Pregabalin is currently controlled under Class C of the Misuse of Dugs Act 1971. The Government takes expert advice from the Advisory Council on the Misuse of Drugs (ACMD), which is the independent advisory body on drugs, on the classification of substances under the 1971 Act and scheduling under the Misuse of Drugs Regulations 2001.

Controlled drugs are placed in the appropriate class and schedule following consideration of advice from the ACMD on the potential harms of misuse, and an assessment of their medicinal or therapeutic usefulness and the need for legitimate access. The ACMD announced in February this year that they are looking to launch an updated harms assessment for gabapentinoids, which includes pregabalin, to review the position of these drugs under the Misuse of Drugs Act 1971. The Government will consider the findings of the ACMD’s review once published.

The ACMD’s work programme is available on the Gov.UK website: ACMD work programme 2024 - GOV.UK

The maximum penalty specified in the Misuse of Drugs Act 1971 for supply of a class A controlled drug is life imprisonment, and for class B or C it is 14 years imprisonment and/or an unlimited fine. The government reclassified pregabalin as a Class C controlled drug in 2019 following an assessment of its harms by the Advisory Council on the Misuse of Drugs.

Sentencing guidelines are developed by the Sentencing Council for England and Wales (‘the Council’). The Council is an independent body which decides on its own priorities and work plan. Guidelines produced by the Council are not applicable to courts in Northern Ireland, as sentencing is a devolved matter.

The Council recently reviewed and revised its drug offences sentencing guidelines, which came into force on 1 April 2021. They set out that exposure of a drug user to the risk of serious harm over and above that expected by the user is an existing aggravating factor for the offence of supplying a controlled drug. An aggravating factor makes an offence more serious and is considered by the court when sentencing.

Justice Ministers have not discussed pregabalin-related deaths with the Northern Ireland Department for Justice.

No specific guidance has been issued. Pregabalin is a controlled substance and the British National Formulary states that healthcare professionals should evaluate patients for a history of drug misuse before prescribing pregabalin and observe patients for the development of signs of misuse and dependence.

As with all medicines, the Medicines and Healthcare products Regulatory Agency, with input from the Government’s independent expert advisory body the Commission on Human Medicines, keep the safety of pregabalin under continual review and ensure the product information contains up to date information, issuing updated advice as appropriate. Details about the possible side effects are provided in the product information for all medicines containing pregabalin.

Prices of pregabalin decreased significantly when it came off patent in July 2017 leading to significant savings for the National Health Service. NHS expenditure in primary care in England on pregabalin went down from £315 million in 2016 to £216 million in 2017 and £38 million in 2018. In 2018, the Supreme Court ruled that all patent protection on pregabalin should have expired in July 2014. This means that the NHS could have benefited earlier from cheaper prices of generic competitors and in this respect, the Department is currently considering its position.

The Medicines and Healthcare products Regulatory Agency (MHRA) continuously monitors the safety of all medicines on the market in the United Kingdom and seeks independent expert advice from the Commission on Human Medicines and its advisory groups on important new safety issues.

The MHRA is aware of the study by Molero et al published in the BMJ on 12 June 2019 which suggests that gabapentinoid medicines, pregabalin and gabapentin, are associated with an increased risk of suicidal behaviour, unintentional overdoses, head/body injuries and road traffic incidents and offences.

Pregabalin is authorised for the treatment of epilepsy, neuropathic pain and generalised anxiety disorder. Pregabalin is recognised to be associated with a range of possible side effects including dizziness, somnolence, loss of consciousness, confusion and mental impairment which could explain the increased risk of injuries and traffic accidents identified in this new study.

The product information for pregabalin currently contains relevant warnings regarding suicidal ideation and behaviour, possible side effects, as well as the possible effects on driving and operating machinery. The MHRA will carefully consider this new study and whether new advice needs to be issued to healthcare professionals and patients.

The information requested is attached.

Prescribing information is not held at local authority level so primary care trust data is provided for 2010-11 to 2012-13 and clinical commissioning group data for 2013-14. It is not possible to provide the full five years requested as data is only held for the latest 60 months.