Adverse event reporting practices in drug-resistant tuberculosis facilities across South Africa

Abstract

Background: The reporting of adverse drug reactions associated with drug-resistant tuberculosis (DR-TB) medication is important for pharmacovigilance, especially in high-burden countries such as South Africa. With DR-TB treatment being so dynamic, it is important to understand adverse event reporting practices at specialised facilities. Objectives: The study aimed to understand the adverse drug reaction (ADR) reporting practices at DR-TB treatment facilities in South Africa. Method: Interviews were conducted with healthcare workers at specialised DR-TB facilities. This was to collect data on demographics, pharmacovigilance training, and determine attitudes and practices towards reporting adverse events. A checklist was developed to review the most recent adverse event forms captured at the facility. Results: Most participants did not have adverse event reporting training since their initial training but were confident that they could complete a form themselves. Most participants could correctly identify the major adverse events associated with DR-TB medication, but some deemed non-adverse events as plausible. Adverse event report forms were not standardised with most participants deeming further training and regular feedback as reasons to report ADRs. Conclusion: Standardisation of adverse event report forms used and the establishment of regular reporting will increase adverse event reporting at DR-TB facilities. Continuous training, empowerment and expansion of staff categories eligible to report adverse events will enhance and sustain such practice. Contribution: The study highlights challenges faced by healthcare professionals in reporting adverse events.