中国非处方药目录中适宜儿童使用的化学药分析

Analysis of Chemical Drugs Suitable for Children in Chinese Over-the-counter Drugs Catalogue

目的梳理中国非处方(over-the-counter,OTC)药目录中供儿童使用的化学药,分析药品类别和说明书规范性,查找易致用药风险的关键点,并提出改进建议。方法依据国家药品监督管理局网站公布的OTC药物说明书范本、临床专家调研的结果以及文献,确定儿童化学药OTC药目录并进行分类,调查说明书规范性和一致性。结果梳理出267种儿童OTC药,涉及18类疾病,有相当比例说明书信息不完整、不规范,且呼吸系统疾病和消化系统疾病药物种类偏少。结论应规范儿童OTC药物说明书编制和宣传,加大儿童OTC药物研发力度,加强药店从业人员培训,保障儿童OTC药物的合理、安全使用。

OBJECTIVE To sort out the chemical drugs for children in China’s over-the-counter(OTC)drugs catalogue and analyze the drug categories and the specification of the instructions,so as to find out the key points that lead to the risk of drug use,and put forward suggestions for improvement.METHODS According to the sample of OTC drugs instructions published on the website of the National Medical Products Administration,as well as the results of clinical expert investigation and literature,the OTC drugs catalog of children’s chemical drugs was determined and classified,and the investigate the standardization and consistency of the instructions.RESULTS There were 267 kinds of OTC drugs for children sorted out,involving 18 kinds of diseases.A considerable proportion of the instructions were incomplete and nonstandard,and there were few kinds of drugs for respiratory and digestive diseases.CONCLUSION The preparation and publicity of children OTC drugs instructions should be standard,the research and development of children’s OTC drugs should be strengthened,the training of pharmacy employees should be strengthened,and ensure the rational and safe use of children’s OTC drugs.