4家综合型三级甲等医院药房药品冷链管理的探讨

Study on Cold-chain Management of Drugs in Pharmacy from 4 Third-grade Class-A Hospitals

目的:为保证在药房冷链管理过程中的医院药品质量提供参考,确保患者用药安全、有效。方法:收集某地区4家综合型三级甲等医院在用的全部药品说明书,查看各医院药房温度登记表,就温度对药品质量的影响、药品说明书中贮藏项下温度的标注情况进行统计分析。结果:4家医院硬件投入不足(无冷库),药房温度为10～29℃,药房对冷链管理药品贮藏量过大,温度设定不能达到药品冷链管理的要求;药品生产企业对药品的贮藏项标注不重视,如药品说明书中贮藏项字体过小,药品内包装上无贮藏项标注,同一药品不同厂家、规格的产品其贮藏项标注不同;相关法律法规更新修订不及时。结论:医院需重视药品冷链管理,加大硬件投入,加强药学人员药品冷链管理培训,强化管理意识;生产企业应重视药品贮藏项标注;相关法律法规应及时更新修订,确保患者用药安全、有效。

OBJECTIVE：To ensure the quality of drug during the cold-chain management process and to ensure the safe and effective drug use of patients.METHODS：Package inserts of drugs were collected from 4 third-grade class-A hospitals.Temperature registration forms of pharmacy were viewed,and the effects of temperature on drug quality,and storage temperature sign of package inserts were analyzed statistically.RESULTS：The insufficient inputs of facilities（no cold storage）in 4 hospitals,with temperature of 10-29 ℃,were unable to achieve the temperature requirements of drug cold-chain management.Pharmacy was unable to store excessive cold-store drugs.Drug manufacturers paid weak attention on storage temperature sign of package inserts,such as the font size of storage item was too small;storage note was not found on inner packaging;the storage notes of the drugs were different among same drugs with different specifications by different manufacturers,the relevant laws and regulations were not renewed and revised timely.CONCLUSIONS：Hospitals should further strengthen cold-chain management,increase facility input,stress on personnel training on cold-chain management and strengthen management awareness.Production enterprises should pay attention to drug store item;renew and revision of relevant laws and regulation timely ensure safety and effectiveness of drug use.