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Pharmacovigilance and safety monitoring

Healthcare professionals, patients, and other stakeholders across Caribbean Member States may observe adverse reactions to medicines or vaccines, or identify potential quality issues during use. These events are reported through national systems or via the VigiCarib platform, a regional pharmacovigilance network coordinated by CARPHA. Reports are submitted through a secure system and routed to the relevant national authority, where they are validated and investigated according to national protocols.

At the regional level, VigiCarib aggregates reports across countries, enabling detection of patterns and safety signals that may not be visible at national level. Verified reports are also shared with global monitoring systems, such as the WHO Programme for International Drug Monitoring.

This use case illustrates how a cross-border healthcare architecture supports post-market surveillance by enabling structured reporting, data sharing, and analysis of safety information across jurisdictions.

Challenge today

  • Underreporting of adverse events
  • Fragmented reporting systems across countries
  • Limited regional visibility of safety signals
  • Delays in validation and investigation of reports
  • Limited integration between pharmacovigilance and regulatory systems

Desired situation

  • A unified and accessible reporting mechanism across the region
  • Standardised reporting of adverse reactions and quality issues
  • Real-time aggregation and analysis of safety data
  • Seamless integration with national and global monitoring systems
  • Improved participation from healthcare professionals and patients

Required capabilities

  • Identification of products, patients (where appropriate), and events
  • Secure submission and exchange of pharmacovigilance data
  • Standardised data formats for adverse event reporting
  • Integration with regulatory and surveillance systems
  • Signal detection and analytics capabilities
  • Traceability of reports and follow-up actions
  • Product Catalogue / Medicine Registry
  • Pharmacovigilance Reporting System
  • Health Data Exchange
  • Terminology & Semantics
  • Audit & Logging

Impact

  • Faster detection of safety risks and adverse reactions
  • Improved patient safety across the region
  • Stronger regulatory and public health decision-making
  • Better contribution to global monitoring systems
  • Increased trust in medicines and vaccination programmes