Evaluation of the chemical contamination by antineoplastic drugs in a Chemotherapy Reconstitution Unit (URC) in a French hospital

Objective
Antineoplastic drugs are classified as dangerous drugs¹. They represent a risk both for patients and healthcare professionals, from preparation to administration. The objective of this study is to evaluate the chemical surface contamination of our URC.

Materials/Methods
Sampling kits are provided to CYTOXLAB ^® (Switzerland). They can detect 25 antineoplastic drugsamong the most used in hospital pharmacy. We carried out 2 series of 15 samples sites in the whole unit: inside and outside the isolators (375 results/series). These samples were sent for analysis using a validated liquid chromatography-mass spectrometry method. The results are expressed in quantity (ng) per wipe for each sample. First series were realized in worst case conditions: after production and before cleaning. Different parts of the URC were analysed: isolators, phone, liberation;s bench, secondary packaging of bags, transport devices. For the second series, we focused on positive sites: inside isolators and transport devices, before and after cleaning.

Results/Discussion
For the first series, 46% (7/15) of samples sites were positives for at least one anti-cancer molecule corresponding to 5.1 % (19/375) of positive samples for a total of 533.4ng. Isolators represented a majority of positive samples: 15/19. The others (4/19) were the transport devices (2/19), the phone and the floor of the storage room. As corrective actions, we have made the entire staff aware of the
importance of monitoring this exposure: dressing procedure, the use of a surfactant detergent, rhythm of cleaning transport devices. For the 2^nd series, we also observed 5.1% of positive samples for a total of 67.2ng. We focused on inside isolators and we observed 4% (22.5ng) of positive samples before cleaning versus 2.8% (14.8ng) after cleaning. A diminution of the chemical contamination has been observed on the transport devices (2/19 versus 1/19). The 2^nd series allowed to evaluate the effectiveness of corrective actions taken. The bin handle of the cytotoxic isolator represents a hot spot of contamination (403.5ng for the 1^st series and 19.1ng for the 2^nd series). It is explained by the difficulty reaching it for decontamination. This work permits to have a global vision of the URC chemical contamination in real conditions and validate corrective actions. The surface contamination was mainly found in the production equipment and then spread in the environment.

Conclusion
There are not threshold values for chemical contamination in the baselines making interpretation difficult. The positive samples proportion remains very low. It seems impossible to have values equal to 0 but the goal is to aim toward 0 by an annual evaluation. To continue this study, we could evaluate the chemical contamination in the oncology day treatment unit and think about choosing isolators easier to decontaminate.

1. Centers for Disease Control and Prevention. Hazardous Drugs: Draft NIOSH List of Hazardous Drugs in Healthcare Settings, 2020; Procedures; and Risk Management Information

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