某三甲妇幼医院97种外用药的儿童用药信息调查

Survey on Pediatric Drug Use of 97 Externally-use Drugs in a Grade Ⅲ Level A Women′s and Children′s Hospital

目的 调查广东某三甲妇幼医院外用药品说明书中的儿童用药信息标注情况,为规范儿童药品说明书提供参考。方法 以广东某三甲妇幼医院正在使用的外用药品作为研究对象,收集整理药品说明书,对其中的儿童用药信息录入Excel进行统计分析。结果 统计共有97种外用药品(其中眼部用药26种,鼻腔给药6种,耳部给药2种,口腔黏膜给药2种,肺部给药8种,经皮给药50种,直肠给药3种)的说明书,仅有1种药为儿童专用药物,即可乐定透皮贴片;有明确标注儿童用法用量的有23种(占总数的23.7%);儿童用药尚不明确30种(30.9%);未标注儿童用药项17种(17.5%);提示儿童慎用、禁用有27种(27.8%)。结论 在外用药品制剂中,我国儿童专用药品种极度匮乏、适宜剂型少、生产企业少,药品说明书中存在儿童用药信息缺乏、说明书内容表述简略等问题,不只是生产企业标注儿童用药信息的管理不到位,对不明确的儿童用药也是临床研究一直要攻克的难关,建议国家制定政策上鼓励对儿童用药安全性的相关研究。

OBJECTIVE To analyze the problem existing in the instructions for externally-use pediatric drugs in a GradeⅢLevel A Women′s and Children′s Hospital in Guangdong to provide references for the standardization of pediatric drug instructions.METHODS Instructions for externally-use drugs used in the hospital were collected.We conducted a statistical analysis of children′s medication labeling information by using Excel.RESULTS Among the 97 kinds of externally-use drugs(including 26 ocular drugs,6 nasal drugs,2 otic drugs,2 oral mucosa drugs,8 pulmonary drugs,50 transdermal drugs,and 3 rectal drugs),there was only 1 drug specially designed and applied for children,which is the Clonidine Transdermal Patches.The instructions of these drugs demonstrated that 23 medicines(23.7%)labelled clear dosage guidance for children;30 medicines(30.9%)labelled unclearly or incompletely guidance for children;17 medicines(17.5%)were absent of labelling of dosage for children;and 27 medicines(27.8%)were labelled using with caution for children or prohibited to use for children.CONCLUSION In externally-use medicines,medicines that are particularly designed and used for children are insufficient,and suitable dosage forms for children and corresponding manufactures are also lacking in our country.Moreover,there are problems such as incomplete guidance information for children′s medication,and too brief or non-standard labeling content in the instructions.These issues are caused by the poor management of manufacturers in terms of label information on drugs used for children.Moreover,the unclear specification of drugs used for children is still difficult to overcome in clinical research.It is suggested that our country should develop relevant policies to facilitate the development of pediatric drugs.