中国药物警戒 ›› 2019, Vol. 16 ›› Issue (2): 123-125.

• 安全性评价与合理用药 • 上一篇    下一篇

安徽省药品不良事件聚集性信号分析

葛文超   

  1. 安徽省药品不良反应监测中心,安徽 合肥 230051
  • 收稿日期:2019-03-12 修回日期:2019-03-12 出版日期:2019-02-25 发布日期:2019-03-12
  • 作者简介:葛文超,男,硕士,主管药师,药品不良反应监测与评价。

Analysis of Cluster Signals of Adverse Drug Events in Anhui Province

GE Wenchao   

  1. Anhui Center for Adverse Drug Reaction Monitoring, Anhui Hefei 230051, China
  • Received:2019-03-12 Revised:2019-03-12 Online:2019-02-25 Published:2019-03-12

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摘要： 目的 探讨药品不良事件聚集性信号产生的规律和原因,分析药品使用环节潜在的风险和问题,为药品风险预警工作提供参考。方法 对2014~2017年国家预警系统共享平台中安徽省产生的804条药品不良事件聚集性信号进行统计与分析。结果 聚集性信号涉及的药品主要为注射剂和抗肿瘤药,其中严重报告产生的信号较多,信号主要集中在每年的第四季度,主要受预警规则、报告数量、报告习惯、报告质量等因素的影响。结论 药品不良事件聚集性信号监测与处置工作的开展,能够及时发现药品上市后可能存在的风险和问题,提高药品安全事件的响应能力,有效发挥了风险防控的作用。

关键词: 药品不良事件聚集性信号, 预警系统, 分析

Abstract: Objective To explore the regularity and cause of cluster signals of the adverse drug events and analyze the potential risks and problems in the use of drugs, so as to provide reference for the drug safety warning in the work. Methods Cluster signals of 804 cases of adverse drug events were summerized and analyzed from 2014 to 2017 in Anhui province. Results The mainly drugs involved in cluster signals were injections and antitumor drugs, in which more severe signals were reported. Distribution of events was concentrated in the fourth quarter of each year, the main factors were warning rules, number of reports, reporting habits, reporting quality and others. Conclusion The monitoring and handling of cluster signals of the adverse drug events can timely find the possible risk and problems. It also can improve the responsiveness of drug safety incidents, and effectively play the role of risk prevention and control.

Key words: cluster signals of adverse drug events, warning system, analysis

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