The present study analyses and discusses the different approaches applied today in assessing the exposure to cytotoxic drugs in comparison with exposure data. Environmental monitoring via wipe sampling can reveal very low cytotoxic drug contaminations of less than 0.1 pg/cm2. Benchmarking systems based on these findings allow a comparison of different settings and developments over time. However, they have no toxicological basis and allow no assertion of the actual risk to personnel exposed. Guidance values within the pharmaceutical industry based on toxicological data allow acceptable daily intakes of several micrograms per day and corresponding environmental contaminations in the magnitude of íg/cm2. However, the derivation of acceptable surface levels is highly simplified. Consideration of exposure in terms of acceptable cancer risks makes it possible to calculate acceptable daily intakes which are in the order of micrograms per day for cyclophosphamide and cisplatine. Surveys in German state-of-the-art facilities showed that actual exposure is well below these values and that the internal load on personnel results in an occupational cancer risk well below the currently valid acceptance risk of 4: 10,000.
Authors: Hadtstein, C.; Eickmann, U.; Heinemann, A.; Hofmann, F. ;Full Source: Gefahrstoffe – Reinhaltung der Luft 2012, 72(1/2), 25-33 (English) ;