Introduction
Literature monitoring is a cornerstone of modern pharmacovigilance, enabling the continuous identification of safety information emerging after a medicinal product enters the market. Scientific publications, case reports, observational studies, and clinical analyses often provide the earliest evidence of adverse drug reactions (ADRs) and evolving safety concerns.
In an increasingly globalised healthcare environment, pharmacovigilance teams must look beyond a single source of information. Global and local medical literature each play a distinct yet complementary role in detecting safety signals. While global literature provides breadth and consistency, local literature offers depth and regional relevance. Together, they form a comprehensive foundation for robust signal detection and risk assessment.
What Is Pharmacovigilance Literature Monitoring?
Pharmacovigilance literature monitoring refers to the systematic and ongoing process of searching, screening, reviewing, and analysing published scientific and medical information to identify potential ADRs, safety signals, and emerging risks associated with medicinal products.
This process typically includes:
- Defining structured search strategies
- Reviewing peer-reviewed journals, reports, and publications
- Identifying individual case safety reports (ICSRs) and safety-relevant findings
- Assessing the clinical relevance and regulatory impact of identified information
Regulatory authorities expect Marketing Authorisation Holders (MAHs) to monitor both global and local literature sources as part of their Good Pharmacovigilance Practices (GVP) obligations. Failure to capture relevant safety information, regardless of where it is published, can result in delayed signal detection, putting patient safety at risk.
Global Literature: Scope and Significance
Global literature covers widely accessible and well-indexed scientific sources that disseminate medical knowledge across borders. These include international textbooks, high-impact journals, and large biomedical databases such as PubMed/MEDLINE and Embase, as well as multinational clinical studies and meta-analyses.
Key characteristics of global literature include:
- Coverage of diverse populations across multiple countries
- Cover the risks associated with global prescribing habits or formulations
- High standards of peer review and editorial oversight
- Standardized terminology and reporting structures
- Predominant publication in English
Global literature plays a critical role in identifying broadly applicable safety signals. Signals detected through multinational trials or widely cited journals often indicate risks that may affect large patient populations. As a result, Global literature helps identify safety information, Individual Case Safety Reports, periodic safety update reports (PSURs), risk management plans (RMPs), regulatory submissions, formal signal evaluation processes, and benefit-risk assessment reports.
However, despite its breadth, global literature may not fully reflect regional prescribing practices, genetic differences, or local healthcare realities.
Local Literature: Why Region-Specific Data Matters
Local literature refers to publications originating within specific countries or regions. These may include national or regional journals, non-indexed publications, local observational studies, conference proceedings, regulatory bulletins, and research published in indigenous or non-English languages.
The value of local literature lies in its ability to:
- Reveal region-specific adverse events influenced by indigenous factors
- Highlight risks associated with local prescribing habits or formulations
- Capture safety data related to environmental, dietary, or cultural practices
- Identify ADRs in populations underrepresented in global studies
Local literature often contains early signals that may not appear in global databases. Rare or population-specific ADRs are particularly likely to surface first in regional publications. Despite this importance, local literature is frequently overlooked due to limited indexing, language barriers, and resource constraints.
Incorporating local literature into safety surveillance is therefore essential for achieving a complete and accurate safety profile of the medicines.
How Global and Local Literature Work Together
A comprehensive pharmacovigilance strategy integrates both global and local literature sources. When used together, these data streams enable safety teams to:
- Validate globally observed signals using regional evidence
- Detect trends that may be limited to specific geographies
- Understand variations in risk magnitude across populations
- Support both local regulatory submissions and multinational safety assessments
For example, a signal first identified in global literature may gain clinical relevance when corroborated by local case reports. Conversely, a region-specific signal identified locally may prompt broader investigation through global sources. This bidirectional relationship strengthens decision-making and improves patient safety outcomes.
SafePhV’s Role in Literature Monitoring
SafePhV operates at the intersection of global and local literature monitoring, offering technology-driven support for the pharmacovigilance teams. As part of its pharmacovigilance services, SafePhV provides an AI-powered literature screening tool that systematically screens both global and Local literature sources.
The SafePhV platform is designed to:
- Screen global and local journals
- Automate searches: deduplication, relevance, frequency, categorization
- NLP classification for ICSR, signals, and aggregate related articles
- Integrate with the SafePhV database
- Assign reviewers and track workflow, decisions, and comments
- Convert ICSR-related literature to XML for SafePhV import
- Support local languages
- Maintain tracker per SOP
- Visualize results on a dashboard
By leveraging artificial intelligence (AI), machine learning (ML), and natural language processing (NLP), SafePhV accelerates literature review while supporting ICSR, aggregation, and signal detection workflows. Insights derived from literature monitoring are seamlessly integrated into pharmacovigilance case management, aggregate reports, and ongoing signal monitoring activities, enabling faster and more consistent safety assessments.
Practical Workflow: Literature Monitoring for Signal Management
A structured literature monitoring workflow typically includes the following steps:
1. Define the search strategy
Establish global and local search terms, including product names, therapeutic classes, and safety concerns.
2. Select relevant databases
Use international databases such as PubMed and Embase alongside regional journals and local publication sources.
3. Automated screening
Apply AI and NLP-based tools, such as those provided by SafePhV, to triage large volumes of results.
4. Data extraction and validation
Identify safety-relevant findings and assess their clinical significance.
5. Correlation with safety databases
Compare literature findings with existing safety data and case reports from safety database.
6. Signal flagging and review
Escalate potential global or region-specific signals for medical and regulatory evaluation.
Best Practices and Strategies
To optimize literature monitoring efforts, pharmacovigilance teams should:
- Regularly review and update global and local search strategies
- Apply Boolean logic and controlled vocabularies consistently
- Maintain clear documentation for regulatory inspections
- Leverage automated platforms such as SafePhV to improve efficiency and scalability
Adopting these practices helps ensure comprehensive coverage while managing the growing volume of published medical data.
Conclusion
Neither global nor local literature alone is sufficient for comprehensive pharmacovigilance signal detection. Global literature provides scale and standardization, while local literature delivers critical regional insights that may otherwise be missed. Together, they enable a more accurate and timely understanding of medicinal product safety.
Technology-enabled platforms such as SafePhV empower pharmacovigilance teams to automate, integrate, and analyze global and local literature in real time. By embedding these insights into safety workflows, organisations can strengthen compliance, enhance signal detection, and ultimately improve patient safety.
Frequently Asked Questions (FAQs)
Yes. Regulatory authorities expect ongoing literature surveillance as part of Good Pharmacovigilance Practices to ensure the timely identification of safety information.
Yes. Case reports, clinical and non-clinical studies published in medical literature often provide early indications of emerging risks associated with medicines.
Local literature may not be indexed in major databases and is frequently published in regional languages, making it harder to access without dedicated strategies.
Yes. SafePhV is designed to support monitoring across both internationally indexed and non-indexed, and region-specific literature sources.
SafePhV can be seamlessly integrated with multiple databases and configured to automatically screen literature based on pre-defined strategies. By leveraging AI, machine learning (ML), and natural language processing (NLP), SafePhV automates large portions of literature review, efficiently categorizing ICSR and non-ICSR information (including aggregate and signal-related data), thereby reducing manual workload while ensuring accuracy, traceability, and regulatory compliance
Yes. By enabling structured monitoring of local literature alongside global sources, SafePhV supports early identification of region-specific safety signals.