我国药品安全信息的管理与交流探讨

目的:为促进我国药品安全信息的有效利用提供参考。方法:分析我国药品安全信息管理现状和主要交流形式,并借鉴美国药品安全信息交流相关指南,提出完善我国药品安全信息交流的建议。结果与结论:目前我国实行药品不良反应报告制度,药品安全信息管理遵循公开原则,要求说明书修订内容须告知药品使用单位,要求向社会公布召回药品存在的安全隐患。药品安全信息的主要交流形式包括建立药品不良反应信息通报制度、国家药品不良反应监测中心编发《药物警戒快讯》警示风险、国家食品药品监督管理局发布专项通知或文件、药品监督管理部门发布药品质量公告。建议健全我国药品安全信息公开发布机制;规范药品安全信息发布的程序、内容、形式,保障信息的时效性、权威性;加强信息利用,为指导临床合理用药发挥积极的作用。

Investigation on Administration and Communication of Domestic Drug Safety Information

OBJECTIVE：To provide references for the promotion of effective use of drug safety information in China.METHODS：The administration status and main communication form of drug safety information in China were analyzed.Suggestions on improving the communication of drug safety information in China were put forward by learning the guidance of drug safety information communication in America.RESULTS CONCLUSIONS：At present,ADR report system,principle of drug safety information openness have been carried out in China,and the revision of package insert must be informed to users and safety risk of recalled drug shall be made public in society.Main communication patterns of drug safety information include the establishment of ADR reporting system,Pharmacovigilance Briefing issued by center of ADR monitoring,announcements and documents issued by SFDA,drug quality announcement issued by drug administration department.It is suggested to prefect drug safety information public issue mechanism,standardize drug safety information dissemination process,content and form,ensure the timeliness and authority of information and enhance information utilization to play an active role on guiding clinical rational use of drug.