Barriers and enablers of adverse drug event reporting in South Africa: a cross-sectional survey of medicine users

Spontaneous reporting is the most frequently used method to collect data on adverse drug events (ADEs). To promote ADE reporting and enhance medicine safety, it is important to understand enablers and barriers to ADE reporting. This study described medicine users’ practices and previous experiences with reporting ADEs, including barriers and enablers to reporting ADEs in South Africa. This was a cross-sectional, analytical study in which adults residing in South Africa were requested to complete an online questionnaire. The majority of participants (70.5%, n = 203; N = 288) indicated that they experienced ADEs in the past and 77.0% (n = 181; N = 235) of these events occurred after the use of medication. Only 59.1% (n = 120; N = 203) of participants who experienced ADEs, reported them. There was no difference in reporting frequency between healthcare professionals (HCP) and non-HCPs (p > 0.9). Furthermore, 78.3% (n = 94; N = 120) of participants reported ADEs to their doctor. The main enabler for reporting ADEs indicated by both HCP and non-HCPs was that reporting could help to keep others safe. The most cited barrier to ADE reporting for both HCP and non-HCPs was the assumption that the side effects would go away once the medication was stopped. A large proportion of participants who experienced ADEs reported them to their doctors, and reporting of ADEs was similar between HCPs and non-HCPs. The barriers and enablers to reporting ADEs were similar for HCPs and non-HCPs. These results could help in planning awareness-raising campaigns aimed at improving ADE reporting in South Africa.