Estrategia de trabajo a seguir en Laboratorios Liorad para la farmacovigilancia desde la industria

Introduccion: la farmacovigilancia es una responsabilidad que comparten los medicos, la industria farmaceutica, las autoridades sanitarias y los pacientes. En Laboratorios Liorad no estaba definida la implementacion de esta actividad. Objetivo: establecer la estrategia de trabajo a seguir por la referida institucion para asumir la farmacovigilancia desde la industria. Metodos: se trazaron las estrategias siguientes: seleccionar una persona para asumir la actividad, definir el marco regulatorio que regiria esta, establecer como se llevaria a cabo el flujo de la informacion, definir el sistema documental para obtener evidencia documentada y valorar el diseno para realizar los estudios de poscomercializacion. Resultados: se definio un especialista del area de Investigacion, Desarrollo e Innovacion para la actividad de farmacovigilancia; asi como sus funciones de trabajo. El profesional designado recibio capacitacion en farmacovigilancia orientada a la industria. Se definio como marco regulatorio las normas que rigen esta accion en Cuba. Se confeccionaron, revisaron y aprobaron los documentos para facilitar la organizacion y dejar constancia del trabajo realizado. Por ultimo, como diseno fundamental para realizar los estudios de poscomercializacion se definio realizar la investigacion de eventos adversos raros e inesperados y la deteccion de aumentos en la incidencia de reacciones adversas conocidas. Conclusiones: al termino del trabajo existe una infraestructura organizativa en la empresa que permite asumir esta tarea desde la industria, lo que contribuira a detectar precozmente manifestaciones inesperadas que pudieran alterar el balance riesgo-beneficio de los medicamentos fabricados en Liorad durante su empleo(AU) Introduction: pharmacosurveillance is a shared responsibility of the physicians, the pharmaceutical industry, the health authorities and the patients. However, Liorad Laboratories had not defined the implementation of this procedure yet. Objective: to establish the working strategy to be followed by the institution to put pharmacosurveillance into practice at the industrial level. Method: the outlined strategies were the selection of a person to take on responsibility for pharmacosurveillance, the definition of the regulatory framework to rule the same, setting up of the information flow, definition of the documentary system to obtain documented evidence and assessment of the design of aftermarket studies. Results: one specialist from the research, development and innovation division was appointed to lead the pharmacosurveillance activity as well as his/her working functions were drafted. The appointed professional was trained in industry-oriented pharmacosurveillance. The regulatory framework was defined as the set of rules governing this activity at domestic level. The documents required for facilitating the organization of this activity and recording all the work done were finally drafted, reviewed and approved. Finally, it was decided that the fundamental design to carry out the aftermarket studies would be based on the research of adverse, unusual and unexpected events and the detection of rises in the incidence of known adverse reactions. Conclusions: once the work is finished, there is an organizational infrastructure that enables the company to take on this task since the industrial phase, which will contribute to early detect unexpected events that could alter the risk-benefit balance of medicinal products manufactured at Liorad Laboratories(AU)