Accompanying the article “Off-Label Use of Prescription Drugs in Childhood and Adolescence—an Analysis of Prescription Patterns in Germany” by Mühlbauer, Janhsen, Pichler, and Schoeller in this issue of Deutsches Ärzteblatt International
The pediatric health care study by Mühlbauer et al. that appears in this issue deserves our close attention: It reminds us once again of a longstanding public health problem, namely, the inadequate safety of prescription drug use in children (1). Pediatricians often give medicines in ways that do not conform with the product licence. The literature generally calls this practice “off-label use.” Arising from the treating physicians’ inadequate knowledge of the medicines that they prescribe, in both ambulatory and inpatient settings, off-label use doubles the frequency of adverse drug reactions, which are sometimes life-threatening (2, 3). As early as 1963, an American pharmacist and pediatrician, Harry C. Shirkey, complained that children risked becoming “therapeutic or pharmaceutical orphans” because many pediatric drugs had not been licensed (4). He felt it was unacceptable that safe and effective medicines should be withheld from this vulnerable group of patients. Yet it is only now, at the beginning of the 21st century, that laws and regulations are being put into effect at the national level and in the European Union as a whole to improve prescription in pediatrics (Directive 2001/20/EC of the European Parliament and Council relating to good clinical practice; 12th Amendment to the German Pharmaceuticals Act [Arzneimittelgesetz]; Regulation EC/1901/2006). Thus, the data from the year 2002 that Professor Mühlbauer and his colleagues have analyzed can still be considered an accurate reflection of the situation as it exists in 2008.