PHA-Exchange> UN HEALTH AGENCY STRESSES NEED TO ENSURE SAFETY OF CHILDREN'S MEDICINES

[Claudio Schuftan]

From: Vern Weitzel vern at coombs.anu.edu.au

UN HEALTH AGENCY STRESSES NEED TO ENSURE SAFETY OF CHILDREN'S MEDICINES
New York, Sep 21 2007 12:00PM

The lack of thorough and reliable clinical data on the way medicines affect
children, particularly side effects, requires strengthened safety monitoring
and
vigilance of medicinal products, the United Nations World Health
Organization
(WHO) <"
http://www.who.int/mediacentre/news/releases/2007/pr51/en/index.html">warned
today.

"We need to learn more about the way children's bodies react to medicines so
we
can improve global child health," WHO Assistant Director-General for Health
Technology and Pharmaceuticals Howard Zucker said as the Agency released a
new
report –
<"
http://www.who.int/medicines/publications/essentialmedicines/Promotion_safe_med_childrens.pdf
">Promoting
Safety of Medicines for Children.

"That's why it's extremely important to keep track of potential side effects
in
child populations. Ultimately, this will save lives and build up a knowledge
base for the future," he added of the study, which is intended for
policy-makers, manufacturers, medicines control bodies and researchers.

It gives an overview of the problem and offers solutions on how best to
address
side effects from medicines in children through improved reporting systems
and
collaboration between governments, regulatory authorities, research
institutions
and the pharmaceutical industry, and is part of a broad effort WHO is
initiating
to expand children's access to quality-assured, safe and effective
medicines.

A large proportion of side effects or adverse reactions to medicines in the
adult population are due to irrational use or human error and are therefore
preventable. In the case of children, even more factors come into play. The
main
challenge is the lack of clinical data, resulting in fewer medicines being
developed, produced and marketed specifically for children. Often, children
are
given medicines that have only been tested in adults and are not officially
approved for use in child populations.

Non-availability of appropriate paediatric formulations forces health care
providers to resort to administering portions of crushed or dissolved
tablets or
the powder contained inside a capsule without any specific indication of the
required dosage. For that reason, according to the report, potentially
harmful
medication errors may be three times more common in children than in adults.

An appropriate format or structure for a child's medicine is also important.
Small children sometimes choke or asphyxiate while trying to swallow big
tablets. For instance, earlier this year four children under 36 months died
from
choking on albendazole tablets during a de-worming campaign in Ethiopia.

In another example, side effects associated with antiretroviral medicines
have
been reported to occur in up to 30 per cent of HIV-infected children. Most
of
those side effects could be reversed by modifying the dosage or changing to
an
alternative medicine.

The study proposes that all countries establish national and regional
monitoring
systems for the detection of serious adverse reactions and medical errors in
children. When such reporting systems exist, it is crucial that
manufacturers
follow up on adverse reactions to their products once they are on the
market.

In addition, regulatory authorities need to make an effort to refine the
science
of clinical trials in children, create an active post-marketing surveillance
programme and develop public databases of up to date information about
efficacy
and safety in paediatric medicines.

To assist countries, WHO will publish an official List of Essential
Medicines
for Children, continue to create awareness in countries and in the research
community on the urgent need to monitor use of medicines in children,
identify
research gaps in children's medicines, and create protocols to monitor
adverse
effects for child-specific medicine.
2007-09-21 00:00:00.000
___________________

For more details go to UN News Centre at http://www.un.org/news
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