中国药物警戒 ›› 2018, Vol. 15 ›› Issue (1): 24-27.

• 法规与管理研究 • 上一篇    下一篇

省级药品不良反应监测服务药品安全监管工作模式探讨

路长飞, 崔小康, 刘文文, 李玉基, 吴世福*   

  1. 山东省药品不良反应监测中心,山东 济南 250014;
  • 收稿日期:2018-02-12 修回日期:2018-02-12 出版日期:2018-01-20 发布日期:2018-02-12
  • 通讯作者: *吴世福,男,主任中药师,药品不良反应监测与评价。E-mail: wushifu@sdfda.gov.cn
  • 作者简介:路长飞,男,主管药师,药品化妆品不良反应监测与评价。

Exploration on the Model of Provincial ADR Monitoring Support the Drug Supervision

LU Chang-fei, CUI Xiao-kang, LIU Wen-wen, LI Yu-ji, WU Shi-fu*   

  1. Shandong Provincial Centre for ADR Monitoring, Shandong Ji'nan 250014, China;
  • Received:2018-02-12 Revised:2018-02-12 Online:2018-01-20 Published:2018-02-12

摘要: 目的 构建省级药品不良反应监测服务药品安全监管的工作模式。方法 以山东省药品不良反应监测工作实践为基础,结合当前药品监管现状,探索制定出包含风险发现、风险会商、风险管控等多个环节的省级药品不良反应监测服务药品安全监管的工作模式。结果与结论 省级药品不良反应监测服务药品安全监管的工作模式不仅能够保证风险的发现和后续处置,理顺了相关部门的职责,还为充分发挥ADR监测效能,发挥药品不良反应监测技术支撑作用提供了新的思路。

关键词: 药品不良反应, 监管, 模式

Abstract: Objective To establish a work model of provincial adverse drug reaction monitoring support the drug supervision. Methods On the basis of the adverse drug reaction monitoring practice in Shandong province, we developed a work model of provincial adverse drug reaction monitoring support the drug supervision, which contains risk discovery, risk discussion, risk control and other links. Results and Conclusion The model can not only ensure the discovery and subsequent disposal of the risk and straighten out the responsibilities of relevant departments, but also provide a new train of thought to enhance the role of adverse drug reaction monitoring.

Key words: adverse drug reaction, administration, model

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