某院门、急诊儿科超说明书用药调查与分析

Investigation and Analysis of Off-label Drug Use in Outpatient and Emergency Pediatrics

目的回顾调查及分析2021年1月~12月我院门、急诊儿科超说明书用药情况,为医院门、急诊儿童安全合理用药提供参考数据。方法从2021年1月~12月中每月随机抽取1000张门、急诊儿科处方,以最新版药品说明书为参考依据,对比处方中开具药品的适应症、给药剂量、给药频次等信息与说明书内容是否相符,不相符则判为超说明书用药处方。结果共抽取门、急诊儿科处方11904张,点评处方用药医嘱29052条,涉及用药品种168种。按处方数量、用药医嘱数量和用药品种数分别统计,超说明书用药发生率分别为:39.24%(4671/11904)、21.07%(6121/29052)、38.10%(64/168)。按用药医嘱统计,超说明书用药占比最高的类型为超适应症52.31%(3202/6121),超说明书用药发生率最高的年龄段为幼儿期24.60%(821/3337),超说明书用药占比最高的药品为平喘药37.85%(2317/6121)。结论我院门、急诊儿科处方存在超说明书用药情况,建议医院管理部门制定院内超说明书用药相关规范,保障区域内儿童安全合理用药。

OBJECTIVE To retrospectively investigate and analyze the off-label use status in outpatient and emergency pediatrics from January to December 2021,and provide reference data for promoting safe and rational drug use in outpatient and emergency pediatrics.METHODS 1000 outpatient and emergency pediatric prescriptions were randomly selected each month from January to December 2021.Based on the drug instructions of the latest version as the reference,compare whether the indications of the drug,dosage and frequency of the drug and other information of the drugs issued in the prescription are consistent with the content of the instructions,which will be judged as off-label prescription.RESULTS A total of 11,904 outpatient and emergency pediatric prescriptions were selected,and 29,052 prescriptions were reviewed,involving 168 drug varieties.According to the number of prescriptions,the number of orders and the number of drugs,the incidence of off-label use was:39.24%(4671/11904),21.07%(6121/29052),and 38.10%(64/168)respectively.According to the medication and doctor′s advice,the highest type of out-label medication was 52.31%(3202/6121)of overindications,the age group with the highest incidence of off-label medication was 24.60%(821/3337)in early childhood,the drugs with the highest proportion of off-label drugs were 37.85%(3202/6121)of plain asthma drugs.CONCLUSION There are off-label drug use in outpatient and emergency pediatric prescriptions in our hospital.It is suggested that the hospital management department formulate relevant norms for the off-label use in the hospital to ensure the safe and rational drug use of children in the region.