失效模式与效应分析法在住院药房药品效期管理中的应用效果分析  

Application effect of failure mode and effect analysis in the drug validity management of inpatient pharmacy

作　　者：李淑佩 姚钊英 陈敏 谭喜莹 王小敏 LI Shupei;YAO Zhaoying;CHEN Min;TAN Xiying;WANG Xiaomin(Department of Pharmacy,Affiliated Hospital of Nanjing University of TCM,Nanjing 210029,China)

机构地区：[1]南京中医药大学附属医院药学部,南京210029

出　　处：《药学前沿》2025年第4期657-664,共8页China Pharmacist

基　　金：江苏省药学会2023年恒瑞医院药学基金项目(H202332)。

摘　　要：目的探讨失效模式与效应分析(FMEA)法在住院药房药品效期管理中的应用效果。方法基于FMEA法对药品质量管理流程进行风险识别,发掘所有潜在失效模式和分析失效原因,从严重度、发生率和检测度3个维度进行量化评分,分别计算出风险优先值(RPN),确定关键失效模式。并从口服拆零药品、除口服拆零药品外的其他药品、病区基数药品管理3个方面,制定、实施改进方案,对干预后的效果进行评价。结果根据RPN值确定28个潜在失效模式,其中需要优先改进的关键失效模式共20个。采取相应措施后,20项关键失效模式的RPN值均有所降低,其中有17项下降幅度≥50%;病区近效期药品品种数明显降低(P<0.05),基数管理、效期管理、标识管理的合格率显著提升(P<0.05);住院药房近效期药品种类数、分包机药品周转天数、效期核查不良事件均有不同程度的降低。结论应用FMEA法能够有效识别和改进药品效期管理流程中的风险点,提高药品管理的质量,确保住院患者用药安全。Objective To explore the application effect of failure mode and effect analysis(FMEA)on the drug validity management of inpatient pharmacy.Methods Based on the FMEA method,risks in the drug quality management process were identified,all potential failure modes were explored and the causes of failure were analyzed.The quantitative scoring was carried out based on severity,occurrence and detection degree,the risk priority number(RPN)was calculated,and key failure modes were determined.Improvement plans were developed and implemented from three aspects:oral dismantling drugs management,other drugs management except for oral dismantling drugs,and cardinal drugs management in inpatient wards,and the effectiveness of the intervention was evaluated.Results Based on the values of RPN,28 potential failure modes were identified,among which 20 were key failure modes that needed to be improved with priority.After taking corresponding measures,the RPN values of the 20 key failure modes all decreased,with 17 of them having a reduction of≥50%.The variety number of drugs that were close to expiry in the ward was significantly reduced(P<0.05),and the qualified rates of cardinal drug management,drug validity management,and drug labeling management were significantly improved(P<0.05).The type number of drugs that were close to expiry in the inpatient pharmacy,the drug turnover days in the repackaging machine,and the number of validity-verification adverse events all decreased to varying degrees.Conclusion The application of FMEA method can effectively identify and improve the risk points in the drug validity management process,enhance the quality of drug management,and ensure the safety of medication for inpatients.

关 键 词：失效模式与效应分析 住院药房 基数药品 药品效期管理 

分 类 号：F763[经济管理—产业经济]