GP concern over GMC guidance
pharmafile | February 5, 2013 | News story | Sales and Marketing | ABPI, GMC, GP, NHS
The ABPI has ‘warmly’ welcomed the new prescribing guidance from the General Medical Council – but GPs are far from convinced.
The GMC guidance, ‘Good practice in prescribing and managing medicines and devices’, comes in to force on 25 February and replaces the GMC’s 2008 document.
“In particular, we welcome the guidance on the circumstances in which unlicensed medicines are prescribed,” explained ABPI chief executive Stephen Whitehead.
The GMC seems to adhere to pharma’s thoughts on off-label prescribing, saying that doctors can in the main only prescribe off-label or unlicensed medicines if a licensed alternative is unavailable or inappropriate.
It is a significant difference from the GMC’s draft guidance on the issue in 2011, which would have allowed doctors to prescribe unlicensed drugs as long as they were as safe and effective as licensed products.
The volte face has apparently come after the GMC looked at the legal implications on this stance of EU regulations, but this has raised the ire of health professionals.
Dr Bill Beeby, chair of the BMA’s prescribing committee, told Pharmafile: “50% of GPs will be in breach [of the guidance] overnight and 50% next week. I’m very concerned.”
Speaking about the common use of off-label medicines, he went on: “We all use amitriptyline for chronic pain rather than pregabalin [Pfizer’s Lyrica].”
The key part of the GMC guidance states: “You should usually prescribe licensed medicines in accordance with the terms of their licence.”
But it goes on: “However, you may prescribe unlicensed medicines where, on the basis of an assessment of the individual patient, you conclude, for medical reasons, that it is necessary to do so to meet the specific needs of the patient.”
In effect, Beeby says, the GMC is saying that doctors should always err towards licensed medicines at the expense of cheaper generics. “If a branded product is available then it must be used, which means GPs will be breaking the law overnight,” Beeby suggests.
“What’s the GMC going to do?” he went on. “If it ignores it, its guidance is worthless. If it does take action it will paralyse the NHS. I’m afraid it’s that serious.”
Beeby believes that the GMC guidance will also have financial implications. “It’s going to make it very difficult and expensive for the NHS when we’re looking to keep a lid on costs,” he concluded.
Whitehead said the ABPI’s only concerns in the consultation on the guidance were to ensure that it “would not compromise patient safety, the medicines licensing system or incentives for medical innovation”.
GMC chief executive Niall Dickson reiterated that safe prescribing is at the heart of good medicine, and that doctors must keep up to date throughout their careers. “This new guidance tightens the current rules on prescribing and addresses the challenges doctors face in this complex area,” he concluded.
Several factors are at play in this debate, but one impetus for the change in guidance came from a contentious and long-running case involving Roche’s Avastin and Novartis’ Lucentis.
Last summer the Southampton, Hampshire, Isle of Wight and Portsmouth (SHIP) cluster was persuaded to reverse its policy of recommending Avastin for wet AMD.
In 2011 the NHS body made Avastin available to patients with the common eye condition, even though the drug is not approved for this licence.
Lucentis is the only licensed and NICE-approved product for the condition, and Novartis had forced a judicial review of the cluster’s practice to stop if from using the much cheaper Avastin.
SHIP is now only recommending Lucentis for wet AMD after Novartis offered the drug at a discounted price.
Other highlights of the new GMC guidance include:
- doctors should avoid prescribing for themselves or their families unless it is an emergency where lives or health are at serious risk
- they must not prescribe performance-enhancing drugs or treatments to athletes
- and they cannot remotely prescribe drugs such as Botox or other similar injectable cosmetics by phone, email, video-link or fax.
Adam Hill
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