[e-drug] Paediatric formulations for malaria drugs (3)

["Suzanne Hill" <HillS@who.int>]

E-DRUG: Paediatric formulations for malaria drugs (3)
-----------------------------------------------------------------

Dear E-druggers,

Yes, there is a problem with availability of appropriate dosage forms
and strengths of antimalarials for children (as is the case for many
other products). However, in this particular case I would like to refer
you to the report of the WHO Expert Committee from October 2007
(http://mednet3.who.int/EMl/expcom/expcom16/WATERMARKED.pdf) which
reports the decision of the Expert Committee not to add this particular
combination product to the Model Essential Medicines List. The reasons
for rejection are stated in the report, but highlight the problems with
development of children's medicines in malaria. In particular, defining
the appropriate dose of components of combination products is
challenging. As noted in the Expert Committee Report, there is the
potential for under dosing (with resulting inefficacy) and overdosing
(with resulting toxicity) for products that are combinations of existing
components that have poorly defined dose response curves. What is needed
first of all is analysis of existing kinetic data for many of the single
components of ACTs in order to better define appropriate doses for
children. Although this process may highlight gaps, there may well be
published studies that are potentially useful for this purpose. These
then also have to be matched to weight or age bands of children that
allow for appropriate and easy dosing. This is part of the work that WHO
is undertaking in the Making Medicines Child Size Campaign.

Kind regards,

Suzanne Hill
Secretary
WHO Expert Committee on Selection and Use of Essential Medicines.
Scientist
Policy, Access and Rational Use
Medicines Policy and Standards
phone 41 22  7913522
fax 41 22 791 4167
email: hills@who.int