中国药物警戒 ›› 2016, Vol. 13 ›› Issue (4): 219-222.

• 法规与管理研究 • 上一篇    下一篇

影响聚集性药品不良事件预警系统运行的风险因素分析及思考

冯红云,刘佳,董铎,侯永芳,杨乐,宋秋洁,郑明节,李馨龄   

  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:2016-01-21 修回日期:2016-06-30 出版日期:2016-04-20 发布日期:2016-06-30
  • 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。

Analysis of the Risk Factors Influencing the Adverse Drug Cluster Events Early Warning System

FENG Hong-yun, LIU Jia, DONG Duo, HOU Yong-fang, YANG Le, SONG Qiu-jie, ZHENG Ming-jie, LI Xin-ling   

  1. Center for Drug Reevaluation, CFDA, Beijing 100045, China
  • Received:2016-01-21 Revised:2016-06-30 Online:2016-04-20 Published:2016-06-30

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摘要： 目的指导预警系统的功能调整和提高预警能力。方法 对国家中心2014年收到的3千余条预警信号进行了系统分析,并讨论影响聚集性药品不良事件预警系统运行的风险因素。结果 预警规则以及运行参数的设置、药品不良反应/事件报告的质量、基础数据库的建设以及相关工作程序的制定等因素均可对预警系统的运行造成影响。结论 聚集性药品不良事件预警系统可以及时有效的发现药品质量风险。针对已经确认的风险因素,提出了相应的调整建议。

关键词: 聚集性药品不良事件, 预警系统, 风险因素

Abstract: Objective To provide support for function adjustment of the adverse drug cluster events early warning system and improve the early warning ability. Methods More than 3 thousands early warning information in 2014 was analyzed systematically, and the risk factors influencing the early warning system were discussed. Results The risk factors included the early warning rules and algorithms, the quality of adverse drug reaction/event reports, foundation database, and the processing procedure for dealing with the early warning information of cluster adverse drug events. Conclusion The early warning system of the adverse drug cluster events can detect the product quality problem effectively. The function adjustment recommendations for the early warning system were proposed according to the identified risk factors.

Key words: cluster adverse drug events, early warning system, risk factor

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