海南省23家医疗机构冷链药品管理风险及改进对策分析  

Risk Analysis and Improvement Measures of Pharmaceutical Cold Chain Management in 23 Medical Institutions in Hainan Province

作　　者：朱灿阳 王瑞祥 冯发明 杨承烨 罗国健 ZHU Canyang;WANG Ruixiang;FENG Faming;YANG Chengye;LUO Guojian(Hainan Women and Children's Medical Center,Haikou,Hainan,China 570312)

机构地区：[1]海南省妇女儿童医学中心,海南海口570312

出　　处：《中国药业》2025年第9期6-11,共6页China Pharmaceuticals

基　　金：海南省自然科学基金面上项目[823MS154];海南省卫生健康委员会行业科研项目[21A200103]。

摘　　要：目的为规范医疗机构的冷链药品管理提供参考。方法采用失效模式与影响分析(FMEA)法对海南省23家医疗机构的冷链药品管理进行断链风险识别,分析其高风险失效模式及其原因,并提出针对性建议。结果根据风险优先(RPN)值筛选出28个潜在失效模式,其中需优先改善的高风险失效模式共14个。各环节高风险失效模式的RPN值及发生率分别为门诊发放[患者无转运冷链设备(37.44,86.96%),患者未按规定贮藏药品(51.91,86.96%),患者家用冷链设备性能损坏(37.17,78.26%),药师发药时未对患者进行有效交代(28.66,65.22%)],药品申领[未配备转运冷链设备/设备性能损坏(20.69,65.22%),未最后集中发放冷链药品(26.47,69.57%),领药人员未知晓冷链药品(20.52,47.83%)],药房储存[未及时将冷链药品放置冷链设备(28.44,73.91%),未了解药品具体贮藏条件及稳定性数据(23.33,65.22%)],药品调配[常温下调配冷链药品(24.97,91.30%),冷链药品调配结束至发放前置常温环境(30.80,82.61%)],病区用药[未使用转运冷链设备送药(25.96,86.96%),接送冷链药品交接不到位(36.46,73.91%),未及时放置送达的冷链药品(34.94,78.26%)]。结论海南省监管部门应建立统一的医疗机构冷链药品管理制度,完善质量管理体系,医疗机构应加强转运冷链设备规范使用、科普宣教、上药时间与顺序控制、相关人员培训等的管理,以降低冷链药品的断链风险。Objective To provide a reference for standardizing the pharmaceutical cold chain management in medical institutions.Methods Failure mode and effects analysis(FMEA)method was used to identify the risk of chain breakage in the pharmaceutical cold chain management of 23 medical institutions in Hainan Province,in order to analyze the high-risk failure modes and their causes,and targeted recommendations were put forward.Results Based on the risk priority number(RPN)value,28 potential failure modes were selected,among which 14 high-risk failure modes need to be prioritized for improvement.The RPN values and incidence rates of high-risk failure modes in each link were outpatient distribution[the patients lacked cold chain equipment for transfer(37.44,86.96%),the patients failed to store the drugs as prescribed(51.91,86.96%),the patients'home refrigerator performance damaged(37.17,78.26%),pharmacists failed to provide patients with effective explanations during the process of dispensing drugs(28.66,65.22%)],application for drug acquisition[cold chain transport equipment not equipped/equipment performance damaged(28.44,73.91%),cold chain drugs not distributed centrally in the final(26.47,69.57%),and cold chain drugs not comprehended by drug recipients(20.52,47.83%)],pharmacy storage[the timely placement of cold chain drugs was not feasible(28.44,73.91%),and the specific storage conditions and stability data of drugs were not understood(23.33,65.22%)],drug dispensing[cold chain drugs were prepared at room temperature(24.97,91.30%),and placed in room temperature environment before dispensing(30.80,82.61%)],medication in the ward[no cold chain transportation equipment was utilized for medication delivery(25.96,86.96%),and the handover of cold chain drugs during transportation failed(36.46,73.91%),and cold chain drugs placed in the refrigerator timely was lacking(34.94,78.26%)].Conclusion The regulatory authorities in Hainan Province should establish a unified pharmaceutical cold chain management system for medical institutio

关 键 词：医疗机构 冷链药品 断链风险 海南省 

分 类 号：R95[医药卫生—药学]