COVID-19 and off label use of drugs: an ethical viewpoint.
Ethical challenges
Investigational off-label uses
Off-label prescription
Off-label uses
Journal
Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences
ISSN: 2008-2231
Titre abrégé: Daru
Pays: Switzerland
ID NLM: 101125969
Informations de publication
Date de publication:
Dec 2020
Dec 2020
Historique:
received:
23
03
2020
accepted:
22
04
2020
pubmed:
10
5
2020
medline:
15
12
2020
entrez:
10
5
2020
Statut:
ppublish
Résumé
The COVID-19 outbreak is rapidly spread over the world and kills infected patients. There is no proven medication for its treatment, so, all of the medications used for treatment are considered to be off-label. Off-label uses are not under regulation in the outbreak because there is no specific regulation for this condition. In this short communication we aim at describing two ways of off-label use as clinical practice or investigational use. Further, we will describe the third way of off-label use, we named it pseudo-research and then we will state the most possible ethical challenges of off-label use for better perceptions and responsibility. The WHO considers off-label uses as country-specific. All international regulatory bodies consider off-label prescription as the physician's responsibility and legal by necessitating some requirements. There is no international guideline for regulating investigational off-label uses as clinical practice. There are different types of approaches, none of them is comprehensive and conclusive. Furthermore, respecting the four ethical principles necessitates codification and strict regulation of off-label uses either as clinical practice or investigational. Besides, compilation of a special guideline based on ethical principles especially non-maleficence and autonomy for investigational off-label uses in disasters is highly recommended.
Sections du résumé
BACKGROUND
BACKGROUND
The COVID-19 outbreak is rapidly spread over the world and kills infected patients. There is no proven medication for its treatment, so, all of the medications used for treatment are considered to be off-label. Off-label uses are not under regulation in the outbreak because there is no specific regulation for this condition.
OBJECTIVES
OBJECTIVE
In this short communication we aim at describing two ways of off-label use as clinical practice or investigational use. Further, we will describe the third way of off-label use, we named it pseudo-research and then we will state the most possible ethical challenges of off-label use for better perceptions and responsibility.
RESULTS
RESULTS
The WHO considers off-label uses as country-specific. All international regulatory bodies consider off-label prescription as the physician's responsibility and legal by necessitating some requirements. There is no international guideline for regulating investigational off-label uses as clinical practice.
CONCLUSION
CONCLUSIONS
There are different types of approaches, none of them is comprehensive and conclusive. Furthermore, respecting the four ethical principles necessitates codification and strict regulation of off-label uses either as clinical practice or investigational. Besides, compilation of a special guideline based on ethical principles especially non-maleficence and autonomy for investigational off-label uses in disasters is highly recommended.
Identifiants
pubmed: 32385829
doi: 10.1007/s40199-020-00351-y
pii: 10.1007/s40199-020-00351-y
pmc: PMC7207985
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
789-793Références
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