Off-label prescribing

Editor, – Craig Patterson and Brian Foster make some strong statements in Letters to the Editor (Aust Prescr 2003;26:51-2#sub_252). Will pharmacists also be 'hung out to dry' and 'subjected to a compensation claim' for off-label dispensing?

I think it would be timely for Australian Prescriber to help clarify the situation with regard to off-label prescribing. The Australian Medicines Handbook uses the terms 'marketed indications' and 'accepted indications'. Do the professional indemnity organisations have an opinion here? Has the Therapeutic Goods Administration had any more recent thoughts than the (1992) reference quoted by Craig Patterson?

If I prescribe sodium valproate for prevention of migraine when other treatment has failed, use pethidine in the epidural space for obstetric analgesia or give ketorolac intravenously for post-operative pain control, where do I stand?

A survey in Sydney showed 26% of prescription medicines were used for off-label indications.¹ Other studies have shown that in the USA 9.2% of 500 medicines were for off-label use², in one UK specialist palliative care unit 25% of prescriptions affecting 66% of their patients were for off-label use, and in European audits between 39 and 55% of prescriptions were for off-label use.³

It would seem that Craig Patterson's washing line will need many clothes pegs!

The issue of using the Pharmaceutical Benefits Scheme to supply a drug outside the restrictions for authority prescribing is much clearer: it is a breach of the National Health Act. It would however be salutary for health professionals to know what penalties the Act provides for even when the prescription is written in good faith.

Roger Goucke
Head, Department of Pain Management
Sir Charles Gairdner Hospital
Perth

Mr C. Patterson, one of the correspondents, comments:

Dr Goucke is right to highlight that off-label prescribing occurs extensively and, in certain populations such as children, this is through necessity. I am uncertain, however, that the potential increase in professional liability is widely recognised. Off-label prescribing would often be defended by the body of published evidence of an effect. My main point is that, in the gabapentin example, the pharmaceutical company was the voice goading this off-label prescribing, and doctors displayed good faith that what they were being told was true and accurate. Should the doctor find themselves in a legal dispute, that same voice would be strangely silent when it comes to supporting off-label use.