中国药物警戒 ›› 2015, Vol. 12 ›› Issue (9): 534-537.

• 药品不良反应监测与评价专栏 • 上一篇    下一篇

我国开展药品重点监测工作的探讨

王丹, 董铎   

  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:2015-09-01 修回日期:2015-12-07 出版日期:2015-09-08 发布日期:2015-12-07
  • 通讯作者: 董铎，女，博士，主任药师，药品不良反应监测与评价。E-mail:dongduo@cdr-adr.org.cn
  • 作者简介:王丹，女，硕士，副主任药师，药品不良反应监测与评价。

Discussion on the Key Drug Monitoring in China

WANG Dan, DONG Duo   

  1. Center for Drug Reevaluation, China Food and Drug Administration, Beijing 100045, China
  • Received:2015-09-01 Revised:2015-12-07 Online:2015-09-08 Published:2015-12-07

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摘要： 2011年修订的《药品不良反应报告和监测管理办法》提出“药品重点监测”这一新的工作任务。截至目前该办法已实施4年有余，有关药品重点监测工作也积累了一些经验。本文主要从技术监管的角度，重新审视药品重点监测的意义和内涵，总结监测的方法及利弊，梳理重点监测工作存在的问题，为推动该项工作深入有效地开展提供思路。

关键词: 药品不良反应监测, 主动监测, 药品重点监测

Abstract: The key drug monitoring is a new task introduced by the approach of adverse drug reaction reporting and monitoring revised in 2011. As of now, the approach has been implemented for more than four years. Experience in the key drug monitoring has been accumulated. The article, in the point of technical supervision view, tries to re-examine the meaning and content of the key drug monitoring, summarizes the methods as well as its advantages and disadvantages, combings the existing problems, and provides ideas in order to promote the work to carry out in deep and effective way.

Key words: adverse drug reaction monitoring, active monitoring, key drug monitoring

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