Pharmacovigilance and drug safety 2011 in Calabria (Italy): Adverse events analysis

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. 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. 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). 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.