中国药物警戒 ›› 2015, Vol. 12 ›› Issue (4): 229-231.

• 药械安全性研究 • 上一篇    下一篇

基于医院信息系统开展药品不良反应监测研究

王玲   

  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:2015-03-02 修回日期:2015-07-27 出版日期:2015-04-08 发布日期:2015-07-27
  • 作者简介:王玲,女,硕士,主任技师,药品不良反应监测。

Study on Adverse Drug Reaction Monitoring Based on Hospital Information System

WANG Ling   

  1. Center for Drug Reevaluation,CFDA, Beijing 100045, China
  • Received:2015-03-02 Revised:2015-07-27 Online:2015-04-08 Published:2015-07-27

摘要: 目的 为进一步促进我国药品不良反应监测工作提供思路和参考。方法 研究国内医院信息系统开展药物警戒相关工作的现状和具体应用,归纳、分析其中的不足,为基于医院信息系统开展药品不良反应监测、上市后临床研究提出建议。结果与结论 利用医院信息系统开展药品不良反应监测工作可以从真实世界获取数据,在源头提高报告质量、减少漏报;加强主动监测可以弥补自发报告的不足,是提升工作质量和工作价值的良好途径。

关键词: 医院信息系统, 药品不良反应

Abstract: Objective To provide thought and references for the promotion of ADR monitoring in China. Methods The current state and the practical application by using of data from the HIS for pharmacovigilance were studied. The shortcomings were summarized and analyzed. Suggestions on improving ADR monitoring and post-marketing clinical studies based on HIS were put forward. Results &Conclusion It can get data from the real world to carry out the ADR monitoring by using HIS, improving the quality of case reporting at source and reducing the omission.To strengthen active surveillance can make up for the inadequacy of spontaneous reporting. It is a good way to improve the quality and the value of ADR monitoring.

Key words: hospital information system, adverse drug reaction

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