Abstract
Off-label drug prescribing in psychiatry is increasing. Many psychotropic drugs are approved for psychopathologic syndromes rather than based on international standard diagnostic classification systems which might facilitate the clinical decision for off-label prescriptions. The objective of this study was to analyze the prevalence and category of off-label use of psychotropic drugs. The study was conducted in 10 psychiatric hospitals in Germany over a period of 2 years. Prescription data of all patients were retrospectively analyzed after identification of antidepressants, antipsychotics, and mood-stabilizers, which were classified as off-label according to the German prescribing information and diagnostic classification according to ICD-10. In total, 53,909 patient cases (46% female) with a mean age of 46.8 (SD: 18) years were included in the study. 30.2% of the cases received at least one off-label prescription of a psychotropic drug during hospital stay. Off-label prevalence rates differed markedly between different diagnostic groups (ICD-10 F0/G3: 47%, F1: 33%, F2: 25%, F3: 21%, F4: 27%, F6: 46%, F7: 84%). The most often off-label prescribed drugs were quetiapine and mirtazapine for organic mental disorders (F0/G3), valproate and quetiapine in patients with disorders due to psychoactive substance use (F1), valproate in patients with psychotic disorders (F2), and risperidone and olanzapine in patients with affective disorders (F3). The prevalence rate of psychotropic off-label prescriptions is high if restricted to product description and ICD-10 diagnosis. Therefore, current psychiatric guidelines should drug-specifically issue this problem by defining psychiatric off-label indications based on a clear benefit–risk assessment.
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Acknowledgements
We thank the ten participating psychiatric hospitals of the Vitos GmbH in Eltville, Friedrichsdorf, Gießen/Marburg, Hadamar, Heppenheim, Herborn, Kassel, Riedstadt, and Weilmünster for their active support during the retrospective data acquisition and agreement to evaluate their psychopharmacological treatment strategies.
Funding
The Federal Joint Committee (G-BA, project executing organization: Deutsches Zentrum für Luft- und Raumfahrt, DLR) is funding healthcare research projects that aim to optimize quality of care for statutory insured persons in Germany. In this regard, the innovative study “Optimization of pharmacological treatment in hospitalized psychiatric patients” (OSA-PSY, study number 01VSF16009, ethical approval reference number FF 116/2017) is sponsored by the DLR.
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Gudrun Hefner, Jan Wolff, Pamela Reißner, and Ansgar Klimke declare no conflicts of interest/competing interests. Sermin Toto is a member of the advisory board for Janssen-Cilag and Otsuka and has received speaker’s honoraria from Janssen-Cilag, Lundbeck/Otsuka, Recordati Pharma GmbH, and Servier.
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Ethical approval was obtained in November 2017 in Hesse, Germany; reference number: FF 116/2017.
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Hefner, G., Wolff, J., Toto, S. et al. Off-label use of antidepressants, antipsychotics, and mood-stabilizers in psychiatry. J Neural Transm 129, 1353–1365 (2022). https://doi.org/10.1007/s00702-022-02542-0
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DOI: https://doi.org/10.1007/s00702-022-02542-0