Anest. intenziv. Med. 2020;31(3):119-123 | DOI: 10.36290/aim.2020.023

Recommendations for the so‑called off‑label use of medicinal products in COVID-19 patientsReview Article

Šustek P., Holčapek T., Šolc M.
Centrum zdravotnického práva a Katedra občanského práva, Právnická fakulta Univerzity Karlovy, Praha

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.

Keywords: COVID-19, off‑label use of medicinal products, legal liability.

Received: May 5, 2020; Revised: June 1, 2020; Accepted: June 8, 2020; Prepublished online: June 22, 2020; Published: July 7, 2020  Show citation

ACS AIP APA ASA Harvard Chicago Chicago Notes IEEE ISO690 MLA NLM Turabian Vancouver
Šustek P, Holčapek T, Šolc M. Recommendations for the so‑called off‑label use of medicinal products in COVID-19 patients. Anest. intenziv. Med. 2020;31(3):119-123. doi: 10.36290/aim.2020.023.
Share...
Download citation
  • BibTeX (.bib)
  • Bookends (.ris)
  • EasyBib (.ris)
  • EndNote (.enw)
  • EndNote 8 (.xml)
  • ISI WoS (.isi)
  • Medlars (.medlars)
  • Mendeley (.ris)
  • MODS (.xml)
  • Papers (.ris)
  • RefWorks (.txt)
  • RefManager (.ris)
  • RIS (.ris)
  • MS Word (.xml)
  • Zotero (.ris)
    • Open full article


    Return to the content


    Anesteziologie a intenzivní medicína

    Madam, Sir,
    please be aware that the website on which you intend to enter, not the general public because it contains technical information about medicines, including advertisements relating to medicinal products. This information and communication professionals are solely under §2 of the Act n.40/1995 Coll. Is active persons authorized to prescribe or supply (hereinafter expert).
    Take note that if you are not an expert, you run the risk of danger to their health or the health of other persons, if you the obtained information improperly understood or interpreted, and especially advertising which may be part of this site, or whether you used it for self-diagnosis or medical treatment, whether in relation to each other in person or in relation to others.

    I declare:

    1. that I have met the above instruction
    2. I'm an expert within the meaning of the Act n.40/1995 Coll. the regulation of advertising, as amended, and I am aware of the risks that would be a person other than the expert input to these sites exhibited

    No
    Yes

    If your statement is not true, please be aware
    that brings the risk of danger to their health or the health of others.