某儿童医院临床超药品说明书用药的现状分析

Analysis on Current Situation of Off-label Drug Usage in a Children’s Hospital

目的:分析医院临床超说明书用药的现状,为促进儿童合理用药提供参考。方法:抽取医院2019年1月—12月患儿处方(医嘱)520份(其中门急诊处方400份和住院医嘱120份),统计超说明书用药处方(医嘱)中患儿的年龄分布和用药类型、常见药品等情况,分析超说明书用药的产生原因。结果:520份处方(医嘱)中,超说明书用药处方(医嘱)有137张,其中门急诊处方67张(占48.91%)和住院处方70张(占51.09%);超说明书用药原因类型TOP 3分别为未提及儿童用药信息(48.30%)、超年龄用药(47.55%)和超给药途径用药(1.89%);超说明书用药在各年龄段的患儿中均有发生,发生率最高的为婴幼儿期和学龄前期;超说明书用药处方(医嘱)涉及药品7类20种,其中TOP 4分别为抗组胺药(37.23%)、消化系统系统用药(22.63%)、呼吸系统用药(20.44%)、维生素及矿物质类(9.49%)。结论:医院儿童超说明书用药现象较为普遍,以婴幼儿期和学龄前期患儿最为多见;超说明书用药所涉药物以抗组胺药、消化系统及呼吸系统用药为主;建议医院制定或定期更新相应的管理制度,规范处方超说明书用药要求,以确保患儿用药安全性和有效性。

Objective: To analyze the current situation of off-label drug use in hospitals, and to provide reference for promoting rational drug use in children. Methods: 520 prescriptions and medical orders, 400 outpatient and emergency prescriptions and 120 medical order of inpatients,were collected from January to December in 2020. The age distribution, type of drug use, common drugs of prescriptions and medical orders of off-label drug use were counted, and the causes of those were analyzed. Results: Among 520 prescriptions and medical orders, 137 were off-label drug use,including 67 outpatient and emergency prescriptions(48.91%) and 70 medical order of inpatients(51.09%).The TOP 3 causes of off-label drug use were no information on children’s drug use(48.30%), over-age drug use(47.55%), and overadministration route drug use(1.89%). The Off label drug use occurred in all age groups, and infants and preschool groups had the highest incidence. The prescriptions and medical orders of off-label drug use involve 7 categories and 20 kinds of drugs, and the TOP 4 drugs were antihistamines(37.23%), digestive system drugs(22.63%), respiratory drugs(20.44%), vitamins and minerals(9.49%). Conclusion: Off label medication is common in hospitalized children, especially in infants and preschool children, and the prescriptions and medical orders of off-label drug use mainly involve antihistamine, digestive system drugs and respiratory drugs. It is suggested that the hospital establishes or regularly updates the corresponding management system to standardize the requirements of off-label prescription medication, so as to ensure the safety and effectiveness of medication for children.