Review of the legal issues of off-label drug usage / 中华医院管理杂志
Chinese Journal of Hospital Administration
;
(12): 690-692, 2014.
Article
in Chinese
| WPRIM
| ID: wpr-456450
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Type of study:
Prognostic study
Language:
Chinese
Journal:
Chinese Journal of Hospital Administration
Year:
2014
Type:
Article
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