铜陵市妇幼保健院静脉滴注药品说明书中儿童用药信息标注情况调查分析

Investigation and analysis of children’s medication information in the drug instructions for intravenous drip medication in Maternal and Child Health Hospital of Tongling

目的调查安徽省铜陵市妇幼保健院(以下简称"我院")静脉滴注药品说明书中儿童用药信息标注情况,为规范说明书标注信息提供参考。方法收集我院2021年1月至4月使用的静脉滴注药品说明书,对说明书中"用法用量""不良反应""儿童用药"等十个项目中提及儿童用药信息列成Excel表,对相关内容进行统计分析。结果104份静脉滴注药品说明书中儿童用药信息标注率整体偏低;外资药说明书中儿童用药信息标注率普遍高于国产药;西药说明书中儿童用药信息标注率普遍高于中成药;"儿童用药"项用药信息标注严重缺失;说明书修订不及时;其中抗菌药物说明书中儿童用药剂量换算不规范;三组外资和国产静脉用抗菌药物说明书中儿童用法用量存在差异。结论静脉滴注药品说明书中儿童用药信息的标注存在较多问题,有待进一步完善,应引起国家有关部门的重视。

Objective To investigate the information labeling conditions of children’s medication in the instructions for intravenous drip medicines in Maternal and Child Health Hospital of Tongling(“our hospital”for short),and to provide a reference for standardizing the information on the instructions.Methods The instructions for intravenous infusion medicines used in our hospital from January to April 2021 was collected,the medication information for children mentioned in ten items such as“usage and dosage”“adverse reactions”and“children’s medications”in the instructions into an Excel table were listed,and statistical analysis to relevant content was carried on.Results The labeling rate of children’s medication information in 104 intravenous drip drug inserts was generally low;the labeling rate of children’s drug information in the foreign-funded drug manuals was generally higher than that of domestic drugs;the labeling rate of children’s medication information in western medicine instructions was generally higher than that of Chinese patent medicines;“children’s medication”item of medication information labeling was seriously missing;the instruction manual was not revised in time;among them,the conversion of children’s drug dosage in the antibacterial drug instructions was not standardized;there were differences in the usage and dosage of the three groups of foreign and domestic intravenous antibacterial drugs in the instructions for children.Conclusion There are many problems in the labeling of children’s medication information in the instructions for intravenous infusion drugs,which need to be further improved and should be paid attention by the relevant national departments.