30组同成分不同厂家或规格注射剂药品说明书调查分析  

Investigation and Analysis of 30 Injection Instructions with the Same Ingredients but Different Manufacturers or Specifications

作　　者：陈华彪[1] 

机构地区：[1]蚌埠市第一人民医院,安徽蚌埠233000

出　　处：《中国药房》2015年第10期1437-1440,共4页China Pharmacy

摘　　要：目的:为医疗机构合理、安全、规范使用药品提供参考。方法:收集我院2013年6月至2014年6月使用的同成分不同厂家或规格注射剂药品说明书60张,成分相同者分为一组,共30组,对同成分不同厂家或规格注射剂药品说明书进行对比分析。结果:30组同成分不同厂家或规格注射剂药品说明书中,在适应证、用法用量、禁忌、贮藏和警示语等方面的内容部分存在差异。其中,在禁忌和贮藏项内容方面存在差异的各有4组,分别占13.33%;在适应证项内容方面存在差异的有3组,占10.00%;在警示语方面,有5组(16.67%)全部标注,11组(36.67%)单张标注,其余14组全部没有标注,未标注的共39张,占65.00%。结论:管理部门应加强药品说明书规范化管理,生产厂家必须重视药品说明书的拟订、更新,医药工作者应加强宣传、增强警示作用,以确保临床安全用药。OBJECTIVE：To provide reference for the reasonable,safe and standardized use of drug. METHODS：A total of60 injection instructions with the same ingredients but different manufacturers or specifications used by our hospital from Jun. 2013 to Jun. 2014 were collected,and then categorized into 30 groups on basis of the same ingredients;and comparatively analyzed the injection instructions with the same ingredients but different manufacturers or specifications. RESULTS：In the 30 groups of injection instructions with the same ingredients but different manufacturers or specifications,there were differences among indication,usage and dosage,contraindication,storage and warnings. There were 4 groups of differences in contraindication and storage which took up 13.33% respectively;3 groups of differences in indication which took up 10.00%;there were 5 groups with the warnings fully marked（16.67%）,11 groups partially marked（36.67%） and the other 14 groups totally unmarked which took up 65.00%with the number of 39. CONCLUSIONS：Administration should strengthen the instruction standardization management,manufacturers must pay much attention to the formulation and update of drug instructions and medical staff should strengthen the propaganda and enhance the warning role to guarantee clinical medication safety.

关 键 词：药品说明书 注射剂 警示 

分 类 号：R952[医药卫生—药学]