瑞典医疗机构不良反应报告和监测研究

Adverse Reaction Reporting and Monitoring Research in Swedish Medical Institutions

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.