Siderov Jim, Kirsa Sue, McLauchlan Robert
Pharmacy Department, Austin Health, Heidelberg, Victoria, Australia.
J Oncol Pharm Pract. 2010 Mar;16(1):19-25. doi: 10.1177/1078155209352543. Epub 2009 Dec 4.
The potential for staff exposure to antineoplastic agents exists in the workplace despite current recommended safe handling procedures. Reliance on cytotoxic drug safety cabinets (CDSC) to provide total protection from exposure to hazardous drugs is insufficient. Preventing workplace contamination is the best strategy to minimise exposure. PhaSeal is a commercially available system for ensuring the leak-free transfer of hazardous drugs, fitting both the NIOSH and ISOPP definitions of a closed system. To date, there have been no published studies examining the use of a closed system drug transfer device (PhaSeal) under Australian conditions.The purpose of this study is to determine the impact of a closed system drug transfer device on cytotoxic surface contamination in the cytotoxic preparation areas of two Australian metropolitan public hospitals.
This was a pre- and post-intervention study in which chemical contamination was tested at baseline then at five and 12 months after the introduction of the a closed system drug transfer device. Cyclophosphamide was used as a surrogate marker for all cytotoxic drugs. Surface wipe sampling was performed at specified sites within the cytotoxic suite using a standardized technique. Commercial products of cyclophosphamide were also sampled.
After five months, contamination was reduced in 13 of the 22 sites sampled (59%), with four of these samples showing undetectable levels of contamination. Two other site samples (9%) remained unchanged. The total contamination of surfaces tested was reduced by 24%. After five months hospital 1 withdrew from the study. After 12 months, surface contamination was reduced in 75% of sample sites. The total contamination of surfaces tested was reduced by 68%. The wipes of the external surface of commercial products detected cyclophosphamide contamination.
When used inside a CDSC, the closed system drug transfer device PhaSeal further reduces surface contamination, in some instances to undetectable levels.
尽管目前有推荐的安全操作程序，但工作人员在工作场所仍有接触抗肿瘤药物的风险。仅依靠细胞毒性药物安全柜（CDSC）来提供完全保护以避免接触危险药物是不够的。预防工作场所污染是将接触风险降至最低的最佳策略。PhaSeal是一种可商购的系统，用于确保危险药物的无泄漏转移，符合美国国家职业安全与健康研究所（NIOSH）和国际肿瘤药学专业人员学会（ISOPP）对封闭系统的定义。迄今为止，尚无已发表的研究考察在澳大利亚条件下使用封闭系统药物转移装置（PhaSeal）的情况。本研究的目的是确定封闭系统药物转移装置对澳大利亚两家大都市公立医院细胞毒性制剂区域细胞毒性表面污染的影响。
这是一项干预前后研究，在引入封闭系统药物转移装置前的基线以及引入后的5个月和12个月对化学污染进行检测。环磷酰胺用作所有细胞毒性药物的替代标志物。使用标准化技术在细胞毒性操作间内的指定部位进行表面擦拭采样。还对环磷酰胺的商业产品进行了采样。
5个月后，在采样的22个部位中的13个（59%）污染减少，其中4个样本的污染水平检测不到。另外2个部位样本（9%）保持不变。所检测表面的总污染减少了24%。5个月后医院1退出了研究。12个月后，75%的采样部位表面污染减少。所检测表面的总污染减少了68%。商业产品外表面的擦拭样本检测到环磷酰胺污染。
当在细胞毒性药物安全柜内使用时，封闭系统药物转移装置PhaSeal进一步减少表面污染，在某些情况下可降至检测不到的水平。
