title: The importance of monitoring adverse drug reactions in pediatric patients: the results of a national surveillance program in Italy.
abstract: OBJECTIVE
  To gain information on safety of drugs used in pediatrics through a 4-year post-marketing active pharmacovigilance program. The program sampled the Italian population and was termed 'Monitoring of the Adverse Effects in Pediatric population' (MEAP).
  
  
  METHODS
  Adverse drug reactions (ADRs) were collected for individuals aged 0 - 17 years treated in hospitals and territorial health services in Lombardy, Tuscany, Apulia and Campania; located to gain an appropriate sampling of the population. ADRs were evaluated using the Adverse Drug Reaction Probability Scale (Naranjo) and analyzed with respect to time, age, sex, category of ADR, seriousness, suspected medicines, type of reporter and off-label use.
  
  
  RESULTS
  We collected and analyzed reports from 3539 ADRs. Vaccines, antineoplastic and psychotropic drugs were the most frequently pharmacotherapeutic subgroups involved. Seventeen percent of reported ADRs were serious; of them fever, vomiting and angioedema were the most frequently reported. Eight percent of ADRs were associated with off-label use, and 10% were unknown ADRs. Analysis of these revealed possible strategies of therapy optimization.
  
  
  CONCLUSIONS
  The MEAP project demonstrated that active post-marketing pharmacovigilance programs are a valid strategy to increase awareness on pediatric pharmacology, reduce underreporting and provide information on drug actions in pediatrics. This information enhances drug therapy optimization in the pediatric patients.
authors.affiliation: Università di Milano, University Hospital "Luigi Sacco", Department of Biomedical and Clinical Sciences, Unit of Clinical Pharmacology , 20157 Milan , Italy.
authors.forename: Carla
authors.initials: C
authors.lastname: Carnovale
authors.forename: Tatiana
authors.initials: T
authors.lastname: Brusadelli
authors.forename: GianVincenzo
authors.initials: G
authors.lastname: Zuccotti
authors.forename: Silvia
authors.initials: S
authors.lastname: Beretta
authors.forename: Maria Giuseppa
authors.initials: MG
authors.lastname: Sullo
authors.forename: Annalisa
authors.initials: A
authors.lastname: Capuano
authors.forename: Francesco
authors.initials: F
authors.lastname: Rossi
authors.forename: Martina
authors.initials: M
authors.lastname: Moschini
authors.forename: Alessandro
authors.initials: A
authors.lastname: Mugelli
authors.forename: Alfredo
authors.initials: A
authors.lastname: Vannacci
authors.forename: Marcella
authors.initials: M
authors.lastname: Laterza
authors.forename: Emilio
authors.initials: E
authors.lastname: Clementi
authors.forename: Sonia
authors.initials: S
authors.lastname: Radice
mesh_terms: D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D002648:Child; D002675:Child, Preschool; 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; D056687:Off-Label Use / Q000706:statistics & numerical data; D060735:Pharmacovigilance; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D011446:Prospective Studies
keywords: adverse drug reaction; off-label drug use; pediatric; pharmacovigilance; post-marketing surveillance