中美药品不良反应/事件监测报告内容对比与启示  

Comparison of the reports of adverse drug reaction /event between the United States and China

作　　者：严瑾[1] 邵蓉[1] 

机构地区：[1]中国药科大学国际医药商学院,江苏南京211198

出　　处：《广东药学院学报》2014年第1期70-75,共6页Academic Journal of Guangdong College of Pharmacy

基　　金：国家社会科学基金(11BFX098)

摘　　要：目的为全面和细化不良反应报告内容,进一步完善我国不良反应报告和监测制度提供参考和建议。方法采用比较法,立足于中美两国药品不良反应/事件监测体系,从报告主体、报告范围以及报告表内容将中国的药品不良反应/事件报告表与美国FDA3500表格的内容进行全面对比。结果与结论与美国相比,我国的不良反应报告表格内容仍有进一步完善的空间。应根据不同上报主体分别设计报告表格,完善产品不良反应信息,扩大报告范围,建立交叉报告体系,区分对待关联性评价。Objective To provide a reference and suggestion on the comprehensive and detailed content of adverse reaction reports, and further improve the adverse reaction reporting and monitoring system. Methods The approach of comparative analysis was adopted. Based on the adverse drug reaction/event monitoring system of the United States and China, this paper conducted a comprehensive comparison between the adverse drug reactions/events reporting form of China and the Form FDA3500 of the United States on the reporter, the reporting scope and content of the report. Results and Conclusion In comparison with the United States, the content of our adverse drug reactions/events reporting form still has room for improvement. We should design reporting forms for different kind of reporter, consummate the information of the products and the events, enlarge the reporting scope, establish cross -reporting system and carefully considerate the related evaluation.

关 键 词：药品不良反应 药品不良事件 FDA3500表格 药品不良反应监测 

分 类 号：R954[医药卫生—药学]