北京大学人民医院儿科门诊超说明书用药调查与分析

A survey of off-label drug use prescriptions in pediatric outpatients in Peking University People's Hospital

目的:了解儿科门诊超说明书用药情况,为开展儿科药学服务,促进儿童安全用药提供依据。方法:抽取北京大学人民医院儿科门诊1周的处方,根据药品说明书判断是否存在超说明书用药,同时对患儿基本信息、药物使用情况、超说明书用药情况进行统计与分析,并对患者按照年龄分组进行比较。结果:共抽取处方755张,分析用药记录1 044条,超说明书用药发生率为38.15%。给药剂量和给药频次超说明书是最常见的类型,分别为28.43%和26.9%;未提及儿童用药信息类也较为多见,占23.86%;适应症、年龄和给药途径相对较少。年龄分段发现各年龄段超说明书用药发生率相似,卡方分析P>0.05。所有超说明书用药中,抗微生物药物类最为多见(43.58%),其次为解热镇痛药物(9.55%),第3位是维生素类(8.06%)。结论:我院儿科门诊用药存在超说明书用药现象,临床药师应对儿童用药进行密切监测及合理干预。药品说明书中儿科用药信息的严重缺乏,需要促进和规范儿童药物临床试验,为儿童用药提供更多的证据。

Objective： To investigate the off-label use status in pediatric outpatients so as to provide references for carrying out pediatric pharmaceutical care and promoting safe medication in children. Methods： The prescriptions for pediatric outpatients within a whole week in Peking University People＇s Hospital were collected. The existing off-label use was evaluated according to drug instructions. Then,the general information of the children patients,the status of drug use,the off-label use status were statistically analyzed. Results： Totally 755 prescriptions were collected,and 1 044 medication records were analyzed,in which. 38. 15% of them were off-label drug use. Dosage（28. 43%） and frequency of administration（26. 9%） were the most common off-label drug use types. Information not mentioned in children medication class was also much common,accounting for 23. 86%. Indications, age and route of administration off-label were relatively less. Age sub-group analysis showed a similar rate of drug use in four groups（P〉0. 05,chi-square analysis）. In all the off-label medications,anti-microbial drugs were the most common（43. 58%）,NISADs were the secondary（9. 55%）,and vitamins were the third one（8. 06%）. Conclusion： Off-label use in pediatric out-patients has been noted in our hospital. Clinical pharmacists should monitor pediatric medication closely and intervene it reasonably. As the serious lack of pediatric medication information in drug instructions,we need to promote and standardize clinical trials of medicines for children,providing more evidence for pediatric medication.