全球短缺药品监测制度的循证评价  

Evidence-based Evaluation of Monitoring System for Global Short Drugs

作　　者：张伶俐[1,2,3] 陈哲 曾力楠[1,2,3] 归舸[1,2,3,4] 张扬 李佳莲[1,2,3,4] 黄宗瑶[1,2,3,4] 宋好鑫[1,2,3,4] 

机构地区：[1]四川大学华西第二医院药学部,成都610041 [2]四川大学华西第二医院循证药学中心,成都610041 [3]出生缺陷与相关妇儿疾病教育部重点实验室,成都610041 [4]四川大学华西药学院,成都610041 [5]四川大学华西临床医学院,成都610041

出　　处：《中国药房》2017年第34期4753-4758,共6页China Pharmacy

基　　金：国家卫生和计划生育委员会2017年委托课题(No.2017bwqt-008-wjw)

摘　　要：目的:系统评价全球短缺药品监测制度,为我国开展短缺药品监测提供循证依据和政策建议。方法:以"药品(廉价药、基本药物、急救药品)短缺""短缺药品""药品供应不足""药品缺货"为中文关键词,"Drug shortage""Out-of-stock drug""Shortage of medicine""Stock out of medicine"为英文关键词,检索各数据库建库起至2017年4月3日发表在PubMed、Embase、中国知网、万方和维普数据库中的相关文献,并检索百度、谷歌等网站及各国家或地区卫生行政部门网站,收集短缺药品监测制度相关文献,提取监测制度的基本信息、数据采集方法、数据审核方法、数据报告方法及反馈与改进措施等信息。结果与结论:共纳入25篇文献,并检索了20个国家或地区卫生行政部门网站。11个国家及欧盟建立了短缺药品监测制度;各国短缺药品上报主体各异,一般以生产企业、经营企业、医疗机构为主,上报方式以网络填报为主;数据审核以各国成立的短缺药品部门或小组为主;监测报告包括短缺药品和停产药品信息;各国针对短缺药品的解决措施包括寻找替代药品、鼓励企业生产、临时进口、寻找新的或其他的原料来源、加快短缺药品审批,预防措施包括制定短缺药品相应的法律法规和管理指南、加大与非政府部门的合作等。我国短缺药品监测制度尚待完善。建议我国建立短缺药品监测预警平台及短缺药品分级干预机制,完善短缺药品相关法律法规,制定短缺药品管理指南。OBJECTIVE：To systematically evaluate the monitoring system for global short drugs,and provide evidence-based reference and policy recommendations for developing the short drug monitoring in China. METHODS：Relevant literatures published in PubMed,Embase,CNKI,Wanfang,VIP database from building to Apr. 3 rd in 2017 were retrieved by using＂Drugs（cheap drugs,essential medicines,emergency drugs）storage＂＂Short drugs＂＂Insufficient supply of drugs＂＂Drug shortage＂as Chinese keywords,and＂Drug storage＂＂Out-of-stock drug＂＂Stortage of medicine＂＂Stock out of medicine＂as English keywords.Literatures about monitoring system for short drugs in Baidu,Google and national or regional health administration websites were collected,and general information,data collection,data validation,data reporting method,feedback and improvement measures of monitoring system were extracted. RESULTS CONCLUSIONS：Totally 25 literatures were included,20 national or regional health administration websites were retrieved. 11 countries and European Union had established monitoring system for short drugs.The main reporting agencies in each country were different,which were production enterprises,business enterprises and medical institutions. It was mainly reported by network. Data validation was mainly conducted by specialized departments or groups for short drugs in each country. The monitoring reporting included information of short drugs and discontinued drugs. Countermeasures in each country mainly included looking for alternative drugs,encouraging production,temporary import,looking for new or othersources of raw materials and speeding up the approval of short drugs. Besides,precautions included implementation relevant laws and guidelines for short drugs,and increasing the cooperation with non-government departments,etc. Monitoring system for short drugs needs to be further improved in China. Itis suggested to establish monitoring and early warning platform for short drugs,and hierarchical intervention mechanis

关 键 词：短缺药品 监测 制度 循证评价 

分 类 号：R95[医药卫生—药学]