European Association of Hospital Pharmacists (EAHP) guidance on the pharmacy handling of in vivo gene therapy medicinal products.

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.

Hospital pharmacist's roles and responsibilities with CAR-T medicines.

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.

[Recommendations for the preparation and administration of antituberculosis drugs in children. Second phase of the Magistral Project of the Spanish Network for the Study of Paediatric Tuberculosis (pTBred)]. / Recomendaciones para la elaboración y administración de fármacos antituberculosos en niños. Segunda fase del Proyecto Magistral de la Red Española de Estudio de la Tuberculosis Pediátrica (pTBred).

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.

Funciones y responsabilidades del farmacéutico de hospital con los medicamentos CAR-T / Hospital pharmacist's roles and responsibilities with CAR-T medicines

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

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

Recomendaciones para la elaboración y administración de fármacos antituberculosos en niños. Segunda fase del Proyecto Magistral de la Red Española de Estudio de la Tuberculosis Pediátrica (pTBred) / Recommendations for the preparation and administration of antituberculosis drugs in children. Second phase of the Magistral Project of the Spanish Network for the Study of Paediatric Tuberculosis (pTBred)

La Red Española de Estudio de la Tuberculosis Pediátrica ha evidenciado una falta de consenso nacional en la administración de antituberculosos en niños, propiciada por la escasez de presentaciones pediátricas específicas. Es prioritario homogeneizar el tratamiento de la tuberculosis en niños en nuestro país. Un grupo de expertos españoles en tuberculosis infantil y en el área de medicamentos pediátricos proponen una actuación conjunta, con la finalidad de mejorar esta situación en nuestro medio. Para ello se constituye un Grupo de Trabajo, liderado por pTBred, en el que participan otras 5 sociedades e instituciones científicas. Se proponen las siguientes fórmulas magistrales en forma de suspensión o solución oral para el tratamiento de la tuberculosis en niños: isoniacida 50mg/ml, pirazinamida 100mg/ml y etambutol 50mg/ml. Se especifican materias primas, periodo de validez y condiciones de conservación y administración. Se establecen recomendaciones para el uso de fármacos combinados a dosis fijas. Si no se consigue la dosis apropiada mediante fármacos combinados a dosis fijas, y no se dispone de fórmula magistral, se recomienda la administración mediante comprimidos triturados. El adecuado cumplimiento terapéutico y la administración de dosis óptimas de los fármacos antituberculosos constituyen pilares fundamentales en el control y erradicación de la enfermedad. La oportunidad de disponer de este documento multidisciplinar en España favorecerá el correcto tratamiento de la tuberculosis pediátrica, y será una guía útil para todos los pediatras y farmacéuticos que lo precisen

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