静脉输注用生物制品药物说明书使用事项标注情况调查与建议  

Labeling of Instructions for Biopharmaceuticals for Intravenous Infusion

作　　者：刘敏[1] 胡雪 李艳娇[1] 宋燕青[1] 王相峰 LIU Min;HU Xue;LI Yanjiao;SONG Yanqing;WANG Xiangfeng(Department of Pharmacy,First Hospital of Jilin University,Changchun Jilin 130021,China)

机构地区：[1]吉林大学第一医院药学部,吉林长春130021

出　　处：《中国药物警戒》2020年第3期165-168,173,共5页Chinese Journal of Pharmacovigilance

摘　　要：目的了解我院静脉输注用生物制品药物说明书使用事项标注情况,为合理用药提供参考。方法收集我院静脉输注用生物制品药物说明书47份,对说明书中涉及的给药途径、贮藏、溶媒选择、输液速度、输液器要求、冲管、配置过程、配置液贮藏是否标注完整进行统计分析。结果47份静脉注射用生物制品药物说明书中,给药途径和贮藏信息标注率达100%;溶媒选择、滴注速度、配置过程信息标注率虽然较高,但部分标注信息模糊,缺乏明确内容;标注输液器具23份(48.94%)、标注冲管1份(2.13%)、标注配置液的贮藏时限20份(42.55%),标注率较低。结论静脉输注用生物制品药物说明书输液器具、冲管、配置液的贮藏时限信息标注严重缺失,建议生产企业修订说明书,监管部门应加强对说明书相关信息标注情况的审批与监管。Objective To find out about the instructions for biopharmaceuticals for intravenous infusions in our hospital in order to provide reference for rational use of drugs.Methods A total of forty-seven instructions for biopharmaceuticals for intravenous infusion were collected in our hospital,and statistical analysis was conducted of the drug delivery route,storage,medium selection,infusion rate,infusion set requirements,flushing,preparation process,and preparation liquid storage.Results Among the fortyseven instructions for intravenous biologics,the labeling rate of drug delivery and storage information was 100%.Despite the high labeling rate of medium selection,infusion rate,and preparation process,some of the information was implicit.Infusion apparatus was labeled in twenty-three instructions(48.94%),flushing in one(2.13%),and the expiry date of preparation liquids was in 20(42.55%).Conclusion The labeling of instructions for the storage of biological products for intravenous infusion is far from detailed.It is recommended that manufacturers revise instructions.Regulatory authorities should strengthen the approval and supervision of related information in instructions for pharmaceuticals.

关 键 词：生物制品药物 静脉输注 说明书 标注信息 

分 类 号：R954.5[医药卫生—药学]