open access

Vol 15, No 2 (2020)
Cardiology and law
Published online: 2020-03-28
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Off-label use: application and reimbursement

Zuzanna Chromiec, Ewa Hoffmann
DOI: 10.5603/FC.2020.0024
·
Folia Cardiologica 2020;15(2):188-191.

open access

Vol 15, No 2 (2020)
Cardiology and law
Published online: 2020-03-28

Abstract

Off-label use of drugs is one of the most important elements of the work of doctors and, unfortunately, it still raises a great deal of controversy and doubt. This is because of the lack of explicit, detailed legal regulations on this. On the one hand, physicians should follow the dosage regimen and indications for use specified in the Summary of Product Characteristics (SPC), while on the other hand, for some patients, in particular regarding paediatrics and oncology, there may be a lack of therapy that would be characterized for such use as in the SPC. When prescribing off-label therapy, doctors must primarily be guided by current medical knowledge and due diligence. Despite the lack of legal regulations, several criteria can be distinguished that justify the off-label use of drugs, e.g. the need to save the patient’s life or the unsatisfactory result of the therapy recommended to date. Before prescribing a particular drug, the patient should be informed, for instance, about the risk of the unregistered use of the medicine. Only after the patient has been properly informed can informed consent for treatment be received. The doctor’s failure to satisfy these obligations can expose him to civil, criminal or disciplinary liability. Polish law also allows for therapy conducted in indications other than those arising from the SPC to be publicly financed. Although this requires compliance with the statutory requirements, this often constitutes the patient’s key opportunity to actually undergo treatment.

Abstract

Off-label use of drugs is one of the most important elements of the work of doctors and, unfortunately, it still raises a great deal of controversy and doubt. This is because of the lack of explicit, detailed legal regulations on this. On the one hand, physicians should follow the dosage regimen and indications for use specified in the Summary of Product Characteristics (SPC), while on the other hand, for some patients, in particular regarding paediatrics and oncology, there may be a lack of therapy that would be characterized for such use as in the SPC. When prescribing off-label therapy, doctors must primarily be guided by current medical knowledge and due diligence. Despite the lack of legal regulations, several criteria can be distinguished that justify the off-label use of drugs, e.g. the need to save the patient’s life or the unsatisfactory result of the therapy recommended to date. Before prescribing a particular drug, the patient should be informed, for instance, about the risk of the unregistered use of the medicine. Only after the patient has been properly informed can informed consent for treatment be received. The doctor’s failure to satisfy these obligations can expose him to civil, criminal or disciplinary liability. Polish law also allows for therapy conducted in indications other than those arising from the SPC to be publicly financed. Although this requires compliance with the statutory requirements, this often constitutes the patient’s key opportunity to actually undergo treatment.
Get Citation

Keywords

off-label use of drugs, off-label, patient consent, drug reimbursement

About this article
Title

Off-label use: application and reimbursement

Journal

Folia Cardiologica

Issue

Vol 15, No 2 (2020)

Pages

188-191

Published online

2020-03-28

DOI

10.5603/FC.2020.0024

Bibliographic record

Folia Cardiologica 2020;15(2):188-191.

Keywords

off-label use of drugs
off-label
patient consent
drug reimbursement

Authors

Zuzanna Chromiec
Ewa Hoffmann

References (14)
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