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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
Published on: December 11, 2016
Vigilancia posterior a la comercialización y reacciones adversas a los medicamentos: perspectivas actuales y
1Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass 02115, USA.
JAMA
|March 10, 1999
Resumen
Los sistemas de notificación espontánea identifican efectivamente las reacciones adversas raras a los medicamentos. Sin embargo, luchan con la detección de ADRs que ocurren mucho después del uso de drogas o eventos comunes en poblaciones no expuestas, lo que requiere métodos de evaluación complementarios.
Área de la Ciencia:
- Farmacovigilancia y farmacovigilancia también.
- Evaluación de la seguridad de las drogas.
Sus antecedentes:
- Los sistemas de notificación espontánea (por ejemplo, MEDWATCH) son cruciales para la identificación de reacciones adversas raras a los medicamentos.
- Es posible que estos sistemas no detecten de manera confiable las ERA con aparición tardía o aquellas que aumentan el riesgo de eventos comunes en individuos no expuestos.
Objetivo del estudio:
- Para resaltar las limitaciones de los sistemas de notificación espontánea en la detección de REA.
- Hacer hincapié en la necesidad de métodos complementarios para la evaluación integral de la seguridad de los medicamentos.
Principales métodos:
- El resumen analiza las limitaciones inherentes de los sistemas de informes espontáneos.
- Propone el desarrollo de métodos que utilicen ensayos clínicos, registros médicos y bases de datos electrónicas de salud.
Principales resultados:
- Los informes espontáneos son insuficientes para la evaluación de la causalidad de eventos adversos retrasados o comunes.
- Los métodos actuales dejan sin detectar RAE significativas y sin cuestionar asociaciones espurias.
Conclusiones:
- Los métodos de evaluación complementarios son esenciales para aumentar los sistemas de informes espontáneos.
- La detección robusta de ADR requiere un enfoque multifacético más allá de la vigilancia pasiva.
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