Italian regional data and oropharyngeal adverse events to drugs and vaccines: insights from a 3-year spontaneous reporting (2022-2024).

BACKGROUND

Oropharyngeal adverse events (O-AEs) represent a potential safety concern associated with several drugs and/or vaccines. Although often underestimated, these events may provide valuable insights into a patient's overall clinical condition, appearing initially mild but later worsening. Therefore, this study aimed to analyze O-AEs related to drugs and/or vaccines using structured safety data.

METHODS

Safety reports from three Italian regions were retrieved from the national pharmacovigilance database (rete nazionale di farmacovigilanza, RNF) and analyzed for the period 2022-2024. All reports were structured and analyzed according to the International Council of Harmonisation (ICH) E2B (R3) format. Additionally, reporting odds ratios (RORs) were calculated to compare the likelihood of O-AEs being reported by different categories of reporters (e.g., physicians, other healthcare professionals, or patients).

RESULTS

Over three years, 47,664 reports were collected, of which 1,740 (3.6%) contained at least one suspected O-AE. Most patients were female (65.7%) with a median age of 55 years (IQR 38-66). The majority of reports described non-serious events (66.7%), and outcomes were favorable in most cases (75.9%). The safety reports related to drugs (90.5%) were largely more than those related to vaccines (9.5%). A total of 129 cases of medication-related osteonecrosis of the jaw (MRONJ) were identified, most of which were serious and had unfavorable outcomes. Disproportionality analysis revealed that physicians were less likely to report O-AEs than patients (ROR=0.72; 0.62-0.84; P<<0.05) and more likely than nurses (ROR=1.34; 0.98-1.87; P<0.05). Compared with 2019-2021, the main difference was the lower proportion of vaccine-related reports, which declined from 47.8% to 9.5% in 2022-2024.

CONCLUSIONS

Only a small proportion of safety reports involved O-AEs. These findings highlight the importance of enhancing awareness among physicians (particularly dentists) regarding O-AEs, and of fostering a collaborative pharmacovigilance culture across healthcare providers, thereby improving patient safety through more timely and reliable reporting.