Pediatric drug safety surveillance in Italian pharmacovigilance network: an overview of adverse drug reactions in the years 2001 – 2012. (September 2014)

• Record Type: Journal Article
• Authors: Ferrajolo, Carmen; Capuano, Annalisa; Trifirò, Gianluca; Moretti, Ugo; Rossi, Francesco; Santuccio, Carmela
• Is Part Of: Expert opinion on drug safety. Volume 13:Number 1(2014:Jan.)
• Page Start: 9
• Page End: 20
• Publication Date: 2014-09
• Subjects: Drugs -- Side effects -- Periodicals; Drugs -- Toxicology -- Periodicals; Chemotherapy -- Periodicals; 615.704
• DOI: 10.1517/14740338.2014.939581
• Languages: English
• ISSNs: 1474-0338

Abstract

<abstract> <title> <x xml:space="preserve">Abstract</x> </title> <p> <bold> <italic>Objective:</italic> </bold> To describe the characteristics of pediatric adverse drug reactions (ADRs) reported in Italian spontaneous reporting database.</p> <p> <bold> <italic>Methods:</italic> </bold> 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.</p> <p> <bold> <italic>Results:</italic> </bold> 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.</p> <p> <bold> <italic>Conclusions:</italic> </bold> 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.</p> </abstract>