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Drug approval: Fifty percent of the drugs are not specifically tested for children
Around half of all medicines taken by young patients have not been specifically tested for their age group. Older active ingredients are particularly affected.
Only fifty percent tested There is always talk of undesirable side effects from medication. Medicines that are actually intended to relieve pain or cure diseases can sometimes pose disproportionately high risks. This is especially true for children, because they are still developing and the active pharmaceutical ingredients often have a different effect on their organism than on the body of adults. Of the medicines used in children, over fifty percent were not previously tested in this age group.
Legal guidelines The EU already issued a drug regulation in 2007, which obliges pharmaceutical companies to test every new drug in studies with children. The first signs of progress are now becoming apparent. Without compliance with the guidelines, which are mandatory in all EU member states, there is no approval. All new registrations are affected, but not so-called generics, i.e. copies of products that are already on the market that have the same active ingredient. Exemptions can be granted for medicines that are not used in pediatrics.
Children involved in around five percent of the studies But 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, said in 2011. At that time, according to the DGKJ, only about five percent of all studies involved children and adolescents between the ages of 12 and 17. Newborns and toddlers up to two years were involved in an average of 0.5 to two percent of the studies.
Blatant test gap One reason for the blatant test gap in pediatric medicinal products could be the thalidomide scandal. At that time, in the early 1960s, manufacturers only had to register new drugs to be on the market. Taking the sedative, which was recommended among other things against morning sickness during pregnancy, led to thousands of cases of malformations or even the lack of limbs and organs in newborns. Only this experience led to the fact that tests for the effectiveness and safety of a drug were prescribed before it received approval. At the same time, the scandal was largely responsible for the fact that drug trials in children with high requirements and restrictions were documented. The argument was to protect children.
Benefits for the entire collective However, this strategy does not seem to work entirely, since the lack of studies often makes drug prescriptions difficult for young patients. Experts believe that it is about protecting children through carefully conducted examinations and that is why the reins for such tests have now been loosened somewhat. However, it still applies that medication should not be tested on healthy children. In contrast to the past, therapeutic benefits no longer have to be expected for every child included in the study. A potential benefit for the whole collective of children suffering from the disease in question is crucial.
Tests not lucrative for the pharmaceutical industry However, the lack of pediatric drug tests is by no means only due to ethical concerns. As is so often the case in healthcare, the economic aspect plays a role. Such tests are simply not lucrative for the pharmaceutical industry. On the one hand, children and adolescents are only a small market and on the other hand, pediatric examinations are usually very expensive. However, the EU directive takes this into account by granting producers of new drugs an extension of patent protection by six months in return.
Only every fifth drug tested for children Currently, despite the EU directive, only every fifth drug on the market for children and adolescents is still tested and approved. It follows that in pediatrics many medicines are still administered in the blue. Over fifty percent of the medication used in children is carried out “off label”, that is, without a license. The European Medicines Agency (EMA) published this figure in 2007. The European Commission took stock five years after the EU directive came into force and submitted a so-called progress report: The EMA has approved 600 pediatric examinations by 2012. 33 tests had already been completed and 31 of a total of 152 new drug registrations 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 Pediatric and Adolescent Medicine, Norbert Wagner, had hoped for more: “We absolutely need a lot more medication for our little patients with guaranteed efficacy and safety profiles . The "off label use" is an unreasonable burden for the sick child and for the treating doctor. "According to Wagner, the EU directive falls short because the large pot of old medicines remains untouched.
Children become guinea pigs The fact that the maladministration with drugs has finally become a political issue is largely thanks to the commitment of the specialist society for pediatric and adolescent medicine. According to the ideas of the pediatricians, there should be special test centers, for example at university clinics, where drugs that have been established in adults for a long time could be specifically tested on children. So far, however, there has been no legislative effort and the problem of “off label use” continues to arise in the case of serious illnesses. There are usually enough medications tested for widespread childhood illnesses, but in the case of more serious illnesses, doctors would often be left with nothing in terms of study technology and have to experiment. Most of these "off-label applications" take place in pediatric intensive care units, with the rate being highest at around 90 percent in newborn intensive care units. So far, a doctor has to take it on his own when a child needs a drug that is not approved for his age. If something goes wrong, he bears sole responsibility and the treated children become guinea pigs at the same time.
"Half a dose for children" is out of date A major problem remains the lack of clarity regarding the correct dose. The doctor must first approach the optimal dosage and lose valuable time in the process. The partly still used rule “half the dose in children” has long been outdated, since it makes far too little differentiation. In addition, child-friendly dosage forms would often be missing if, for example, large tablets could not be divided exactly. There are often no other variants that are easier to swallow, such as juices.
Children are still developing In children and adolescents, the developing organism has physiological peculiarities that influence the absorption, distribution and excretion of medicines. For example, organs such as the liver, kidney, stomach and intestine are not yet fully developed and function differently than in adults. In addition, children usually have a higher respiratory rate, lower blood pressure and more sleep. All of these are factors that can play a role in the effects of medication.
Special features of the child's organism Other circumstances that need to be taken into account when administering medication to the youngest: infants can only break down and excrete medication very slowly in the first few weeks. Since the percentage of body fat in children changes over time and some drugs preferentially accumulate in the adipose tissue, this has an effect on the drug dosage. Another point is the amount of water in the body, which decreases with age. Therefore, fat-soluble medications are dosed significantly lower in children and water-soluble ones higher than in adults. So it is important to take into account all these special features of the child's organism, otherwise there are sometimes undesirable or dangerous side effects that are sometimes unknown or extremely rare in adults. (ad)
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