(348) Recent Trends in Global Adverse Event Reporting: A Descriptive Analysis of VigiBase

Background: VigiBase, the WHO global database of adverse event (AE) reports for medicines and vaccines, collects information on AEs from member countries of the WHO Programme for International Drug Monitoring. The programme has grown extensively since its inception in 1968, but insights into global reporting patterns and trends are limited, particularly in recent years.

Objectives: To describe global patterns and trends of AE reporting to VigiBase from 2010 through 2023.

Methods: This is an observational descriptive study including de-duplicated reports listing medicinal products (excl. Covid-19 vaccines) as suspected or interacting received from VigiBase inception until December 31, 2023. Cumulative case counts by the end of 2010 and 2023 were extracted, and cumulative proportions or means were calculated for geographic region, World Bank income classification, reporter qualification and information completeness measured by the vigiGrade score (scale 0 to 1).

Results: A total of 31,144,981 AE reports were identified, a 5-fold increase in reports was observed since 2010. Overall, 47.6% originated from North America, 23.1% from Asia, 22.4% from Europe, 3.6% from Latin America and the Caribbean, 1.9% from Oceania and 1.4% from Africa. From 2010, a 4-fold increase in proportion of reports from Asia was noted, upward trends were also seen for Africa (3-fold), and Latin America and the Caribbeans (2-fold). In 2023, the majority of reports came from high-income countries. Nonetheless, since 2010, there has been a 3-fold increase in proportion of reports from low and middle-income countries, accounting for 17.8% of the reports in 2023. The most common reporter qualifications were consumers/non-health professionals (36.7%) and physicians (35.9%), followed by other health professionals (16.0%), pharmacists (10.5%), and lawyers (2.2%). From 2010, an approximately 2-fold increase in proportion of reports from consumers/non-health professionals, pharmacists, and other health professionals was observed, with this trend being broadly consistent across geographic regions. The average information completeness score across all reports was 0.47. The score increased by 7.4% since 2010, the largest increment in information completeness was found for reports from Asia.

Conclusions: VigiBase has not only grown in size but also in information completeness and coverage, with increasing contributions from geographic regions and reporters that were less represented in 2010. Whether these trends translate into improved pharmacovigilance and patient safety remains to be determined, but knowledge of these patterns will provide context to users of VigiBase and the global pharmacovigilance community.