Children are not small adults. They represent a particularly fragile patient group as they react differently to medicines. For example, infants generally metabolise medicines less quickly and also excrete them less rapidly. There are also medicines that can impair growth and development.

These and other particularities must be taken into account when prescribing and dispensing medicines to children. In addition, medicines developed for adults are often not suitable for children. Small children are usually unable to swallow tablets and refuse to take a syrup that does not taste good.

Use in children is only officially recognised if clinical studies have been carried out in the relevant age group. However, new medicines are often initially - or even only - developed exclusively for adults. This problem exists worldwide.

Even for drugs that have been on the market for some time, there are often no clinical studies on efficacy and safety in younger age groups; this applies in particular to newborns and infants. Furthermore, there is often a lack of age-appropriate dosage strengths for children, infants and babies and/or adequate dosage forms such as suppositories, drops, syrup, etc.

The reasons why less has been invested in research and development for childhood diseases are, on the one hand, the smaller market and, on the other hand, studies in children are more difficult to realise. Also, the population is not uniform (compare a premature baby with a 15-year-old adolescent).

Whether a medicinal product can be used in children and adolescents can be found in the product information and package leaflet. If corresponding clinical studies have been carried out, a note for doctors and pharmacists is included in the information for healthcare professionals for medicinal products authorised in recent years. This was often not the case with older medicinal products, and precise information on dosage in children and adolescents was often missing.

This problem was addressed in the years 2003-2009, and today almost all medicinal product information should contain adequate information on use in paediatrics and indicate the age group from which use in paediatrics is approved. It should be noted that a dosage indication in milligrams per kilogram body weight (mg/kg) does not allow any conclusions to be drawn about the use in children and adolescents, nor about the authorisation of the medicinal product for paediatric use.