The aim of the present study was to monitor adverse drug reactions (ADRs) in the Medicine outpatient department (OPD) of a University Teaching Hospital. Method: A prospective evaluation of the ADRs reported in the Department of Medicine of our University Teaching Hospital over a period of 4-months was conducted. Results: During the study period, a total of 600 patients visited the Medicine OPD and 122 ADRs were reported. Out of 122 reports that were identified, a higher percentage of ADRs in males (52.4%) was observed as compared to females (47.5%). Of the 122 ADRs, 50 were found to be mild (41.0%), 49 moderate (40.2%), and 23 severe (18.2%). A total of 71 (58.0%) ADRs were observed in patients receiving 4 or more medications concurrently. Conversely 46 (37.7%) ADRs were detected in patients using 3 or less medicines. The largest number of reports were associated with antihypertensive therapy (39.3%), followed by antimicrobials (31.1%) and antidiabetics (10.7%). Amongst the organ systems affected, gastrointestinal ADRs constituted a major component (24.7%) followed by skin reactions (22.2%). On causality assessment, nearly 29.5% ADRs were considered as probable, 33.6% possible and 6.6% could not be categorised and were placed under unassessable. Conclusion: The present work is the maiden pharmacovigilance study conducted at our university teaching hospital. The data presented here will be useful in future, long term and more extensive ADR monitoring in the hospital and in promotion of rational prescribing and drug use in the hospital.
El objetivo del presente estudio fue monitorizar las reacciones adversas medicamentosas (RAM) en el departamento de consultas externas (DCE) de un Hospital Universitario. Método: Se realizó una evaluación prospectiva del as RAM comunicada sen el Departamento de Medicinad e nuestro Hospital Universitario durante un periodo de 4 meses. Resultados: Durante el periodo de estudio, 600 pacientes visitaron el DCE y en 122 se comunicaron RAM. De las 122 comunicaciones, se observó un mayor porcentaje de hombres (52,4%) que de mujeres (47,5%). De las 122 RAM, 50 fueron leves (41,0%), 49 moderadas (40,2%) y 23 graves (18,2%). 71 RAM (58,0%) se observaron en pacientes con 4 o más medicamentos simultáneos. Mientras que 46 (37,7%) RAM se observaron en pacientes con 3 o menos medicamentos. El mayor número de comunicaciones estaba asociado a tratamientos antihipertensivos (39,3%), seguidos de antimicrobianos (31,1%) y antidiabeticos (10,7%). Entre los órganos y sistemas afectados, el gastrointestinal constituía el mayor (24,7%) seguido del as reacciones cutáneas (22,2%). Ene n análisis de causalidad, casi el 29,5% de las RAM se consideraron como probables, el 33,6% como posibles y el 6,6% no pudieron clasificarse por ser invalorables. Conclusión: El presente trabajo es el principal estudio de farmacovigilancia realizado en nuestro hospital universitario. Los datos aquí presentados serán útiles para la monitorización futura y más intensa de RAM en el hospital y para promover la prescripción y el uso racionales en el hospital