Ethical issues and countermeasures of off-label drug use in children
10.12026/j.issn.1001-8565.2025.02.13
- VernacularTitle:儿童超说明书用药的伦理问题及对策
- Author:
Limin LI
1
;
Haipeng HU
1
;
Xiaoqin CAO
1
;
Xiaohong LIU
1
Author Information
1. Department of Pediatrics， the First Affiliated Hospital of Xi’an Jiaotong University， Xi’an 710061， China
- Publication Type:Journal Article
- Keywords:
children;
off-label drug use;
medical ethics;
doctor-patient communication;
medical management;
standardized diagnosis and treatment
- From:
Chinese Medical Ethics
2025;38(2):227-231
- CountryChina
- Language:Chinese
-
Abstract:
Children， as a special group， frequently experience of off-label drug use worldwide. Common reasons for off-label drug use in children include the lack of data on pediatric patients during the clinical trial stage of drug development， delayed updates to drug instructions， and the non-standard professional behavior of some doctors. Off-label drug use in children is a double-edged sword. It could save lives and provide a way to explore additional functions of drugs， while it may also lead to the phenomenon of hyper-indication abuse， increasing the risk of adverse drug events. Regulating off-label drug use in children can safeguard the best treatment rights and interests of children. It is recommended to encourage pharmaceutical enterprises to conduct research and development of pediatric new drugs， simplify the approval process for drug instructions amendments， accumulate evidence-based medical evidence for off-label drug use in children， standardize the process of off-label drug use in children in medical institutions， continuously improve the standardized diagnosis and treatment capabilities of pediatricians， and actively cooperate with the families of pediatric patients in diagnosis and treatment， so as to comprehensively safeguard the rights and interests of both doctors and patients.
