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GM-009 Multicenter study of environmental 5-FU contamination during normal mixing of antineoplastic drugs

Background Antineoplastic drugs have often been shown to be mutagenic, teratogenic and carcinogenic, and these drugs are recommended to be prepared in a biological safety cabinet (BSC). Among them, 5-fluorouracil (5-FU) is a common cytotoxic antineoplastic drug, and can potentially cause harm if not handled properly. Purpose To investigate the relationship between the level of 5-FU contamination during normal mixing, the time spent in preparation, the operator’s experience in mixing, the number of 5-FU vials prepared during this study, and the number of anticancer agents prepared at each hospital. Material and methods During preparation, 5-FU contamination was determined on 2 stainless steel plates (10 × 10 cm) in the BSC in 8 national hospitals. These stainless steel plates were collected at the end of the study period. Samples were analysed by a validated liquid chromatography coupled to tandem mass spectrometry method. Results The subjects were 16 pharmacists from 8 hospitals. The median preparation experience was 18 months (1–168 months), and the median number of 5-FU vials prepared by each pharmacist was 7 vials (2–38 vials). The level of 5-FU contamination was 2,079.5 ng (0–10,148.0 ng)/200 cm2. Comparing the level of contamination to the amount of 5-FU prepared, the time spent in preparation, the years of preparation experience, and the number of anticancer agents prepared at each hospital, no correlations were observed (r2 = 0.0062, 0.0002, 0.0562, 0.016). Conclusion 5 pharmacists achieved 5-FU contamination at levels below the detection limit. Importantly, years of preparation experience varied among these pharmacists. These results suggested that even experienced pharmacists may underestimate the risk of environmental exposure during normal preparation. Routine training in mixing skills is needed to safely handle antineoplastic agents. Reference National Institute for Occupational Safety and Health (NIOSH) NIOSH alert 2004-165. Preventing occupational exposures to antineoplastic and other hazardous drugs in health care settings. Cincinnati, OH: NIOSH; 2004. No conflict of interest.