Ncube Nokukhanya, Lubbe Martha S, Steyn Hanlie, Motaze Nkengafac V
Medicine Usage in South Africa, Faculty of Health Sciences, North-West University, Potchefstroom, South Africa.
Ther Innov Regul Sci. 2025 May 13. doi: 10.1007/s43441-025-00795-x.
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.
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.
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).
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.
消费者报告药品不良事件（ADEs）可加强与用药相关的风险监测、提高公众意识并增进对药品安全性的理解。本研究旨在探讨南非成年人对药品不良事件的认知、对报告的态度以及对自身在报告药品不良事件中所起作用的看法。
我们开展了一项横断面分析研究，居住在南非的成年人完成了一份在线问卷。收集到的数据采用描述性统计和推断性统计进行分析。
我们收到了350名参与者的回复。大多数参与者（86.2%，n = 302；N = 350）报告听说过药品不良事件，且大多数参与者（94.4%，n = 301；N = 319）表示报告药品不良事件很重要。药品安全应用程序并不广为人知（17.3%，n = 58；N = 336），而南非卫生产品监管局（SAHPRA）相对较为知名（77.4%，n = 260；N = 336）。医疗保健提供者仅向55.7%（n = 180；N = 323）的参与者介绍过药品不良事件，只有50.5%（n = 163；N = 323）的参与者向其医疗保健提供者询问过药品不良事件。与非医疗保健专业人员（非HCP）相比，医疗保健专业人员（HCP）对药品不良事件的认知显著更高（p < 0.001）。
大多数参与者了解药品不良事件，并认同报告药品不良事件很重要，尽管诸如药品安全应用程序等报告工具并不广为人知。我们建议开展关于报告流程的宣传活动，因为这可能会改善南非消费者对药品不良事件的报告情况。
