Characterization of serious adverse drug reactions as cause of emergency department visit in children: a 5-years active pharmacovigilance study.

ABSTRACT: BACKGROUND:To describe frequency, preventability and seriousness of adverse drug reactions (ADRs) in children as cause of emergency department (ED) admission and to evaluate the association between specific factors and the reporting of ADRs. METHODS:A retrospective analysis based on reports of suspected ADRs collected between January 1st, 2012 and December 31st, 2016 in the ED of Meyer Children's Hospital (Italy). Demographics, clinical status, suspected drugs, ADR description, and its degree of seriousness were collected. Logistic regression was used to estimate the reporting odds ratios (RORs) with 95% confidence intervals (CIs) of potential predictors of ADR seriousness. RESULTS:Within 5 years, we observed 834 ADRs (1100 drug-ADR pairs), of whom 239 were serious; of them, 224 led to hos

SUBMITTER: Lombardi N 

PROVIDER: S-EPMC5902928 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature