中国药物警戒 ›› 2021, Vol. 18 ›› Issue (10): 940-943.
DOI: 10.19803/j.1672-8629.2021.10.09

• 法规与管理研究 • 上一篇    下一篇

药品上市许可持有人开展药品不良反应聚集性事件监测与分析的探讨

杨乐, 田春华*, 夏东胜, 董铎, 樊蓉, 张美玲   

  1. 国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京 100022
  • 收稿日期:2020-05-10 出版日期:2021-10-15 发布日期:2021-10-27
  • 通讯作者: *田春华,女,硕士,副主任药师,药品不良反应监测与评价。E-mail：tianchunhua@cdr-adr.org.cn
  • 作者简介:杨乐,男,本科,副主任药师,药品不良反应监测与评价。
  • 基金资助:
    重大新药创制国家科技重大专项2017年度（2017ZX09101001-001-003)

Discussion on the Monitoring and Analysis of Cluster Adverse Drug Events by Drug Marketing Authorization Holders

YANG Le, TIAN Chunhua*, XIA Dongsheng, DON Duo, FAN Rong, ZHANG Meiling   

  1. Center for Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100022, China
  • Received:2020-05-10 Online:2021-10-15 Published:2021-10-27

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摘要： 目的 为药品上市许可持有人（MAH）开展药品不良反应聚集性事件（简称聚集性事件）监测与分析提供启示。方法 分析聚集性风险/事件主要特点与成因,介绍聚集性风险监测方法、预警信号规则设置要素、现场调查要点、聚集性风险/事件分析等内容。结果与结论 MAH可以通过建立监测方法对药品不良反应数据库中的聚集性风险信号进行识别和研判,确认和控制有关潜在的药品质量风险或使用风险,最大限度保障公众用药安全。

关键词: 药品上市许可持有人, 聚集性事件, 预警信号, 监测, 药品不良反应

Abstract: Objective To provide reference for drug marketing authorization holders (MAH) to monitor and analyze cluster adverse drug events (referred to as "cluster events"). Methods The main characteristics and causes of cluster risks/events were analyzed, introduces Monitoring methods of cluster risks, setting rules for early warning signals, key points of on-site investigation, cluster risks/event analysis were introduced. Results and Conclusion MAH can identify and judge cluster risk signals in the adverse drug reaction(ADR) database by establishing monitoring methods, to confirm and control potential drug quality risks or use risks in advance, and maximize the protection of public medication safety.

Key words: MAH, cluster events, early warning signals, monitoring, adverse drug reaction

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