目的 探讨失效模式与效应分析（failure mode and effect analysis，FMEA）在住院药房药品调剂流程风险管理中的应用效果，提高药品调剂质量。方法 对天津医科大学肿瘤医院住院药房口服药物调剂流程中各个环节进行FMEA，计算风险优先指数（risk priority number，RPN）。选出高风险等级的失效模式和中等风险等级中S≥4的失效模式，整理分析其失效原因，制定并实施改进措施。比较实施FMEA方法前后失效模式变化情况，分析改进效果。结果 住院药房药品调剂流程中共找出13个失效模式，其中高风险失效模式4项，极高风险失效模式2项。通过规范药物医嘱流程、优化HIS信息系统与摆片机对接执行程序、修订完善制度以及对药师、护士进行培训等方面干预，13项失效模式RPN均值由38降至15，降幅为60.53%。其中4项高等风险失效模式经改进后风险明显降低，且差异有统计学意义（P＜0.05）。结论 将FMEA应用于住院药房药品调剂流程风险管理，能够有效降低拆药过程药品损失、机器误差、HIS系统与摆片机信息对接失误和取药次数多、等候时间长等问题，提高药品调配的及时性和准确性，更好地服务于住院患者。

Objective To explore the application effect of failure mode and effect analysis (FMEA) in the risk management of drug dispensing process in inpatient pharmacy, and improve the quality of drug dispensing. Methods FMEA was performed on each link of oral drug dispensing process in inpatient pharmacy of Tianjin Medical University Cancer Hospital, and risk priority number (RPN) was calculated. The failure mode of high risk level and the failure mode of S ≥ 4 in medium risk level are selected, the failure causes are analyzed, and the improvement measures are formulated and implemented. The change of failure mode before and after the implementation of FMEA method was compared, and the improvement effect was analyzed. Results A total of 13 failure modes were found in the drug dispensing process of inpatient pharmacy, including 4 high-risk failure modes and 2 extremely high-risk failure modes. By regulating the process of drug doctor's advice, optimizing the implementation procedure of HIS information system and tablet dispensing machine, revising and improving the system, and training pharmacists and nurses, the mean RPN of 13 failure modes decreased from 38 to 15, with a decrease of 60.53%. The risk of four high risk failure modes was significantly reduced after improvement, and the difference was statistically significant (P < 0.05). Conclusion The application of FMEA in the risk management of drug dispensing process in inpatient pharmacy can effectively reduce the problems of drug loss, machine error, information docking error between HIS system and tablet machine, more drug taking times and long waiting time in the process of drug disassembly, improve the timeliness and accuracy of drug dispensing, and better serve the hospitalized patients.

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