Guidance

Context

Context

Cannabis-based medicinal products have been suggested for a variety of medical conditions. In line with prescribing for all medicines, the potential for harm must be weighed up against the potential for benefit for individual patients.

Current practice

At the time of developing this guideline, delta-9-tetrahydrocannibinol combined with cannabidiol (Sativex), nabilone and cannabidiol (Epidyolex) were the only cannabis-based medicines licensed for use in the UK. Delta-9-tetrahydrocannibinol combined with cannabidiol (Sativex) has been licensed by the MHRA as a treatment for spasticity in adults with multiple sclerosis and is listed under Schedule 4 of the Misuse of Drugs Regulations 2001 ('2001 Regulations'). Nabilone has been licensed by the MHRA as a control of chemotherapy-induced nausea and vomiting in adults and is listed under Schedule 2 of the 2001 Regulations. Cannabidiol (Epidyolex) has been licensed by the MHRA as an add-on treatment for seizures associated with Lennox-Gastaut syndrome or Dravet syndrome, in conjunction with clobazam, for people aged 2 years and over and is listed under Schedule 2 of the 2001 Regulations. Dronabinol is listed under Schedule 2 controlled drugs but does not have a marketing authorisation from the MHRA in the UK.

Until September 2018, in cases of exceptional and unmet clinical need, legislation allowed the prescribing of cannabis-based medicinal products through the granting of an individual licence. As Schedule 1 controlled drugs, prescribing was controlled through the licensing process operated by the Home Office.

In November 2018, the UK Government set out the following requirements for the prescription of a cannabis-based product:

'A preparation or other product, other than one to which paragraph 5 of part 1 of schedule 4 applies, which:

  • is or contains cannabis, cannabis resin, cannabinol or a cannabinol derivative (not being dronabinol or its stereoisomers)

  • is produced for medicinal use in humans; and

  • is a medicinal product, or

  • a substance or preparation for use as an ingredient of, or in the production of an ingredient of, a medicinal product.'

Cannabis-based products for medicinal use related only to cannabis and cannabis preparations (such as extracts from cannabis as well as cannabinoids isolated from cannabis). It does not include synthetic versions of naturally occurring cannabinoids (for example, dronabinol) or any non-natural cannabinoids obtained by chemical synthesis (nabilone).

In this guideline, cannabis-based medicinal products include:

  • cannabis-based products for medicinal use as set out by the UK Government in the 2018 Regulations

  • the licensed products delta-9-tetrahydrocannibinol combined with cannabidiol (Sativex) and nabilone

  • plant-derived cannabinoids such as pure cannabidiol (CBD)

  • synthetic compounds which are identical in structure to naturally occurring cannabinoids such as delta-9-tetrahydrocannabinol (THC), for example, dronabinol.