Today, the medicine has largely abandoned the traditional chemical-physical characteristics of a simple molecule, sometimes assuming different forms as those of a cell: this requires a different management approach. The Chimeric Antigen Receptor T cells (CAR-T) are considered advanced therapy medicinal products and represent the last frontier of immunotherapy in oncology. The main objective of this work is the implementation of the CAR-T product management operational instruction by Hospital Pharmacy in collaboration with Transfusion Medicine. At the same time, a second objective has been defined: an analysis of the first case study of patients treated at the first Veneto’s Center with the aim of evaluating the clinical impact of this therapy. Materials and methods. For the realization of the main objective of this work the organizational, structural and technological characteristics of the cryobiological room of Hospital were analyzed and were used information programs such as the computerized system of prescription and administration and the warehouse management system. For the realization of the second objective, the information has been acquired through the NFS management system with the combined consultation of the AIFA monitoring register. Results. Starting from a pathway already defined for the management of an apheretic cell product, a pathway has been prepared that applies as a management model for the advanced cell therapy product obtained from lymphocytoapheresis or other cellular product autologous or allogeneic, genetically modified, classified as “drug” and administered to the patient. The data obtained from the analysis of the first infused patients shows that 38% went through complete remission of the disease while 31% died, showing a variability in the response to treatment. Conclusions. The increasing number of new cell-based therapies may require significant changes in the organization of Hospital Pharmacy, in terms of space and equipment. Faced with this therapeutic innovation, the hospital pharmacist is not excluded but is called to develop new skills and make its contribution with specific training as a health professional within multidisciplinary teams involved in the complete and safe management of medicinal products advanced therapy.

Modello di gestione dei prodotti medicinali di terapia cellulare avanzata CAR-T

Realdon N.
2024-01-01

Abstract

Today, the medicine has largely abandoned the traditional chemical-physical characteristics of a simple molecule, sometimes assuming different forms as those of a cell: this requires a different management approach. The Chimeric Antigen Receptor T cells (CAR-T) are considered advanced therapy medicinal products and represent the last frontier of immunotherapy in oncology. The main objective of this work is the implementation of the CAR-T product management operational instruction by Hospital Pharmacy in collaboration with Transfusion Medicine. At the same time, a second objective has been defined: an analysis of the first case study of patients treated at the first Veneto’s Center with the aim of evaluating the clinical impact of this therapy. Materials and methods. For the realization of the main objective of this work the organizational, structural and technological characteristics of the cryobiological room of Hospital were analyzed and were used information programs such as the computerized system of prescription and administration and the warehouse management system. For the realization of the second objective, the information has been acquired through the NFS management system with the combined consultation of the AIFA monitoring register. Results. Starting from a pathway already defined for the management of an apheretic cell product, a pathway has been prepared that applies as a management model for the advanced cell therapy product obtained from lymphocytoapheresis or other cellular product autologous or allogeneic, genetically modified, classified as “drug” and administered to the patient. The data obtained from the analysis of the first infused patients shows that 38% went through complete remission of the disease while 31% died, showing a variability in the response to treatment. Conclusions. The increasing number of new cell-based therapies may require significant changes in the organization of Hospital Pharmacy, in terms of space and equipment. Faced with this therapeutic innovation, the hospital pharmacist is not excluded but is called to develop new skills and make its contribution with specific training as a health professional within multidisciplinary teams involved in the complete and safe management of medicinal products advanced therapy.
2024
Immunotherapy, CAR-T, advanced therapy.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11562/1165267
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