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The GMC must defend off-label scripts

GP prescribing should be determined by evidence, not commercial interests, writes Dr Bill Beeby

In 2010, the GMC started a process to review its guidance document Good practice in prescribing and managing medicines and devices.

There was a recognition that GP behaviour and prescribing practice on unlicensed or off-label drugs was putting them in conflict with GMC guidance.

A consultation draft therefore included advice that ‘unlicensed or off-label medicines could be prescribed where, on the basis of authoritative clinical guidelines, a doctor judged that the medicine was as safe and as effective as an appropriately licensed
medicine'.

Prescribers are faced with over 200 off-label recommendations in the BNF – and even clear and explicit guidance from NICE suggesting we use products outside of their licensed indications.

The proposed changes to the GMC Good practice document were well received by 70% of respondents, reflecting that in many cases we were using older medicines in off-label situations to avoid prescribing a high-cost, licensed product.

Established clinical practice left us comfortable with using amitriptyline as our first line as an adjunct to managing chronic pain before turning to the newer and far
more expensive drugs with the right approvals.

So it is with disappointment that many of us will read the GMC's new conclusions, reported in Pulse last month.

Its attention has been drawn to the EC directives on medicinal products for human use, and the advice it has received is that unlicensed medicines could only be prescribed where there is a ‘special need'.

Such a special need does not include people with a rare disease if there is a licensed alternative.

Nor does the decision of a commissioning body that the licensed medicine cannot be funded constitute a special need.

Cost and affordability of near-identical products is not to be considered, just the licence.

Off-label prescribing is not covered specifically by the EC directive, but the implication and concern is that the same situation will exist here and may prevent off-label use when there is a licensed alternative.

The revised GMC guidance will therefore be published with many welcome revisions, such as prohibiting botox prescribing without a face-to-face consultation, but will retain the old wording on off-label and unlicensed prescribing – while advice is taken to ensure that the GMC document is legal.

Meanwhile, we are left in a no man's land when following the guidance from NICE or the BNF that puts us in conflict with our registering body.

Many will wonder why I am so unhappy with this. After all, I have consistently warned GPs that prescribing medicines in these off-label and unlicensed situations might expose them to risk as they will not have the fallback of diverting liability to a manufacturer if things go wrong.

But we must consider that not all risks are the same, and many of these situations are supported by a considerable body of opinion that such use is safe and effective, as well as financially astute. 

Recent news reports show that this has already started to move from the theoretical to the courts. Novartis has started legal action to prevent advice being issued that authorises the use of one product over another in exactly the situations described above.

Bevacizumab (Avastin) and ranibizumab (Lucentis) are each derived from a common origin and were developed to block vascular endothelial growth factor.

They differ in cost, and that one has been marketed with a licence for cancer and the other for the condition in question, age-related macular degeneration.

The outcome of this legal action, and of the GMC's legal opinions, will have effects far beyond the narrow circumstances of this specific case.

Decisions taken by pharmaceutical companies will determine the use of medicines by all prescribers, whether in primary or secondary care. Research and learned experience in the way medicines are used to the benefit of patients under our care will count for nothing.

Peer-reviewed papers supporting innovative uses for existing medicines could be worthless unless a manufacturer chooses to apply for their inclusion in a product licence, which they may not care to do if there is a competing licensed product already available. That would be a commercial decision – not a scientific one.

It will be a sad day for medicine if commerce – not science – ultimately determines our use of medicines, and if the GMC says that allowing men of science to apply their knowledge to the benefit of patients contravenes good practice.

Dr Bill Beeby is chair of the GPC's clinical and prescribing subcommittee and a GP in Middlesbrough

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Readers' comments (1)

  • The cynicism of the pharma industry knows no bounds; 3,4 diaminopyridine for the treatment of LEMS was unlicensed, and cost around £100 per month. A pharma company applied for (a heavily subsidised) orphan liicense for a similar product in the EU, and promptly launched the product at well over £2,000 per month. They conducted no clinical trials that I can identify. How, exactly, does this benefit society ?

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