Published: 1. May, 2020
Children differ pharmacokinetically from adults, and medication for adults cannot simply be administered in smaller doses
Children are not small adults
Off-label medicine use among children and adolescents constitutes an important public health issue as the effects and potential health risks may be unpredictable. Pioneering work in this area was conducted already in the year 1953 by the paediatrician F. Dost who stated, that children differ pharmacokinetically from adults, and medication for adults cannot simply be administered in smaller doses. As children differ in their absorption, distribution, metabolism, and excretion of medicine, they have special needs with respect to their diseases and the dosing of medicines and they often require special formulations to permit administration of adequate doses. Particularly young children are unable to swallow tablets and are vulnerable to the taste of medicine. However, many medicines are not specifically developed for children. Among medicines which were newly licensed by the European Medicine Agency (EMA) between 1995 and 2005 only one third was specifically licensed for children. There is hope that this situation will improve with the Paediatric Regulation which came into force in 2007 and which requires companies to develop a paediatric investigation plan (PIP), while granting incentives once a license for paediatric use has been obtained. Nevertheless, up to date there is still a high use of off-label medicine in children. National and international studies report a wide range of prevalence rates of off-label medicine use in children and adolescents, reaching from 3.2% to 80%.