What organisation is needed to ensure the safe preparation of on-call chemotherapy?

Sonia Martelli1, Emilie Seguin1, Antoine Bruneau1 Clara Balouzet2, Anne-Pauline Thivilliers3,
Marion Jobard4, Marie-Laure Brandely-Piat1, Rui Batista1,2,3,4 1-Unité de Préparations Stériles Ophtalmologiques et Oncologiques, 2- Unité de Radiopharmacie, 3- Unité de Nutrition Parentérale Pédiatrique, 4- Unité d’Assurance Qualité, Service de Pharmacie, GH Centre Université de Paris, AP-HP Hôpital Cochin, 27 rue du faubourg St Jacques, 75014 Paris, France

Most Centralized Preparation Units (CPUs) encounters difficulties due to chemotherapy requests outside their opening hours. The causes are varied and include clinical emergencies (macrophagic activation syndrom), drugs instability or organisational issues (late prescriptions, storage error of preparations). In parallel to the work that needs be done to eliminate unjustified causes, the CPUs must also find a solution for the management of residual cases. The objective of this work was to set up an organisation to guarantee an equivalent level of safety for on-call preparations to that of preparations made during opening hours.

Materials and Methods
An inventory of on-call chemotherapy preparations requests since 2016 has been carried out. The analysis of the chemotherapy preparation process highlighted the critical points. For each critical step, an organisation allowing their control has been chosen and implemented for the on-call period from 2021.

From 2016 to 2020, an average of 16 preparations have been made each year on Sundays or bank holidays. The analysis of on-call requests shows that these are mostly anticipated (89% of the 79 preparations). A pool of 7 senior pharmacists ensures the on-call preparations. As senior pharmacist, they are empowered if necessary to pharmaceutically validate prescriptions as well as the chemotherapy preparation. Regarding the critical step of release control : either the preparation can be controlled by the QCRx® machine (Icônes services, France) and the pharmacist ensures himself the analytical control, or the preparation cannot be analytically controlled and a second senior pharmacist of the pool connects remotely to the cameras which film the workplans via a secured connection and directly controls the manipulation performed by his colleague. The video sequence is automatically recorded and can therefore be reviewed if necessary. In the first half of 2021, this case occurred for 2 preparations (1 IV azacitidine bag and 1 preparation of a new drug stable for 4 hours) among the 5 preparations made on-call. In both cases, the preparation could be controlled remotely via the camera.

Our objective was to ensure the safety of preparations made on-call. The use of senior pharmaceutical staff avoids the need to train pharmacy residents or to call on the nurses on the wards. The QCRx® release control coupled with the presence of remotely accessible cameras on our isolators has enabled us to ensure 100% control of preparations without requiring the presence of a second senior pharmacist or the use of the on-call pharmacist resident. However, we must remain vigilant about the control of on-call requests because the on-call pharmacist is a lone worker, which in itself constitutes a risk.

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