精神药物说明书中儿童用药信息标注情况分析The Analysis of Pediatric Use Information labeled in Product Instruction of Psychotropic Drugs
林悦甜,许艳,杨国瑛,邱畅,胡晋卿,温预关,徐伏莲
LIN Yuetian,XU Yan,YANG Guoying,QIU Chang,HU Jinqing,WEN Yuguan,XU Fulian
摘要(Abstract):
目的了解江门市第三人民医院精神药物药品说明书中儿童用药信息的标注情况,促进临床合理用药。方法以该院2015年以来使用精神药物(包括抗精神病药、抗抑郁药及镇静安眠药)药品说明书为研究对象,对其在儿童用药信息方面的标注情况进行统计分析。结果在调查的71份药品说明书中,有29份标注"儿童用药信息",但仅有4份清晰标注儿童的用法用量;有5种药物在不同生产企业的药品说明书提供的儿童用药的信息存在差异。结论精神药物说明书在儿童用药方面的信息缺失严重、不同生产企业说明书不一致,增加儿童应用精神药物时面临的风险,亟需加强说明书中儿童用药信息的补充完善工作,以保证儿童用药安全。
To investigate the medication information for children in product instruction of psychotropic drugs available in Jiangmen Third People's Hospital and to enhance the rational use of drugs. METHODS The statistical analysis was conducted based on the pediatric use information labeled in product instruction of psychotropic drugs,including antipsychotics,antidepressants and anxiolytic-hypnotics,ever used in 2015 in Jiangmen Third People's Hospital. RESULTS Among 71 Inserts,29Inserts( 40. 85%) marked "Pediatric Use ",in which only 4 Inserts marked "Dosage and Administration"clearly,and 5 drugs of different manufacturers were inconsistent in "Pediatric Use". CONCLUSION Risks of pediatric patients prescribed psychotropic drugs may increase due to lack of pediatric use information in instruction for most drugs and inconsistency between different production enterprises. The establishment and verification of pediatric use information in drug instruction should be conducted to enhance the safety for children and adolescents.
关键词(KeyWords):
药品说明书;儿童用药信息
product instruction;pediatric use information
基金项目(Foundation): 广东省医院药学研究基金(2017A14);; 广州市脑科医院广州市医学重点学科建设项目子项目(GBH2014-QN08);; 江门市卫计委立项课题(16A028)
作者(Author):
林悦甜,许艳,杨国瑛,邱畅,胡晋卿,温预关,徐伏莲
LIN Yuetian,XU Yan,YANG Guoying,QIU Chang,HU Jinqing,WEN Yuguan,XU Fulian
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