Articles and Case Studies

Off-label prescribing - what you need to know

20 Nov 2019

Marika Davies

by Ms Marika Davies

Balance ball

A patient or specialist asks you to prescribe a medicine in a way that is not indicated in the drug’s product information – how would you handle this situation?

Off-label prescribing is the prescription of a registered medicine for a use that is not included in the Therapeutic Goods Administration (TGA)-approved Product Information. A medicine can be legally prescribed off-label, and many drugs are routinely used in this way.


Case studies

  • A psychiatrist assessed a 22-year-old student by video link and diagnosed him with bipolar disorder. She wrote to the patient’s GP and recommended treatment with topiramate. The GP was concerned that the medication was not listed in the therapeutic guidelines for use in bipolar disorder.
  • A young mother consults her GP with concerns about her breastmilk supply and asks for domperidone to boost her supply.

A question of clinical judgement

The TGA recognises that off-label prescribing may be clinically appropriate in some circumstances but advises doctors to use caution when considering it. In general, off-label use of a medicine should only be considered when the TGA-approved use of a registered medicine does not address the clinical needs of a patient. The decision to prescribe off-label must take into account the risks and benefits to the patient, and the evidence supporting the safety and efficacy of the proposed treatment.

Clearly communicate the potential risks and benefits with your patient so they can provide informed consent, and answer their questions about the proposed treatment. Keep a clear record of the medications prescribed and your reasons for prescribing an off-label medicine, especially if you are not following common practice.

Follow up essential

Ensure that the patient is appropriately monitored and followed up. The TGA encourages doctors to report any adverse events that occur during off-label use.

Guidance published by the Council of Australian Therapeutic Advisory Groups  says  that, in the event of harm to the patient, “if the off-label use  of the medicine in a particular situation is accepted by the practitioner’s peers as constituting competent professional practice, and  the patient has  given  informed consent for its  use,  then prescribing off-label should not imply negligence.”

In summary

The Council of Australian Therapeutic Advisory Groups sets out guidance for doctors in public hospitals considering the use of an off-label medicine:

  • Only consider an off-label use of a medicine when all other options are unavailable, exhausted, not tolerated or unsuitable.
  • Use high-quality evidence to determine the drug’s appropriateness.
  • Involve the patient/carer in shared decision-making so that they may provide informed consent.
  • Consult the Drug and Therapeutics Committee (except when off-label use of a medicine is considered routine).
  • Ensure appropriate information is available at all steps of the medicines management pathway.
  • Monitor outcomes, effectiveness and adverse events

Further information:

Communication with Patients, Clinical, Regulation and Legislation, General Practice


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