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全球短缺藥品監(jiān)測(cè)制度的循證評(píng)價(jià)

發(fā)布時(shí)間:2018-06-22 10:27

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


【摘要】:目的:系統(tǒng)評(píng)價(jià)全球短缺藥品監(jiān)測(cè)制度,為我國(guó)開展短缺藥品監(jiān)測(cè)提供循證依據(jù)和政策建議。方法:以"藥品(廉價(jià)藥、基本藥物、急救藥品)短缺""短缺藥品""藥品供應(yīng)不足""藥品缺貨"為中文關(guān)鍵詞,"Drug shortage""Out-of-stock drug""Shortage of medicine""Stock out of medicine"為英文關(guān)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(guó)知網(wǎng)、萬方和維普數(shù)據(jù)庫中的相關(guān)文獻(xiàn),并檢索百度、谷歌等網(wǎng)站及各國(guó)家或地區(qū)衛(wèi)生行政部門網(wǎng)站,收集短缺藥品監(jiān)測(cè)制度相關(guān)文獻(xiàn),提取監(jiān)測(cè)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(bào)告方法及反饋與改進(jìn)措施等信息。結(jié)果與結(jié)論:共納入25篇文獻(xiàn),并檢索了20個(gè)國(guó)家或地區(qū)衛(wèi)生行政部門網(wǎng)站。11個(gè)國(guó)家及歐盟建立了短缺藥品監(jiān)測(cè)制度;各國(guó)短缺藥品上報(bào)主體各異,一般以生產(chǎn)企業(yè)、經(jīng)營(yíng)企業(yè)、醫(yī)療機(jī)構(gòu)為主,上報(bào)方式以網(wǎng)絡(luò)填報(bào)為主;數(shù)據(jù)審核以各國(guó)成立的短缺藥品部門或小組為主;監(jiān)測(cè)報(bào)告包括短缺藥品和停產(chǎn)藥品信息;各國(guó)針對(duì)短缺藥品的解決措施包括尋找替代藥品、鼓勵(lì)企業(yè)生產(chǎn)、臨時(shí)進(jìn)口、尋找新的或其他的原料來源、加快短缺藥品審批,預(yù)防措施包括制定短缺藥品相應(yīng)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(guó)短缺藥品監(jiān)測(cè)制度尚待完善。建議我國(guó)建立短缺藥品監(jiān)測(cè)預(yù)警平臺(tái)及短缺藥品分級(jí)干預(yù)機(jī)制,完善短缺藥品相關(guān)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(xué)華西第二醫(yī)院藥學(xué)部;四川大學(xué)華西第二醫(yī)院循證藥學(xué)中心;出生缺陷與相關(guān)婦兒疾病教育部重點(diǎn)實(shí)驗(yàn)室;四川大學(xué)華西藥學(xué)院;四川大學(xué)華西臨床醫(yī)學(xué)院;
【基金】:國(guó)家衛(wèi)生和計(jì)劃生育委員會(huì)2017年委托課題(No.2017bwqt-008-wjw)
【分類號(hào)】:R95

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