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Adverse drug reactions in hospitalized Colombian children

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 pro...

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Autores principales: de las Salas, Roxana, Díaz-Agudelo, Daniela, Burgos-Flórez, Francisco Javier, Vaca, Claudia, Serrano-Meriño, Dolores Vanessa
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Universidad del Valle 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5091272/
https://www.ncbi.nlm.nih.gov/pubmed/27821893
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author de las Salas, Roxana
Díaz-Agudelo, Daniela
Burgos-Flórez, Francisco Javier
Vaca, Claudia
Serrano-Meriño, Dolores Vanessa
author_facet de las Salas, Roxana
Díaz-Agudelo, Daniela
Burgos-Flórez, Francisco Javier
Vaca, Claudia
Serrano-Meriño, Dolores Vanessa
author_sort de las Salas, Roxana
collection PubMed
description 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.
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spelling pubmed-50912722016-11-07 Adverse drug reactions in hospitalized Colombian children de las Salas, Roxana Díaz-Agudelo, Daniela Burgos-Flórez, Francisco Javier Vaca, Claudia Serrano-Meriño, Dolores Vanessa Colomb Med (Cali) Original Article 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. Universidad del Valle 2016-09-30 /pmc/articles/PMC5091272/ /pubmed/27821893 Text en http://creativecommons.org/licenses/by/3.0/ 2016. Universidad del Valle. This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Original Article
de las Salas, Roxana
Díaz-Agudelo, Daniela
Burgos-Flórez, Francisco Javier
Vaca, Claudia
Serrano-Meriño, Dolores Vanessa
Adverse drug reactions in hospitalized Colombian children
title Adverse drug reactions in hospitalized Colombian children
title_full Adverse drug reactions in hospitalized Colombian children
title_fullStr Adverse drug reactions in hospitalized Colombian children
title_full_unstemmed Adverse drug reactions in hospitalized Colombian children
title_short Adverse drug reactions in hospitalized Colombian children
title_sort adverse drug reactions in hospitalized colombian children
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5091272/
https://www.ncbi.nlm.nih.gov/pubmed/27821893
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