Off-label prescribing: what does it mean?

2 December 2013

An editorial in the December edition of Australian Prescriber explains what off-label prescribing means.

Professor Richard Day from the University of NSW and St Vincent’s Hospital Sydney comments that off-label prescribing occurs when a medicine is prescribed for an ‘indication’ (an illness) or a patient group that is not included in the approved product information.

He explains that this doesn’t necessarily mean that the Therapeutic Goods Administration has rejected the indication for which the medicine is being prescribed off-label, but rather that (for various possible reasons) the indication has not been officially registered.

There are many scenarios of off-label prescribing, especially in prescribing for pregnant women or children.

“In the cases of some medicines, studies probably just haven’t been undertaken to extend the indication of that medicine to a particular group such as children, pregnant women or the elderly,” says Professor Day.

“In some cases, an indication isn’t registered because it’s uncommon. If there are very few people with the illness, the market is small, so there is little motivation for the drug company to register the medicine.”

There is no legal impediment to prescribing off label, writes Professor Day, however the onus is on the prescriber to defend their prescription for an indication that is not listed in the product information.

“If, in the opinion of the prescriber, the off-label prescription can be supported by reasonable quality evidence, then they should go ahead with the prescription if it’s in the patient’s best interests,” he writes.

Professor Day also says that it is best if the patient knows that their prescription is off label, and has an understanding of why their medicine was prescribed in this way.

The Consumer Medicines Information (CMI) leaflet for a medicine only contains information about approved indications. Professor Day encourages anyone with concerns about their medicine, especially if it has been prescribed off-label, to ask questions of their doctor or pharmacist.

To read the full article and others visit

Other articles in this issue:

Individuals with questions about their medicine can call NPS Medicines Line (1300 MEDICINE or 1300 633 424), Monday to Friday 9am to 5pm AEST.


Australian Prescriber is an independent peer-reviewed journal providing critical commentary on therapeutic topics for health professionals, particularly doctors in general practice. It is published every two months and distributed to health professionals free of charge, and is also available online at 

If you are a journalist seeking comment on a story or more information on any of our programs or campaigns please contact one of our media advisers: Stephanie Childs on 02 8217 8667 or Erin Jardine on 02 8217 8733 (during office hours) or call the NPS MedicineWise media phone on 0419 618 365 (for urgent media requests outside of office hours). If your enquiry is not urgent you can also send us an email.