Exploring the utility of a spontaneous adverse drug reaction reporting system in identifying drug–drug interactions between antiretrovirals, antitubercular drugs, and cotrimoxazole: a case/non-case analysis

Abstract

Background: Drug–drug interactions (DDIs) cause significant morbidity and mortality, especially in patients with HIV with opportunistic infections such as tuberculosis. However, the literature on quantitative signal detection analyses for DDIs within the national spontaneous reporting systems (SRSs) of countries with high HIV/tuberculosis burdens is lacking. Objective: Our objective was to explore the utility of using post-marketing SRSs in quantitative signal detection analyses of DDIs. Methods: A case/non-case analysis using the Zimbabwean adverse drug reaction (ADR) database obtained from VigiBase® was utilized for quantitative signal detection using 2 × 2 contingency table calculations. Cases were defined as individual case safety reports (ICSRs) with the ADR of interest, and non-cases included the rest of the ICSRs.