Taking Medication in Diabetes Self-Management: Issues and Recommendations for Reducing Barriers

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The American Journal of Pharmacy Benefits, September/October 2011, Volume 3, Issue 5

This paper considers opportunities and barriers relating to medication taking and self-management by people with diabetes and related conditions as discussed during an invitational symposium.

On September 12, 2009, The American Association of Diabetes Educators (AADE) hosted a “Taking Medication Symposium” in Chicago, Illinois. Fourteen invited participants examined diabetes self-management, attributes of diabetes education, and barriers to medication among people with diabetes. The symposium was designed to consider pre-set questions regarding how diabetes education can more effectively address barriers to medication use for diabetes and related conditions. The questions can be summarized as:

  • What are the roles of healthcare providers in assisting people with diabetes relating to identification of strategies for taking prescribed medication and improving health?

  • Within the context of medication adherence, what can be done to improve: a) clinical and b) behavioral assessments and interventions so that the best treatment and behavior change plans can be tailored for the individual living with diabetes?

  • What are best practices for addressing barriers (including system barriers) to taking medication in relation to diabetes and its comorbid conditions?

  • What can members of the diabetes care team do to enhance diabetes self-management education and training (DSME/T) and ongoing self-management support for people who are taking medication, with specific attention to populations with low literacy and low numeracy and other issues (eg, age-related, cultural, sociological)?

A Symposium Workgroup, comprising members of the AADE Research Committee, planned the symposium and established criteria for selecting a panel of academics and practitioners that would possess knowledge of diabetes, selfmanagement, and medications. Using the selection criteria, the workgroup searched the published literature and lists of conference speakers to identify potential attendees. Four multidisciplinary diabetes educators (nurse, dietitian, pharmacist, and behaviorist) who serve as members of the AADE Research or Professional Practice Committees were also invited. The Symposium Workgroup shaped the questions that would be addressed by the participant attendees and searched relevant literature to suggest a pre-reading list. A member of the AADE Research Committee served as the symposium chair; the event was facilitated by a professional moderator. These thought leaders (

Table

) included 1 physician, 3 pharmacists, 1 advanced practice nurse, 1 registered dietitian, 1 public health nurse, 2 academic researchers, 1 pharmacy student, and 2 staff members from a national association. These participants came together to examine self-care behaviors for people with diabetes, attributes of diabetes education, and factors influencing and barriers to medication use. The discussants distilled findings from published literature with the aim of providing practical advice for healthcare practitioners regarding medication use for people with diabetes, so that the overall health of this population will be enhanced.

The Taking Medication Symposium marked the third in a series of symposia designed to focus on 7 specific self-care behaviors (healthy eating, being active, taking medication, monitoring, reducing risks, healthy coping, and problem solving), described as the AADE7 Self-Care Behavior Construct.1 The symposia series is designed to translate research findings from the literature into practice and develop recommendations for members of the diabetes care team to apply to practice.

The Taking Medication Symposium began with 2 presentations: 1) a review of the literature on taking medication, and 2) Internet-based support interventions in chronic disease self-management. Following these presentations, the panel engaged in a facilitated discussion of the questions that had been shaped by the participants prior to the discussion. The moderator synthesized the key messages throughout the event. Because all portions of the discussion were recorded, the authors were able to capture the richness of the discussion.

This report provides a summary of the panel’s discussion and highlights the key points, which apply to providers involved with diabetes care. It also links the Chronic Care Model with the multidisciplinary diabetes care team and the use of motivational interviewing skills and techniques to improve pharmacotherapy adherence.2 Motivational interviewing, for example, is one approach that is used to help people with diabetes become confident and motivated so that they can effectively make behavioral changes that are essential to the self-management of diabetes.3,4

The Chronic Care Model underlies effective diabetes self-management because it places the patient at the center of the model and then intertwines the healthcare system, healthcare providers, and community to ensure that the needs of that patient are met.2 Likewise, Murray’s conceptual framework for studying medication adherence in older adults focuses on the relationship between environmental factors, patient characteristics, and medication adherence. This framework recognizes the importance of enabling resources (behavioral support), need, and outcomes, and thus has relevance for those engaged in diabetes self-management.5 While these models are relevant to the subject matter discussed in the Symposium, it was noted that there are few conceptual models that relate directly to diabetes self-management, behavior change, and medication use.

The symposium panel agreed that the field of diabetes education would best be advanced by discussing selfcare behaviors as a whole rather than separately. Indeed, what is known about diabetes self-management in general appears to also apply to taking medication. Rather than self-managing by performing each of the behaviors individually, people with diabetes make choices based on how these behaviors fit into their lifestyle. Therefore, taking medication is viewed as an integral part of the self-management continuum.6

PHARMACOTHERAPY CONSIDERATIONS

Point 1.

Pharmacologic therapy plays a vital role in the management of diabetes and is therefore a key element in the self-management of the disease.

Robust research provides clear evidence of the value of pharmacotherapy in achieving and maintaining glycemic control. Well-designed studies also document the benefits of medication in improving avoidable and costly microvascular and macrovascular outcomes of diabetes.7,8 Because of the efficacy of pharmacotherapy in lowering glycosylated hemoglobin (A1C) levels and keeping diabetes management on track, medication use has been identified by the AADE as one of the AADE7 Self-Care Behaviors.1,9 Together these behaviors form a framework for patient-centered diabetes management provided by a diabetes care team.10

Recent pharmacologic advances have broadened the antihyperglycemic options available to persons with diabetes. However, despite this expansion in medication choices and the plethora of evidence supporting diabetes pharmacotherapy, adherence to prescribed drugs is often hindered by 1 or more barriers. Consequently, the control of diabetes is suboptimal in the United States.

Optimal diabetes control is individualized but most individuals are likely to benefit from lifestyle interventions and pharmacotherapy that aims to control A1C, blood pressure, and lipid levels. Ample literature exists on A1C control and its relationship to microvascular and macrovascular complications. In 2007, Qaseem et al published a guidance statement that built upon other organizations’ guidelines and an evaluation of the strengths and weaknesses of those guidelines. The authors used an accepted appraisal instrument to evaluate the guidelines and, based on the review, developed the following recommendations: 1) “To prevent microvascular complications of diabetes, the goal for glycemic control should be as low as is feasible without undue risk for adverse events or an unacceptable burden on patients. Treatment goals should be based on a discussion of the benefits and harms of specific levels of glycemic control with the patient. A hemoglobin A1C level <7% based on individualized assessment is a reasonable goal for many but not all patients;” and 2) “The goal for hemoglobin A1C level should be based on individualized assessment of risk for complications from diabetes, comorbidity, life expectancy, and patient preferences.” A third recommendation calls for additional research.11

Three recent studies (Action to Control Cardiovascular Risk in Diabetes [ACCORD], Action in Diabetes and Vascular Disease: Preteraz and Diamicron MR Controlled Evaluation [ADVANCE], and Veterans Affairs Diabetes Trial [VADT]) have been undertaken to advance understanding of effective A1C target levels by comparing tight glycemic control with standard glycemic control. The ACCORD clinical trial, with 10,251 participants, examined an intensive blood sugar—lowering strategy. The trial ended in 2008 due to safety concerns. A data review found that patients who received intensive treatment to lower blood glucose were at higher risk for death; participants in the intensive blood sugar treatment group were transitioned to the standard treatment strategy.12

The ADVANCE trial, with over 11,000 participants worldwide, demonstrated that “intensive glucose control with a gliclazide MR—based treatment regimen in people with type 2 diabetes reduces the combined risk of microvascular and macrovascular events, primarily through reductions in the risk of diabetic nephropathy.13 The ADVANCE data found that compared with standard treatment, intensively lowering A1C levels does not pose a greater risk to patients with type 2 diabetes. The VADT compared a group under intensive therapy (targeting A1C of <7%) with the group under standard therapy (A1C target of 8% to 9%) to assess macrovascular complications. The VADT participants were also treated with drugs and lifestyle therapies to control their blood pressure and blood lipid levels. The study found that while it is difficult to manage the therapy in an older population with long-term diabetes and chronic complications, it is possible to obtain significant improvement in glycemic levels and other risk factors of these individuals. However, the study also found that isolated glycemic control does not have significant effect in reducing cardiovascular events in people with long-standing type 2 diabetes.14

It is not surprising that guidelines for A1C control differ slightly.15,16 The American Diabetes Association (ADA) 2010 clinical practice recommendations state, “Lowering A1C below or around 7% has been shown to reduce microvascular and neuropathic complications of type 1 and type 2 diabetes. Therefore, for microvascular disease prevention, the A1C goal for nonpregnant adults in general is <7%.” The ADA recommendations also note that less stringent A1C goals may be appropriate for patients with a history of severe hypoglycemia, limited life expectancy, advanced microvascular or macrovascular complications, and extensive comorbidities.17 The ADA also supports the use of diagnosing diabetes using A1C, for which the diagnostic criterion is 6.5%.17 The American Association of Clinical Endocrinologists (AACE) “recommends that people with type 2 diabetes reach an A1C goal of 6.5% or less.”18 Moreover, AACE and the American College of Endocrinologists (ACE) “do not endorse A1C criteria for pre-diabetes or for those at risk for diabetes. AACE/ACE support an A1C of 5.5% to 6.4% as a screening test for pre-diabetes if it leads to measurement of fasting glucose or a glucose tolerance test for diagnosis.”19

Findings of the ACCORD, ADVANCE, and VADT studies provide a vital link between A1C control, selfmanagement, and medication taking. Clinical practice guidelines indicate the importance of pharmacologic therapy as a component of diabetes management, along with self-management education. In summary, pharmacologic therapy plays a vital role in the management of diabetes and is a key element of the self-management of the disease.

Point 2.

Several factors can impede medication adherence among persons with diabetes, and a link has been shown between poor medication adherence and suboptimal diabetes control.20-22

Community pharmacists are in a prime position to help patients with medication adherence, as they see the patients more often than any other healthcare provider does. However, the current healthcare delivery system hinders optimal patient-centered care. Most community practice pharmacists do not have access to patients’ medical records. They may not even have complete prescription records, if patients filled medications at more than 1 pharmacy. This presents a challenge for pharmacists to provide a thorough medication review, adherence assessment, and optimal therapy management.

Many pharmacists work with people with diabetes and recognize 3 types of impediments to medication adherence:

1. Knowledge deficit (eg, patient lacks knowledge/understanding of the purpose of taking the medication, when to take the medication to get the best therapeutic effect with the fewest adverse effects [AEs], or how to use the medication correctly).

2. Practical (eg, financial constraints, busy schedule, poor health literacy, inability to see vial/syringe due to impaired eyesight).

3. Motivational (eg, cultural, family, and health beliefs).

A medication use systematic review examined the challenges and barriers to taking medication (adherence) for people with diabetes.23 Medication adherence is problematic in diabetes. The symposium participants concurred that few interventions on adherence in diabetes self-management have been rigorously studied, and assessment of medication adherence does not appear to be a standard practice. Diabetes medication adherence rates range from 31% to 87% in retrospective studies and from 53% to 98% in prospective studies.23 An 80% adherence rate translates into missing 1 of every 5 doses of a once-daily medication—or 1 to 2 doses per week.

Factors most frequently reported to hinder diabetes medication adherence are regimen complexity (eg, >1 diabetes medication, need to split tablets, need to mix products), dosing frequency greater than twice daily, remembering doses and refills, depression, and AEs or fear of them.20-24 Pharmacies may be able to improve medication adherence rates of oral antihyperglycemic agents by using refill reminders and unit-dose packaged medication.15 While more evidence is needed to support specific interventions for medication adherence, diabetes educators are in a key position to promote medication adherence.24

Insulin use presents a unique set of challenges. According to an informal survey of diabetes educators in 2005, factors suggested as barriers to using insulin include patient resistance and fear, weight gain, inconvenience, physician resistance, inadequate support, cost, lack of access to medications, and confusion about medication use.25 In a survey of 1267 individuals with diabetes, 28% of people who were not taking insulin indicated an unwillingness to use insulin therapy.26 The

most frequently cited reasons for wanting to avoid insulin therapy included the sense of personal failure (55%), pain of injection (51%), effect of insulin on increasing illness severity (47%), permanence of therapy (45%), restrictiveness (45%), and concern about problematic hypoglycemia (43%).

Point 3. Integrate taking medication with self-care education.

It is important that people with diabetes develop knowledge and self-management skills related to medication use. “The goal is for the patient to be knowledgeable about each medication, including its action, side effects, efficacy, toxicity, prescribed dosage, appropriate timing and frequency of administration, effect of missed and delayed doses, and instructions for storage, travel and safety.”27 The diabetes care team therefore not only determines which medications a patient with diabetes requires, but also helps the patient understand how the medications work, how and when to take them, and how to problem solve in regard to medication use. Essentially, adherence can be achieved most effectively by integrating medication use into the patient’s overall understanding of the disease and self-management.

Point 4.

Clinical and behavioral assessments, clinical interventions, and treatment plans for people with diabetes are most effective when they are customized for the needs and situations of the people with diabetes.

All members of the diabetes care team must consider the patient’s lifestyle and then tailor behavior change plans accordingly. It is also essential to consider where the patient is in the life cycle. Individualized plans begin by asking people with diabetes to describe how taking their medication fits into their lifestyle. An important element of this approach is the patient’s involvement in developing the plan, which increases the likelihood of the adherence. For this reason, a didactic approach to medication use should be avoided.

Various cultural, sociological, age-related, and other issues impact a person’s motivation, willingness, and ability to adhere to prescribed diabetes medications. Polonsky et al have found “psychological insulin resistance” to be common among a substantial number of people with diabetes who refuse insulin therapy once it is prescribed.26 In addition to fearing needles, many people with diabetes are fearful of taking insulin because they believe it signals a worsening of their disease and worry about developing a dependency on insulin once they begin therapy. The panelists noted that some providers create or exacerbate psychological insulin resistance by using insulin as a “threat,” indicating it will be needed if other interventions fail to achieve glucose control. Educating people with diabetes is essential to overcome the mind-set of psychological insulin resistance. Primary care providers can work in partnership with diabetes educators to assure that people with diabetes receive self-management education. All providers must convey the same messages to the patient and inform the patient that they are working as a team.

Age influences taking medication, with each stage in life posing a different set of potential barriers and challenges.27 Vision impairments and arthritis can make it difficult for elderly people with diabetes to self-administer insulin. Unique challenges also extend to younger individuals with diabetes. Adolescents often struggle with stigmas at school because of their need to take insulin. In addition, young women influenced by today’s “thin culture” may skip their insulin doses due to a fear of gaining weight. The symposium discussants noted that in families where English is the second language, younger family members are responsible for translating education to older adults with diabetes. Appropriate training and guidance needs to occur so that these younger individuals, some as young as middle-school age, are supported in their roles as translator and cultural advocate. It would therefore be helpful to implement educational interventions that focus on diabetes at schools.

Point 5. Best practices for addressing barriers to taking medication begin with sound principles in communication.

To help overcome any knowledge deficit that may exist, the clinician must use terms that are comprehensible to people with diabetes, without speaking down to them.28 The use of understandable analogies is an excellent means for communicating technical information. As an example, A1C can be called a “detective” that provides a critical piece of information in the management of diabetes. To help people with diabetes identify strategies for taking their medication, a safe environment in which no judgments will be made about a patient’s behavior or situation is critical. The provider needs to facilitate an honest dialogue, asking the patient to relate any problem he or she foresees in taking the prescribed medication.

Point 6. There is overlap across the roles of members of the diabetes care team in regard to taking medication.

It is often the diabetes educator who initiates discussion on concerns relating to taking medication. Educators would be better equipped to approach this topic if they understood that medication nonadherence is the norm rather than the exception among persons with diabetes. People with diabetes often wrestle with the effects of comorbidities as well as life challenges that may make them less likely to adhere to their pharmacotherapy. Instead of adhering, many people with diabetes make choices to “trade off” dealing with one challenge (eg, taking medication) for another. The history of healthcare suggests that nonadherence may constitute an adaptive characteristic of humans, suggesting differences in the underlying beliefs between those being treated and those providing the care. Diabetes educators have the competencies to provide individualized and culturally sensitive self-management education that aligns with the individual’s unique belief system; moreover, they can work with community health workers (CHWs) to overcome what might be called “the belief gap.”29

As detailed in the Chronic Care Model, community resources should be involved in providing diabetes selfmanagement support. Medical assistants and CHWs can play a valuable role.10 Often these individuals hear about problems a patient is encountering before the provider learns of them; some people with diabetes wish to avoid “looking bad” in the eyes of the provider, but have no such qualms regarding community workers.

Effective and sustainable diabetes education teams are beginning to involve CHWs. As an example, a certified diabetes educator (CDE) serves as the education program supervisor, has the overall responsibility for the self-management education of the person with diabetes, and provides all the clinical self-management teaching. The CHW provides all the nonclinical instruction, serves as a bridge to the community, and adds cultural relevancy. While the “supervisor” reads the patient’s chart, the CHW provides training on community resources that are available to support people with diabetes and helps identify sources of affordable medications. The CHW also reminds participants what they were taught by the educator and provides them opportunities to restate and practice what they have been taught, assisting people with low literacy or language gaps by reading materials to them in their native language.30

Point 7. Tools to screen for medication adherence are emerging.Participants in the panel explained that many pharmacists ask people with diabetes 3 primary questions about their understanding of the indications for the medications. The questions were developed by the Indian Health Service.13,31,32 Pharmacists discuss the questions and responses with the person with diabetes, with the aim of improving medication adherence by overcoming fear and confusion.

For newly prescribed medications:

1. What did your doctor tell you this medication is for?

2. How did your doctor tell you to take this medication?

3. What did your doctor tell you to expect from this medication?

For refills:

1. What are you taking this medication for?

2. How are you currently taking this medication?

3. What have you noticed that is different since you started taking this medication?

Based on these questions, a medication checklist is created delineating key questions that people with diabetes can ask their provider and pharmacist. Members of the diabetes care team could use a similar checklist to ensure that people with diabetes are well-informed on their pharmacotherapy. New medication adherence screening tools for people with diabetes with chronic illness are emerging.33

Medication adherence can be facilitated by printed materials that educate people with diabetes on the progressive, variable nature of diabetes and on the impact that life changes may have on the disease. Such education should begin early in the DSME/T process and include a discussion of the role of pharmacotherapy. Resistance among people with diabetes to use insulin in the future may be minimized if they are advised—early on and continually—that insulin is a safe and effective medication for lowering A1C and might be required at some point in their lives to manage the disease.

Point 8.

Overcoming system barriers via the concept of empowerment within the healthcare system, across the healthcare team, and into the community.

Adherence is subject to systemwide barriers that reduce access to care and affordable medications. Both the use of medication and self-management are cost-effective for people with diabetes.34,35 To communicate this, some employee groups bring in pharmacists to coach their employees about diabetes, the role of medication, and pharmaceutical coverage policies.36

As part of the diabetes care team, diabetes educators (nurses, dietitians, and pharmacists) apply in-depth knowledge and skills in the biological and social sciences, communication, counseling, and education to provide self-management education/self-management training. The diabetes educator’s ability to play a role in addressing system barriers and serve as a patient advocate is limited because there are 24 million people in the United States with diabetes and only 16,000 diabetes educators. The need to better fill this gap is apparent. In this regard, the role of community resources takes on greater importance, but often is accompanied by reduced assurance in the provision of accurate and consistent diabetes information. Regardless of this concern, information about diabetes is being exchanged throughout the community every day—at beauty shops, barbershops, the supermarket, coffee shops, and elsewhere.

Members of the diabetes care team can strive to improve the quality of information that is provided in the community. Even small steps toward improvement would be useful. Clinicians are urged to explore new ways to achieve outreach to people with diabetes and those in the community who provide support to them. Diabetes educators can serve as the initiators—addressing options for reaching out to the people in their communities and making diabetes self-management education a viable, reimbursable service for persons with diabetes. At the same time, the public health community is urged to work in tandem with clinical care. This calls for acknowledging and facilitating the critical link between diabetes selfmanagement and clinical care.

Point 9.

With medical care becoming continually more complex, people with low health literacy and low numeracy will be in even greater need of medication information and adherence interventions tailored to their capabilities.

The provision of pharmacotherapy information and strategies that are comprehensible to people with low health literacy or for whom English is a second language is a serious concern today that will only loom larger in the future.37,38 This spotlights the need for rigorous research in this area, and members of the diabetes care team clearly can play a leading role.

The discussants suggested that typically, diabetes medication information today is written at the 10th or 12th grade reading level; materials and adherence interventions aimed at low health literacy/numeracy people with diabetes are virtually nonexistent. Both literacy and numeracy skills are important for successful self-management of diabetes. Numeracy is particularly relevant for taking the correct medication dosage, self-monitoring of blood glucose, and carbohydrate counting by those on insulin.

Various cues can help or hinder determination of a patient’s literacy level. With this population, it is particularly helpful to assess the individual’s best method of learning. The panel emphasized that inability to read is not a reflection of a person’s intelligence. Furthermore, in this context, the terms “health literacy” or “functional literacy” are more descriptive than “literacy.”

Point 10.

Ongoing support of persons with diabetes is as important as diabetes self-management education and training.

Diabetes self-management training is often erroneously viewed and reimbursed by healthcare systems as a finite process. In reality, diabetes self-management education should be a continual, lifelong learning process—not only because diabetes is a progressive disease but also because it can fluctuate in the face of lifestyle changes and added stressors. The National Standards for DSME/T require educators to establish a plan for their people with diabetes to ensure that they receive ongoing support. Diabetes Self-Management Support (DSMS) builds upon the principles of patient empowerment and self-determination.39

Online Self-Management Support Interventions, also called technology-enabled behavior change interventions, include a useful construct for addressing the different influences on health behavior change and improvement of outcomes and can be integrated into DSMS.40 Online Self-Management Support Interventions can help people with diabetes adopt and sustain healthful behaviors. Two hallmark features of these online support programs are patient engagement in health applications and integration of their performance using data from biometric devices.

Typically, online support programs consist of evidence-based behavioral or cognitive-behavioral approaches, are highly structured, and are either fully or partially self-guided. These programs are personalized to the user and provide customized follow-up and feedback from the clinician.41 Although not all people with diabetes have access to computers or use them with confidence, making optimal use of information technology, online interventions can offer several potential advantages to people with diabetes and their clinicians. These interventions may enable people with diabetes to receive interactive, evidence-based support at any time and improve population monitoring, tracking, and reporting and facilitate long-term follow-up of each patient.

CONCLUSIONS

Adherence to antihyperglycemic medication often is impeded by a variety of barriers. Lifelong DSME is needed to help people with diabetes with taking medication as changes occur in their lives. Members of the diabetes care team are urged to look at the patient as a whole and consider age and other characteristics, respecting the patient’s right to make decisions and taking into consideration lifestyle factors that impact taking medication and other behaviors. The chronic care model, which supports the multidisciplinary team, provides only an indirect link to delivery of self-management education and training that is designed to achieve appropriate medication use and adherence. Although there is a gap in available conceptual models upon which to advance medication-taking by those with diabetes, new pharmacologic therapies and changes in dosing are driving an ongoing evolution in self-management of diabetes that builds upon a concerted team approach and includes diabetes education.