pharmacovigilance and drug safety 2011 in calabria (italy): adverse events analysis

normal 0 false false false en-us x-none ar-sa microsoftinternetexplorer4 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 italianadel 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 analysed 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 (%). 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 (%).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.