美国FDA药品风险沟通的发展与启示

中国药物警戒 ›› 2016, Vol. 13 ›› Issue (1): 24-27.

美国FDA药品风险沟通的发展与启示

田怡,杨悦,田丽娟

沈阳药科大学工商管理学院 ,辽宁沈阳 1100 16

收稿日期:2015-11-17 修回日期:2016-02-25 出版日期:2016-01-08 发布日期:2016-02-25
通讯作者: 田丽娟,女,博士,副教授·硕导,合理用药。
作者简介:田怡, 女, 在读硕士, 药事管理与法规。

Progress and Implication of FDA Risk Communication in the United States

TIAN Yi, YANG Yue, TIAN Li-juan

School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China

Received:2015-11-17 Revised:2016-02-25 Online:2016-01-08 Published:2016-02-25

摘要/Abstract

摘要： 目的通过介绍 FDA风险沟通体系建设发展情况及风险沟通实施效果 ,为监管机构风险沟通提供参考。方法主要采用文献分析法 ,通过查阅中外文献和检索 FDA官网 ,总结FDA风险沟通相关内容。结果 FDA风险沟通起步早 ,经过不断探索实践 ,现已形成健全沟通体系 ,构建起完善沟通平台 ,取得良好效果。结论我国风险沟通起步晚 ,基础较薄弱 ,对风险沟通的关注还有待加强 ,风险沟通共享方式还有待完善。FDA 经验值得借鉴 ,从风险沟通关注重点、沟通模式转换、沟通方式和战略四方面入手 ,促进我国风险沟通的发展与完善。

关键词: 风险沟通, 进展, 方式

Abstract: Objective To provide suggestions for drug risk communication in China by introducing the development and implementation effect of FDA risk communication system. Methods The material of FDA risk communication was summarized through the method of literature analysis and searching FDA official website. Results The development of FDA risk communication is more perfect, and through continuous exploration and practice FDA has formed a sound risk communication system and built up a perfect communication platform. Conclusion The drug risk communication is still weak in China. It is urgent to pay attention to Chinese risk communication and establish the sharing platform of risk communication. China should draw experiences from FDA to promote the development and improvement of Chinese drug risk communication from four aspects of focus, model, way and strategy.

Key words: risk communication, progress, way

中图分类号:

田怡,杨悦,田丽娟. 美国FDA药品风险沟通的发展与启示[J]. 中国药物警戒, 2016, 13(1): 24-27.

TIAN Yi, YANG Yue, TIAN Li-juan. Progress and Implication of FDA Risk Communication in the United States [J]. Chinese Journal of Pharmacovigilance, 2016, 13(1): 24-27.

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