Use of a Closed System Device to Reduce Occupational Contamination and Exposure to Antineoplastic Drugs in the Hospital Work Environment
1 Department of Environmental Health, Osaka Prefectural Institute of Public Health, 1-3-69, Nakamichi, Higashinari-ku, Osaka 537-0025, Japan
2 Department of Pharmacy, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka 537-0025, Japan
3 Department of Research Planning and Coordination, National Institute of Occupational Safety and Health, Kawasaki 214-8585, Japan
* Author to whom correspondence should be addressed. Tel: +81-6-6972-1321; fax: +81-6-6972-2393; e-mail: jnyosida{at}iph.pref.osaka.jp
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.
Keywords: antineoplastic drugs • biological monitoring • closed system device • hospital work environment • surface contamination
Received August 5, 2008; in final form November 12, 2008