Antineoplastic Hazardous Drugs Research Articles

Published review of closed-system drug-transfer devices: Limitations and implications.

Occupational exposure of pharmacists, pharmacy technicians, and ancillary pharmacy staff to surface contamination from antineoplastic hazardous drugs, many of which are carcinogens or reproductive and/or developmental toxicants, has been a concern for decades. AJHP has published countless studies on

Multicenter evaluation of a new closed system drug-transfer device in reducing surface contamination by antineoplastic hazardous drugs

Results of a study to evaluate the effectiveness of a recently introduced closed system drug-transfer device (CSTD) in reducing surface contamination during compounding and simulated administration of antineoplastic hazardous drugs (AHDs) are reported. Wipe samples were collected from 6 predetermined surfaces in compounding and infusion areas of 13 U.S. cancer centers to establish preexisting levels of surface contamination by 2 marker AHDs (cyclophosphamide and fluorouracil). Stainless steel templates were placed over the 6 previously sampled surfaces, and the marker drugs were compounded and infused per a specific protocol using all components of the CSTD. Wipe samples were collected from the templates after completion of tasks and analyzed for both marker AHDs. Aggregated results of wipe sampling to detect preexisting contamination at the 13 study sites showed that overall, 66.7% of samples (104 of 156) had detectable levels of at least 1 marker AHD; subsequent testing after CSTD use per protocol found a sample contamination rate of 5.8% (9 of 156 samples). In the administration areas alone, the rate of preexisting contamination was 78% (61 of 78 samples); with use of the CSTD protocol, the contamination rate was 2.6%. Twenty-six participants rated the CSTD for ease of use, with 100% indicating that they were satisfied or extremely satisfied. A study involving a rigorous protocol and 13 cancer centers across the United States demonstrated that the CSTD reduced surface contamination by cyclophosphamide and fluorouracil during compounding and simulated administration. Participants reported that the CSTD was easy to use.

Abstract 4231: Significant reduction in workplace contamination of antineoplastic hazardous drugs in 13 U.S. hospitals following utilization of a new closed-system drug transfer device

Abstract Background: Adverse effects of worker exposure to antineoplastic hazardous drugs (AHD) have been well documented with dermal absorption from contaminated surfaces in the work environment being one of the most well researched sources of exposure. Multiple studies have documented decreased surface contamination when using CSTDs for AHD handling. Decreased surface contamination should result in decreased worker exposure and decreased risk of adverse effects. Purpose: The purpose of this study was to determine the effectiveness of a new CSTD in reducing surface contamination of marker AHDs cyclophosphamide (CP) and 5-fluorouracil (5FU) during compounding and administration in multiple cancer centers, using surface wipe-sampling methodology. The results of the wipe sampling were compared to existing contamination in the sites and to similar studies in peer-reviewed literature to determine relative effectiveness. Methods: Wipe samples of six predetermined surfaces were collected in designated compounding and infusion areas of 13 cancer centers to establish the preexisting level of surface contamination with two marker AHDs. Stainless steel templates of approximately 500 cm2 were placed over previously sampled surfaces, and a specific protocol of set doses of the AHDs were compounded and infused, using all of the components of the new CSTD system, over the templates. Wipe samples of the templates were collected following the completion of tasks and analyzed for both marker AHDs. Results: A total of 312 wipe samples were collected from the 13 centers, 156 at baseline and 156 with the CSTD. All samples were reported as ng/cm2 with the analytical limit of detection (LOD) for each drug being 0.002 ng/500 cm2. In the aggregate results of 13 sites sampled for existing contamination, 67% of wipe samples had detectable levels of the AHDs with a range of LOD to 19.880 ng/cm2 of 5FU and 0.648 ng/cm2 of CP. With the new CSTD the contaminated samples were reduced to 5.8% with a range LOD to 0.004ng/cm2 of 5FU and 2.60ng/cm2 of CP. Conclusions: The new CSTD significantly reduced surface contamination by the marker AHDs during both compounding and administration. Compared to published results of two multi-site studies of another CSTD for compounding, the new CSTD is superior in reducing surface contamination with marker AHDs, as determined by wipe sampling of similar surfaces. Research reported in this study was supported by the National Cancer Institute (NCI) of the National Institutes of Health (NIH) under award number 5R44CA153636. Citation Format: Timothy Tyler, Luci Power. Significant reduction in workplace contamination of antineoplastic hazardous drugs in 13 U.S. hospitals following utilization of a new closed-system drug transfer device [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 4231. doi:10.1158/1538-7445.AM2017-4231