中国药物警戒 ›› 2020, Vol. 17 ›› Issue (9): 572-573.
DOI: 10.19803/j.1672-8629.2020.09.06

• 法规与管理研究 • 上一篇    下一篇

新《药品管理法》下医疗机构药物警戒工作面临的挑战

冯亚楠, 刘欣欣, 李永辉*, 王芳, 郭瑞锋   

  1. 河北省药品监测评价中心,河北 石家庄 050090
  • 收稿日期:2020-08-17 修回日期:2020-08-17 出版日期:2020-09-15 发布日期:2020-08-17
  • 通讯作者: *李永辉,男,硕士,副主任药师,药物警戒。E-mail:hbfda157@126.com
  • 作者简介:冯亚楠,女,本科,主管药师,药物警戒。

Challenges to Pharmacovigilance by Medical Institutions under the New Drug Administration Law

FENG Yanan, LIU Xinxin, LI Yonghui*, WANG Fang, GUO Ruifeng   

  1. Center for Drug Monitoring and Evaluation of Hebei, Shijiazhuang Hebei 050090
  • Received:2020-08-17 Revised:2020-08-17 Online:2020-09-15 Published:2020-08-17

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摘要： 目的 研究探索医疗机构在2019年新《药品管理法》下药物警戒工作面临的挑战。方法 采用文献分析、综合分析的方法进行论述性分析。结果 医疗机构发现和研判药品安全性风险隐患能力不足,开展药物警戒工作的热情不高,工作人员数量不够。结论 建立完备的医院药物警戒体系,加强相关工作的业务培训,广泛发挥社会力量,共同促进医疗机构开展药物警戒工作。

关键词: 药品管理法, 药物警戒, 医疗机构, 挑战

Abstract: Objective To explore the challenges to pharmacovigilance by medical institutions under the new Drug Administration Law. Methods Literature analysis and comprehensive analysis were conducted for the discussion. Results Medical institutions lacked the ability to find and evaluate the potential risks to drug safety, showed poor initiative for pharmacovigilance, and were understaffed. Conclusion It is recommended that a complete hospital pharmacovigilance system be established, related training be improved, and social forces be given full play to in order to promote pharmacovigilance by medical institutions.

Key words: Drug Administration Law, pharmacovigilance, medical institutions, challenge

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