title: A retrospective review of paediatric adverse drug reactions reported in Lombardy and Croatia from 2005 to 2013.
abstract: OBJECTIVE
  to characterise the adverse drugs reactions (ADRs) reported in the Lombard and Croatian paediatric population and to compare data to specific paediatric age groups, in terms of trend, pattern and severity of ADRs, increasing understanding of paediatric ADRs.
  
  
  METHODS
  We selected and analysed all the spontaneous reports in which children were involved (0 < 18 years old) reported in the Lombardy and in Croatian pharmacovigilance databases from 1thMarch 2005 to 31thDecember 2013.
  
  
  RESULTS
  9175 ADR reports were reported in the Lombardy, 2457 were included in the Croatian database. The age groups most involved were 2-11 for both countries. The 13.2% and 40.3% of reports retrieved in Lombardy and Croatia were classified as serious, respectively. Fatalities account for 0.09% and 0.12% in Lombardy and Croatia, respectively.
  
  
  CONCLUSIONS
  Data on serious reports reflect a similar scenario in terms of age range; strikingly different therapeutic subgroups were involved in reporting activity likely due to greater self-medication practices with penicillins and anti-inflammatory, analgesic and antipyretics drugs in Lombardy than in Croatia, highlighting the need to closely monitor this paediatric therapeutic area to ensure a safe use of these drugs.
authors.affiliation: a Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences , University Hospital 'Luigi Sacco', Università di Milano , Milan , Italy.
authors.forename: Carla
authors.initials: C
authors.lastname: Carnovale
authors.affiliation: a Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences , University Hospital 'Luigi Sacco', Università di Milano , Milan , Italy.
authors.forename: Marta
authors.initials: M
authors.lastname: Gentili
authors.affiliation: a Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences , University Hospital 'Luigi Sacco', Università di Milano , Milan , Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Matacena
authors.affiliation: b Department for Pharmacovigilance and Rational Pharmacotherapy , Agency for Medical Products and Medical Devices of Croatia , Zagreb , Croatia.
authors.forename: Marina
authors.initials: M
authors.lastname: Dimov Di Giusti
authors.affiliation: b Department for Pharmacovigilance and Rational Pharmacotherapy , Agency for Medical Products and Medical Devices of Croatia , Zagreb , Croatia.
authors.forename: Darko
authors.initials: D
authors.lastname: Krnic
authors.affiliation: b Department for Pharmacovigilance and Rational Pharmacotherapy , Agency for Medical Products and Medical Devices of Croatia , Zagreb , Croatia.
authors.forename: Barbara
authors.initials: B
authors.lastname: Dolinic
authors.affiliation: b Department for Pharmacovigilance and Rational Pharmacotherapy , Agency for Medical Products and Medical Devices of Croatia , Zagreb , Croatia.
authors.forename: Darija
authors.initials: D
authors.lastname: Kolaric
authors.affiliation: b Department for Pharmacovigilance and Rational Pharmacotherapy , Agency for Medical Products and Medical Devices of Croatia , Zagreb , Croatia.
authors.forename: Zeljana
authors.initials: Z
authors.lastname: Margan Koletic
authors.affiliation: b Department for Pharmacovigilance and Rational Pharmacotherapy , Agency for Medical Products and Medical Devices of Croatia , Zagreb , Croatia.
authors.forename: Viola
authors.initials: V
authors.lastname: Macolic Sarinic
authors.affiliation: b Department for Pharmacovigilance and Rational Pharmacotherapy , Agency for Medical Products and Medical Devices of Croatia , Zagreb , Croatia.
authors.forename: Maja
authors.initials: M
authors.lastname: Culjak
authors.affiliation: c Region Health Ministry , Milan , Italy.
authors.forename: Ida
authors.initials: I
authors.lastname: Fortino
authors.affiliation: c Region Health Ministry , Milan , Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Merlino
authors.affiliation: d Scientific Institute , IRCCS E. Medea , Lecco , Italy.|e Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, Consiglio Nazionale delle Ricerche Institute of Neuroscience , University Hospital 'Luigi Sacco' , Milan , Italy.
authors.forename: Emilio
authors.initials: E
authors.lastname: Clementi
authors.affiliation: a Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences , University Hospital 'Luigi Sacco', Università di Milano , Milan , Italy.
authors.forename: Sonia
authors.initials: S
authors.lastname: Radice
mesh_terms: D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems; D000367:Age Factors; D002648:Child; D002675:Child, Preschool; D017523:Croatia / Q000453:epidemiology; 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; D012189:Retrospective Studies; D012651:Self Medication / Q000706:statistics & numerical data
keywords: Adverse drug reaction; children; paediatrics; pharmacovigilance