六西格玛管理模式在临床试验药房质量管理中的应用  

Application of six sigma management mode in quality management of good clinical practice pharmacy

作　　者：孟新源[1] 宋建忠 梁永红[1] MENG Xin-yuan;SONG Jian-zhong;LIANG Yong-hong(Department of Pharmacy,Tumor Hospital Affiliated to Xinjiang Medical University,Urumqi 830011,China;College of Pharmacy,Xinjiang Medical University,Urumqi 830000,China)

机构地区：[1]新疆医科大学附属肿瘤医院药学部,乌鲁木齐830011 [2]新疆医科大学药学院,乌鲁木齐830000

出　　处：《临床药物治疗杂志》2022年第8期61-65,共5页Clinical Medication Journal

摘　　要：目的在药物临床试验质量管理规范(GCP)药房质量管理中,通过运用六西格玛管理模式,提高临床试验用药物管理的规范性。方法运用六西格玛法定义、测量、分析、改进与控制等步骤,优化GCP药房管理中药物的接收、储存、发放等关键流程。结果运用六西格玛管理模式后,优化了GCP药房管理中药物超温、医嘱及处方差错、使用后剩余药物及空包装回收等关键流程,降低了相关问题差错率(P<0.05),有效避免了由于试验用药物管理不当带来的临床试验实施过程中方案偏离或违背。结论六西格玛管理法能优化GCP药房药物管理流程,提高各环节管理质量,促进药物临床试验安全、有序开展。Objective To improve the standardization of drug management for clinical trials by applying six sigma management mode in the quality management of good clinical practice(GCP)pharmacy.Methods Six sigma method was used to define,measure,analyze,improve and control the key processes of receiving,storing and distributing drugs in GCP pharmacy management.Results After applying six sigma management mode,the key processes in GCP pharmacy management,such as drug over temperature,the doctor’s advice and prescription errors,residual drugs after use and empty package recovery,were optimized,and the error rate of related problems was reduced(P<0.05).It effectively avoided the deviation in the process of implementing schemes due to improper management of experimental drugs clinical trials.Conclusion Six sigma management method can continuously optimize the management process of GCP pharmacy,improve the management quality of each link,and promote the safe and orderly development of drug clinical trials.

关 键 词：GCP药房 六西格玛 管理模式 规范性 临床试验 

分 类 号：R95[医药卫生—药学]