Drugs are regularly prescribed to children in outpatient care that have not been licensed for children. The pharmacologist Bernd Mühlbauer and his colleagues present the result of their health services analysis in the new edition of Deutsches Ärzteblatt International (Dtsch Arztebl Int 2009; 106: 25).
In 2005, about 14 million children and adolescents were prescribed drugs under the statutory health insurance funds. However, not all the prescribed drugs have been licensed for use in this age group.
The authors' analysis contained the first analysis of the approval of medical prescriptions of 289 000 patients aged between 0 and 16 years and insured with the German statutory health insurance provider GEK. "Off-label use" means that a drug is used outside the approved characteristic, such as age. The main deficiency is that safety is not always guaranteed for infants. Only 42.5% of prescriptions for neonates were approved and only 82.8% for babies. These figures were under average; prescriptions for older children were mostly in accordance with approval.
At the same time, the authors systematically examined the quality of the Summary of Product Characteristics (SPC), i.e., the information for physicians for the medication in question. Because of the lack of information, it was impossible to determine the licensing status for one drug in five.