中国药物警戒 ›› 2020, Vol. 17 ›› Issue (10): 688-691.
DOI: 10.19803/j.1672-8629.2020.10.08

• 法规与管理研究 • 上一篇    下一篇

新型冠状病毒肺炎事件下市级药物警戒工作实践与思考

吴文宇, 肖霄, 吴建茹   

  1. 深圳市药物警戒和风险管理研究院,广东 深圳 518024
  • 收稿日期:2020-10-14 修回日期:2020-10-14 出版日期:2020-10-15 发布日期:2020-10-13
  • 作者简介:吴文宇,男,本科,主管药师,药物警戒与风险管理。
  • 基金资助:
    广东省药品不良反应监测中心委托项目:粤港澳大湾区药物警戒模式研究

The Practice and Thinking of Pharmacovigilance at the Municipal Level under COVID-19

WU Wenyu, XIAO Xiao, WU Jianru   

  1. Shenzhen Institute of Pharmacovigilance and Risk Management, Shenzhen Guangdong 518024, China
  • Received:2020-10-14 Revised:2020-10-14 Online:2020-10-15 Published:2020-10-13

摘要: 目的 以深圳市为例对新型冠状病毒肺炎疫情期间市级药物警戒实践及制度建设进行思考。方法 对深圳市在疫情防控期间的药物警戒工作实践进行总结,并通过文献研究方法对药物警戒理论内涵、体系构成等进行分析。结果 突发公共卫生事件下的药物警戒工作开展需建立更加完善的风险监测、数据共享和利用机制。结论 应从国家层面将药物警戒制度建设纳入突发公共卫生技术体系建设总体规划,从拓展数据来源、加强信息化建设、构建数据共享机制、制定有效应急处置预案等方面,提高药品风险监测应急处置能力和药品监管的科学性。

关键词: 新型冠状病毒肺炎, 突发公共卫生事件, 药物警戒, 工作实践

Abstract: Objective To summarize the practice of pharmacovigilance in Shenzhen during the outbreak of COVID-19, and to consider the construction of pharmacovigilance system. Methods On the basis of pharmacovigilance practice in Shenzhen, literature research was conducted to analyze the theoretical connotation and system composition of pharmacovigilance. Results The development of pharmacovigilance work under public health emergencies required the establishment of a more complete risk monitoring, data sharing, and utilization mechanism. Conclusion It is necessary to incorporate the construction of the pharmacovigilance system into the overall public health technology system plan from a national perspective, and to improve the capacity of drug risk monitoring and emergency response in terms of expanding data sources, strengthening information construction, building a data sharing mechanism, and formulating effective emergency response plans.

Key words: COVID-1P, emergencies in public health, pharmacovigilance, practices

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