Resumen de Logistics of the car-t medicines in a hospital pharmacy service
Javier García Pellicer, María José Ruiz Caldes, José Luis Poveda Andrés
Introduction: CAR-T medicines have a high economic and health impact. Their main difference regarding other medications is that owing to their nature and to maintain their therapeutic efficacy, they should be stored in cryopreservation conditions (-180ºC) in liquid nitrogen in vapor phase, an exceptional circumstance for hospital pharmacy services (HPS), which requires having new structural elements to achieve it, besides they originate new safety requirements, applicable to both staff and medicine. On the other hand, public funding through a risk-sharing model implies that HPS and the center should be certified by the manufacturing laboratories in order to use these medicines.
Objective: Determine and implement structural and safety requisites in HPS to execute the logistics processes of the industrially manufactured CAR-T medicines, currently availablle in Spain.
Method: Create Advanced Therapies Unit in the HPS by establishing the necessary requisites for its accreditation, development of the structure and safety conditions needed for the cryopreservation of CAR-T medicines, certification of the unit by the manufacturing laboratories and the training of the personnel involved.
Results: Advanced Therapies Unit of the HPS centered on structure, safety, and post-administration monitoring processes. Structural elements include liquid nitrogen tank in vapor phase for cryopreservation, the ranger for supplying liquid nitrogen, dry-shipper for transporting the medicine to the clinical services, and racks for storing the medicines in the tank. For environmental health and safety, fixed and individual alarms for detecting anoxia, temperature sensors of the nitrogen tank, dry-shipper with personal protection equipment. Adjusted logistics processes and post-administration monitoring of these medicines.
Conclusions: An HPS can and should implement the logistics of CAR-T medicines in its healthcare practice because it is their legally establlished responsibilityand it is more efficient to centralize setups in the HPS than for each Clinical Service handling CAR-T medicines to have its own, and even though specific safety conditions and structures are needed, it is the same standard logistics process as for other medicines. Thus, it is about regulating their logistics.
On the other hand, the participation of the HPS should not be limited to logistical aspects and should cover the entire patient care process in a multidisciplinary manner with the rest of the healthcare team
