我院1338个药品的储存条件调查及启示  

Survey and Enlightenment of Storage Condition of 1 338 Kinds of Drugs in Our Hospital

作　　者：白帆[1] 樊华[1] 田娜[1] 张翠莲[1] 

机构地区：[1]中国医学科学院/北京协和医学院北京协和医院药剂科,北京100730

出　　处：《中国药房》2015年第34期4884-4886,共3页China Pharmacy

基　　金：国家临床重点专科建设项目

摘　　要：目的:了解我院药品的储存条件与2013年版《药品经营质量管理规范》(GSP)及药品说明书规定的符合程度。方法:参照2013年版GSP及药品说明书规定,统计我院2013年外购药品中需在阴凉处、冷处、常温及冷冻储存药品所占的比例,回顾性分析我院药库、药房的储存条件与规定的符合程度。结果:在我院2013年外购的1 338个药品(国产药品886个,占66.22%;进口或进口分装药品452个,占33.78%)中,需在冷处和冷冻储存的分别有110个(8.22%)和3个(0.22%)、阴凉处(包括凉暗处)和常温储存的分别有271个(20.25%)和954个(71.30%)。结论:通过实施持续改进管理,我院可保障药品储存条件符合2013年版GSP及药品说明书规定。政府相关部门需进一步完善相关法规,提升药品说明书标注储存条件的可操作性,从而确保药品质量。OBJECTIVE：To investigate the conformance of drug storage condition in our hospital with the criterion of Good Supply Practice of Drug（GSP）or drug instructions. METHODS：The ratio of drugs which should be stored at cold chain or below20 ℃ or room temperature in our hospital in 2013 was analyzed statistically according to drug instruction and GSP（2013 edition）.The conformance of storage condition between our hospital and GSP（2013 edition）or drug instructions was analyzed retrospectively. RESULTS：Among 1 338 drugs in our hospital in 2013（886 domestic drugs,66.22%;452 imported or import-packing drugs,33.78%）,110 drugs should be refrigerated（8.22%）,3 be frozen（0.22%）,271 be kept below 20 ℃（20.25%）and 954 be kept at room temperature（71.30%）,respectively. CONCLUSIONS：Through continuous improvement of management,drug storage condition could meet the requirements of GSP（2013 edition） and drug instruction. In order to ensure drug quality,the government should improve related laws and regulations,and promote the operability of storage condition stated in drug instruction.

关 键 词：药品 储存条件 温度 湿度 

分 类 号：R95[医药卫生—药学]