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Una intervención educativa para mejorar el informe médico de las reacciones adversas a los medicamentos: un ensayo

Adolfo Figueiras¹, Maria T Herdeiro, Jorge Polónia

¹Department of Preventive Medicine and Public Health, University of Santiago de Compostela, Spain, Portugal. adolfo.figueiras@usc.es

|September 7, 2006

Resumen

La difusión educativa mejoró significativamente la notificación por parte de los médicos de las reacciones adversas a los medicamentos (REA). Esta intervención específica mejoró la calidad y la cantidad de informes de ADR, cruciales para la vigilancia de la seguridad de los medicamentos después de la comercialización.

Área de la Ciencia:

Farmacovigilancia y seguridad de los medicamentos.
Servicios de salud Investigación Servicios de salud Investigación
Educación médica y educación médica.

Sus antecedentes:

Existen datos limitados sobre los efectos adversos de los medicamentos recién comercializados.
La subutilización por parte de los médicos de los sistemas de notificación voluntaria dificulta la vigilancia posterior a la comercialización.
Se necesitan estrategias efectivas para mejorar la notificación de las reacciones adversas a los medicamentos (RAA).

Objetivo del estudio:

Evaluar la efectividad de las visitas de divulgación educativa en la mejora de los informes de REA de los médicos.
Evaluar el impacto de la educación dirigida en la calidad de las ERA notificadas.

Principales métodos:

Un ensayo controlado aleatorizado por clúster en el que participaron 6451 médicos en el norte de Portugal.
El grupo de intervención recibió visitas de extensión educativa personalizadas de una hora.
Se utilizaron modelos mixtos lineales generalizados para analizar los cambios en las tasas de notificación de ADR.

Principales resultados:

El grupo de intervención mostró un aumento significativo en las tasas generales de notificación de ADR (RR, 10.23).
Se observaron mejoras significativas en la notificación de reacciones adversas graves, de alta causalidad, inesperadas y relacionadas con nuevos medicamentos.
El impacto positivo en las tasas de notificación persistió durante al menos 12 meses después de la intervención.

Conclusiones:

Los programas de extensión educativa dirigidos pueden mejorar efectivamente la calidad y la cantidad de informes de ADR por parte de los médicos.
Tales intervenciones son valiosas para fortalecer los sistemas de vigilancia de la seguridad de los medicamentos después de su comercialización.

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