Implementation of a training course on risk management for handling cytotoxics in collaboration with a Qualiopi-certified simulation center

4 October 2023

A. Delavau, E. Bernikier, C. Nowak, L. Danguy Des Déserts, I. Baudin
Centre Hospitalier d’Angoulême, France

The preparation of cytotoxic injectable drugs is a high-risk activity, for which the 2022 Good Preparation Practices specify that training (initial and ongoing) is required for authorization to carry out this activity.
The aim has been to create a Qualiopi training course in partnership with a healthcare simulation center, for the ongoing training of compounders in this activity.

For this training, we reused a refurbished single-user isolator, relabelled drug vials (lyophilisate, ready-to-use), printed out erroneous manufacturing sheets, and used bags and medical devices from the establishment’s reconstitution unit. The simulation center provided us with the equipment we needed to carry out the scenarios and debrief (classroom, stage cameras, simulation room...).

The training day took place in our simulation center, and was organized into 3 sessions of 2 hours each (theoretical review and 2 practical workshops).
In order to assess the impact of the training, participants completed a 40-items questionnaire before and after.
During the theoretical session, the participants were reminded of the theory and asked open-ended questions in the form of a metaplan.
For the practical workshops, the first scenario reproduced the activity of a cytotoxic reconstitution unit (preparation of trays with picking of vials and medical devices according to a manufacturing sheet, passage through the isolator, handling (10 preparations were carried out)). The second workshop dealt with a broken vial scenario. These 2 practical workshops were filmed for debriefing purposes.
This training course was tested by 4 preparers with different backgrounds and locations. The results of the pre-test were 6.11/10 and the post-test 7.57/10. 2 of the 10 errors in the isolator scenarios were not found by the participants. They were reviewed and corrected by viewing. The bottle-breaking scenario enabled participants to practice on 3 types of situation (lyophilisate, liquid and on an agent’s clothing). 100% of participants said they were satisfied with the survey. The handling part in the isolator was highly appreciated, as it simulated real-life conditions. 2 of the participants reported a desire to cover more theoretical points (reminders about the premises, "rules" for handling in a microbiological safety post).

Participants appear to have been satisfied with the course. For the organizers, it demonstrated both its robustness and areas for improvement. A video of the course has been produced to promote it, and an application has been submitted for the course to be certified as Continuous Professional Development.

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