Application of wipe samples to assess practices and limit the risk of occupational exposure to hazardous drugs in two hospitals: from vial receipt to drug administration

A. Acramel 1, A. Hurgon1, J. Fouque2, S. Huguet2, H. Bothorel-Maquart3, A. Laissus3, B. Marie3, M. Lafay1, M. Friou1, K Rezai2, O. Madar2, L. Escalup1 1 Département de Pharmacie, Institut Curie, Paris et Saint-Cloud, France
2 Département de Radio-pharmacologie, Institut Curie, Saint-Cloud, France
3 Département de Santé au travail, Institut Curie, Paris et Saint-Cloud, France

Goal

The aim of this study was to assess the risk of occupational exposure to hazardous drugs on the circuit of injectable chemotherapy using wipe samples and to compare the practices of two hospitals with a high compounding activity (83,000 preparations/year).

Methods

A wipe sampling procedure was designed to cover the whole chemotherapy process: reception area, storage, production, transport, administration and elimination. Samples were analyzed by a validated LC-MS/MS method allowing trace quantification of cyclophosphamide (limit of quantification (LOQ): 0.05 ng/cm2; limit of detection (LOD): 0.01 ng/cm2; wiping recovery yield: 87.5%). An observation of care practices on both sites was also carried out.

Results

A total of 389 samples were analyzed and 46% (n=179) were positive. In the production units, the drugs vials were contaminated before (range = [non-quantifiable (NQ)-106] ng) and after cleaning procedure ([NQ-92] ng), especially when the flip-off was removed during cleaning. The contamination found on manual preparations is operator-dependent: [non-detectable (ND)-404] ng on infusion bag surfaces; [37-4,861] ng on injection sites. For automated preparations, the average contamination was higher on infusion bag surfaces ([279-4,239] ng) and lower on injection sites ([49-880] ng). Contamination of the analytical control area was also highlighted. In the daily care unit, the contamination was located near the infusion area (armchairs, infusion stands, floor, and patient toilets) with disparities between the two sites: contamination on the floor was respectively [0.46-27.32] compare to [ND-0.18] ng/cm2. We did not detect contamination on the door handles or in the disposal areas.

Discussion-Conclusion

To evaluate the risk of exposure, critical areas were defined based on threshold values of contamination (Shierl et al., 2009). This study helped us to map the environmental contamination of our chemotherapy circuit. The variability of contamination observed between the two sites can be explained in part by the difference in routine practices, especially cleaning procedures. Compliance with recommendations, homogenization of the practices and the consolidation of decontamination measures decrease the risk of occupational exposure.

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