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

Francesca Scicchitano, Chiara Giofrè, Caterina Palleria, Carmela Mazzitello, Miriam Ciriaco, Luca Gallelli, Laura Paletta, Giuseppina Marrazzo, Salvatore De Fazio, Michele Menniti, Rubens Curia, Concetta Arena, Serafina Chimirri, Marinella Patanè, Stefania Esposito, Felisa Cilurzo, Orietta Staltari, Emilio Russo, Giovambattista De Sarro


  • 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.
  • key words: Adverse drug reaction reporting systems, adverse effects, calabria, drugtoxicity, Italy, pharmacovigilance

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