中国药物警戒 ›› 2015, Vol. 12 ›› Issue (10): 600-602.

• 药品不良反应监测与评价专栏 • 上一篇    下一篇

药品不良反应主动监测及其发展趋势

王丹   

  1. 国家食品药品监督管理总局药品评价中心,北京 100045
  • 收稿日期:2015-08-31 修回日期:2015-12-07 出版日期:2015-10-08 发布日期:2015-12-07
  • 作者简介:王丹,女,副主任药师,药品不良反应监测与评价。

Active Surveillance of Adverse Drug Reaction and Its Development Trend

WANG Dan   

  1. Center for Drug Reevaluation, CFDA Beijing 100045, China
  • Received:2015-08-31 Revised:2015-12-07 Online:2015-10-08 Published:2015-12-07

摘要: 药品不良反应主动监测是被动监测的重要补充。本文旨在明确主动监测与被动监测的区别,探究主动监测的发展历程和发展趋势,讨论大数据背景下主动监测的利弊,为国内开展药品不良反应主动监测提供思路及方向。

关键词: 药品不良反应, 主动监测, 药品不良反应监测

Abstract: Active surveillance of adverse drug reaction(ADR) is an important supplement to passive ADR monitoring. In this article, we aim to make clear the difference between active and passive monitoring, explore the development process and trend of active surveillance, discuss the pros and cons of active surveillance under the background of big data, and provide ideas and direction for its practice in China.

Key words: adverse drug reaction (ADR), active surveillance, ADR monitoring

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