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. Method: 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. Conclusion: 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.