title: Ten years of pharmacovigilance in Italy: the experience of Emilia-Romagna region in the monitoring of drug's safety profile.
abstract: OBJECTIVE
  To describe the evolution of adverse drug reactions (ADRs) spontaneously reporting in the Emilia-Romagna region (ERR) in the period 2001 - 2010 through qualitative and quantitative indicators following local educational and editorial initiatives.
  
  
  METHODS
  Data of regional spontaneous reporting from 1 January 2001 to 31 December 2010 were obtained from the Pharmacovigilance National Network of the Italian Medicines Agency. Drugs were classified according to the Anatomical Therapeutic Chemical classification. ADRs were coded using the Medical Dictionary for Regulatory Activities Terminology.
  
  
  RESULTS
  The overall contribution of the ERR was 9.7% of the total national number of reports (9631 out of 99,319) with a rate of 8 reports per 100 physicians and 230 per million inhabitants. Reports concerned more females and more patients aged 0 - 2 and 60 - 80 years. Differences between the individual local health authorities were identified in rate of ADR reporting. Hospital doctors were the main source of reports followed by general physicians. Out of 2555 serious reports, 124 cases were lethal (4.9% of serious ADRs and 1.3% of all regional reports).
  
  
  CONCLUSIONS
  The results represent a useful trend analysis of the post-marketing surveillance and suggest that, although the pharmacovigilance system has succeeded in reaching a stable and lasting flow of information in ERR, there is considerable place for improvement.
authors.affiliation: University of Bologna, Department of Medical and Surgical Sciences, Unit of Pharmacology , Via Irnerio 48, 40126 Bologna , Italy +39 0512091779 ; +39 0512091780 ; domenico.motola@unibo.it.
authors.forename: Domenico
authors.initials: D
authors.lastname: Motola
authors.forename: Mauro
authors.initials: M
authors.lastname: Melis
authors.forename: Salvatore
authors.initials: S
authors.lastname: Lo Bianco
authors.forename: Elena
authors.initials: E
authors.lastname: Buccellato
authors.forename: Chiara
authors.initials: C
authors.lastname: Biagi
authors.forename: Alberto
authors.initials: A
authors.lastname: Vaccheri
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D002675:Child, Preschool; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007558:Italy; D008297:Male; D008875:Middle Aged; D060735:Pharmacovigilance
keywords: adverse drug reaction; drug safety; pharmacovigilance; spontaneous reporting