[e-drug] Children need better medicines

E-DRUG: Children need better medicines
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[This message was written by Philippa as a briefing document for civil
society and NGOs. WB]

Children need better medicines

This briefing identifies gaps that exist in the provision of medicines
for children and outlines key challenges and solutions.

What are the problems?

Medicines for children are frequently unavailable, impractical to
administer or difficult to use well, and unsafe and unaffordable.
Action is needed to ensure children's medicines meet the standards
expected for medicines available to adults. All children are affected,
but the impact is most acute and the needs most urgent in poor
countries, where the proportion of children in the population is highest
and health services are weakest.

Four challenges require attention in the short-term: absence of
scientific data; lack of products that are practical to administer; lack
of usable information about existing medicines; and market failure for
paediatric medicines.

Absence of scientific data

Scientific evidence is essential to ensure appropriate use and access to
medicines for children. Fewer than half the products used to treat
children have been properly developed. Pharmacokinetic studies defining
optimal doses for children in relation to age or weight are often not
done. Much of the treatment offered to children lacks a scientific
basis, i.e. is 'off-label', and estimation of doses and treatment
effects are based on studies in adults. This wrongly assumes that
children metabolise medicines in the same way as adults without taking
account of maturity of the liver, kidneys and enzyme systems. The result
can be under- or over-dosing, leading to inefficacy or toxicity.

Insufficient appropriate dosage forms

Medicines are needed in forms that are appropriate for use in household
and clinical settings. In addition to being available and affordable,
paediatric medicines must be palatable and acceptable to the child,
stable and practical to use in difficult conditions, packaged
appropriately, and accompanied by information that parents can
understand and use. Many are now unpleasant to taste, difficult to
administer, and costly. In some diseases several drugs have to be
taken, making fixed-dose combinations a practical solution. Impractical
dosage forms result in inefficiencies in busy clinical settings, waste
money and have poor health outcomes.

Weak pharmaceutical markets for paediatric products

Without scientific data, the registration of products in countries is
inhibited. Weak competition among available products leads to high
prices. In the absence of suitable products, there is no real demand and
new manufacturers are reluctant to enter the market.

Why has this situation arisen?

The difference in standards for children's and adults' medicines stems
partly from the perceived risks of conducting studies in children. There
has been lack of demand for appropriate medicines and information.
Higher expectations have resulted from recent developments including:
the new paediatric medicines' legislation in the European Union (2007) ;
identification of essential medicines for children - the WHO Essential
Medicines List for Children (EMLc 2007); and pressure from AIDS,
tuberculosis and malaria public health programmes.

What are the priorities for better products?

For better products, more research and development of medicines is
needed.
Globally 1000 children under five die every hour. HIV/AIDS, TB,
malaria, neonatal sepsis, pneumonia and diarrhoea cause most of these
deaths and serious illness. Products appropriate for children in all
age-groups are needed to treat these diseases, including:
. appropriately packaged antibiotics to treat pneumonia and neonatal sepsis;
. a palatable and easily used formulation of zinc in combination with Oral Rehydration Salts for treating diarrhoea;
. effective pain relief; in many countries access to simple oral
morphine is denied;
. new fixed-dose combination medicines for tuberculosis in children;
. better dosage forms of existing products, including fixed-dose
combinations for malaria and HIV/AIDS; and
. more easily administered dosage forms - such as sprinkles, small or scored tablets, drops etc.

Support is needed

Progress on WHO's World Health Assembly Resolution 60.20 "Better
Medicines for Children" will be reported to the 2009 WHO Executive Board
in January 2009. WHO has developed and updated the Essential medicines
List for Children, commissioned work to identify ideal fixed-dose
combination products for tuberculosis, undertaken preliminary surveys of
availability of key medicines for children in Africa, and begun to
define the optimal dosage forms of medicines suitable for children of
all ages. This work provides a framework for global support for better
research into children's medicines, which if implemented will enable
progress toward MDG targets.

It is now necessary for the entire public health community -
governments, donor agencies, academic research units, regulators, the
industry and all who have a duty to care for children - to recognize the
need for safe and appropriate medicines for this population. A start
has been made, but without sustained commitment by all concerned during
2009 (the year of the Rights of the Child) and beyond children will
continue to be disenfranchised: their rights to adequate healthcare, as
well as the global agenda for health, will be undermined. It is time
for action.

Regards

Philippa Saunders
Independent consultant
UK
EDP@GN.APC.ORG