儿科住院医嘱超说明书用药调查

Investigation of off-label medication use in pediatric inpatient prescriptions

目的调查儿科住院医嘱中超说明书用药情况。方法回顾性分析复旦大学附属儿科医院(我院)2023年6月至11月的住院医嘱,根据最新版药品说明书判定医嘱中的超说明书用药情况,并对超说明书用药类型、药物种类以及使用科室进行统计分析。结果住院医嘱共615309条,其中超说明书医嘱13824条,占比2.25%;超说明书用药类型主要为超适应证(35.83%)、超给药剂量(46.16%)和超适应人群(14.41%),共涉及药物种类22类,涉及16个科室。结论我院住院医嘱存在超说明书用药情况,应建立院内超说明书用药流程,加强超说明书用药的规范性,同时建议相关部门通过制定超说明书用药管理规定、鼓励临床试验完善说明书中儿童用药信息等政策,规范并减少儿科超说明书用药情况,以促进儿童的合理用药。

Objective To investigate the off-label medication use in pediatric inpatient prescriptions.Methods The inpatient prescriptions of Children’s Hospital of Fudan University(our hospital)from June to November 2023 were retrospectively analyzed.According to the latest version of the medication instructions,the off-label drug use in medical orders was determined,and the types of off-label medication use,drug types,and departments were statistically analyzed.Results There were 615309 inpatient prescriptions,of which 13824 were off-label medical prescriptions,accounting for 2.25%.Off-label medication use was mainly off-indication(35.83%),off-dose(46.16%),and off-indication population(14.41%),involving 22 types of drugs and 16 departments.Conclusion There are cases of off-label medication use in inpatient prescriptions in our hospital,so we should establish a process of off-label medication use in the hospital and strengthen the standardization of off-label medication use.Meanwhile,it is suggested that relevant departments should standardize and reduce the situation of off-label medication use in pediatrics by formulating regulations on off-label medication use management and encouraging clinical trials to improve the information of children’s medication use in the instructions,so as to promote rational medication use in children.