In Italy, reports of suspected adverse reactions increased by 38% during 2012. These figures were published in an AIFA report presented by Minister Lorenzin to Parliament.
Overall, 148,340 reports of suspected adverse reactions to medicinal products and vaccines were collected, resulting in 29,036 reports entered into the Italian National Pharmacovigilance Network (RNF), corresponding to 479 reports per million inhabitants. These figures place Italy well above the World Health Organization (WHO) gold standard of 300 reports per million inhabitants.
However, the report also highlighted significant regional differences in reporting rates. While Lombardy and Tuscany reached approximately 1,200 reports per million inhabitants, reporting activity decreased in Molise, Lazio, Basilicata, and Liguria.
Some data on reported suspected adverse reactions
Approximately 21.8% of reports required or prolonged hospitalization, while 70.3% were classified as non-serious.
The increase was more pronounced for medicinal products (+47%) than for vaccines (+7%).
Antineoplastic agents and immunomodulators accounted for the highest proportion of reports (25.5%), followed by antimicrobials (15.5%) and central nervous system medicines (13.0%).
Among individual active substances, some of the most widely used medicines ranked highest:
- Amoxicillin/clavulanic acid: 1,361 reports (+21% vs. 2011)
- Warfarin: 1,347 reports (+36% vs. 2011)
- Acetylsalicylic acid: 936 reports (+43% vs. 2011)
According to the authors, these data suggest a positive impact of the new European pharmacovigilance legislation, which has contributed to improving the effectiveness, speed, and transparency of pharmacovigilance activities and regulatory interventions.