我国药品不良反应公众报告模式研究

Research on the Public Reporting Model for Adverse Drug Reactions in China

目的研究建立我国药品不良反应公众报告模式。方法采用文献检索的方法,研究发达国家药品不良反应公众报告现状,分析公众报告的作用和特点。利用问卷调查的方式,了解我国公众和药品不良反应监测机构的需求。结果药品不良反应公众报告是发达国家自愿报告系统的重要组成部分,具有降低漏报率、完善报告信息、发现和增强风险信号等作用。我国鼓励公众报告药品不良反应,已有监测机构探索开展了相关工作。提出了建立多种途径报告、分级审核评价的公众报告模式。结论我国应重视药品不良反应公众报告的作用,加强相关法律法规、技术规范、信息化平台和人才队伍建设,分阶段稳步推进药品不良反应公众报告工作。

Objective To establish a public reporting model for adverse drug reactions in China. Methods Analyze the roles and characteristics of public reporting by retrieve the situation of public reporting of adverse drug reactions in developed countries, and carry out a questionnaire survey to understand the needs of the public and adverse drug reaction monitoring institutions in China. Results Public reporting of adverse drug reactions is an important part of the voluntary reporting system in developed countries, with the effect of reducing the rate of omission, supplementing the report of professionals and enhancing the strength of the risk signal. It＇s encouraged for the public to report adverse drug reactions in China. Several monitoring agencies had explored and carried out relevant works. The public reporting model with a variety of ways to report and grading audit evaluation was established. Conclusion We should pay attention to the roles of public reporting of adverse drug reactions, and steadily promote the public reporting with strengthening the construction of the relevant laws and regulations, technical specifications, information platform and the talent team.