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瑞典医疗机构不良反应报告和监测研究 被引量:1

Adverse Reaction Reporting and Monitoring Research in Swedish Medical Institutions
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摘要 目的:探索研究瑞典医疗机构不良反应报告和监测的组织体系、法律依据、药物警戒系统特点,为我国开展医疗机构不良反应报告和监测工作提供参考。方法:根据瑞典药品管理局网站发布的法律法规文件、年度报告、工作信息,以及相关文献,对瑞典医疗机构药物警戒体系各要素进行分析。结果:瑞典在医疗机构报告和监测工作方面开展了诸多工作,建立了较为成熟的安全性监测体系。结论:我国可以借鉴瑞典相关工作经验,提高我国医疗机构不良反应报告和监测能力,提出优化国家药物不良反应中心和区域中心的职责分工、简化医务人员不良反应报告途径、建立基于医疗机构数据的主动监测系统的建议。 Objective:To explore the organization system,legal basis and characteristics of pharmacovigilance system of adverse drug reaction(ADR)reporting and monitoring in medical institutions in Sweden,so as to provide reference for ADR reporting and monitoring in medical institutions in China.Methods:Analyze the elements of pharmacovigilance system in Swedish medical institutions according to the laws and regulations,annual reports,work information published on the website of Swedish drug administration,and related literature.Results:Sweden has carried out a lot of work in the reporting and monitoring of medical institutions,and established a relatively mature safety monitoring system.Conclusion:China could learn from the experience of Sweden to improve the ADR reporting and monitoring ability of medical institutions,and this paper puts forward the suggestions of optimizing the division of responsibilities between National Center and regional center,simplifying the ADR reporting channels of medical staff,and establishing an active monitoring system based on the data of medical institutions.
作者 乌兰其其格 杨悦 WU Lan-qiqige;YANG Yue(School of Business Administration,Shenyang Pharmaceutical University,Liaoning Shenyang 110015,China;School of Pharmaceutical Science,Tsinghua University,Beijing 100062,China)
出处 《中国药物评价》 2021年第3期255-258,共4页 Chinese Journal of Drug Evaluation
关键词 瑞典 医疗机构 不良反应报告 不良反应监测 Sweden Medical institutions Adverse reaction reports Adverse reaction monitoring
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  • 1王大猷.药物警戒刍议[J].中国药物警戒,2004,1(1):20-24. 被引量:25
  • 2陈易新,李少丽,曹立亚,等.现代药品不良反应报告制度的建立与其医药背景[J].中国药品不良反应通讯,2003,13(5):1-4.
  • 3[3]the Uppsala Monitoring Center.Official member countries and their year of entering the programme[EB/OL].http://www.who-umc.org/index2.html.2005-05-30.

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