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