A One-Day Survey of Characteristics of Off-Label Hospital Prescription of Psychotropic Drugs

Abstract

Introduction: The aim of this study was to explore the characteristics of off-label prescriptions of psychotropic drugs among patients hospitalised in psychiatry.

Methods: A one-day cross-sectional study was used to explore off-label prescribing in patients hospitalised in four wards of a state psychiatric hospital. Information regarding patients and treatment characteristics was collected from medical records. Off-label prescribing was defined according to the Summary of Product Characteristics.

Results: Seventy-five patients were included. Of the 261 prescriptions, more than one out of three (n=104, 39.8%) were off-label. Off-label prescribing was particularly high for anticonvulsants (97%), and to a lesser extent for mood stabilisers (33%) and anxiolytics (31%). The rate of off-label prescription was higher for 2nd compared to 1st generation antipsychotics. Most patients (84%) were prescribed at least one psychotropic drug outside of the licensed indication or recommended dosage. Patients with and without off-label prescription did not differ regarding history of prior admission, type of current admission (voluntary vs. compulsory) and diagnosis.

Conclusion: In spite of its frequency in routine practice, off-label prescribing should not be trivialised. Prescribers should be better informed about the potential legal consequences of off-label prescribing.

Key words

off-label - psychotropic drugs - hospital prescription

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