aged 65 or older and to those who are chronically disabled regardless of age. Private health insurance plans offer Medicare benefits through the Medicare Advantage (MA) plans.

CMS developed and adopted the Medicare Five-Star Rating System in 2006 to promote quality in individual MA plans. This tool also measures performance across MA plans. Under the Affordable Care Act, CMS applies star measures to all Medicare plans that offer a prescription drug benefit (Part D prescription drug plans, or PDPs, and MA plans that offer prescription drug coverage, or MA-PD plans).

Initially, star ratings were designed to educate consumers on health plan quality and to make quality data more transparent. However, a Kaiser Family Foundation study showed that cost was a greater a direct increase in secondary cardiovascular events occurred when adherence rates dropped below driver than quality as a predictor of health plan selection by seniors.29 The star rating system continues to evolve to meet the challenges of a rapidly growing Medicare population saddled with chronic disease and will place a greater emphasis on patient satisfaction and quality outcomes in coming years.

A plan’s star ratings are calculated by averaging performance across more than 50 performance measures, which are broken down by domains. For prescription drug benefits, these 4 domains are as follows:

  1. Member experience with the health plan
  2. Member complaints and barriers to high-quality service
  3. Customer service
  4. Patient safety and accuracy of drug pricing

Specific examples of the Part D PDP measures include call center hold time, members’ ability to get prescriptions filled easily when using the drug plan, plans’ fairness of denials to members’ appeals, and evaluating medication adherence. Individual measures may carry different weights, as determined annually by CMS. An average of these measures yields a summary score for the plan.

Based on quality of services delivered, a health plan’s performance is described by a star rating of 1 to 5 stars, with 5 stars being the highest rating. Overall star ratings are derived from the compilation of individual performance indicators that span Part C (MA-PD) and Part D, many of which focus on appropriate medication use. Of the 14 measures included in the 2019 Part D call letter, 3 medication adherence measures fall under the Drug Safety and Accuracy of Drug Pricing Domain: Diabetes medications, Hypertension (renin-angiotensin system antagonists), and Cholesterol (statins). Adherence to medications in these categories is triple-weighted; most other measures are single weighted. The triple weighting demonstrates the value CMS places on interventions that emphasize medication adherence and persistence (continuing to adhere to prescribed therapies over time) in chronic disease.30

As noted earlier, CMS calculates medication adherence in these categories using the PDC from pharmacy claims. Additionally, CMS supports numerous other star measures that also focus on medication use quality; these will not be discussed here. Health plans and their providers are incentivized to design initiatives and place efforts on programs that address these measures. Pharmacist delivery of medication management services that emphasize medication adherence would promote performance in these specific areas.

CMS displays specific plan performance publicly on its website; it offers higher reimbursement and expanded enrollment to plans with overall star ratings of 4 or above. Conversely, poor performance on both star measures (overall star rating below 3) may result in disciplinary action from CMS and potential shutdown. Medication management for chronic diseases provides evidence-based treatment and emphasizes adherence as central ways of meeting star quality measures. Pharmacists should be familiar with these standards because delivery of pharmaceutical care to Medicare beneficiaries is tied to reimbursement from activities such as medication therapy management and adherence counseling.

Adherence Interventions

Interventions designed to prevent or resolve adherence-related issues are central to improving outcomes in chronic disease and reducing health care costs. Because of frequent patient interactions and high patient trust, pharmacists are in prime positions to offer adherence interventions. Addressing adherence may not be a simple conversation, however, as barriers to adherence are multifactorial and change over time.18

Patient-Related Factors

Factors associated with medication adherence relate to patient, provider, and health-system factors. For patients, these include behavioral factors of psychiatric illness that can interfere with adherence and health literacy.

Psychiatric factors include major depressive disorder, bipolar disorder, schizophrenia, and post-traumatic stress disorder. A closer look at depression illustrates the impact it can have on medication adherence.

Depression has a lifetime prevalence of 17% in the general population; it occurs in about one-third of people with chronic medical conditions.31 One study showed that undiagnosed or untreated depression had a significant impact on chronic disease and may have contributed to greater functional impairment, decreased adherence to all medications, poor self-care, and increased mortality. Patients who presented with diabetes, heart disease, or chronic obstructive pulmonary disorder plus depression died 5 to 10 years earlier than those in a matched control group with 1 or more of the first 3 conditions but without depression.32

Compared with patients who had diabetes but were not depressed, those with diabetes plus depression demonstrated poorer adherence to self-care activities of healthy eating, exercise, and glucose monitoring. They were notably less adherent to guideline-recommended statins, ACE inhibitors/ARBs, and oral antidiabetic medications.33 Recognizing the presence of depression and providing appropriate treatment holds promise; once depression is treated, other chronic disease outcomes normalize to those of nondepressed control groups.18,34

Pharmacists must recognize and ensure appropriate treatment of depression in patients they serve. Recognition of depression through pharmacy claims is an opportunity for pharmacists to consider whether patients have reached their goals of therapy (symptom remission) or are nonadherent and in need of coaching. Since the presence of chronic disease is a risk factor for depression, patients can also be screened for the presence of depression using the verbally administered Patient Health Questionnaire–2 (see Table 1) and if positive, the more expanded Patient Health Questionnaire–9.35 Because the population with chronic disease is growing, appropriate diagnosis and treatment of depression may become a routine care activity through which pharmacists can improve medication adherence outcomes.

Table 1. Items Used for Initial Screening of Depression Using the Patient Health Questionnaire–2 Instrument
Items Rating Scalesa
Little interest or pleasure in doing things 0, not at all; 1, several days; 2, more than half the days; 3, nearly every day
Feeling down, depressed, or hopeless
aThe 2 ratings are summed; respective probabilities of major depressive disorder or any depressive disorder with the summed scores total of 1, 15.4% and 36.9%; 2, 21.1% and 48.3%; 3, 38.4% and 75.0%; 4, 45.5% and 81.2%; 5, 56.4% and 84.6%; and 6, 78.6% and 92.9%.38

Health literacy is the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.36 Nearly 9 of every 10 adults struggle with use of everyday health information.37-39 Health information delivered either verbally or in writing can be confusing, distorted, or misunderstood by a person with low literacy. Limited health literacy leads to negative health outcomes, including medication errors and medication nonadherence. Risk factors for low health literacy include older age, chronic disease, English as a second language, education level, presence of disabilities, and lack of medical insurance. Addressing disparities in health literacy is cited as 1 of the 20 necessary actions to improve health care quality on a national scale.39,40

Pharmacists develop and disseminate information and services to address a wide range of health issues and topics, such as smoking cessation, immunizations, and disease state management in everyday practice. Resources include the extensive library of drug administration and information pictograms that can be downloaded from the website of the United States Pharmacopeial Convention and consumer-oriented documents that pharmaceutical companies are required to make available with their products (e.g., patient package inserts, medication guides).41

Pharmacists must ensure that patients can access, understand, and use the information and services they provide in the daily lives. Former U.S. Surgeon General Richard Carmona, MD, said, “Health care professionals do not recognize that patients do not understand the health information we are trying to communicate.” To overcome this problem, pharmacists should be aware of the common barriers to health literacy listed in Table 2.42

Table 2. Barriers to Health Literacy42
Barriers Examples
Use of technical or medical terminology Words that can be misinterpreted, such as pandemic, immunize, and prevalence. Other terms lack meaning, including hypertension or "high cholesterol."
Using print as the only means of communications Relying on 1 source disregards individuals' preferences and learning styles.
Focusing on information rather than actions Delivering information is less effective than giving instructions on what to do.
Limited awareness of cultural differences Difference in language and word meanings can lead to misinterpretation and poor understanding. Information as basic as print instructions on medication bottles may be misleading or misunderstood.

The delivery of health information should follow the “3 As”42

  • Accurate
    • Avoid “dumbing down” information. Simplify the message to make it accurate and understandable.
  • Actionable
    • Avoid giving excessive background information. Instead, focus attention on what patient should do about that information (start something, stop something, do more of something).
  • Accessible
    • The Plain Writing Act of 2010 requires government agencies to use “clear government communication that the public can use and understand.”
    • Plain language puts the most important information first, keeps sentences and paragraphs short, and deletes unnecessary words and sentences.

Health care providers should put health literacy awareness into daily clinical use, in both verbal and print forms of communication. Pharmacists should consider these questions:

  • Are the messages I give participatory and patient-centered?
  • How do I know I am effective in my communication?
  • Have I considered the current literacy level of my patient and designed messages on that level?

Provider-Related Factors

A key feature of the CMS-sponsored patient-centric model is “communication to the patient”; however, racial concordance and relationship with the patient also play a role. Conversation aimed at patient engagement, or the methods used to deliver health information, are critical to involve patients in their health choices, provide education, and identify and resolve barriers to adherence. The following example compares 2 different delivery styles, called the “compliance style” and the “engagement style.” The 2 approaches produce very different patient outcomes.

Providers across health care settings driven to fulfill high quotas in limited timeframes often use the more familiar “compliance conversation.” The pharmacist drives the conversation, and offers information he or she considers necessary to the patient in a unidirectional manner.

Here is an everyday example of a compliance conversation: “This medication is called metformin. Your doctor prescribed this for diabetes. You should take this medicine twice a day, and if it causes stomach pain, please take it with food. Do you have any questions for me?” This style of delivery assumes that the necessary information is shared and understood and that the patient will do as instructed. However, studies show that this method is ineffective and that patient retention of information is low.43

In contrast, an engagement style of conversation is patient-centric and built from a coaching/collaborative model that incorporates the following elements: open-ended questions and motivational interviewing (MI) to identify and resolve barriers to medication adherence, simple and clear communication that overcomes health literacy challenges, and adequate time for exchange of information.

An engagement-style may begin with questions such as these, “Can you tell me why you are taking metformin?” “How are you taking metformin?” “Do you have any problems with adverse effects from metformin?” After each question, the patient has an opportunity to respond, which provides the pharmacist the chance to provide patient-specific education or coaching. Another patient-engagement opportunity may be to inquire about disease goals; “What are your blood sugar readings? What was your last hemoglobin A1c? Can you tell me why it is important to lower your blood sugar?” All of these questions reveal patient knowledge, gauge patient engagement in their disease management, and offer opportunity for troubleshooting and relationship building. This approach yields great reward for both pharmacist and patient, and requires very little extra time over that required in a compliance conversation.

Numerous studies have examined the impact of physician communication to patients. A meta-analysis of more than 100 studies in the literature found that poor communication from physicians to patients is associated with a higher incidence of nonadherence (19%) compared with those physicians who communicate well.44 When physicians received training on communication, patients became 1.62 times more adherent.44 Improving provider communication and patient engagement is a priority element of health care reform under the Affordable Care Act.13

Using open-ended questions facilitates patient engagement and promotes a dialogue that allows patients to express their beliefs, fears, or knowledge gaps about the disease and its treatment. With this approach, pharmacists can personalize health information to meet the individual’s health literacy level and address his or her unique concerns. This establishes patient–provider relationships and accountability.

MI is a core element of health communication. Understanding that “one-way communication” from the pharmacist to the patient is often unsuccessful in changing behavior (in this case, medication adherence), MI embraces an alternate approach. MI results in provider–patient engagement that honors patients' autonomy to change, works with patients to help them realize their desire to change, and cultivates a collaborative approach aimed at achieving change. MI incorporates active listening and reflection, which facilitates compassion, connection, and patient empowerment.45

Many other factors can influence adherence to medications. Since 50% of people with chronic disease do not take their medicines are prescribed, the presence of chronic disease should be a flag for nonadherence counseling and intervention. Pharmacists should review the PDC or refill history of all long-term medications at each patient encounter and address any gaps. Common barriers to adherence among Medicare recipients are presented in Table 3.18,46

Table 3. Common Barriers to Medication Adherence and Steps to Resolution2
Barriers to Medication Adherence Steps to Resolution
Pill burden Simplified dosing regimens (e.g., once-daily dosing)
Combination tablets
Patient preference with schedule
Forgetfulness Reminder devices: text messaging, pill boxes, bubble packs
Dosing schedules that match patient preferences
Once-daily dosing
Asymptomatic chronic disease Patient-centric empowerment
Multimodal education with repetition
Addressing patient beliefs and values about disease
Cost/copayments Generic formulary alternatives
Formulary options
90-Day supplies
Transportation Medication delivery services
Mail-service delivery of medications
Medication synchronization (having all refills due on a specific day)
Health literacy/English as a second language Patient-centric education
Use of translation services
Prescription services in native language

Recognizing that a patient may present with a variety of barriers is an important step in providing meaningful solutions for adherence. Barriers may also change over time. No one solution is effective in improving long-term adherence.22 Many commonly encountered barriers can be resolved through education-driven communication that is patient-centric, interactive, and focused on the importance of medication adherence to achieve successful disease outcomes. Patients recall less than 50% of what is discussed in a medical encounter; pharmacists must offer repeated, multimodal education that empowers patients to manage their diseases. Concerns about “repeating the same conversation” on follow-up visits are unwarranted and interfere with patients receiving appropriate care.

Once barriers are identified, pharmacists should be proactive in resolving the barrier for the patient. Simple steps such as requesting a refill from a provider, using native languages on prescription labels, providing pill boxes that help patients keep their medications organized by time of administration, or requesting a medication sync or prior authorization/formulary alternative from a health plan are “low-hanging fruit” that can bolster adherence and produce optimal disease control. Using pharmacy technicians to facilitate these services is critical to workflow. Follow-up is an important key to ensure understanding, provide adverse effect counseling, and identify any new barriers. Pharmacists can bolster their skills in these areas through awareness, training, and ongoing application in their patient care settings.

HIGH-TOUCH MODEL

The high-touch model brings all of the previously discussed components of medication adherence counseling into a concise approach.

This model encourages an interactive conversation with the patient—conversation that is repeated, individualized, and aimed at identifying and resolving barriers to adherence (Figure 2).47 Adherence counseling requires interactive engagement with the patient and must be repeated to be effective. Repetition is congruent with the coaching concept. Pharmacists can reinforce counseling points, provide ongoing education, answer new questions, and assess and reinforce behavioral change. Individualized attention to patient care respects each individual’s wishes, acknowledges specific concerns, and builds trust. The high-touch model also encourages barrier identification and resolution, acknowledging that barriers may be multifactorial and change over time.

Figure 2. Elements of the high-touch model of patient care47

CONCLUSION

In the next 25 years the Medicare population will double in size, requiring further reform of the health care system to control costs and improve outcomes. Performance measures, including Medicare star ratings, will place greater emphasis on quality outcomes and patient satisfaction. Medication adherence to cholesterol-lowering agents (statin medications), oral antidiabetic medications, and antihypertensives affecting the renin-angiotensin system are triple-weighted star measures. Pharmacists can improve patient care using various methods of engagement and high-touch techniques.

Medication adherence is complex and requires specific interviewing skills. Delivery of quality-based pharmacy services will require a shift in practice, from models that incentivize quantity to models that emphasize disease management along the continuum of care. Pharmacists can improve care by recognizing low health literacy and changing delivery style, practicing basic skills of MI to involve patients in care and promote self-empowerment, and actively identify and resolve barriers that interfere with medication adherence.

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