Antimalarial Drug Quality in Mekong Region

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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
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Global Malaria Burden

• - 90 of Malaria occur in Sub-Sahara Africa
• - 10 in Asia, South Central Americas and
  others

There is hope for winning the battle against
malaria
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3.0
2.0
Annual Deaths from Malaria (millions)
1.0
0.1
1900 1930 1950 1970 1990 2000
(R.Carter,1999)
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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

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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

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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

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Antimalarial drug resistance worldwide, 2001
Chloroquine resistance
S/P resistance
Mefloquine resistance
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Map of Mekong Countries showing MDR malaria 2001
MDR Multidrug resistant P. falciparum
P.falciparum resists to CHL, SP, MEF
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ACT and MDR

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

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Treatment of drug resistant malaria by a chinese
medicineExtracted from Qing hao - Sweet
wormwood (Artemisia annua)Photo PR China
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National Treatment Policy for P.
falciparumMekong Countries

• Cambodia
• Lao PDR
• Myanmar

• Mefloquine Artesunate
• Artemether/Lumefantrine
• (Coartem ),
• QNN Tetra
• CHL, SP -----gt Mefloquine Artesunate or ATM/Lum
  (Coartem)
• QNN Tetra
• Mefloquine Artesunate or ATM/Lum (Coartem)
• QNN Tetra or Doxy or Clinda

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National Treatment Policy for P.
falciparumMekong Countries (cont)

• Thailand
• Vietnam
• PR China (Yunnan)

• Mefloquine Artesunate
• QNN Tetra
• Artesunate, Mefloquine
• CV8
• QNN, SP
• CHL
• SP
• QNN
• Artesunate
• Pyronaridine

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National Treatment Policy for P. vivax Mekong
Countries

• Chloroquine
• Primaquine

• All countries

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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

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Drug outlets in Cambodia
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• Two channels of distribution were established
• (to prevent misuse of drugs, to prevent
  counterfeit drugs)

Public Sector
Private Sector
Routine distribution system (CMS)
Commercial distribution
Public Health Services
Private Drug sellers
Re Dr. Doung Socheat, Cambodia
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Improve drug use by prepackaging blister packs
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• 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

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Table 1 Number of counterfeit antimalarial drugs
in Mekong Countries (Dandrop et all, 2004) Feb
2002-Feb2003Dye test HPLC, drug sellers,
pharmacies
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Implications of the GFATM in Drug QualityGlobal
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

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Implications of the GFATM in Drug QualityGlobal
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

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Implications of the GFATM in Drug QualityGlobal
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)

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Antimalarial Drug Quality ControlMekong Region

• Initial survey conducted in 5 countries in 2002
• Training in good laboratory practice, drug
  sampling and testing conducted in 3 countries
• Cambodia, Lao (LaoMMR) and Thailand (THAVTN
  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

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