Many medications have not been tested for children

Medication: Fifty percent of the drugs not specifically tested for children

09/15/2013

Around half of all medicines taken by young patients have not been tested specifically for their age group. Above all, older drugs are affected.

Only fifty percent tested
Again and again there is talk of undesirable side effects of medication. Medicines that are supposed to relieve pain or cure illness can sometimes pose disproportionate risks. This is especially true for children, because they are still in development and the drugs have often a different effect on their organism than on the body of adults. Of the drugs used in children, over fifty percent were not previously tested in this age group.

Legal guidelines
The EU has already passed a pharmaceutical regulation in 2007, which requires pharmaceutical companies to test every new drug in studies with children. First progress would become apparent in the meantime. Without compliance with the directives, which are mandatory in all EU member states, there is no approval. Affected are all new registrations, but not so-called generics, so drug-like copies of products already on the market. Exemptions may be granted for medicines that do not play a role in paediatrics.

Children involved in about five percent of the studies
However, until a few years ago, the number of studies with children had not increased significantly, as the president of the German Society for Pediatric and Adolescent Medicine (DGKJ), Prof. Fred Zepp in 2011 said. At that time, according to the DGKJ, only about five percent of all studies involved children and adolescents aged between 12 and 17 years. Newborns and infants up to two years have been involved in 0.5 to 2 percent of the studies on average.

Flagrant test gap
One reason for the glaring test in pediatric medicines could be the thalidomide scandal. At that time, in the early 1960s, manufacturers simply had to register new medicines to get to market. The use of the sedative, which was recommended against, among other things, the morning sickness, led to thousands of cases of malformations or even the absence of limbs and organs in newborns. It was only from these experiences that tests on the efficacy and safety of a drug were prescribed before it was approved. At the same time, the scandal was largely responsible for the fact that drug tests in children were subject to high restrictions and restrictions. Was argued with the protection of children.

Benefit for the entire collective
However, this strategy does not seem to work, as missing studies often make the drug prescription difficult in young patients. Experts say that it is about protecting children through carefully conducted examinations and that is why the reins for such tests have been loosened a bit. However, it still applies that drugs should not be tested on healthy children. But unlike in the past, a therapeutic benefit would no longer be expected for every child included in the study. A potential benefit for the entire collective of children suffering from the disease is crucial.

Tests not lucrative for the pharmaceutical industry
However, ethical concerns are by no means responsible for the absence of pediatric drug tests. As so often in healthcare, the economic aspect plays a role. For the pharmaceutical industry such tests are simply not lucrative. On the one hand, children and adolescents are only a small market and on the other hand, pediatric examinations are usually very costly. However, the EU directive takes this into account by granting the producers of new medicines an extension of the patent protection by six months in return.

Only every fifth drug tested for children
However, despite the EU Directive, only one in five drugs on the market is currently being tested and approved by children and adolescents. It follows that in pediatrics many remedies are still being administered in the dark. More than fifty percent of drug use in children „Off label“, that is without approval. The European Medicines Agency EMA published this figure in 2007. Five years after the entry into force of the EU Directive, the European Commission took stock and presented a so-called progress report: the EMA approved 600 pediatric examinations until 2012. Thirty-three examinations had already been completed and 31 of a total of 152 new drug approvals were intended for use on children and adolescents. In addition, 72 drugs that were already established in adults were subsequently approved for children.

Off-label use is an imposition
The head of the University Hospital in Aachen and President of the German Society for Paediatrics and Youth, Norbert Wagner, had hoped for more: „For our little patients, we definitely need a lot more drugs with proven safety and security profiles. The "off label use" is an unreasonable burden on the sick child and the attending physician.“ According to Wagner, the EU directive goes too far, as the large pot of old-established drugs remains untouched.

Children become guinea pigs
That the maladministration has finally become a political issue, was largely due to the commitment of the Society for Paediatrics and Adolescent Medicine. According to the pediatricians' ideas, there should be special testing centers, such as university clinics, where drugs that have already been established in adults for a long time could be tested specifically for children. So far, however, there are no efforts by the legislature and so continue to put in serious illness, the problem of „Off Label Use.“ For widespread teething troubles, there are usually enough tested drugs, in more serious diseases, however, doctors would often stand in front of nothing and have to experiment. Thereby most of these find „Off-label uses“ in pediatric intensive care units, with the rate being highest at about 90 percent in neonatal intensive care units. So far, a doctor must take it on his own cap if a child needs a drug that is not approved for his age. So if something goes wrong, he has sole responsibility and the treated children become guinea pigs at the same time.

„For children half the dose“ is outdated
A major issue remains ambiguity about the right dose. The doctor must first get the optimal dosage and lose valuable time. Also the partly still applied rule „in children half the dose“ was long outdated, because it differentiates too little. In addition, child-appropriate dosage forms would often be missing, for example, if large tablets could not be divided exactly. Other variants that are easier to swallow, such as juices are often not.

Children are still developing
In children and adolescents, the developing organism has physiological peculiarities that influence the uptake, distribution and excretion of drugs. For example, organs such as the liver, kidneys, stomach and intestines are not yet mature and work differently than in adults. In addition, children usually have a higher respiratory rate, lower blood pressure, and a greater amount of sleep. All these are factors that may play a role in the effect of drugs.

Special features of the child's organism
Other circumstances that need to be considered when administering drugs to the youngest: Infants can break down and eliminate medication very slowly in the first few weeks. Since the body fat percentage in children changes over time and some drugs preferentially accumulate in adipose tissue, this has an effect on the dosage of medication. Another issue is the amount of water in the body, which decreases with age. Therefore, fat-soluble drugs in children are significantly lower and water-soluble higher doses than in adults. It is therefore important to consider all these peculiarities of the child's organism, otherwise unwanted or dangerous side effects sometimes threatened, which are partly unknown or extremely rare in adults. (Ad)