Off-label use of prescription drugs in childhood and adolescence: an analysis of prescription patterns in Germany.

Background: Not all drugs prescribed for children and adolescents are certified for use in these age groups. The present study describes the extent of off-label prescriptions in the outpatient sector and identifies deficits in the quality of product information.

Methods: This analysis is based on patient-specific but pseudonymized drug prescription data for approximately 289,000 0- to 16-year-old members of the Gmünder Ersatzkasse, a German statutory health insurance provider, in the year 2002.