摘要
目的:了解某院多剂量包装药品说明书启用后使用期限的标注情况,为安全用药提供参考。方法:收集该院多剂量包装药品说明书,统计【用法用量】、【注意事项】、【贮藏】、【有效期】等项目中启用后使用期限、贮藏条件的标注情况。结果:共收集208份多剂量包装药品说明书,口服制剂88份,注射制剂26份,外用制剂49份,眼用制剂37份,鼻用制剂7份及耳用制剂1份。其中44份标注了启用后使用期限,标注率最高的为注射制剂21份,其次是眼用制剂14份。18份说明书标注在【贮藏】项内,9份标注在【有效期】项。26份药品说明书标注了启用后的贮藏条件。结论:多剂量包装药品说明书中启用后使用期限及贮藏条件标注率较低,建议药监部门加大监管力度敦促药品生产企业完善说明书中启用后使用期限信息的标注,降低用药风险。
OBJECTIVE To understand service life labeling after initiation of 208 multi-dose package inserts in our hospital, so as to provide reference for safe drug use. METHOD: The package inserts of multi-dose package drugs were collected from the hospital, and the labeling of service life and storage conditions after use in [usage and dosage][precautions][storage][shelf life] and other items were collected. RESULTS A total of 208 multi-dose packaged drug instructions were collected, including 88 oral preparations, 26 injection preparations, 49 external preparations, 37 ophthalmic preparations, 7 nasal preparations and 1 otic preparation. Forty-four of them were labeled with service life after use, and the highest labeling rate was 21 for injection preparations, followed by 14 for ophthalmic preparations. Eighteen(18) inserts are labeled in [Storage] and nine(9) inserts are labeled in [Shelf life]. Twenty-six package inserts labeled storage conditions after use. CONCLUSION The labeling rate of service life and storage conditions in the package inserts of multi-dose package drugs is relatively low. It is recommended that drug regulatory authorities should strengthen supervision and urge drug manufacturers to improve the labeling of service life information in the package inserts and reduce the medication risk.
作者
刘雅娟
张四喜
王相峰
张文锐
LIU Ya-juan;ZHANG Si-xi;WANG Xiang-feng;ZHANG Wen-rui(Department of Pharmacy,the First Hospital of Jilin University,Jinlin Changchun 130021,China)
出处
《中国医院药学杂志》
CAS
北大核心
2019年第13期1405-1408,1413,共5页
Chinese Journal of Hospital Pharmacy
关键词
多剂量包装药品
启用
使用期限
Multi-dose package medicine
initiation
service life
