Certification of Theory and Correction of Laws and Regulations for Off-label Drug Use
- VernacularTitle:超说明书用药的理论证成及规制修正
- Author:
Yafang QIAN
1
Author Information
1. 杭州医学院 浙江 杭州 310053
- Keywords:
off-label drug use;
certification of theory;
laws and regulations
- From:
Chinese Hospital Management
2024;44(10):87-90
- CountryChina
- Language:Chinese
-
Abstract:
Off-label drug use,being urgent and rational under certain circumstances,has existed in clinical practice all the time.While the academic community is divided on this issue,resolving the balance between ensuring the safety of medicines for the public and the availability of medicines for certain groups of the population remains a major concern of the society,but to favour either side is to neglect the defence of the rights of the other side.The implementation of"Law on Practicing Doctors of the People's Republic of China"brings new opportunities and requirements for off-label drug use.With the causes and ethical certification of off-label drug use as a starting point,it holds to the premise of strictly controlling the applicable conditions of off-label drug use and brings forward countermeasures of laws and regulations for the following three aspects:the realization of legal involvement and cohesion of off-label drug use,the issue of unified standards for evidence-based medicine and the encouragement of updating and replacing drug specifications.