Monitoring Effect Study for Swab Samples in Pharmacies (MEWIP)
Duration: February 1, 2004 – October 31, 2008
Description
The primary objective of the MEWIP study was to determine the level of cytostatic drug contamination in the environment of compounding pharmacies through environmental monitoring. In addition, the study aimed to investigate the impact of monitoring on pharmacies’ awareness of the problem, their willingness to improve work processes, and, indirectly, a potential reduction in contamination levels already during the course of the study. Using correlation analyses between measured values and information on work practices, release and exposure mechanisms were investigated, and the work steps particularly critical for unintended and unnoticed contamination were identified. The project also served to provide a robust database for evaluating contamination levels and establishing guideline values.
With 130 of an estimated 800 pharmacies at the time, the MEWIP study represented approximately 16% of the pharmacies in Germany involved in the preparation of cytostatic drugs.
Of the 1,269 swab samples analyzed, a total of 774 (61%) were positive, meaning that at least one of the eight substances was detected. The measured contamination levels spanned a range of six orders of magnitude.
Cyclophosphamide was the most frequently detected substance on the surfaces examined (37%), followed by gemcitabine (32%), 5-fluorouracil (31%), and ifosfamide (21%). These substances also accounted for the vast majority (95%) of the total surface contamination.
By comparing the temporal trends in exposure levels between the two study groups, it is possible to demonstrate the effectiveness of monitoring. This is evident in the decrease in the number of positive swab samples when comparing the 1st and 5th cycles of the study groups.
Since there were neither limit values nor process- and substance-specific criteria (VSK) for CMR substances, the 90th percentiles from the MEWIP study served as substance-specific reference values, from which a substance-independent reference value of 0.1 ng/cm² was subsequently derived. Wipe sample monitoring has proven suitable for routine use and effective for indirectly improving occupational safety in accordance with the Hazardous Substances Ordinance.
Funded by:
German Social Accident Insurance Institution for the Health and Welfare Services (BGW)
