某院中成药说明书的儿科用药风险分析与管理思考

doi:10.19803/j.1672-8629.20230625

摘要/Abstract

摘要： 目的调查我院儿科用中成药种类、药品说明书和使用现状,分析临床用药风险,为儿童安全合理用药提供参考。方法调查我院使用的128种中成药药品情况,统计分析其说明书中用法用量、不良反应、禁忌、注意事项、药物相互作用、临床试验或药理毒理等内容标注情况。随机抽取2021年6月和10月门急诊中成药处方进行点评,判断处方规范性和合理性,挖掘潜在的儿科用药风险。结果 128种中成药中,儿童专用品种54种,占42.19%。含有毒性饮片的中成药共计47种,涉及毒性中药材21种。说明书标注内容调查显示,明确儿童用法用量的药品占52.35%,标注不良反应、禁忌、注意事项的药品分别占32.03%、32.81%、82.03%,药物相互作用、临床试验或药理毒理标注率不高。我院门急诊中成药处方不合理问题集中于缺少中医诊断和用法用量不适宜,存在一定的用药风险。结论中成药儿童品种少、说明书中儿童用药信息缺失增加了临床用药风险,建议加强儿童专用药物研发,开展多维度研究以补充中成药儿童用药相关信息。药师应针对儿童机体、患病及用药特点,形成针对化、精细化、个性化的药学服务路径,加强对儿童用药的监督和指导,保障儿童合理安全用药。

关键词: 中成药, 说明书, 儿科, 儿童, 处方, 风险分析, 风险管理

Abstract: Objective To investigate the types, drug instructions and current usage of Chinese patent medicines for pediatric use in our hospital, analyze the risks, and provide data for safe and rational use of pediatric drugs. Methods The way in which 128 types of Chinese patent medicines were used in our hospital was investigated. The labeling of usage and dosage, adverse reactions, contraindications, precautions, drug interactions, clinical trials or pharmacology and toxicology in the instructions were analyzed. Prescriptions of traditional Chinese patent medicines given by outpatient and emergency departments in June and October 2021 were randomly selected to find out whether these prescriptions were up to standard and proper before the potential risks to pediatric drugs were explored. Results Among the 128 types of Chinese patent medicines, 54 were children specific medicines, accounting for 42.19%. There were 47 types of drugs containing toxic decoction pieces, involving 21 types of toxic Chinese medicinal materials. According to the survey on the contents marked in the instructions, 52.35% of the drugs were marked with clear usage and dosage for children, and 32.03%, 32.81% and 82.03% of the drugs labeled with adverse reactions, contraindications and precautions, respectively. The rate at which drug interactions, clinical trials or pharmacological and toxicological labeling were specified was not high. Improper prescriptions of Chinese patent medicines in the outpatient and emergency departments included the lack of diagnosis by TCM clinicians and inappropriate use and dosage. There were some drug risks. Conclusion The limited diversity of traditional Chinese patent medicines and the lack of information on children's drug use in the instructions can increase the risk of clinical drug use. It is recommended that the research and development of children specific drugs be enhanced and multi-dimensional research be conducted to supplement the information on traditional Chinese patent medicines for children. Based on the characteristics of children's s bodies, conditions and medications, pharmacists should provide targeted, refined and personalized pharmaceutical service, strengthen the supervision and guidance of drug use for children, and ensure the rational and safe use of drugs for children.

Key words: Chinese patent medicines, drug instructions, pediatrics, children, prescriptions, risk analysis, risk management

中图分类号:

R994.11
R985

刘洁, 张建民, 张晓朦, 刘芳, 宋远, 钟旭丽. 某院中成药说明书的儿科用药风险分析与管理思考[J]. 中国药物警戒, 2024, 21(4): 422-427.

LIU Jie, ZHANG Jianmin, ZHANG Xiaomeng, LIU Fang, SONG Yuan, ZHONG Xuli. Management of risks to pediatric medications based on drug instructions of Chinese patent medicines in a hospital[J]. Chinese Journal of Pharmacovigilance, 2024, 21(4): 422-427.

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