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Government told to restrict gabapentin and pregabalin availability

The prescription drugs gabapentin and pregabalin could soon be more tightly regulated in the UK, after Government advisors called for them to be classed as controlled drugs.

The plan – which would see gabapentin and pregabalin categorised as ‘Class C’ drugs and placed under schedule 3 prescribing regulations – would mean the drugs cannot be repeat dispensed and prescriptions will only be valid for one month.

The move comes after increasing concerns over recreational use of the drugs, particularly amongst the opioid abusing population, and a rise in deaths related to their misuse.

In a letter to Home Office ministers, Professor Les Iverson, chair of the Advisory Council on the Misuse of Drugs, noted that Office for National Statistics data on deaths related to drug poisoning had recorded a ‘significant increase in deaths from 2012 onwards’.

This included 38 deaths where pregabalin was mentioned on the death certificate and 26 where gabapentin was mentioned.

The letter added that ‘pregabalin and gabapentin present a risk of addiction and a potential for illegal diversion and medicinal misuse’ and recommended that both drugs ‘are controlled under the Misuse of Drugs Act 1971 as Class C substances, and scheduled under the Misuse of Drugs Regulations 2001 (as amended) as Schedule 3’.

It comes after NHS England and Public Health England issued advice to GPs and other prescribers urging caution with the drugs, particularly where a patient may have a history of drug misuse.

RCGP prescribing advisor Dr Martin Duerden, a GP in North Wales, said the move would mainly affect users, as it will become an offence to carry either drug unless they are obtained through prescription, but that GPs ‘may need to be more circumspect in terms of carefully checking for appropriate use, and not writing prescriptions for large quantities’.

Dr Andrew Green, chair of the GPC’s clinical and prescribing subcommittee, said he ‘would support the move’.

Dr Green said: ‘All GPs will recognise the problems described in the submission, pregabalin in particular has huge potential for abuse and dependency.’

However, Pfizer, which markets both gabapentin and pregabalin, said it ‘strongly disagreed’ with the plans, which it said was based on ‘potentially misleading information’ that could impact negatively on patients.

In a statement, the company said: ‘We strongly disagree with this and are extremely concerned about the negative impact this recommendation, if adopted, could have on many patients living with chronic neuropathic pain, generalised anxiety disorder and epilepsy.’

The statement added: ‘We are concerned that the advice contains a number of inaccuracies and some potentially misleading information, and is contrary to the totality of the safety data available for pregabalin and gabapentin.

‘Controlling the supply of these products across the whole UK, would be a disproportionate measure that would impact on patients and their quality of life, and could also result in additional economic and operational burden on an already strained healthcare system.’

Correction: This story was changed on 27 January 2016 to indicate that under schedule 3 regulations drugs cannot be repeat dispensed (not prescribed)




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