中国医院药物警戒系统药品不良反应主动监测模块的应用探讨  

Application of Active Monitoring Module for Adverse Drug Reaction in Chinese Hospital Pharmacovigilance System

作　　者：魏传梅[1] 高菲[1] 张华琦 路长飞 WEI Chuan-mei;GAO Fei;ZHANG Hua-qi;LU Chang-fei(Department of Pharmacy,Binzhou Medical University Hospital,Binzhou 256603,China;Center for Adverse Drug Reaction Monitoring of Shandong,Jinan 250014,China)

机构地区：[1]滨州医学院附属医院药学部,滨州256603 [2]山东省药品不良反应监测中心,济南250014

出　　处：《中国合理用药探索》2023年第4期140-146,共7页Chinese Journal of Rational Drug Use

基　　金：山东省药品不良反应监测哨点课题(2020SDADRKY03)。

摘　　要：目的:探讨中国医院药物警戒系统(CHPS)药品不良反应(ADR)主动监测模块在医院上报ADR时的作用。方法:从报告例数、报告类型、涉及药品、损害部位等方面,对比分析2020年下半年ADR主动监测上报情况与自发上报情况。结果:主动监测报告占总ADR报告例数的20%,严重的和新的、严重的ADR报告占总ADR报告例数的25%;主动监测ADR报告涉及的药品中有27种为自发上报未涉及品种,占所有ADR报告品种数的12.86%;严重的和新的、严重的ADR报告涉及的药品品种中,25%为主动监测获得;主动监测ADR报告涉及9个损害部位、40个科室,其中8个科室此前为自发上报零报告科室。结论:自发上报ADR仍为医院ADR报告收集的主要渠道;主动监测可扩大ADR报告的药品品种,提供重点监测药品品种选择依据,减少零报告科室,发现ADR上报工作中的薄弱环节。Objective:To explore the role of active monitoring module for adverse drug reaction(ADR)in Chinese Hospital Pharmacovigilance System(CHPS)in ADR reporting.Methods:The active monitoring and spontaneous reporting of ADR in the second half of 2020 were compared and analyzed in terms of the number of reports,types of reports,drugs involved and damaged sites.Results:Active monitoring reports accounted for 20%of the total number of ADR reports,and serious,new and severe ADR reports accounted for 25%of the total number of ADR reports;27 drugs involved in the active monitoring ADR reports were not involved in the spontaneous reporting,accounting for 12.86%of the total number of varieties in the ADR reports;25%of the drug varieties involved in serious and new and severe ADR reports were obtained by active monitoring;9 damaged sites and 40 wards were involved in the active monitoring ADR reports,and among which 8 wards had no spontaneous reporting previously.Conclusion:Spontaneous reporting is still the main channel for ADR collection in hospitals.Active monitoring can expand the range of drug varieties involved in ADR reports,provide the basis for the selection of key drug varieties for monitoring,reduce the wards with zero reports,and identify the weak lines in ADR reporting.

关 键 词：中国医院药物警戒系统 药物不良反应报告 主动监测 自发上报 

分 类 号：R95[医药卫生—药学]