(B-184) Equity in Pharmacoepidemiology: Improving Understanding of Use, Benefits, and Risks of Medicinal Products in Human Populations

Background: Clinical research has a long history of underrepresentation of women, racial and ethnic minorities, and sexual minorities among others. This disparity exists across the spectrum of medical conditions, contributing to worse health outcomes and inadequate understanding of medicinal product effects. Drug safety and effectiveness studies including social determinants of health (SDoH) and other drivers of health disparities will describe for pharmacoepidemiologists what is currently included and offer direction in conducting future research.

Objectives: This review describes the landscape of published research on the impact of SDoH and other drivers of health disparities on drug safety and effectiveness in the past 10 years.

Methods: The authors searched PubMed for observational studies conducted between 2014 – 2024 on drug safety and effectiveness, stratified by SDoH (e.g., education) or underrepresented populations (e.g., race and ethnicity). The search combined a comprehensive set of terms for each component, including, study design (e.g. observational, cohort, real-world), intervention (e.g. drug), outcomes (e.g. safety, effectiveness), and covariates (e.g. health disparity, healthcare access, education).

The authors screened titles and abstracts and collected reasons for exclusion. After hitting a saturation of results, as determined by the consensus of all reviewers, full-text reading and data extraction were conducted. Extracted data included: populations, outcomes, settings, covariates, and study methods. Study quality was assessed using the Newcastle–Ottawa Scale (NOS).

Results: From the 4202 titles first identified, data were extracted from 22. Many studies were excluded for only describing sociodemographic or SDoHs as baseline characteristics, without stratified analyses.

Most studies stratified analyses by age (n = 21) and sex (n = 20); 6 also stratified by race and ethnicity. Several studies also stratified results by SDoH indices [residential location (n = 4), education status (n = 3), employment status (n = 2) and health literacy (n = 2)]. Seven studies were conducted in the Asia Pacific, six studies in Europe, five studies in North America and two studies each in Africa and South American region, respectively.

Conclusions: Integrating sociodemographic and SDoH indices into study designs enables researchers to produce findings with broader applicability to more patients; however, our review suggests that these analyses are infrequently performed in pharmacoepidemiologic research. Improving data collection and establishing guidelines for study designs in observational studies may further illuminate the role of SDoHs in drug safety and effectiveness.