Review of the legal issues of off-label drug usage
10.3760/cma.j.issn.1000-6672.2014.09.016
- VernacularTitle:对超说明书用药法律问题的再认识
- Author:
Liangyu WEI
;
Yu LIU
;
Suli SUI
;
Pengcheng SUN
- Publication Type:Journal Article
- Keywords:
Off-label uses;
Medication specifications;
Legal status;
Subject of evaluation
- From:
Chinese Journal of Hospital Administration
2014;(9):690-692
- CountryChina
- Language:Chinese
-
Abstract:
This paper identified misunderstandings of the measures taken in China to overcome the problems incurred by off-label uses (namely reliance on drug makers to modify their medicine specifications,on medical institutions to enhance their regulation and management of off-label uses,and on informed consent to avoid risks).Based on such findings,the paper named defects found with such measures,and puts forward feasible ideas and methods to make such off-label uses legitimate and reasonable.These include clarification of the legal status of the medicine specifications,encouraging authoritative guidance for off-label uses,and determining the subject of evaluation to approve the off-label uses as reasonable.Such efforts aim at helping off-label uses out of the legal difficulties.
