A large-scale study was carried out in order to determine the contamination level of antineoplastic drugs in pharmacies and to investigate the suitability and effects of wipe sample monitoring at regular intervals. A specific study design was developed. The 130 participating pharmacies were divided into a study and a control group, carrying out five and two wipe sampling cycles, respectively. The work practice was analyzed using questionnaires to identify factors that influence the contamination level. From 1269 wipe samples, 774 (61%) were contaminated with at least one of the analyzed cytotoxic drugs: cyclophosphamide, docetaxel, etoposide, 5-fluorouracil, gemcitabine, ifosfamide, methotrexate, and paclitaxel. A significant decrease of the contamination with cyclophosphamide and 5-fluorouracil was observed in the study group. The Monitoring-Effect Study of Wipe Sampling in Pharmacies method has proven to be a reliable and affordable tool for contamination control. Based on the 90th percentile of the contamination values, a substance-independent performance-based guidance value of 0.1ng cm(-2) has been derived.

译文

进行了大规模研究,以确定药房中抗肿瘤药物的污染水平,并调查定期擦拭样品监测的适用性和效果。开发了一个特定的研究设计。将130家参与的药房分为研究组和对照组,分别进行了五个和两个擦拭采样周期。使用问卷调查对工作实践进行了分析,以确定影响污染水平的因素。从1269擦拭样品中,774 (61%) 被至少一种分析的细胞毒性药物污染: 环磷酰胺,多西他赛,依托泊苷,5-氟尿嘧啶,吉西他滨,异环磷酰胺,甲氨蝶呤和紫杉醇。在研究组中观察到环磷酰胺和5-氟尿嘧啶的污染显着减少。药房擦拭采样方法的监测效果研究已被证明是控制污染的可靠且负担得起的工具。根据污染值的第90个百分位数,得出了与物质无关的基于性能的指导值0.1ng cm(-2)。

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