静脉用药配置中心抗肿瘤药物静脉配置全过程质控管理措施及价值研究

Quality control management throughout the entire process of antineoplastic agent intravenous admixture using PIVAS and its significance

目的 选取静脉用药配置中心(PIVAS)抗肿瘤药物静脉调配全过程标准化、规范化质控管理及价值研究。方法 选取2018年7月至2020年8月间上海复旦大学附属华山医院PIVAS的35名工作人员为研究对象,将质控管理实施前(2018年7月至2019年7月)的配药数据纳入对照组,将质控管理实施后(2019年8月至2020年8月)的配药数据纳入观察组。观察两组的审方时间、排药时间、药物配置时间、药品库存周转天数以及药物配置不合理情况。结果 观察组审方时间、排药时间、药物配置时间和药物库存周转天数均低于对照组,差异均有统计学意义(均P<0.05)。观察组不合理溶剂剂量、药物存放发生率均低于对照组,差异均有统计学意义(均P<0.05)。两组不合理溶剂选择、药物剂量、药物容器选择和配伍禁忌比较,差异无统计学意义(P>0.05)。结论 PIVAS抗肿瘤药物静脉调配全过程标准化、规范化质控管理,能够降低配置不合理发生率,提高抗肿瘤药物配置质量,对PIVAS抗肿瘤药物静脉调配质量提高具有重要价值。

Objective To assess the standardized and normalized quality control management throughout the entire process of intravenous antineoplastic agent using pharmacy intravenous admixture service(PIVAS) and its significance. Methods Thirty-five PIVAS staff were selected at Huashan Hospital Affiliated to Fudan University Pharmacy from July 2018 to August 2020. Data on agent preparation after implementation of quality control management were included in an observation group from August 2019 to August 2020 and data on agent preparation before implementation of quality control management were included in a control group from July 2018 to July 2019. Time for prescription review, agent discharge and agent admixture, agent inventory turnover days, and unreasonable agent admixture were observed in the two groups. Results Time for prescription review, agent discharge and agent admixture, agent inventory turnover days were significantly lower in the observation group than in the control group(all P<0.05). The incidence of irrational solvent doses and agent storage was significantly lower in the observation group than in the control group(all P<0.05). There was no significant difference in unreasonable solvent selection, agent dosage, agent container selection and incompatibility between the two groups(P>0.05). Conclusion Standardized and normalized quality control management throughout the entire process of intravenous antineoplastic agent using PIVAS can reduce the incidence of irrational admixture and improve the quality of antineoplastic agent admixture, which is of great value for improving the quality of intravenous antineoplastic agent admixture using PIVAS.