国际药品不良反应公众报告现状的分析与思考

Analysis and Reflection on the Current Situation of International Public Reporting of Adverse Drug Reactions

我国已经建立较为完善的药品不良反应监测体系,并鼓励公众主动报告不良反应,但历年来公众报告数量很少。本文分析了国际发达国家,主要是美国、加拿大、澳大利亚和英国药品不良反应公众报告的现状,总结了在法律法规、报告途径、报告表格设计等方面的模式,为我国建立药品不良反应公众报告模式提供参考。

A relatively perfect adverse drug reactions monitoring system has been established in China. The public was encouraged to report adverse drug reactions in our country while the number of the public reports was very small over the years. To provide reference for the establishment of public reporting model of adverse drug reactions in China, current situations of the public reporting of adverse drug reactions in the developed countries mainly including the United States, Canada, Australia and the UK was analyzed, and the laws and regulations, the reporting ways and the reporting forms were summarized.