Transcript Mekong Countries Greater Mekong Subregion (GMS)

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
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
Resurgence in
Central Asia &
Eastern Europe
Poor
access to
health
care in the
Amazons
Childhood
dealths in
subSaharan
Africa
Major malaria epidemics in the past
4 years
MDR
falciparum
Vast burden
malaria
of morbidity
&
economic
loss
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
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
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
L aboratory-C onfirmed malaria C as es 1997-2002
160,000
140,000
120,000
1997
100,000
1998
1999
80,000
2000
60,000
2001
2002
40,000
20,000
0
Vietnam
Lao PDR
Cambodia
Thailand
Myanmar
PR China
(Yunnan)
API / 1000
1997 - 2002
9.00
8.00
7.00
6.00
1997
1998
5.00
1999
2000
4.00
2001
2002
3.00
2.00
1.00
0.00
Vietnam
Lao PDR
Cambodia
Thailand
Myanmar
PR China
(Yunnan)
Malaria Deaths 1997-2002
4500
4000
3500
3000
1997
1998
2500
1999
2000
2000
2001
2002
1500
1000
500
0
Vietnam
Lao PDR
Cambodia
Thailand
Myanmar
PR China
(Yunnan)
Malaria Motality rates 1997-2002
12.00
10.00
8.00
1997
1998
1999
6.00
2000
2001
2002
4.00
2.00
0.00
Vietnam
Lao PDR
Cambodia
Thailand
Myanmar
PR China
(Yunnan)
Antimalarial drug resistance worldwide, 2001
Chloroquine resistance
S/P resistance
Mefloquine resistance
Map of Mekong Countries showing MDR malaria
2001
N
W
E
S
0
250
Kilometers
MDR: Multidrug resistant P. falciparum
P.falciparum resists to CHL, SP, MEF
500
ACT and MDR
• WHO recommended Artemisinin-based
combination therapy (ACT) for
combating against multidrug resistant P.
falciparum malaria
Treatment of drug resistant malaria by
a chinese medicine
Extracted from “ Qing hao - Sweet wormwood”
(Artemisia annua)
Photo: PR China
National Treatment Policy for P.
falciparum
Mekong Countries
• Cambodia
• Mefloquine + Artesunate
• Artemether/Lumefantrine
(Coartem® ),
• QNN +Tetra
• Lao PDR
• Myanmar
• CHL, SP -----> Mefloquine +
Artesunate or ATM/Lum
(Coartem®)
• QNN +Tetra
• Mefloquine + Artesunate or
ATM/Lum (Coartem®)
• QNN + Tetra or Doxy or Clinda
National Treatment Policy for P.
falciparum
Mekong Countries (cont’)
• Thailand
• Mefloquine + Artesunate
• QNN +Tetra
• Vietnam
• Artesunate, + Mefloquine
• CV8
• QNN, SP
• PR China (Yunnan)
•
•
•
•
•
CHL
SP
QNN
Artesunate
Pyronaridine
National Treatment Policy for P. vivax
Mekong Countries
All countries
• Chloroquine
• Primaquine
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
Drug outlets in Cambodia
Two channels of distribution were established
(to prevent misuse of drugs, to prevent counterfeit drugs)
Public Sector
Routine distribution system
(CMS)
Public Health Services
Private Sector
Commercial distribution
Private Drug sellers
Re: Dr. Doung Socheat, Cambodia
“Improve drug use” by prepackaging blister packs
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
Table 1 Number of counterfeit antimalarial drugs in
Mekong Countries
(Dandrop et all, 2004)
Feb 2002-Feb2003
Dye test + HPLC, drug sellers, pharmacies
drugs
country
Thailand Lao
PDR
3/11
(27%)
Mefloquine
0/2
tab.
(0%)
Artesunate
tab.
25/46
(54%)
0/2
(0%)
Cambodia Myanmar Vietnam
Total
5/22
(23%)
1/10
(10%)
99/188
(53%)
4/44
(9%)
10/48
(21%)
3/30
(10%)
56/61
(92%)
NA
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
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
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)
Drug Combinations under development
in Mekong countries
CV8
Artecom
Artekin
Artepie
DHA + PIP + TMP + PQ
DHA + PIP + TMP
DHA + PIP
Artemisinin + PIP + (PQ)
Prof Li, Aug 04
Antimalarial drug development meeting
Shanghai, Nov 2001
1) Drug combinations in pipeline + further developement
2) Counterfeit/substandard drugs and GMP were addressed
3) agreed:
-the production of antimalarial must follow international
standard for GMP
-drug management and utilization and strategy to combat
counterfeit products
-National Strategies for improving drug management and drug
utilization are needed
- Collaboration with law enforcement agencies and other
relevant partners is essential in order to enforce legislation
against counterfeiting
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
THANK YOU