Off-label utilization of antipsychotics

Abstract

Objective: The newer atypical antipsychotics are prescribed because of their enhanced safety profiles and their larger pharmacological profile in comparison to the conventional antipsychotics. This has led to broad off-label utilisation. The aim of the present survey was to study the prescribing practice of hospital psychiatrists with regard to antipsychotic drugs, comparing patients treated for psychoses or other registered indications to patients receiving off-label antipsychotic treatment. Methods: As part of a pharmacovigilance/pharmacoepidemiology program, all drugs given on 5 reference days (1999-2001) in the 98bed psychiatric hospital of the University of Lausanne, Switzerland, were recorded along with age, sex, and diagnosis. The prescriptions of 202 patients were assessed. Patients were classified in 3 diagnostic groups: (1) patient with psychotic disorders, (2) patients with manic episodes and depressive episodes with psychotic symptoms, and (3) patients with other disorders. Group (1) and (2) formed the class of patients receiving an antipsychotic for a registered indication, and the prescriptions in group (3) were considered as off-label. Results: A lesser number of psychotic patients received antidepressant (p<0.05) and nonbenzodiazepine hypnotics (p<0.001) compared to the patients of the other two groups. The patients with affective disorders seldom received a combination of an atypical and a conventional antipsychotic, whereas a lesser number of patients with offlabel indications received atypical antipsychotics less often than those of the two comparison groups (p<0.05). Stepwise logistic regression revealed that patients with a psychotic disorder were more likely to receive an antipsychotic medication in medium or high doses (p<0.001), in comparison to the two other groups. Conclusion: The new antipsychotic drugs seem to be prescribed with less hesitation and mainly for approved indications. Physicians prescribed new drugs, off-label , only after having gained some experience in the field of the approved indications, and were more cautious with regard to doses when treating on an offlabel basis.

The metabolic adverse effects of antipsychotic use in individuals with intellectual and/or developmental disability: A systematic review and meta‐analysis

“…Unfortunately, most of the long‐term studies did not report on intermediate time points, so this could not be explored further. However, this finding further suggests that clinician assumptions related to the safety of “short‐term” AP use may be misguided 54 . Future long‐term naturalistic observation studies reporting multiple intermediate timepoints are warranted.…”

“…However, this finding further suggests that clinician assumptions related to the safety of "short-term" AP use may be misguided. 54 Future long-term naturalistic observation studies reporting multiple intermediate timepoints are warranted.…”