Sistema Nacional de Farmacovigilancia
El Sistema Nacional de Farmacovigilancia se encarga de detectar, evaluar, comprender y prevenir efectos adversos derivados del uso de los medicamentos.
¿Por qué notificar al Sistema Nacional de Farmacovigilancia?
Cualquier notificación de reacciones adversas, aunque estas sean conocidas, puede contribuir a detectar problemas relacionados con el uso de los medicamentos.
Por esta razón, el Departamento de Farmacovigilancia de la ANMAT convoca a todos los profesionales de la salud, responsables de la industria farmacéutica y pacientes a notificar las sospechas de reacciones adversas y de fallas de calidad.
Es importante poner especial atención a:
- Las reacciones adversas graves de todos los medicamentos comercializados en el país. Se entiende por reacciones adversas graves las que amenacen la vida, provoquen hospitalización o la prolonguen, provoquen incapacidad o defectos congénitos, ocasionen la muerte.
- Las sospechas de reacciones adversas de los nuevos principios activos durante los primeros cinco años.
- Las interacciones con otros medicamentos, alcohol y alimentos.
¿Quiénes pueden notificar?
- Efectores periféricos: instituciones públicas y privadas de reconocida trayectoria académica o clínica. Entre ellos se encuentran los ministerios de Salud provinciales, colegios de profesionales, hospitales públicos y privados, universidades, obras sociales y asociaciones de profesionales.
- Profesionales independientes: profesionales del equipo de salud (médicos, farmacéuticos, enfermeros, odontólogos, etc.) pertenecientes a hospitales, clínicas, consultorios privados, farmacias privadas, consultorios odontológicos, etc., que detectan eventos adversos y comunican su hallazgo directamente al Departamento de Farmacovigilancia, contribuyendo al enriquecimiento de la base de datos nacional.
- Pacientes y familiares de pacientes: usuarios de medicamentos que en forma particular envían su notificación al Departamento de Farmacovigilancia.
- Industria farmacéutica: por Disposiciones 3870/1999 y 2438/2000, la industria farmacéutica se incorporó al sistema. Debe realizar las notificaciones de las reacciones adversas y otros eventos relacionados con sus productos según los plazos establecidos en la Disposición 5358/2012, entre otras obligaciones que la norma establece.
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