中国药物警戒 ›› 2016, Vol. 13 ›› Issue (4): 223-225.

• 法规与管理研究 • 上一篇    下一篇

关于药品群体不良事件应急演练的思考

张秋   

  1. 国家食品药品监督管理总局高级研修学院,北京 100073
  • 收稿日期:2015-12-01 修回日期:2016-06-30 出版日期:2016-04-20 发布日期:2016-06-30
  • 作者简介:张秋,女,博士,讲师,食品药品应急管理。

Study on Group Adverse Drug Events Emergency Exercises

ZHANG Qiu   

  1. Institute for Executive Development,CFDA,Beijing 100073, China
  • Received:2015-12-01 Revised:2016-06-30 Online:2016-04-20 Published:2016-06-30

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摘要： 目的 为提高药品群体不良事件的防范和应急处置能力提供参考和借鉴。方法 通过介绍应急演练以及药品群体不良事件应急演练的定义和类型,结合应急演练的基本属性与药品群体不良事件的特殊性,探讨药品群体不良事件应急演练的设计与思考。结果与结论 药品群体不良事件应急演练需具备一定的硬件条件与软件系统,并根据需要设计良好的应急演练情景,在演练设计以及演练过程中要特别注意不良事件应急响应分级、舆情管理、信息管理以及信息报告等内容。

关键词: 药品群体不良事件, 应急演练, 药品安全事件

Abstract: Objective To enhance emergency prevention to group adverse drug events and response ability. Methods Through introducing the emergency exercises and the specific characteristics of group adverse drug events emergency exercises, this paper discusses how to design group adverse drug events emergency exercises. Results and Conclusion Group adverse drug events emergency exercises need to be equipped with both hardwares and software systems. It is necessary to pay attention to the emergency response levels, supervision of public opinion, information management and report during the exercise design and process.

Key words: group adverse drug events, emergency exercises, drug safety events

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