Recommendations for the so-called off-label use of medicinal products in COVID-19 patients

被引:0
|
作者
Sustek, P. [1 ,2 ]
Holcapek, T. [1 ,2 ]
Solc, M. [1 ,2 ]
机构
[1] Univ Karlovy, Pravnicka Fak, Ctr Zdravotnickeho Prava, Prague, Czech Republic
[2] Univ Karlovy, Pravnicka Fak, Katedra Obcanskeho Prava, Prague, Czech Republic
来源
ANESTEZIOLOGIE A INTENZIVNI MEDICINA | 2020年 / 31卷 / 03期
关键词
COVID-19; off-label use of medicinal products; legal liability;
D O I
暂无
中图分类号
R614 [麻醉学];
学科分类号
100217 ;
摘要
During the epidemic of COVID-19, there often arises an urgent need for the so-called off- label use of medicinal products, i.e. use of a medicinal product that is not in accordance with its Summary of Product Characteristics (SPC). Most often, a medicinal product registered for a different indication is used. The goal of this paper is to provide the reader with an analysis of legal conditions under which the off-label use of medicinal products in COVID-19 patients is legally safe. If the provider of health services fulfils these conditions, they will not be held liable for immaterial harm that could potentially occur to the patient.
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页码:119 / 123
页数:5
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