基于药物警戒思维的药品效期风险管理根因分析

Root Cause Analysis in Risk of Drug Expiration Date Management Based on Pharmacovigilance Thinking

目的基于药物警戒思维探讨根因分析法在药品效期风险管理中的应用。方法针对1例医院水合氯醛自制制剂(简称水合氯醛)近效期药物警戒事件,利用医院风险管理模式对此事件进行风险评估和干预。通过评估风险数值(RPN)确定风险干预分级;成立根因分析小组,调查水合氯醛药物警戒事件,访谈相关人员,确定时间轴;以鱼骨图分析法确定水合氯醛药物警戒事件的7个近端原因,采用柏拉图分析法确定其根本原因,包括制度不完善、缺乏考核培训、无绩效考核、请领计划不合理。制订和实施的风险对策包括制度、流程的制订和完善,人员的培训和考核,质控督查的实施,自制制剂请领计划的完善。结果药学部构建了自制制剂在院使用完整的全流程风险防控体系,修订了与药品效期管理相关的制度、流程及预案。培训后,56名调剂药师药品效期考核结果不低于9分者为100.00%,显著高于初次考核的28.57%(P<0.01);且RPN由128下降至32,危险度降低。结论基于药物警戒思维的根因分析法可有效降低药品效期管理的风险,优化细节管理,促进临床安全、合理用药。

Objective To investigate the root cause analysis(RCA)method of the risk in drug expiration date management based on the pharmacovigilance thinking.Methods Taking one case of the pharmacovigilance event of chloral hydrate homemade preparation(hereinafter referred to as chloral hydrate)near expiration date in the hospital as an example,the hospital risk management model was used to carry out the risk assessment and intervene for this event.The risk intervention grading was determined by the risk priority number(RPN).The RCA group was estabished,the chloral hydrate pharmacovigilance event was investigated,the related personnel were interviewed and the time axis was determined.The fishbone diagram was used to determine seven proximal causes leading to the chloral hydrate pharmacovigilance event,the Pareto analysis was used to determine the root causes including imperfect system,lack of assessment and training,no performance assessment and unreasonable application plan.The formulated and implemented risk countermeasures included the formulation and improvement of systems and processes,the training and assessment of personnel,the implementation of quality control supervision and the improvement of application plan for homemade preparation.Results The Department of Pharmacy had established a complete whole-process risk prevention and control system for the use of homemade preparation in the hospital,and had revised the systems,processes and plans related to the management of drug expiration date.After the training,100.00%of the 56 dispensing pharmacists got no less than 9 points in the drug expiration date assessment,which was significantly higher than 28.57%in the initial assessment(P<0.01),and the RPN decreased from 128 to 32 with lower risk.Conclusion The RCA method based on the pharmacovigilance thinking can effectively decrease the management risk of drug expiration date,optimize detail management,and promote safe and rational drug use in the clinic.