Medication for children Often severe deficiencies in research, development and testing

Negligence in the children's pharmacy

Since 2006, there is the European pediatric drug regulation. According to this, drug manufacturers are required to test new drugs for the suitability, efficacy and safety of children. The foundation child health complains now many existing deficiencies in this connection. According to the Foundation, many manufacturers still do not comply with this obligation, mainly for financial reasons.

"Even today, children are still disadvantaged in the treatment with drugs," says the chairman of the Foundation for Child Health Professor. Berthold Koletzko in a statement. In many cases, children would be treated with medications that are not approved or appropriate for their age group. This is a fatal situation.

The Foundation for Child Health denounces current maladministration in medicines for children. According to the Foundation, there are major shortcomings in research, development and testing. Often, children are given untested remedies for adults. (Image: redpepper82 / fotolia.com)

The stepchildren of medicine

"At a first glance, the EU regulation has made significant progress, but on closer inspection, medicines for children still turn out to be step-children in medicine," explains the professor. Especially in the treatment of children with cancer, there is a lot of catching up to do.

Children suffering from cancer are uninteresting for the pharmaceutical industry

The physicians of the Foundation for Child Health report that in children occurring diseases or forms of tumors in adults hardly or not at all. Thus, they would also for the pharmaceutical industry a very minor relevance. In the last ten years, only two drugs have been approved for the treatment of children with cancer.

Children are given unchecked adult medications

"Especially for the treatment of very young children and children with rare diseases, there is a lack of tested medicines," emphasizes Dr. med. Koletzko. Therefore, pediatricians would often have to resort to medicines that were actually only tested on adults.

About every third drug unchecked

Data from the KiGGS child health study show that around 30 percent of medications prescribed for children have not been tested for them. The more frequently untested remedies are used, the younger and the more seriously ill the child is. For example, representative studies in neonatal departments and in pediatric intensive care units show that nearly 90 percent of the prescribed arnees are given to children without explicit approval.

Old rule of thumb: "Half for children" - wrong and dangerous!

The deficiencies go so far that with many drugs more accurate dosage information for children are missing or not adequately described. The rule of thumb often applies to prescriptions: children receive half the dosage of adults. "This has since proved to be wrong and sometimes dangerous as well", write the experts of the Foundation for Child Health. Because metabolism and water balance often work for children according to other rules.

Children are not half adults

"Children are not small adults and adolescents are not big children," explains the Foundation for Child Health. The individual development phases would be clearly differentiated. According to international guidelines, adolescents have five stages of development. For each phase, the correct dosage of an active substance would have to be checked by studies. The five stages are:

• Premature babies,
• Newborns up to 27 days,
• Infants and toddlers from 28 days to 23 months,
• Children from two to eleven years,
• Teenagers from twelve to 18 years.

Why are there such serious shortcomings??

"Clinical studies with children are associated with a considerable effort," write the experts of the Foundation Child Health. On the one hand, the search for participants is very difficult because the patient groups are small and many parents are unwilling to give their child as a "guinea pig". Secondly, the research costs for new medicines are very high. On average, a new drug would cost around 20 million euros in pre-approval costs.

With adults, the costs come back in quickly

The cost is probably one of the main factors for the disinterest of the industry. "Medicines with high sales figures in chronically ill adults make it possible to recoup the research effort quickly," says the Foundation for Child Health. On the other hand, children are rarely ill and sick children would only need smaller amounts of an active ingredient. (Vb)