某综合医院儿科门诊中成药药品说明书信息标注问题分析与对策探讨

Content of the package inserts of patent Chinese medicines used in the pediatric outpatient clinic of a general hospital

目的针对我院儿科门诊常用中成药说明书的信息标注情况进行分析,了解药品使用现状及存在的问题,以强化儿童用药临床合理使用。方法对医院儿科门诊常用的39种中成药说明书标注情况进行统计。结果中成药说明书中辅料明确的占48.72%;有明确儿童适应证的占66.67%;有儿童用法和用量标准的占64.10%;半数以上药品的安全性内容,如不良反应、禁忌、相互作用等标注不完善,药理作用明确标注者占20.51%;所有说明书中均未涉及儿童药代动力学参数。结论我院儿科常用中成药的说明书标注信息有待完善,医疗机构应加强中成药药事管理工作,临床药师应积极开展中成药药学干预和合理用药指导,以促进临床用药的合理性,保证患儿用药安全。

Objective To analyze the content of the package inserts of patent Chinese medicines(pCms)commonly used in the pediatric outpatient clinic of our hospital and investigate the current pCm usage and relevant problems,thus promoting the rational use of pCms in children.Methods The content of the package inserts of 39 pCms commonly used in the pediatric outpatient clinic of our hospital was analyzed.Results About half(48.72%)of the package inserts clearly indicated the auxiliary materials,66.67%had definite indications for pediatric patients,and 64.10%had indicated the pediatric dosages.More than half of the pCms had imperfect labeling of safety information,including adverse reactions,contraindications,and interactions,and only 20.51%of the drugs had clear labeling of their pharmacological effects.Pediatric pharmacokinetics was not included in any of the package inserts.Conclusions The labeling information of pCms commonly used in the Pediatrics Department of our hospital requires improvement.To promote the rational use of pCms and ensure medication safety for children,medical institutions should strengthen pharmacological management of pCms and clinical pharmacists should be actively involved in providing guidance and interventions related to pCm use.