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.
引用
收藏
页码：119 / 123
页数：5
相关论文
共 50 条
  • [1] Nationwide Shortage of Albuterol Inhalers and Off-Label Use in COVID-19 Patients
    Hendeles, Leslie
    Prabhakaran, Sreekala
    PEDIATRIC ALLERGY IMMUNOLOGY AND PULMONOLOGY, 2020, 33 (04) : 216 - 219
  • [2] Observational study on off-label use of tocilizumab in patients with severe COVID-19
    Albertini, Laetitia
    Soletchnik, Mickael
    Razurel, Anais
    Cohen, Johana
    Bidegain, Frederic
    Fauvelle, Francis
    Safrano, Geoffroy
    Piquet, Jacques
    Maurer, Cyril
    Goldgran-Toledano, Dany
    EUROPEAN JOURNAL OF HOSPITAL PHARMACY, 2021, 28 (01) : 22 - 27
  • [3] ADRs due to off-label use of hydroxychloroquine for COVID-19
    Reactions Weekly, 2022, 1907 (1) : 3 - 3
  • [4] Evaluating interest in off-label use of disinfectants for COVID-19
    Rivera, Jessica Malaty
    Gupta, Shagun
    Ramjee, Divya
    El Hayek, Ghinwa Y.
    El Amiri, Nisrine
    Desai, Angel N.
    Majumder, Maimuna S.
    LANCET DIGITAL HEALTH, 2020, 2 (11): : E564 - E566
  • [5] OFF-LABEL USE OF MEDICINAL PRODUCTS - LEGAL RULES AND PRACTICES
    Jaroszynski, Janusz
    Mela, Aneta
    Furtak-Niczyporuk, Marzena
    Poniatowski, Lukasz A.
    Dabrowski, Jan
    Czajka-Belz, Anna
    Zimmermann, Agnieszka
    Dreher, Piotr
    Drop, Bartlomiej
    Staniszewska, Anna
    ACTA POLONIAE PHARMACEUTICA, 2019, 76 (04): : 621 - 628
  • [6] Unlicensed and off-label use of medicinal products.: An overview
    García-Sáiz, M. M.
    BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY, 2006, 99 : 13 - 14
  • [7] Multiple drugsPancytopenia, COVID-19 and off-label use: case report
    Reactions Weekly, 2020, 1831 (1) : 209 - 209
  • [8] Off-label use of orphan medicinal products: a Belgian qualitative study
    Marc Dooms
    David Cassiman
    Steven Simoens
    Orphanet Journal of Rare Diseases, 11
  • [9] Off-label use of orphan medicinal products: a Belgian qualitative study
    Dooms, Marc
    Cassiman, David
    Simoens, Steven
    ORPHANET JOURNAL OF RARE DISEASES, 2016, 11 : 1 - 9
  • [10] Dexamethasone/rituximabWorsening of COVID-19 pneumonia and off-label use: case report
    Reactions Weekly, 2022, 1929 (1) : 248 - 248
12345