广泛使用的抗肿瘤药物的瓶面和交叉污染的定量分析:生产和职业安全的关键评估。

IF 0.9 4区 医学 Q4 ONCOLOGY
Orhan Ziya, Tuba Reçber, Emirhan Nemutlu, Merve Güdül Bacanlı
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引用次数: 0

摘要

全球癌症发病率的上升导致对抗肿瘤药物的需求增加,加剧了与药物处理相关的职业风险。方法采用标准化擦拭取样法,采用LC-MS/MS分析,定量评估瑞基耶、5-氟尿嘧啶(5-FU)、阿霉素、依托泊苷、吉西他滨、异环磷酰胺和环磷酰胺6种常用细胞毒性药物的表面污染和交叉污染。本研究定量评估了65瓶6种常用细胞毒性药物的表面污染和75瓶(包括奥沙利铂)的交叉污染,采用标准化擦拭取样方法,然后进行LC-MS/MS分析。结果65瓶中原料药污染率为63.08%,与其他原料药交叉污染率为49.33%。值得注意的是,100%的5-FU和吉西他滨样本都存在污染,最高记录水平达到2276.920 ng/cm2 (133199.848 ng/小瓶)。我们明确指出,这是第一个在全国范围内评估细胞毒性药物小瓶表面和交叉污染的研究。这些发现强调了制造业卫生实践的重大差异,并强调了迫切需要进行监管,以减轻卫生保健工作者的暴露风险。该研究提倡强制性污染报告,更严格的去污协议,以及加强药品生产设施的批次控制措施。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Quantitative analysis of vial surface and cross-contamination of widely used antineoplastic drugs in Türkiye: A critical assessment for manufacturing and occupational safety.

IntroductionThe global rise in cancer incidence has led to an increased demand for antineoplastic agents, intensifying occupational risks associated with drug handling.MethodsThis study aimed to quantitatively assess both surface contamination and cross-contamination on the vials of six frequently used cytotoxic drugs in Türkiye, 5-fluorouracil (5-FU), doxorubicin, etoposide, gemcitabine, ifosfamide, and cyclophosphamide, using a standardized wipe sampling method followed by LC-MS/MS analysis. This study quantitatively assess both surface contamination on 65 vials of six frequently used cytotoxic drugs and cross-contamination on an extended set of 75 vials (including oxaliplatin), using a standardized wipe sampling method followed by LC-MS/MS analysis.ResultsOut of 65 vials, 63.08% were contaminated with the active pharmaceutical ingredient (API), while 49.33% of 75 vials exhibited cross-contamination with other APIs. Notably, contamination was present in 100% of 5-FU and gemcitabine samples, with the highest recorded level reaching 2276.920 ng/cm2 (133199.848 ng/vial).ConclusionsWe explicitly state that this is the first study in Türkiye to assess both surface and cross-contamination on cytotoxic drug vials at a national level. These findings underscore significant disparities in manufacturing hygiene practices and highlight an urgent need for regulatory oversight to mitigate healthcare worker exposure risks. The study advocates mandatory contamination reporting, stricter decontamination protocols, and enhanced batch control measures in drug production facilities.

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来源期刊
CiteScore
2.70
自引率
7.70%
发文量
276
期刊介绍: Journal of Oncology Pharmacy Practice is a peer-reviewed scholarly journal dedicated to educating health professionals about providing pharmaceutical care to patients with cancer. It is the official publication of the International Society for Oncology Pharmacy Practitioners (ISOPP). Publishing pertinent case reports and consensus guidelines...
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