Global Reporting Patterns of Suspected Adverse Drug Reactions and Their Relationship with a Country’s Socioeconomic Status- Insights from VigiBase Data- Study Protocol
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Introduction
Pharmacovigilance is vital for detecting Adverse Drug Reactions (ADRs), with Individual Case Safety Reports (ICSRs) serving as the primary source, despite growing interest in other data sources like electronic health records and social media. However, ICSR reporting rates remain low in low- and middle-income countries due to weak pharmacovigilance systems. Furthermore, the impact of socioeconomic factors such as health, education, and income on reporting rates has not been studied on a global scale previously.
Aims
To compare global ICSR reporting patterns and quantify potential differences in their characteristics across pre-defined socioeconomic strata.
Methods
In this observational descriptive quantitative study, numbers of ICSRs will be obtained from VigiBase for members of the World Health Organization Programme for International Drug Monitoring, from 01/01/2010 to 31/12/2022. Yearly total population data and Inequality-adjusted Human Development Index (IHDI) values will be obtained from the United Nations Development Programme (UNDP) for all countries, for the same interval. Yearly ICSR reporting rates for each country will be calculated by dividing the total ICSRs submitted to VigiBase each year, and median reporting rates computed across the study period. Similarly, the median IHDI and its dimensional indices (Health, Education, and Income) will be calculated for each country. Countries will be categorized into four human development groups based on the UNDP classification: low, medium, high, and very high. To assess the relationship between IHDI (and its dimensions) and reporting rates, a linear regression model will be applied, with adjustments made as needed based on the data characteristics. VigiPoint will also be used to compare the relative frequency of covariates between reports of low, medium, and high IHDI, against those submitted to VigiBase by very high IHDI countries. VigiPoint identifies key features for review using shrunk log odds ratios, highlighting the overrepresented characteristics of ICSRs. We will present descriptive and statistical analyses in tables and scatter plots will be used to examine the relationship between ICSR reporting rates and IHDI (and its dimensions), using the calculated median values for IHDI (and its dimensions). Trendlines will highlight temporal changes in population, IHDI, and dimensional indices.
Discussion
The findings will offer insights into how socioeconomic factors affect reporting practices and may guide targeted interventions to enhance global drug safety monitoring.
