Comparison of surface contamination with cyclophosphamide and fluorouracil using a closed-system drug transfer device versus standard preparation techniques.

PURPOSE: A comparison was conducted of the levels of surface contamination with two commonly used antineoplastic drugs, cyclophosphamide and fluorouracil, on countertops, floors, and hood surfaces in three oncology pharmacies following preparation with standard hazardous drug (HD) preparation techniques, or a closed-system drug transfer device (CSTD) in conjunction with standard HD preparation techniques, or a CSTD in conjunction with standard HD preparation techniques but prepared on a countertop outside the biological safety cabinet (BSC). METHODS: Wipe samples of the various surfaces in each pharmacy were obtained biweekly for 12 weeks (six samples) to establish a baseline. Following implementation of the CSTD, an additional six biweekly samples were collected. The CSTD was then removed, and a final six samples were collected again using standard preparation techniques. During the CSTD Phase, fluorouracil was prepared on the countertop outside the BSC. RESULTS: During the 36-week study, 342 samples were collected. A total of 8% positive fluorouracil wipe samples were found in the three pharmacies. The proportion of positive fluorouracil samples was significantly less in the CSTD Phase than in the control phases (p = 0.0002). There were 324 (95%) positive cyclophosphamide wipe samples. The median surface contamination was significantly different across the three phases (p < 0.00001). This was consistent at all sites, for both the BSC work surfaces and countertops. Contamination on floors adjacent to the BSCs was not consistently reduced. CONCLUSION: The use of a CSTD in the BSC in conjunction with standard HD preparation techniques significantly reduced cyclophosphamide surface contamination as compared to standard techniques alone. Preparation of fluorouracil outside the BSC using the CSTD did not result in significant analytically detectable contamination on the countertops.

Surface contamination of chemotherapy drug vials and evaluation of new vial-cleaning techniques: results of three studies.

PURPOSE: The results of three studies that describe the external contamination of chemotherapy drug vials are presented. New techniques for the improved decontamination of vials containing cisplatin are also described. SUMMARY: Study 1 evaluated the external contamination of drug vials with cyclophosphamide and ifosfamide in a pharmacy setting. Widespread contamination of the outside of drug vials was found with each drug. Study 2 evaluated the surface contamination of drug vials with cyclophosphamide and fluorouracil in three pharmacies. Sporadic contamination with fluorouracil was detected, while cyclophosphamide was found on most vials. In study 3, investigators compared the decontamination abilities of a standard decontamination procedure at the manufacturer level with an improved decontamination procedure and the use of sleeves to further decrease contamination. Though the methods of each study reported herein differed, the outcomes were similar. All chemotherapy drug vials studied demonstrated levels of contamination with the drug well above the limit of detection. Improved decontamination procedures, combined with the use of protective sleeves, reduced the level of platinum contamination by 90%, suggesting that standard decontamination procedures should be reconsidered. CONCLUSION: The results of these studies are consistent with several others that have reported contamination of the outside surface of drug vials for a number of chemotherapy drugs. Contamination can be reduced by using decontamination equipment and protective sleeves during the manufacturing process.