Rôle du pharmacien hospitalier dans le circuit d’une catégorie de Médicament de Thérapie Innovante : les lymphocytes T exprimant un Récepteur Chimérique à l’Antigène

Abstract

ROLE OF THE HOSPITAL PHARMACIST IN THE MANAGEMENT OF A CATEGORY OF ADVANCED THERAPY MEDICINAL PRODUCT: CHIMERIC ANTIGEN RECEPTOR T-CELLS: Chimeric Antigen Receptor T-cells (CART) belongs to a new class of medicine, Advanced Therapy Medicinal Product, such as define by the European Regulation 1394/2007, and more exactly to the category of gene therapy medicinal product. Their status of medicine, as well as genetically modified organisms, imposes a particular circuit at hospital while maintaining a way over the Hospital Pharmacy. The manipulation of genetically modified cells is not usual in pharmacy. It requires, besides the acquisition of new skills, a not insignificant reorganization of the teams and the rooms of the pharmacy as well as an adapted training of the staff. A good communication is essential between the various actors of the circuit. The hospital pharmacist plays a key role in the implementation of a circuit adapted to this new type of medicine. This article aims to identify the roles of the hospital pharmacist and more generally of the pharmacy in the management of CART. We shall detail the specificities of this type of medicine in every stage of the circuit and the adaptations necessary to realize to guarantee the quality and the safety of the treatment by CART. Beyond the implementation of the circuit in the hospital, the pharmacist has an important role to be played in the follow-up of the patients after administration in view of the complexity of the side effects and a certain role in the training of the teams to this new medicine. Cet article fait partie du numéro supplément Les cellules CAR-T : une révolution thérapeutique ? réalisé avec le soutien institutionnel des partenaires Gilead : Kite et Celgene.

Keywords: Chimeric Antigen Receptor T cells (CART); Circuit du médicament; Drug circuit; Gene therapy; Hospital pharmacist; Lymphocytes T exprimant un; Pharmacien hospitalier; Récepteur Chimérique à l’Antigène (CART); Thérapie génique.