中国药业2025，Vol.34Issue(9)：6-11,6.DOI:10.3969/j.issn.1006-4931.2025.09.002
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
摘要
Abstract
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 institutions,and improve the quality management system.Medical institutions should strengthen the management of standardized use of cold chain transportation equipment,science popularization and education,control of drug delivery time and sequence,and training of relevant personnel to reduce the risk of chain breakage of cold chain drugs.关键词
医疗机构/冷链药品/断链风险/海南省Key words
medical institutions/cold chain drugs/chain break risk/Hainan Province分类
医药卫生引用本文复制引用
朱灿阳,王瑞祥,冯发明,杨承烨,罗国健..海南省23家医疗机构冷链药品管理风险及改进对策分析[J].中国药业,2025,34(9):6-11,6.基金项目
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]. （）
