A JOINT POLICY STATEMENT BY THE EAP AND THE ESDPPP ON OFF-LABEL USE OF MEDICINES IN NEONATES, INFANTS, CHILDREN AND ADOLESCENTS WAS PUBLISHED EARLIER THIS YEAR
Health-care professionals who prescribe medicines have the professional duty to choose medicines that are in the best interest of their individual patient,
irrespective if that patient is an adult or a child. However, the availability of medicines with an appropriate label for pediatric use is lagging behind those for adults, and even available
pediatric drugs are sometimes not suitable to administer to children. Consequently, health-care professionals often have no other option than to prescribe off-label medicines to children. An
important reason for use of off-label medicines is to improve access to (innovative) treatments or to address medical needs and preferences of patients, especially when no other options are
available. However, off-label use of medicines is in general not supported by the same level of evidence as medicines licensed for pediatric use. This may result in increased uncertainty on
efficacy as well as the risk for toxicity and other side effects. In addition, liability may also be of concern, counterbalanced by professional guidelines.
ESDPPP VZW p/a University Hospital
Gasthuisberg Herestraat 49
The primary aim of the society is to promote research in the field of paediatric pharmacology and to offer a forum for exchange between pharmacologists and clinical physicians about more adequate drug administration.
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