RESUMO
Gene therapy is becoming increasingly prevalent, with new gene therapy medicinal products (GTMPs) being approved for use every year. Hospital pharmacists are expected to prepare and dispense these products, but there is substantial heterogeneity in the availability of up-to-date, practical guidance at a national level in Europe. Many institutions have no or very limited experience in handling GTMPs. As such, there is a need for updated, practical guidance to aid hospital pharmacy teams in developing institutional standard operating procedures (SOPs) for the safe handling of GTMPs across the entire workflow. Here, we present the European Association of Hospital Pharmacists' updated guidance on the handling of GTMPs, developed by a team of recognised experts from around Europe. Each aspect of the GTMP handling process is addressed, including receipt and storage, dispensing and reconstitution, transportation, administration, waste disposal, decontamination of spills and accidental exposure. A series of figures are provided to aid the development of practical workflows. This guidance document is intended as a framework to help develop institutional SOPs and should always be used in conjunction with local regulations.
Assuntos
Terapia Genética , Farmacêuticos , Serviço de Farmácia Hospitalar , Serviço de Farmácia Hospitalar/normas , Serviço de Farmácia Hospitalar/métodos , Humanos , Farmacêuticos/normas , Europa (Continente) , Terapia Genética/métodos , Terapia Genética/normas , Sociedades Farmacêuticas/normasRESUMO
The development and commercialization of cell therapy drugs with chimeric antigen receptor T cells (CAR-T) represent a new challenge for Spain's hospital pharmacy. The aim of this article is to review the key aspects of these medicines and to describe the oncohematological pharmacist's role within the multidisciplinary clinical team. This includes the different phases in the transversal process that involves a therapy with CAR-T medicines, ranging from indication to short and long term follow-up of patients treated with this type of therapy, and emphasizing on the management of its main adverse effects. CAR-T therapy offers the hospital pharmacist the opportunity to work closely with the rest of the clinical professionals involved in the process, allowing their contribution to the development of procedures, clinical practice guidelines of global approach, and establishing starting points when facing future therapies of similar complexity -and even improving previously established basic processes-.
El desarrollo y la comercialización de medicamentos de terapia celular con células T con receptor de antígeno quimérico (CAR-T) suponen un nuevo reto para la farmacia hospitalaria en España. El objetivo de este artículo es revisar los aspectos clave de estos medicamentos y describir el papel del farmacéutico oncohematológico dentro del equipo clínico multidisciplinar en las diferentes fases del proceso transversal que implica el tratamiento con medicamentos CAR- T, desde la indicación hasta el seguimiento a corto y largo plazo de los pacientes tratados con este tipo de terapias, con una importante mención al manejo de sus principales efectos adversos. La terapia tipo CAR-T ofrece al farmacéutico hospitalario la oportunidad de trabajar en estrecha colaboración con el resto de los profesionales clínicos implicados en el proceso, permitiendo su contribución en el desarrollo de procedimientos, guías de práctica clínica de abordaje global y estableciendo puntos de partida para afrontar tratamientos futuros de complejidad similar e incluso mejorar procesos base anteriormente establecidos.
Assuntos
Imunoterapia Adotiva/métodos , Farmacêuticos , Serviço de Farmácia Hospitalar/organização & administração , Receptores de Antígenos Quiméricos , Humanos , Equipe de Assistência ao Paciente , EspanhaRESUMO
The Spanish Network for the Study of Paediatric Tuberculosis has shown a lack of national consensus on the treatment of tuberculosis in children, partly due to the unavailability of paediatric presentations of antituberculosis drugs. The harmonisation of tuberculosis treatment in children is a priority in Spain. A joint action is proposed by a group of Spanish experts in childhood tuberculosis and in the area of Paediatric Pharmacology. To this end, a pTBred-led workgroup of members from five scientific bodies has been created. Drug pharmaceutical compounding in oral suspensions or oral solutions are recommended as follows: isoniazid 50mg/mL, pyrazinamide 100mg/mL, and ethambutol 50mg/mL. Raw materials, period of validity, and storage conditions are specified. Recommendations for the use of fixed-dose combination drugs are also established. If oral solutions/suspensions or fixed-dose combination drugs are not appropriate, the use of crushed tablets is recommended. Adherence to treatment and optimal dosing of antituberculosis drugs are critical in the control and eradication of TB. This multidisciplinary document provides an opportunity to promote the appropriate treatment of paediatric tuberculosis in Spain, and should become a useful tool for paediatricians and pharmacists.