我国药品信息追溯体系建设存在的问题及对策研究
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篇名: 我国药品信息追溯体系建设存在的问题及对策研究
TITLE:
摘要: 目的:为完善我国药品信息追溯体系建设提供参考。方法:以“药品信息追溯”“药品追溯”“药品电子监管” “Drug information traceability”“Drug traceability”“Electronic drug supervision”等为关键词,计算机检索2014年1月-2019年4月于PubMed、中国知网、万方、维普等数据库发表的相关文献以及美国、欧盟和我国药品监督管理部门或卫生行政部门网站发布的有关药品信息追溯的法律法规。通过与美国、欧盟比较,分析我国药品信息追溯体系存在的问题并提出对策建议。结果与结论:共纳入31篇文献。美国、欧盟和我国均建立了药品信息追溯体系。美国、欧盟具有编码与国际标准接轨,充分利用第三方平台以避免形成垄断等优点。我国药品信息追溯体系建设尚处于完善的关键阶段,存在缺乏部分具体操作规范、指南,供应链参与主体众多,信息化水平参差不齐,药品信息追溯系统与交易、报销及其他信息系统的独立性、协同度不够等问题。建议我国药品监管部门尽快完善药品信息追溯体系的相关法律法规,并充分发挥第三方平台的集约作用,建立基于药品交易平台的药品信息追溯平台,使其在深化医药卫生体制改革、保障短缺药品供应、促进合理用药、综合监管等方面发挥重要作用。
ABSTRACT: OBJECTIVE: To provide reference for the improvement of drug information traceability system in China. METHODS: Using “drug information traceability”“drug traceability”“electronic drug supervision” as keywords, related literatures,relevant laws and regulations about drug information traceability were retrieved from PubMed, CNKI, Wanfang database, VIP, Drug Supervision Department or Health Administration websites of USA, EU and China from Jan. 2014 to Apr. 2019. Compared with USA and EU, the problems of drug information traceability system in China were analyzed to put forward the countermeasures and suggestions. RESULTS & CONCLUSIONS:A total of 31 literatures were included. The drug information traceability system was established in USA, EU and China. USA and EU have the advantages of coding to be in line with international standards, making full use of third-party platforms to avoid forming monopoly, etc. Drug information traceability system was still in a crucial stage of improvement in China. There were still many problems, such as more specific operating standards and guidelines are needed, too many supply chain participants, uneven information level, drug information traceability system independent of the transaction, reimbursement and other information systems, and insufficient coordination. It is suggested to improve the relevant laws and regulations on drug information traceability system by drug supervision department as soon as possible, and give full play to the role of third-party platform, and establish drug information traceability platform based on drug trading platform so as to ensure the system to play an important role in deepening the reform of medical and health system, ensuring the supply of shortage drugs, promoting rational drug use and comprehensive supervision.
期刊: 2019年第30卷第22期
作者: 胡泽利
AUTHORS: HU Zeli
关键字: 药品信息追溯;全程追溯;合理用药;问题;对策
KEYWORDS: Drug information traceability; Whole-course traceability; Rational drug use; Problem; Countermeasure
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