REVIEW

Medication adherence part one: Understanding and assessing the problem Mary B. Neiheisel, BSN, MSN, EDD, CNS-BC, FNP-BC, FAANP (Professor of Nursing, Family Nurse Practitioner)1,2 , Kathy J. Wheeler, PhD, APRN, NP-C, FAANP (Assistant Professor)3 , & Mary Ellen Roberts, DNP, RN, APN-C, FAANP (Assistant Professor)4 1

University of Louisiana at Lafayette, Lafayette, Louisiana Faith House, Inc, Lafayette, Louisiana 3 University of Kentucky College of Nursing, Lexington, Kentucky 4 Seton Hall University, South Orange, New Jersey 2

Keywords Medication adherence; medication nonadherence; adherence; nonadherence. Correspondence Mary Neiheisel, ULL Box 41932, Lafayette, LA 70504. Fax: 337-482-6683; E-mail: [email protected] Received: August 2013; accepted: October 2013 doi: 10.1002/2327-6924.12099

Abstract Purpose: This is the first of a three-part series on medication adherence in which the authors describe the continuum of adherence to nonadherence of medication usage. Data sources: Research articles through MEDLINE and PubMed. Conclusions: Understanding the magnitude and scope of the problem of medication nonadherence is the first step in reaching better adherence rates. The second step is to evaluate the risk factors for each patient for medication adherence/nonadherence. The third step is to assess for adherence. The process will continue with a consistent systematic process to evaluate continual adherence. Implications for practice: The implications for nurse practitioners include using time with patients to assist them in adherence, building a trusting relationship with patients, and developing protocols for assessing and preventing nonadherence.

According to Dr. C. Everett Koop, former U. S. Surgeon General: “Drugs don’t work in patients who don’t take them,” (Bogh, 2004; Smolen, 2010). In 2003, the World Health Organization (WHO), alarmed at the significance of the problem of nonadherence, published an extensive review stating (p. 22) medication nonadherence was “a worldwide problem of striking magnitude.” In order to understand the scope and complexities of nonadherence, and then offer system and patientspecific solutions, the authors performed an extensive literature review through an online search of MEDLINE and PubMed for articles published between 1998 and 2012. Key search terms included medication, medication adherence, medication nonadherence, adherence, and nonadherence. Search terms also included compliance, noncompliance, medication compliance, and medication noncompliance with the recognition that those terms are considered outdated. The search generated 175 articles. Analysis of the material yielded three domains of information: definitions and significance, predictors of nonadherence and adherence, and strategies to improve adherence. This series was developed according to those divisions.

Magnitude of the problem of medication adherence While medications are essential elements of many healthcare interventions, particularly for patients with chronic physical and mental health conditions, the appropriate use of medications presents significant challenges to both patients and healthcare providers (Bosworth et al., 2011). Assessments of medication adherence suggest an average medication nonadherence rate of 24.8% with wide variability between disease states and patient populations (DiMatteo, 2004). The highest adherence rates are estimated for patients with cancer at about 80.0% (Dittmer, 2011; Ma et al., 2008; O’Connor, 2006), with lower rates reported for cardiovascular disease (Ho, Bryson, & Rumsfield, 2009), hypertension (Fitzgerald & Powers, 2011; Lewis, 2012; Munger, Van Tassell, & LaFleur, 2007; Vrijens, 2008), infectious diseases (Cramer & Rosenheck, 1998), diabetes mellitus; (Asche, Lafleur, & Conner, 2011; Bailey & Kodack, 2011; Fitzgerald & Powers, 2011), osteoporosis (Ettinger, Gallagher, & MacCosbe, 2006; Reginster, Rabenda, & Neuprez, 2006), asthma, and chronic obstructive pulmonary

C 2014 The Author(s) Journal of the American Association of Nurse Practitioners 26 (2014) 49–55 

 C 2014 American Association of Nurse Practitioners

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disease (Cramer & Rosenheck, 1998). Some of the lowest adherence rates are reported for patients with psychiatric disorders, particularly elderly patients with depression and patients with cognitive disorders (Velligan et al., 2009; Zivin & Kales, 2008). Patients with multiple chronic diseases also are at significantly greater risk of medication nonadherence (Barber, Parsons, Clifford, Darracott, & Home, 2004; Katon et al., 2005; Lin et al., 2010; Vogeli et al., 2007) with adherence declining after the first 6 months of treatment (Brunton, 2011; Burnier, 2006; Caro, Salas, Speckman, Raggio, & Jackson, 1999; Osterberg & Blaschke, 2005). Current estimates suggest that one-half of 3.2 billion prescriptions annually issued in the United States are not taken as prescribed (Osterberg & Blaschke, 2005). The implications of nonadherence are staggering including increased risk of poor clinical outcomes (Asche et al., 2011; Brunton, 2011; Fitzgerald & Powers, 2011; Frishman, 2007; Gehi, 2007; Gehi, Ali, Na, & Whooley, 2007; Ho, Bryson, & Rumsfield, 2009; Ho, Rumsfeld et al., 2006; Ho, Spertus et al., 2006; Rasmussen, Chong, & Alter, 2007), higher direct and indirect medical costs (Bosworth et al., 2011; Brunton, 2011; Caro et al., 1999; Doggrell, 2010; Roebuck, Liberman, Gemmill-Toyama, & Brennan, 2011), social costs such as diminished or lost productivity in the workforce (Bosworth et al., 2011; WHO, 2003), and decreased quality of life (Bosworth et al., 2011; Doggrell, 2010; Roebuck et al., 2011; WHO, 2003). The cumulative total of avoidable medical costs associated with medication nonadherence in the United States for 2008 is estimated at $310 billion with the highest costs associated with hospital admissions and long-term care admissions. Most of the cost is related to hospital admissions at $198 billion. Significantly, approximately 125,000 deaths per year (McCarthy, 1998) and an estimated 33.0%–69.0% of medication-related hospitalizations in the United States are attributed to medication nonadherence (Osterberg & Blaschke, 2005). Nonadherence frequently results in increased doses of medication, which contributes to higher medical costs as well as increased risk of adverse drug events (Bosworth et al., 2011; WHO, 2003), misdiagnoses, unnecessary treatment, increased severity of disease, and death (Brunton, 2011, DiMatteo, 2002; Spertus, 2006). Furthermore, the indirect costs of medication nonadherence includes increased burden on caregivers (Dunbar, 2008) and lost work productivity for both patients and their family caregivers (Giovannetti, Wolff, Frick, & Boult, 2009; Wolff, 2010). The purpose of this series is to review critical issues in the assessment and management of medication adherence in an effort to support the efforts of nurse practitioners (NPs) and other healthcare providers to under50

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stand the scope of the problem and its implications for the health and well-being of their patients. Part One addresses the definitions of medication adherence and persistence and methods of assessment. Part Two presents the factors associated with nonadherence and Part Three discusses the evidence-based strategies for application in real-world clinical settings to improve patients’ medication adherence and persistence.

Definitions of medication adherence and persistence Medication adherence is usually defined as the degree to which a patient’s medication behaviors are congruent with the recommendations and instructions of his/her healthcare provider regarding timing, dose, and frequency (Cramer et al., 2008; Osterberg & Blaschke, 2005). Medication persistence refers to the duration of time patients take prescribed medications and is defined as ”the duration of time from initiation to discontinuation of therapy” (Cramer et al., 2008). Importantly, adherence is evaluated as the percent of prescribed doses taken during a defined period of time while persistence is measured in terms of time. Primary nonadherence is defined as medications ordered but the prescription is never filled (Raebel, Carroll, Ellis, Schroeder, & Bayliss, 2011), while medications that are dispensed once but never refilled are considered to define early nonpersistence (Raebel et al., 2011). It is important to recognize that both adherence and persistence are not stable over time (Burnier, 2006). For example, some patients may demonstrate partial adherence that may be prompted by scheduled visits with their healthcare provider or exacerbation of symptoms. Following the visit or improvement of symptoms, adherence and/or persistence rates may decline (Burnier, 2006; Crame, Scheyer, & Mattson, 1990). The WHO also distinguishes between preventable and nonpreventable, nonadherence and nonpersistence (WHO, 2003). Examples of preventable nonadherence include (a) patient forgets to take medication, (b) patient misunderstands instructions for medication use, or (c) patient encounters barriers to obtaining the medication such as lack of financial resources to pay the prescription cost or no transportation to pharmacy (Bosworth et al., 2011). Reasons for nonadherence and nonpersistence that cannot be prevented include serious mental illness, intolerable drug side effects, and adverse events (WHO, 2003).

Methods of adherence assessment Adherence assessments should be focused and conducted on two levels by healthcare providers. The first

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Table 1 Direct methods of assessment for medication adherence and persistence Method

Strengths

Direct observation (Balkrishnan, 2005; MacLaughlin, 2005; Osterberg & Blaschke, 2005; Rolley et al., 2008; Shi et al., 2010).

• Accurate • Objective

Measurement of medication level or metabolite in blood or urine (Balkrishnan, 2005; Osterberg & Blaschke, 2005; Rolley et al., 2008; Shi et al., 2010; WHO, 2003). Measurement of biologic marker (Balkrishnan, 2005; Osterberg & Blaschke, 2005; Shi et al., 2010; WHO, 2003).

• Objective

• Objective

level is determination of the nonadherence risk or the patient and his/her willingness and readiness to adhere to the treatment routine as planned with the healthcare provider. The second level of assessment is the determination of how many of the prescribed medications are being taken on a regular schedule. There is no standard definition or metric for adequate medication adherence or persistence, although some studies suggest that rates of 80.0% or greater are acceptable while others advocate for rates greater than 95.0%, particularly for patients with serious medical conditions (Osterberg & Blaschke, 2005). There also is no consensus about the best method to define adherence and persistence and both direct and indirect methods are used to measure the two behaviors. Direct methods include observation of the patient taking the medication, measurement of levels of the medication or metabolite in plasma or urine, and measurement in plasma of biologic markers added to the drug formulation (Osterberg & Blaschke, 2005). Indirect assessments include patient self-report, patient questionnaires, assessment of clinical response, pill counts, use of pharmacy databases to determine refill rates and intervals, electronic medication monitors, and patient or caregiver diaries. Each of these strategies has strengths and limitations. Direct methods are shown in Table 1 and indirect methods are shown in Table 2. The diverse methods used to assess medication adherence and persistence provide only an estimate of patients’ actual behaviors. Many are based on subjective reporting and are potentially affected by response and recall bias. More objective measures such as pharmacy or claims databases provide information about filling and refilling prescriptions but fail to yield information about whether patients take medications as prescribed. The medication event-monitoring system (MEMS), which has a lid with a digital chip that records the date and time when the lid on the medication container is opened and closed, is among the most popular and widely accepted methods of electronic monitoring. However, electronic monitor-

Weaknesses • Expensive • Patients can manipulate data (hide pills in mouth and then discard them) • Not practical for routine clinical use • Variations in metabolism • “White coat” adherence can give impression of adherence • Expensive • Expensive assays • Invasive • Not appropriate for all medications

ing systems such as the MEMS are costly and fail to provide information that the medication was actually taken. Similarly, reliance on objective clinical outcome measures may not yield accurate assessments of patient adherence and persistence and are more expensive than self-report measures or those that track quantities of pills or prescription filling/refilling behaviors (WHO, 2003). The patient’s willingness and readiness to practice medication adherence are crucial to successful treatment and interventions. Tools to measure these attributes are the readiness ruler, the Morisky Medication Assessment Scale (Morisky, Ang, Krousel-Wood, & Ward, 2008), and the Adherence Estimator. Using the readiness ruler, the patient is placed on a 0– 10 scale. The 0 level on the ruler means not prepared to change and the 10 is at the level of change in progress. Ascertaining a patient’s knowledge of his/her medication involves asking questions such as the name, reason, amount, time, number of pills, and if the patient has a plan for continuing the medication. The Morisky Medication Assessment Scale was developed by Donald Morisky and colleagues and has been validated in a number of studies. The Morisky scale looks at motivation and knowledge that assists in determining the degree to which patients will be medication adherent. The Adherence Estimator is a three-item Likert-scale survey developed to be given to patients shortly after starting a new prescription to assess risk of nonadherence. The questions assess patients’ perceptions about (a) the importance of a new prescription, (b) worry that the prescription may cause more harm than good, and (c) financial concerns (McHorney, 2009). Use of such a tool can facilitate healthcare providers’ efforts to identify patients at risk for nonadherence when starting a new prescription while reassessment at periodic intervals can help determine medication persistence rates. This information can form the basis for discussions between patients and their caregivers about patients’ beliefs about their health condition and treatment plan and can help identify areas 51

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Table 2 Indirect methods of assessment for medication adherence and persistence Methods

Strengths

Patient self-report (Balkrishnan, 2005; MacLaughlin, 2005; Osterberg & Blaschke, 2005; Rolley et al., 2008; Shi et al., 2010; WHO, 2003).

• Simple • Inexpensive • Most practical in "real-world" clinical settings

Questionnaires and quantitative scales (Osterberg & Blaschke, 2005; Rolley et al., 2008; WHO, 2003).

• Simple • Inexpensive

Pill counts (Balkrishnan, 2005; MacLaughlin, 2005; Murray, 2004; Osterberg & Blaschke, 2005; Rolley et al., 2008; WHO, 2003).

• Objective • Quantifiable • Simple to perform

Prescription refill rates (Balkrishnan, 2005; MacLaughlin, 2005; Murray, 2004; Osterberg & Blaschke, 2005; Rolley et al., 2008; Shi et al., 2010).

• Objective • Can be easy to obtain in closed pharmacy system

Clinical response counts (Balkrishnan, 2005; Osterberg & Blaschke, 2005).

• Objective • Generally easy to assess

Physiologic markers (e.g., heart rate, blood pressure) (Balkrishnan, 2005; Osterberg & Blaschke, 2005).

• Easy to obtain

Patient or caregiver diaries (Osterberg & Blaschke, 2005).

• Can improve recall • Useful for patients with cognitive or mental disorders who lack ability to provide self-report • Precise • Quantifiable results • Tracks pattern of taking medication

Electronic monitors (Murray, 2004; Osterberg & Blaschke, 2005; Rolley et al., 2008; Shi et al., 2010; WHO, 2003).

that may need to be addressed and collaboratively solved (Bosworth, 2011; Brunton, 2011). In 2006, Velligan et al. analyzed 161 publications to compare the variety of ways clinicians determined adherence in patients. Methods ranged from indirect methods such as self-reporting, to more direct methods such as use of the MEMS described earlier. Most relied on selfreporting (Figure 1), with only a modest number relying on more direct methods. The analysis additionally listed the shortcomings of all the methods and found significant variations in the data because of variations in the definition of adherence. It was for these reasons Velligan et al. suggested any understanding of adherence can only be accomplished by combining methods of analysis, 52

Weaknesses • Potential for error (e.g., recall bias) • Potential for inaccurate reporting by patient (response bias) • Accuracy diminishes with increased time between visits • Potential for discrepancy between patient and caregiver definitions of adherence • Potential for response bias • Potential for recall bias • May be time-consuming to complete • Patient can modify data (throw away pills not taken) • Not accurate measure of taking medication as prescribed • Usually overestimates adherence [46] • Primarily used in clinical trials or for controlled substances • Not accurate measure of • Taking medication as prescribed • Requires single source or closed pharmacy system • Often overestimates adherence • Factors other than adherence can affect clinical response • Not accurate measure of taking medication as prescribed • Marker may be absent for reasons other than nonadherence • Not accurate measure of taking medication as prescribed • Potential for response bias • Potential for recall bias • Likely to overestimate adherence • Expensive • Requires return visits to assess • Requires ability to download data from medication containers • No verification medication actually taken

preferably with one of them including a direct method. These and similar recommendations will be discussed in Part Three.

Rates of medication adherence and persistence There are significant variations in estimated rates of adherence and persistence for diverse disease states. A review of 328 studies reported an average medication adherence rate of 79.4% (95% confidence interval [CI], 77.4%–81.4%; DiMatteo, 2002). However, results revealed that an important predictor of variability in medication adherence was the method of

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Figure 1 Methodologies to assess medication adherence reprinted with permission from Velligan et al. (2009).

measurement. The highest adherence rates were evident for pill counts at 85.1% based on 127 studies while the lowest level of 66.6% was evident for collateral reports provided by caregivers including family members and healthcare providers (DiMatteo, 2002). Furthermore, pill counts are generally considered to overestimate adherence and provide no information about medication persistence or whether patients take the medication as prescribed (Balkrishnan, 2005; MacLaughlin et al., 2005; Osterberg & Blaschke, 2005; Rolley et al., 2008). Types of medical conditions are also associated with variations in medication adherence rates. For example, patients with cancer have 60% adherence rate while patients with depression have about 50% adherence rates (Forissier, 2011). In addition, adherence rates dramatically decline across the duration of therapy with average rates shown in Figure 2 (Forissier, 2011).

Figure 2 Rates of medication adherence and persistence by duration of therapy adapted from Forissier (2011).

copyrighted but Dr. Morisky is willing to allow the use of the scale. It is clear that medication adherence and nonadherence are complicated issues. NPs play key roles in assessing for adherence/nonadherence and willingness to accept responsibility for adherence. This assessment should be a component of the initial interaction with all patients if nonadherence is to be decreased and/or avoided. It is also clear the ramifications for nonadherence, in all its forms, are significant and need planned interventions. These will be discussed in detail in Parts Two and Three of the series.

Acknowledgments Implications for practice Healthcare providers have major responsibilities and roles to play if patients are to practice 100% adherence. No one method of assessing adherence is totally effective. Self-reporting is the simplest and most popular method of assessing adherence but is not totally accurate and inaccuracy increases with long intervals between visits. Pill counts are another popular, simple method with the same limitations. Healthcare providers have diverse methods to utilize and many opportunities for researching the methods that provide the best data. Variations among patients may be necessary based on geographical location, gender, age, and ethnic and cultural backgrounds. The Morisky Medication Assessment Scale is an excellent research tool and has been widely used. It is

The assistance of Dr. Mary Jo Goolsby, Former Vice President of Research and Education of AANP, for her role in developing the project; Carole Alison Chrvala, PhD, of Health Matters, Inc. of Hillsborough, NC 27278, for her role in project coordination, and Pfizer, for an unrestricted educational grant is greatly appreciated and acknowledged.

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Medication adherence part one: understanding and assessing the problem.

This is the first of a three-part series on medication adherence in which the authors describe the continuum of adherence to nonadherence of medicatio...
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