本文通过内容研究、问卷调研、实证分析、专家访谈等方法,分析国内外短缺药品价格和供应监测方法及处置方式的历史沿革和实施现状,梳理总结典型做法和我国短缺药品价格和供应监测处置存在的问题,基于国家医保信息平台药品和医用耗材招采管理子系统的短缺药价格和供应监测体系,提出优化我国短缺药品价格和供应监测处置机制涉及的挂网政策、平台建设、监测方法、协同联动等方面的建议。
Abstract
By means of content research, questionnaire survey, empirical analysis and expert interview, this article analyzes the history and implementation of under-supply drugs price and supply monitoring methods and administration, summarizes the typical practice and problems in China. Based on the under-supply drugs price and supply monitoring system of National Medical Insurance Information Platform Drug and Medical Consumables Procurement Management Subsystem, the paper proposes to optimize the under-supply drugs price and supply monitoring and administration involving the online procurement policy, platform construction, monitoring methods and coordination.
关键词
短缺药品 /
价格监测处置 /
供应监测处置 /
对策
Key words
under-supply drug /
price monitoring and administration /
supply monitoring and administration /
countermeasures
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参考文献
[1] 陈琳宁,丁锦希,姚雪芳,等.国外短缺药品定义及对我国的启示[J].现代商贸工业,2021,42(36): 28-30.
[2] FDA.Drug shortage staff[EB/OL].https://www.fda.gov/drugs/drug-shortage-staff.
[3] ASHP.Guidelines on managing drug product shortages[M], 2001.
[4] 宋雅梅.美国药品短缺相关法规、指南及其对我国的启示[J].中国医院药学杂志,2012,32(11): 890-893.
[5] FDA.Ninth annual report on drug shortages for calendar year 2021[M].2022.
[6] Drug shortages statistics[EB/OL].https://www.ashp.org/drug-shortages/shortage-resources/drug-shortages-statistics.
[7] 宫丽娜.美国药品短缺的法律应对研究[D].天津:南开大学,2021.
[8] 高弘杨.FDA如何应对药品短缺问题[J].中国药店,2023,(2):64-66.
[9] 黄哲,施卉,徐凤翔.中美短缺药品管理的比较与建议[J].沈阳药科大学学报,2021,38(12): 1339-1345.
[10] 王胜鹏,王翀,张弛,等.美国近期短缺药品管理策略与启示[J].中国药事, 2020, 34(10): 1191-1199.
[11] Drug shortages homepage[EB/OL].https://www.drugshortagescanada.ca.
[12] 刘倩楠,孙静,刘远立.应对药品短缺保障供应的国际实践及对我国的启示[J].中国药房, 2017, 28(18):2452-2455.
[13] Preventing drug shortages: identifying risks and strategies to address manufacturing-related drug shortages in Canada[EB/OL].https://www.drugshortagescanada.ca/blogs.
[14] Drug shortages in Canada[EB/OL].https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-shortages.html.
[15] 刘青泽,韩月,朱虹,等.国内外短缺药品监测预警体系对比分析[J].中国药业, 2019, 28(18): 1-4.
[16] 何梦婷,冯国忠,周振,等.国外药品短缺处理机制的比较及对我国的启示[J].中国药事, 2017, 31(9):980-983.
[17] 邵蓉,孙海顺,张梦.英国短缺药品联络人报告制度对我国的启示[J].卫生经济研究, 2016, (12): 22-25.
[18] 房冰.药品短缺的防范及管控策略研究[D].郑州:郑州大学,2021.
[19] A reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices[EB/OL].https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022R0123.
[20] 杨露.云南省短缺药品监测指标设计及处置体系构建研究[D].昆明:昆明医科大学,2022.
[21] 国家卫健委:推进短缺药品信息化管理建设,全力以赴做好重点药品供应保障[EB/OL].(2021-05-26)[2023-09-20].https://baijiahao.baidu.com/s?id=1700806153256522573&wfr=spider&for=pc.
基金
国家医疗保障局课题项目“短缺药品价格和供应监测处置机制研究”
