Improving Medication Adherence in Cardiometabolic Disease: Practical and Regulatory Implications

Abstract

Medication nonadherence, a major problem in cardiovascular disease (CVD), contributes yearly to approximately 125,000 preventable deaths, which is partly attributable to only about one-half of CVD patients consistently taking prescribed life-saving medications. Current interest has focused on how labeling and education influence adherence. This paper summarizes the scope of CVD nonadherence, describes key U.S. Food and Drug Administration initiatives, and identifies potential targets for improvement. We describe key adherence factors, methods, and technological applications for simplifying regimens and enhancing adherence, and 4 areas where additional collaborative research and implementation involving the regulatory system and clinical community could substantially reduce nonadherence: 1) identifying monitoring methods; 2) improving the evidence base to better understand adherence; 3) developing patient/health provider team-based engagement strategies; and 4) alleviating health disparities. Alignment of U.S. Food and Drug Administration approaches to dissemination of information about appropriate use with clinical practice could improve adherence, and thereby reduce CVD death and disability.

Keywords: United States Food and Drug Administration; cardiovascular disease; nonadherence; polypill.

CENTRAL ILLUSTRATION. Multifactorial Approach to Influence Medication Adherence

Patient nonadherence to prescribed medications presents a multifactorial challenge for physicians and other health care providers. In 2011, the American College of Preventive Medicine documented 5 key factors that affect adherence (7), and recommended that research and monitoring efforts be focused on them. These factors include: 1) socioeconomic factors; 2) health care system–related factors; 3) medical condition–related factors; 4) therapy-related factors; and 5) patient-related factors. The multifactorial challenges of medication adherence require a multifactorial solution, and have thus prompted a collaborative effort between the Food and Drug Administration and other agencies or campaigns (i.e., Million Hearts Campaign, National Forum for Heart Disease and Stroke Prevention, National Consumer League, Duke Adherence Alliance, and the Enhanced Adherence Strategic Initiative Consortium). This collaborative effort has linked together several independent programs in an effort to formulate an overall strategy to improve medication adherence: knowledge dissemination, patient advocacy, improvement of the evidence base to optimize adherence monitoring and engagement strategies, and alleviation of health disparities that adversely affect medication adherence.