中国医学伦理学2025，Vol.38Issue(2)：227-231,5.DOI:10.12026/j.issn.1001-8565.2025.02.13
儿童超说明书用药的伦理问题及对策
Ethical issues and countermeasures of off-label drug use in children
李立敏 1胡海鹏 1曹晓琴 1刘小红1
作者信息
- 1. 西安交通大学第一附属医院儿科,陕西 西安 710061
- 折叠
摘要
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.关键词
儿童/超说明书用药/医学伦理/医患沟通/医疗管理/规范诊疗Key words
children/off-label drug use/medical ethics/doctor-patient communication/medical management/standardized diagnosis and treatment分类
医药卫生引用本文复制引用
李立敏,胡海鹏,曹晓琴,刘小红..儿童超说明书用药的伦理问题及对策[J].中国医学伦理学,2025,38(2):227-231,5.
