全球短缺药品监测制度的循证评价

发布时间：2018-06-22 10:27

本文选题：短缺药品 + 监测　；参考：《中国药房》2017年34期

【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。
[Abstract]:Objective: to systematically evaluate the global drug shortage monitoring system and provide evidence-based evidence and policy advice for the development of drug shortage monitoring in China. Methods: the key words of "shortage of drugs (cheap drugs, essential drugs, first aid drugs)", "shortage of drugs", "shortage of drugs" and "drug shortage" Out-of-stock drug "," Shortage of medicine "," Stock out of medicine "were used as the keywords. To search the relevant documents published in PubMeden Embase, China Zhiwang, Wanfang and Weip databases until April 3, 2017, and to search Baidu, Google and other websites, as well as the websites of health administration departments of various countries or regions, Collecting relevant documents of shortage drug monitoring system, extracting basic information of monitoring system, data collection method, data audit method, data reporting method, feedback and improvement measures, etc. Results & conclusion: a total of 25 articles were included, and the websites of health administrative departments of 20 countries or regions were searched. 11 countries and the European Union established the shortage drug monitoring system. Business enterprises, medical institutions, the main way to report to the network to fill in the main; data audit based on the establishment of the shortage of drugs departments or groups; monitoring reports including shortage of drugs and stop production drug information; National solutions to shortages include finding alternative drugs, encouraging businesses to produce them, importing them temporarily, finding new or other sources of raw materials, and expediting the approval of medicines in short supply. Preventive measures include the formulation of laws, regulations and guidelines for drug shortages, and increased cooperation with the non-government sector. China's shortage of drugs monitoring system needs to be improved. It is suggested that China should set up a platform for monitoring and warning of shortage drugs and establish a hierarchical intervention mechanism for shortage drugs, perfect the laws and regulations related to shortage drugs, and formulate guidelines for the management of shortage drugs.
【作者单位】：四川大学华西第二医院药学部;四川大学华西第二医院循证药学中心;出生缺陷与相关妇儿疾病教育部重点实验室;四川大学华西药学院;四川大学华西临床医学院;
【基金】：国家卫生和计划生育委员会2017年委托课题(No.2017bwqt-008-wjw)
【分类号】：R95

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