基于失效模式与效应分析的麻精药品临床管理安全相关风险因素研究  

Safety-related risk factors in clinical management of narcotics and psychotropic substances via failure mode and effect analysis

作　　者：袁偲偲[1] 王广燕 李轶凡[1] 李瑞莲 杜博冉[1] 冯欣[1] YUAN Sisi;WANG Guangyan;LI Yifan;LI Ruilian;DU Boran;FENG Xin(Department of Pharmacy,Beijing Obstetrics and Gynecology Hospital,Capital Medical University/Beijing Maternal and Child Health Care Hospital,Beijing 100026,China;Department of Pharmacy,Women and Children’s Hospital,Qingdao University,Qingdao Shandong 266034,China)

机构地区：[1]首都医科大学附属北京妇产医院,北京妇幼保健院药事部,北京100026 [2]青岛大学附属妇女儿童医院药学部,山东青岛266034

出　　处：《中国药物警戒》2023年第9期1027-1030,1059,共5页Chinese Journal of Pharmacovigilance

基　　金：国家自然科学基金资助项目(72204170);北京市属医院科研培育计划(PG2019028)。

摘　　要：目的 采用失效模式和效应分析(FMEA)法探索麻精药品在临床管理与使用中的安全相关风险因素。方法 在北京妇产医院建立麻精药品管理与使用错误防范策略研究组,通过文献检索、问卷调查和实地考察等途径收集失效模式和风险因素,应用FMEA法对其严重程度(S)、发生频率(O)和发现指数(D)进行评分,确定风险优先级数(risk priority numbers,RPN),并针对RPN评分>100的高风险因素制订管理和防范策略。结果 基于FMEA分析结果,麻精药品全生命周期中存在RPN>100的高风险因素10个(共23个);其中患者用药环节包含4个,药品生产环节包含2个,而管理制度、信息系统、药品管理和药品使用等4个环节中各存在1个高风险因素。结论 利用FMEA法可有效识别临床中麻精药品用药错误风险因素。通过完善管理体系、规章制度及质量目标管理等,持续优化医疗机构防范措施,保障麻精药品用药安全,减少不良影响。Objective To investigate the safety-related risk factors in clinical management of narcotics and psychotropic substances by means of failure mode and effect analysis(FMEA).Methods A research group on the management of narcotics and psychotropic substances and on prevention strategies for medication errors was established at Beijing Obstetrics and Gynecology Hospital.The failure modes and risk factors were collected via literature retrieval,questionnaire surveys and field investigation.FMEA was used to score the severity(S),frequency of occurrence(O)and discovery index(D)and determine risk priority numbers(RPNs).Management and prevention strategies were formulated for high-risk factors with RPN scores>100.Results Based on results of FMEA,there were ten high-risk factors(23 in total)with RPN>100 in the whole life cycle of narcotics and psychotropic substances,four of which were found in patient medications,two in drug production,and one in the management system,information system,drug management and drug use respectively.Conclusion The application of FMEA can effectively identify medication error-related risk factors for narcotics and psychotropic substances in clinical practice.By improving management systems,rules and regulations,and quality targets,the prevention and management strategies in medical institutions can be continuously optimized to ensure the medication safety of narcotics and psychotropic substances,thereby reducing negative social impacts.

关 键 词：失效模式 效应分析 麻精药品 用药错误 风险管理 安全管理 

分 类 号：R994.11[医药卫生—毒理学] R971[医药卫生—药学]