中国药物警戒 ›› 2011, Vol. 8 ›› Issue (10): 596-599.

• 管理及工作研究 • 上一篇    下一篇

药品不良反应自发报告系统信息采集内容和方式的分析

吴桂芝, 王春婷, 张力   

  1. 国家食品药品监督管理局药品评价中心,北京100045
  • 收稿日期:2011-04-20 出版日期:2011-10-10 发布日期:2015-07-30
  • 作者简介:吴桂芝,女,博士,副主任药师,药品不良反应监测。

Analysis on Collecting Information for Adverse Drug Reaction and Ways to Report Through Spontaneous Reporting System in China

WU Gui-zhi, WANG Chun-ting, ZHANG Li   

  1. Center for Drug Reevaluation, SFDA Beijing 100045, China
  • Received:2011-04-20 Online:2011-10-10 Published:2015-07-30

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摘要： 药品不良反应自发报告系统所采集药品不良反应监测信息的内容和方式都决定了自发报告系统能否快速有效的收集药品不良反应的相关信息,这些信息在药品不良反应/事件报告表及其填写说明中能够体现,报告表的填写说明通常包括对报告内容、报告原则、报告范围、报告方式以及保密原则等方面的说明。本文通过介绍英国、美国、澳大利亚以及加拿大的药品不良反应/事件报告表及其填写说明中的主要内容,并与我国药品不良反应/事件报告表进行对比分析,希望能为进一步优化我国的药品不良反应信息采集的内容和方式提供参考。

关键词: 药品不良反应信息, 药品不良反应/事件报告表, 对比分析

Abstract: Collecting information for adverse drug reactions and ways to collect are two determined factors to fast and effectively collect adverse drug reactions through the spontaneous reporting system. This information usually is represented in a drug adverse reaction reporting form and its instructions. The instructions usually include principle for reporting, what to report, how to report and confidentiality. This article compared the drug adverse reaction reporting form and instructions from United Kingdom, United States, Australia and Canada with the reporting from our country. Some suggestions on how to optimize the collecting information for adverse drug reaction and ways to report in our country were also discussed.

Key words: adverse reaction information, drug adverse reaction reporting form, compare analysis

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