中国药物警戒 ›› 2017, Vol. 14 ›› Issue (3): 150-152.

• 药物警戒概念与制度研究 • 上一篇    下一篇

药物警戒解析及与药品不良反应监测的区别

王丹, 彭丽丽, 刘翠丽, 刘佳, 王涛, 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:2017-04-20 修回日期:2017-04-20 出版日期:2017-03-20 发布日期:2017-04-20
  • 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,主任药师,药品不良反应监测与评价。
  • 基金资助:
    国家食品药品监督管局总局委托课题(C201501)

Analysis of Pharmocovigilance and Difference with the ADR Monitoring in China

WANG Dan, PENG Li-li, LIU Cui-li, LIU Jia, WANG Tao, DONG Duo*   

  1. Center for Drug Reevaluation, CFDA, Beijing 100045, China
  • Received:2017-04-20 Revised:2017-04-20 Online:2017-03-20 Published:2017-04-20

摘要: 目的 探讨药物警戒在中国的应用。方法 对药物警戒的概念进行剖析,比较药物警戒与我国不良反应监测工作的区别。结果 我国药品不良反应监测的对象、范围、方法均与药物警戒存在差距,但监测工作与国际药物警戒的理念一致,并朝着药物警戒的方向发展。结论 实施药物警戒能为药品不良反应监测工作的发展提供更加广阔的空间。

关键词: 药物警戒, 药品不良反应监测, 解析, 区别

Abstract: Objective To explore the application of pharmacovigilance in China. Methods The concept of parmocovigilance and the differences between pharmacovigilance and ADR Monitoring were disserted. Results There is a gap between ADR monitoring and pharmacovigilance in the aspect of object, scope and method. However, ADR monitoring is in keeping with international pharmacovigilance theoretically and is developing towards it. Conclusion Pharmacovigilancecan provide growth space for development of ADR monitoring in china.

Key words: parmocovigilance, ADR monitoring, analysis, difference

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