Association between occupational exposure and control measures for antineoplastic drugs in a pharmacy of a hospital.

OBJECTIVES: To investigate the association between occupational contamination and exposure levels to antineoplastic drugs and the application of control measures in a hospital work environment. METHODS: Wipe samples of equipments were collected at a hospital in Osaka Prefecture, Japan, from 2007 to 2011. These samples were subjected to measurements of cyclophosphamide (CP), gemcitabine (GEM), platinum-containing drugs (Pt), and fluorouracil (5FU). Additionally, 24-h urine samples were collected from pharmacists who handled antineoplastic drugs, which were analyzed for CP and alpha-fluoro-beta-alanine (AFBA). The application of control measures was scored according to a checklist, which consisted of the following five items: safety equipment and maintenance, training and documentation, devices for safe handling, personal protective equipment, and emergency care. The aim was to obtain a score of 80%. RESULTS: The median CP, GEM, and 5FU concentrations of all wipe samples were significantly lower during the period when the mean score was >80% (attainment period) versus when the mean score was ≤80% (nonattainment period; all P < 0.001, Mann-Whitney's U-test). Additionally, the median urinary CP and AFBA concentrations of pharmacists during the attainment period tended to be lower than that of those during the nonattainment period (P = 0.061 and 0.061, respectively, using Mann-Whitney's U-test). CONCLUSIONS: Contamination and levels of exposure to antineoplastic drugs decreased with a score higher than 80%. The scores of the items on the checklist appeared to adequately reflect the condition of the control measures, as increases in all five items were associated with reductions in the contamination by and levels of exposure to all drugs.

Use of a closed system device to reduce occupational contamination and exposure to antineoplastic drugs in the hospital work environment.

OBJECTIVES: The aim of the preset study was to evaluate the applicability of a closed system device to protect against occupational contamination and exposure to antineoplastic drugs in the work environment of a hospital. METHODS: We compared the contamination by and exposure to cyclophosphamide (CPA) between a conventional mixing method and a mixing method using a closed system device. Wipe samples in the preparation room, gloves samples and 24-h urine samples of pharmacists preparing antineoplastic drugs were collected. Working surfaces inside the biological safety cabinet (BSC), front side of the air grilles of the BSC, stainless steel trays, working table and floor were wiped. At first, sample collection was done on 5 days over an interval of 2 weeks using the conventional mixing method. After 2 weeks training for using the closed system device, sample collection was done 5 days over an interval of 2 weeks using the closed system device. RESULTS: When pharmacists prepared antineoplastic drugs by the conventional method, CPA was detected from all wipe samples, and the mean and median concentrations of CPA were 1.0 and 0.16 ng cm(-2), respectively (range was from 0.0095 to 27 ng cm(-2)). When pharmacists prepared antineoplastic drugs with a closed system device, CPA was detected from 75% of the wipe samples at mean and median concentrations of 0.18 and 0.0013 ng cm(-2), respectively (the range was from lower than detection limit to 4.4 ng cm(-2)). Using the closed system device significantly reduced the surface contamination of CPA for all wipe sampling points in the preparation room (Mann-Whitney's U-test). The range of CPA of glove samples used in the conventional method and closed system device ranged from lower than detection limit to 3200 ng per glove-pair and from lower than detection limit to 740 ng per glove-pair, respectively. Using the closed system device significantly reduced the gloves contamination of CPA (Mann-Whitney's U-test). The range of urinary CPA of six pharmacists preparing the antineoplastic drugs with the conventional method and closed system device ranged from lower than detection limit to 170 ng day(-1) and from lower than detection limit to 15 ng day(-1), respectively. Using the closed system device significantly reduced the amount of urinary CPA in pharmacists preparing the antineoplastic drugs (Wilcoxon's signed ranks test). CONCLUSIONS: We concluded that a closed system device can reduce occupational contamination and exposure to antineoplastic drugs in the hospital work environment.