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GMC does U-turn on extending use of off-label medicines

The GMC has reversed proposed changes to prescribing guidance that would have allowed greater use of off-label and unlicensed treatments by GPs.

New guidance published this afternoon rows back from a previous draft that said GPs may prescribe off-label or unlicensed medicines if they are satisfied ‘on the basis of authoritative clinical guidance’ they were necessary.

The decision comes after the regulator carried out a review of European legislation, prompted by opposition from the pharmaceutical industry and the MHRA.

The GMC said the guidance was published to bring the UK in line with EU regulations, but GP leaders have said it could stop CCGs making savings for the NHS by using cheaper drugs.

The Association of the British Pharmaceutical Industry ‘warmly welcomed’ the final draft of the guidace that reinstates previous guidance that urged GPs to only prescribe outside a product’s licensed indications ‘when it is necessary to do so to meet the specific needs of the patient’.

Good practice in prescribing and managing medicines and devices says GPs must ‘be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy’ when prescribing an unlicensed or off-label medicine.

The guidance says: ‘You may prescribe unlicensed medicines, where, on the basis of an assessment of the individual patients, you conclude, for medical reasons that it is necessary to do so to meet the specific needs of the patient.’

The guidance also gives examples of when prescribing an unlicensed or off-label medicine might be appropriate, such as where there is no licensed medicine applicable, for example if the patient is a child and the appropriate medicine is only licensed for adults, or when no licensed medicine is available, for example in the event of a temporary shortage in supply of certain drugs.

A spokesperson from the ABPI said the previous guidance ‘almost promoted’ unlicensed prescribing and welcomed the rethink by the GMC.

Stephen Whitehead, chief executive of the ABPI said: ‘We warmly welcome the GMC’s updated guidance to clinicians on good practice in prescribing medicines, which is a significant improvement on the draft. In particular, we welcome the guidance on the circumstances in which unlicensed medicines are prescribed, which retains the GMC’s previous position.

‘The GMC has listened to stakeholders and taken an open and constructive approach to engaging with us. The new guidance reaffirms that patient need should be at the heart of clinical decisions.’

GMC chief executive Niall Dickson said the guidance tightened the current rules, and would improve patient care.

He said: ‘Safe prescribing is at the heart of good medicine and it a skill that doctors must develop and 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.’

But Dr Nigel Watson, chair of the GPC’s commissioning subcommittee and chief executive of Wessex LMCs said although the new guidance would have little effect on GP’s say-to-day practice, it would tie the hands of CCGs.

He said: ‘The guidance won’t change much for individual GPs but across populations is a different argument.

‘The Lucentis argument is a good one - there’s a bit of politics in the advice. We’ve only got limited resources, so I wouldn’t want there to be barriers which restrict us from prescribing the cheapest drug across populations.’

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