The Ghent University Hospital started a medical surveillance program to monitor health care workers and the environment during preparatory activities of hazardous drugs in the pharmacy oncology unit. The hospital compared two different systems for the preparation of hazardous drugs; the traditional system versus the PhaSeal system. The study was conducted in four phases, traditional method, cleaning the hood, PhaSeal implementation and finally traditional method; wipe sampling was done to establish a baseline at each interval of implementation with urinalysis testing beginning at the third phase of the study. Analyses were performed using gas chromatography in tandem with mass spectroscopy.
Wiping was conducted on the biological safety cabinet (BSC) in addition to the surrounding areas by moistening the area with 10 mL of NaOH 0.03 M solution. The area was then wiped until dry with a paper tissue and collected in a labeled plastic screw top container with the name of the location collected and stored at -80C. Urine samples of the technicians and pharmacists involved in the preparatory activities of hazardous drugs was collected in a beaker, time and dated, and the volume of each sample was recorded on a special report form. From each sample, 50 mL was stored in a screw-top plastic container for analysis. The plastic container was labeled with the name of the person and the sequence number, the containers were then stored at -80C. Each technician was required to reconstitute and handle at least 6 g of cyclophosphamide on the day he/she entered the study; from the start of reconstitution of the drug, he/she collected the urine during 48 hours. A pharmacist had to be present in the preparation area the same time as the technician at the day of the entry in the study and the pharmacist also collected urine over the same 48-hour period. The results of the study showed that there was significant surface contamination and human uptake with the use of the traditional method of preparing cyclophosphamide and that with the use of PhaSeal these levels were significantly decreased. The implications of this study suggest that there has been a significant difference found in the surface contamination rate and in the number, periods and values of contaminated urine samples when a comparison is done with traditional method and PhaSeal, the results are in favor of the PhaSeal system.
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