Going Forth in July? Off-Label Use in Psychiatry

Abstract

A colleague in private practice commented recently that despite his best efforts he is fi nding it increasingly frustrating to treat patients optimally. Specifi cally, in many instances he has to resort to off-label use of medications. This is a growing concern as shown by a recent study in which more than half of the psychiatrists routinely prescribed psychotropic medications off-label (1). In Australia, medications are licensed by the Therapeutic Goods Administration (TGA) for a specifi c set of indications following application by the manufacturer. Prescribing ‘ off-label ’ refers to the use of a medication outside such indications. There are a number of ways in which this can occur: a drug may be deemed to be prescribed off-label if the dose exceeds that specifi ed by the manufacturer; the prescription is for an indication that has not got TGA approval; the medication is administered to a patient that falls outside a specifi ed group by virtue of age or diagnosis; or the method of administration is altered. A complication for clinicians is that a medication may have a strong evidence base for its use for a specifi c condition, be recommended in guidelines and licensed for use internationally, but not in Australia and New Zealand. The use of this medication for this particular condition would still be regarded as “ off-label ” . Off-label prescription is particularly problematic in psychiatry where accurate and defi nitive diagnoses are often diffi cult and the optimal treatment option is seldom self-evident. For example, in complex cases or where there is already polypharmacy an additional medication is unchartered territory. This is important because the prescription of a drug off-label carries with it potential risks, and it is often diffi cult to determine the precise benefi ts or risks of such treatment. For example, if a patient suffers from an adverse event whilst on a medication that has been prescribed off-label, the responsibility, and indeed liability, rests with the prescriber and in turn, their employer unless it can be shown that administration of the drug was in the best interest of the patient. Thus, off-label prescribing increases the professional responsibility of the doctor. In such cases it is wise to carefully document your rationale for the prescription, and if possible, consult with a colleague about what action to take. This is because doctors may sometimes have to justify why they have not acted in accordance with the manufacturers guidelines. In reality, in most cases, it is possible to argue that there is widespread use of a particular drug for a ‘ specifi c off-label indication ’ and that there is evidence of benefi t to patients with such off-label use. In fact, some off-label uses have been adopted by prescribing guidelines and are essentially regarded as the norm. Such wellestablished use is also referred to as ‘ near label ’ . But why is it that doctors are put in this invidious position in the fi rst place? In some instances psychiatrists themselves are to blame as they are simply not aware that they are prescribing off-label (2). Defending this in part, this is not particularly surprising, given the fact that the evidence base for most medications is vast and ever changing and it is diffi cult for most clinicians to remain up to date. Further, in psychiatry it is often diffi cult to establish the ‘ boundaries of evidence ’ and there is perhaps greater scope for innovation and trialing new applications. However, off-label prescribing also arises because pharmaceutical companies almost always obtain an initial license for a relatively narrow indication predicated upon diagnoses within DSM. This is because they have