With everything going on at the moment it is easy to forget that there are things other than Brexit happening. An important one for the pharma supply chain is the scheduling of Pregabalin and Gabapentin as Class C, schedule 3 controlled drugs from 1st April 2019.
Following public consultation it was decided to exclude the both products from the requirements for safe storage which will reduce the impact of the re-classification on wholesalers and pharmacies, though a final decision about storage within a individual environment should be based on a local risk assessment, as ‘safe storage’ may be appropriate is certain situations (don’t forget to write up a risk assessment even if the decision is not to use safe storage).
Wholesalers are reminded to check that their Home Office licensing is appropriate, and that they need to ensure that these products are suitably classified within their systems to ensure that operational requirements relating to schedule 3 Controlled Drugs are applied to these products; such as the requirement for invoice retention, witnessed destruction, relevant stock checks and inclusion on the Annual Statistical return. You are also reminded that the importation and/or exportation of these products will require a suitable licence from April.
Pharmacies will be familiar with the prescription writing requirements but will probably need to check that regular patient’s repeat prescriptions and schedules are reviewed to ensure continuity of supply.Don’t forget the requirement for a Controlled Drug Requisition form, in hardcopy with a wet signature prior to supply to relevant groups of customers. And finally both wholesalers and pharmacies will need to decide on the appropriateness of keeping running balances for these products, whilst these products obviously do not need to be recorded in the CD register keeping a running balance is seen as best practice.fff