首页|超说明书用药的理论证成及规制修正

超说明书用药的理论证成及规制修正

扫码查看
超说明书用药在临床实践中一直存在,具有一定的紧迫性和合理性,学术界对此争论不一,解决保证公众用药安全和某些人群有药可用的平衡问题仍是社会关注的焦点问题,但偏重任何一方皆是对另一方权利维护的忽视.《中华人民共和国医师法》的实施给超说明书用药带来新契机和要求.以超说明书用药成因及伦理证成作为切入点,在严格把控超说明书适用条件的前提下,从实现超说明书用药法律衔接、出台统一规范的循证医学依据和程序、激励药品说明书更新迭代等方面提出法律规制对策.
Certification of Theory and Correction of Laws and Regulations for Off-label Drug Use
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.

off-label drug usecertification of theorylaws and regulations

钱亚芳

展开 >

杭州医学院 浙江 杭州 310053

超说明书用药 理论证成 规制

浙江省高等教育"十三五"第一批教学改革研究项目

jg20180423

2024

中国医院管理
中国医院管理杂志社

中国医院管理

CSTPCD北大核心
影响因子:2.15
ISSN:1001-5329
年,卷(期):2024.44(10)