Cannabis Based Products for Medicinal Use - Leeds Teaching Hospitals NHS Trust Guideline

Publication: 25/05/2022  
Next review: 25/05/2025  
Clinical Guideline
CURRENT 
ID: 7523 
Approved By: Trust Clinical Guidelines Group 
Copyright© Leeds Teaching Hospitals NHS Trust 2022  

 

This Clinical Guideline is intended for use by healthcare professionals within Leeds unless otherwise stated.
For healthcare professionals in other trusts, please ensure that you consult relevant local and national guidance.

Cannabis Based Products for Medicinal Use Leeds Teaching Hospitals NHS Trust Guideline

Summary of Guideline

The guideline comprises of the legal aspects relating to cannabis-based products, the prescribing restrictions of medicinal products at LTHT and a table to support staff in determining whether products can be used at LTHT.

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Background

Definitions [i],2

  • Cannabis: a broad term used to describe organic products (e.g., cannabinoids, marijuana, hemp) derived from the Cannabis genus of plants.
  • Cannabinoids - a class of diverse chemical compounds that can be naturally derived from the cannabis plant or that can be manufactured. They act on cannabinoid receptors (CB1) in cells to alter neurotransmitter release in the brain, spinal cord and peripheral nerves.
  • Tetrahydrocannabinol (THC) - one of the two most well-known and investigated cannabinoids. It is the main psychoactive constituent of cannabis and thought to be responsible for the “highs” associated with cannabis use.  
  • Cannabidiol (CBD) - the second of the two most well-known and investigated cannabinoids. It is known for its therapeutic effects and is not psychoactive. It is not a controlled drug in its purest form; however, it is near impossible to extract CBD without any other cannabinoids. There are a range of products marketed as herbal and food supplements. Provided no medicinal claims are made, these fall outside medicine law.

The different forms of cannabis based products can be confusing, always seek advice if unclear.

Cannabis Based Products for Medicinal Use

Cannabis based products for medicinal use (CBPMs) that are of a suitable quality are classified as Schedule 2 of the Misuse of Drugs Regulations 2001 (MDR) [ii]. 

CBPMs are defined as[iii]:

  1. Containing cannabis, cannabis resin, cannabinol or a cannabinol derivative;
  2. Produced for medicinal use in humans and is
  3.  i. a medicinal product; or ii. a substance or preparation for use as an ingredient of a medicinal product; or iii. a substance for use in the preparation or manufacture of an ingredient of a medicinal product.

Licensed CBPMs

There are currently CBPMs in the UK that have been granted marketing authorisation by the Medicines and Healthcare Products Regulatory Agency (MHRA); known as “licensed medicines”[iv]. At the time of writing these are Epidyolex®, Sativex® and Nabilone.

Unlicensed CBPMs

There are a number of products which meet the Home Office definition3 of a CBPM as described above and whose manufacturers hold a Home Office Controlled Drug License to produce, supply, import and export their product but do not hold a marketing authorisation from the MHRA so are ‘unlicensed’. These products are classified under Schedule 2 of the MDR4. The MHRA has issued guidance for those involved in the prescribing and supply of these unlicensed CBPMs.[v] Examples of unlicensed CBPMs include Bedrocan®, Bedrolite® and Celixir®. [vi],[vii]

Food Supplements

Food supplements are not classed as medicinal products, and their manufacturers cannot make any medicinal claims. Food businesses must apply for regulated product authorisation via the Food Standards Authority[viii] in order for their CBD extract or isolate to be placed on the UK market.

Illicit Products

For a cannabis based product to be lawfully available for human use, it must either meet the definition of a CBPM or be produced as a food supplement as described above3. Where a product is neither a CBPM nor a food supplement it would be classed as a Schedule 1 CD of the MDR, so possession would be unlawful. This includes, but isn’t limited to products obtained ‘on the street’, home grown or otherwise produced.

Products may be legal in another country but illegal in the UK. Where a CBD containing product is exported from a country and imported by individuals it must conform to the legal requirements set out above. Possession of a product that does not would be unlawful. LTHT cannot support the use of any such product.

Any product that contains more than 1mg of THC regardless of the volume is illegal unless it is an unlicensed CBMP as defined above.

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Prescribing at LTHT

Licensed CBPMs

At LTHT[i] the licensed CBPMs are supported for prescribing as described in the Leeds Medicines Formulary.

Unlicensed CBPMs

There are no unlicensed CBPMs currently supported for initiation at LTHT.

Some patients may present with their own unlicensed CBPM prescribed by another Trust or a private clinician on the General Medical Council’s (GMC) Specialist Register. In such cases, LTHT can support the ongoing use of these medications during an inpatient stay. The Trust CD Accountable Officer must be made aware of all prescribing and administration of these products. Staff should follow the CD Standard Operating Procedure (SOP) for managing Patient’s Own CDs CD SOP 1.4. On-going supplies of these medications are the responsibility of the patient and/or their carer and the prescribing physician, not LTHT.

Food Supplements

There are no routine food supplements supported for prescribing at LTHT. However, due to the fact there is significant discussion and publicity in the media regarding the claimed health benefits of CBD, it is recognised that some patients may choose to self-medicate with these CBD food supplements which are currently widely available from health food shops and online.

Provided the product is from a reputable UK source and is labelled as a food supplement, and does not purport to contain THC, then it may be treated as any other such product. The patient may retain possession and be responsible for their own administration. There are no CD related requirements for food supplements. It is good practice to record the use of the product but it not recorded as a ‘prescribed’ product. If there is any doubt about whether a product can be supported for use by LTHT then advice should be sought from the pharmacy team.

Be aware that certain products purchased over the internet may appear legal and in the country of origin may be so but are not in the UK. These products should be handled as a suspected illicit substance. Where there is any doubt over the content of a CBD preparation it should be treated as a suspected illicit substance.

Illicit Substances

Using cannabis based products that do not meet the official definition of a CBPM or is a food supplement as described above , is illegal and potentially dangerous. Staff should follow the CD SOP 1.5 Suspected Illicit Substances.

Under no circumstances can a suspected illicit substance be returned to a patient once they have been handed to a member of LTHT staff.

Staffs should always ‘Think Family’ and discuss any safeguarding concerns with the relevant LTHT Safeguarding Team. See the LTHT Safeguarding Policies below for more details:

Safeguarding Children Policy.

Safeguarding Adults at Risk Policy

Guidance on use of products for Ward Staff

See Appendix 1 for guidance on the management of products related to cannabis in LTHT products

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Provenance

Record: 7523
Objective:

This guideline explains the Trust’s position in relation to the prescribing and use of cannabis based products for patients under the care of Leeds Teaching Hospitals NHS Trust (LTHT). It is designed to aid staff in their discussions with patients and their families and ensures appropriate handling of all cannabis-based products.

Clinical condition:
Target patient group: Patients using cannabis based products for therapeutic benefit legally or otherwise
Target professional group(s): Pharmacists
Secondary Care Doctors
Secondary Care Nurses
Adapted from:

Evidence base

[1] NHS England » Cannabis-based products for medicinal use: Frequently asked questions
[2] Cannabis Scheduling Review Part 1 (publishing.service.gov.uk)
[3] Drug licensing factsheet: cannabis, CBD and other cannabinoids - GOV.UK (www.gov.uk)
[4] Cannabis-based products for medicinal use (CBPMs) in humans (publishing.service.gov.uk)
[5] Cannabis_Guidance__unlicensed_CBPMs__updated_2020.pdf (publishing.service.gov.uk)
[6] Cannabis products by Bedrocan - for patients and medicine development
[7] Medicated Drops | BOL Pharma
[8] Apply for a regulated product authorisation | Food Standards Agency
[9] CBMPs.pdf (leedsformulary.nhs.uk)

Approved By

Trust Clinical Guidelines Group

Document history

LHP version 1.0

Related information

Appendix 1 - Medicines Management & Pharmacy Services (MMPS) Guidance on the management of products related to cannabis in LTHT

        Product

Licensed Cannabis Based Products for Medicinal Use (CBPMs)

Unlicensed CBPM

Cannabidiol (CBD) products

All other cannabis and cannabis-derived products

Examples

Nabilone / Sativex® / Epidyolex®

None routinely available in the UK

CBD oil available from reputable suppliers

An obvious illicit substance, home grown products or products known/suspected to contain more than 1mg of tetrahydrocannabinol (THC).

How to identify

Licensed medicinal products

Product meeting the definition of a CBPM from the MHRA that is not licensed. In practice, referral to pharmacy procurement or Medicines Advice may be necessary

A product from a reputable source supplied as a herbal or nutritional supplement, with CBD listed as the only cannabis-derived ingredient

Any cannabis or cannabis-derived product of unknown or unidentifiable origin. Any product listing THC or cannabinol as an ingredient. An imported product may be included in this group.

Legal to possess

Yes, subject to normal legal requirements

Yes, subject to normal legal requirements of Schedule 2 CDs

Yes (these products are not licensed medicines)

No

Available for routine prescribing within LTHT

See the relevant Leeds Medicines Formulary entry

No

No

No

Applications to the Drug and Therapeutics Group for individual patients could be considered

Yes

Yes. Guidance is that prescribing should be initiated by a doctor on the GMC Specialist Register (i.e. a consultant in an appropriate speciality). Guidance from NHS England and other national bodies would need to be considered

Yes

No - a Home Office license would be required, and other products would need to be considered as alternatives.

Management of patients presenting with their own product

As per usual handling of other medicines taking care to determine whether it is a CD.

The Trust CD Accountable Officer must be made aware. Would need to be prescribed under the direction of a suitable person as above. LTHT staff could manage the product on behalf of a patient.

Can continue to take. Patient or carer remains responsible for the product and administration. Nursing staff would not be expected to manage the product. Treat as any other alternative and complementary products.

These are not recognised as medicines and are illegal products; they should be managed in line with Trust SOP CD 1.5 Suspected Illicit substances.

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Equity and Diversity

The Leeds Teaching Hospitals NHS Trust is committed to ensuring that the way that we provide services and the way we recruit and treat staff reflects individual needs, promotes equality and does not discriminate unfairly against any particular individual or group.