Title of article
Pharmacovigilance and drug safety 2011 in Calabria (Italy): Adverse events analysis
Author/Authors
Scicchitano, Francesca Department of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance’s Centre Calabria Region - University Hospital Mater Domini, Catanzaro , Giofrè, Chiara Department of Science of Health - School of Medicine - University of Catanzaro, Italy and Pharmacovigilance’s Centre Calabria Region - University Hospital Mater Domini, Catanzaro , Palleria, Caterina Department of Science of Health - School of Medicine - University of Catanzaro, Italy and Pharmacovigilance’s Centre Calabria Region - University Hospital Mater Domini, Catanzaro , Mazzitello, Carmela Department of Science of Health - School of Medicine - University of Catanzaro, Italy and Pharmacovigilance’s Centre Calabria Region - University Hospital Mater Domini, Catanzaro , Ciriaco, Miriam Department of Science of Health - School of Medicine - University of Catanzaro, Italy and Pharmacovigilance’s Centre Calabria Region - University Hospital Mater Domini, Catanzaro , Gallelli, Luca Department of Science of Health - School of Medicine - University of Catanzaro, Italy and Pharmacovigilance’s Centre Calabria Region - University Hospital Mater Domini, Catanzaro , Paletta, Laura Department of Science of Health - School of Medicine - University of Catanzaro, Italy and Pharmacovigilance’s Centre Calabria Region - University Hospital Mater Domini, Catanzaro , Marrazzo, Giuseppina Department of Science of Health - School of Medicine - University of Catanzaro, Italy and Pharmacovigilance’s Centre Calabria Region - University Hospital Mater Domini, Catanzaro , De Fazio, Salvatore Department of Science of Health - School of Medicine - University of Catanzaro, Italy and Pharmacovigilance’s Centre Calabria Region - University Hospital Mater Domini, Catanzaro , Curia, Rubens Department of Science of Health - School of Medicine - University of Catanzaro, Italy and Pharmacovigilance’s Centre Calabria Region - University Hospital Mater Domini, Catanzaro , Menniti, Michele Department of Science of Health - School of Medicine - University of Catanzaro, Italy and Pharmacovigilance’s Centre Calabria Region - University Hospital Mater Domini, Catanzaro , Arena, Concetta Department of Science of Health - School of Medicine - University of Catanzaro, Italy and Pharmacovigilance’s Centre Calabria Region - University Hospital Mater Domini, Catanzaro , Chimirri, Serafina Department of Science of Health - School of Medicine - University of Catanzaro, Italy and Pharmacovigilance’s Centre Calabria Region - University Hospital Mater Domini, Catanzaro , Patanè, Marinella Department of Science of Health - School of Medicine - University of Catanzaro, Italy and Pharmacovigilance’s Centre Calabria Region - University Hospital Mater Domini, Catanzaro , Esposito, Stefania Department of Science of Health - School of Medicine - University of Catanzaro, Italy and Pharmacovigilance’s Centre Calabria Region - University Hospital Mater Domini, Catanzaro , Cilurzo, Felisa Department of Science of Health - School of Medicine - University of Catanzaro, Italy and Pharmacovigilance’s Centre Calabria Region - University Hospital Mater Domini, Catanzaro , Staltari, Orietta Department of Science of Health - School of Medicine - University of Catanzaro, Italy and Pharmacovigilance’s Centre Calabria Region - University Hospital Mater Domini, Catanzaro , Russo, Emilio Department of Science of Health - School of Medicine - University of Catanzaro, Italy and Pharmacovigilance’s Centre Calabria Region - University Hospital Mater Domini, Catanzaro , Giovambattista De Sarro Department of Science of Health - School of Medicine - University of Catanzaro, Italy and Pharmacovigilance’s Centre Calabria Region - University Hospital Mater Domini, Catanzaro
Pages
4
From page
872
To page
875
Abstract
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. Materials and 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.
Keywords
Adverse drug reaction reporting systems , adverse effects , calabria , drug toxicity , italy , pharmacovigilance
Journal title
Astroparticle Physics
Serial Year
2012
Record number
2446277
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