Transcript Procurement and manufacture of immediate release morphine

Procurement & Manufacture of IR Oral Morphine: Uganda experience
Meg O’Brien, Ph.D.
Director, Global Access to Pain Relief Initiative
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Mindset
Ensure that government policy makers are familiar with the issues and
prepared to take a lead role in improving access to pain relief
Organize
Consult key stakeholders and partners and identify key barriers to
access to pain relief and solutions to address them
Regulations
Review national quotas from the International Narcotics Control Board
as well as national importation, storage, and prescribing regulations to
ensure that they are up to date or identify needed changes
Procurement
Establish budget for medication purchase, storage, and distribution.
Estimate quantities by product and formulation, identify suppliers,
secure product registrations, develop tenders, place and pay for orders,
receive and distribute to regional medical stores
Health workers
Organize awareness-raising activities, in-service training, and continuing
medical education; develop reference materials and guidelines; and
sensitize health workers and administrators
Initiation
Establish pain treatment by trained clinicians, usually at large clinical
centers or specialized clinical units (for example in cancer centers)
Nationalization
Scale-up by integrating pain treatment into service delivery at regional
and district hospitals and ensuring adequate geographical coverage to
make pain relief accessible to all who need it in the country.
Empowerment
Create a sustainable stakeholder base in a country
O’Brien et al, Lancet Oncology (in press)
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Background
Population: 33 million
Deaths in pain: 69,000
Coverage: 4%
Hospice Africa Uganda (HAU) and the Ministry of Health (MOH)
work in close collaboration
Other key partners:
• Palliative Care Association of Uganda (PCAU)
• African Palliative Care Association (APCA)
Data from 2010
History of access to pain relief
• HAU began to reconstitute oral
morphine in 1993 for hospice
patients
• Govt reconstituted for public
sector at the national hospital
• Specially trained nurses
prescribe morphine
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Disruption in 2010 leads to transformation
• Public-sector stock-out due to changes in
procurement regulations and lack of clarity
about the best way forward
• HAU provided morphine to hospice patients
and some public sector facilities
• GAPRI and APCA invited to assist with finding a
solution
Extensive discussions with all players led to design of a new approach, starting early 2011
• National Medical Stores (NMS) contracts with HAU for an annual order
• HAU procures powder and produces finished oral solution
• HAU upgraded and expanded production facility
• NMS distributes to public and private, not-for-profit facilities
• NMS provides morphine to all patients for free
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Experience after one year
Price for govt reduced by 40%
Cost for HAU reduced from 50,000 USD/year to 4,000 USD/year
Oral morphine has been continuously available at central stores
• 15.9 kg produced in 2011
• 7.0 kg produced first half of 2012
Total morphine produced 2011 (kg)
Total morphine produced
2012 (kg)
5.000
4.000
3.000
2.000
1.000
-
3.500
3.000
2.500
2.000
1.500
1.000
0.500
-
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Production
Based on HAU blue book guidance
Some changes to come closer to GMP:
• Amber bottles
• Labels with batch no. and expiry
• Deionized water
• Product testing
HAU uses bronopol preservative
• Shelf life~6-12 months
• Alcohol-free
Color-code by strength
• Green: 5mg/5mL –vast majority of use
• Red: 50mg/5mL
• Blue: 100mg/5mL
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Cost
Cost of 500mg/500mL
Current cost is ~1.86 USD for 500mg
• This is about 1 week of treatment
Morphine powder
Bronopol crystals
Gauze for filtering water
Water
Bottle: 500mL
Label
Packing
Human resources
Adminstrative costs for Hospice Africa-Uganda
Other recurring costs
Total
$
$
$
$
$
$
$
$
$
$
$
Cost in USD
0.85
0.01
0.04
0.11
0.09
0.03
0.38
0.22
0.15
1.86
Cost component
• 45% is morphine powder
• 20% is human resources
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Upgrading production
GAPRI recently secured 85kg donation of morphine powder for HAU
• 1 million doses
• ~3-5 years supply
Expected to generate about
170,000 USD surplus for HAU
upgrades
• Renovate space
• Rainy-day fund
• Automation equipment
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Why oral liquid instead of tablets?
Patient
• Reduce pill burden
• Inability to swallow
• May be only immediate release option
• Easy to finely titrate doses
Procurement
• Morphine powder is API-does not need to be registered
• Volume is small, easy to ship and store
• Price is about 1/3 of tablet price
(~2,000 USD per kg)
Distribution
• Production on demand maximizes shelf-life
• Can make various strengths on demand
• Creates local jobs
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Drawbacks of oral liquid morphine?
Drawbacks
• Liquid is bulkier to distribute locally
• Requires technical capacity in country for production
• Requires supplies and equipment
• Dosing may be less accurate
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www.TreatThePain.org
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