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 1

2. 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

3. 75 countries have adopted ACTs
Countries which need ACT policy
Countries which adopted ACT
Countries Deploying ACTs
Countries with ACTs at Community level
Update: May 2008

4. 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

5. Pipeline of new antimalarial medicines up to 2010
AS-MQ
2010
2009
2008
2007
co-blistered products
AS-AQ
CD-AS (CDA)
DHA-PPQ
Paediatric
Coartem™
Pyronaridine-AS
Pyramax™
Art-Naphthoquine
Art-PPQ
< 2006
Fixed-dose combinations
artemether-lumefantrine X
Alternatives
to artemisinin + ?

6. 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

7. WHO/GMP has developed standardised methodologies
2007
2008
2003
2004
Updated 2008
New report in 2009
Planned: guidelines on pharmacokinetic and molecular markers for drug resistance

8. TET is important specially where SP and AQ are partner medicines
Regional and sub-regional networks on monitoring drug efficacy
Mekong
TET is important specially where SP and AQ are partner medicines
RAVREDA
HANMAT

9. 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

10. January 2006

11. Steps to implement WHO recommendations
19 January 2006 – WHO Press Release
Monitoring marketing practices and position of NDRA
Dissemination of WHO position via WHO Offices, WHO staff briefings, inter-country and regional meetings with MOH officials
19 April 2006 – WHO technical briefing on malaria guidelines and artemisinin monotherapies
Alignment of funding and procurement agencies
23 May WHA Resolution 60.18
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

12. Manufacturers of oral artemisinin monotherapies:
12/67 (18%) withdrew their products
22/67 (33%) intend to comply with WHO ban
Number of companies
Substandard
Medicines ?

13. National Drug Regulatory Authorities
No. countries marketing oral artemisinin monotherapies
Risk of developing resistance
2006
2007
2008

14. Strategies to prolong the life of Artemisinins
Use of combination medicines – discontinue the use of AS alone
Withdraw oral artemisinin monotherapeis from market

15. Access to medicines
Availability of any antimalarial medicine and ACTs to children with fever, 2006–2007 (DHS, MICS, MIS surveys)

16. 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

17. 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

18. 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