Publication
Title
Off-label prescription of medication
Author
Abstract
Off-label use of medication refers to prescribing a registered medicine outside its approved marketing authorization, purpose, target group, or indication. Off-label prescription is a widely accepted practice. However, no or little regulation can be found. In this article, the legal status of off-label prescription will be examined. Does off-label prescription fall under the therapeutical freedom and is it free from regulation? Or should we equalize off-label prescription with a therapeutical experimentation and should it follow the rules of experimentation? I will also examine whether the patient can give an informed consent. Whether or not this is possible leads to intense discussions. Finally, the potential liability of the prescribing physician is of great importance.
Language
English
Source (journal)
European journal of health law. - Dordrecht, 1994, currens
Publication
Dordrecht : 2015
ISSN
0929-0273 [print]
1571-8093 [online]
Volume/pages
22:2(2015), p. 165-186
Full text (Publisher's DOI)
Full text (publisher's version - intranet only)
UAntwerpen
Faculty/Department
Research group
Publication type
Subject
Law 
Affiliation
Publications with a UAntwerp address
External links
VABB-SHW
Record
Identification
Creation 01.04.2015
Last edited 20.06.2017
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