RESUMO
In 2009, with the implementation of the National Hospital Pharmacy Model, Mexico began regulating single-dose drugs. The repackaging of oral drugs is fundamental and critical and should be standardized by Mexican health legislation to enable quality drugs to be dispensed. Data is required on stability, compatibility, drug interactions, containers, and repackaging methods, in order to establish a new expiration date. The literature on health regulations applicable to repackaging was analyzed, revealing major conceptual imprecisions since there is no legislation in Mexico that regulates repackaging; rather, everything is carried out according to pharmacists' recommendations and criteria. The conclusion is that the regulations need to be rewritten to establish minimum single-dose oral drug criteria for dispensing hospitals-regulations that cover infrastructure, equipment, and professionals complying with good practices in oral drug repackaging. A proposal is offered to implement an official Mexican standard that regulates single-dose repackaging and unifies concepts, criteria, and means of verification, while the pharmaceutical industry would be responsible for the technology and resources for single-dose drug packaging designed for the health sector.
Assuntos
Embalagem de Medicamentos/legislação & jurisprudência , Administração Oral , Humanos , MéxicoRESUMO
RESUMEN En 2009, con la implementación del Modelo Nacional de Farmacia Hospitalaria en México, se establece una integración de la disposición de medicamentos en dosis unitaria, donde el reenvasado de medicamentos orales es un punto crítico y medular que debe ser normalizado y estandarizado por la legislación sanitaria mexicana, de tal forma que permita la dispensación de un medicamento de calidad. Para ello, es necesario conocer los datos de estabilidad, compatibilidad e interacciones entre medicamentos y envases utilizados, así como considerar las técnicas con las que se efectúa el reenvasado, con el objetivo de establecer la nueva fecha de caducidad. Se realizó un análisis bibliográfico de la regulación sanitaria en materia de reenvasado, el cual revela que existen imprecisiones conceptuales importantes, debido a que no existe legislación que regule esta actividad en México: todo se desempeña en un marco de recomendaciones y criterios del farmacéutico. Se concluye que la ley debe ser reformada para establecer los criterios mínimos que deben cumplir los hospitales que implementen el sistema de dosis unitaria de medicamentos orales, en materia de infraestructura, equipamiento y profesionales para el cumplimiento de las buenas prácticas en el reenvasado de medicamentos orales. Para ello, se propone implementar una norma oficial mexicana que regule el proceso de reenvasado en dosis unitaria en el que la autoridad sanitaria unifique conceptos, criterios e instrumentos de verificación, mientras la industria farmacéutica desarrolla la tecnología y recursos para el acondicionamiento en dosis unitaria de los medicamentos con formas farmacéuticas orales dirigidos al sector de la salud.
ABSTRACT In 2009, with the implementation of the National Hospital Pharmacy Model, Mexico began regulating single-dose drugs. The repackaging of oral drugs is fundamental and critical and should be standardized by Mexican health legislation to enable quality drugs to be dispensed. Data is required on stability, compatibility, drug interactions, containers, and repackaging methods, in order to establish a new expiration date. The literature on health regulations applicable to repackaging was analyzed, revealing major conceptual imprecisions since there is no legislation in Mexico that regulates repackaging; rather, everything is carried out according to pharmacists’ recommendations and criteria. The conclusion is that the regulations need to be rewritten to establish minimum single-dose oral drug criteria for dispensing hospitals—regulations that cover infrastructure, equipment, and professionals complying with good practices in oral drug repackaging. A proposal is offered to implement an official Mexican standard that regulates single-dose repackaging and unifies concepts, criteria, and means of verification, while the pharmaceutical industry would be responsible for the technology and resources for single-dose drug packaging designed for the health sector.