title: Pharmacovigilance in Italy: An overview.
abstract: BACKGROUND
  Spontaneous reporting of adverse drug reactions (ADRs) is the basis of pharmacovigilance. In fact, ADRs are associated with a high degree of morbidity and mortality. However, underreporting by all healthcare professionals remains the major problem in Italy and in the rest of the world. The dissemination of pharmacovigilance knowledge among Italian healthcare professionals, and the new pharmacovigilance regulations may promote the early detection and reporting of ADRs. This review examines the legislative framework concerning the pharmacovigilance in Italy.
  
  
  METHODS
  The information was collected from scientific articles and the websites of the Italian Ministry of Health and the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA).
  
  
  RESULTS
  The pharmacovigilance system, both in Italy and Europe, has undergone profound changes. European legislation on pharmacovigilance has been changed in 2010 according to the EU Regulation 1235/2010 and Directive 2010/84/EU. Basically, the changes tend to increase the efficiency, speed and transparency of pharmacovigilance activities. The new Regulation (1235/2010) and the Directive (2010/84/EU) aim to strengthen the system of pharmacovigilance, establish more precisely who is obliged to do what, and allow faster and easier circulation and retrieval of information about ADRs.
  
  
  CONCLUSIONS
  A greater knowledge on what is the Italian pharmacovigilance legislation will be useful to improve the status of ADRs reporting and spread the culture of spontaneous reporting.
authors.affiliation: Department of Science of Health, School of Medicine, University of Catanzaro, and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
authors.forename: Carmela
authors.initials: C
authors.lastname: Mazzitello
authors.affiliation: Department of Science of Health, School of Medicine, University of Catanzaro, and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
authors.forename: Stefania
authors.initials: S
authors.lastname: Esposito
authors.affiliation: Pharmacy Unit, Mater Domini Hospital, Catanzaro, Italy.
authors.forename: Adele E
authors.initials: AE
authors.lastname: De Francesco
authors.affiliation: Regional Centre of Pharmacovigilance and Pharmacoepidemiology, and Department of Experimental Medicine "L. Donatelli", Second University of Naples, Naples, Italy.
authors.forename: Annalisa
authors.initials: A
authors.lastname: Capuano
authors.affiliation: Department of Science of Health, School of Medicine, University of Catanzaro, and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
authors.forename: Emilio
authors.initials: E
authors.lastname: Russo
authors.affiliation: Department of Science of Health, School of Medicine, University of Catanzaro, and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
authors.forename: Giovambattista
authors.initials: G
authors.lastname: De Sarro
keywords: ADRs; AIFA; Italian; legislation; monitoring