This study provides a concise overview of the Italian and European pharmacovigilance (PV) systems.
Objective
To evaluate the regulatory frameworks of above mentioned systems, operational tools, and recent trends in adverse drug reaction (ADR) reporting. The primary objective is to highlight the strengths and critical issues of the current system in improving drug safety and protecting public health.
Methods
Our analysis confirms a progressive increase in ADR reporting in Italy over the past decade, with a peak in 2021 during the COVID-19 vaccination campaign, followed by a subsequent decline.
Results
Hospital physicians and pharmacists remain the primary reporters, while patient reports account for around 10%. The causality assessment process continues to rely heavily on tools such as the Naranjo algorithm and the WHO-UMC criteria, although no single gold standard exists. Despite regulatory improvements and digital infrastructure development, key limitations persist, notably underreporting, inconsistent report quality, and lack of population exposure data.
Conclusion
While Italy’s PV system has evolved considerably, a more integrated, proactive, and technology-enhanced approach is required to improve the sensitivity and timeliness of signal detection. Future directions should include the use of artificial intelligence, electronic health records, and real-world evidence to enhance pharmacovigilance performance.
CrescioliGBonaiutiRCorradettiR, et al.Pharmacovigilance and pharmacoepidemiology as a guarantee of patient safety: the role of the clinical pharmacologist. J Clin Med2022; 11(12): 3552, PMID: 35743619; PMCID: PMC9225198.
World Health Organization. International drug monitoring: the role of national centres. WHO; 1972. WHO Technical Report Series No 498 Available from. https://apps.who.int/iris/handle/10665/40968 (Last accessed: May 24, 2025).
5.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. MedDRA - medical dictionary for regulatory activities. ICH, 2023. Available from. https://www.ich.org/page/meddra (Last accessed: March 24, 2025).
World Health Organization. The importance of pharmacovigilance: safety monitoring of medicinal products. WHO, 2002. Available from. https://apps.who.int/iris/handle/10665/42493 (Last accessed 24 March 2025).
9.
European Union. Regulation (EU) No. 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending Regulation (EC) No. 726/2004 regarding pharmacovigilance of medicinal products for human use and Regulation (EC) No. 1394/2007 regarding pharmacovigilance of advanced therapy medicinal products. Off J Eur Union2010; L348: 1–16. Available from. https://eur-lex.europa.eu/legal-content/IT/TXT/?uri=uriserv%3AOJ.L_.2010.348.01.0001.01.ITA&toc=OJ%3AL%3A2010%3A348%3AFULL (Last accessed 29 May 2025).
10.
Italian Ministry of Health. Decree April 30, 2015: operational procedures and technical solutions for effective pharmacovigilance action adopted pursuant to paragraph 344 of Article 1 of Law No. 228 of December 24, 2012 (Stability Law 2013). Official Gazette of the Italian Republic, 2015. General Series No. 143. Available from. https://www.gazzettaufficiale.it/eli/id/2015/06/23/15A04666/sg (Last accessed 27 May 2025).
Uppsala Monitoring Centre. VigiBase: the WHO global ICSR database system. UMC, 2023. Available from. https://who-umc.org/vigibase/vigibase/ (Last accessed 27 May 2025).
NaranjoCABustoUSellersEM, et al.A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther1981; 30(2): 239–245, PMID: 7249508.
17.
ManjhiPKSinghMPKumarM. Causality, severity, preventability and predictability assessments scales for adverse drug reactions: a review. Cureus2024; 16(5): e59975, PMID: 38854273; PMCID: PMC11162198.
18.
RawatBPSLiFYuH. Naranjo question answering using end-to-end multi-task learning model. KDD2019; 2019: 2547–2555, Available from. (Last accessed 27 May 2025).
19.
Italian Medicines Agency (AIFA). National pharmacovigilance report 2021. AIFA, 2021.
FerraraFMancanielloCNavaL, et al.A retrospective pharmacovigilance analysis: could decreased reporting of suspected adverse reactions lead to future safety issues?Recent Progress Med2022; 113(3): 198–201. https://www.recentiprogressi.it/archivio/3761/articoli/37485/ (Last accessed 27 May 2025).
HoffmanKBDimbilMErdmanCB, et al.The weber effect and the United States Food and drug administration's adverse event reporting system (FAERS): analysis of sixty-two drugs approved from 2006 to 2010. Drug Saf2014; 37(4): 283–294.
26.
García-AbeijonPCostaCTaracidoM, et al.Factors associated with underreporting of adverse drug reactions by health care professionals: a systematic review update. Drug Saf2023; 46(7): 625–636, Epub 2023 Jun 6. PMID: 37277678; PMCID: PMC10279571.
27.
CastellanaEBudauPMChiappettaMR. Pharmacovigilance and stevens-Johnson Syndrome (SJS)/Toxic Epidermal necrolysis (TEN): 55 Years of retrospective analysis of the FDA adverse event reporting system (FAERS) database. Hosp Pharm2025; 30: 00185787251337610, Epub ahead of print. PMID: 40321431; PMCID: PMC12043618.
28.
CastellanaEBudauPMChiappettaMR. Women and hyponatremia: an analysis of sex differences in adverse drug reactions. Hosp Pharm2025; 13: 00185787251337618, Epub ahead of print. PMID: 40376453; PMCID: PMC12075165.
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