质量风险管理在医院药房退药环节的应用

发布时间：2018-12-07 11:54

【摘要】：目的:控制医院药房退药环节的药品质量风险,为药品质量风险管理(QRM)在医院药房的应用提供参考。方法:通过风险识别、风险评估、风险控制、风险审核等步骤对我院药房退药环节实施药品QRM;以各风险因素的发生率和退回药品可再利用率为指标,比较我院实施QRM前(2015年7月-12月)、后(2016年1月-6月)的相关数据,评价药品QRM实施效果。结果:确定需特殊贮存药品是否按所需贮存条件保存、退回药品的数量是否清点到最小包装等5项因素为高风险因素(各因素风险评分均大于4分);经对各高风险因素分别采取相应的控制措施后均降低至可接受水平(风险评分均小于4分);实施QRM后与实施前比较,各风险因素的发生率均降低(降低1.35%~6.19%),退回药品可再利用率升高(98.64%vs.86.32%)(P均小于0.05)。结论:医院药房在退药环节实施QRM可降低药品质量风险。
[Abstract]:Objective: to control the risk of drug quality in hospital pharmacy and to provide reference for the application of drug quality risk management (QRM) in hospital pharmacy. Methods: through the steps of risk identification, risk assessment, risk control and risk audit, drug QRM; was implemented in the pharmacy of our hospital. Based on the incidence of risk factors and the reutilization rate of returned drugs, the data before (July-December 2015) and after (January-June 2016) in our hospital were compared to evaluate the effect of drug QRM implementation. Results: the high risk factors were determined as follows: whether the special storage drugs should be kept according to the required storage conditions, and whether the quantity of returned drugs was counted to the minimum packaging, the risk score of each factor was more than 4 points; All the high risk factors were reduced to acceptable level (risk score less than 4). Compared with before QRM, the incidence of each risk factor was decreased (1.35%, 6.19%), and the reutilization rate of returned drug was increased (98.64vs.86.32%) (P were less than 0.05). Conclusion: QRM can reduce the risk of drug quality in hospital pharmacy.
【作者单位】：新疆生产建设兵团医院/石河子大学医学院第二附属医院药学部;
【分类号】：R952

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