CAR-T: luces y sombras / CAR-T: lights and shades

La terapia celular adoptiva está revolucionando el panorama de la terapéutica actual. La gestión de los medicamentos CAR-T supone un reto para el sistema nacional de salud (SNS), pues se trata de medicamentos complejos de un elevado impacto sanitario. En esta línea, la elaboración de protocolos fármaco-clínicos con criterios claramente definidos ayudará a un correcto posicionamiento y selección de los pacientes candidatos a estas terapias. Así mismo, la administración de estos fármacos debe realizarse en centros previamente seleccionados y cualificados para tal fin, garantizando la equidad en el acceso. Por otro lado, es prioritario un abordaje multidisciplinar de todos los pacientes que sean tratados con las terapias CAR-T. Finalmente es fundamental la evaluación y el registro constante de resultados, los cuales contribuirán a determinar el beneficio real de la terapia, reclamando la necesidad de precios equitativos para garantizar la sostenibilidad del SNS y el acceso a los pacientes previamente seleccionados

Adoptive cell therapy is revolutionizing the current therapeutic landscape. The management of CAR-T drugs is a challenge for The National Health System (NHS), as they are complex drugs with high impact on health. This way, the development of clinical pharmaceutical protocols with clearly defined criteria, will help in correct positioning and selection of patients candidates for these therapies. Likewise, administration of these drugs must be carried out in centers previously selected and qualified for this purpose, guaranteeing equity of access. On the other hand, a multidisciplinary approach of all patients treated with CAR-T therapies is a priority. Finally, the assessment and the constant result recording are essencial, since they will contribute to determining the real benefit of these therapies, claiming the need for equitable prices, guaranteeing the sustainability of the NHS and the access of previously selected patients to them

[A project for the implementation of a unit-dose drug dispensation system in an intensive care unit]. / Proyecto de implantación del sistema de distribución de medicamentos en dosis unitarias en una unidad de cuidados intensivos.

OBJECTIVE: To describe the implementation of a unitary dose drug dispensation system (UDDDS) with computerized medical orders in an intensive care unit (ICU) including 10 multi-purpose offices, and to obtain a medication error index as an indicator of the process quality. METHOD: A UDDDS with computerized medical orders for intensive care was defined. By consensus among nurses, intensivists and pharmacists, the administration of high-risk drugs by perfusion or through a gastric tube was protocolized, and computerized medical orders were adapted to ICU dynamics, with both fluid therapy and enteral and parenteral nutrition becoming fully integrated. A prospective observational 8-month study with 15 cross-sectional time points was performed to estimate the overall error index and mean error per drug use process stage. The error index is estimated by dividing the number of errors into error opportunities, and is expressed as a percentage. RESULTS: Computerized medical orders favored compliance with consensus protocols defined in software programs at the pharmacy department, even though the degree of adhesion degree was not quantitized. They also allowed a validation of all medical prescriptions by a pharmacist before dispensation. The total number of errors detected during the study period was 86. Error opportunities were 26,695, and the overall error index was 0.32%. During the study an error occurred every 312.5 error opportunities.

Proyecto de implantación del sistema de distribución de medicamentos en dosis unitarias en una unidad de cuidados intensivos / A project for the implementation of a unit-dose drug dispensation system in an intensive care unit

Objetivo: Describir la implantación del sistema de distribuciónde medicamentos en dosis unitarias (SDMDU) con orden médicainformatizada en una unidad de cuidados intensivos (UCI) dotadade 10 boxes de atención polivalente y obtener el índice de errorde medicación como indicador de la calidad del proceso.Método: Se definió el SDMDU con orden médica informatizadaa utilizar en cuidados intensivos. Se protocolizó, por consenso,entre personal de enfermería, intensivistas y farmacéuticos laadministración de las perfusiones de medicamentos de riesgo ypor sonda nasogástrica y se adaptó la orden médica informatizadaal dinamismo de una UCI, integrando tanto la fluidoterapia comola nutrición enteral y parenteral.Se realizó un estudio observacional prospectivo, durante ochomeses, con 15 cortes transversales para calcular el índice de errorglobal y el error medio por etapa del proceso de utilización demedicamentos. El índice de error se calcula dividiendo el númerode errores entre las oportunidades de error, expresado en tantopor ciento.Resultados: La orden médica informatizada favoreció el cumplimientode los protocolos consensuados, definidos en el aplicativoinformático del servicio de farmacia, aunque no se cuantificó elgrado de adhesión. También permitió la validación de todas lasprescripciones médicas por un farmacéutico antes de su dispensación.El número total de errores detectados en el periodo de estudiofue de 86. Las oportunidades de error fueron 26.695 y elíndice de error global fue de 0,32%. Durante el estudio se cometióun error por cada 312,5 oportunidades de error

Objective: To describe the implementation of a unitary dosedrug dispensation system (UDDDS) with computerized medicalorders in an intensive care unit (ICU) including 10 multi-purposeoffices, and to obtain a medication error index as an indicator ofthe process quality.Method: A UDDDS with computerized medical orders forintensive care was defined. By consensus among nurses, intensivistsand pharmacists, the administration of high-risk drugs byperfusion or through a gastric tube was protocolized, and computerizedmedical orders were adapted to ICU dynamics, with bothfluid therapy and enteral and parenteral nutrition becoming fullyintegrated.A prospective observational 8-month study with 15 cross-sectionaltime points was performed to estimate the overall errorindex and mean error per drug use process stage. The error indexis estimated by dividing the number of errors into error opportunities,and is expressed as a percentage.Results: Computerized medical orders favored compliancewith consensus protocols defined in software programs at thepharmacy department, even though the degree of adhesiondegree was not quantitized. They also allowed a validation of allmedical prescriptions by a pharmacist before dispensation.The total number of errors detected during the study periodwas 86. Error opportunities were 26,695, and the overall errorindex was 0.32%. During the study an error occurred every 312.5error opportunities