The General Medical Council (GMC) says it has postponed plans to allow doctors, for the first time, to prescribe cheaper off-label or unlicensed alternatives to licensed medicines.
In proposals put out for consultation last year, the doctors’ regulatory body had called for a change to its guidance. This currently limits the prescribing of off-label or unlicensed medicines to circumstances where there is no appropriately licensed alternative and, in relation to off-label prescribing, where the doctor judges that such a medicine would better serve the patient’s needs than the appropriately licensed alternative.
The GMC had proposed that prescribing of off-label or unlicensed medicines should be permitted – even where a licensed product is available – if the prescriber was satisfied, on the basis of authoritative clinical guidance, that it was as safe and effective as an appropriately licensed alternative.
However, the consultation revealed “significant divergence of views” among respondents on the proposal, it says. A recurrent theme was the high costs of prescribing licensed medicines when there were unlicensed versions – often in use for many years – containing the same active ingredients and which were in some cases wholly or virtually identical.
Respondents had also pointed to National Institute for Health and Clinical Excellence (NICE) clinical guidelines that recommended off-label use of drugs as a preferred option. “Doctors were therefore sometimes put in a position in which they were unable to comply both with GMC guidance and follow the guidelines issued by NICE or their contracting or employing organisation,” says the Council.
It had also received a number of letters inquiring about the use of off-label medicines in the treatment of wet age-related macular degeneration (AMD), it says, but adds: “at the time of drafting the guidance there were no ‘authoritative clinical guidelines’ to support this approach, so this particular issue would not have been resolved by our advice.”
70% of respondents to the consultation supported the Council’s proposed changes, but the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Association of the British Pharmaceutical Industry (ABPI) opposed them, and as a result of these concerns, the GMC sought legal advice on the European Union (EU) directive on medicinal products for human use.
This advice confirmed that unlicensed medicines could be prescribed only where there was a “special need,” and that this could not be taken to encompass unlicensed medicines for patients with rare conditions if there were a licensed alternative or circumstances in which commissioning bodies did not support the funding of a licensed alternative.
“As a result, we agreed that we should revert to the existing guidance on prescribing unlicensed medicines,” says the GMC.
The situation relating to prescribing drugs outside the terms of their licence is more complex, it adds. The EU directive does not specifically address this issue, and the Council is still exploring “the extent to which this should be taken to prevent prescribing medicines off-label other than in circumstances in which there is no licensed alternative.”
Since the consultation closed in June 2011, the Council has met and corresponded with the MHRA, ABPI and NICE, and says it is now seeking further legal advice, “so that we are able to reach a conclusion which we are satisfied is lawful and provides an appropriate balance between patient safety, good use of resources and the need to respond to patients’ needs.”
Doing so “may take some time,” it adds.
– Commenting yesterday, the ABPI said that the prescribing of unlicensed medicines can not only put patients at risk, “it undermines the UK’s entire regulatory process, which is designed to make our medicines as safe as possible.”
The practice can potentially be dangerous and should be strictly limited to those occasions where there is no licensed alternative, said the Association, which went on to warn that: “often, unlicensed medicines are reconstituted and delivered in to the patient in a different way than originally intended. This process in itself is not without risk and can lead to complications which can harm patient health.”
