中国药物警戒 ›› 2010, Vol. 7 ›› Issue (1): 25-27.

• 管理研究 • 上一篇    下一篇

药品安全性监测数据综合分析标准与规范的研究

黄传海1, 李泮海1, 田月洁1, 刘巍2, 金少鸿2*   

  1. 1山东省药品不良反应监测中心,山东 济南 250013;
    2国家食品药品监督管理局药品评价中心, 北京 100045
  • 收稿日期:2016-02-18 修回日期:2016-02-18 出版日期:2010-01-08 发布日期:2016-02-18
  • 通讯作者: *通讯作者：金少鸿,男,研究员,本课题负责人,国家食品药品监督管理局药品评价中心主任。E-mail:jinshaohong@cdr.gov.cn
  • 作者简介:黄传海,男,硕士,主治医师,药品不良反应监测。
  • 基金资助:
    十一五国家科技支撑计划项目（2006BAI14B03）“安全用药监测研究与预警技术系统的研究及应用”

Study on Standards and Norms of Drug Safety Monitoring Data and Comprehensive Analysis

HUANG Chuan-hai1, TIAN Yue-jie1, LI Pan-hai1, LIU Wei2, JIN Shao-hong2,*   

  1. 1Shandong Center for ADR monitoring,Shandong Jinan 250013, China;
    2Center For Drug Reevaluation, SFDA, Beijing 100045, China
  • Received:2016-02-18 Revised:2016-02-18 Online:2010-01-08 Published:2016-02-18

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摘要： 药品安全性监测是药物警戒的基本内容,监测数据的综合分析是药物警戒的关键环节,也是最复杂、最困难的步骤,至今仍无统一的国际国内标准。通过对药品安全性监测数据的评价和分析利用进行系统研究,分析我国药品安全性监测数据的特点,借鉴国际经验,结合我国国情,制订药品安全性监测数据综合分析的标准与规范,可有效提高评价分析的规范化,降低因人员因素而导致的结偏倚,有利于提升药品安全性信息的分析利用水平,完善药品安全监测系统,降低药品安全事件的发生和影响。

关键词: 药品安全性监测, 评价分析, 标准, 规范

Abstract: Drug safety monitoring is the basic content of pharmacovigilance.Comprehensive analysis on monitor-ing data which is the most complex and most difficult step, is a key step in pharmacovigilance. No unified standards in the world update. With the analyzed characteristics of drug safety monitoring data through systematic research in China, drawing on international experience, combining with our national conditions, development of drug safety monitoring data, a comprehensive analysis of standards and norms, the standardization of evaluation and analysis were improved effectively, and the result of bias due to human factors is reduced, and contribute to enhancing drug safety analysis of information utilization levels, to improve drug safety monitoring system, and also to reduce the incidence of drug safety and impact.

Key words: drug safety monitoring, evaluation and analysis, standards, norms

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