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Guidelines flaw accusation rejected by ACD

by Dr Linda Calabresi

Calls to have the latest guidelines for the management of BCCs and SCCs withdrawn because they include treatments that are not TGA approved, have been rejected by the Australasian College of Dermatologists.

In a media release , Associate Professor Anthony Dixon from the Australasian College of Skin Cancer Medicine expressed concerns that the ‘Clinical Practice Guide for Management of BCCs and SCCs’ (link) suggests that topical imiquimod is suitable for indications outside of TGA approval.

In particular, he claims the guidelines ‘encourage’ the use of imiquimod for the treatment of nodular BCCs and Bowen’s disease, which evidence shows are more effectively treated with surgical excision.

‘Australians risk having their skin cancers managed poorly with an official guide being used to justify the poor treatment choices,” he said. 

However, Dr Stephen Shumack, Honorary Secretary of the ACD said the guidelines specifically state that surgery is the primary treatment for non-melanoma skin cancer.

They do not ‘encourage’ the use of imiquimod for treating nodular BCC or Bowen’s disease but state its use should be restricted as an ‘alternative treatment where surgery or other therapies are inappropriate or contraindicated.’

In addition, he says the guidelines make it clear that imiquimod does not have a TGA-approved indication for the treatment of these conditions, however the topical treatment is an approved product in Australia and doctors are free to use it off-label.

“The guidelines are there to advise on all the available options for the treatment of [non-melanoma skin cancer] in Australia,” Dr Shumack said.    


17 December 2008
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Latest Comments

  • I'm always amazed when individuals 'reject' guidelines - they are, after all, only guidelines. They are prepared after extensive consultation with as many interested parties as possible and represent a consensus opinion. Dr Dixon, as a GP, is probably not used to using products off-label but it can be necessary in specialist practice to provide certain individuals with the best option for them. The statement that the guidelines 'encourage' off-label use is a misreading of these guidelines and begs the question - has he read them and what is the motivation for making the statement?

    Posted by Duncan Stanford 18/12/2008 9:07:53 PM

  • Off-label prescribing is at times quite appropriate and should not be dismissed out of hand. Remember when imiquimod was only approved for genital warts, but often safely prescribed (with informed patient consent for off-label use) for superficial BCC? I do agree however that Imiquimod would be a treatment of desperation rather than a treatment of choice for nodular BCC!

    As for "consensus" positions, remember that primary care practitioners are a small minority of these clinical oncology working parties - and that primary care practitioners with particular expertise in the area of interest may not be representated at all....

    Posted by Dr Jeffrey G Keir, Ballina 18/12/2008 11:41:48 PM

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