Risk factors for adverse drug reactions in pediatric inpatients: A cohort study.

Paulo Henrique Santos Andrade,Wellington Barros Da Silva,Iza Maria Fraga Lobo

doi:10.1371/journal.pone.0182327

Paulo Henrique Santos Andrade, Wellington Barros Da Silva + Show 1 more

Open Access

https://doi.org/10.1371/journal.pone.0182327

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Journal: PloS one	Publication Date: Aug 1, 2017
Citations: 13	License type: CC BY 4.0

Affiliation: Universidade Federal de Sergipe

Abstract

PurposeThe present study aims to identify the risk factors for adverse drug reactions (ADR) in pediatric inpatients.MethodsA 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 17th and November 6th, 2015, and the second one between March 1st and August 25th, 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.ResultsA 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.ConclusionsWe 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.

Highlights

The vulnerability of children to Adverse Drug Reactions (ADR) into the hospital environment, the risk factors associated with the occurrence of these events and the association of these events with death are issues that awaken the interest of the scientific and healthcare communities around the world [1,2,3,4,5,6,7,8]
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
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

Summary

Introduction

The vulnerability of children to Adverse Drug Reactions (ADR) into the hospital environment, the risk factors associated with the occurrence of these events and the association of these events with death are issues that awaken the interest of the scientific and healthcare communities around the world [1,2,3,4,5,6,7,8]. The only significant association observed among the studies is polypharmacy [8, 10]. In this perspective, some studies have methodological biases, which may affect the results found. The lack of documentation and underreporting ADR, for example, may compromise the studies that restrict their data collection to the medical records and pharmacovigilance databases respectively [11]

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