Adverse drug reactions in hospitalized Colombian children

• Published in: Colombia médica (Cali, Colombia) Colombia), 2016-09, Vol.47 (3), p.142-47
• Main Authors: de las Salas, Roxana, Díaz-Agudelo, Daniela, Burgos-Flórez, Francisco Javier, Vaca, Claudia, Serrano-Meriño, Dolores Vanessa
• Format: Article
• Language: English
• Subjects: adverse reactions; child; Colombia; drug monitoring; Drug-related side effects; efectos secundarios relacionados con los medicamentos; farmacovigilancia; monitoreo de fármacos; niño; Original; pediatria; pharmacovigilance; reacciones adversas; riesgo
• ISSN: 0120-8322; 1657-9534
• DOI: 10.25100/cm.v47i3.2184

Introduction: The occurrence of adverse drug reactions is an important issue due to the lack of drug safety data in children. Objective: To describe the Adverse Drug Reactions in inpatient children under 6 years of age in two general pediatrics wards located in Barranquilla, Colombia. Methods: A prospective cohort study based on intensive pharmacovigilance was conducted during six months in order to monitor the emergence of Adverse Drug Reactions in inpatients children under 6 years of age with at least one medication prescribed. The study was conducted in two pediatric wards of two hospitals located in Barranquilla, Colombia. Naranjo´s Algorithm was used to evaluate imputability, the modified Hartwig and Siegel assessment scale to establish severity and the Schumock and Thornton criteria to determine preventability. Results: Of a total of 772 monitored patients, 156 Adverse Drug Reactions were detected on 147 children. The cumulative incidence of Adverse Drug Reactions was 19.0% (147/772); the incidence density was 37.6 Adverse Drug Reactions per 1,000 patients-days (147/3,913). The frequency was higher in children under 2 years of age (12.7%). Emergence of Adverse Drug Reactions was higher in male patients (RR= 1.66; 95% CI= 1.22-2.22, p= 0.001) and in those who used systemic antibiotics (RR= 1.82; 95% CI= 1.17-2.82, p= 0.005). Conclusions: Adverse Drug Reactions are common among hospitalized children and represent an additional burden of morbidity and risk, particularly in those who used several medicines, including antibiotics. Introducción: La aparición de reacciones adversas a medicamentos es un tópico importante debido a la escasa información sobre seguridad de medicamentos en niños. Objetivo: Describir las reacciones adversas a medicamentos en niños menores de 6 años de edad hospitalizados en dos servicios de pediatría general en Barranquilla, Colombia. Métodos: Estudio prospectivo de una cohorte de pacientes basado en farmacovigilancia intensiva, realizado durante seis meses para monitorizar la aparición de reacciones adversas a medicamentos en niños menores de 6 años de edad hospitalizados y con indicación de al menos un medicamento. El estudio fue conducido en dos servicios de pediatría general de dos hospitales en Barranquilla, Colombia. El algoritmo de Naranjo fue usado para evaluar imputabilidad, la escala modificada de Hartwig y Siegel para establecer severidad y los criterios de Schumock y Thornton para determinar evitabilidad. Resultados: