Magnitude and Characteristics of Adverse Drug Events in Saudi Arabia: A Systematic Review.

Aims: We aimed to determine the prevalence, nature, and identification methods of the adverse drug events (ADEs) as well as explore if standard definitions were utilized while assessing ADEs in Saudi Arabia.

Methods: We systematically searched MEDLINE via PubMed and Embase from their inceptions to April 2022. We investigated experimental and observational studies conducted in Saudi Arabia.

Results: We screened 14,398 records and included 12 studies. This review indicated that the incidence of ADEs ranged from 0.58% to 74.2%, while three cross-sectional study reports highlighted that the proportion of subjects experiencing ADEs ranged from 28% to 98.5%. This wide variation can be attributed to factors such as diverse study designs, measurement variability, and heterogeneous populations. ADR was the most frequently reported type of ADE in all studies. Chart review (58%) was the commonly utilized ADE detection method, followed by patient interviews (25%), and trigger tools (17%). Five studies (42%) used their own ADE definition, and only one study (8%) reported the standard ADE definition; however, half of the studies (n = 6) did not report any ADE definition.

Conclusions: This systematic review suggests that ADE prevalence varied between studies, with chart review being the most used approach for ADE identification in Saudi Arabia, followed by patient interviews. ADR was the most common type of ADE among all studies. Further, most studies did not use the standard ADE definitions. To improve medication safety and patient care outcomes, our review highlights the crucial need for standardized ADE detection and reporting practices in Saudi Arabia. Future research should prioritize prospective studies with standardized methodologies to accurately assess ADE prevalence rates and evaluate the impact of interventions on reducing ADEs in Saudi Arabia.