BACKGROUND: The number of suspected adverse drug reactions (ADRs) yearly submitted to the Italian Network of Pharmacovigilance (RNF) has progressively increased after the new European Pharmacovigilance legislation (July 2012). These results have mostly reflected the agreements between Italian Medicines Agency (AIFA) and Italian Regions, enabling the implementation of active pharmacovigilance projects. A project was funded by the AIFA in Calabria region (Southern Italy) in 2010 to increase ADRs reporting and promote a safer medicines' use. Based on this background, we investigated the trend of ADRs in Calabria in 2011-2014, trying to analyze the possible entailments of the new law. METHODS: Quantitative and descriptive analysis of ADRs submitted by Calabrian healthcare professionals and patients to the RNF database between 2011 and 2014. RESULTS: A sharp rise in regional reporting rate was observed over study period. Calabrian Pharmacovigilance system completely fulfilled the World Health Organization gold standard for ADR reporting rate, both in 2013 and 2014. However, heterogeneity was observed regarding reporting health facilities, healthcare professionals and patients among the study years. CONCLUSIONS: These findings reflect the success of the project performed in Calabria. However, this initiative should go on in the next future to obtain better and more homogeneous reporting behavior.
BACKGROUND: The number of suspected adverse drug reactions (ADRs) yearly submitted to the Italian Network of Pharmacovigilance (RNF) has progressively increased after the new European Pharmacovigilance legislation (July 2012). These results have mostly reflected the agreements between Italian Medicines Agency (AIFA) and Italian Regions, enabling the implementation of active pharmacovigilance projects. A project was funded by the AIFA in Calabria region (Southern Italy) in 2010 to increase ADRs reporting and promote a safer medicines' use. Based on this background, we investigated the trend of ADRs in Calabria in 2011-2014, trying to analyze the possible entailments of the new law. METHODS: Quantitative and descriptive analysis of ADRs submitted by Calabrian healthcare professionals and patients to the RNF database between 2011 and 2014. RESULTS: A sharp rise in regional reporting rate was observed over study period. Calabrian Pharmacovigilance system completely fulfilled the World Health Organization gold standard for ADR reporting rate, both in 2013 and 2014. However, heterogeneity was observed regarding reporting health facilities, healthcare professionals and patients among the study years. CONCLUSIONS: These findings reflect the success of the project performed in Calabria. However, this initiative should go on in the next future to obtain better and more homogeneous reporting behavior.
Entities:
Keywords:
Active pharmacovigilance projects; adverse drug reaction reports; new pharmacovigilance law; reporting rate; safety
Authors: Christian Leporini; Caterina De Sarro; Caterina Palleria; Iolanda Caccavo; Brunella Piro; Rita Citraro; Giovambattista De Sarro Journal: Drug Saf Date: 2022-09-16 Impact factor: 5.228
Authors: Luigi Francesco Iannone; Luigi Bennardo; Caterina Palleria; Roberta Roberti; Caterina De Sarro; Maria Diana Naturale; Stefano Dastoli; Luca Donato; Antonia Manti; Giancarlo Valenti; Domenico D'Amico; Santo D'Attola; Adele Emanuela De Francesco; Vincenzo Bosco; Eugenio Donato Di Paola; Steven Paul Nisticò; Rita Citraro; Emilio Russo; Giovambattista De Sarro Journal: PLoS One Date: 2020-11-03 Impact factor: 3.240