In pharmacovigilance (PV), keeping track of adverse drug reactions (ADRs) is often associated with spontaneous reports from hospitals, healthcare professionals, or patients. But a less talked about, yet equally critical, piece of the puzzle is literature monitoring.
For pharmaceutical companies operating in Africa, this is not just a regulatory requirement. It is a vital practice for ensuring patient safety, maintaining credibility, detecting region-specific safety issues, and strengthening your compliance posture in an evolving regulatory environment.
What Exactly Is Literature Monitoring?
Literature monitoring refers to the systematic and periodic review of published medical and scientific information for any mention of your medicinal products and their potential adverse effects.
This includes reviewing:
- Peer-reviewed journals — both international and local.
- Case reports and case series — where individual patient experiences might highlight rare or unexpected reactions.
- Conference abstracts and proceedings — where preliminary findings are often shared before full publication.
- Bulletins, newsletters, and alerts from professional associations, hospitals, and ministries of health.
- Online medical portals and repositories — which may include grey literature or preprints.
It ensures that what is being observed and reported publicly, even if not reported to you directly — still informs your safety surveillance activities.
In the European Union, for instance, the EMA mandates that Marketing Authorization Holders (MAHs) monitor both indexed and local literature weekly for their products. In Africa, this standard is beginning to take hold, with regulators like Nigeria’s NAFDAC and South Africa’s SAHPRA incorporating literature monitoring expectations into their pharmacovigilance guidelines.
Why It Matters in the African Context
Africa presents a unique and complex environment for drug safety monitoring, and literature monitoring is particularly important here because:
- Diverse Populations: Genetic variability and cultural practices (such as the concurrent use of herbal medicines) can lead to ADR patterns not observed elsewhere.
- Varied Healthcare Settings: Differences in healthcare infrastructure, diagnostic capabilities, and treatment protocols can affect drug outcomes.
- High Burden of Comorbidities: Diseases like HIV, malaria, and tuberculosis often coexist, leading to polypharmacy and higher chances of drug-drug interactions.
- Unindexed Journals: Many African medical journals are not indexed in major international databases like PubMed, so the only way to capture their content is through dedicated local monitoring.
For example, a Nigerian journal may publish a case series on liver toxicity linked to a commonly prescribed antimalarial, which might not appear in global databases for months — if ever — unless proactively sought.
Ignoring these local sources could result in delayed detection of safety signals, regulatory noncompliance, and ultimately, harm to patients.
Beyond Compliance: Why Literature Monitoring is Strategic
Literature monitoring is more than just a compliance exercise. It offers strategic advantages that help companies operate responsibly and competitively:
1. Early Detection of Emerging Risks
It helps identify rare or serious adverse events before they escalate into widespread issues.
2. Support for Risk Management Plans
Findings can inform periodic safety update reports (PSURs), risk minimization measures, and updates to risk management plans.
3. Facilitating Label Changes
Relevant findings may necessitate updates to the product label, package insert, or patient information leaflet to reflect new warnings or precautions.
4. Building Trust with Stakeholders
Demonstrating that you actively monitor and respond to safety concerns reinforces confidence among regulators, healthcare professionals, and patients.
5. Informing Business Decisions
Literature findings can guide market access decisions, post-marketing studies, and even the decision to withdraw or modify a product in specific markets.
Safety Starts With Local Insight
No two regions are identical when it comes to drug use and safety. In Africa, environmental factors like diet, disease prevalence, cultural practices, and genetic predispositions all contribute to how a medicine performs in real-world use.
For example:
- A drug considered safe in Europe may trigger unexpected reactions in African populations due to different metabolic profiles.
- Off-label use of a medicine, common in some settings, may result in unanticipated outcomes not reflected in the global data.
Only by systematically scanning local sources can companies pick up on these regional differences early and take appropriate action.
Strengthening Regulatory Readiness
African regulators are moving toward harmonized PV standards aligned with ICH and WHO guidelines. In countries like Nigeria, Kenya, and Egypt, companies are increasingly required to demonstrate that they are actively monitoring all available safety data, including local literature.
Companies that already have robust literature monitoring processes in place are better positioned to:
- Respond promptly to regulatory queries or inspections.
- Submit accurate and complete PSURs and other periodic reports.
- Avoid fines, sanctions, or reputational damage from noncompliance.
- Build collaborative relationships with regulators based on transparency and diligence.
Literature Monitoring Service at IntraHub
At IntraHub, we recognize the unique challenges African companies face in accessing and reviewing local medical literature.
Our team offers a comprehensive, end-to-end service tailored for the African context:
✔ Systematic searches of indexed global databases and local African journals.
✔ Inclusion of grey literature, ministry of health newsletters, and conference abstracts.
✔ Analysis of findings to highlight relevant safety signals, product mentions, and regulatory implications.
✔ Timely delivery of actionable reports aligned with your PV obligations and timelines.
Whether you are a local manufacturer or a regional office of a multinational, IntraHub ensures your PV activities remain compliant, current, and informed by the most relevant data.
Common Misconceptions
“Our product has been safe for years — nothing new will come up.”
Even well-established products can reveal new risks over time, particularly in diverse real-world use.
“We only need to check the big databases.”
Local journals and regional publications often capture issues specific to African populations that global databases overlook.
“We can just do this once or twice a year.”
Literature monitoring must be ongoing, with weekly or monthly reviews depending on regulatory expectations and risk level of the product.
Looking Ahead
In summary, literature monitoring is not just a behind-the-scenes task but one of the foundational practices of responsible pharmacovigilance.
For Africa, where the drug safety landscape is still evolving, this practice becomes even more critical. Companies that invest in robust, proactive literature monitoring protect their patients, safeguard their products, and position themselves as leaders in compliance and safety.
Why Choose IntraHub?
At IntraHub, we go beyond simply collecting data. We help you interpret the findings and integrate them into your PV strategy.
Our service delivers:
- Timely insights from both local and global sources.
- Customized search strategies tailored to your product portfolio and markets.
- Professional, clear, and actionable reporting.
- A dedicated team that understands the African context while meeting global standards.
By partnering with IntraHub, you gain more than a service provider — you gain a trusted ally in your commitment to patient safety and regulatory compliance.
📩 Ready to strengthen your PV system with robust literature monitoring? Contact IntraHub today to learn how we can support your pharmacovigilance goals with insight and expertise.
