The drugs – used to treat anxiety, nerve pain and epilepsy – will be placed in schedule 3 under the Misuse of Drugs Regulations 2001, but will be excluded from the requirement to be stored in a safe, the Home Office said yesterday (October 15).
As controlled drugs, pharmacies will only be able to accept physically-signed prescriptions – rather than electronic copies. Pharmacies must also dispense the drugs within 28 days of the prescription being written, the Home Office stressed.
The decision follows the results of a consultation, which the Home Office launched in November after the Advisory Council on Misuse of Drugs raised concerns.
Victoria Atkins, minister for crime, safeguarding and vulnerability, said: “We accepted expert advice and will now change the law to help prevent misuse of pregabalin.”
Regulations implementing the law change will be laid before parliament tomorrow, ready for the reclassification of both medicines in April 2019, the Home Office added.
Costs of safes “considerable”
The Home Office acknowledged that its original “preferred option” to require reclassified pregabalin and gabapentin to be stored in safes, “would be disproportionate and result in considerable costs, owing to the need to buy and install new controlled drug cabinets in many organisations”.
By removing the “safe custody requirements”, the extra cost for pharmacies to implement the reclassification is “negligible”, as measures would be the same for other medicines such as tramadol, it said.
“It is assumed that it will take health professionals five minutes to acquaint themselves with the new classification of the drugs,” it said.
RPS: “Positive step”
Royal Pharmaceutical Society (RPS) president Ash Soni said the reclassification would be regarded as a “positive step” by pharmacists, as the dispensing restrictions are designed to improve patient safety.
“It is likely there will be some reduction in the prescribing of these drugs and pharmacies will need support in managing their stock holding to ensure they meet patient demand, but not end up with significant stocks that go out of date,” Mr Soni said.
“The fact that this is being notified in advance will help with this, but it will be important for all health professionals to be aware of the change and to start to support patients in understanding the changes,” he added.