Gabapentin and pregabalin to be subject to tighter controls

The Government's decision to reclassify gabapentin and pregabalin as class C drugs under the Misuse of Drugs Act is based on the findings of a public consultation which was launched after concerns were raised by the Advisory Council on Misuse of Drugs (ACMD) over the risk of medicinal misuse, potential illegal diversion and addiction associated with the drugs.

Abuse potential

Gabapentin and pregabalin are licensed to treat anxiety, epilepsy and neuropathic pain. According to the ACMD, both drugs are increasingly being reported as possessing a potential for misuse. When used in combination with other depressants they can cause drowsiness, sedation, respiratory failure and death.

The ACMD states that pregabalin may have a higher abuse potential than gabapentin owing to its rapid absorption and faster onset of action and higher potency. Pregabalin causes a 'high' or elevated mood in users. Similarly, gabapentin can produce feelings of relaxation, calmness and euphoria and some users have reported that the 'high' from snorted gabapentin can be similar that of a stimulant.

The aim of the Government consultation, which garnered responses from pharmacies, doctors, pharmaceutical companies and patients, was to assess the impact of reclassification of these drugs on the healthcare sector.

Practical implications

Gabapentin and pregabalin will still be available for legitimate use on prescription, but there will be stronger controls in place to ensure accountability and minimise the chances of stockpiling by patients or illegal diversion.

Prescriptions for gabapentin and pregabalin will need to be physically signed by doctors; electronic copies will not be accepted by pharmacists. As for other controlled drugs the total quantity will need to be written on the prescription in both words and figures. In addition, pharmacists will need to dispense the drugs within 28 days of the prescription being written.

Safe custody and record keeping

The drugs will not be subject to safe custody requirements. The Government states in its consultation document that while safe custody would provide the highest level of protection to prevent diversion and misuse, the effect of the application of the requirements would be disproportionate and result in considerable costs owing to the need to buy and install new controlled drug cabinets in many organisations.

Patients who are legitimately prescribed these drugs will have a slight burden of having to renew their prescription each month. However, the Government says it is satisfied that this requirement will provide sufficient safeguards to prevent diversion without imposing a disproportionate burden on those most affected by the changes, including prescribers and pharmacists.

Commenting on the new regulations, Minister for Crime, Safeguarding and Vulnerability, Victoria Atkins, said: "Any death relating to the misuse of drugs is a tragedy. We have accepted expert advice and will now change the law to help prevent misuse of pregabalin and gabapentin and addiction to them."