Odraska Pavel, Dolezalova Lenka, Kuta Jan, Oravec Michal, Piler Pavel, Blaha Ludek
Masaryk Memorial Cancer Institute Zluty kopec 7 Brno, Czech Republic, CZ65653.
Ann Occup Hyg. 2013 Mar;57(2):240-50. doi: 10.1093/annhyg/mes057. Epub 2012 Aug 27.
Due to their adverse effects, antineoplastic drugs are considered as a potential health risk to healthcare personnel. The objective of the study was to compare the surface contamination level of the conventional preparation room and outpatient clinic before and after the implementation of a set of additional protective measures.
The measures were targeted at eliminating potential sources of environmental contamination, and modification of the cleaning procedure. The measures introduced into the preparation room consisted of (i) the introduction of manual cleaning of drug vials before they enter the preparation room, (ii) the modification of the routine cleaning procedure performed at the end of each working day (i.e. shifting the cleaning of the isolators as the most contaminated objects from the beginning of the cleaning process to the end), and (iii) the introduction of regular cleaning of the work table every 2 h. The measures introduced into the outpatient clinic consisted of (i) replacement of the standard infusion sets with multichannel sets for safe drug administration, (ii) the introduction of self-cleaning seats to the patient lavatories supporting hygienic and contamination-free seated urination, and (iii) replacement of standard infusion stands with wall-mounted stands, supporting the regular and proper cleaning of the floor beneath. To determine the surface contamination level with antineoplastic drugs, cyclophosphamide and platinum were determined in wipe samples with high performance liquid chromatography with tandem mass spectrometry and inductively coupled plasma mass spectrometry.
In the preparation room, depending on the sampling spot and analyte, median concentrations ranged from 5 to 267 pg cm(-2) and from 2 to 368 pg cm(-2) before and after implementation of the measures, respectively. In the outpatient clinic, median concentrations ranged from 5 to 5310 pg cm(-2) and from <0.2 to 574 pg cm(-2) before and after implementation of the measures, respectively. Depending on the sampling spot, median contamination of the outpatient clinic with cyclophosphamide and platinum was reduced by 57-99% and 61-98%, respectively.
The measures implemented in the outpatient clinic were shown to reduce workplace contamination effectively. Therefore, they can be recommended also for other workplaces where antineoplastic drugs are administered. In contrast, measures implemented in the preparation room, where relatively strict regulations had already been adopted before the study, were less effective. To decrease the actual contamination of the preparation room, other protective measures (e.g. closed-system transfer devices) should be considered.
由于抗肿瘤药物具有不良反应，它们被视为对医护人员的潜在健康风险。本研究的目的是比较在实施一系列额外防护措施前后，传统制剂室和门诊的表面污染水平。
这些措施旨在消除环境污染的潜在来源，并修改清洁程序。引入制剂室的措施包括：（i）在药瓶进入制剂室之前进行人工清洁；（ii）修改每个工作日结束时执行的常规清洁程序（即将隔离器作为污染最严重的物品的清洁从清洁过程开始时转移到结束时）；（iii）每2小时对工作台进行定期清洁。引入门诊的措施包括：（i）用多通道输液器替换标准输液器以确保安全给药；（ii）在患者厕所引入自清洁座椅以支持卫生且无污染的坐姿排尿；（iii）用壁挂式输液架替换标准输液架，以利于对下方地面进行定期和适当的清洁。为了确定抗肿瘤药物的表面污染水平，采用高效液相色谱-串联质谱法和电感耦合等离子体质谱法测定擦拭样本中的环磷酰胺和铂。
在制剂室，根据采样点和分析物的不同，实施措施前后的中位数浓度分别为5至267 pg/cm²和2至368 pg/cm²。在门诊，实施措施前后的中位数浓度分别为5至5310 pg/cm²和<0.2至574 pg/cm²。根据采样点的不同，门诊中环磷酰胺和铂的中位数污染分别降低了57 - 99%和61 - 98%。
门诊实施的措施被证明能有效减少工作场所的污染。因此，这些措施也可推荐用于其他使用抗肿瘤药物的工作场所。相比之下，制剂室实施的措施效果较差，因为在研究之前该制剂室已经采用了相对严格的规定。为了降低制剂室的实际污染，应考虑其他防护措施（如密闭系统转移装置）。
