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Background <p>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.</p> Methods <p>Safety reports from three Italian regions were retrieved from the national pharmacovigilance database (<i>rete nazionale di farmacovigilanza</i>, 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).</p> Results <p>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&lt;&lt;0.05) and more likely than nurses (ROR=1.34; 0.98-1.87; P&lt;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.</p> Conclusions <p>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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月15日

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  • Liberata Sportiello,
  • Mario Gaio,
  • Alessia Zinzi,
  • Gaetano La Mantia,
  • Vera Panzarella,
  • Giuseppe Colella,
  • Paola Martina Marra,
  • Laura Sottosanti,
  • Simona Potenza,
  • Giacomo Oteri,
  • Martina Coppini,
  • Giuseppe Seminara,
  • Rodolfo Mauceri,
  • Ilaria Morreale,
  • Vittorio Fusco,
  • Giuseppina Campisi,
  • Annalisa Capuano

摘要

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.