Faculty of Pharmaceutical Sciences, Prince of Songkla University, Hatyai, Thailand.
Medway School of Pharmacy, Universities of Kent and Greenwich, Chatham Maritime, Kent, UK.
Drug Saf. 2021 Apr;44(4):421-437. doi: 10.1007/s40264-020-01038-8. Epub 2021 Mar 5.
Published reviews of written medicine information (WMI) have mainly drawn on studies published in high-income countries, including very few Asian or African studies. We therefore set out to scope the research literature to determine the extent and type of studies concerning WMI for patients/consumers across these two continents. We sought empirical studies published between January 2004 and December 2019, conducted in any Asian or African country, as defined by the United Nations, in English or with an English abstract. The majority of the 923 papers identified were from high-income countries. We retained 26 papers from Africa and 99 from Asia. Most African studies (n = 20) involved patients in the development of PILs, in the assessment of the effectiveness of PILs or in surveys. In contrast, the highest proportion of Asian studies concerned the content of WMI (n = 42). WMI is desired, but needs to be in local languages, and there needs to be more use made of pre-tested pictograms. Existing WMI frequently does not meet local regulatory requirements, particularly locally manufactured products. A number of studies reported potentially positive impacts of providing WMI on knowledge and medicine use behaviours. Provision of medicine information is essential for safe use of medicines in all countries. Internationally agreed guidelines, incorporating good design principles, are needed to ensure the optimal content and design of WMI. The World Health Organization should support African and Asian regulatory bodies to share best practice in relation to WMI for patients/consumers and to develop and implement pan-continental guidelines that take into account consumer needs and preferences.
已发表的书面医学信息 (WMI) 评论主要借鉴了高收入国家发表的研究，其中包括极少数亚洲或非洲的研究。因此，我们着手对研究文献进行范围界定，以确定跨这两个大陆的患者/消费者的 WMI 相关研究的范围和类型。我们寻找了 2004 年 1 月至 2019 年 12 月期间在联合国定义的任何亚洲或非洲国家以英文或附有英文摘要发表的实证研究。在确定的 923 篇论文中，大多数来自高收入国家。我们保留了来自非洲的 26 篇论文和来自亚洲的 99 篇论文。大多数非洲研究（n = 20）涉及患者参与 PILs 的制定、PILs 的效果评估或调查。相比之下，亚洲研究中比例最高的是 WMI 的内容（n = 42）。WMI 是人们所期望的，但需要使用当地语言，并且需要更多地使用经过预先测试的象形图。现有的 WMI 常常不符合当地法规要求，特别是本地制造的产品。一些研究报告称，提供 WMI 可以对知识和药物使用行为产生潜在的积极影响。提供药物信息是所有国家安全使用药物的必要条件。需要制定纳入良好设计原则的国际商定准则，以确保 WMI 的最佳内容和设计。世界卫生组织应支持非洲和亚洲监管机构分享患者/消费者 WMI 的最佳实践，并制定和实施考虑到消费者需求和偏好的泛大陆准则。
