Margaret McCartney: Second use patents—why do we have to prescribe branded Lyrica for pain?
BMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h2734 (Published 20 May 2015) Cite this as: BMJ 2015;350:h2734
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Lyrica is not licensed for pain but neuroapthic pain, but what constitutes neuopathic pain? The Pain Society defines this as pain arising from the nerve itself. Most musculoskeletal specialists agree that sciatica or nerve root pain is not neuropathic pain, as it arises from without the nerve ie mechanical and/or inflammation around the nerve root due to disc or other spinal pathology. In a GP practice nearby, of nearly 10,000 patients there were only 10 patients who were prescribed pregabluin for neuropathic pain.
Prescribing a drug for a reason it is not licensed for, is off label, so prescribing amitriptyline for pain is off label is not an unlicensed use. So prescribing pregabulin for non neuropathic pain, which is common, would therefore be off label?. althought the GMC guidance about off label precribing states that can be used when the in patients best interests, although this may apply to an individual patient, does it serve patients interests if NHS does not prescribe cost effectively? the NHS has to take cost into consideration in prescrbing, it would be unethical not to, this is public money. There are lots of alternatives to Lyrica for neuropathic pain, amitripyline for one, at the fraction of the cost.
Competing interests: No competing interests
it seems that the GMC is moving more from protecting patients to being seen to be politically and legally bombproof. The same messages are coming down from NHS England. At the same time at individual, practice , CCG levels we struggle to fund good care. Does England want efficiency savings? If so publicly support ophthalmologists and others to use less expensive medication. Does the gmc want us to do the greatest good for the greatest number or stop some people having any treatment as the money will run out?
Competing interests: I work in a health care system that is cash limited. Money can't be spent twice, so expense on branded drugs means less to use for other needs
Re: Margaret McCartney: Second use patents—why do we have to prescribe branded Lyrica for pain?
It sure looks like a mess !
This distressing directive from the GMC ( their interpretation of a European Court ruling) undermines lots of long-hallowed presumed effective practice, not just amitryptiline for pain. Just think of all those proven cheap medications in common use.
" The ruling effectively prohibits authorities
from engaging in budget-driven practices which circumvent the regulatory system and its most basic requirement, namely that to ensure patient safety a medicine should have a marketing authorization before being placed on the market and being used for a specific indication. The ruling also confirms that patient safety must not be put at risk via by off-label use that is not the choice of (and responsibility of) a doctor but imposed at a central level by authorities for financial reasons."
Nobody will find it worthwhile seeking a licence for a proven cost-effective unlicensed use, and few GPs will be brave enough to challenge the GMC. But it is clearly in our national best interests to change the law !
So why not have the NHS itself take on the GMC and Pharma industry ? Start by issuing a list of 'recommended cost-effective prescriptions'. currently unlicensed or off-label, and publicise it widely.
Competing interests: I use NHS services, and am taxed to pay for them.