Abstract
In daily paediatrics, drugs are commonly used off-label, as they are not
approved for children. Approval is lacking because the required clinical
studies were limited to adults in the past. Without clinical studies,
evidence-based recommendations for drug use in children are limited. In
the meantime, paediatric regulation came into force where the approval
of new drugs requires clinical studies in children. Still, most of the
drugs currently prescribed to children are not yet covered by this new
regulation. Information on drug dosing in children can be found in
different handbooks, databases, and scientific publications but the
dosing recommendations can differ considerably. Accordingly, prescribing
medicines to children remains a challenge. To improve drug safety and
efficacy in children and assist the prescribers, stakeholders in Swiss
paediatrics started a pilot project, supported by the Federal Office of
Public Health, with the aim to create a database, providing healthcare
professionals with so called “harmonised” dosage recommendations based
on national consensus. A standardised process for dosage harmonisation
was defined, guided, and documented in an electronic tool, developed for
this purpose thereby integrating the latest available scientific
evidence and best clinical practice for optimal dosage recommendations.
As proof of principle, a total of 102 dosage recommendations for 30
different drugs have been nationally harmonised in the pilot phase
considering the current literature and the consent of the most
experienced national experts in the field. This approach paved the way
for unified national dosage recommendations for children.