What is off-label prescribing?

What is off-label prescribing, and is it safe?

What is off-label prescribing?
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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


    To make a comment, please register or login
    6th Jan 2014
    My view is that we must have responsibility for taking medications as prescribed. All meds come with an information sheet; read it, ask questions and if not satisfied, ask for an alternative. Make sure your doctor knows what meds - including 'over the counter' meds - you are taking and tell the prescriber why you take them and how often. Whilst I support informing the community about trends / events in health care, I suspect some may see this as potentially disturbing, even though it is not meant to be - or is it? I'm a retired nurse.
    6th Jan 2014
    As someone involved in the area of pharmaceuticals and their promotion to doctors I would like to add a note here.
    Pharmaceutical companies do not promote off license (in my experience at least). There are substantial penalties involved if they are found in breach and the prescriber may have some arguments in their defence if this was found proved.
    Doctors may use drugs off license but it will be a private script (fully paid by the patient) and should be fully explained to the patient to ensure they are giving fully informed consent.
    Many drugs are used differently around the world in various countries for various complaints. It is far from consistent and should therefore be between doctor and patient on a case by case basis.
    6th Jan 2014
    The penalties may well be written into law but have you ever heard of an Australian prosecution of a Pharma company for this type of behavior? No, me neither.
    Mr Google can tell you plenty about the overseas ones though, mostly multi million dollar claims against the companies concerned.
    6th Jan 2014
    According to the guidelines there has to be high quality evidence to support use off label of any drug for any specific condition i.e. safety and efficacy derived from published research.
    Too many examples already here in Australia of script writing by habit or word of mouth. An example is the drug Seroquel, being used particularly in the elderly when it shouldn't be, given some of the side effects.
    The guidelines state that if there is no published research then there can be no justification for prescribing other than for controlled research.
    There is also supposed to be a documented and signed approval process between the prescriber and the patient.
    Strictly speaking if the above procedures are not complied with the law is being broken.
    It's one area where extensive lobbying both from the public and medical experts falls on deaf ears.
    About time the TGA and the administrators of the PBS had enough teeth to deal with it.

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