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Main Article Content
Medical practitioners’ perceptions of adverse event reporting for rare diseases in South Africa
Leith F. Kwaan
Leith F. Kwaan
Helen L. Malherbe
Helen L. Malherbe
Colleen Aldous
Colleen Aldous
David Blackbeard
David Blackbeard
Abstract
Background: Adverse events (AEs) are underreported. In rare diseases (RDs), this is compounded by small patient populations, complex pathology and limited treatments. Most related research is from developed countries using survey methods.
Aim: This qualitative study aimed to expand on existing knowledge by exploring perceptions of medical practitioners (MPs) managing RDs regarding AE reporting.
Setting: The study took place in the South African public and private healthcare sectors.
Methods: A qualitative, exploratory and interpretive design was employed. Individual interviews were conducted with 12 purposively sampled MPs, exploring their perceptions and experiences of AE reporting, and relevant barriers and facilitators. Transcripts were analysed using reflexive thematic analysis.
Results: Three themes were generated: (1) Trust in healthcare systems, colleagues and doctor–patient interaction impacted reporting. (2) Reporting AEs for medicines with delayed local launch was perceived to contribute insignificantly to safety profiles. Participants’ stewardship of limited treatment options caused reluctance to report AEs and caution around direct patient reporting. (3) Risk tolerance for treatment gain, including off-label use, was perceived to be balanced by medicine safety knowledge.
Conclusion: Pharmacists were trusted for AE reporting. Medical practitioners’ reluctance to report AEs associated with singular treatment options was grounded in concern regarding treatment access. Caution around direct patient reporting was driven by a reluctance to jeopardise treatment access as a result of potentially irrelevant patient-reported events. Risks associated with medicines are mitigated by knowledge generated through AE reporting.
Contribution: Issues surrounding trust relationships, resources and practice risk were identified as underlying AE underreporting by MPs. Proposed solutions included pharmacist involvement and improved medicine supply.
