pharm sector in laos

Strategies for improving Strategies for improving Pharmaceutical Use - Pharmaceutical Use - The Role The Role

of Drug Regulatory Agencyof Drug Regulatory Agency in Lao PDRin Lao PDR

Conference on Health and Social ProtectionConference on Health and Social ProtectionMeeting the Needs of the Poor Meeting the Needs of the Poor

09-10 October 2008, Lane Xang Hotel09-10 October 2008, Lane Xang HotelBy Lamphone SyhakhangBy Lamphone Syhakhang

Head of drug Control Division, Food and Drug Head of drug Control Division, Food and Drug Department, Department,

Ministry of Health Lao PDRMinistry of Health Lao PDR

Outline of presentationOutline of presentation

1. Drug Regulatory Authority at different 1. Drug Regulatory Authority at different levelslevels

2. Main Role of Drug Regulatory Authority2. Main Role of Drug Regulatory Authority3. Important Regulatory instruments 3. Important Regulatory instruments 4. Challenges4. Challenges5. Lessons learned/ suggestions5. Lessons learned/ suggestions

1. Drug Regulatory 1. Drug Regulatory Authorities at different Authorities at different

levelslevels Central level: Food and Drug Department (FDD)Central level: Food and Drug Department (FDD)

Province level: Provincial Food and Drug UnitProvince level: Provincial Food and Drug Unit

District level: District Food and Drug UnitDistrict level: District Food and Drug Unit

+ Food and Drug committee at each level + Food and Drug committee at each level

+ Cooperation with Customs, Police, Trade, + Cooperation with Customs, Police, Trade,

Justice and Local GovernmentsJustice and Local Governments

2. Main Role of Drug 2. Main Role of Drug Regulatory AuthoritiesRegulatory Authorities

Ensuring quality and use of medicinesEnsuring quality and use of medicinesPre-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 3. Important Regulatory InstrumentsInstruments

• National Medicine Policy • Law and Regulations

Registration and licensing system Registration and licensing system including including stampsstamps for imported and for imported and registered drugsregistered drugs

• Drug selection and Drug selection and nomenclature nomenclature - - National Essential Medicine List

• System for drug System for drug procurementprocurement

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of Lao PDR

3. Important Regulatory 3. Important Regulatory Instruments (con’t)Instruments (con’t)

Quality Assurance Quality Assurance System System

- Monitoring system for Monitoring system for pharmacies, companies and pharmacies, companies and factories through GPP, factories through GPP, GWP and GMP indicators, GWP and GMP indicators, drug sampling and analysisdrug sampling and analysis

- Sanctions and punishmentsSanctions and punishments

3. Important Regulatory 3. Important Regulatory Instruments (con’t)Instruments (con’t)

Promotion of RUDPromotion of RUD::

• IEC to Health providers IEC to Health providers and general public through and general public through different media meansdifferent media means

• Monitoring the use of Monitoring the use of medicines in hospitals medicines in hospitals through STG and RUD through STG and RUD indicatorsindicators

• Drug Therapeutic Drug Therapeutic Committees at all Committees at all provincial hospitals.provincial hospitals.

4. Challenges4. ChallengesEnforcement of law and regulationsEnforcement of law and regulations

Availability of substandard, counterfeitAvailability of substandard, counterfeitStrict sanctions and punishmentStrict sanctions and punishment

Strengthening the drug QA systemStrengthening the drug QA system Improve RUD through IEC and trainingImprove RUD through IEC and trainingEffective management and financial Effective management and financial

systemssystemsLimitations of human resources in terms Limitations of human resources in terms

of skilled personnels of skilled personnels

5. Lessons learned5. Lessons learned

1. Increase enforcement of law and 1. Increase enforcement of law and regulations regulations

2. Strong Cooperation with relevant 2. Strong Cooperation with relevant organisations e.g., organisations e.g., Police, customs, Trade Police, customs, Trade and Local Government and Local Government

3. Increase awareness of community, private 3. Increase awareness of community, private providers and health workers on the providers and health workers on the counterfeit and substandard of medicinescounterfeit and substandard of medicines

5. Lessons learned 5. Lessons learned (con’t)(con’t)

4. Provide adequate training to provincial 4. Provide adequate training to provincial and district inspectors on technical and district inspectors on technical issues how to do inspections issues how to do inspections

5. 5. Improvement of rational use of drugs among health staff, providers and consumers

6. Provide necessary equipment, tools and 6. Provide necessary equipment, tools and human resources to DRA at each levelhuman resources to DRA at each level

Thank youThank you