Characteristics and Trends in Adverse Drug Reactions in Ghana- Evidence of Spontaneous Reports, 2005-2021

Abstract Purpose Adverse drug reaction (ADR) monitoring is crucial in ensuring patient and pharmaceutical safety. However, there is lack of evidence regarding the trend pattern of ADR reports in Ghana. We therefore, aimed to analyse and characterize trends in ADRs reported in Ghana over 16 years. Methods We retrospectively analysed ADR reports received by the Ghana National Pharmacovigilance Centre from 2005 to 2021. Jointpoint regression was used to estimate age-adjusted ADR rates, stratified by sex and patient characteristics, suspected medication groups, clinical indications and the manifestation of ADRs. To evaluate trends over time, the percentage annualised estimator was used. Results We identified a total of 6,189 ADR reports from 2005 to 2021. The age-adjusted ADR report rates increased significantly from 2005–2019, with an annual increase of 18.6%, however, there was a downward trend from 2019–2021, although not statistically significant. Males accounted for the majority (64.3%) of ADR reports compared to females (35.7%). The medication group most frequently associated with ADRs were antiprotozoals accounting for 35.6% of all ADR reports while vascular disorders (21.0%) were the most commonly observed clinical indication in relation to ADRs. An increase in ADR report rates was noted for infections and infestation with an annual increase of 22.4% (95% CI: 9.7–36.7%; p < 0.001). Conclusion ADRs significantly contribute to health problems in Ghana, with an increasing trend of ADR-related medication use. The findings of this study call for multifaceted strategies aimed at reducing the risks associated with drug use, thus improving patient safety.