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. 2025 Jul;59(4):882-891.
doi: 10.1007/s43441-025-00795-x. Epub 2025 May 13.

Awareness and Attitudes Regarding Adverse Drug Events and Reporting in South Africa

Nokukhanya Ncube  1 , Martha S Lubbe  1 , Hanlie Steyn  1 , Nkengafac V Motaze  2
Affiliations

Awareness and Attitudes Regarding Adverse Drug Events and Reporting in South Africa

Nokukhanya Ncube et al. Ther Innov Regul Sci. 2025 Jul.

Abstract

Background: Reporting of adverse drug events (ADEs), by consumers enhances medication-related risk surveillance, public awareness, and understanding of medicine safety. The aim of this study was to explore adults' awareness of ADEs, attitudes towards reporting and perceptions of their role in reporting ADEs in South Africa.

Method: We conducted a cross-sectional, analytical study in which adults residing in South Africa completed an online questionnaire. The data collected was analysed using both descriptive and inferential statistics.

Results: We received responses from 350 participants. Most participants (86.2%, n = 302; N = 350) reported having heard about ADEs and the majority of participants (94.4%, n = 301; N = 319) indicated that reporting of ADEs was important. The Med Safety App was not widely known (17.3%, n = 58; N = 336) while the South African Health Products Regulatory Authority (SAHPRA) was relatively well known (77.4%, n = 260; N = 336). Healthcare providers only educated 55.7% (n = 180; N = 323) of the participants about ADEs and only 50.5% (n = 163; N = 323) of the participants asked their healthcare providers about ADEs. Awareness regarding ADEs was significantly higher (p < 0.001) among healthcare professionals (HCPs) compared to non-healthcare professionals (non-HCP).

Conclusion: Most participants were aware of ADEs and agreed it was important to report ADEs although reporting tools, such as the Med Safety App, were not well known. We recommend awareness campaigns on reporting processes because this could improve consumer reporting of ADEs in South Africa.

Keywords: Adverse drug events; Consumer; Drug side-effects; Pharmacovigilance; Reporting.

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Conflict of interest statement

Declarations. Competing Interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
HCPs consulted for health-related needs
Fig. 2
Fig. 2
Professions of healthcare workers. The category referred to as “other” includes fields such as epidemiologist, medical scientist and paramedics
Fig. 3
Fig. 3
Participants’ sources of information for learning about ADE reporting. The category referred to as “other” includes work, school, and medicine package inserts
Fig. 4
Fig. 4
Participants’ current knowledge on, and desire to learn about ADEs
See this image and copyright information in PMC

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