access to medicines: antimalarials dr maryse dugué malaria medicines and supplies service
TRANSCRIPT
Access to medicines: antimalarials
Dr Maryse Dugué
Malaria Medicines and Supplies Service
Situation analysis: the challenges
• Quality of antimalarial drugs has been declining.
• "Disease of the South": not much investment in the North, or export-only productions
• The efficacy of (affordable) antimalarial drugs has been declining (drug resistance) and high cost of replacement options.
• 60-90% of the population seek initial treatment from non- public sector, i.e. street vendors, kiosks.
• Supply of drugs is often inefficient and unreliable.
• Pharmacovigilance very weak in most affected countries
Factors leading to development of resistance
• Lack of guidelines/poor drug treatment policies
• Irrational prescribing
• Irrational drug use
• Drug concentration “tail” – poor formulations
• Liberalized, uncontrolled drug market leading to poor quality products circulating in international and domestic markets
Malaria distribution and reported case of resistance or treatment failure
Artesunate + amodiaquine
• Artemether/lumefantrine
• Artesunate + SP
• Artesunate + mefloquine
FDC
ACTs
WHO recommandation: Artemisinin-based Combination Therapies
(ACTs)
Still many challenges!
• Relatively high price of ACTs (average of UNICEF/WHO price $1.21/treatment): critical aspects of external financial support
• Slow process of changing drug policy at country level
• Artemisinin monotherapies have to be banned!
• Only one ACT prequalified yet
In April 2003, tripartite meeting to discuss possible solutions and actions until a sufficient number of products are pre-qualifiedWHO/UNICEF cooperation on selection and procurement.
Procurement of ACT'sWHO/UNICEF Interim solution
WHO/UNICEF joint tender 2003, 2004, 2005, 2006
Evaluation based on the UNICEF product quality questionnaire (similar to WHO's)
Criteria included GMP certification, registration information (countries), API, stability reports, shelf-life and storage conditions
Quality assurance based on a review of the documentation submitted jointly by UNICEF Pharmaceutical Team and WHO (EDM and Procurement with assistance from QSM when necessary)
Availability of ACTs
There is NO SHORTAGE of recommended ACTs
There are GOOD QUALITY manufacturers for all the recommended combinations
12–18 month lag time between ACT adoption &
implementation
2001 2002 2003 2004 2005
0
10
20
30
40
50
60
No countries w ACT 1st line No countries implementing ACT
Cumulative No. of countries adopting ACT as 1st-line Rx
Cu
mu
lati
ve N
o. o
f co
un
trie
s a
do
pti
ng
AC
T a
s 1s
t-lin
e R
x
Cumulative No. of countries
implementing ACT
66 countries have adopted ACTsContinent
Countries Drug Line
AFRICA
Burundi, Cameroon, Congo, Côte d'Ivoire, Democratic Republic of Congo, Eq. Guinea, Gabon, Ghana, Guinea, Liberia, Madagascar, Mauritania, Senegal,
Sao Tomé & Principe (ST&P), Sierra Leone, Sudan (S), Zanzibar
AS + AQ
1st
Angola, Benin, Burkina Faso, Central African Republic, Comoros, Ethiopia, Gambia, Guinea Bissau, Kenya, Mali, Namibia, Niger, Nigeria, Rwanda,
Uganda, S. Africa, Tanzania, Tchad, Togo, Zambia, Zimbabwe
AL 1st
Côte d'Ivoire, Djibouti, Gabon, Mozambique, Sudan (N), ST&P, Zanzibar AL 2nd
Mozambique, Djibouti, Somalia, South Africa (Mpumalanga), Sudan (N) AS + SP 1st
ASIA
Cambodia, Malaysia, Myanmar, Thailand AS + MQ
1st
Bangladesh, Bhutan, Laos, Saudi Arabia AL 1st
Indonesia AS + AQ
1st
Afghanistan, India (5 Provinces), Iran, Tajikistan, Yemen AS + SP 1st
Viet Nam DP 1st
Papua New Guinea AS + SP 2nd
Iran, Philippines, Solomon Islands AL 2nd
SOUTH
AMERICA
Ecuador, Peru AS + SP 1st
Bolivia, Peru, Venezuela AS + MQ
1st
Brazil, Guyana, Suriname AL 1st
39 are deploying ACTsUpdated
September 2006
AQ=amodiaquine; AL=artemether/lumefantrine; AS=artesunate; DP=dihydroartemisinin/piperaquine; MQ=mefloquine; SP=sulfadoxine/pyrimethamine;
75% deploying
72% deploying
56% deploying
Procurement of ACTs (2001–2006)
0
10
20
30
40
50
60
70
Millions of treatment courses
2001 2003 2005Year
2006 as of 31.08.2006
20042002
0.5 0.6 2.15
31.3
65
After a slow start, orders are picking up
Treatments delivered from the 1st of January
to the 30th of June 2005
Treatments delivered from the 1st of January
to the 30th of June 2006
AS+AQ 3,239,830 7,585,652
AL 1,250,080 37,311,150
2007 ACT forecast
150
110
2.10.5 0.65
31.3
0
20
40
60
80
100
120
140
160
2001 2002 2003 2004 2005 2006 2007
0
10
20
30
40
50
60
70
ACT procured No countries w ACT 1st line No countries implementing
ACT forecast
Mill
ion
s o
f tr
eatm
ent
cou
rses
Cu
mu
lati
ve N
o. o
f co
un
trie
s a
do
pti
ng
AC
T a
s 1s
t-lin
e R
x
Cumulative No. of countries adopting ACT as 1st-line Rx
Cumulative No. of countriesimplementing ACT
150
What will influence access/demand/market size
• FDCs/new combinations
manufacturers/research• Price manufacturers/procurement/
competition• Paediatric formulations
manufacturers/research• Private sector market penetration (up to 80%)
manufacturers/donors/countries• Global subsidy donors
What else will influence ACCESS?
Timely procurement, logistics and distribution systems!