Reducing off-label prescribing in psychiatry

There are few more controversial topics in mental health than what constitutes evidence-based prescribing. Medications not indicated for common conditions like anxiety or depression, or particular age groups such as the young or old, are often prescribed for these conditions or age groups. Consequently, strident calls for clamping down on such “off-label” prescribing are common. Three drivers are behind these public and professional concerns.

First, precision in diagnostic and therapeutic practice is hard to achieve because of low reliability and questionable validity of the major diagnostic groupings.1-3

Second, a wide gap persists between the number of people affected by mental disorders and the number who demand and receive care.4 In Australia, the continuing growth in demand for clinical services extends across all age groups for psychological as well as pharmacological interventions.5,6

Third, there is growing recognition of the potential for longer-term harms, including metabolic complications and an enhanced risk of cardiovascular disease (CVD) that may accompany prolonged use of various psychotherapeutic drugs.7 This is especially true for the second-generation antipsychotic medications.8 The increased CVD risks may be tolerable when treating patients with major mental disorders, but if the drugs are being used for off-label purposes the risk equation is much more questionable.

The reality for much clinical practice, however, is that practitioners are largely managing individuals with prolonged and disabling symptom sets with a wide mix of psychological and medical interventions. They are doing so without the assistance of well defined laboratory-based markers of illness type, pathophysiology or indicators of response to specific interventions. They also rely on a relatively small clinical trial database for key population-based subgroups — younger and older persons, those with complex medical comorbidity or those with concurrent substance misuse.

Within this context, recent attempts by the major United States regulatory agencies to develop more precise therapeutic targets (eg, cognitive enhancement in schizophrenia9) and the National Institute of Mental Health’s promotion of a more pathophysiologically based research classification system10 offer significant hope of a move to a more solid evidence base to underpin clinical prescribing for the major mental disorders.

In the interim, however, it remains important for clinicians to maximise the use of non-pharmacological interventions for common forms of anxiety and depression and minimise the use of major psychotropic medications in situations in which there is no clear evidence from clinical trials of a clear benefit-to-risk ratio.