中国药物警戒 ›› 2013, Vol. 10 ›› Issue (9): 523-526.

• 政策与法规研究 • 上一篇    下一篇

应用德尔菲法研究药品生产企业不良反应报告和监测指南

董铎1,孙利华2*   

  1. 1.国家食品药品监督管理局药品评价中心,北京100045；
    2.沈阳药科大学,辽宁沈阳110016
  • 收稿日期:2013-07-02 修回日期:2016-03-09 出版日期:2013-09-08 发布日期:2016-03-09
  • 通讯作者: 孙利华,女,教授·博导,博士,药物政策与药物经济学。 E-mail:slh-3632@163.com
  • 作者简介:董铎,女,博士,副主任药师,药品不良反应监测。

Study of Guideline for Drug Man ufacturer on Adverse Drug Reaction Reporting and Monitoring with Delphi Method

DONG Duo1, SUN Li-hua2*   

  1. 1.Center For Drug Reevaluation, SFDA, Beijing 100045, China;
    2.Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China
  • Received:2013-07-02 Revised:2016-03-09 Online:2013-09-08 Published:2016-03-09

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摘要： 目的 建立药品生产企业不良反应报告和监测指南性文件。方法 应用德尔菲法进行两轮专家调研,确定指南性文件的15项关键内容。结果 两轮咨询的回收率均为100%,专家权威程度分别为0.86 和0.87,专家咨询问题集中程度达到75%的为12 项内容。结论 专家代表性好,积极性高,权威性好,初步构建了生产企业药品不良反应报告和监测指南性文件。

关键词: 德尔菲法, 药品生产企业, 药品不良反应报告和监测, 指南

Abstract: Objective To build up Guideline for drug manufacturer on adverse drug reaction reporting and monitoring. Methods Using the Delphi method, experts were consulted in two rounds to confirm 15 critical items in the Guideline. Results The response rates of the two investigations were all 100% . The authority means of the two rounds were .86 and 0.87 respectively. 12 critical items are reached 75% concentration of expert consultations. Conclusion The enthusiasm and authority of the experts were good. An initial Guideline for drug manufacturer on adverse drug reaction reporting and monitoring has been set up.

Key words: Delphi method, drug manufacturer, adverse drug reaction reporting and monitoring, guideline

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