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Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead pharmacist, Health and Wellbeing Directorate, Public Health England
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pregabalin-pack-shotMarch 4 2015

NHS England has issued advice about the prescribing and dispensing of pregabalin, warning of the need to take into account the indication.

In advice being sent out to GP practices and pharmacies, NHS England says: “Pregabalin should only be prescribed for the treatment of neuropathic pain under the brand name Lyrica (unless there are clinical contra-indications or other special clinical needs eg patient allergic to an excipient, branded product unavailable etc which apply to Lyrica, when you should not prescribe Lyrica or pregabalin).”

The advice has been prompted due to Warner Lambert Company LLC being engaged in a dispute with pharmaceutical suppliers regarding pregabalin. While generic versions are now available and can be used for general anxiety disorder and in epilepsy, the patent remains on the neuropathic pain indication. As part of the dispute, the Court has instructed NHS England to issue the guidance.

NHS England is advising prescribers that if prescribing pregabalin for neuropathic pain, “so far as is reasonably possible” they should prescribe by reference to the brand name Lyrica, write the prescription only with the brand name Lyrica, and not prescribe generically whether as pregabalin or any other branded generic name.

If prescribing pregabalin for anything other than pain, the prescriber should continue to prescribe by reference to the generic name pregabalin.

If dispensing pregabalin, then if the person has been told that it has been prescribed for pain then the person dispensing “should ensure, so far as reasonably possible, that only Lyrica, the branded form of pregabalin, is dispensed. However, when dispensing pregabalin for the treatment of anything other than pain, you are not restricted to dispensing Lyrica.”

NHS England is advising that electronic prescription system software be amended where possible to have a reminder message appear with the following message: “If treating neuropathic pain, prescribe Lyrica (brand) due to patent protection. For all other indications, prescribe generically.”

Pharmacists have been concerned that if they were to supply Lyrica against a generic prescription for pregabalin, but for the indication of neuropathic pain, they could lose out on reimbursement; if they supplied generic pregabalin they could be in breach of the patented indication.

Pharmacy Voice, the trade body representing pharmacy owners, has welcomed the “long-awaited guidance” from NHS England.

Rob Darracott, its Chief Executive, commented: “It is a relief to see NHS England publish the long-awaited guidance on pregabalin today. Pharmacy teams were being unfairly placed in a difficult position if they received a prescription for generic pregabalin when the diagnosis was for neuropathic pain.

“The guidance emphasises that the prescriber should prescribe by brand (Lyrica) in these circumstances. This will help minimise the legal risk for pharmacy teams and avoid delays for patients getting their medicine.

“The issue is a complicated mix of patent and trademark legislation and medicines licensing issues, and Pharmacy Voice wanted to help ensure both that prescribers are properly advised by the authorities and that the message is consistent across CCGs.”

Two generic versions of pregabalin are currently available, says Pharmacy Voice. The eMC electronic Medicines Compendium website lists product details for Pfizer’s Lyrica, as well as the generic products Lecaent from Actavis and Rewisca from Consilient Health.

Announcing its product launch, Actavis states: “Lecaent is indicated for epilepsy as adjunctive therapy in adults with partial seizures with or without secondary generalisation and generalised anxiety disorder in adults.

“Lecaent is currently not indicated for peripheral and central neuropathic pain in adults and should not be prescribed or dispensed for this purpose.”
 

Links:

NHS England Pregabalin Guidance (Via Pharmacy Voice)    

Pharmacy Voice response    

Actavis announcement    

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