Rolf Panel Syhakhang

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Conference on Health and Social Protection: Meeting the needs of the poor, 9-10 October 2008
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Rolf Panel Syhakhang

  1. 1. Strategies for improving Pharmaceutical Use - The Role of Regulatory Agency in Lao PDR Conference on Health and Social Protection Meeting the Need 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
  2. 2. Outline of presentation <ul><li>1. Drug Regulatory Authority at different levels </li></ul><ul><li>2. Main Role of Drug Regulatory Authority </li></ul><ul><li>3. Important Regulatory instruments </li></ul><ul><li>4. Challenges </li></ul><ul><li>5. Lessons learned/ suggestions </li></ul>
  3. 3. 1. Drug Regulatory Authorities at different levels <ul><li>Central level: Food and Drug Department (FDD) </li></ul><ul><li>Province level: Provincial Food and Drug Unit </li></ul><ul><li>District level: District Food and Drug Unit </li></ul><ul><li>+ Food and Drug committee at each level </li></ul><ul><li>+ Cooperation with Customs, Police, Trade, Justice and Local Governments </li></ul>
  4. 4. 2. Main Role of Drug Regulatory Authorities <ul><li>Ensuring quality of medicines </li></ul><ul><li>Pre-marketing quality assessment: </li></ul><ul><li>marketing authorization, licensing and registration </li></ul><ul><li>Post-marketing surveillance: </li></ul><ul><li>quality and adverse events, advertising, and promotion control </li></ul><ul><li>Adequate legislation and law enforcement </li></ul>
  5. 5. 3. Important Regulatory Instruments <ul><li>National Medicine Policy </li></ul><ul><li>Law and Regulations </li></ul><ul><ul><li>Registration and licensing system </li></ul></ul><ul><ul><li>including stamps for imported and </li></ul></ul><ul><ul><li>registered drugs </li></ul></ul><ul><ul><li>Drug selection and </li></ul></ul><ul><ul><li>nomenclature </li></ul></ul><ul><ul><li>- National Essential Medicine List </li></ul></ul><ul><ul><li>System for drug </li></ul></ul><ul><ul><li>procurement </li></ul></ul>
  6. 6. 3. Important Regulatory Instruments (con’t) <ul><li>Quality Assurance System </li></ul><ul><li>Monitoring system for pharmacies, companies and factories through GPP, GWP and GMP indicators, drug sampling and analysis </li></ul><ul><li>Sanctions and punishments </li></ul>
  7. 7. 3. Important Regulatory Instruments (con’t) <ul><li>Promotion of RUD : </li></ul><ul><li>IEC to Health providers and general public </li></ul><ul><li>Monitoring the use of medicines in hospitals through STG and RUD indicators </li></ul><ul><li>Drug Therapeutic Committees at all provincial hospitals. </li></ul>
  8. 8. 4. Challenges <ul><li>Enforcement of law and regulations </li></ul><ul><li>Strengthening the drug QA system </li></ul><ul><li>Improve RUD through IEC and training </li></ul><ul><li>Effective management and financial systems </li></ul>
  9. 9. 5. Lessons learned <ul><li>1. Increase enforcement of law and regulations </li></ul><ul><li>2. Strong Cooperation with relevant organisations e.g., Police, customs, Trade and Local Government </li></ul><ul><li>3. Increase awareness of community, private providers and health workers on the counterfeit and substandard of medicines </li></ul>
  10. 10. 5. Lessons learned (con’t) <ul><li>4. Provide adequate training to provincial and district inspectors on technical issues how to do inspections </li></ul><ul><li>5. Improvement of rational use of drugs among health staff, providers and consumers </li></ul><ul><li>6. Provide necessary equipment, tools and human resources to DRA at each level </li></ul>
  11. 11. Thank you

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