Many Kids' Drugs Not TestedJan 21, 2009 | Parker Waichman LLP
A recent study confirms that medications routinely prescribed to pediatric patients are not always approved for children and teens. The study appears in the current issue of Deutsches Ärzteblatt International.
The German study, conducted by pharmacologist Bernd Mühlbauer and colleagues. found that in 2005, approximately 14 million children and adolescents were prescribed drugs under the statutory health insurance funds, a type of health insurance geared to workers and other population groups whose income does not exceed certain threshold amounts. The children and teens were given medications that were not always licensed—similar to the approval process a medication undergoes in the United States—for their age demographic.
The team looked at 289,000 patients from infancy to 16 years of age who were insured under Germany’s statutory health insurance provider GEK; the study represented the first review of the approval of prescriptions medications, said Science Daily.
Off-label use in this case is the same as it is in the United States, use of an approved prescription drug for a purpose not covered under the auspices of that approval. In the United States, drug approval is handled by the U.S. Food and Drug Administration (FDA) and, while off-label drug use is permissible by doctors, drug manufacturers are not permitted to market drugs and medical devices for off-label purposes. Prescribing a drug geared to adults to children, infants, and teenagers—for example—falls under the characteristics of off-label prescribing. This practice is the same in Germany.
The problem with prescribing adult medications to children, points out Science Daily, is that a drug might not be effective, and could even pose serious dangers and adverse reactions, in children. The study found that only 42.5 percent of prescriptions for newborns were approved for that group, which means that nearly 60 percent are not approved for use in newborns. Also, only 82.8 percent were approved for babies.
The team also analyzed information from the Summary of Product Characteristics (SPC). The SPC is similar to the PDR—the Physicians Desk Reference—used in the United States. Both books outline a drug’s appearance, approved uses, and adverse effects, to name a few. The researchers found that when looking at the quality of information in the SPC that there was a lack of data, which presented significant difficulties in determining the licensing status for about 25 percent—or one medication in five—of the drugs tested.
In the past, the World Health Organization (WHO) has reported on the problem of children dying over a lack of child-sized drugs tailored to their needs and went so far as to launch a global campaign to urge increased research into pediatric medicine. The move highlighted the fact that over half of all drugs meant for pediatric patients have not received specific testing on children, global, industrialized nation problem.
Also, it is widely understood that children metabolize medications differently than adults and that physicians often lack clear guidelines on the best drugs to use for children, often guessing at prescription dosages. Pediatric pharmacology is a challenge for a number of reasons. For instance, testing medicines on children is problematic since good ethical practice requires informed consent from people participating in clinical trials, which is not always feasible with children; research-based drug companies are wary of developing child-friendly medicines; generics companies are not eager to produce such medications at lowered costs; and children- and adult-sized medications sometimes become confused as was the case in a number of scandals over the blood thinner Heparin.