Pharm Sector In Laos
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Pharm Sector In Laos



Conference on Health and Social Protection: Meeting the needs of the poor, 09-10 October 2008

Conference on Health and Social Protection: Meeting the needs of the poor, 09-10 October 2008



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Pharm Sector In Laos Pharm Sector In Laos Presentation Transcript

  • Strategies for improving Pharmaceutical Use - The Role of Drug Regulatory Agency in Lao PDR Conference on Health and Social Protection Meeting the Needs of the Poor 09-10 October 2008, Lane Xang Hotel By Lamphone Syhakhang Head of drug Control Division, Food and Drug Department, Ministry of Health Lao PDR
  • Outline of presentation
    • 1. Drug Regulatory Authority at different levels
    • 2. Main Role of Drug Regulatory Authority
    • 3. Important Regulatory instruments
    • 4. Challenges
    • 5. Lessons learned/ suggestions
  • 1. Drug Regulatory Authorities at different levels
    • Central level: Food and Drug Department (FDD)
    • Province level: Provincial Food and Drug Unit
    • District level: District Food and Drug Unit
    • + Food and Drug committee at each level
    • + Cooperation with Customs, Police, Trade, Justice and Local Governments
  • 2. Main Role of Drug Regulatory Authorities
    • Ensuring quality and use of medicines
    • Pre-marketing quality assessment:
    • marketing authorization, licensing and registration
    • Post-marketing surveillance:
    • quality and adverse events, advertising, and promotion control
    • Adequate legislation and law enforcement
  • 3. Important Regulatory Instruments
    • National Medicine Policy
    • Law and Regulations
      • Registration and licensing system
      • including stamps for imported and
      • registered drugs
    • Drug selection and
      • nomenclature
      • - National Essential Medicine List
    • System for drug
      • procurement
  • 3. Important Regulatory Instruments (con’t)
    • Quality Assurance System
    • Monitoring system for pharmacies, companies and factories through GPP, GWP and GMP indicators, drug sampling and analysis
    • Sanctions and punishments
  • 3. Important Regulatory Instruments (con’t)
    • Promotion of RUD :
    • IEC to Health providers and general public through different media means
    • Monitoring the use of medicines in hospitals through STG and RUD indicators
    • Drug Therapeutic Committees at all provincial hospitals.
  • 4. Challenges
    • Enforcement of law and regulations
      • Availability of substandard, counterfeit
      • Strict sanctions and punishment
    • Strengthening the drug QA system
    • Improve RUD through IEC and training
    • Effective management and financial systems
    • Limitations of human resources in terms of skilled personnels
  • 5. Lessons learned
    • 1. Increase enforcement of law and regulations
    • 2. Strong Cooperation with relevant organisations e.g., Police, customs, Trade and Local Government
    • 3. Increase awareness of community, private providers and health workers on the counterfeit and substandard of medicines
  • 5. Lessons learned (con’t)
    • 4. Provide adequate training to provincial and district inspectors on technical issues how to do inspections
    • 5. Improvement of rational use of drugs among health staff, providers and consumers
    • 6. Provide necessary equipment, tools and human resources to DRA at each level
  • Thank you