1. Antimalarial Drug Quality in Mekong Region by Krongthong Thimasarn Coordinator RBM Mekong UN-ESCAP Bangkok Acting Regional Advisor for Malaria SEARO Prepared for the workshop on GMP and quality assurance of antimalarial medicines Bangkok, Thailand 18-22 Oct 2004

2. - 90 % of Malaria occur in Sub-Sahara Africa - 10 % in Asia, South + Central Americas and others Global Malaria Burden There is hope for winning the battle against malaria

3. 1900 1930 1950 1970 1990 2000 0.1 1.0 3.0 2.0 China N.America & Europe Africa World Annual Deaths from Malaria (millions) (R.Carter,1999) Central & S.America Asia

4. Poor access to health care in the Amazons MDR falciparum malaria Resurgence in Central Asia & Eastern Europe Childhood dealths in sub- Saharan Africa Vast burden of morbidity & economic loss Major malaria epidemics in the past 4 years

6. Challenges of Mekong Roll Back Malaria Drug resistant P. falciparum malaria Forest related malaria and potent exophagic vectors Cross border movement, migration of labor force low quality of drugs/fake drugs (esp. artemisinin ) Lack of fund Lack of trained personnel

7. RBM Mekong objectives Reduce malaria mortality and incidence in selected populations in the Mekong Region, with ultimate reduction of malaria mortality by 50% of the level in 1998, by the year 2010; Halt the spread of multi-drug resistance through effective, well-targeted disease management and prevention operations

8. Strategy of RBM Mekong 1. Increase partnership (UN, GO, NGO, community, donor, etc) 2. Increase access & coverage of prompt diagnosis and effective treatment 3. Increase coverage of malaria prevention

14. Antimalarial drug resistance worldwide, 2001 Chloroquine resistance S/P resistance Mefloquine resistance

15. Map of Mekong Countries showing MDR malaria 2001 MDR: Multidrug resistant P. falciparum P.falciparum resists to CHL, SP, MEF N S EW 0250500 Kilometers

16. ACT and MDR WHO recommended Artemisinin-based combination therapy (ACT) for combating against multidrug resistant P. falciparum malaria

17. Treatment of drug resistant malaria by a chinese medicine Extracted from “ Qing hao - Sweet wormwood” (Artemisia annua) Photo: PR China

18. National Treatment Policy for P. falciparum Mekong Countries Cambodia Lao PDR Myanmar Mefloquine + Artesunate Artemether/Lumefantrine (Coartem® ), QNN +Tetra CHL, SP -----> Mefloquine + Artesunate or ATM/Lum (Coartem®) QNN +Tetra Mefloquine + Artesunate or ATM/Lum (Coartem®) QNN + Tetra or Doxy or Clinda

19. National Treatment Policy for P. falciparum Mekong Countries (cont’) Thailand Vietnam PR China (Yunnan) Mefloquine + Artesunate QNN +Tetra Artesunate, + Mefloquine CV8 QNN, SP CHL SP QNN Artesunate Pyronaridine

20. National Treatment Policy for P. vivax Mekong Countries All countries Chloroquine Primaquine

21. Treatment of malaria patients in Public and Private sectors Thailand –Mainly by public sector –MEF, QNN, ATS, etc are procured using govt budget, not GFATM Vietnam and PR China –mainly by public sector –are drug manufacturers of Artemisinin derivatives Myanmar, Lao PDR, Cambodia –Mainly by private sector –rely on GFATM and other donors for drug policy revision –are targets of drug counterfeiting

22. Drug outlets in Cambodia

23. Two channels of distribution were established (to prevent misuse of drugs, to prevent counterfeit drugs) Public Health Services Routine distribution system (CMS) Private Drug sellers Public Sector Private Sector Commercial distribution Re: Dr. Doung Socheat, Cambodia

24. “Improve drug use” by prepackaging blister packs

25. Fake “Artesunate” Deadly scourge Proportion of fakes in total artesunate antimalarial drug sales drug samples from drug stores, NGOs, hospitals Dye test (Aug 99-Aug2000) 38% fake

26. Table 1 Number of counterfeit antimalarial drugs in Mekong Countries (Dandrop et all, 2004) Feb 2002-Feb2003 Dye test + HPLC, drug sellers, pharmacies

27. Implications of the GFATM in Drug Quality Global Fund to fight AIDS, TB and Malaria (GFATM) All Mekong Countries received global fund for malaria(2002-2004) GF provided opportunity to expedite drug policy revision and drug policy implementation Artemisinin-based combination therapy (ACT) has been promoted by WHO in order to treat multi-drug resistant falciparum malaria

28. Implications of the GFATM in Drug Quality Global Fund to fight AIDS, TB and Malaria (GFATM) (cont’) All drugs procured using GF must be pre-qualified drugs (GMP) Below are pre-qualified products –Artesunate 50mg tab. Sanofi, man. Guilin –Artemether/Lumefantrine (Coartem®) -- Norvatis China passed

29. Implications of the GFATM in Drug Quality Global Fund to fight AIDS, TB and Malaria (GFATM) (cont’) None of the Mekong countries have drug quality monitoring component in the GFATM proposal As it is evidenced that substandard drugs and conterfeit drugs are substantial, it is strongly suggested that the drug QA component should be incorporated in the next round proposal, or in the reprogramming (if applicable)

32. Antimalarial Drug Quality Control Mekong Region Initial survey conducted in 5 countries in 2002 Training in good laboratory practice, drug sampling and testing conducted in 3 countries: Cambodia, Lao (Lao+MMR) and Thailand (THA+VTN +CHN) Minilab (R) test kits for 6 countries Drug quality monitoring being carried out in 5 countries and started in Myanmar HPLC being procured by JICA for CAM USP DQI-Mid project review meeting 7-9 July 2004 Vientiane