基于门急诊处方分析和评价儿童患者超说明书用药情况

Evaluation of the off-label drug use in pediatric patients based on the analysis of outpatient and emergency prescriptions

目的基于门急诊处方点评,调查和分析门急诊儿童处方药品超说明书用药情况,评价其相关危险因素,为促进儿童合理用药提供基数数据。方法抽取2012-2014年玉林市第一人民医院门急诊儿童处方,以药品说明书为依据,判断超说明书用药情况,分析超说明书用药类型、以及各年龄段超说明书用药发生率等情况。结果共抽取1 883张处方,含4 962条用药记录,其中超说明书用药处方737张（39.14%）;超说明书用药记录960条（19.35%）。超说明书用药类型中居前3位的分别为未提及儿童用药信息（53.13%）、给药剂量（16.04%）和给药频次（11.14%）。变态反应性疾病、神经系统疾病和全身感染性疾病居前3位。超说明书用药高发生率前3位的单品种药品为注射用单磷酸阿糖腺苷（18.85%）、注射用乳糖酸阿奇霉素（9.27%）和注射用头孢呋辛钠（4.79%）。处方数和用药记录方面的超说明书用药情况发生率在各年龄阶段均有显著性差异（P〈0.01）,发生率不同或不全相同。超说明书用药发生的风险与使用非基本药物有关（P〈0.01）。结论门急诊中儿童处方超说明书用药情况普遍,药品说明书中儿童用药信息严重缺乏,需要国家规范可能日趋严重的超说明书用药行为,为儿童用药提供更多科学的循证依据。

Objective To analyze and evaluate the present situation of off-label drug use in children according to the outpatient and emergency prescription,and analyze its possible risk factors,so as to provide the basic data for off-label drug use and improve the rational drug usage in children.Methods The outpatient and emergency prescriptions were collected in the first people′s hospital of Yulin city from 2012-2014.According to drug instructions,off-label drug use of prescriptions of all selected children was analyzed in the category of off-label drug use and incidence rate of off-label drug use in different ages.The relationship between off-label use and different ages,sex,essential medicines was obtained by logistic regression analysis.Results Totally 1 883 prescriptions were collected,and 737 prescriptions were off-label drug use accounting for 39.14%,and 4 962 medication records were analyzed,in which 960 medication records were off-label drug use accounting for 19.35%.The main categories of off-label drug use were no pediatric information（53.13%）,dosage（16.04%）and frequency of administration（11.14%）.The top 3systemic disease with highest incidence rate of off-label drug use were allergic disease,nervous system disease and infectious diseases.The top 3drugs with highest incidence rate of off-label drug use were adenine arabinoside monophosphate（18.85%）,lactose acid azithromycin（9.27%）,and cefuroxime（4.79%）.Incidence rate of off-label drug use of different ages were significanly different in prescriptions and medication records（P〈0.01）.The off-label use risks were related with non essential drugs usage（P〈0.01）.Conclusion The off-label drug use of pediatric outpatient and emergency department is common in children.The drugs instructions lack pediatric information,so it is necessary to regulate and standardize the off-label drug use for children,and provide more evidence for pediatric medication.