Children are not small adults. They represent a particularly vulnerable group of patients since they react to medicinal products in a different way. Infants usually metabolise medicinal products less rapidly and also excrete them more slowly. Some medicinal products can moreover affect growth and development.
These and other specific aspects must be taken into consideration when prescribing and dispensing medicinal products for children. In addition, medicinal products that were developed for adults are in many cases not appropriate for children. Small children are usually unable to swallow tablets, and refuse to take a syrups unless it has a pleasant taste.
The use of a product for children is only officially approved if clinical trials have been carried out with the corresponding age group. In many cases, new medicinal products are however initially – or even only – developed for adults. This problem exists worldwide.
It is frequently the case that clinical trials on efficacy and safety for younger age groups are not even conducted with medicinal products that have been on the market for some time; this particularly applies for newborns and infants. Often, age-appropriate dosage strengths for children, infants and babies do not exist, and / or there are no appropriate dosage forms such as suppositories, drops, syrup, etc.
The reasons for fewer investments being made in research and development for diseases affecting children include, on the one hand, the fact that this is a smaller market, and on the other that trials on children are more difficult to conduct. The population concerned is moreover not a uniform one (a newborn is, for example, not comparable with a 15-year old adolescent).
The product information should be used in order to see whether a medicinal product can be used by children and adolescents. If the corresponding clinical trials have been conducted, the product information for healthcare professionals will – for medicinal products that have been authorised in recent years – contain information in this respect for these professionals (doctors and pharmacists). For older medicinal products, however, this information was not included in the information and precise details regarding the dosage for children and adolescents were frequently missing.
This problem was addressed during the years 2003-2009, and today nearly all medicinal product information should contain appropriate information concerning paediatric use, and specify the age group as of which paediatric use is authorised. It should be noted that stating a dosage in milligrams per kilogram of body weight (mg/kg) is not an indication that it can be used for children and adolescents, and nor does it mean that the medicinal product concerned is authorised for paediatric use.
In many cases, paediatricians must rely on their personal, practical experience when prescribing, since no medicinal products for paediatric use have been developed for the treatment of certain diseases, and only a product that has been authorised for adults can be used. This type of prescribing (so-called off-label use) is permitted under the Therapeutic Products Act as long as the acknowledged rules relating to medical and pharmaceutical sciences are taken into consideration.
It is precisely in such cases, however, that suspected adverse reactions are reported in the interests of safety.