If presented with a prescription, the pharmacist should check that the prescriber is authorised to prescribe a CBPM product. The pharmacist is also expected to check that the prescriber is fully aware of the unlicensed status of the product.
The prescription needs to specify:
· the brand/supplier, the cannabis strain and content of THC/CBD (and ratio of THC/CBD where relevant), as appropriate
· the route of administration and dosage instructions
· the quantity.
The script should comply with the other prescription requirements for a Schedule 2 Controlled Drug.
The MHRA guidance includes a flowchart summarising the process for prescribing, procuring (including import) and supplying unlicensed CBPMs. It notes that “once a substance receives Marketing Authorisation this prescribing restriction will no longer apply, and the product is available for patient use as with other Schedule 2 drugs.”
Labelling of dispensed CBPMs must comply with standard labelling requirements, with special warnings for drivers:6
· ‘WARNING’ This medicine may make you feel sleepy. If this happens do not drive or use tools or machinery. Do not drink alcohol
· Do not drive while taking this medicine until you know how it affects you
· Do not drive if you feel sleepy, dizzy, unable to concentrate or make decisions, or if you have blurred or double vision.
The record of supply must be kept for five years, and follow standard Schedule 2 CD record keeping under the Misuse of Drugs Regulation 2001, including:
· product details and THC/CBD strength, and quantity
· date and source of obtaining the product and batch number.
In addition, there is a requirement to record details of any suspected adverse reaction (ADR) to the product “of which the person is aware or subsequently becomes aware”, and to electronically report suspected ADRs using the electronic Yellow Card system.