我国零售药店药品贮藏温湿度监测与管理现状的横断面调查OA
Cross-Sectional Study on the Current Practices of Temperature and Humidity Monitoring and Management in Drug Storage Among Retail Pharmacies in China
目的 调查我国零售药店药品贮藏温湿度监测与管理现状,分析存在的问题及影响因素,并提出针对性改进策略,为保障公众用药安全提供数据支持与决策依据.方法 运用便利抽样法,在全国范围内对零售药店药品贮藏开展横断面调查.结果 共调查1 039家药店,97.02%药店对需常温贮藏药品实施温湿度监测,其中99.21%记录监测结果,仅有5.77%的药店有专人负责监测温湿度;此外,调查发现仍有2.21%的药店未在店内或库房中设置阴凉区域.常温区域和阴凉区最常使用的温湿度监测设备为普通温度计(占比分别为61.29%和53.49%),冷藏区域中单体药店和连锁直营店使用自动监测系统的比例分别为42.31%和40.78%,37.50%的连锁加盟店仍使用普通温度计.出现过温度不达标的药店比例为16.36%、出现过湿度不达标的药店比例为23.68%,呈季节和地域差异.5.77%的药店 2024 年度被监管部门检查出药品储藏不当.结论 该研究揭示我国零售药店药品贮藏温湿度监测与管理现状在责任落实、设备配置及季节性风险防控等方面存在的问题.建议从明确专人责任、升级智能监测设备、建立气候适应性管理机制、强化监管自查协同等方面系统提升药品贮藏质量管理水平,以保障药品在零售终端的储存安全.
Objective To investigate the current status of temperature and humidity monitoring and management for drug storage in retail pharmacies in China,analyze existing problems and influencing factors,propose targeted improvement strategies,and provide data support and a decision-making basis for ensuring public medication safety.Methods A nationwide cross-sectional survey was conducted using convenience sampling to investigate drug storage conditions in retail pharmacies.Results A total of 1 039 pharmacies were surveyed.Among them,97.02%monitored temperature and humidity for drugs requiring room-temperature storage,and 99.21%of these pharmacies recorded the monitoring results.However,only 5.77%of pharmacies had designated staff responsible for temperature and humidity monitoring.Furthermore,2.21%of pharmacies did not have a cool storage area within the store or in their warehouse.Standard thermometers were the most commonly used monitoring devices in both room-temperature areas and cool storage areas(accounting for 61.29%and 53.49%,respectively).For refrigerated storage,the proportions of independent pharmacies and directly-operated chain pharmacies using automatic monitoring systems were 42.31%and 40.78%,respectively,while 37.50%of franchise chain pharmacies still used standard thermometers.The proportions of pharmacies that had experienced non-compliance with temperature standards and humidity standards were 16.36%and 23.68%,respectively,showing seasonal and regional variations.In 2024,5.77%of pharmacies were cited by regulatory authorities for improper drug storage practices.Conclusions The study highlights the ongoing challenges and current practices in temperature and humidity management for drug storage in Chinese retail pharmacies,especially concerning the assignment of responsibilities,equipment use,and seasonal risk management.Define personnel roles,enhance monitoring technology,develop climate-responsive management strategies,and reinforce collaborative regulation and self-audits to improve drug storage quality and retail medication safety systematically.
田晶辰;吴汀溪;苏丽丽;杨莉;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
医药卫生
零售药店药品贮藏管理温湿度监测药品质量管理监测设备
Retail pharmacyDrug storage managementTemperature and humidity monitoringDrug quality managementMonitoring equipment
《医药导报》 2026 (8)
1350-1354,5
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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