Medicines for children in developing countries: from challenges to specifications Atieno Ojoo Technical Specialist, Pharmaceuticals UNICEF Supply Division,

Medicines for children in developing countries: from challenges to specifications

Atieno OjooTechnical Specialist, PharmaceuticalsUNICEF Supply Division, Copenhagen, Denmark

WHO PreQ; EU generic manufacturers meeting 261109, Copenhagen, Denmark

Presentation outline

UNICEF EU generic manufacturers meeting 261109, Copenhagen, Denmark


3 33

8

11

17

19

26

10injuries

AIDS

measles

malaria

others

diarrhoealdiseases

pneumonia

other neonatalcauses

neonatal severeinfections

Causes of death in under 5s

World Health Statistics 2007

http://www.who.int/child_adolescent_health/data/child/en/index.html


Some success stories2006

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 !


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


Solutions?

Current solution: ½, ¼, 1/8 tablets



Patient/caregiver challenges• 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

• Also significant if caregiver has to carry and walk long distances

• Difficult to follow Instructions• 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

• Crush tablets and mix with condensed milk prior to administration

• Break tablets into 8 equal pieces (How?)

• Dissolve tablet water, then administer by dropper, oral syringe (not provided) or drink directly

• To be swallowed whole- not to be chewed


Challenges for HIV+ childrenChild: too many bottles Adult


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”


WHO-UNICEF joint planWork on a global project to make paediatric medicines a priority• 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

Ideal paediatric medicine1. Route of administration: Oral most frequently used

2. Dosage form? SODF** Liquids?1. Sufficient bioavailability

2. Dose uniformity

3. Non toxic excipients

4. Acceptable organoleptic properties: Taste

5. 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



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.

https://service.gmx.net/de/cgi/derefer?TYPE=3&DEST=http%3A%2F%2Fwww.unicef.org%2Fsupply%2Findex_47129.html

https://service.gmx.net/de/cgi/derefer?TYPE=3&DEST=http%3A%2F%2Fwww.unicef.org%2Fsupply%2Findex_47129.html

Coated particles in tablet form for preparing suspension


Courtesy of J. Breitkreutz


Example of win-win strategiesReduced 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!


Thank you

Documents

Medicines for children in developing countries: from challenges to specifications Atieno Ojoo Technical Specialist, Pharmaceuticals UNICEF Supply Division,