Monitoring campaign for professional exposure to cytostatics

23 November 2020

A. Rambaud1, B. Delmas2, M.A Cadeac2, L. Caumette2, J. Aubry2, M. Fernandez2, N. Barascud2, C. Egea2, N. Boulay1, A. Séché1, J. Rousseau1, A. Nicolas1 1 Toxilabo, Nantes, FRANCE
2 Pharmacie, CH Val d’Ariège, FRANCE

Professional exposure to cytostatics is the main reason of the centralization of preparations. But which level of residual exposure persists, whether to the CRU (cytotoxic reconstitution unit), the hospital pharmacies, in the care units and during the transport of cytotoxics? The INRS study (1) conducts on 250 participants, showed that 53% of professionals had at least one quantifiable cytotoxic substance in their urine and that 85% of samples taken from the surface of pharmacies were positive for at least one cytotoxic molecule. A study (2) in one establishment between 2010 and 2016 showed during an increase of activity, an increase of staff exposure. Thus, an evaluation of the efficiency of surface cleaning-decontamination procedures is essential, insomuch as air samples are not relevant because molecules are not very volatile and processes are not very dispersive. In this work we present the results of surface measurements of two cytotoxic agents (5-fluorouracil (5-FU) and platinum (Pt)), from a French hospital which performs 7,000 preparations per year, under isolator.

Material and methods
After two mornings of preparation (25 preparations/day: 5-FU=6 prep / Pt=4 prep), the chosen areas were immediately wiped, according to a validated protocol using Kimtech wipes on an area of 0.01m². The non-planar surfaces (gloves and handles) were completely wiped. Between each sample, the sampler gloves were changed to avoid cross-contamination. For each zone, one wipe per molecule was necessary. After elution, Pt was assayed by ICP-MS (LOQ: 2.5 ng) and 5-FU by HPLC-UV (LOQ: 10 ng).

A total of 55 wipes were used for 28 areas (25 strategic areas and 3 pairs of gloves). 49 samples were found below the LOQ. The samples from the exit airlock were positive: the left side (5-FU: 0.17 µg et Pt: 2.9 ng) and the right side more strongly (5-FU: 0.36 µg et Pt: 10.2 ng), as well as the work surface of the double isolator (5-FU: 0.18 µg et Pt: 2.5 ng) considered as a positive control.

Samples have shown that the method used allows to identify the presence of these molecules (isolator work plan, airlock). The most used airlock was the most contaminated. Apart from these positive points, which correspond to sensitive points of contamination (work area, exit for non-over-wrapped bags), the decontamination procedures are correct. A next sampling campaign will take place in 2020 to continued monitoring and define if the improvements of the procedures have reduced the risk of contamination. The interest of biometrology should also be considered in addition to these surface samples.


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