Off-label drugs in otolaryngological practice against the background of legal conditions of Polish legislation-Reference-Cited by-同舟云学术

Off-label drugs in otolaryngological practice against the background of legal conditions of Polish legislation

Published:2024-02-29 Issue:1 Volume:78 Page:36-43
ISSN:0030-6657
Container-title:Otolaryngologia Polska
language:
Short-container-title:Otolaryngol Pol

Author:

Kopczyk Renata¹^ORCID,Jurkiewicz Dariusz²^ORCID,Rogowski Marek³^ORCID,Szydłowski Maciej⁴,Wierzbicka Małgorzata⁵

Affiliation:

1. Wroclaw University of Science and Technology, Wroclaw, Poland

2. Clinic of Otolaryngology and Oncological Otolaryngology with the Clinical Department of Cranio-Maxillofacial Surgery, Military Institute of Medicine – National Research Institute, Warsaw, Poland

3. Department of Otolaryngology, Medical University of Bialystok, Poland

4. Wroclaw Regional Specialist Hospital, Research & Development Centre, Wrocław, Poland

5. Wroclaw University of Science and Technology, Wroclaw, Poland, Wroclaw Regional Specialist Hospital, Research & Development Centre, Wrocław, Poland

Abstract

Introduction: ‘Off-label drug use’ refers to the administration of drugs for unapproved indications or age groups, a different dosage or other form of administration. Considering the legal issues, there clearly exists a need to implement rules that would regulate the use of pharmaceuticals outside the scope of a marketing authorisation. The brevity and diversity of Polish laws in the field of health care leads to many interpretative doubts associated with particular legal acts. Aim: We aimed to present clinical examples from everyday practice of off-label drug use from the medical and legal perspectives, and to support it with relevant legal acts. Material and method: Off-label drug use in various otolaryngology subspecialties – otology (mesna), laryngology (bevacizumab, cidofovir and botulinum toxin) and head and neck surgery (botulinum toxin) – are presented and discussed in detail. Results: Fourteen Polish legal acts regarding off-label drug use and 4 from EU legislation are commented on. The algorithm of cascade of decision-making processes in off-label drug use is shown. Conclusions: Off-label use of medicinal products is not prohibited in Poland or the EU; nevertheless, it is undeniable that the unclear legal situation regarding the use of medicinal products for nonregistered indications creates difficulties. To minimise a doctor’s liability risk, obtaining the informed consent from the patient for such treatment is advisable.

Publisher

Index Copernicus

Link

https://otolaryngologypl.com/gicid/pdf/01.3001.0054.1185

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