Adverse drug events among older adults in Brazil before and after the onset of the COVID-19 pandemic

ABSTRACT

Introduction: Harm resulting from adverse drug events (ADE) is among the most frequent in the world. Therefore, its monitoring is essential, especially among older adults, who are at greater risk of suffering such type of harm. Additionally, the COVID-19 pandemic, its high incidence among older adults and frequent use of off-label medications have reinforced the importance of monitoring ADE in this population. Objective: To describe the suspected ADE among older adults in Brazil before and after the beginning of the COVID-19 pandemic. Method: A description of suspected ADEs reported in the VigiMed system of the National Health Surveillance Agency was carried out, involving older adults (age >= 65 years) in the pre- (01/2019 to 03/2020) and post-onset of the pandemic period (04/2020 to 06/2021). The difference between the proportion of severe ADE between the periods was evaluated using Pearson's chi-square test. Results: 57,167 suspected ADE were reported in the global period evaluated;22.2% involved older adults. In the pre-pandemic period, 2,924 suspected ADEs were reported (44.2% were severe ADEs), especially those involving antineoplastic, antimicrobial, and anticoagulant drugs. In the post-pandemic period, 9,771 suspected ADEs were reported (57.5% severe), especially related to hydroxychloroquine and vaccines against COVID-19. The difference in the proportion of severe suspected ADE reported for the older adults between the periods evaluated was statistically significant (p < 0.001). Conclusions: ADE notifications and studies that evaluate ADE among older adults are essential to generate information that can support drug therapy optimization and prioritization of harm reduction among them, especially in the pandemic context that considerably affects this population.