US Pharm. 2015;40(10):HS31-HS40.

ABSTRACT: Providing medication therapy management (MTM) for patients with diabetes presents many challenges. Adherence problems include drug regimen, system, and patient-related barriers. Diabetes therapy should always incorporate components of behavior change. Therefore, a variety of counseling topics are needed in order to achieve optimal outcome goals. At a minimum, counseling sessions should include the following subjects: goals of therapy, drug regimen concerns, diet, and exercise. Motivational interviewing can serve as a valuable tool for achieving behavior changes. To obtain reimbursement for their services, pharmacists could complete a credentialing program and set up MTM services. Although providing MTM for patients is challenging, proper implementation of such services can be highly rewarding.

Diabetes is a debilitating disease that affected 29.1 million Americans, or 9.3% of the population, in 2012.¹ Diabetes is the seventh leading cause of death, and the risk of mortality is doubled in people with this disease.² For patients who do not achieve therapeutic goals, microvascular diseases (e.g., nephropathy, neuropathy, and retinopathy) and macrovascular diseases (e.g., heart disease and stroke) can be a frightening future reality. An increasing number of patients annually are affected by diabetes, which can be attenuated mainly by behavior change measures and appropriate medication management. Therefore, pharmacists in a variety of practice settings are well positioned and qualified to fulfill this role. Pharmacists should be able to recognize barriers to optimal diabetes care, counsel patients appropriately, and—if needed—provide medication therapy management (MTM) services.

BARRIERS TO ADHERENCE

Overcoming Common Medication Barriers

Barriers to adherence can be associated with the medications themselves. Commonly cited barriers in this category include drug costs, adverse effects (AEs), increasing regimen complexity, or increased frequency of dosing.^3,4 Insurance companies’ changing payment terms and tiers of classification can also result in nonadherence. Pharmacists can help reduce costs in a variety of ways. Generics should be used when available, and changing to combination drug formulations can be effective. Regimens may also be simplified by changing to once-daily extended-release formulations. Ancillary supplies, such as monitors, strips, needles, and pen needles, should be written as prescriptions to enhance the likelihood of insurance coverage. Pill organizers, alarms or calendars, and blister packaging could enhance adherence.⁵ Patients who are technologically inclined should be introduced to cell phone applications on diabetes self-management.

Common AEs should also be addressed. For example, extended-release metformin is less likely to cause gastrointestinal effects. Patients experiencing hypoglycemia with sulfonylureas could be changed to another class, or glyburide could be changed to glimepiride. The pharmacist should ensure, however, that the A1C-lowering capacity of the new drug product is comparable. Pharmacists should recommend changing to products with a lower risk of AEs or drug interactions. Of course, nonadherence also could result from patients attributing AEs to a drug when it is not necessarily causing the problem. Pharmacists should address such concerns appropriately.

Special attention should be paid to patients taking insulin. Pharmacists could recommend less expensive insulin regimens. Community pharmacists should be cognizant of the number of pens or vials in the prescription versus the number actually needed for the patient’s dose. If the patient receives insufficient insulin for the entire month, the patient may “adjust” the dose, resulting in poor glycemic control. Patients may also reduce the insulin dose on their own when taking medium-acting insulin with peaks (e.g., neutral prolamine Hagedorn insulin 70/30) and experiencing unexpected hypoglycemic episodes.⁶ It is important for pharmacists to identify these problems and take appropriate action.

Other Types of Barriers

System- and patient-related barriers can lead to nonadherence. Examples of system-related barriers include insufficient counseling time with healthcare professionals (HCPs) and lack of appropriate follow-up appointments.⁷ Patient-related barriers can be highly individualized, including poor health literacy, misunderstanding or fear of drugs, fear of worsening disease, lack of skills to perform self-monitoring of blood glucose (SMBG), poor injection technique, poor family dynamics or health habits, depression, and concurrent medical conditions.⁸

Pharmacists are in an opportune position to address these barriers, given their knowledge of appropriate diabetes treatment and good counseling skills. Pharmacists should ask patients about self-monitoring habits and injection technique, and knowledge-based discrepancies should be resolved. Patients should be instructed thoroughly on the use of drug products, including dosing, storing, efficacy, and AEs. Patients can make wrong decisions when their understanding is incomplete. For example, after experiencing hypoglycemia, the patient may discontinue the incorrect drug (e.g., stop metformin instead of the sulfonylurea or short-acting insulin) and fail to relay this information to the HCP.

Patients’ perceptions of their treatment plan can differ from those of the HCP. One study comparing patient views with treatment guidelines discovered that negative perceptions occurred with dose or therapy escalation.⁹ Patients viewed therapy intensification as a personal failure and believed more strongly that complications would develop. To counter these perceptions, pharmacists can emphasize that drug products are tools to improve health. Just as a builder may need special and multiple tools instead of simply a hammer and nails to build a house, the patient may need multiple drug products. How these products work together should be emphasized.

Progression from oral medications to insulin therapy is common. However, for many reasons, patients often perceive this negatively—they may have a fear of giving injections or may view this progression as a personal failure or even as an end stage of diabetes (e.g., “My father was started on insulin years ago and died soon afterward”). These perceptions should be addressed definitively, with insulin promoted as simply another (and often more effective) tool for achieving the goal A1C, and the long-term perspective for good glycemic control should be emphasized.¹⁰

COUNSELING AND MTM CONCEPTS

Primary Counseling Concepts

In order to achieve therapeutic goals, patients with diabetes need to understand some key concepts, including

• Types of diabetes, and which type they have (the misconception persists that a person who takes insulin has type 1 diabetes mellitus [T1DM])

• Goals of therapy (including A1C goals, fasting and postprandial glucose goals, and how to correlate self-monitoring results with overall A1C)

• At what blood glucose (BG) levels hypoglycemia and hyperglycemia present and what action to take for each

• Lifestyle modifications (exercise, medical nutrition therapy [MNT])

• Medications (with possible barriers addressed as well)

• Diabetes self-management education (including SMBG)

• Appropriate foot care and sick-day management.

Diet and Exercise

In a person with diabetes, behavior change is an essential part of the ability to achieve therapeutic goals. Exercise and diet are still considered the cornerstone of therapy. If a patient does not fully adhere to a new exercise and diet plan and make this his or her new standard, the pharmacist can titrate even insulin to maximum doses without ever achieving therapeutic goals.

According to the American Diabetes Association (ADA), the exercise goal for adults is to engage in moderate-intensity aerobic exercise for at least 150 minutes each week.¹¹ Although the ADA indicates that this amount of exercise could be spread over at least 3 days per week, patients could be encouraged to pursue a goal of one 30-minute aerobic exercise, or two 15-minute sessions, for 5 days per week.¹¹ No more than two consecutive days should pass without exercising. This directive should encourage the development of a standard exercise routine, which is essential in behavior change.

Patients should exercise aerobically to achieve a heart rate that is 50% to 70% of the maximum heart rate, and they should be encouraged to limit sedentary time to no more than 90 minutes at a time.¹¹ Studies have shown an added benefit from implementing resistance training into aerobic exercises. Resistance training is the use of an opposing force, such as dumbbells or resistance bands, to exercise the muscles. At least two sessions of resistance exercises per week should be encouraged.¹¹

Patients often think they are exercising adequately when, in fact, they are not. They may think that the level of exercise involved in doing office work, watching young children, or performing gardening or yard work is adequate. In reality, patients may not be achieving an elevated heart rate during these activities. When discussing exercise goals with patients, the pharmacist should be sensitive to inadvertently discounting the activities patients already engage in. If baseline activities are recognized, the patient is often willing to discuss other ways of increasing exercise levels.

The ADA addresses dietary goals through MNT, which includes the development of an individualized eating plan. The following concepts are supported: providing a variety of nutrient-dense foods, basing choices on personal and cultural preferences, and maintaining the overall pleasure of eating. While portion control and healthful food choices may be emphasized, patients should be provided with practical tools for day-to-day meal planning rather than focusing on single foods.¹¹

Exercise and dietary recommendations should be tailored to weight-loss goals. Type 2 diabetes mellitus (T2DM) patients who receive individualized recommendations have experienced a weight loss of 4 to 16 pounds, especially early in the disease process. Weight-loss studies have incorporated a variety of eating patterns, along with exercise plans. Examples include the Dietary Approaches to Stop Hypertension (DASH) diet and Mediterranean-style, plant-based, lower-fat, and lower-carbohydrate plans.^12-15

While there exists no one-size-fits-all approach to weight loss from exercise and MNT, the prudent pharmacist should be prepared to initiate a personalized plan. Often, patients are overwhelmed with the volume of literature available, some of which can be contradictory and perplexing. Simple literature tailored to the particular population can assist the patient in getting started, and having such handouts available to review with the patient can be very helpful. TABLE 1 contains examples of material that could be covered. Any efforts the patient is making should be applauded during each visit, whether the achievement is losing weight, starting an exercise regimen, or altering some aspect of his or her diet. Behavior change is difficult and usually achieved through a series of small steps.

Patient Motivation

One excellent tool at the pharmacist’s disposal to help the patient implement behavior change is motivational interviewing.¹⁶ This involves collaborating with the patient to strengthen motivation for and movement toward therapeutic goals. Most diabetes patients encounter an authoritative style of counseling from HCPs. In contrast, a patient-centered counseling style explores the patient’s readiness to make changes and assists him or her in making the decisions necessary for change. When faced with the necessity for behavior changes and medication adherence, patients are frequently ambivalent—or even actively resistant.

Developing a therapeutic relationship with the patient and allowing the patient to maintain autonomy in each decision are key components of motivational interviewing.¹⁶ For example, consider a patient who routinely has poor glycemic control and over a period of several months seems to be making only minimal behavior changes. At this point, pharmacists tend to discuss the microvascular complications that could occur. This scare tactic may come across to the patient as a parental style in which he or she is being admonished for doing something wrong. Instead, the pharmacist should give this type of information—and only in a nonjudgmental way—after first asking the patient’s permission to do so. The pharmacist can ask, “Would you mind my discussing with you what could happen in the long term if your blood sugar continues to be elevated?”

Another example is to discuss self-monitoring of BG, and then offer to check it during the visit. Whatever the patient’s BG result, the pharmacist can ask, “Did you expect the result to be higher or lower than this?” This often leads to a full discussion of the patient’s eating and exercising habits, the need for regular BG monitoring, and actions that could be undertaken for hyperglycemia or hypoglycemia.

These techniques enable the patient to maintain autonomy in whether and how behavior changes are made. They also allow the patient to self-identify the ramifications of his or her actions (or inaction, as the case may be). This approach is much more powerful than an authoritative style for discussing aspects of diabetes self-care. Other components of motivational interviewing are reviewed in TABLE 2.

Goals of Therapy

For most adults with diabetes, the A1C goal is <7%, the preprandial glucose level should be 80 to 130 mg/dL, and the peak postprandial level should be <180 mg/dL.¹¹ However, goals should be individualized, with many factors (including patient preference) taken into account. Less stringent goals may be warranted for individuals who cannot safely tolerate such targets because of hypoglycemia. Other unmodifiable characteristics that may necessitate less stringent goals include long-standing diabetes, shorter life expectancy, severe comorbidities, and severe vascular complications. Although HCPs are aware of these goals, they may not discuss them thoroughly with patients. Such patients should be encouraged to talk about these goals with their healthcare team. The patient with sufficient knowledge about his or her goals is more likely to be diligent in using the tools needed to achieve them—exercise therapy and MNT, medication adherence, and self-management of BG.

Optimal Pharmacotherapy

For T1DM, multiple-dose insulin injections or continuous SC insulin infusions are recommended.¹¹ Three to four injections per day should be given in a combination of basal and prandial insulin regimens. This is the optimal way to achieve therapeutic goals while mimicking the normal physiological function of the pancreas. Additionally, the use of insulin analogues is recommended in order to reduce the risk of hypoglycemia as much as possible.

For T2DM, metformin therapy is recommended upon or soon after diagnosis. Metformin can reduce the A1C significantly, has a good safety profile and low cost, and offers a possible reduction of cardiovascular events.¹¹ If metformin is not tolerated, the A1C goal is not achieved after 3 months, or the initial A1C is 9%, combination therapy should be considered. The ADA recommends six treatment options in combination with metformin: sulfonylureas, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide-1 agonists, and basal insulin. An individualized, patient-centered approach is optimal. Drug choices should be based on a consideration of patient preference, hypoglycemia risk, effects on weight, other AEs, and cost.

Insulin therapy should be initiated if combination therapy fails to achieve therapeutic goals or if the A1C is 10%.¹¹ Basal insulin is usually initiated at 10 U daily or 0.1 to 0.2 U/kg, and then titrated up by 10% to 15% or 2 to 4 U once or twice weekly to reach therapeutic goals. Basal insulin may be used in combination with metformin and possibly another noninsulin drug choice. Titrated basal insulin may be insufficient for achieving the target A1C goal, but fasting glucose levels may be reaching the goal. At that time, mealtime insulin injections may be necessary. Pharmacists should provide such patients with comprehensive education, including exercise, MNT, SMBG, hypoglycemia awareness, and what to do when hypoglycemia occurs.

SETTING UP MTM

A number of credentialing options are available for pharmacists. A certificate training program offered by the American Pharmacists Association includes education on appropriate drug management, lifestyle modifications, use of devices, and physical assessment.¹⁷ One of the best-recognized credentials among HCPs and the health insurance industry is Certified Diabetes Educator (CDE).¹⁸ Many HCPs, including pharmacists, are eligible to sit for the examination after completing at least 2 years of professional practice experience and 1,000 hours of direct diabetes patient care. Another credentialing opportunity is Board Certified-Advanced Diabetes Management (BC-ADM) certification. After completing 500 clinical practice hours, the HCP can then sit for the examination.¹⁹ Becoming credentialed can also assist in marketing the MTM service. Pharmacists are also encouraged to complete continuing education programs on diabetes and to read associated journals, such as Diabetes, Diabetes Care, Clinical Diabetes, and The Diabetes Educator.

Having an appropriate area for counseling the patient and conducting MTM services is key. While a separate, dedicated room is optimal, it is not absolutely necessary for providing MTM services. However, the area should be conducive to counseling. Sufficient storage space should be available for documentation, brochures, handouts, models, and other demonstration devices. If point-of-care testing is allowable by state law, BG testing and A1C testing could be included after appropriate Clinical Laboratory Improvement Amendments (CLIA) application forms are completed and filed.²⁰ For other specific state requirements for working with CLIA-waived devices, the Occupational Safety and Health Administration may be consulted.

Needs Assessment

The needs of diabetes patients in the pharmacy should be evaluated, including such factors as the percentage of patients obtaining refills for oral diabetes drug products or insulin and self-monitoring equipment. Other questions should be asked about the population of patients with diabetes. Are drugs purchased through insurance or self-pay? Do patients with diabetes generally ask questions of the pharmacy staff? Has the number of separate drugs needed and/or doses increased over time? Are more people taking insulin over time? What percentage of the local population has diabetes? Are other diabetes programs available in the community? Even if other diabetes programs are available, considering the high prevalence of patients with diabetes and the tendency for the disease state to worsen over time, such services may be needed.²¹

External Stakeholders and Marketing

External stakeholders mainly include patients and HCPs. Patients who can be targeted for MTM services would be those discussed above, most likely the ones with whom the pharmacist already has a relationship. This principle of targeting applies to HCPs as well. Not all HCPs in the community have to be included for a successful MTM service to be implemented. Often, a collaborative relationship with one HCP can lead to relationships with other providers in the community.

Physicians and other HCPs could be contacted for face-to-face discussions, preferably away from their busy clinics, in order to pitch the MTM service. The discussion should concentrate on services the pharmacy could provide and how therapeutic goals for diabetes could be achieved.²² The pharmacist should have a sample of handouts, monitoring programs, and point-of-care instruments. The mechanism by which provider communication would take place is important also. Counseling aspects for exercise and MNT should be emphasized along with MTM, as the HCP is likely to have an appreciation of the time-consuming nature of behavior change counseling. Support staff should not be forgotten, either. Nurses and other clinic staff are valuable resources for identifying potential patients who could use more intensive diabetes education. Once suitable providers agree to the MTM proposal, they should sign a collaborative practice agreement. This document permits MTM within a certain scope of practice for the pharmacist under terms that are acceptable to the provider.²³

When marketing MTM services, word of mouth through patients and HCPs with whom the pharmacist has established a relationship is invaluable. The traditional avenues, such as advertisements on local television and radio stations, should be pursued. Recorded messages could be played when a caller is on hold, and posters and bag-stuffers are good marketing tools. Social media is becoming increasingly important for all businesses. Patients should be encouraged to “like” the MTM Facebook account and to “follow” the Twitter account. Make sure that advertisements include the kickoff day or grand-opening event that the pharmacy will hold for its MTM services. This event, in particular, should be well staffed. Having glucose or even blood pressure or cholesterol screenings will attract more attention to the event.

The Value of Simple Counseling

Patients with diabetes receive unsolicited information from a multitude of sources, including television, magazines, friends, and relatives. These sources can appear authoritative, but may provide conflicting (and often misleading) information. Pharmacists should not underestimate the value of appropriate counseling in any setting. Support, encouragement, and correct advice from a medical professional are essential. MTM is important, but the foundation for gaining control ultimately lies with behavior change by the person with diabetes. When the patient feels that an HCP genuinely cares about his or her health and therapeutic goals, a collaborative relationship is built that can lead to successful achievement of those goals.

CONCLUSION

Many barriers exist for optimal drug adherence for diabetes, including those that are system-related, patient-related, and associated with the drugs themselves. Patients should be counseled on a variety of topics, including drug products and behavior change with regard to exercise and MNT. When patients are resistant to components of behavior change, motivational interviewing can be a helpful tool to assist them in taking the necessary steps for change. Pharmacists interested in serving patients with diabetes more intensively could create an MTM service. When implemented and maintained, an MTM service for diabetes is a valuable asset to the community and for the individual to achieve optimal glycemic control and therapeutic goals.

REFERENCES

1. American Diabetes Association. Statistics about diabetes. www.diabetes.org/diabetes-basics/statistics. Accessed July 25, 2015.
2. CDC. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014. Atlanta, GA: U.S. Department of Health and Human Services; 2014.
3. Odegard PS, Capoccia K. Medication taking and diabetes: a systematic review of the literature. Diabetes Educ. 2007;33:1014-1029.
4. Bubalo J, Clark RK Jr, Jiing SS, et al. Medication adherence: pharmacist perspective. J Am Pharm Assoc (2003). 2010;50:394-406.
5. Marzec LN, Maddox TM. Medication adherence in patients with diabetes and dyslipidemia: associated factors and strategies for improvement. Curr Cardiol Rep. 2013;15:418.
6. Edelman S, Pettus J. Challenges associated with insulin therapy in type 2 diabetes mellitus. Am J Med. 2014;127(suppl 10):S11-S16.
7. Ross SA. Breaking down patient and physician barriers to optimize glycemic control in type 2 diabetes. Am J Med. 2013;126(9 suppl 1):S38-S48.
8. Beardsley RS, Kimberlin CL, Tindall WN. Communication Skills in Pharmacy Practice. 5th ed. Baltimore, MD: Lippincott Williams & Wilkins; 2007:38-49.
9. Grant RW, Pabon-Nau L, Ross KM, et al. Diabetes oral medication initiation and intensification: patient views compared with current treatment guidelines. Diabetes Educ. 2011;37:78-84.
10. Peyrot M, Rubin RR, Lauritzen T, et al. Psychosocial problems and barriers to improved diabetes management: results of the Cross-National Diabetes Attitudes, Wishes, and Needs (DAWN) Study. Diabet Med. 2005;22:1379-1385.
11. American Diabetes Association. Standards of medical care in diabetes—2015. Diabetes Care. 2015;38(suppl 1):S20-S48.
12. Estruch R, Ros E, Salas-Salvadó J, et al. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med. 2013;368:1279-1290.
13. Azadbakht L, Fard NR, Karimi M, et al. Effects of the Dietary Approaches to Stop Hypertension (DASH) eating plan on cardiovascular risks among type 2 diabetic patients: a randomized crossover clinical trial. Diabetes Care. 2011;34:55-57.
14. Turner-McGrievy GM, Barnard ND, Cohen J, et al. Changes in nutrient intake and dietary quality among participants with type 2 diabetes following a low-fat vegan diet or a conventional diabetes diet for 22 weeks. J Am Diet Assoc. 2008;108:1636-1645.
15. Stern L, Iqbal N, Seshadri P, et al. The effects of low-carbohydrate versus conventional weight loss diets in severely obese adults: one-year follow-up of a randomized trial. Ann Intern Med. 2004;140:778-785.
16. Miller WR, Rollnick S. Motivational Interviewing: Helping People Change Behavior. 3rd ed. New York, NY: Guilford Press; 2013:155-243.
17. American Pharmacists Association. The pharmacist & patient-centered diabetes care [diabetes certificate program]. www.pharmacist.com/pharmacist-patient-centered-diabetes-care. Accessed July 24, 2015.
18. National Certification Board for Diabetic Educators. Certification information. www.ncbde.org/certification_info. Accessed July 24, 2015.
19. American Association of Diabetes Educators. Target audience statement. www.diabeteseducator.org/education-career/certification/bc_adm. Accessed July 24, 2015.
20. CMS.gov. Clinical laboratory improvement amendments (CLIA). www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia. Accessed July 24, 2015.
21. Kliethermes MA, Brown TR, eds. Building a Successful Ambulatory Care Practice: A Complete Guide for Pharmacists. Bethesda, MD: American Society of Health-System Pharmacists; 2012.
22. Chawla S. Nontraditional or noncentralized models of diabetes care: medication therapy management services. J Fam Pract. 2011;60(suppl 11):S12-S18.
23. Lewin Group. Medication therapy management services: a critical review. J Am Pharm Assoc (2003). 2005;45:580-587.
24. American Diabetes Association. DiabetesPro professional resources online. http://professional.diabetes.org/PatientEducationLibrary.aspx. Accessed July 24, 2015.

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