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El proyecto de investigación sobre eventos e informes adversos de drogas (RADAR) es un proyecto de investigación
Charles L Bennett1, Jonathan R Nebeker, E Allison Lyons
1Jesse Brown VA Medical Center/Mid-West Center for Health Services and Policy Research, Chicago, Ill 60611, USA. cbenne@northwestern.edu
JAMA
|May 5, 2005
Resumen
El programa de Investigación sobre eventos e informes adversos de medicamentos (RADAR) identificó 16 reacciones adversas graves a los medicamentos, mejorando la seguridad del paciente. Esta vigilancia basada clínicamente complementa los sistemas existentes para un mejor monitoreo de la seguridad de los medicamentos.
Área de la Ciencia:
- Farmacovigilancia y farmacovigilancia también.
- La investigación clínica es la investigación clínica.
- La seguridad del paciente.
Sus antecedentes:
- Establecido en 1998, el programa Research on Adverse Drug Events And Reports (RADAR) es una iniciativa de vigilancia clínica después de la comercialización.
- Investiga y difunde sistemáticamente información sobre reacciones adversas graves y no reconocidas previamente a fármacos y dispositivos (RAD).
Objetivo del estudio:
- Describir la estructura, las operaciones y los hallazgos iniciales del proyecto RADAR.
- Para describir los esfuerzos de difusión que involucran a los proveedores farmacéuticos y la FDA.
Principales métodos:
- Investigación basada en hipótesis de eventos clínicos graves e inesperados.
- Recopilación de datos de consultas médicas, ensayos clínicos, informes de casos, bases de datos de la FDA y cifras de ventas.
- Derivación de las estimaciones de incidencia y soporte de laboratorio para las hipótesis.
Principales resultados:
- RADAR identificó 16 tipos de reacciones adversas graves en 1699 pacientes, con 169 (10%) muertes.
- Múltiples fuentes de datos contribuyeron a la identificación de casos y a la estimación de la incidencia.
- La difusión incluyó prospectos revisados, cartas de "querido doctor" y artículos revisados por pares.
Conclusiones:
- Se ha desarrollado un enfoque novedoso, clínicamente basado y basado en hipótesis para la vigilancia posterior a la comercialización.
- Este método puede complementar los sistemas de vigilancia regulatoria existentes.
- El programa RADAR tiene el potencial de mejorar significativamente la seguridad del paciente.
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