title: [Off-label drug prescriptions among outpatient children and adolescents in Germany--a database analysis].
abstract: BACKGROUND
  Due to lack of respective studies children often receive medication that is applied beyond the approved indication. The consequence of this off-label use is often an increased risk of unexpected and undesirable side effects. This study deals with the amount of off-label drug prescriptions among children and adolescents receiving outpatient treatment in Germany. The aim is to outline age-, gender-, region-, and insurance specific differences and to determine risk factors for an off-label prescription.
  
  
  METHODS
  This is a retrospective study that has been conducted by means of the IMS Patient Database Disease Analyzer for the year 2010 considering three therapy classes (analgesics, antibiotics and antidepressants). The evaluation of the risk factors for an off-label prescription resulted from a multivariate logistic regression. Age- and dose-specific prescriptions were analyzed but not indication-specific prescriptions.
  
  
  RESULTS
  In total 189,285 children and adolescents with analgesics-, 147,089 with antibiotics-, and 15,405 with antidepressants prescriptions were identified. The percentage of patients with off-label prescriptions amounted to 0.9 % for analgesics, 2.5 % for antibiotics and 8.5 % for antidepressants. The off-label prescriptions made by general practitioners were significantly higher than those made by pediatricians and child psychiatrists. The number of off-label prescriptions in country sides was higher than in cities. In eastern states more off-label prescriptions were made than in western states of Germany.
  
  
  CONCLUSIONS
  The study shows that outpatient treatment of children and adolescents occurs widely with drugs corresponding to age and dosage. Off-label prescriptions not conform to indication were not determined. However, off-label drug use should be reduced further for outpatient treatment to ensure a safe and low-risk medical treatment for children and adolescents.
authors.affiliation: Department für Frauen- und Kindermedizin, Klinik für Kinder- und Jugendmedizin, Universität Leipzig.
authors.forename: D
authors.initials: D
authors.lastname: Sonntag
authors.forename: D
authors.initials: D
authors.lastname: Trebst
authors.forename: W
authors.initials: W
authors.lastname: Kiess
authors.forename: T
authors.initials: T
authors.lastname: Kapellen
authors.forename: T
authors.initials: T
authors.lastname: Bertsche
authors.forename: K
authors.initials: K
authors.lastname: Kostev
mesh_terms: D000293:Adolescent; D017677:Age Distribution; D000553:Ambulatory Care / Q000706:statistics & numerical data*; D000700:Analgesics / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000928:Antidepressive Agents / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D016208:Databases, Factual; D017723:Drug Utilization Review; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D056687:Off-Label Use / Q000706:statistics & numerical data*; D010045:Outpatients / Q000706:statistics & numerical data*; D017678:Sex Distribution
chemical_list: D000700:Analgesics; D000900:Anti-Bacterial Agents; D000928:Antidepressive Agents