摘要
目的 比较风险系数法和行动优先级两种过程失效模式和影响分析评价方法在临床试验药物管理中的应用。方法 在“临床试验药物管理”项下构建3个约定层次,共24个失效模式,运用过程失效模式和影响分析法、问卷调查法、Cronbach'sα系数和Grubbs检验对药物管理流程进行分析,比较风险系数法和行动优先级两种方法的实际应用效果,并对高、中风险失效模式提出改进措施。结果 在临床试验药物管理上,失效模式的风险系数值是24.661~54.302,行动优先级均为L,风险系数法更加合理有效。按风险系数排序,高风险失效模式主要集中在“人员”项下,改进措施包括设置专职药师和调整取药时间;中风险失效模式主要集中在“环境”和“药物”项下,改进措施包括设置严格的温控程序和药物色标管理。结论 风险系数法比行动优先级更适合于该院临床试验药物管理,过程失效模式和影响分析应不断进行分析和更新改进措施,以完善药物管理过程,保证临床试验规范性。
Objective To compare process failure mode and impact analysis methods regarding the risk priority number and action priority,and to apply the method to improve the clinical trial drug management.Methods Three levels are constructed under“Clinical Trial Drug Management”with 24 failure modes by using process failure mode and impact analysis,questionnaire investigation,cronbach'sαcoefficient and grubbs test analyze.The actual effects of risk priority number and action priority were compared.The results were divided into high,medium and low risks by using risk priority number,and improvement measures were proposed for high and medium risks.Results The results showed that risk priority number ranges from 24.661 to 54.302,and level of action priority is L.Risk priority number is more reasonable than action priority.High risk failures were mainly concentrated in the“Personnel”item,and improvement measures include setting up a full-time pharmacist and adjusting the time of drug collection.Medium risk failures are mainly concentrated in"Environment"and"Drug"items,and improvement measures include setting up strict temperature control procedures and drug color label management.Conclusion Risk priority number is more suitable than action priority for clinical trial drug management.Process failure mode and impact analysis should be continuously analyzed and updated to improve the drug management process and ensure the standardization of clinical trials.
作者
丁琮洋
邱博
宋浩静
孙雪
李亚静
李宵
董占军
DING Congyang;QIU Bo;SONG Haojing;SUN Xue;LI Yajing;LI Xiao;DONG Zhanjun(Department of Pharmacy,Hebei General Hospital,Shijiazhuang 050051,China)
出处
《医药导报》
CAS
北大核心
2022年第6期916-919,共4页
Herald of Medicine
关键词
临床试验
药物管理
过程失效模式和影响分析
风险系数
行动优先级
Clinical trial
Drug management
Process failure mode and impact analysis
Risk priority number
Action priority
