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 Pharmacovigilance System Construction in the Foreign Countries
林翼旻 1张纾 1张玲萍 1黄榕珍1
作者信息
- 1. 福建省药品审评与监测评价中心,福州 350003
- 折叠
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.
Abstract
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.
关键词
欧盟/美国/韩国/日本/医疗机构/药物警戒/体系建设Key words
the European Union/the Unitcd States/South Korea/Japan/medical agencies/pharmacovigilance/system construction引用本文复制引用
基金项目
福建省药品监督管理局科技项目(2022006)
出版年
2024
NETL
NSTL
维普
万方数据