Home Doctors Need To Review Pregabalin (Lyrica) Prescription ASAP

Today's post from pulsetoday.co.uk (see link below) is an interesting one because it illustrates the ongoing issues around patents, generic v brand name drugs and health authority finances. It concerns pregabalin (Lyrica), which many would argue is an inappropriate drug for certain forms of neuropathic pain anyway. (Pfizer themselves withdrew their own recommendation for Lyrica for diabetes and HIV-related neuropathy in May 2013 - should tell you enough). There have been law-suit issues and issues regarding severe side effects from Lyrica for years yet it is still widely prescribed for all forms of neuropathic pain. This article highlights the UK medical services' dilemmas regarding recommendation of generic pregabalin (cheaper) or the brand name version Lyrica, which is still under patent, though not for long. It's a political and financial problem that really has nothing to do with the patient unless the patient is being prescribed the wrong drug for their condition, which in the case of Lyrica, still widely happens. If your doctor prescribes Lyrica, it's always worthwhile starting a conversation as to whether that is the best option for you. The potential side effects are not to be underestimated, although that applies to many other 'neuropathic pain' drugs too.
 

GPs told to carry out review of patients taking pregablin 'as soon as possible' 
6 March 2015 | By Caroline Price

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 pregabalin 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.’

Vinci Ho | GP Partner | 06 March 2015 5:20pm

These are the words in NHSE guidance:

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

http://www.pulsetoday.co.uk/clinical/prescribing/gps-told-to-carry-out-review-of-patients-taking-pregablin-as-soon-as-possible/20009393.article#.VSet25P437A