Off-label and non-classical prescriptions of antipsychotic agents in ordinary in-patient practice.
OBJECTIVE
To estimate the proportion of off-label prescriptions of antipsychotics (APs) in ordinary in-patient practice.


METHODS
From the South-Verona Psychiatric Case Register all admissions to the in-patient unit during 2001-02 were extracted. Prescriptions of APs were defined off-label when dispensed outside the licensed indications. In addition, the proportion of "non-classical prescriptions" was calculated.


RESULTS
During the 2 years surveyed AP agents were prescribed in 311 cases. Nearly 50% of second-generation AP prescriptions were for an off-label indication. In contrast, <15% of first-generation AP prescriptions were for an off-label indication. About 30% of first- and second-generation agents were prescribed for a non-classical indication.


CONCLUSIONS
Approved labels for second-generation AP agents cover a much narrower range of indications than any of the first-generation agents, and this explains the higher proportion of off-label prescriptions. In contrast, the everyday use of first- and second-generation APs cover a similar range of clinical indications.
Department of Medicine and Public Health, Section of Psychiatry, University of Verona, Ospedale Policlinico, 37134 Verona, Italy. corrado.barbui@univr.it
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Barbui
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Ciuna
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Nosé
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Patten
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Stegagno
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Burti
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Amaddeo
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Tansella
D014150:Antipsychotic Agents / Q000627:therapeutic use*; D003937:Diagnosis, Differential; D004348:Drug Labeling; D011307:Drug Prescriptions / Q000706:statistics & numerical data*; D005260:Female; D006760:Hospitalization; D006778:Hospitals, Psychiatric; D006801:Humans; D038801:International Classification of Diseases; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D011618:Psychotic Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000534:rehabilitation*; D012042:Registries; D011795:Surveys and Questionnaires
D014150:Antipsychotic Agents