title: Pharmacovigilance and drug safety 2011 in Calabria (Italy): Adverse events analysis.
abstract: BACKGROUND
  Pharmacovigilance assesses the safety profile of drugs. Its main aim is the increase of spontaneous reporting of adverse drug reactions (ADRs). The Italian Drug Agency (AIFA; Agenzia Italiana del Farmaco) is financing several projects to the aim of increasing reporting, and in Calabria a Pharmacovigilance Information Centre has been created.
  
  
  METHODS
  We analyzed the AIFA database relatively to Calabria in the year 2011 and we have analyzed ADRs using descriptive statistics. We have also collected a questionnaire-based interview in order to describe the background knowledge in the field.
  
  
  RESULTS
  Regarding the number of AIFA reported ADRs from Calabria, a 38% increase (138 vs. 100) in comparison to 2010 was evidenced. Hospital Doctors represent the main source of signaling (71.7 %). Ketoprofene and the combination amoxicillin/clavulanic acid represent the most frequently reported drugs causing ADRs. Our questionnaires indicated that despite the health professionals have met at least once an ADR only a small percentage of them was reported to the authorities (37%). There is a very good knowledge of the ADR concept and reporting system (90% of interviewed distinguish an ADR and knows how to report it), and there is a strong interest in participating to training courses in the field (95% are interested).
  
  
  CONCLUSIONS
  Despite Calabria has had a positive increase in the number of reported ADRs, the total number is very low and the pharmacovigilance culture is far from being achieved in this region.
authors.affiliation: Department of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Scicchitano
authors.forename: Chiara
authors.initials: C
authors.lastname: Giofrè
authors.forename: Caterina
authors.initials: C
authors.lastname: Palleria
authors.forename: Carmela
authors.initials: C
authors.lastname: Mazzitello
authors.forename: Miriam
authors.initials: M
authors.lastname: Ciriaco
authors.forename: Luca
authors.initials: L
authors.lastname: Gallelli
authors.forename: Laura
authors.initials: L
authors.lastname: Paletta
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Marrazzo
authors.forename: Salvatore
authors.initials: S
authors.lastname: De Fazio
authors.forename: Michele
authors.initials: M
authors.lastname: Menniti
authors.forename: Rubens
authors.initials: R
authors.lastname: Curia
authors.forename: Concetta
authors.initials: C
authors.lastname: Arena
authors.forename: Serafina
authors.initials: S
authors.lastname: Chimirri
authors.forename: Marinella
authors.initials: M
authors.lastname: Patanè
authors.forename: Stefania
authors.initials: S
authors.lastname: Esposito
authors.forename: Felisa
authors.initials: F
authors.lastname: Cilurzo
authors.forename: Orietta
authors.initials: O
authors.lastname: Staltari
authors.forename: Emilio
authors.initials: E
authors.lastname: Russo
authors.forename: Giovambattista
authors.initials: G
authors.lastname: De Sarro
keywords: Adverse drug reaction reporting systems; adverse effects; calabria; drug toxicity; italy; pharmacovigilance