NCPIE’s National Action Plan for Improving Patient Compliance to Medications – an Opportunity Missed – Varun Ektare

Poor compliance to medications is a serious problem that has plagued the healthcare system in USA. The cost of non compliance to medications has reached a staggering $177 billion annually. (1) Around a quarter of total employer healthcare costs arise because of noncompliance to drug regimen. (2) Non compliance is seen in almost half of the patients with chronic illnesses; which is a cause of serious concern, as chronic conditions represent 75% of total healthcare expenditure. (3, 4) Noncompliance toward drugs that treat chronic diseases such as diabetes, hypertension or elevated cholesterol can often have serious health consequences. It is also a business issue for the pharmaceutical industry whose sales are affected by billions of dollars due to non compliance.

The National Council on Patient Information and Education (NCPIE) is at the forefront of tackling the issue of safe and effective use of medicines in USA. In 2007, the NCPIE released an action plan, which suggests ten key policy initiatives to improve the medication adherence among patient population. (5) Some of the recommendations in the action plan are admirable. These include mounting a unified national campaign to make medication adherence a national health policy issue, addressing the barriers to compliance for patients with low health literacy, raising funds for carrying out rigorous research on medication adherence and developing curriculum on medication adherence for use in medical schools. Nonetheless, the action plan misses several key points that are crucial in dealing with the issue of non compliance. The most important flaw is the assumption that awareness leads to action, which is based on the Health Belief Model. (6) Another major flaw is the lack of attention to the non compliance issues regarding long term care for elderly. The action plan completely disregards the non compliance to treatment regimen arising due to economic constraints like high costs of medicines and administrative constraints like highly complicated benefit packages offered under private prescription drug plans as well as Medicare Part D prescription drug plans.

In this paper, I will first analyze the above mentioned flaws in the NCPIE action plan from the perspective of social and behavioral science principles. I will then make suggestions to improve the action plan by taking into consideration the factors likely to have an impact in determining patient behavior regarding compliance to medication treatment.

Awareness leads to action – a misconception:

The focus of the policy recommendations in the NCPIE action plan is to create awareness among patients through dissemination of educational materials. In fact the tagline of NCPIE is “Educate before you Medicate ”. The focus on creating awareness stems from the “Health Belief Model” which assumes that all health behaviors are rational and awareness about the health hazards associated with non compliance to drug treatment will inspire patients to take the necessary action . This approach primarily focuses on individual decision making process and does not address the social and environmental factors. The decisions taken by individuals regarding their health are to a great extent affected by external rewards, whereas the NCPIE action plan does not put any emphasis on the external context. Awareness alone is insufficient to motivate patients to adopt compliance. Patients need internal as well as external motivation and incentives to perform a particular healthy behavior.

Another critical factor which is disregarded in the education based approach is the fact that not everyone has equal access to the right knowledge at the right time. Currently, the primary means of disseminating information is NCPIE’s website. Access to education material provided through internet is highly dependent on a person’s socioeconomic status. Caucasians are nearly twice as likely to have internet access at home as are Blacks or Hispanics. (7) Moreover; internet use is highly correlated to income level, education, and geographic region. (8) Therefore, dissemination of education using internet as the primary medium runs the risk of poor penetration into the target population.

Lack of attention to non-compliance seen in long term chronic care for elderly:

Although non compliance affects patients from all age groups, elderly patients receiving chronic long term care have some specific barriers against effective use of medications. These include cognitive impairment and vision loss which make the elderly vulnerable to the side effects associated with poor compliance. In patients aged 60 and older, noncompliance to the treatment regimen varies from 25% - 60%. (9) Availability of new, effective and safe medications and improvement in the knowledge of chronic disease treatment has led to use of multiple medications in elderly patients. In many cases the dosage regimen involves multiple daily doses of the same drug. This coupled with the poor provider-physician relationship arising out of use of multiple providers has led to drop in compliance rates among elderly patients. (10, 11)

The NCPIE action plan does not include any specific measures to improve the compliance rates among elderly. Educational materials will not be of great help to improve patient compliance in elderly because of the specific barriers – vision and cognitive impairment, mentioned above. Cognitive impairment causes loss of memory and forgetfulness in old age which could be the reason of high rates of non compliance. The action plan disregards these specific issues in elderly care and uses a one size fits all strategy of creating awareness. The highly complicated nature of the Medicare Part D plans, which provide prescription drug benefit to people aged 65 and older, make it difficult for the elderly patients to select the right plan with the right formulary and in turn affect compliance to medication treatment.

Lack of attention to reduce non compliance due to financial and administrative barriers:

High costs of prescription drugs have a detrimental impact on their access. Increasing cost sharing arrangements through increased co-pays, which are aimed at reducing the pharmacy costs, could in reality lead to long term consequences due to patients skipping doses, cutting pills in half or going without medicines. (12) Non compliance could lead to adverse events causing hospitalization or less productivity at workplace. It could also lead to intangible costs like pain and suffering on part of the patient. The NCPIE action plan does not address the issue of rising prescription drugs cost and non compliance resulting out of it. Although creating awareness about effective use of medications is a step in right direction, it alone is not sufficient to change the patient behavior. An awareness campaign could turn out to be wastage of resources and time in case of patients who have financial barriers to the access of medicines. Dissemination of right knowledge at the right time is hardly of any use in case of such patients.

Administrative barriers further aggravate the situation. For instance, patients receiving low income subsidy under the Medicare Part D prescription drug plans are randomly assigned to a plan every year. (13) Every drug plan has its own formulary and the patient, when assigned randomly to a drug plan, has to stick to the formulary of that plan. While assigning patients to these formularies, it is not determined if the drugs needed by the patient are present on the formulary list. This could lead to non compliance due to lack of access to the required prescription drugs. The NCPIE action plan could have raised this issue while formulating the policy recommendations.

It can thus be seen, that the NCPIE action plan providing policy recommendations to improve medication compliance contains some serious flaws. The recommendations are based on false assumptions about the decision making process of patients. The recommendations do not take into account several key factors influencing patient compliance to drug treatment. Thus, in order to make the recommendations an effective tool to combat the issue of patient non compliance, changes should be made in the action plan. These changes should focus on multiple factors as determinants of patient behavior and should not concentrate just on educating the patients. In light of the urgent need for a renewed action plan for improving patient compliance to drug regimen, I propose following policy initiatives. These initiatives make use of the social and behavioral sciences principles to influence patient behavior.

Extrinsic and intrinsic reward systems:

Interventions to improve patient compliance to medications need to focus on external as well as internal factors that influence patient behavior. People from different backgrounds and different socioeconomic and cultural groups have different motivations and incentives to perform a particular health behavior. These motivations and incentives must be identified and capitalized on in order to drive patient behavior in the right direction. It necessitates use of a multi pronged strategy to improve compliance and relinquishing complete dependence on the one size fits all education campaign. Nevertheless, such education campaigns have their own place in any public health campaign and are essential to create basic awareness about the health hazards associated with a risky behavior.

The reason behind failure of the current campaigns to improve patient adherence to treatment could be their treatment of all patients as a single entity. The fundamental assumption that all patients behave rationally and respond well to similar incentives is flawed. The truth is, however, that people respond to incentives very differently. Where money might motivate one person, an appeal to competition, community, or common sense might motivate the next. Extrinsic and intrinsic reinforcement systems have proven to be effective in improving patient compliance. (14) Extrinsic reward systems involve using forms of reinforcements such as, reductions in copayments or giving gifts in the form of health products related to disease state, for complying with drug treatment regimen. These rewards motivate some patients to comply with the treatment as they focus on the incentive that determines the behavior of those people. Other type of reward systems is intrinsic reward system, which employs charitable donations and other forms of altruistic reinforcements as a driver for healthy behavior. The patient is incentivized through use of one or both of the above reinforcement platforms to make him perform the healthy behavior , which in this case is compliance to medication treatment.

This approach coupled with the awareness campaign has some serious potential to address the issue of non compliance. It goes a step ahead of the “Health Belief Model” in motivating the patient to perform a particular health behavior after he has been made aware of the health hazards involved in not performing the behavior. It does not assume that awareness will automatically lead to action and takes into account the importance of motivation and incentives in driving people’s behavior. In this manner, the reinforcement systems have the potential to correct the major flaw in the NCPIE action plan using principles of social and behavioral sciences. Incorporation of these reward systems in healthcare system could lead to increase in compliance rates.

Strategies to improve compliance to medications in elderly patients:

Observational studies have found that adherence drops steeply with increasing number of doses per day, with average adherence falling from roughly 80% in patients taking once-daily regimens to 50% in those taking 4-times-per-day regimens. (15) Minimizing dosing frequency by using drugs that act for longer duration and dosing different drugs at the same time could improve compliance rates. Blister packaging has been shown to be an effective tool in improving treatment compliance in elderly patients. (16) Novel applications employing electronic dispensing systems have been recently introduced. But these applications require presence of cognitively intact caregivers for their operation. (17)

Another strategy to counter the forgetfulness arising out of cognitive impairment in elderly patients is effective use of technology to improve compliance rates. Telephone based adherence programs have proven efficacy. In a study conducted at University of North Carolina, Chapel Hill, automated telephone reminders were found to be effective in improving adherence to repeat mammography testing. (18) Similar strategies could be used to improve the adherence to medication regimens as well. Programs have been developed that give patients an option to receive text messages on their cell phones or pre-recorded phone calls to remind them to take their medicines. These calls have a built in snooze feature which calls back on the same number if the earlier call is not received. (19) These technologies use psychographic screening and patient centered communication programs to provide personalized and effective support to improve adherence.

Telephone based reminder systems are a promising way of improving compliance in elderly patients. The NCPIE action plan does not provide proper attention to use of these novel approaches to improve medication adherence in elderly. Considering the significant costs incurred to healthcare system out of long term care management in elderly patients, improving compliance to medications in such patients has the potential to save billions of dollars. Thus, any action plan to improve medication adherence has to deal with the issue of non compliance in elderly patients. The NCPIE action plan has missed on this key point in its policy recommendations.

Strategies to deal with non compliance due to economic and administrative constraints:

As discussed above, cost is a critical determinant of patient behavior when it comes to prescription medicines. A rise in cost sharing arrangements has detrimental impact on patient compliance to the drug treatment. The costs of prescription drugs have risen steadily in USA and are the highest in the world. (20) Thus, it is imperative for public health practitioners to advocate for lowering the costs of prescription drugs in USA. This could have a significant impact on the compliance rates due to improved access to medicines. The NCPIE action plan should include this factor in the policy recommendations so that the issue of cost related non compliance receives proper attention at national level.

Patients also face administrative barriers to accessing prescription drugs which could have a negative impact on their compliance rates. The complexity of Medicare part D plans and the plight of patients receiving low income subsidy aggravates the issue of non compliance. There is an urgent need to educate patients about the insurance policies offered under Medicare Part D in order to avoid confusion. Physician and pharmacist support could play an important role in educating patient regarding the selection of the right benefit plan.

In designing the drug adherence improvement strategy, patients’ needs should be given priority. Patient preferences should be taken into account and a holistic approach, wherein patient’s overall health conditions are considered while prescribing medicines should be incorporated into physician practice. A successful drug adherence intervention should be multi-layered and address various issues such as behavioral aspects in treatment compliance, cost and cultural barriers in treatment compliance and efforts to achieve optimum drug regimen.

Conclusion:

The NCPIE action plan on enhancing prescription drug adherence is the first serious initiative in the USA at improving patient compliance to treatment regimen. The action plan is prepared with the goal of creating a blueprint for action by all stakeholders. The report has serious potential to serve as the catalyst for a collaborative effort to address the issue of non compliance. Despite its admirable goals, the plan carries a risk of failure because of the false assumptions about patient behavior that it makes. Patient behavior in today’s world is increasingly being determined by complex trade-offs between various influences. The assumption that patient behavior is rational is flawed and thus any efforts to improve patient compliance that are based on this assumption have very less chances of producing the desired outcome. Thus, it is imperative to understand the incentives that drive patient behavior in the right direction as well as the disincentives that drive patient behavior in the wrong direction. An intervention formulated after carefully considering the trade-offs between incentives and disincentives will have the best chances of accomplishing the target.

References:

(1) Ernst FR and Grizzle AJ, “Drug-Related Morbidity and Mortality: Updating the Cost-of-Illness Model,” Journal of the American Pharmaceutical Assn., March/April 2001

(2) 10th Annual Survey of large employers: Watson Wyatt Worldwide and National Business Group on Health, 2005.

(3) World Health Organization (2003), “Adherence to Long-Term Therapies: Evidence for Action,” page 35

(4) Thomas Bodenheimer, MD, and Alicia Fernandez, MD, “High and Rising Health Care Costs. Part 4: Can Costs Be Controlled While Preserving Quality?” Annals of Internal Medicine, 143:1 (2005), pages 26-31.

(5) National council on Patient Information and education: Enhancing Prescription medicine Adherence: An Action Plan Available at: http://www.talkaboutrx.org/documents/enhancing_prescription_medicine_adherence.pdf

(6) Individual health behavior theories (chapter 4). In: Edberg M. Essentials of Health Behavior: Social and Behavioral Theory in Public Health. Sudbury, MA: Jones and Bartlett Publishers, 2007, pp. 35-49.

(7) US Census Bureau. Computer and Internet Use in the United States: 2003. Available at: http://www.census.gov/prod/2005pubs/p23-208.pdf.

(8) National Telecommunications and Information Administration. US Department of Congress, July 1998. Falling Through the Net: Defining the Digital Divide. Available at: http://www.ntia.doc.gov/NTIAHOME/FTTN99/part2.html.

(9) van Eijken M, Tsang S, Wensing M, et al. Interventions to improve medication compliance in older patients living in the community: A systematic review of the literature. Drugs Aging 2003; 20(3):229-240.

(10) Vik SA, Maxwell CJ, Hogan DB. Measurement, correlates, and health outcomes of medication adherence among seniors. Ann Pharmacotherapy 2004; 38(2):303-312.

(11) Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther. 2001; 23(8):1296-1310.

(12) American Journal of Managed Care: Report on Impact of Copays on Vulnerable Population Available at:

http://www.ajmc.com/media/pdf/A166_06NovImpactofS359to63.pdf

(13) Henry J. Kaiser Family Foundation: Medicare Part D Low Income Subsidy Program – Experience to Date and Policy Issues for Consideration. Available at:

http://www.kff.org/medicare/upload/8094.pdf

(14) Halthonors Corporation : Braintree MA: Patient Reinforcement Systems -

http://www.healthhonors.com/reinforcement.html

(15) Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther. 2001; 23(8):1296-1310.

(16) Wong BS, Norman DC. Evaluation of a novel medication aid, the calendar blister-pack, and its effect on drug compliance in a geriatric outpatient clinic. J Am Geriatric Soc 1987; 35:21-26.

(17) Buckwalter KC, Wakefield BJ, Hanna B, Lehmann J. New technology for medication adherence. Electronically managed medication dispensing system. J Gerontol Nurs 2004; 30(7):5-8.

(18) Jessica T Defrank: Impact of Mailed and Automated Telephone Reminders on Receipt of Repeat Mammograms – American Journal of Preventive Medicine, June 2010. Available at:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2698939/

(19) Memotext, Toronto – Ontario. Memotext Patient Adherence Intervention. Available at:

http://www.memotext.com/abstract.html

(20) Henry J. Kaiser Family foundation: Prescription Drug Trends. Available at:

http://www.kff.org/rxdrugs/upload/3057-08.pdf