Off-label utilization of antipsychotics
AbstractObjective: 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 98- bed 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 off-label 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 off-label basis.
Keywords: antipsychotic drugs, off-label use, prescription habits, psychotic disorders, affective disorders
South African Psychiatry Review Vol. 9(1) 2006: 38-43