global antimalarial drug resistance management and containment strategies dr kamini mendis who...
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Global Antimalarial Drug Resistance Management and Containment Strategies
Global Antimalarial Drug Resistance Management and Containment Strategies
Dr Kamini Mendis WHO Global Malaria ProgrammeDr Kamini Mendis WHO Global Malaria Programme
Challenges & responses for malaria in Asia
15th RBM Partnership Board Meeting
New Delhi, India, 10th November 2008
Challenges & responses for malaria in Asia
15th RBM Partnership Board Meeting
New Delhi, India, 10th November 2008
RBM Board Meeting, New Delhi 10-11 November 2008 2 |GLOBAL
MALARIA PROGRAMME
The situation todayThe 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
RBM Board Meeting, New Delhi 10-11 November 2008 3 |GLOBAL
MALARIA PROGRAMME
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 Update: May 20082008
RBM Board Meeting, New Delhi 10-11 November 2008 4 |GLOBAL
MALARIA PROGRAMME
The situation todayThe 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
RBM Board Meeting, New Delhi 10-11 November 2008 5 |GLOBAL
MALARIA PROGRAMME
Pipeline of new antimalarial medicines up to 2010Pipeline of new antimalarial medicines up to 2010
+
AS-MQ
2010200920082007
co-blistered products
AS-AQCD-AS (CDA)
DHA-PPQ
PaediatricCoartem™
Pyronaridine-ASPyramax™
Art-Naphthoquine
Art-PPQ
<2006
Fixed-dose combinations
artemether-lumefantrine
X
Alternatives Alternatives to artemisininto artemisinin
? ?
RBM Board Meeting, New Delhi 10-11 November 2008 6 |GLOBAL
MALARIA PROGRAMME
How best can we delay the onset and spread of drug resistance?
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
RBM Board Meeting, New Delhi 10-11 November 2008 8 |GLOBAL
MALARIA PROGRAMME
RAVREDA
Mekong
HANMAT
Regional and sub-regional networks on monitoring drug efficacy
Regional and sub-regional networks on monitoring drug efficacy
TET is important specially where SP and
AQ are partner medicines
RBM Board Meeting, New Delhi 10-11 November 2008 9 |GLOBAL
MALARIA PROGRAMME
Strategies to prolong the life of ArtemisininsStrategies to prolong the life of Artemisinins
Use of combination medicines – and prevent the use of
AS by itself
– Withdraw oral artemisinin monotherapeis from market
RBM Board Meeting, New Delhi 10-11 November 2008 11 |GLOBAL
MALARIA PROGRAMME
Steps to implement WHO recommendationsSteps 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 monotherapies5. Alignment of funding and procurement agencies
6. 23 May 2007 - WHA Resolution 60.187. 24 August 2007 – WHO informal consultation with
manufacturers of artemisinin-based antimalarials 8. WHO country meetings with pharmaceutical companies
(India, China, Pakistan, Viet Nam)9. Monitoring system on http://malaria.who.int/
RBM Board Meeting, New Delhi 10-11 November 2008 12 |GLOBAL
MALARIA PROGRAMME
0
5
10
15
20
25
30
2006 2007 2008
Identified in
Not yet contacted
No intention disclosed
Intention to comply
Withdrawn monotherapies
Number of companies
Manufacturers of oral artemisinin monotherapies: 12/67 (18%) withdrew their products
22/67 (33%) intend to comply with WHO ban
SubstandardMedicines ?
RBM Board Meeting, New Delhi 10-11 November 2008 13 |GLOBAL
MALARIA PROGRAMME
National Drug Regulatory Authorities National Drug Regulatory Authorities
0
10
20
30
40
50
60
70
Janu
ary
April
July
Octo
ber
Janu
ary
April
July
Octo
ber
Janu
ary
April
Risk of developing resistanceRisk of developing resistance
20062006 20072007 20082008
No. countries marketing oral artemisinin monotherapiesNo. countries marketing oral artemisinin monotherapiesNo. countries marketing oral artemisinin monotherapiesNo. countries marketing oral artemisinin monotherapies
RBM Board Meeting, New Delhi 10-11 November 2008 14 |GLOBAL
MALARIA PROGRAMME
Strategies to prolong the life of ArtemisininsStrategies to prolong the life of Artemisinins
Use of combination medicines – discontinue the use of
AS alone
– Withdraw oral artemisinin monotherapeis from market
RBM Board Meeting, New Delhi 10-11 November 2008 15 |GLOBAL
MALARIA PROGRAMME
Access to medicinesAccess to medicines
0
20
40
60
80
100
Ch
ild
ren
<5
yr t
reat
ed w
ith
an
tim
alar
ial
(%)
Any antimalarial
ACTtarget
Availability of any antimalarial medicine and ACTs to children with fever, 2006–2007 Availability of any antimalarial medicine and ACTs to children with fever, 2006–2007 (DHS, MICS, MIS surveys)(DHS, MICS, MIS surveys)
RBM Board Meeting, New Delhi 10-11 November 2008 16 |GLOBAL
MALARIA PROGRAMME
Strategies to prolong the life of ArtemisininsStrategies to prolong the life of Artemisinins
– Improve access to ACTs & parasitological confirmation of
diagnosis
Use of combination medicines – discontinue the use of
AS alone
– Withdraw oral artemisinin monotherapeis from market
– Reducing transmission rates
• To lower the risk of spreading mutant resistant parasites
RBM Board Meeting, New Delhi 10-11 November 2008 17 |GLOBAL
MALARIA PROGRAMME
Main challengesMain 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
RBM Board Meeting, New Delhi 10-11 November 2008 18 |GLOBAL
MALARIA PROGRAMME
To avoid artemisinin resistance….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