Transcript Slide 1

Global Antimalarial Drug Resistance
Management and Containment Strategies
Challenges & responses for malaria in Asia
15th RBM Partnership Board Meeting
New Delhi, India, 10th November 2008
Dr Kamini Mendis
WHO Global Malaria Programme
The situation today
 P.falciparum has developed a tolerance to artemisinins at the
Cambodia-Thailand border – which will progress to resistance if
not contained.
 Most of the antimalarials of the past have been lost to resistance
 Today the world is entirely dependent on artemisinins for the
treatment of falciparum malaria
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RBM Board Meeting, New Delhi 10-11 November 2008
GLOBAL
MALARIA PROGRAMME
75 countries have adopted ACTs
Countries which adopted ACT
Countries Deploying ACTs
Countries with ACTs at Community level
Countries which need ACT policy
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RBM Board Meeting, New Delhi 10-11 November 2008
GLOBAL
MALARIA PROGRAMME
Update: May
2008
The situation today
 P.falciparum has developed a tolerance to artemisinins at the
Cambodia-Thailand border – which will progress to resistance if
not contained.
 Almost all antimalarials of the past have been lost to resistance
 Today the world is entirely dependent on artemisinins for the
treatment of falciparum malaria
 No replacements for artemisinins in the late pipeline of
development
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RBM Board Meeting, New Delhi 10-11 November 2008
GLOBAL
MALARIA PROGRAMME
Pipeline of new antimalarial medicines up to 2010
Fixed-dose combinations
artemetherlumefantrine
Alternatives
to artemisinin
Art-Naphthoquine
+
co-blistered
products
< 2006
Art-PPQ
2007
2008
2009
2010
Paediatric
Coartem™
AS-AQ
AS-MQ
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X
CD-AS (CDA)
RBM Board Meeting, New Delhi 10-11 November 2008
Pyronaridine-AS
Pyramax™
DHA-PPQ
GLOBAL
MALARIA PROGRAMME
?
How best can we delay
the onset and spread of drug resistance?
Early detection of tolerance / resistance to artemisinins
 Routinely monitor therapeutic efficacy of ACTs
– In vivo studies on ACTs and artesunate
 WHO supported routine surveillance of drug resistance
– Standardized methodologies, tools and technical assistance
– To countries and regional and sub-regional networks
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RBM Board Meeting, New Delhi 10-11 November 2008
GLOBAL
MALARIA PROGRAMME
Regional and sub-regional networks on monitoring drug
efficacy
Mekong
RAVREDA
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RBM Board Meeting, New Delhi 10-11 November 2008
HANMAT
GLOBAL
MALARIA PROGRAMME
Strategies to prolong the life of Artemisinins
 Use of combination medicines – and prevent the use of
AS by itself
– Withdraw oral artemisinin monotherapeis from market
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RBM Board Meeting, New Delhi 10-11 November 2008
GLOBAL
MALARIA PROGRAMME
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RBM Board Meeting, New Delhi 10-11 November 2008
GLOBAL
MALARIA PROGRAMME
Steps to implement WHO recommendations
1. 19 January 2006 – WHO Press Release
2. Monitoring marketing practices and position of NDRA
3. Dissemination of WHO position via WHO Offices, WHO staff briefings,
inter-country and regional meetings with MOH officials
4. 19 April 2006 – WHO technical briefing on malaria guidelines and
artemisinin monotherapies
5. Alignment of funding and procurement agencies
6. 23 May 2007 - WHA Resolution 60.18
7.
8.
9.
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24 August 2007 – WHO informal consultation with
manufacturers of artemisinin-based antimalarials
WHO country meetings with pharmaceutical companies
(India, China, Pakistan, Viet Nam)
Monitoring system on http://malaria.who.int/
RBM Board Meeting, New Delhi 10-11 November 2008
GLOBAL
MALARIA PROGRAMME
Manufacturers of oral artemisinin monotherapies:
12/67 (18%) withdrew their products
22/67 (33%) intend to comply with WHO ban
Number of companies
30
Substandard
Medicines ?
25
20
Not yet contacted
No intention disclosed
Intention to comply
Withdrawn monotherapies
15
10
5
0
2006
2007
2008
Identified in
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RBM Board Meeting, New Delhi 10-11 November 2008
GLOBAL
MALARIA PROGRAMME
National Drug Regulatory Authorities
No. countries marketing oral artemisinin monotherapies
70
60
50
40
30
Risk of developing resistance
20
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RBM Board Meeting, New Delhi 10-11 November 2008
Ap
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2007
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Ap
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2008
GLOBAL
MALARIA PROGRAMME
Strategies to prolong the life of Artemisinins
 Use of combination medicines – discontinue the use of
AS alone
– Withdraw oral artemisinin monotherapeis from market
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RBM Board Meeting, New Delhi 10-11 November 2008
GLOBAL
MALARIA PROGRAMME
Access to medicines
Availability of any antimalarial medicine and ACTs to children with fever, 2006–2007
(DHS, MICS, MIS surveys)
100
Children <5 yr treated with
antimalarial (%)
Any antimalarial
80
ACT
target
60
40
20
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RBM Board Meeting, New Delhi 10-11 November 2008
GLOBAL
MALARIA PROGRAMME
Strategies to prolong the life of Artemisinins
 Use of combination medicines – discontinue the use of
AS alone
– Withdraw oral artemisinin monotherapeis from market
– Improve access to ACTs & parasitological confirmation of
diagnosis
– Reducing transmission rates
• To lower the risk of spreading mutant resistant parasites
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RBM Board Meeting, New Delhi 10-11 November 2008
GLOBAL
MALARIA PROGRAMME
Main challenges
 Weak surveillance systems to monitor therapeutic efficacy of ACTs in
countries
 Companies non responsive to request to withdraw marketting of
monotherapies
 Poorly regulated pharmaceutical market in endemic countries
 Limited access to ACT: i) slow roll-out of ACTs in the public sector and ii)
limited penetration of ACTs in the private sector
 Manufacturing of sub-standard products exploiting "niche market" left open
by companies complying with WHO recommendations
 Need for multiple sources of information for monitoring
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RBM Board Meeting, New Delhi 10-11 November 2008
GLOBAL
MALARIA PROGRAMME
To avoid artemisinin resistance….
 Correct policies in place
 Support implementation of strategies including with
necessary funding
 Effective Government regulation
 Co-operation from the pharmaceutical sector
 Supportive action by all partners
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RBM Board Meeting, New Delhi 10-11 November 2008
GLOBAL
MALARIA PROGRAMME