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。
OBJECTIVE：To control the drug quality risk in drug withdrawal links of hospital pharmacy,and provide reference for the application of quality risk management（QRM）in hospital pharmacy. METHODS：Drug QRM was developed in drug with-drawal links through risk identification,risk assessment,risk control,risk assessment and other steps. Using the incidence of risk factors and reusable rate of withdrawal drug as indexes,related data of before（Jul.-Dec. 2015）and after（Jan.-Jun. 2016）devel-oping QRM in our hospital were compared to evaluate the effect of drug QRM. RESULTS：Determining whether specific storage drugs kept the required storage conditions,whether the numbers of withdrawal drugs counted to minimal packaging and other 5 fac-tors were high-risk factors（the risk score of each factor〉4 points）;control measures were taken separately for high risk factors, then high-risk factors were reduced to acceptable levels（risk score〈4 points）. After developing QRM,the incidence of risk factors were reduced than before（reduce 1.35%-6.19%）,reusable rate of withdrawal drug was increased（98.64% vs. 86.32%）（all P〈0.05）. CONCLUSIONS：Developing QRM in drug withdrawal links of hospital pharmacy can reduce the drug quality risk.
出处
《中国药房》
CAS
北大核心
2017年第13期1809-1812,共4页
China Pharmacy
关键词
质量风险管理
医院药房
退药
药品质量
Quality risk management
Hospital pharmacy
Drug withdrawal
Drug quality
