欧美患者定向的药品风险沟通工具研究及启示

Study on patient-targeted drug risk communication tool in europe and america and its enlightenment to China

目的通过借鉴美国食品药品监督管理局(Food and Drug Administration,FDA)和欧洲药品管理局(European Medicines Agency,EMA)的有益经验,并结合我国的国情,为我国患者定向的风险沟通工具——安全用药提示的落地实施提供合理化建议。方法利用文献研究、对比研究等方法,阅读欧美相关的法规政策,总结FDA和EMA的患者定向的风险沟通工具及具体实施细节,提取可供我国借鉴的有益经验。结果国家应尽快制定出台相关指南,围绕着安全用药提示的形式、文本内容与格式、发放流程、效果评价以及持有人法律责任等做出明确规定。结论借鉴欧盟患者定向沟通形式,建议我国采用安全用药提示卡(纸质版与电子版两种版本)进行患者定向沟通。持有人承担沟通的主体责任,自行裁决并发放安全用药提示卡,制定实施效果评价计划,在必要时可请求监管部门协助。

Objective To provide reasonable suggestions for the implementation of patient-targeted risk communication tools-safe medication tips in China by referring to the beneficial experiences of US Food and Drug Administration(FDA)and European Medicines Agency(EMA)and combining with the national conditions in China.Methods Literature study,comparative study and other methods were used to read the relevant regulations and policies in Europe and the United States,summarize the patient-targeted risk communication tools and specific implementation details of FDA and EMA,and extract the beneficial experiences that can be used for reference in China.Results The state should develop and issue relevant guidelines as soon as possible,which clearly specify the form,text content and format,distribution process,effect evaluation and legal liabilities of marketing authorization holder(MAH)of safe medication tips.Conclusion Drawing on the form of patient-targeted communication in the EMA,it is recommended to use safe medication tips card(paper version and electronic version)for patient-targeted communication in China.MAH shall assume the subject responsibility of communication,make a self-adjudication and issue safe medication tips card and develop an implementation effect evaluation plan,and request the assistance of regulatory authorities when necessary.