Longitudinal evaluation of environmental contamination with hazardous drugs by surface wipe sampling.

INTRODUCTION: Exposure of healthcare workers to hazardous drugs can lead to adverse health effects supporting the importance of a continuous monitoring program, for example, by taking surface wipe samples. The objective was to describe the results of repeated monitoring of contamination with hazardous drugs on multiple surfaces in a hospital pharmacy and at two wards using standardized preparation techniques and cleaning procedures. METHODS: Twelve surfaces in the hospital pharmacy and at two wards were sampled and analyzed for contamination with the hazardous drugs cyclophosphamide, doxorubicin, 5-fluorouracil, gemcitabine, methotrexate, and paclitaxel. The drugs were prepared with a closed-system drug transfer device (CSTD). Sampling of the drugs was performed in four trials during eight months. Liquid chromatography tandem mass spectrometry was used for the analysis of the drugs. RESULTS: During the four trials, contamination with five of the six hazardous drugs was found on half of the surfaces in the pharmacy and in a ward. Seventeen out of 288 possible outcomes were positive (6%), with the biological safety cabinet grate (n = 6) and scanner (n = 5) most frequently contaminated. The highest level of contamination was observed on the pass-thru window (cyclophosphamide: 2.90 ng/cm2) and the touch screen of the Diana device (5-fluorouracil: 2.38 ng/cm2). Both levels were below the action level of 10 ng/cm2. CONCLUSIONS: The long-term use of a CSTD in combination with appropriate cleaning has proven effective in achieving low levels of surface contamination with hazardous drugs.

Validation of chemotherapy drug vapor containment of an air cleaning closed-system drug transfer device.

PURPOSE: The purpose of this study was to test the efficacy of ChemfortTM, an air filtration closed-system drug transfer device to prevent release of chemotherapy drug vapors and aerosols under extreme conditions. The air cleaning system is based on the adsorption of drug vapors by an activated carbon filter in the Vial Adaptor before the air is released out of the drug vial. The functionality of the carbon filter was also tested at the end of device's shelf life, and after a contact period with drug vapors for 7 days. Cyclophosphamide and 5-fluorouracil were the chemotherapy drugs tested. METHODS: The Vial Adaptor was attached to a drug vial and both were placed in a glass vessel. A needle was punctured through the vessel stopper and the Vial Adaptor septum to allow nitrogen gas to flow into the vial and to exit the vial via the air filter into the glass vessel which was connected to a cold trap. Potential contaminated surfaces in the trap system were wiped or rinsed to collect the escaped drug. Samples were analyzed using liquid chromatography tandem mass spectrometry. RESULTS: Cyclophosphamide and 5-fluorouracil were detected on most surfaces inside the trap system for all Vial Adaptors without an activated carbon filter. Contamination did not differ between the Vial Adaptors with and without membrane filter indicating no effect of the membrane filter. The results show no release of either drug for the Vial Adaptors with an activated carbon filter even after 3 years of simulated aging and 7 days of exposure to drug vapors. CONCLUSIONS: Validation of air cleaning CSTDs is important to secure vapor and aerosol containment of chemotherapy and other hazardous drugs. The presented test method has proven to be appropriate for the validation of ChemfortTM Vial Adaptors. No release of cyclophosphamide and 5- fluorouracil was found even for Vial Adaptors after 3 years of simulated aging and 7 days of exposure to drug vapors.