我国儿童专用药品说明书调查与分析

Investigation and Analysis of the Child-specific Medicine Instructions in China

目的:了解我国儿童专用药品(化学药品与生物制品)中药品说明书的标注情况及存在问题,为促进儿童用药信息的完善提供参考。方法:对儿童专用药品进行汇总,并依据药品说明书进行信息表的填写与统计,分析儿童专用药品说明书存在的问题。结果:共收集到儿童专用药品说明书1214份,其中国产药品1180个(占97.20%),进口药品34个(占2.80%);儿童专用药品数量最多的为呼吸系统用药(占42.01%);儿童专用药品口服剂型1094个(占90.11%),注射剂型57个(占4.70%),外用剂型59个(占4.86%),吸入剂型4个(占0.33%);说明书中标注的剂量调整依据主要为年龄和体重(占45.80%),只依据年龄进行剂量调整的占41.02%,而7.91%的药品未标注剂量调整依据;说明书中标有儿童用药最大剂量的占17.46%,标有儿童用药疗程的占28.01%,而标有儿童药代动力学的仅有16.72%。结论:我国儿童专用药品说明书存在标签撰写不规范、内容不完善、同一品规药品说明书差异大等问题,建议相关部门加强药品说明书的规范和管理,加大上市后的监管和数据监查,督促药品生产企业对儿童专用药品说明书中的内容进行完善与改进,提高儿童合理用药水平。

Objective:To investigate the medication information and existing problems in the instructions of child-specific medicine(chemicals and biological products)in our country and provide references for promoting the improvement of drug information for children.Methods:The child-specific medicines were summarized,and the information sheet was filled and statistically analyzed according to the drug instructions,and the problems existed in the special drug instructions for children were analyzed.Results:A total of 1214 drug instructions for children were collected,including 1180 domestic drugs(97.20%)and 34 imported drugs(2.80%).The largest number of child-specific medicine was respiratory system drugs(42.01%).There were 1094 oral dosage forms(90.11%),57 injectable dosage forms(4.70%),59 external dosage forms(4.86%)and 4 inhalation dosage forms(0.33%)for child-specific medicine.The dose adjustment was mainly based on age and weight(45.80%),and only 41.02%of the drugs were adjusted based on age,while 7.91%of the drugs were not labeled with the dose adjustment basis.In the instructions,only 17.46%of the drugs had the maximum dose,28.01%of the drugs had the course of medication,and 16.72%of the drugs had the pharmacokinetics.Conclusion:The child-specific medicines in our country exist some problems such as non-standard instructions label,imperfect content and great differences in the same drug instructions and so on.It is suggested that the relevant departments should strengthen the specification and management of the child-specific medicines,strengthen the supervision and monitoring data after listing,and supervise the pharmaceutical production enterprise improve the contents of the child-specific medicines and promote the level of rational drug use of children.