Transcript UNICEF - World Health Organization

Medicines for children in
developing countries: from
challenges to specifications
Atieno Ojoo
Technical Specialist, Pharmaceuticals
UNICEF Supply Division, Copenhagen, Denmark
WHO PreQ; EU generic manufacturers
meeting 261109, Copenhagen, Denmark
Presentation outline
UNICEF
EU generic manufacturers meeting 261109,
Copenhagen, Denmark
Causes of death in under 5s
10
3
3
injuries
3
AIDS
8
measles
malaria
11
26
others
diarrhoeal
diseases
pneumonia
other neonatal
causes
17
19
UNICEF
neonatal severe
infections
World Health Statistics 2007
http://www.who.int/child_adolescent_health/data/child/en/index.html
EU generic manufacturers meeting 261109,
Copenhagen, Denmark
Some success stories
2006
U5M <10 million (9.7m in 2006)
2007
1st WHO paediatric EML
1st Paediatric ARV FDCs
2008
1st Paediatric ACT antimalarial FDC
U5M <8.8 million
2009
2nd Paediatric ACT Antimalarial FDC
BUT
Its not yet time to celebrate !
UNICEF
EU generic manufacturers meeting 261109,
Copenhagen, Denmark
Health worker challenges
• Weight & height measurements often not taken
• Busy clinics
• No weight and height measuring devices
• No suitable dose measuring & administration devices
• What is a teaspoonful? Any spoon?
• No spacers for MD Inhalers (Cost issue)
• Reconstitution of powders for oral suspension/liquid
• Challenge if bottles not marked
• Water supply challenges
• no cold storage
• Repackaging
• No clean bottles - patients have to bring own bottles,
• no measuring/counting devices
• no labels
UNICEF
EU generic manufacturers meeting 261109,
Copenhagen, Denmark
Solutions?
UNICEF
EU generic manufacturers meeting 261109,
Copenhagen, Denmark
Current solution: ½, ¼, 1/8 tablets
UNICEF
EU generic manufacturers meeting 261109,
Copenhagen, Denmark
Patient/caregiver challenges
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Palatability-Child refuses to take medicine
Too much liquid volume per dose
Child vomits, not sure how much to re-administer
No storage space for bulky liquids
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Also significant if caregiver has to carry and walk long distances
• Difficult to follow Instructions
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Mix with apple or apple-grape juice or applesauce or yoghurt
Open capsule and sprinkle contents over a spoonful of applesauce, or yoghurt,
consume immediately
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Crush tablets and mix with condensed milk prior to administration
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Break tablets into 8 equal pieces (How?)
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Dissolve tablet water, then administer by dropper, oral syringe (not provided) or
drink directly
• To be swallowed whole- not to be chewed
UNICEF
EU generic manufacturers meeting 261109,
Copenhagen, Denmark
Challenges for HIV+ children
Child: too many bottles
UNICEF
Adult
EU generic manufacturers meeting 261109,
Copenhagen, Denmark
No cold storage
Quote “ two years ago, I was involved in a study…….in
children and adolescents. One of the subjects, a 5 year old
boy, had to commute daily accompanied by either of his
parents to the hospital to take the drug, which was a
suspension that needed to be stored in a refrigerator. The
family did not have a refrigerator and did not have
electricity connection either, so we could not even donate a
refrigerator as there was provision for this”
UNICEF
EU generic manufacturers meeting 261109,
Copenhagen, Denmark
WHO-UNICEF joint plan
Work on a global project to make paediatric medicines a
priority
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Add missing essential formulations to the Model list in 2009; advise on doses
Develop EML for children (2007-8)
Update treatment guidelines (2007-9)
Develop paediatric prescribing information – a formulary
Develop effective methods for provision of information at the point of care
Collaborate with regulatory authorities to encourage appropriate drug
development and approval processes in all regulatory authorities
Develop quality standards for paediatric medicines
Public development support for missing essential medicines for children
Advocate for the development of paediatric medicines by the industry
Develop a system for enhancing safety monitoring of medicines in children
Provide guidance on procurement and supply of paediatric medicines
UNICEF
EU generic manufacturers meeting 261109,
Copenhagen, Denmark
Ideal paediatric medicine
1. Route of administration: Oral most frequently used
2. Dosage form? SODF** Liquids?
1.
2.
3.
4.
5.
Sufficient bioavailability
Dose uniformity
Non toxic excipients
Acceptable organoleptic properties: Taste
Dosing aids
3. Ease of administration for both parent and child
4. Clear product information/instructions
5. Cost effective
6. Does not require cold storage
7. Minimum steps of manipulation before use
** Chewable, fast melts, effervescent, granules, sprinkles, soluble tablets,,
sublingual, etc
UNICEF
EU generic manufacturers meeting 261109,
Copenhagen, Denmark
We need the support of manufacturers
• Solid oral dosage forms that can me made
into liquid at the time of use
• Dispersible tablets, effervescents, solubles
• Reduce requirements for additional water
• Fast melts, sublingual, lollipops
• Reduce requirements for cold storage
• Course of therapy individual patient packs
• No bulk packs for repacking
• Provide information on sources and prices
of paediatric medicines
http://www.unicef.org/supply/index_47129.html.
UNICEF
EU generic manufacturers meeting 261109,
Copenhagen, Denmark
Coated particles in tablet form
for preparing suspension
Courtesy of J. Breitkreutz
UNICEF
EU generic manufacturers meeting 261109,
Copenhagen, Denmark
Example of win-win strategies
Reduced input costs for solid formulations Vs liquid formulations
• Most Solid dose manufacture technology already exists
• Reduced need for excipients, less safety concerns
• Reduced complexity
Going green/reducing carbon foot prints while meeting developing
country end user needs
• Drug product with no cold storage requirements
• Reduced freight loads-reduced cost
• No need to transport water around the world!
UNICEF
EU generic manufacturers meeting 261109,
Copenhagen, Denmark
Thank you
UNICEF
EU generic manufacturers meeting 261109,
Copenhagen, Denmark