省市两级药品不良反应监测评价技术体系建设路径探讨  

Discussion on the Technical System Construction Path for Adverse Drug Reaction Monitoring and Evaluating between Province and Municipality

作　　者：许海波 王颖 王广平 XU Haibo;WANG Ying;WANG Guangping(Shanghai Center for Adverse Drug and Medical Device Reaction Monitoring,Shanghai 200040,China)

机构地区：[1]上海市药品和医疗器械不良反应监测中心,上海200040

出　　处：《中国医药导刊》2024年第6期560-565,共6页Chinese Journal of Medicinal Guide

基　　金：浙江省哲学社会科学规划课题(20NDJC221YB);上海市药品监督管理局2023年度研究课题(LX-2023-20)。

摘　　要：省市两级药品不良反应(ADR)监测评价技术体系建设和发展规划,事关国家药物警戒体系和能力建设的全局,也是建立健全国家药物警戒制度和提升地方药品监管技术支撑能力的重要保障。省市两级ADR监测评价技术体系建设思维,不仅是由上而下的考评工作,更是一种服务公众和提升基层监测评价能力的策略。为助力提升地方药品监管技术支撑能力,推进基层监管数字化转型升级和提升基层监测评价能力,本研究在梳理省市两级ADR监测评价技术体系建设现况、发展现状以及医疗机构ADR监测报告现状的基础上,分析了省市两级ADR能力建设制度文件、省市职权划分设置和人力资源配置等监测评价技术体系的制度基础,提出了省市两级ADR监测评价技术体系建设框架体系和建设路径等,其中省级ADR监测评价技术体系指标包括上市后监测、安全性评价、药物警戒(GVP)核查和监管决策支持等方面,市县级包括药品安全责任体系和ADR监测评价指标两方面。省市两级ADR监测评价技术体系建设路径,包括落实药品安全责任、推进数字化应用场景、优化营商环境目标等。The construction and development plan of the monitoring and evaluation technology system for adverse drug reaction(ADR)between the province and town,is not only related to the national pharmacovigilance system and capacity building,which is but also an important guarantee for establishing and improving the national drug alert system and enhancing the technical support capacity of local drug supervision.The construction of ADR monitoring and evaluation technology system at provincial and municipal levels is not only a top-down assessment work,but also a service awareness of serving the public and strategies for improving the monitoring and evalu-ation capacity of grass-roots work.In order to help enhance the technical support capacity of local drug regulation,promote the digitized transformation and improving the monitoring and evaluation capacity of grass-roots supervision,based on the status analysis of ADR moni-toring and evaluation technology system construction between the province and municipality,and the status of ADR monitoring reports in hospitals,the study discussed the system foundation and development status of local ADR capacity building,authority division setting between the province and city,and the allocation of regulatory human resource.Then the study proposed the construction framework and the construction path of ADR monitoring and evaluation technology systems between the province and municipality.The indicators of the provincial ADR monitoring and evaluation technology system included the post market monitoring,safety evaluation,pharmacovigilance(GVP)verification,and the regulatory decision support.The indicators of the municipality ADR monitoring and evaluation technology system included the drug safety responsibility system and ADR monitoring and evaluation.The construction path of ADR monitoring and evaluation technology system between the province and municipality included the implementing drug safety responsibilities,promoting digital application scenarios,optimizing business environment

关 键 词：省市 药品不良反应 药物警戒 监测评价 责任体系 

分 类 号：R95[医药卫生—药学]