Relevancia de la farmacovigilancia hospitalaria en la práctica médica actual
2013
Las reacciones adversas medicamentosas (RAM) generan actualmente una notable morbimortalidad, llegando a representar entre la cuarta y sexta causa de muerte y hasta un 12% de las hospitalizaciones en paises desarrollados. Este es, ademas, un problema creciente. El objetivo del trabajo fue revisar la incidencia de RAM en un hospital de alta complejidad. Se reviso la base de datos del sistema de farmacovigilancia, desde junio de 2008 hasta febrero de 2012. Para determinar la causabilidad de una droga en un evento medico se aplico el indice de Naranjo de efectos indeseables medicamentosos. Se considero RAM grave a aquella que provoca la internacion, la prolonga, compromete seriamente la vida, genera discapacidad permanente o teratogenesis o induce la muerte. Se detectaron 2420 RAM en este periodo. 469 (19.38%; IC 95%: 17.80-20.95) fueron serias, principalmente debido a que fueron causa de hospitalizacion (n = 287). Hubo 14 muertes atribuibles a RAM. Los grupos farmacologicos mas frecuentemente asociados a toxicidad fueron drogas cardiovasculares, antibioticos, neuropsiquiatricas y corticoides. Las RAM mas frecuentes afectaron al sistema endocrinometabolico, causaron hepatotoxicidad, nefrotoxicidad y farmacodermias. Las causas mas frecuentes de hospitalizacion por RAM fueron infecciones graves asociadas a tratamiento inmunosupresor y hemorragia digestiva por anticoagulacion y antiinflamatorios no esteroides. La incidencia de RAM en pacientes hospitalizados y el numero de hospitalizaciones por este motivo fue elevado. Las drogas involucradas fueron similares a las comunicadas en la bibliografia internacional, salvo la alta incidencia de RAM relacionadas a inmunosupresores. Adverse drug reactions (ADRs) are cause of significant morbi-mortality They are between the fourth and sixth cause of mortality in developed countries and cause nearly 12% of hospitalizations. The objective of this publication was to analyze the incidence of ADRs in a tertiary care hospital in Buenos Aires City. The hospital phamacovigilance database for the period June 2008- February 2012, was analyzed. The Naranjo score was applied to assess drug causality. We consider serious an ADRs when it potentially compromised life, induced hospitalization or prolonged it, caused discapacity, teratogenesis or death. In this period, a total of 2420 ADRs were detected: 469 (19.38%; CI 95%: 17.80 - 20.95) were serious, mainly because they induced hospitalization (n = 287). There were 14 ADRs-related deaths. Cardiovascular and neuropsychiatric drugs, antibiotics and corticoids were those most frequently related to toxicity. Endocrine-metabolic disorders, hepatotoxicity, nephrotoxicity and pharmacodermy were the most frequently involved. Among the ADR most frequently associated to hospitalization were Immunosuppressant-associated severe infections and upper gastrointestinal bleeding related to oral anticoagulants and non steroids anti-inflammatory drugs. The ADRs incidence in hospitalized patients and ADRs related hospital admissions were considered relatively high. Drugs involved were similar to those reported in the international bibliography except for the higher incidence of immunosuppressants related admissions here observed.
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