Reassessment of practices around chemical contamination associated with the chemotherapy production activity: application of fluorescein tests
Department of Pharmacy, Institut Curie, Paris, France
In 2018, we carried out a wipe sampling campaign from the whole injectable chemotherapy process of our 2 hospital sites allowing trace quantification of cyclophosphamide by a validated LC-MS/MS method. In our production units, contamination of the vials and final products (external surface and injection sites) had been quantified in the order of ng. In light of these results, we wanted to reassess our good preparation practices and specifically the correct use of compresses in order to limit the risk of occupational exposure related to the contamination of our preparations using a visual method with a strong educational impact.
Pharmacy technicians from our unit formed a working group to re-discuss the risky steps related to the decontamination of anti-cancer vials and the production of chemotherapy preparation. These different processes were then simulated by 3 pharmacy technicians using reconditioned fluorescein solutions in a vial (with flip-off) and by comparing different scenarios. Macroscopic contamination of vials, gloves, absorbent fields and compresses was carried out visually using a UV lamp.
The following processes were studied by comparing the practices: (1) Decontamination of the vials with removal of the flip-off; (2) Removal of the flip-off; (3) Decontamination of the vial collection site; (4) Installation of the spike® (=bidirectional valve for multiple samples); (5) Installation of an air intake; (6) Reconstitution with spike® or needle; (7) Sampling with a spike® / spiros® (=closed needle free system for safe transfer) or with a needle; (8) Injection into the bag; (9) Use of waste boxes. The steps most at risk of environmental contamination were: handling the flip-off, handling with the needle, disconnecting the various devices and disposal of waste.
This study was presented to the pharmacy department and new recommendations were proposed.
Thus, the decontamination of the vials will be carried out under a laminar flow hood (1 wipe / bottle) by removing the flip-off. The spike® can be insert without compresses. The use of the compress is imperative for handling with the needle (insertion and withdrawal) and for all disconnections, taking care to wipe the spike®, spiros® and injection sites. The removal of compresses should be done with precaution, the regular renewal of the needle boxes, the recapping of spiros® and needles should also be promoted while respecting the safety instructions. The impact of these various recommendations was assessed during our annual monitoring project of environmental contamination demonstrating the possibility of achieving non-detectable to non-quantifiable levels on the external surface of the vials and preparations.