中国药物警戒 ›› 2015, Vol. 12 ›› Issue (12): 727-730.

• 药物警戒专栏 • 上一篇    下一篇

聚集性药品不良事件预警系统共享平台的建设和实践

冯红云1, 葛文超2, 夏旭东3, 路长飞4, 吕小琴5, 林燕芬6   

  1. 1国家食品药品监督管理局药品评价中心,北京100045；
    2安徽省药品不良反应监测中心,安徽 合肥 230051；
    3河南省食品药品评价中心,河南 郑州450004；
    4山东省药品不良反应监测中心,山东 济南250013；
    5浙江省药品不良反应监测中心,浙江 杭州 310012;
    6广东省药品不良反应监测中心,广东 广州 510080
  • 收稿日期:2016-02-02 修回日期:2016-02-02 出版日期:2015-12-08 发布日期:2016-02-02
  • 作者简介:冯红云,女,博士,副主任药师,药品不良反应监测与评价。

Construction and Practice of Early Warning System Sharing Platform on Cluster Adverse Drug Events

FENG Hong-yun1, GE Wen-chao2, XIA Xu-dong3, LU Chang-fei4, LV Xiao-qin5, LIN Yan-fen6   

  1. 1Center for Drug Reevaluation, Beijing 100045, China;
    2Anhui Center for Adverse Drug Reaction Monitoring, Anhui Hefei 230051, China;
    3Henan Food and Drug Reevaluation Center, Henan Zhengzhou 450004, China;
    4Shandong Centre for ADR Monitoring, Shandong Ji'nan 250013, China;
    5Zhejiang Center for ADR Monitoring, Zhejiang Hangzhou 310012,China;
    6Center for ADR monitoring of Guangdong Province, Guangdong Guangzhou 510080, China
  • Received:2016-02-02 Revised:2016-02-02 Online:2015-12-08 Published:2016-02-02

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摘要： 聚集性药品不良事件特征表现为同一企业同一批号或相邻批号的同一药品在短期内集中出现多例临床表现相似的药品不良事件。通过对聚集性药品不良事件进行分析、评价,判断是否构成药品群体不良事件。已经建成的聚集性药品不良事件预警系统对于保证国家中心对可疑质量安全事件的早期预警、快速反馈、及时处理发挥了重要作用。但国家中心工作界面中基于全国药品不良反应/事件报告数据产生的预警信息在省级中心工作界面中并能不同步出现,因此,省级中心和国家中心对预警信息的处理并没有保持连续性和一致性。为了解决这一问题,国家中心开始设计及搭建药品聚集性事件预警信息共享平台。本文对聚集性药品不良事件预警系统共享平台的建设和实践进行了介绍。

关键词: 聚集性药品不良事件, 预警系统, 共享平台

Abstract: The characteristics of cluster adverse drug events are shown as multiple adverse drug events with similar clinical manifestations centrally occuring in the same drug of the same or adjacent batch number manufactured by the same manufacturer within a short-term period. By analysis and evaluation on cluster adverse drug events, it is determined whether cluster adverse drug event is constituted. The early warning system on the cluster adverse drug events, which has been built by the National Center for ADR Monitoring, China, has an important role to monitor, feedback rapidly and control the suspicious product quality events. However, the warning information, based on the national database of the ADR individual case reports, could not present on the provincial work interface simultaneously. So the events settlement between national center and provincial centers did not keep consistency and continuity. In order to deal with the problem, the early warning system sharing platform was designed and practiced in the national database of the ADR individual case reports.

Key words: cluster adverse drug events, early warning system, sharing platform

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