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Meg O’Brien, Ph.D. Director, Global Access to Pain Relief Initiative

Procurement & Manufacture of IR Oral Morphine: Uganda experience. Meg O’Brien, Ph.D. Director, Global Access to Pain Relief Initiative. O’Brien et al, Lancet Oncology (in press). Background. Population: 33 million Deaths in pain: 69,000 Coverage: 4%.

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Meg O’Brien, Ph.D. Director, Global Access to Pain Relief Initiative

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  1. Procurement & Manufacture of IR Oral Morphine: Uganda experience Meg O’Brien, Ph.D. Director, Global Access to Pain Relief Initiative

  2. O’Brien et al, Lancet Oncology (in press)

  3. 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

  4. Disruption in 2010 leads to transformation • Public-sector stock-out due to changes in procurement regulations and lack of clarityabout 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

  5. 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

  6. 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

  7. Cost Cost of 500mg/500mL • Current cost is ~1.86 USD for 500mg • This is about 1 week of treatment • Cost component • 45% is morphine powder • 20% is human resources

  8. 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

  9. 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

  10. 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

  11. www.TreatThePain.org

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