我国医疗机构药品贮藏环境与设施配置现状研究:基于全国横断面调查分析OA
Assessment of Medicine Storage Conditions and Facility Configuration in Chinese Medical Institutions:A National Cross-Sectional Study
目的 调查我国医疗机构药品贮藏环境与设施配置现状,并结合温湿度异常发生情况和监管检查结果分析潜在风险,为优化药品贮藏管理提供依据.方法 本研究为全国横断面调查,于 2024 年 11 月 1-9 日采用结构化电子问卷收集药房药品贮藏环境信息,包括贮藏区域设置、温湿度监测、监测设备及记录与达标情况等内容.结果 共计2 289家医疗机构参与调查.92.46%医疗机构药品储藏有专人负责温湿度监测;97.68%医疗机构药房在常温区实施温湿度监测,其中98.70%有监测记录;81.13%医疗机构设有阴凉区,以静脉药物调配中心药房、门诊药房和住院药房配备阴凉区比例最高,4.99%的阴凉区未配备监测设备.常温区(75.76%)和阴凉区(62.14%)最常使用的温度监测设备是普通温湿度计,冷藏区常使用自动监测可报警的冷链设备(55.51%).37.96%和44.82%的医疗机构出现过药品储藏区域温湿度不达标的情况,呈季节和地域差异.11.49%的医疗机构在去年被监督管理部门检查出药品贮藏不当问题.结论 我国医疗机构药品贮藏总体情况较为规范,但仍存在一定比例的温湿度不达标和设备配置不足,尤其在阴凉区和高温季节更为突出.建议进一步推进自动化、可报警的温湿度监控系统,以降低药品贮藏不当的风险.
Objective To investigate the current status of medicine storage conditions and facility configurations in Chinese medical institutions,and to explore potential risks associated with deviations in temperature and humidity as well as regulatory inspection findings,with the aim of optimizing medicine storage management.Methods A nationwide cross-sectional study was conducted between 1 and 9 November 2024 using a standardized,structured electronic questionnaire.The questionnaire collected information on the configuration of medicine storage areas,temperature and humidity monitoring practices,types of monitoring equipment,documentation of monitoring records,and compliance with storage requirements.Results A total of 2 289 hospitals participated in the survey.Among these,92.46%reported having designated personnel responsible for monitoring temperature and humidity in medicine storage areas.Temperature and humidity were monitored in room-temperature storage areas in 97.68%of hospitals,with 98.70%of these hospitals maintaining monitoring records.Designated cool storage areas were available in 81.13%of hospitals,most commonly located in intravenous drug preparation centers,outpatient pharmacies,and inpatient pharmacies;however,4.99%of cool storage areas lacked monitoring equipment.Ordinary thermometers and hygrometers were the most frequently used monitoring devices in room-temperature storage areas(75.76%)and cool storage areas(62.14%),whereas cold-chain devices with automatic monitoring and alarm functions were predominantly used in refrigerated storage areas(55.51%).Non-compliance with temperature and humidity requirements in medicine storage areas was reported in 37.96%and 44.82%of hospitals,respectively,with notable seasonal and regional variation.In the past year,11.49%of hospitals were identified as having improper medicine storage practices during inspections by regulatory authorities.Conclusions Most surveyed medical institutions had well-structured medicine storage areas that met regulatory requirements.Widespread adoption of intelligent temperature and humidity monitoring systems may facilitate real-time supervision of the storage conditions,ensure drug quality,and reduce adverse events associated with improper storage.
吴汀溪;杨莉;苏丽丽;商然;田晶辰;赵志刚
首都医科大学附属北京天坛医院药学部,北京 100070首都医科大学附属北京天坛医院药学部,北京 100070首都医科大学附属北京天坛医院药学部,北京 100070首都医科大学附属北京天坛医院药学部,北京 100070首都医科大学附属北京天坛医院药学部,北京 100070首都医科大学附属北京天坛医院药学部,北京 100070
医药卫生
医疗机构药品贮藏管理温湿度监测监测设备规范化管理
Medical institutionsMedicine storage managementTemperature and humidity monitoringMonitoring equipmentStandardized management
《医药导报》 2026 (8)
1338-1343,6
中国药品监督管理研究会立项课题资助项目(2024-Y-Y-005).
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