如何规范儿童超说明书用药

How to regularize the off-label drug use in children

因缺乏临床研究，药品说明书中常缺少儿童用药相关信息，超说明书用药在儿童广泛存在，同时也存在较大的医疗风险和纠纷隐患。研究并规范儿童超说明书用药是必须面对的重要课题。通过立法、制定超说明书用药规范、儿童用药信息研究、加强监管是规范儿童超说明书用药管理的关键。

Pediatric information for medication is insufficiency in the instruction due to the absence of clinical study special for children. Off-label drug use is ubiquitous in pediatric clinical works, and likely to medical risks and medical disputes. We should be confronted with the reality to standardize the off-label drug use. The enactment of the law, norms and standards setting, medication information study, and intensive super- vision are the key strategies for off-label drug use in children.