Open AccessRisk factors for adverse drug reactions in pediatric inpatients: A cohort study
Author(s) -
Paulo Henrique Santos Andrade,
Iza Maria Fraga Lôbo,
Wellington Barros da Silva
Publication year - 2017
Publication title -
plos one
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.99
H-Index - 332
ISSN - 1932-6203
DOI - 10.1371/journal.pone.0182327
Subject(s) - medicine , cohort study , adverse effect , drug , cohort , drug reaction , intensive care medicine , pharmacology
Purpose The present study aims to identify the risk factors for adverse drug reactions (ADR) in pediatric inpatients. Methods A prospective cohort study in one general pediatric ward in a hospital in Northeast Brazil was conducted in two stages: the first stage was conducted between August 17 th and November 6 th , 2015, and the second one between March 1 st and August 25 th , 2016. We included children aged 0–14 years 11 months hospitalized with a minimum stay of 48 hours. Observed outcomes were the ADR occurrence and the time until the first ADR observed. In the univariate analysis, the time to the first ADR was compared among groups using a log-rank test. For the multivariate analysis, the Cox regression model was used. Results A total of 173 children (208 admissions) and 66 ADR classified as “definite” and “probable” were identified. The incidence rate was 3/100 patient days. The gastro-intestinal system disorders were the main ADR observed (28.8%). In addition, 22.7% of the ADR were related to antibacterials for systemic use and 15.2% to general anesthesia. Prior history of ADR of the child [hazard ratio (HR) 2.44; 95% confidence interval (CI) 1.19–5.00], the use of meglumine antimonate (HR 4.98; 95% CI 1.21–20.54), antibacterial for systemic use (HR 2.75; 95% CI 1.08–6.98) and antiepileptic drugs (HR 3.84; 95% CI 1.40–10.56) were identified risk factors for ADR. Conclusions We identified as risk factors the prior history of ADR of the child and the use of meglumine antimonate, antibacterial for systemic use and antiepileptic drugs.