世界银行-大韩民国药物警戒系统概述：从最佳实践中学习（英）-2023.8-31页_1mb

Overview of Republic of Korea Pharmacovigilance System

Introduction

Pharmacovigilance monitors drug safety post-approval, ensuring patient protection through collection, detection, and prevention of adverse effects. It informs health decisions and addresses real-world drug performance, as clinical trials often lack population diversity.

Drug Regulation

• Legislation: Governed by the Pharmaceutical Affairs Act, aligned with international standards, managing drug approval and safety oversight.
• Regulatory Bodies: Ministry of Food and Drug Safety (MFDS) leads drug regulation, with Ministry of Health and Welfare handling healthcare institutions and pricing.
• Funding for Medicines: Single-payer system via National Health Insurance covers most populations, with cost-effective reimbursement through a positive drug list.

Monitoring Safety of Drugs and Medicines

• National Pharmacovigilance System: Decentralized system with KIDS as the central hub coordinating Regional Pharmacovigilance Centers (RPVCs).
• Korea Institute of Drug Safety and Risk Management (KIDS): Manages adverse event reporting, signal detection, and provides evidence-based drug safety information.
• Pharmacovigilance Network: RPVCs handle local reporting, education, and intensive monitoring of special populations and designated drugs.
• Korea Adverse Event Reporting System (KAERS): Computerized system for individual case safety reports; mandatory since 2014 for marketing authorization holders; integrates with NeDrug for comprehensive data management.
• Completeness and Trends: High completeness in hospital reports, with initiatives to improve consumer and manufacturer submissions through training.
• Pharmacoepidemiology: In-depth studies on serious adverse events to prioritize safety actions and inform regulatory decisions.
• Drug Utilization Review (DUR): Identifies inappropriate drug use, reduces preventable adverse drug reactions, and supports COVID-19 response through data integration.

Safety Measures Based on Pharmaceutical Information

• Domestic Reports: Lead to safety actions like label changes or recalls based on signal detection and statistical analysis.
• International Information: Revised based on global data to address drug safety concerns not captured domestically.

Adverse Drug Reaction Relief System

• Relief Mechanism: Government-funded compensation scheme through KIDS, operated with industry contributions to avoid legal proceedings.
• Product Liability Act: Provides defenses for manufacturers but requires preventive measures upon defect awareness.
• Claim Process: Involves causality assessment by expert committees and offers various relief benefits, including lump sum compensation and coverage for medical expenses.

Challenges and Future Improvements

• Current Limitations: Reliance on voluntary spontaneous reporting; opportunity for expansion to include primary care facilities and enhanced public education.
• Future Directions: Development of active surveillance systems using electronic health data, as exemplified by the KFDA's common data model for nationwide implementation.

Takeaways and Lessons

• Korea's system is a best practice model from sustained government effort, offering lessons in structured pharmacovigilance.
• Key pillars include strong legal foundations, decentralized monitoring with coordination, computerized reporting (KAERS), data-driven policy and actions, and sustainable funding.
• It strengthens health systems, especially in countries with integrated ministries, by ensuring drug safety throughout the lifecycle.

Conclusion

Korea's pharmacovigilance investment is a critical public good for ensuring drug efficacy and safety post-market, with systemic benefits demonstrated through continuous improvement and integration with national health structures.