Off-label prescribing for psychiatric disorders

‘Off-label prescribing’ refers to prescription of a registered medicine outside the licensed indication(s) in the product information. This may be for a condition, age range, dosage or route of administration that is different to that approved by the Australian Therapeutic Goods Administration (TGA).

Off-label prescribing is common for psychiatric disorders. Approved indications may be more restrictive than the range of conditions or doses for which evidence is available to guide practice; often the product information of older drugs may not reflect accepted use in practice. Off-label prescribing is especially common when treating children and pregnant patients because limited clinical data is available in these patient groups.

Recommendations in these guidelines reflect careful consideration of the clinical evidence, current practices and the adverse effects of drugs. Off-label recommendations have been included for an indication when the medicine is considered to be a safe and effective treatment.

It is important to discuss off-label use of a medicine with the patient to explain the rationale for use. In line with good clinical practice, obtain informed consent before prescribing off label. Monitor physiological and psychological indices of adverse effects and therapeutic outcomes in patients taking off-label medicines. Document off-label use in the patient’s records and advise the patient that consumer information may not include information about unapproved uses.

Prescribers should be able to justify off-label use of a medicine with evidence and be confident in its use. If a psychiatrist prescribes off label, it is important to communicate this to the general practitioner and provide advice on the duration of treatment and any ongoing monitoring requirements.

For further information on off-label prescribing for psychiatric disorders, see the Royal Australian and New Zealand College of Psychiatrists Professional Practice guideline 4: ‘Off-label’ prescribing in psychiatry.