Exclusive: GPs could face a ban on off-label prescribing whenever there is a licensed alternative, under a GMC review of European legislation prompted by the pharmaceutical industry.
The GMC has abandoned plans to ease restrictions on off-label prescribing after protests from drug companies, and is instead seeking legal advice on whether even GPs’ current restricted access may contravene European law.
The GPC said the legal review could rock GP prescribing ‘to its foundations’, with legal advice received by the GMC so far suggesting European regulations could require a rewrite of its existing drug guidance.
GPs are currently able to prescribe off-label if doing so would ‘better serve’ the patient’s needs than the licensed alternative, and the GMC had planned to extend that to cases where the off-label drug was as safe and effective as the alternative.
But a GMC board paper published this month reveals it has scrapped that move, even though it had the support of 70% of respondents to a consultation, after the Association of the British Pharmaceutical Industry and the MHRA expressed concerns.
Instead, the GMC has been forced to consult its lawyers and has warned it may rewrite its guidance once it has ‘resolved the legal questions’.
Senior GPs warned new restrictions would rewrite NICE guidelines and put huge pressure on drug budgets.
The board paper said: ‘We sought legal advice on the requirements of the EU directive on medicinal products for human use, confirming unlicensed medicines could be prescribed only where there was a special need.
‘The directive does not specifically address prescribing outside the licence, and we are still exploring the extent to which it prevents prescribing off-label other than when there is no licensed alternative.’
Dr Bill Beeby, chair of the GPC’s prescribing subcommittee and a GP in Middlesbrough, said the implications of the legal review were ‘horrifying’.
He said: ‘There are various guidelines that don’t comply with this. It could rock things to their foundations and cause tremendous problems. It is highly likely it will have considerable cost implications.’
Restrictions on off-label prescribing would mean drugs such as amitriptyline in neuralgia or sertraline in anxiety would be effectively off limits and paediatric prescribing would have to radically change.
A GMC spokesperson said it had received ‘a number of different views’ on off-label prescribing and would be reconsidering its guidance: ‘We are seeking further legal advice.’
A spokesperson for the ABPI said: ‘We are concerned moves to appraise off-label or unlicensed medicines could compromise patient safety.
‘There can be occasions where people are prescribed a medicine that hasn’t gained the required regulatory approval, but this should be strictly limited to those circumstances where there is no suitable licensed treatment.’
But Dr Grant Ingrams, a GP in Coventry, said any change to GMC guidance would be ‘barmy’: ‘If they are going to do this they need to look at the whole licensing system and the Government taking out licences.’