Is this the guidance on cannabis-based medicines we have all been waiting for?

As a doctor, or patient, you may be confused about the current status of cannabis-based medicinal products (CBMPs). On the 8^th of August 2019, the National Institute for Health and Care Excellence (NICE) published draft guidance in respect of CBMPs, and how it is envisaged they should be used.
 

To clarify, at present, Sativex and Nabilone are the only CBMPs licensed for use in adults in the United Kingdom (UK). The medicines are listed under Schedule 4 and Schedule 2 of the Misuse of Drugs Regulations 2001 respectively. 

The guidelines cover ‘prescribing of cannabis-based medicinal products for people with intractable nausea and vomiting, chronic pain, spasticity and severe treatment-resistant epilepsy’, and are proposed for publication in November 2019.

The recommendations are broadly that:

• Nabilone should be considered as an add-on treatment for adults with chemotherapy-induced nausea;
• Pure Cannabidiol (CBD) or CBD with Tetrahydrocannabinol (THC) should not be offered as a treatment for chronic pain, unless as part of a clinical trial;
• Sativex should not be offered to treat spasticity in patients who also suffer with multiple sclerosis (MS), and further that other CBMPs should not be offered to treat spasticity, except as part of a clinical trial; and
• In respect of treatment-resistant epilepsy, no recommendation has been made due to the lack of ‘good quality evidence in this population’.

Prescribing of CBMPs

The guidelines confirm that initial prescribing of CBMPs should be by a specialist doctor, who has a special interest in the condition being treated.

After the initial prescription, repeat prescription of CBMPs can be ‘issued by another prescriber as part of a shared care agreement under the direction of the initiating specialist prescriber’.

The shared care agreement should include:

• The responsibilities of all parties, including the patient and/or their family;
• The nature and frequency of monitoring and how this will be recorded;
• The circumstances in which treatment might be stopped;
• How communication between the parties will be managed and recorded;
• How the treatment will be funded; and
• How the patient’s care will be maintained if either the patient or initial prescriber moves location.

The guidelines have made recommendations for research in relation to:

• Fibromyalgia or persistent treatment-resistant neuropathic pain in adults;
• Chronic pain in children and young people;
• CBD for severe treatment-resistant epilepsy;
• THC in combination with CBD for severe treatment-resistant epilepsy; and
• Spasticity.

As stated in our previous commentary, the floodgates for prescription of CBMPs is not going to open at any time soon in the UK. The consultation is open until the 5^th of September 2019. Until then; watch this space!

Further Information

For further information in relation to any matters raised in this blog, please contact a member of our regulatory or criminal team.

About the authors

Shannett Thompson is a Senior Associate in the Regulatory team. She has substantial experience in advising individuals in relation to their regulatory obligations in the wider context. She is adept at advising and assisting individuals in respect of registration/licensing applications. She regularly works with the criminal team with regard to regulatory matters emanating from criminal convictions and cautions.

Nicola Finnerty is a Partner in the Criminal Litigation team and is a leading criminal defence expert in both business and general crime. She advises on a wealth of matters related to both these areas as well as representing individuals and families in public inquiries and inquests.