gms | German Medical Science

MAINZ//2011: 56. GMDS-Jahrestagung und 6. DGEpi-Jahrestagung

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e. V.
Deutsche Gesellschaft für Epidemiologie e. V.

26. - 29.09.2011 in Mainz

Antidepressant Drug Use and Off-label Prescribing in Children and Adolescents in Germany

Meeting Abstract

  • Michael Dörks - Bremer Institut für Präventionsforschung und Sozialmedizin/Universität Bremen, Bremen
  • Ingo Langner - Bremer Institut für Präventionsforschung und Sozialmedizin/Universität Bremen, Bremen
  • Ulrich Dittmann - Bremer Institut für Präventionsforschung und Sozialmedizin/Universität Bremen, Bremen
  • Antje Timmer - Bremer Institut für Präventionsforschung und Sozialmedizin/Universität Bremen, Bremen
  • Edeltraut Garbe - Bremer Institut für Präventionsforschung und Sozialmedizin/Universität Bremen, Bremen

Mainz//2011. 56. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (gmds), 6. Jahrestagung der Deutschen Gesellschaft für Epidemiologie (DGEpi). Mainz, 26.-29.09.2011. Düsseldorf: German Medical Science GMS Publishing House; 2011. Doc11gmds239

doi: 10.3205/11gmds239, urn:nbn:de:0183-11gmds2397

Published: September 20, 2011

© 2011 Dörks et al.
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Outline

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Background: Intensive off-label use of antidepressant medication in pediatric patients has been reported from the US and other European countries. An increased risk of suicide has been of concern particularly for selective serotonin reuptake inhibitors (SSRI), leading to a warning of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in April 2005.

Objectives: To characterize prescribing of antidepressant drugs for children and adolescents in Germany in 2004-2006

Methods: We obtained data from the German Pharmacoepidemiological Research Database (GePaRD) for the years 2004-2006.This database includes more than 14 million insurance members from 4 German health insurances. Prevalence of antidepressant use was assessed. Off-label use of all antidepressant prescribing was considered in relation to age and indication. Logistic regression analysis was used to identify predictors of off-label use.

Results: Of 2,599,685 children, we identified 9,383 who received a total of 26,543 antidepressant drug dispensations in the study period. Prevalence of antidepressant drug use (SSRI use) was 1.84 (0.47) per 1,000 person-years in 2004, 1.57 (0.45) in 2005 and 1.66 (0.54) in 2006. Of all antidepressant dispensations, 11,172 (42.09%) were tricyclic antidepressants (TCA), 9,179 (34.58%) were SSRI, 4,371 (16.47%) were drugs of St John's wort and 1,821 (6.86%) were other antidepressants. Of all children treated with antidepressant drugs, 6,353 (67.71%) ever got an off-label prescription, 3,446 (36.73%) with respect to age and 4,378 (46.66%) with respect to indication. Male sex and specialist treatment increased the risk of getting an antidepressant prescribed off-label with odds ratios of 1.56 (95% CI 1.49 to 1.64) and 1.14 (95% CI 1.08 to 1.20), respectively.

Conclusions: Our study showed considerable off-label use of antidepressants in pediatric patients in Germany. After warning of CHMP, prevalence of SSRI use did not decrease during the study period.