title: 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.
authors.affiliation: Department of Medicine, Tulane Heart and Vascular Institute, Tulane University School of Medicine, New Orleans, Louisiana. Electronic address: kcferdmd@aol.com.
authors.forename: Keith C
authors.initials: KC
authors.lastname: Ferdinand
authors.affiliation: U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Fortunato Fred
authors.initials: FF
authors.lastname: Senatore
authors.affiliation: U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Helene
authors.initials: H
authors.lastname: Clayton-Jeter
authors.affiliation: CryerHealth, Washington, DC.
authors.forename: Dennis R
authors.initials: DR
authors.lastname: Cryer
authors.affiliation: Cardiovascular Research Foundation, New York, New York.
authors.forename: John C
authors.initials: JC
authors.lastname: Lewin
authors.affiliation: Department of Clinical Research and Leadership, George Washington University School of Medicine and Health Sciences, Washington, DC.
authors.forename: Samar A
authors.initials: SA
authors.lastname: Nasser
authors.affiliation: U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Mona
authors.initials: M
authors.lastname: Fiuzat
authors.affiliation: U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
mesh_terms: D002318:Cardiovascular Diseases / Q000188:drug therapy*; D019091:Critical Pathways; D016568:Drugs, Generic; D057220:Health Literacy; D006293:Health Promotion; D006801:Humans; D033181:Information Dissemination; D055118:Medication Adherence; D010353:Patient Education as Topic; D012959:Socioeconomic Factors; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D016568:Drugs, Generic
keywords: United States Food and Drug Administration; cardiovascular disease; nonadherence; polypill