抗肿瘤药物智能调配模式与人工调配模式的成品输液质量和环境残留风险分析OA

Objective To compare the differences between intelligent and manual dispensing modes for antineoplastic drugs in terms of finished infusion quality and environmental contamination risk,thereby providing practical evidence to support the adoption of intelligent dispensing systems.Methods Finished infusions were assessed for dose accuracy(using the weighing method),sterility(via media fill tests),and insoluble particulate levels(by light obscuration)under both dispensing modes.Environmental contamination risk was evaluated by measuring antineoplastic drug residues on infusion bag surfaces,personnel protective equipment(PPE),and within the dispensing environment using high-performance liquid chromatography-tandem mass spectrometry.Results The absolute dispensing error was lower in the machine group compared to the manual group,although statistical significance depended on the drug tested[cisplatin:(0.22±0.19)%vs.(1.56±0.95)%,P<0.05;carboplatin:(0.28±0.20)%vs.(4.40±0.61)%,P<0.05;irinotecan:(1.83±0.28)%vs.(2.71±2.42)%,P>0.05].The machine group also showed better intra-group consistency.No bacterial contamination was detected in finished infusions from either group.Insoluble particulate levels complied with the Chinese Pharmacopoeia(2020 edition)in both groups.Antineoplastic drug residues on infusion bag surfaces,PPE,and in the dispensing environment were consistently lower in the machine group,with the significance of the difference varying by drug.The machine group again demonstrated superior consistency across all residue measurements.Conclusions The intelligent dispensing mode offers a more precise and safer approach to antineoplastic drug preparation.This study provides valuable evidence to support the wider implementation of intelligent dispensing systems in pharmacy intravenous admixture services.