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Malaria Pharmaceutical Management in
Low-Incidence Settings: Lessons learned from the Americas
Andwele Mwansasu Edgar Barillas
Wonder Goredema John Marmion
April 25, 2014
Malaria in Africa: Epidemiological Trends Andwele Mwansasu
Definitions
• Elimination entails reducing to zero the incidence of locally acquired malaria infection in a specific geographic area as a result of deliberate efforts, with continued measures in place to prevent re-establishment of transmission
• Eradication is the permanent reduction to zero of the global incidence of infection caused by Plasmodia as a result of deliberate efforts, so that intervention measures are no longer needed.
Malaria Elimination: The Milestones
elimination
SPR <5% in fever cases
<1 case/1000 population at risk/year
0 locally acquired cases
WHO
certification
3 years
control pre-elimination prevention of reintroduction
1st programme
reorientation
2nd programme
reorientation
Source: Malaria elimination A field manual for low and moderate endemic countries, WHO 2007
Progress Towards Elimination (2013)
Pre elimination Elimination Prevention of re introduction
Certified malaria Free
Cape Verde Argentina Belize Costa Rica Ecuador El Salvador Mexico Paraguay Bhutan Democratic People’s Republic of Korea Malaysia
Algeria Iran Saudi Arabia Azerbaijan Tajikistan Turkey Sri Lanka Republic of Korea
Egypt Iraq Oman Syrian Arab Republic Georgia Kyrgyzstan Uzbekistan
Morocco - 2010 United Arab Emirates – 2007 Armenia - 2011 Turkmenistan – 2010
Trends in Reported Malaria Incidence 2000 - 2012
• Botswana, Cape Verde, Eritrea, Namibia, Rwanda, Sao Tome and Principe, South Africa and Swaziland and the island of Zanzibar are projected to achieve reductions in malaria admission rates of >75% by 2015
• Ethiopia and Zambia by 50%–75%
• Madagascar by <50%
• No data from other 32 countries
Change in Malaria Mortality Rates, 2000-2012
• 16.1% decrease in the population living in areas of highest transmission intensity
• 26·7% of the population in the malaria-endemic countries lived in areas where endemicity had reduced by at least one endemic class
• Large declines in transmission in several areas that were of moderate-to-low transmission even though these areas remained within the same range of endemicity by 2010
Population at Risk in Hyperendemic/ Holoendemic Areas (2000 and 2010)
Malaria Elimination in Africa
• Eight countries in southern Africa are signatories to the Elimination Eight (E8) regional initiative launched in March 2009, a goal of which is to achieve the eventual elimination of malaria in the region, and elimination in four countries Botswana, Namibia, South Africa and Swaziland by 2015.
• Others are Angola, Mozambique, Zambia and Zimbabwe
Implications
• Sustaining control and possibly embarking on elimination requires
• Improved targeted interventions
• Procurement and distribution commodities
• Detection of epidemics
• Shift of scope or expanse of interventions(e.g. surveillance)
• Requires stronger health systems including supply chain management
Implications and Challenges of Decreasing Incidence on
Pharmaceutical Management Edgar Barillas
Background
• 2000 – 2009: malaria in the Americas decreased by 43% percent
• 15 countries reported decreases of more than 50 %
• Timely treatment is the cornerstone of malaria control in regions with low incidence and in plans to move to pre-elimination and elimination
• Paradox: just when fewer medicines are required, their supply management faces greater challenges
Current Situation in the Americas
• Higher incidence in locations of poor geographic accessibility or confined to populations “on special circumstances”
• Pharmaceutical vendors have lost interest in marketing the reduced volumes that are now required
• Areas with low or no incidence cease to receive medicines, even when the risk of reintroduction is high
• Personnel lose the skills required to make a diagnosis and provide treatment. Institutions lose capacity to respond to outbreaks
Strategies of Differing Geographic Ranges Supported by AMI
National Regional Local
Incorporation of provision of antimalarials into national pharmaceutical management systems
Regional monitoring of stock and pooled purchase of medicines
Decentralized support in high-incidence areas Study the supply
situation→ interventions: first-level guide; delivery procedures
Programming and distribution criteria in low-incidence areas
Standardizing treatment regimens
Management of donations for the treatment of severe cases
Differentiated strategies for groups living and working in special circumstances Artisanal miners
(garimpeiros) Chestnut harvesters
(castañeros)
Pharmaceutical Management in Low-Incidence Settings: Lessons from Latin America
Wonder Goredema
Objective
• Share SIAPS experiences developing and implementing strategies to improve pharmaceutical management for malaria in low-incidence settings in Latin America
• Review and explore how the strategies/tools could possibly be adapted and applied in low-incidence areas elsewhere
PM: pharmaceutical management
Strategies
• Pooled procurement
• Provision of stock in areas of no incidence
• Assuring the quality of slow-moving medicines
• Emphasis on remaining “pockets” of malaria incidence
Pooled Procurement
• Challenge:
• Low incidence and low quantities of antimalarials used
• Commercial companies not interested in supplying small quantities of antimalarials
• Strategies:
• PAHO Strategic Fund (PSF) set up as a regional pooled procurement system for first-line antimalarials • Aggregates the requirements of all LAC countries
• Floats tender, negotiates/selects suppliers, sends agreed price to countries
• Countries order through PAHO, based on the prices; pay upfront
• PAHO places bulk order once per year; ships directly to countries
• USAID funds donations of medicines for second-line medicines for severe cases; procurement process managed by the PSF
Provision of Stock in Areas of No Incidence • Challenge:
• Morbidity-based forecasting in allocating supplies means low-incidence areas reporting zero cases receive no medicines, although they may still be at risk
• With no medicines, these areas are not adequately prepared for re-emergence/outbreaks of malaria.
• Strategy: Revised criteria for programming and distribution in low-incidence areas, to ensure medicines are always available to treat patients in event of outbreak
• Workshops w/ local experts and stakeholders; agreed levels of disease occurrence and min. quantities stock for facilities at different levels of care
• Cost: national procurement budget increases; expiry of meds
Provision of Stock in Areas of No Incidence (2)
Level of care/storag
e
Reported cases of
past treatmen
t
Reserve stock criteria
Low Potosi, Cochabamba La Paz, Chuquisaca,
Santa Cruz
Medium Tarija, Chuquisaca, Santa Cruz, La Paz
High Riberalta, Pando
Hyperendemic Guayaramerín
Severe cases (regional programs
and hospitals)
Special
P. vivax
P. falciparum
P. vivax
P. falciparum
P. vivax
P. falciparum
P. vivax
P. falciparum
P. falciparum
P. falciparum
Health post (Health post FIM)
Cases
2 Tx 4 Tx 10 Tx 3 Tx 15 Tx 5 Tx No cases
Health center (Health center FIM)
Cases
3 Tx 6 Tx 15 Tx 3 Tx 20 Tx 8 Tx 2 Tx No cases
Referral hospitales (level III) (Referral FIM)
Cases
5 Tx 10 Tx 20 Tx 5 Tx 20 Tx 10 Tx 5 Tx* 2 Tx
No cases
Depart-mental and regional programs
Cases
15 Tx 5 Tx 30 Tx 10 Tx 100 Tx 25 Tx 500 Tx 30 Tx 5 Tx 2 Tx No cases
ADRA 100 Tx 40 Tx
Example: Bolivia
Provision of Stock in Areas of No Incidence (3)
Progress in Implementing Planning Distribution Criteria in Low-Incidence Areas
Country
Criteria
established and
validated
Criteria incorporated
into national
guidelines
Redistribution of
stock already
available in country
Planning for annual
procurement
National distribution of
adjusted purchase
Ecuador X
X X X
Nicaragua X X
Honduras X
X X
Brazil X X X
Peru X
X X
Bolivia X
X
Assuring Quality of Slow-moving Medicines
• Challenge:
• Antimalarials distributed to low-incidence sites consumed slowly and therefore have low turnover
• Exposed to prevailing high/sub-optimal temperature conditions for long periods
• Strategy:
• Implement interventions to assure quality of meds • Improve storage conditions in health facilities
• Periodically test the quality of medicines
Improving Storage Conditions in Health Facilities
Testing the Quality of Slow-moving Medicines
• AMI partner USP assisting countries to implement the 3-level approach to periodically sample and verify the quality of medicines: • 1st level: visual inspection of packaging,
labeling and physical appearance (at all levels of the supply chain)
• 2nd level: basic rapid quality tests, mainly TLC/minilabs
• 3rd level: compendial tests (medicine control lab staff)
USP: Three-Level Approach for Ensuring the Quality of Medicines in Low-resource countries <http://www.usp.org/sites/default/files/usp_pdf/EN/PQM/threeLevelApproach.pdf>
Emphasis on remaining “pockets” of incidence
• Challenge:
• Incidence of malaria is limited to “hot spots” with limited access to health facilities
• Artisanal gold mines along Guyana, Suriname, French Guyana, Brazil borders
• Strategy:
• Analyze the situation and design locally appropriate interventions
• Suriname malaria KAP study
Suriname Malaria KAP Study
Suriname Malaria KAP Study (2)
• Stakeholders workshop held in Feb 2014 to review the results and agree local intervention plan and regional-level recommendations • example of an innovative, locally
appropriate intervention: local stakeholders in Suriname exploring developing a basic malaria survival kit that could be distributed to gold-miners
• Suriname KAP study presented and discussed at AMI Regional meeting in Managua, March 2014 Courtesy: Suriname MOH
Malaria Pharmaceutical Management Logistics for Malaria “Hot Spots” in Remote, Hard-to-Reach Areas
Courtesy of: Suriname MOH
Malaria Pharmaceutical Management Logistics for Malaria “Hot Spots” in Remote, Hard-to-Reach Areas
Courtesy of: Guyana MOH
Key Messages
• Pharmaceutical management for malaria in low-incidence settings is different from pharmaceutical management in high-incidence settings
• New, innovative, locally appropriate and affordable strategies/tools are needed for low-incidence settings. SIAPS is piloting such tools in AMI/LAC
• The tools could be adapted and customized to other settings in Africa and/or Asia