A patient in Limpopo receives a generic antiretroviral from a local clinic. Months later, she develops an adverse reaction that has already been documented in a case report published in a regional African medical journal. The journal is not indexed by PubMed or Embase. Her prescriber has not seen it. Her MAH’s pharmacovigilance team has not seen it.
The signal exists. It simply has not reached the people responsible for acting on it.
This is not hypothetical. It reflects a structural gap in how literature surveillance works in Africa, and it has direct implications for patient safety.
The blind spot in your literature search
Most MAHs operating in South Africa rely on PubMed, Embase, or both for literature surveillance. These are robust, globally trusted databases that index thousands of journals and form the backbone of most pharmacovigilance programmes.
But they do not cover everything.
More than 100 African medical and pharmaceutical journals remain outside these indexing systems. These are legitimate, peer-reviewed publications where local clinicians and researchers publish case reports, adverse events, and drug safety observations that are directly relevant to African markets.
If your surveillance programme relies only on globally indexed databases, you are covering international literature well, but systematically missing regionally relevant data. In many cases, this is where safety signals emerge first.
Why this matters now
Africa’s pharmaceutical landscape is evolving rapidly, and that evolution increases the importance of comprehensive literature monitoring.
The growth of generic medicines has expanded access and improved affordability. However, it also introduces variability. Differences in manufacturing, excipients, and supply chains mean that safety data for an originator product does not always translate directly to all generic equivalents. Adverse events linked to specific formulations may only become visible through real-world use and are often reported in regional publications.
At the same time, substandard and falsified medicines remain a concern. The World Health Organization estimates that around 1 in 10 medical products in low- and middle-income countries is substandard or falsified. These products generate adverse events that may appear as unexpected reactions to legitimate medicines, complicating signal detection and causality assessment.
In both cases, the earliest evidence may be published locally. If those sources are not monitored, the signal is delayed or missed entirely.
Why this matters under SAHPRA’s framework
South Africa is estimated to under-report adverse drug reactions compared to global benchmarks. While spontaneous reporting gaps play a role, literature surveillance is part of the equation.
The South African Health Products Regulatory Authority requires MAHs to monitor all available sources of safety information. A programme limited to internationally indexed databases introduces three risks:
- Compliance exposure: The gap between available African literature and what is monitored is measurable.
- Signal delay: Region-specific safety insights may appear in local journals months before entering global databases, if at all.
- Audit vulnerability: During inspections, the expectation is no longer limited to standard database searches. It extends to demonstrating coverage of regionally relevant sources.
This is not about failing to follow best practice. It is about the limitations of the systems traditionally used.
This is an indexing problem, not a quality problem
The African journals in question are not inferior in quality. Many are produced by universities, medical societies, and national institutions.
The issue is structural. Global indexing systems were not designed with African publication ecosystems in mind. As a result, a significant portion of locally relevant safety data sits outside standard search pathways.
Why AI must be validated in pharmacovigilance
AI can help address this gap, but only if implemented within a regulated framework.
Pharmacovigilance operates under strict GxP requirements. Any system used for literature monitoring must be auditable, reproducible, and validated. General-purpose AI tools do not meet these standards. Without validation, they introduce new compliance risks rather than resolving existing ones.
This is where many approaches fall short. Speed without governance is not an advantage in a regulated environment.
It also reinforces a broader vision of health sovereignty. By working together, African regulators can reduce duplication, strengthen internal capacity, and create a regulatory environment that supports innovation and local manufacturing.
At Vicore Health, we see regulatory reliance as a cornerstone of smarter regulation in Africa. By supporting trust-based collaboration, strengthening regulatory systems, and aligning practices across jurisdictions, reliance offers a practical pathway toward improved health outcomes and more resilient healthcare systems across the continent.
How LewisLit closes the gap
LewisLit was developed to address both the coverage gap and the compliance requirement.
It combines three core elements:
- Expanded coverage: Systematic screening of over 100 non-indexed African journals alongside standard global databases.
- Validated AI with human oversight: Automated screening and classification supported by expert pharmacovigilance review.
- Managed service delivery: Audit-ready outputs without the need for additional internal infrastructure or headcount.
Developed by Vicore Health in partnership with Scigenix, LewisLit brings together regional regulatory expertise and validated AI capability designed specifically for pharmacovigilance workflows.
What automation means in practice
Literature screening is one of the most time-intensive pharmacovigilance activities. For many teams, especially in resource-constrained environments, it competes directly with higher-value work such as signal assessment and regulatory reporting.
Automating large portions of the screening process does not remove the need for human expertise. It reallocates it.
By reducing manual workload, pharmacovigilance professionals can focus on interpretation, decision-making, and patient safety outcomes rather than repetitive tasks.
The question every PV lead, Africa focused QPPV and Responsible Pharmacist should ask
The African literature gap is real, measurable, and growing. As regional research output increases, so does the volume of safety data that may not be captured through traditional monitoring approaches.
Two questions matter:
- Does your current literature surveillance programme cover the sources where African safety signals are most likely to appear?
- Is your approach compliant with regulatory expectations for validation and auditability?
If the answer to either is uncertain, there is a gap.
And behind that gap is a patient whose safety depends on whether that signal is seen in time.
Contact us at info@vicorehealth.com or reach out directly to start the conversation.
Automating large portions of the screening process does not remove the need for human expertise. It reallocates it.
By reducing manual workload, pharmacovigilance professionals can focus on interpretation, decision-making, and patient safety outcomes rather than repetitive tasks.
