Clinical characteristics and unlicensed applications of licensed psychotropic drugs within a regional tertiary service for patients with affective disorders.

BACKGROUND

Referral to tertiary services is recommended when patients with mood and anxiety disorders have not responded to multiple treatments in primary or secondary care. Within specialist services, some patients undergo treatment with licensed psychotropic medications outside the narrow terms of their market authorization ('unlicensed applications'). We examined the demographic and clinical characteristics of patients referred to a regional specialist service to determine the extent of and factors associated with recommendations for unlicensed ('off label') prescriptions.

METHODS

Retrospective examination of demographic and clinical characteristics and treatment recommendations in patients seen within a 5-year period. Patients were allocated to three broad diagnostic clusters (unipolar depressive disorders, bipolar disorder, anxiety disorders), and two groups (with or without comorbid disorders). We compared patients in whom all treatment recommendations were for licensed applications with patients in whom at least one treatment was for an unlicensed application, across a range of variables reflecting illness 'burden' (duration, inpatient treatment, electroconvulsive therapy, nonfatal self-harm, psychosis).

RESULTS

From 177 new referrals, 148 patients (91 females, 57 males) could be placed within one of the three clusters. Many patients with bipolar disorder had not undergone treatment with lithium or formal psychological interventions in secondary care. Treatment recommendations involving unlicensed applications of medications were common (approximately 50%) in all clusters, but there were no significant differences in measures of illness burden between groups of patients, categorized according to licensed or unlicensed prescriptions.

LIMITATIONS

Retrospective examination of notes recorded for other purposes, within a single service, in which treatment recommendations might reflect idiosyncratic practice is a limitation of our findings. Also, examined variables could not provide a comprehensive indication of illness severity or functional impairment.

CONCLUSION

Our findings confirm that 'off label' prescribing is common in psychiatric practice. Treatment decisions relating to unlicensed applications appear to be influenced by factors other than overall illness burden.