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GPs told to carry out review of patients taking pregabalin 'as soon as possible'

Exclusive CCGs will issue guidance to GPs instructing them to carry out an urgent review of patients taking pregabalin following a High Court ruling.

The guidance – which NHS England said CCGs must send out to all GP practices by today – advises practices they should review all patients on long-term prescriptions of pregabalin for neuropathic pain and make sure any on a generic version of the drug are switched to the branded form Lyrica.

In addition, NHS England said GPs should from now on make sure to stipulate Lyrica on any new prescriptions of pregabalin they write for patients being given the drug for pain.

GPs are free to continue prescribing generic versions of the drug for other conditions.

The move comes after a recent High Court ruling that the NHS should stop promoting generic pregabalin for neuropathic pain.

The guidance states: ‘When prescribing pregabalin for the treatment of neuropathic pain to patients you should (so far as reasonably possible): prescribe by reference to the brand name Lyrica and write the prescription with only the brand name “Lyrica” and not the generic name pregabalin or any other generic brand.

‘When prescribing pregabalin for the treatment of anything other than pain, you should continue to prescribe by reference to the generic name pregabalin.’

And in a ‘frequently asked questions’ document accompanying the advice, NHS England explains that for new patients the guidance should be implemented ‘immediately’ and ‘when reasonably possible’ for repeat prescriptions.

But leading GPs criticised NHS England’s response, arguing it was not GPs’ role to take action and that practices were too overloaded to take on the work.

Dr Andrew Mimnagh, NHS Sefton CCG lead on urgent care, said it was up to dispensing pharmacists to resolve the issue.

Dr Mimnagh told Pulse: ‘Asking me to change a prescription for non-clinical reasons is not part of my professional duty of care or contractual obligation – I am not a contracted dispensor.

‘It is my belief NHS England are using GPs as the no-cost errand boy to sort their problem out, without regard for the intolerable workload pressures decimating the profession.’

 An NHS England spokesperson told Pulse: ‘The NHS is committed to ensuring the best outcome for every patient. The primary objective for this unique case has been to ensure that practitioners are aware of new guidance when dispensing certain pain medication. Information will be provided to CCGs outlining this advice.’

Drugs company Pfizer holds a ‘second medical use patent’ on pregabilin protecting its use in pain, although the basic patent has expired.

Pfizer said in a statement: ‘Pfizer is aware this is a relatively unusual exclusivity situation that has led to some confusion among prescribers and pharmacists. This is a legal matter not a clinical one.  It is for this reason that we have been actively seeking to provide this essential guidance for prescribers and pharmacists by engaging with a broad range of stakeholders over the past six months, including the Department of Health, commissioning bodies, pharmacy associations as well as NHSE and other NHS devolved bodies.’

It continued: ‘In line with the measures sought by Pfizer to help prevent infringement of the pain patent, NHSE issued guidance on 27 February 2015 for prescribers via Clinical Commissioning Groups (CCGs) and pharmacists via NHS Business Services Authority (BSA) that directs the prescription and dispensing of Lyrica®, by brand name only, when pregabalin is used for the treatment of neuropathic pain.  The NHSE guidance issued on Friday 27 February requests that the CCGs and NHS BSA distribute the notice on or before Friday 6 March 2015.’

The statement added: ‘The patent at issue, EP (UK) 0934061, expires in July 2017. A full hearing on the infringement and validity of the patent is scheduled to begin on 29 June 2015. Pfizer takes no issue with the supply of generic pregabalin products for use in the treatment of epilepsy or generalised anxiety disorder.’

Readers' comments (50)

  • Vinci Ho

    These are the words in NHSE guidance:

    ''If treating neuropathic pain, prescribe Lyrica (brand) due to patent protection. For all other indications, prescribe generically.”

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  • The Bma should challenge this. Up to pharmacists not gps.

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  • How strongly do we (GPs) have to follow NHSE guidance? Is there a contractual obligation?

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  • You don't have to follow it at all.

    But you'll be open to litigation and I doubt your indemnity cover will cover this as you chose to ignore NHSE directive.

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  • Drug company dictates NHS spending costs on legal technicality no shit Sherlock
    Cameron who is scared of TV debates promotes increased NHS spending on dementia drugs
    No shit Sherlock

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  • GPC say prescribers have to change but High Court says dispensers have to. Does anyone have a definitive answer to this

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  • 7.53pm.
    Typical gp fear and anxiety. How is pfizer going to prove the indication prescribed for short of access to patient records? And how are they going to get access to records without directly soliciting patients? Get a grip and grow some balls!

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  • Lmc and bma need to give us guidance on our responsibilities here. I don't see how it is actively our responsibility to make this unworkable patent request work.

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  • 11:16

    It's very easy.

    1) Pay some patients for privilege of their medical record, it will be an easy law suite. Make an example of a few GPs, you don't have to sure all of them.

    2) sue NHSE as class action for damages. Add NHSE will have access to medication record via spine, you will then be contacted to justify.

    Yes, you may not be targeted. Good luck if you want to take the risk, I for one will not be taking this unnecessary risk

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  • @255. And in your comments lie the entire reason why general practice is going down the pan. With attitudes like this I feel ashamed to be part of this so called profession.

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