Sign in with your email address username.


Lots to consider in going off-label


Doctors have been warned they should only consider the off-label use of a medicine where regulator-approved use of a registered drug does not meet the clinical needs of their patient.

In a set of principles developed to help guide medical practitioners in deciding whether or not to use a drug in ways other than that specified by the Therapeutic Goods Administration, the Council of Australian Therapeutic Advisory Groups has advised that it should only be considered “when all other options, including the use of medicines approved by the TGA, are unavailable, exhausted, not tolerated or unsuitable”.

In Guiding Principles for the quality use of off-label medicines, the Council said that, “in determining the appropriateness of using a medicine off-label, there should be sufficient evidence to support its efficacious and safe use, and an overall favourable harm:benefit ratio for the intended clinical use and population”.

The off-label use of medicines has come to attention in recent days after it was revealed that dozens of children younger than five years were given the Fluvax vaccine despite a TGA ban on its use for younger children because of a heightened risk of seizures.

AMA President Dr Hambleton told ABC radio many medicines were “routinely” used by doctors off-label, but the use of Fluvax on young children was not condoned by the Association.

“If you give a product that’s off-label and, in this particular case, it was off-label, you do accept and take on all the responsibility for the benefits and the risks of giving that particular product,” Dr Hambleton said. “And there are many products that we routinely use off-label. This particular one the AMA wouldn’t support, the College of GPs wouldn’t support and, certainly, the TGA doesn’t support its use.”

It has also been revealed that some doctors are prescribing acne treatment Diane 35 as a contraceptive pill, even though it is linked to the formation of blood clots.

Under the Council’s Guiding Principles, not only should off-label use only be considered when all other options have been exhausted or ruled out, but the decision should involve reference to high-quality evidence, the decision of its use must be a shared one with the patient or carer, the Drugs and Therapeutic Committee should be consulted (except where off-label use is considered routine). Doctors must ensure appropriate information is available at all steps, monitor outcomes for effectiveness and adverse events, and consider liability and accountability.

The Guiding Principles can be viewed at:

Adrian Rollins