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二级医疗环境中的《假药指令》——对供应链的影响

Falsified Medicines Directive in a Secondary Care Environment-Impact on Supply Chain.

作者信息

Merks Piotr, Religioni Urszula, Pinto de Castro Nuno, Augustynowicz Anna, Plagens-Rotman Katarzyna, Brindley David, Kowalczuk Anna, Kaźmierczak Justyna, Neumann-Podczaska Agnieszka, Blicharska Eliza, Sola Katarina Fehir, Hug Martin J, Gajewski Klaudiusz, Piątkiewicz Paweł

机构信息

Faculty of Medicine, Collegium Medicum, Cardinal Stefan Wyszyński University, 01-938 Warsaw, Poland.

School of Public Health, Centre of Postgraduate Medical Education of Warsaw, 01-826 Warsaw, Poland.

出版信息

Int J Environ Res Public Health. 2022 Mar 10;19(6):3276. doi: 10.3390/ijerph19063276.

DOI:10.3390/ijerph19063276
PMID:35328963
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8953181/
Abstract

The Falsified Medicines Directive (FMD) and the Delegated Regulation (DR) impact the pharmaceutical supply chain. Ahead of the deadline for implementation, in February 2019, every entity of the supply chain had to adapt its operations to the regulatory requirements to be compliant with the directive. This paper analyzes the supply chain of a hospital pharmacy and the impact of the FMD implementation. Furthermore, a cost analysis was performed demonstrating that the FMD increases expenditure in the secondary care environment dispensing operations. Governments should be aware that this regulation will certainly impact public healthcare institutions in the long term.

摘要

《假药指令》(FMD)和《委托条例》(DR)对药品供应链产生影响。在2019年2月实施截止日期之前,供应链中的每个实体都必须调整其运营以符合监管要求,从而遵守该指令。本文分析了医院药房的供应链以及FMD实施所产生的影响。此外,还进行了成本分析,结果表明FMD增加了二级医疗环境配药操作中的支出。各国政府应意识到,从长远来看,这项法规肯定会对公共医疗机构产生影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d254/8953181/61807e44bdbd/ijerph-19-03276-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d254/8953181/1b49395b9725/ijerph-19-03276-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d254/8953181/61807e44bdbd/ijerph-19-03276-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d254/8953181/1b49395b9725/ijerph-19-03276-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d254/8953181/61807e44bdbd/ijerph-19-03276-g002.jpg

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本文引用的文献

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Pilot Implementation of Falsified Medicines Directive in Hospital Pharmacy to Develop Best Practices for Medicine Decommissioning Process.在医院药房试点实施《假药指令》,以制定药品退役流程的最佳实践。
Pharmacy (Basel). 2020 Mar 9;8(1):34. doi: 10.3390/pharmacy8010034.
2
Evaluation of community pharmacists' readiness to implement the Falsified Medicines Directive (Directive 2011/62/EC): an English cross-sectional survey with geospatial analysis.评估社区药剂师实施假药指令(指令 2011/62/EC)的准备情况:一项带有地理空间分析的英国横断面调查。
BMJ Open. 2020 Jan 9;10(1):e033405. doi: 10.1136/bmjopen-2019-033405.
3
Differential Pricing of Pharmaceuticals: Theory, Evidence and Emerging Issues.
药品差别定价:理论、证据与新问题。
Pharmacoeconomics. 2018 Dec;36(12):1395-1405. doi: 10.1007/s40273-018-0696-4.
4
The European Falsified Medicines Directive in Poland: background, implementation and potential recommendations for pharmacists.波兰的《欧洲假药指令》:背景、实施情况及对药剂师的潜在建议。
Eur J Hosp Pharm. 2018 Jan;25(1):10-15. doi: 10.1136/ejhpharm-2016-000970. Epub 2016 Jul 27.
5
Hospital Audit as a Useful Tool in the Process of Introducing Falsified Medicines Directive (FMD) into Hospital Pharmacy Settings-A Pilot Study.医院审计作为将《假药指令》(FMD)引入医院药房环境过程中的一种有用工具——一项试点研究
Pharmacy (Basel). 2017 Nov 9;5(4):63. doi: 10.3390/pharmacy5040063.
6
Falsified Medicines-Bridging the Gap between Business and Public Health.假药——弥合商业与公共卫生之间的差距
Pharmacy (Basel). 2016 Mar 28;4(2):16. doi: 10.3390/pharmacy4020016.
7
Establishing good authentication practice (GAP) in secondary care to protect against falsified medicines and improve patient safety.在二级医疗保健中建立良好的认证实践(GAP),以防范假药并提高患者安全。
Eur J Hosp Pharm. 2016 Mar;23(2):118-120. doi: 10.1136/ejhpharm-2015-000750. Epub 2015 Oct 1.
8
The Falsified Medicines Directive: How to secure your supply chain.《假药指令:如何保障你的供应链》
J Generic Med. 2014 Sep;11(3-4):169-172. doi: 10.1177/1741134315588986.