Awareness of caregiver reporting of suspected adverse drug reactions in children treated for drug-resistant tuberculosis

Abstract

Introduction: Despite the advances in treatment for drug-resistant tuberculosis (DR-TB) in children, children are still at risk of developing adverse drug reactions (ADRs) during the prolonged treatment process. Monitoring and reporting of ADRs to ensure patient safety is a critical component of pharmacovigilance. The foundation of pharmacovigilance activities relies on ADR reporting by healthcare professionals and patients. However, there are limited studies that have focused on how caregivers of children navigate ADR reporting processes. This study aimed to explore the awareness of caregiver reporting of suspected ADRs in children treated for DR-TB. Methods: A qualitative exploratory study was conducted at Brooklyn Chest Hospital (BCH), a centralised provincial TB institution in Cape Town, between January and June 2025. The study consisted of two phases, phase one included direct observations of healthcare professionals (doctors, nurses, pharmacists) and caregivers for a period of two weeks (Monday to Friday). Phase two included semi-structured interviews with five caregivers. The participants were purposively sampled and included caregivers of children (0-14 years) treated for DR-TB. Observation field notes and interview transcripts were analysed using thematic analysis. Results: Four main themes emerged: (1) caregivers’ understanding and perceptions of ADRs and side effects; (2) access to healthcare and system influences on ADR reporting; (3) caregivers’ role, motivation, and responsibility in ADR reporting; and (4) social context, stigma and coping. Caregivers were unfamiliar with the term ‘adverse drug reaction’ but understood side effects as harmful bodily reactions. Caregivers preferred reporting ADRs to doctors at BCH due to the perceived expertise in managing paediatric TB and ease of accessibility. Reporting at primary clinics was limited by untrained staff, long waiting times, poor communication and stigma. Caregivers’ demonstrated strong commitment in their children’s care, motives for ADR reporting included emotional concerns, moral duty, and altruism. Stigma and discrimination in both healthcare settings and communities caused emotional strain. Coping strategies such as shared caregiving, family education, and positive reinforcement supported treatment adherence. Conclusion: Caregivers demonstrated strong commitment and vigilance in managing their child‘s DR-TB treatment, yet gaps in ADR awareness and alternative reporting pathways persisted. Reliance on doctors for reporting ADRs reflected trust in medical authority, while the pharmacist’s role in pharmacovigilance remains under-recognised. Limited training of healthcare workers and system insufficiencies at primary care clinics hindered reporting by caregivers.