Original Research

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

Razia Gaida, Adlai S. Davids, Ronel Sewpaul
Southern African Journal of Infectious Diseases | Vol 38, No 1 | a564 | DOI: https://doi.org/10.4102/sajid.v38i1.564 | © 2023 Razia Gaida, Adlai S. Davids, Ronel Sewpaul | This work is licensed under CC Attribution 4.0
Submitted: 16 August 2023 | Published: 19 December 2023

About the author(s)

Razia Gaida, Department of Public Health, Societies and Belonging, Human Sciences Research Council, Pretoria, South Africa; and Centre for Community Technologies, Faculty of Engineering, Built Environment and Technology, Nelson Mandela University, Gqeberha, South Africa
Adlai S. Davids, Department of Public Health, Societies and Belonging, Human Sciences Research Council, Pretoria, South Africa; and Faculty of Health Sciences, Nelson Mandela University, Gqeberha, South Africa
Ronel Sewpaul, Department of Public Health, Societies and Belonging, Human Sciences Research Council, Cape Town, 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.


Keywords

pharmacovigilance; tuberculosis; adverse events; drug resistant; reporting.

Sustainable Development Goal

Goal 3: Good health and well-being

Metrics

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