Ferdinand Keith C, Senatore Fortunato Fred, Clayton-Jeter Helene, Cryer Dennis R, Lewin John C, Nasser Samar A, Fiuzat Mona, Califf Robert M
Department of Medicine, Tulane Heart and Vascular Institute, Tulane University School of Medicine, New Orleans, Louisiana.
U.S. Food and Drug Administration, Silver Spring, Maryland.
J Am Coll Cardiol. 2017 Jan 31;69(4):437-451. doi: 10.1016/j.jacc.2016.11.034.
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.
药物治疗依从性是心血管疾病(CVD)中的一个主要问题,每年导致约125,000例可预防的死亡,部分原因是只有约一半的CVD患者持续服用规定的救命药物。目前的关注点集中在标签和教育如何影响依从性。本文总结了CVD不依从性的范围,描述了美国食品药品监督管理局的关键举措,并确定了潜在的改进目标。我们描述了关键的依从性因素、方法以及简化治疗方案和提高依从性的技术应用,以及4个领域,在这些领域中,涉及监管系统和临床社区的额外合作研究与实施可以大幅减少不依从性:1)确定监测方法;2)改善证据基础以更好地理解依从性;3)制定基于患者/医疗服务提供者团队的参与策略;4)缓解健康差异。美国食品药品监督管理局传播有关合理用药信息的方法与临床实践保持一致,可以提高依从性,从而减少CVD导致的死亡和残疾。