The Home Office has announced that Pregabalin and Gabapentin will be reclassified from a Prescription Only Medicine (POM) to a Schedule 3 Controlled Drug in April 2019.

What does this mean for wholesalers and pharmacies?

Well for pharmacies, the storage of these two drugs will not change as both Pregabalin and Gabapentin will be excluded from the requirement to be stored in a safe – similar to Tramadol. This is positive news for Pharmacy owners that were anticipating this reclassification in the fear of spending more money on a big enough Controlled Drugs cabinet. The prescription itself has its validity reduced from six months to 28 days from the date of the prescription written. Overall, this reclassification is considered as a positive move as the dispensing restrictions designed to improve patient safety.

For wholesalers, if they wish to continue their wholesaling activity of these two drugs they must obtain a Home Office licence in addition to their WDA, and the Home Office licence must include Schedule 3 Controlled Drugs. The consequence for not acting appropriately are serious since both Pregabalin and Gabapentin will be considered as a class C controlled substance from April 2019.

In 2016 the Advisory Council on the Misuse of Drugs raised concerns over medicinal misuse and recommended that pregabalin and gabapentin should be controlled as class C Drugs under the Misuse of Drugs Act. This now will be the case from April 2019.