[e-drug] WHO to launch first essential medicines list for children

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E-DRUG: WHO to launch first essential medicines list for children
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WHO to launch first essential medicines list for children

Bulletin of the World Health Organisation
Volume 85, Number 4, April 2007, 245-324
[copied as fair use]

A list of essential paediatric medicines is sorely needed. The WHO 
essential medicines list, first launched in 1977, is predominantly for 
adults. It includes some dosages for children, but in most cases 
formulations for children simply do not exist.

Children cannot be treated as "little adults" when it comes to 
medicines. "Children differ in the way they ingest, absorb, metabolize 
and excrete drugs, and behavioural and developmental issues complicate 
their treatment," said the United Nations Children's Fund (UNICEF) and 
the World Health Organization (WHO) in a report last year.
The report concluded: "These factors are not constant but vary as the 
child grows. The majority of medications worldwide are not formulated 
for easy or accurate administration to children."

An estimated 10 million children die every year, many from diarrhoea, 
malaria, respiratory tract infection, pneumonia or HIV/AIDS. Medicines 
for these illnesses exist, but paediatric formulations and knowledge on 
how best to use them in children are often lacking. To remedy this, WHO, 
UNICEF and others proposed a paediatric essential medicines list at a 
meeting in August 2006 in Geneva.

WHO has since developed a draft list of medicines and distributed it, 
setting a 30 April deadline for feedback. A committee of experts will 
finalize the list at a meeting to be held from 9 to 13 July.The list 
will be made available to countries by September or October and will 
undergo revision as more children's medicines become available.
It would not be the first list of its kind -- Canada, the United 
Kingdom, the United States of America and other developed countries have 
their own versions -- but it would be the first to address diseases of 
children in developing countries.

The project is timely given a number of factors. The changing nature of 
childhood diseases is one. Children today need more chronic treatment 
than in the past, when health systems mainly had to manage children with 
acute diseases for which some medicines exist.

Secondly, the world's health systems and public health organizations are 
making a concerted effort to deal with malaria -- which accounts for one 
in five of childhood deaths in Africa alone -- and other major 
infections, such as HIV, in children. But there are few age-appropriate 
formulations for antimalarials or antiretrovirals.

Thirdly, the USA and the European Union have acknowledged the lack of 
children's medicines in developed countries and are seeking ways to 
address it from a regulatory perspective.

At the August 2006 meeting, experts from WHO, UNICEF and other 
organizations took stock of existing children's medicines and their 
availability. The meeting's report found that of 284 medicines on the 
adults' list, 119 required an approved indication for use in children. 
While 52 of the 119 had a paediatric formulation listed, the remaining 
59 did not. There were eight duplicate listings.

Certain diseases are common in childhood, such as meningitis, pneumonia, 
ear and respiratory infections, and gastrointestinal infections. "You 
might need additional drugs that you wouldn't use in adults," said Dr 
Suzanne Hill, a scientist from WHO's Policy, Access and Rational Use 
team. "What we've not had is a separate list that covers comprehensively 
all the diseases of childhood," Hill told the Bulletin. "And we 
certainly haven't looked in detail at medicines for neonates."

HIV infection and malaria are diseases in adults too, but the dosage for 
the medicines used to treat them is different for children. On the 
existing essential medicines list for HIV, there are 12 antiretrovirals 
with syrup formulation, which can be used in children. But dosage forms 
that combine antiretrovirals in one tablet would be more appropriate, as 
children usually need to take three or four drugs at a time.

Research is just beginning into many paediatric medicine formulations 
and it's no small task. "Several hundred medicines need to be evaluated 
as to whether they should be on the children's essential medicines 
list," said Dr Howard Zucker, assistant director-general of WHO's Health 
Technology and Pharmaceuticals cluster of departments.

Dr Jane Schaller, executive director of the International Paediatric 
Association in British Columbia, Canada, said that drugs on the list 
need to be affordable, and take into consideration distribution and 
storage. Many existing formulations need to be refrigerated, which is 
difficult in places with unreliable electricity supplies, Schaller said. 
Not all adult medicines are palatable to children. For example, zinc is 
an effective treatment for diarrhoea in children, but children don't 
like the existing tablet formulation and refuse to take it. Kids often 
dislike syrups too. What's needed is solid-dose formulations that a 
child can swallow, Hill said. "We know they work, they're on the 
essential medicines list, but we need to have a dose and a formulation 
that is palatable to children," she said. "And we need a manufacturer 
who will make that and do so at a reasonable price. So that's the sort 
of process we'll be going through for all the different diseases."

Developing medicines for children requires clinical trials. An important 
part of researching adult medicines to enable their use in children will 
involve looking at side-effects. Currently there is very little 
information on adverse drug reactions in children. Trials involving 
children -- who can be more vulnerable than adults -- need to done 
according to the highest possible standards with close monitoring.

Several companies and research organizations are doing clinical trials 
in children. GlaxoSmithKline is studying chewable asthma tablets, 
ointment against impetigo in children aged 1 month to 1 year, and drugs 
to combat HIV/AIDS. Other trials include a study of the use of lithium 
in treating paediatric mania by the National Institute of Child Health 
and Human Development at Case Western Reserve University in the USA, and 
Pfizer's comparison of adults' versus children's doses of a drug for ear 
infections.

The big question is how to encourage pharmaceutical companies to start 
costly and often challenging trials for a whole new series of children's 
medicines, when the markets for these medicines are mainly in developing 
countries with small health budgets.

UNICEF has proposed an advocacy plan to promote the development of such 
medicines. WHO has a prequalification programme: a list of medicines it 
recommends for purchase by United Nations agencies for developing 
countries, which also serves as a market incentive, Hill said. She added 
that this system had successfully encouraged generic manufacturers to 
produce high-quality, affordable medicines for adults.

"Our challenge at WHO is to work with Member States on this 
comprehensive approach to improve medicines for children and make them 
available, in the right dose and form, for the right purpose, to improve 
children's health," Hill said. 

Theresa Braine, Mexico City.