全球短缺药品管理相关指南与共识的循证评价  

Evidence-Based Evaluation of Global Guidelines and Consensus on Management of Drug Shortage

作　　者：刘骁 杨楠 曾力楠[2,3] 李海龙 陈哲 LIU Xiao;YANG Nan;ZENG Linan;LI Hailong;CHEN Zhe(Dept.of Pharmacy,the Third People’s Hospital of Chengdu,Chengdu 610031,China;Dept.of Pharmacy/Evidence-Based Pharmacy Center,West China Second University Hospital of Sichuan University,Chengdu 610041,China;Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation,National Medical Products Administration,Chengdu 610041,China)

机构地区：[1]成都市第三人民医院药学部,成都610031 [2]四川大学华西第二医院药学部/循证药学中心,成都610041 [3]国家药品监督管理局药物制剂体内外相关性技术研究重点实验室,成都610041

出　　处：《中国医院用药评价与分析》2024年第12期1417-1422,1428,共7页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：国家卫健委药政司课题(No.2024131001-0421)。

摘　　要：目的:系统评价全球短缺药品管理相关指南与共识,为我国短缺药品管理提供循证依据。方法:系统检索7个文献数据库、4个指南数据库以及48个卫生行政部门、药监局和相关行业协会官方网站,检索时间为建库至2024年7月。筛选后纳入短缺药品管理相关指南与共识,以统一资料表提取文献基本情况,短缺药品信息收集、评估、上报和发布方法、应对和预防措施等。采用描述性分析,比较全球短缺药品管理指南与共识的内容。结果:纳入来自6个国家或组织的短缺药品指南17篇。短缺药品信息上报主体多为生产企业、经营企业、医疗机构,上报方式以网络填报为主,上报信息包括药品信息、生产企业信息、短缺时间等;监测报告包括短缺药品和停产药品信息;应对处置措施为使用替代药品,鼓励企业生产和寻找其他来源,制定法律或指南,以规范短缺药品管理。结论:建议相关卫生行政部门进一步完善短缺药品管理配套政策措施;医疗机构加强短缺药品库存管理,制定短缺药品替代和分配方案;药品生产企业保障药品质量,及时跟踪原料情况,合理计划库存。OBJECTIVE:To systematically review global guidelines and consensus on management of drug shortage,so as to provide evidence-based reference for the management of drug shortage in China.METHODS:A total of 7 bibliographic databases,4 guideline databases and 48 official websites of health administrative departments,pharmacological regulatory bureaus and relevant industry associations were systematically searched from the time of base-building to Jul.2024.Guidelines and consensus related to drug shortage management were screened and enrolled,the basic information of the literature,information collection,assessment and reporting of drug shortage,publication methods,response and preventive measures were extracted with a unified information sheet.Descriptive analysis was used to compare the contents between global guidelines and consensus on drug shortage management.RESULTS:A total of 17 guidelines on drug shortage from 6 countries or organizations were enrolled.The main subjects of drug shortage information reporting were mostly manufacturers,operating enterprises and medical institutions,the reporting way was mainly online reporting,the reported information included drug information,manufacturer information and time of shortage,etc.;the monitoring report included information on shortage drugs and discontinued drugs;the response and disposal measures were the use of alternative drugs,encouragement of enterprises to produce and search for other sources,formulation of laws or guidelines to regulate the drug shortage management.CONCLUSIONS:It is recommended that relevant health administrative departments should further improve supporting policies and measures for the management of drug shortage;and medical institutions should strengthen the inventory management of drug shortage,formulate programme for the substitution and distribution of drug shortage;and drug manufacturers should guarantee drug quality,follow up on raw materials in time and allocate inventory reasonably.

关 键 词：医疗机构 短缺药品 指南 共识 系统评价 

分 类 号：R954[医药卫生—药学]