某三级甲等综合医院门诊药房中成药药品说明书信息标注情况分析  

Analysis on the Information Labeling of Chinese Patent Medicine Instructions in the Outpatient Pharmacy of a Grade-A Tertiary General Hospital

作　　者：杜雅丽 胡晨吉 何璐璐[1] 郭毅 高洋洋[1] 王世燕 樊萍[1] DU Yali;HU Chenji;HE Lulu;GUO Yi;GAO Yangyang;WANG Shiyan;FAN Ping(Department of Clinical Pharmacy,West China Hospital,Sichuan University,Chengdu,Sichuan,China 610041)

机构地区：[1]四川大学华西医院临床药学部,四川成都610041

出　　处：《中国药业》2024年第10期16-20,共5页China Pharmaceuticals

基　　金：四川省自然科学基金[2023NSFSC1014]。

摘　　要：目的完善医院门诊药房中成药药品说明书的信息标注,促进临床合理用药。方法通过医院信息系统收集某三级甲等(简称三甲)综合医院门诊药房83种中成药的药品说明书,参照相关法规、指南等分析各项目信息标注情况。结果83份药品说明书中,非处方药中除11份未标注警示语外,其余各项目均标注完整;处方药药品说明书【药品名称】【成分】【性状】【功能主治】【规格】等17项内容均标注完整,【药代动力学】【老年患者用药】【儿童用药】【孕妇及哺乳期妇女用药】【药物相互作用】等7项有缺项。结论该院门诊药房使用的中成药药品说明书信息标注存在缺项严重、表述模糊、界定不清的情况,建议相关部门加强对中成药药品说明书的管理,督促药品上市许可持有人进行修改和完善,以保障临床用药安全。Objective To improve the information labeling of Chinese patent medicine instructions in outpatient pharmacy of hospitals,and to promote the clinical rational drug use.Methods Eighty-three instructions of Chinese patent medicines in the outpatient pharmacy of a grade-A tertiary general hospital were collected from the Hospital Information System,and the information labeling of each item was analyzed based on the relevant laws and guidelines.Results Among the 83 drug instructions,the information labeling in instructions of nonprescription drugs was complete except for 11 instructions without warning signs;17 items such as drug name,ingredients,properties,functions and indications and specifications were complete in the instructions of prescription drugs,while seven items such as pharmacokinetics,medication for elderly,medication for children,medication for pregnant and lactating women and drug interactions were missing.Conclusion There are serious deficiencies,vague expressions and unclear definitions in the Chinese patent medicine instructions in outpatient pharmacy of the hospital.It is suggested that relevant departments should strengthen the management of Chinese patent medicine instructions,urge the marketing authorization holders to modify and improve the instructions to ensure the clinical medication safety.

关 键 词：三级甲等综合医院 门诊药房 中成药 药品说明书 信息标注 用药安全 合理用药 

分 类 号：R95[医药卫生—药学]