本文選題：短缺藥品 + 監(jiān)測��； 參考：《中國藥房》2017年34期

【摘要】：目的:系統(tǒng)評價全球短缺藥品監(jiān)測制度,為我國開展短缺藥品監(jiān)測提供循證依據(jù)和政策建議。方法:以"藥品(廉價藥、基本藥物、急救藥品)短缺""短缺藥品""藥品供應不足""藥品缺貨"為中文關鍵詞,"Drug shortage""Out-of-stock drug""Shortage of medicine""Stock out of medicine"為英文關鍵詞,檢索各數(shù)據(jù)庫建庫起至2017年4月3日發(fā)表在PubMed、Embase、中國知網(wǎng)、萬方和維普數(shù)據(jù)庫中的相關文獻,并檢索百度、谷歌等網(wǎng)站及各國家或地區(qū)衛(wèi)生行政部門網(wǎng)站,收集短缺藥品監(jiān)測制度相關文獻,提取監(jiān)測制度的基本信息、數(shù)據(jù)采集方法、數(shù)據(jù)審核方法、數(shù)據(jù)報告方法及反饋與改進措施等信息。結(jié)果與結(jié)論:共納入25篇文獻,并檢索了20個國家或地區(qū)衛(wèi)生行政部門網(wǎng)站。11個國家及歐盟建立了短缺藥品監(jiān)測制度;各國短缺藥品上報主體各異,一般以生產(chǎn)企業(yè)、經(jīng)營企業(yè)、醫(yī)療機構(gòu)為主,上報方式以網(wǎng)絡填報為主;數(shù)據(jù)審核以各國成立的短缺藥品部門或小組為主;監(jiān)測報告包括短缺藥品和停產(chǎn)藥品信息;各國針對短缺藥品的解決措施包括尋找替代藥品、鼓勵企業(yè)生產(chǎn)、臨時進口、尋找新的或其他的原料來源、加快短缺藥品審批,預防措施包括制定短缺藥品相應的法律法規(guī)和管理指南、加大與非政府部門的合作等。我國短缺藥品監(jiān)測制度尚待完善。建議我國建立短缺藥品監(jiān)測預警平臺及短缺藥品分級干預機制,完善短缺藥品相關法律法規(guī),制定短缺藥品管理指南。
[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.
【作者單位】： 四川大學華西第二醫(yī)院藥學部;四川大學華西第二醫(yī)院循證藥學中心;出生缺陷與相關婦兒疾病教育部重點實驗室;四川大學華西藥學院;四川大學華西臨床醫(yī)學院;
【基金】：國家衛(wèi)生和計劃生育委員會2017年委托課題(No.2017bwqt-008-wjw)
【分類號】：R95

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