What is off-label prescribing?

You may have heard the term ‘off-label prescribing’ used in the media recently. But what is it, and is it a safe practice?

All prescription medicines come with approved product information. This is where a drug company can register which illnesses or conditions a drug is designed to help. For example, anti-inflammatory medication could be prescribed for back pain, headaches and joint pain. Antacids may state that they should be prescribed to reduce the symptoms of reflux.

An off-label prescription occurs when a doctor prescribes a medication for an illness or condition which does not appear in the approved product information. This does not necessarily mean that the Therapeutic Goods Administration has rejected the indication (illness) for which the medicine is being prescribed off-label. It simply means that the particular indication has not been officially registered.

So why would a medicine which can help with a particular condition not include that condition in the approved product information? Professor Richard Day fromSt Vincent’s Hospital Sydney explains, “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.

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 reason for your GP or health professional not to write up an off-label prescription. If, however, something goes wrong, the onus is on the prescriber (your GP) to explain why they wrote a prescription for something other than the drug’s registered uses.

If you have any concerns about your medicine, especially if it has been prescribed off-label, you should talk to your doctor or pharmacist about why they have chosen that particular drug.

You can also call NPS Medicines Line on 1300 MEDICINE, or 1300 633 424, Monday to Friday, 9am to 5pm AEST.

Read more about off-label prescribing in the December edition of Australian Prescriber