Pharmacovigilance in Georgia

Pharmacovigilance in Georgia: Progress, Challenges, and Future Directions

Abstract
Pharmacovigilance (PV) ensures the safety of pharmaceutical products by monitoring adverse drug reactions (ADRs) and ensuring regulatory compliance. In Georgia, the PV system is evolving through international collaboration, adherence to global standards, and increasing public awareness. This article explores the current state of pharmacovigilance in Georgia, highlighting advancements, challenges, and prospective developments.

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Introduction

Pharmacovigilance is critical for ensuring patient safety and enhancing the effectiveness of medicinal products. Georgia, as part of its health system modernization efforts, has adopted international PV practices, aligning with guidelines from the World Health Organization (WHO) and the European Medicines Agency (EMA). Despite notable progress, challenges remain in fully integrating PV into healthcare systems and improving ADR reporting rates.

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Current Pharmacovigilance Framework

1. Regulatory Oversight
   Georgia’s pharmacovigilance activities are overseen by the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health, and Social Affairs and the State Agency for Medicines and Medical Activities. These bodies ensure compliance with local and international PV regulations.
2. Adherence to International Standards
   Georgia participates in the WHO Programme for International Drug Monitoring, reporting ADRs to VigiBase. It follows EMA’s Good Pharmacovigilance Practices (GVP), particularly for risk management plans (RMPs) and periodic safety update reports (PSURs). The adoption of these standards helps harmonize Georgian PV practices with global trends.
3. ADR Reporting Systems

• Spontaneous Reporting: The primary method for collecting ADR data relies on voluntary submissions from healthcare professionals and patients. Efforts are underway to enhance digital reporting infrastructure to improve efficiency.
• Surveillance of Clinical Trials: Pharmacovigilance is a critical component of clinical trial monitoring in Georgia, ensuring safety in pre-market and post-market settings.

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Pharmacovigilance in Georgia: Achievements

1. Integration with WHO Systems
   Georgia has made significant progress in integrating its pharmacovigilance activities with international databases such as VigiBase, enabling comprehensive global monitoring of ADRs.
2. Training and Capacity Building
   Regular training sessions for healthcare professionals have improved awareness and technical capacity for ADR reporting. Educational programs emphasize the importance of pharmacovigilance for patient safety.

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Challenges in the Georgian PV System

1. Underreporting of ADRs
   Despite educational initiatives, ADR underreporting remains a significant issue, primarily due to low awareness among healthcare professionals and patients.
2. Infrastructure Limitations
   Georgia’s reliance on manual ADR reporting methods highlights the need for advanced electronic systems to streamline data collection and analysis.
3. Limited Public Engagement
   Patient involvement in ADR reporting is minimal, necessitating targeted awareness campaigns to encourage participation in pharmacovigilance.

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Pharmacovigilance in Georgia: Future Directions

1. Digital Transformation
   The introduction of electronic pharmacovigilance systems is a key priority for Georgia. These systems aim to enhance data accuracy and improve real-time reporting capabilities.
2. Public Awareness Campaigns
   Educating patients about their role in pharmacovigilance through media campaigns and community outreach is essential for addressing ADR underreporting.
3. Regional Collaboration
   Georgia seeks to strengthen pharmacovigilance by fostering partnerships within the Eurasian region. Collaborative efforts with neighboring countries could lead to shared databases and harmonized reporting protocols.

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Conclusion
Georgia’s pharmacovigilance system has advanced significantly, integrating international standards and emphasizing training and education. By prioritizing technological modernization and public engagement, Georgia is poised to further strengthen its pharmacovigilance system, ensuring better patient safety and compliance with global standards.

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References

1. State Agency for Medicines and Medical Activities. Overview of Pharmacovigilance in Georgia. 2024.
2. WHO Programme for International Drug Monitoring. VigiBase Database Reports. 2024.
3. EMA Guidelines on Good Pharmacovigilance Practices (GVP). Risk Minimization Measures and ADR Monitoring. 2024.