Reacciones adversas a medicamentos: una revisión actualizada del problema en España

Adverse drug reactions: an update review of the problem in Spain

E. Puche Cañasa, J de Dios Lunab

a Departamento de Farmacología. Facultad de Medicina. Universidad de Granada.

b Departamento de Bioestadística. Facultad de Medicina. Universidad de Granada.

Las reacciones adversas a medicamentos (RAM) son un problema clínico importante del que desconocemos su impacto en los enfermos españoles. En un intento por conocerlo se han seleccionado veintisiete estudios de RAM en pacientes españoles en un total de noventa artículos publicados en revistas nacionales e internacionales entre 1974-2004.En 139.799 pacientes se halló una incidencia del 3% de RAM con una mortalidad del 0,6% y un 17% de graves. Un 67% fueron del tipo A. La hospitalización por RAM fue del 6,5% con una estancia media de 4 ± 1,3 días. Un 13% fueron ciertas y un 57% probables. Un 50% de las RAM fueron previsibles y evitables. Los fármacos más implicados fueron antibacterianos, antiinflamatorios no esteroideos (AINE), psicofármacos, broncodilatadores, digoxina, analgésicos no opiáceos, vasodilatadores, antidiabéticos y diuréticos de asa. Los órganos y sistemas más afectados fueron digestivo, piel, sistema nervioso central (SNC), cardiovascular, endocrino y respiratorio. Los factores más fuertemente asociados con las RAM fueron la edad avanzada y la polimedicación. El sexo, la historia previa y la comorbilidad están por definir. Destacamos la importancia de los estudios sobre las RAM y la utilidad de esta revisión para futuras publicaciones sobre el tema.

Adverse drug reactions (ADR) are an important clinical problem and their impact on the Spanish population is unknown. The aim of this study was to provide an overview of ADR based on a review of observational studies published in Spain since 1974. Twenty-seven studies of Spanish patients were selected from a total of 90 articles published in national and international journals between 1974 and 2004. Studies eligible for inclusion were identified with an especially designed checklist. The incidence of ADR among 139,799 patients was 3%; 0.6% of the events led to death, and 17% led to severe illness. Two-thirds (67%) of the ADR were classified as type A. The rate of hospitalization for ADR was 6.5%, and mean length stay was 4 ± 1.3 days. Thirteen percent of the ADR were considered confirmed, and 57% were considered probable. Half (50%) of the ADR were considered preventable. The groups of medications involved most frequently were antibacterial, NSAID, psychoactive medications, bronchodilators, digoxin, non-opiate analgesics, vasodilators, antidiabetics and loop diuretics. The organs and systems involved most frequently werethe digestive tract, skin, central nervous system, cardiovascular, endocrine and respiratory systems. The factors associated most strongly with ADR were advanced age and use of multiple medications. The relationships of gender, previous history of ADR and comorbidity with the incidence of ADR have yet to be established. This review of ADR provides useful information on the incidence of ADR in the Spanish population and serves as a baseline for future studies.