文章摘要
林翼旻,张纾,张玲萍,黄榕珍.国外药物警戒体系建设现状探究及启示[J].中国药事,2024,38(1):105-110
国外药物警戒体系建设现状探究及启示
Exploration and Inspiration on the Current Situation of PharmacovigilanceSystem Construction in the Foreign Countries
投稿时间:2023-08-22  
DOI:10.16153/j.1002-7777.2024.01.014
中文关键词: 欧盟  美国  韩国  日本  医疗机构  药物警戒  体系建设
英文关键词: the European Union  the United States  South Korea  Japan  medical agencies  pharmacovigilance  system construction
基金项目:福建省药品监督管理局科技项目(编号 2022006)
作者单位
林翼旻 福建省药品审评与监测评价中心福州 350003 
张纾 福建省药品审评与监测评价中心福州 350003 
张玲萍 福建省药品审评与监测评价中心福州 350003 
黄榕珍 福建省药品审评与监测评价中心福州 350003 
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中文摘要:
      目的:探讨欧盟、美国、韩国、日本和中国的药物警戒体系建设现状,为我国医疗机构药物警戒体系建设提供建议与参考。方法:对欧盟、美国、韩国和日本药物警戒体系建设现状进行分析,并与我国医疗机构药物警戒体系建设进行对比,提出我国的医疗机构药物警戒建设建议。结果与结论:药物警戒是药品安全监管的重要内容,贯穿药品全生命周期,我国应充分利用医疗机构报告主渠道优势,建立具有我国特色的医疗机构药物警戒体系,并强化风险监测和预警,促进临床安全用药。
英文摘要:
      

Objective: To explore the current situation of pharmacovigilance system construction in the European

Union, the United States, South Korea, Japan, and China, and to provide suggestions and references for the

construction of pharmacovigilance system in medical agencies in China. Methods: The current situation of

pharmacovigilance system construction in the European Union, the United States, South Korea, and Japan was

analyzed, and the construction of pharmacovigilance system in medical agencies in China was compared with that.

The suggestions for pharmacovigilance construction in medical agencies in China were put forward. Results and

Conclusion: Pharmacovigilance is an important aspect of drug safety supervision, which runs through the entire

lifecycle of drugs. China should fully utilize the advantages of the main reporting channel of medical agencies,

establish a pharmacovigilance system of medical agencies with Chinese characteristics, and strengthen risk

monitoring and early warning to promote safe use of drugs in clinical settings.

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