中国药物警戒 ›› 2019, Vol. 16 ›› Issue (4): 212-214.

• 法规与管理研究 • 上一篇    下一篇

基于中国医院药物警戒系统开展主动监测的实践与探讨

侯永芳, 宋海波, 刘红亮, 李馨龄*   

  1. 国家药品监督管理局药品评价中心,北京 100022
  • 收稿日期:2019-05-09 修回日期:2019-05-09 出版日期:2019-04-20 发布日期:2019-05-09
  • 通讯作者: 李馨龄,男,副主任药师,药品不良反应监测。E-mail:lixinling@cdr-adr.org.cn
  • 作者简介:侯永芳,男,硕士,高级工程师,药品不良反应监测。

Practice and Discussion on Active Surveillance by China Hospital Pharmacovigilance System

HOU Yongfang, SONG Haibo, LIU Hongliang, LI Xilin*   

  1. Center for Drug Reevaluation, NMPA, Beijing 100022, China
  • Received:2019-05-09 Revised:2019-05-09 Online:2019-04-20 Published:2019-05-09

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摘要： 目的 概述中国医院药物警戒系统,为利用真实世界电子诊疗数据开展主动监测提供参考。方法 通过国家药品不良反应监测哨点联盟建立各方合作机制,建立中国医院药物警戒系统来打通数据源之间的数据通道,并通过建立风险分析模型验证药品安全性问题。结果与结论 中国医院药物警戒系统作为主动监测的一种尝试,能够提高药品不良反应报告效率与质量,减少不良反应漏报病例,共享药物安全性警示信息,未来可在验证风险信号方面发挥作用。

关键词: 主动监测, 药品不良反应, 通用数据模型, 监测哨点

Abstract: Objective To summarize China Hospital Pharmacovigilance System(CHPS), so to provide reference for active surveillance using real-world electronic medical data. Methods We have built CHPS by establishing China ADR Sentinel Surveillance Alliance to build cooperation mechanisms, and establishing Chinese Hospital Pharmacovigilance System to open data channels between data sources, and establishing risk analysis models to verify drug safety issues. Results & Conclusion CHPS, as an attempt to active surveillance, has been initially established, which can improve the efficiency and quality of adverse drug reaction reports, reduce missing cases of adverse reactions, and share drug safety information. It can play a role in verifying risk signals in the future.

Key words: active surveillance, adverse drug reaction, common data model, sentinel

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