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
Link To Document :
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