儿童中成药非处方药说明书信息调查分析

Investigation on Information of Over-The-Counter Drug Instructions of Chinese Patent Medicines for Children

目的:分析儿童中成药非处方药(OTC)说明书信息情况,以提高儿童合理用药水平,促进中成药说明书规范化。方法:收集186种儿童用中成药OTC的1 441份流通药品说明书,对儿童不良反应、用药禁忌、注意事项、药物相互作用等进行调查分析,并与国家药品监督管理局(NMPA)发布的范本说明书进行比较,重点关注缺项、不明确和差异内容。结果:1 441份说明书中,不良反应、用药禁忌、注意事项、药物相互作用的缺项和不明确内容总占比分别为94.1%、85.9%、16.6%、95.0%。86种流通药品说明书与范本说明书存在差异,差异率为47.0%。结论:目前儿童中成药OTC说明书内容不完善,缺项、表述不明确与范本比较存在差异的现象较严重,相关部门应督促申报企业对不规范药品说明书进一步修订完善,为临床合理用药提供可靠的法定依据。

Objective:To analyze the information of over-the-counter drug(OTC)instructions of Chinese patent medicines in children,so as to improve the level of rational drug use in children and promote the standardization of drug instructions of Chinese patent medicines.Methods:Totally 1,441 instructions of 186 kinds of OTC Chinese patent medicines for children were collected,and adverse drug reactions,drug contraindications,precautions and drug interactions in children were investigated and analyzed.The sample instructions issued by the National Medical Products Administration(NMPA)was compared with OTC instructions of Chinese patent medicines,focusing on the missing items,unclear and different contents.Results:Of the 1,441 instructions,the total proportion of adverse drug reactions,drug contraindications,precautions,missing items and unclear contents of drug interactions were 94.1%,85.9%,16.6%and 95.0%,respectively.There were differences between the instructions of 86 kinds of circulating drugs and the sample instruction,the difference rate was 47.0%.Conclusion:At present,the content of OTC instructions of Chinese patent medicines for children is not complete,and the phenomenon of missing items and unclear expression is serious.Relevant departments should urge the declaration of enterprises to further improve the specification of non-standard drug instructions,so as to provide reliable legal basis for the clinical rational drug use.