title: Pediatric drug safety surveillance in Italian pharmacovigilance network: an overview of adverse drug reactions in the years 2001 - 2012.
abstract: OBJECTIVE
  To describe the characteristics of pediatric adverse drug reactions (ADRs) reported in Italian spontaneous reporting database.
  
  
  METHODS
  Reports of suspected ADRs related to children and adolescents were extracted from 2001 - 2012. After exclusion of duplicates, vaccines and reports containing missing age data, the report characteristics were investigated in terms of implicated drug and adverse drug event across different age-categories.
  
  
  RESULTS
  Among 123,129 selected reports, 8338 (6.8%) concerned pediatrics. Of these, 52.2% involved male patients compared to 47.5% female up to the age of 11. After the age of 11 this statistic reversed. 39.4% of pediatric reports were serious and of these, 75.2% required hospitalization mainly in very young children. Most of reports were issued by hospital physicians (61.9%), followed by pharmacists (10.1%), while reports from family pediatricians accounted for 8.1%. The most frequently implicated drug categories were anti-infectives for systemic use (44.9%), drugs for the nervous system (15.6%), and anti-inflammatory drugs (10.2%). The most frequently suspected compounds differed between children and adults and reports for the same drug were likely to be more serious in adults than in children.
  
  
  CONCLUSIONS
  This ADR reporting system reflects real safety concerns for drugs used in children and emphasizes the need for stratifying analyses by age-subgroup to increase the sensitivity of signal detection procedure.
authors.affiliation: Second University of Naples, Campania Regional Centre of Pharmacovigilance and Pharmacoepidemiology, Experimental Medicine Department, Pharmacology Section , Naples , Italy +39 081 5667652 ; +39 081 5667652 ; carmen.ferrajolo@unina2.it.
authors.forename: Carmen
authors.initials: C
authors.lastname: Ferrajolo
authors.forename: Annalisa
authors.initials: A
authors.lastname: Capuano
authors.forename: Gianluca
authors.initials: G
authors.lastname: Trifirò
authors.forename: Ugo
authors.initials: U
authors.lastname: Moretti
authors.forename: Francesco
authors.initials: F
authors.lastname: Rossi
authors.forename: Carmela
authors.initials: C
authors.lastname: Santuccio
mesh_terms: D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D002648:Child; D002675:Child, Preschool; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007558:Italy / Q000453:epidemiology; D008297:Male; D060735:Pharmacovigilance; D011358:Product Surveillance, Postmarketing / Q000379:methods
keywords: adverse drug reaction; children; pharmacovigilance; spontaneous reporting system