Category: Fellows Posters
Chimeric antigen receptor (CAR) T cell therapies contain genetically modified autologous T lymphocytes that are specifically directed towards a tumor antigen. CAR-T cell-based therapies are advanced therapy medicinal products (ATMP) that are considered as drugs by the European regulatory authorities. In the year 2018, tisagenlecleucel and axicabtagene ciloleucel gained the approval from the European Medicines Agency. The aim of this work is to describe the role of the advanced-therapies pharmacists and the hospital pharmacy in an institutional CAR-T cell therapy program in a public hospital in Spain to ensure a safe and efficient use of these drugs.
Our CAR-T cell Therapy Committee is a multidisciplinary board formed by members of the following departments: hematology, oncology, pediatric oncohematology, hospital pharmacy, neurology, critical care medicine and immunology. A total of four hospital pharmacist with different backgrounds, such as clinical oncohematology, clinical trials and sterile compounding, participate in the Committee. At first, the Committee reviewed the documentation available in relation to CAR-T cell therapy requirements in order to develop the appropriate department-focused procedures. This documentation included: the national and regional action plans for ATMPs in the public health system and the risk management plans for each drug. In the first phase: the advanced-therapies pharmacists developed a draft of the pharmacy procedure that was presented to the Committee. In the second phase: the different hospital units underwent the processes for center qualification. In the third phase: after the qualification process, new needs were identified and answered in a new version of the protocol, which was presented and approved in the Committee. The protocol is valid for both marketed and investigational drugs.
This procedure is fully implemented and includes the participation of the advanced-therapies pharmacists in the following steps:
The establishment of a CAR-T cell therapy program requires the commitment of several departments and units along the institution. A multidisciplinary team is needed for the successful delivery of these therapies to patients. Traceability, from the apheresis cells to drug administration, was considered a key element by the pharmacists to guarantee the safety of patients treated with CAR-T cell drugs. In a public health system with multiple stakeholders, hospital pharmacists play an important role in the access and procurement of CAR-T therapies.