Around 45,000 medicines are available on the German market, but only 20 percent of them have been tested for their suitability for children. Yet the little patients get sick much more often than adults: seven to ten times a year they have a cold; coughs, colds, fevers and gastrointestinal infections are the most common illnesses.
Problems with dosage
Problems are often caused by the correct dosage of the drug. This is because the immune system of children is in a process of development, it is constantly “learning“. A major problem for physicians is the correct dosage of medications that achieve good effects in adults, but can lead to significant risks and side effects in children if overdosed or underdosed.
No rule of thumb for medication
Dr. Ute Galle-Hoffmann, a pharmacist with the AOK Bundesverband, warns parents in particular, however, who determine the dosage themselves without consulting a doctor or pharmacist: “At every stage of development, the body reacts differently. The immune system and metabolism work very differently in children than in adults.”
Premature and newborn babies, for example, whose liver and kidneys are not yet fully developed, excrete some drugs more slowly, while toddlers and children up to eight years of age have a fast metabolism and therefore also excrete the substances more quickly than adults – they often need a higher dose measured per kilogram of body weight. A rule of thumb along the lines of “take half” would therefore be fundamentally wrong. Increased caution also applies to herbal remedies, because many juices or drops often contain a high alcohol content of up to 45 percent, with fatal consequences for children. In case of doubt, parents therefore always need the advice of a doctor or pharmacist.
The dilemma: formal approval for many drugs is lacking
Quite a few cold medications, such as nasal drops or fever suppositories, have been adequately tested for their suitability for children. But for about 80 percent of the medications available in Germany, there are no studies on the mode of action and dosage for children. The package insert then states that there are no findings on effects and side effects for children under 14 years of age. Doctors can actually only treat children with medications on their own responsibility or thanks to good experience; some clinics, such as the University Hospital in Hamburg, conduct research on their own initiative. But they cannot approve the drugs. This dilemma particularly affects children suffering from serious diseases.
Professor Hansjörg Seyberth of the German Society for Pediatrics and Adolescent Medicine puts it succinctly: “Drug safety in the treatment of children leaves much to be desired throughout Europe.” He calls the physicians’ drug therapy a “legal and medical tightrope walk.” More than two years ago, a study was published in the British Medical Journal that was conducted in five European children’s hospitals. The conclusion: two-thirds of the children treated as inpatients were given drugs that were not approved for children at all in the respective country or were not approved for the specific disease.
Hurdles in research
Pharmaceutical companies are aware of the situation, but they face the problem: drugs for children must be tested in different age groups before they can be launched, which is ethically controversial; moreover, there are few parents willing to give up their children as test subjects. In addition, there is the issue of cost-effectiveness, because the reference price for lower-dose pediatric medicines is often so low that the expensive research is not covered by the revenues.
Government incentives such as those in the United States are lacking in Germany. A European directive to be implemented in the Federal Republic later this year is an important step in the right direction, encouraging pharmaceutical companies to test drugs for children and helping doctors out of the gray area.
Now what?
So what’s left for parents? They should definitely not experiment with drugs that work for them; expert advice must be sought. For many rather harmless diseases such as colds, home remedies help. Particular care should be taken with infants. Here, medical advice is essential.
