Off-Label Use of Prescription Drugs in Childhood and Adolescence—an Analysis of Prescription Patterns in Germany: In reply

by Prof. Dr. med. Bernd Mühlbauer, Dr. rer. pol. Katrin Janhsen, Dr. hum. biol. Josef Pichler, Dr. rer. nat. Petra Schoettler in volume 3/2009

One has to agree with Dr. Helwig's plea. There can be no reliable information on the benefit and risk of a drug in the target population unless there are data from well controlled studies. For many years, almost all participants—the registration authorities, pharmaceutical companies, pediatricians and the parents of sick children—have offered an enormous variety of excuses for not demanding, performing or supporting good study projects. Good clinical research can cost much less than is usually thought, as can be seen in the pediatric study projects supported by the HEXAL initiative for pediatric medicines (1).

As already mentioned in article (2), a new ordinance came into force in the European Union in 2007 (Regulation [EC] No. 1901/2006; http://www.emea.europa.eu/htms/human/paediatrics/introduction.htm). The elements of this are intended actively to support clinical research on children. We must hope that the planned or already introduced measures will not be structured in such a clumsy manner that years will have to pass before data on pediatric drugs will attain a standard which is regarded as a matter of course for most indications in adult medicine. DOI: 10.3238/arztebl.2009.0210b


Prof. Dr. med. Bernd Mühlbauer
Institut für Pharmakologie, Klinikum Bremen Mitte gGmbH
Sankt-Jürgen-Str. 1
28177 Bremen, Germany
[e-mail]

Conflict of interest statement
Prof. Mühlbauer is involved in cooperative research projects with the companies Bayer Vital, Janssen Cilag and Pfizer AG, as well as with the AOK-BV and the KV Bremen. He also receives financial support for projects from the Drug Safety Foundation and from the DFG and the BMBF.

References

1. Uhlig U, Pfeil N, Gelbrich G, Spranger C, Syrbe S, Huegle B, Teichmann T, Kapellen, Houben T, Kiess W, Uhlig HH: Dimenhydrinat bei Kindern mit Enteritis und Erbrechen – eine prospektive randomisierte plazebokontrollierte Studie (Abstract) www.stgkjm.de/Tagungen/ 2008/Abstracts/v25.jsp

2. Mühlbauer B, Janhsen K, Pichler J, Schoettler P: Off-Label Use of Prescription Drugs in Childhood and Adolescence—an Analysis of Prescription Patterns in Germany [Off-label-Gebrauch von Arzneimitteln im Kindes- und Jugendalter: Eine Verordnungsanalyse in Deutschland]. Dtsch Arztebl Int 2009; 106(3): 25–31.