Division of General Internal Medicine and Geriatrics, Feinberg School of Medicine, Northwestern University, 750 N. Lake Shore Drive, 10th Floor, Chicago, IL, 60611, United States.
Pharmacovigilance and Patient Safety, AbbVie, Inc., 1 N. Waukegan Rd., GM60, AP51-2, North Chicago, IL, 60064, United States.
Patient Educ Couns. 2018 Aug;101(8):1351-1367. doi: 10.1016/j.pec.2018.03.012. Epub 2018 Mar 8.
To present evidence supporting best-practices for prescription drug labeling and educational materials.
Articles were selected from three online databases (PubMed, Embase, CINAHL). Eligible manuscripts were: 1) English-language, 2) randomized, controlled trials, and 3) focused on improving prescription drug labeling practices.
Forty-nine articles were reviewed, and included both regulated label materials and pharmacy or health systems-generated tools. Best-practices included use of plain language principles, typographic cues, quantitative descriptors, and standardized formats, when applicable. Common outcomes included preference and comprehension, while few studies examined actual medication use (e.g. adherence, harms) or clinical health outcomes. Approximately half of studies directly engaged patients' perspectives in intervention development, which may have helped increase tool effectiveness.
Several best practices were apparent in the literature, particularly for written materials and pharmacy-generated container labeling. Design principles for supplemental instructions and multimedia tools were less cohesive, albeit less researched. The impact of patient involvement in tool design is promising, though requiring further study.
Definitive studies to inform practice standards on how to best communicate medication information to consumers are needed, especially as communication modalities continue to evolve. Increased research on if and how to incorporate patient-centered decision-making into the development process should be considered.
为处方药标签和教育材料提供最佳实践的证据。
从三个在线数据库(PubMed、Embase、CINAHL)中选择文章。合格的手稿包括:1)英语,2)随机对照试验,以及 3)专注于改善处方药标签实践的研究。
共审查了 49 篇文章,包括法规标签材料和药房或健康系统生成的工具。最佳实践包括使用通俗易懂的原则、排版提示、定量描述符和标准化格式(在适用的情况下)。常见的结果包括偏好和理解,而很少有研究检查实际的药物使用(如依从性、危害)或临床健康结果。大约一半的研究直接涉及患者对干预措施发展的看法,这可能有助于提高工具的有效性。
文献中出现了一些最佳实践,特别是对于书面材料和药房生成的容器标签。补充说明和多媒体工具的设计原则不太一致,尽管研究较少。患者参与工具设计的影响很有前景,但需要进一步研究。
需要进行明确的研究,以告知有关如何向消费者最佳传达药物信息的实践标准,特别是随着沟通方式的不断发展。应考虑增加关于是否以及如何将以患者为中心的决策纳入开发过程的研究。