中国药物警戒 ›› 2015, Vol. 12 ›› Issue (5): 275-278.

• 政策与法规研究 • 上一篇    下一篇

我国基层药品不良反应监测体系建设现状分析及展望

金锋1,曲毅1,2,樊若曦1,李馨龄3*   

  1. 1.吉林省食品药品安全监测中心，吉林长春 130062;
    2长春中医药大学，吉林长春 130117;
    3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:2015-04-09 发布日期:2015-06-08
  • 通讯作者: 李馨龄，男，副主任医师，上市后药械安全性监测。
  • 作者简介:金锋，男，硕士，副主任药师，上市后药械安全性监测。

Analysis and Prospect of the Present Situation of Grassroots Level Adverse Drug Reaction Monitoring System Construction in Our Country

JIN Feng1 ,QU Yi1,2 ,FAN Ruo-xi1 ,LI Xin -ling3   

  1. 1.Jilin Safety Monitoring Center For Food and Drug, Jilin Changchun 130062, China;
    2.Changchun University of Traditional Chinese Medicine, Jilin Changchun 130117,China;
    3.Center for Drug Reevaluation, CFDA, Beijing 100045, China
  • Received:2015-04-09 Published:2015-06-08

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摘要： 目的对当前全国基层药品不良反应监测机构现状进行分析，旨在为各级食品药品监督管理部门促进药品不良反应监测体系建设提供参考，更好地服务药品、医疗器械、化妆品上市后安全性监管工作大局。方法通过问卷调研的方式对我国目前基层药品不良反应监测体系建设现状进行了调研。结果与结论通过现状分析，讨论了基层药品不良反应监测技术机构存在的普遍问题，如改革进程尚未完成、机构职责还不健全、机构设置多未独立、人员队伍建设尚需加强等，并对未来全国基层药品不良反应监测体系建设提出了愿景，对各级监管部门完善监测体系建设工作提出了建设性的意见。

关键词: 不良反应, 体系建设, 现状, 展望

Abstract: Objective Through analyzing researches on the current status of the grassroots adverse drug reaction (ADR) monitoring organization in the country, to provide reference for the food and medicine monitoring organizations at different levels to develop ADR monitoring system, so as to better serve the overall safety monitoring of the medicine, medical device and cosmetic product. Methods Questionnaire survey was used to conduct research on the current status of the local adverse drug reaction monitoring system in our country. Results and Conclusion Through analyzing current status, common issues of the grassroots ADR monitoring organizations are discussed. These issues include incomplete reform progress, insufficient organization functions, most of the organizations not being independent, personnel team needing improvement, etc. The author makes proposals to the future local adverse drug reaction monitoring system development in the country and gives constructive advices to all levels of the monitoring departments to improve the monitoring system development.

Key words: adverse reaction, system construction, present situation, prospect

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