CBPMs are products derived from cannabis that are intended for medicinal purposes. This summary provides essential information for healthcare professionals to assist in prescribing these products. It also outlines the legal framework surrounding CBPMs.

Publication and Content: This document offers guidance and advice for healthcare providers making decisions about the use of CBPMs. It covers the indications for use, product information, prescribing recommendations, and more.

Guidance and Advice: The National Institute for Health and Care Excellence (NICE) has published Technology Appraisals for the use of cannabidiol (Epidyolex®) for specific treatment-resistant epilepsies. NICE has also issued guidelines on cannabis-based products for medicinal use. These include recommendations for individuals dealing with chronic pain, intractable nausea and vomiting, spasticity, and severe treatment-resistant epilepsy.

Specialized Guidance: The British Paediatric Neurology Association (BPNA) has specific guidance on the use of cannabis-based products for pediatric patients with certain severe forms of epilepsy. It recommends Epidiolex® (CBD) as the preferred choice for prescription within its licensed indications. The use of non-licensed cannabis-derived medical products, including artisanal cannabis oils, is not recommended.

Efficacy and Safety: The most robust evidence for the efficacy and safety of CBPMs in childhood epilepsy relates to pure cannabidiol (Epidyolex®). Products containing THC, another compound in cannabis, do not have sufficient evidence for safety or efficacy. There are concerns about the potential adverse effects of THC on the developing brain, particularly with chronic high exposure.

Cannabis Compounds: Cannabis contains numerous chemical constituents, but two of the most researched are tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is the psychoactive component, responsible for the “high” associated with cannabis, while CBD is non-psychoactive.

Regulations and Quality: Pure CBD is not considered a controlled drug under the Misuse of Drugs Act. Products categorized under Schedule 2 may contain varying quantities of THC and CBD, and their quality has not been assessed by regulators. These unlicensed products are available in various forms and are not subject to regulatory review.

E-Learning Package: NHS England offers an e-learning package in collaboration with Health Education England and the University of Birmingham. This resource provides healthcare professionals with information about cannabis and cannabis-based products for medicinal use, including pharmacology, legislation, and therapeutic areas.

Indications for Use: CBPMs can be prescribed for a range of medical conditions. There are licensed products available for intractable nausea and vomiting, MS-related spasticity, and severe treatment-resistant epilepsy. However, most CBPMs are unlicensed, and it is essential to consider the patient’s condition, clinical evidence, and other licensed treatment options when prescribing.

Use in Multiple Sclerosis: The NICE guideline recommends a trial of THC:CBD spray (Sativex®) for treating moderate to severe spasticity in adults with multiple sclerosis if other treatments are ineffective. Sativex® is a licensed product and preferred over unlicensed cannabis-based products.

Use in Chronic Pain: The current evidence for using CBPMs in chronic pain is limited. While some patients may perceive benefits, this has not been fully confirmed in large-scale clinical trials. The safety and long-term efficacy of these products remain uncertain.

Synthetic Cannabinoids: There are three categories of synthetic cannabinoids, some of which are associated with severe harm and are found in illicit street products known as “Spice” and “Black Mamba.” Regulatory bodies are concerned about these compounds, and further research is ongoing.

Cannabidiol (CBD): Cannabidiol oral solution (Epidyolex®) is a licensed medicinal cannabis product proven effective for certain epilepsy syndromes. Pure CBD-based products, including synthetic versions, are not classified as cannabis-based products for medicinal use and are not controlled drugs due to their low THC content.

Quality of Products: Unlicensed medicines are not subject to the same regulatory assessments as licensed medicines, so their quality is not guaranteed. The law change aims to encourage clinical trials and further research.

Clinical Trials: Rescheduling CBPMs makes it easier to conduct clinical trials to gather more evidence regarding their efficacy and safety. The evidence base for these products is still evolving.

Second Opinions: Patients have the option to seek a second opinion, which should be supported by healthcare providers. Protocols are in place for referrals to specialists.

Funding: Unlicensed CBPMs are not routinely commissioned in the NHS. Decisions to prescribe these products are made on a case-by-case basis, considering individual patient clinical needs and safety.

Prescribing Information: CBPMs can only be prescribed by a clinician on the General Medical Council’s Specialist Register. A specialist should consider the relevant GMC guidance and local NHS Trust governance procedures.

Shared Care: Shared care arrangements are under consideration, but any shared care of these products should be based on clinical data and evidence.

Medicinal Cannabis Patient Registry: A patient registry has been launched to collect data on the prescribing of CBPMs, enabling monitoring of patient outcomes and experiences.

Private Prescribing: Private doctors on the GMC specialist register can legally prescribe CBPMs. In the private sector, clinicians are expected to follow similar processes for prescribing unlicensed medicines as in the NHS.

UK Regulations: Prescriptions from outside the UK are not permissible, as the law restricts prescribing of CBPMs to clinicians on the General Medical Council’s Specialist Register.

Monitoring: Local controlled drugs accountable officers will monitor prescribing, ensuring it follows established protocols.

Prescribing by Non-Specialists: Non-specialists may continue prescribing CBPMs under the direction of a specialist, especially if the patient is established on a particular treatment.

This comprehensive guide provides healthcare professionals and patients with essential information about CBPMs, their regulations, and clinical considerations. It’s important to make prescribing decisions based on individual patient needs and the available evidence.

CBPMs are products derived from cannabis that are intended for medicinal purposes. They are used to treat a variety of medical conditions, including chronic pain, intractable nausea and vomiting, spasticity, and severe treatment-resistant epilepsy ¹. The National Institute for Health and Care Excellence (NICE) has published Technology Appraisals for the use of cannabidiol (Epidyolex®) for specific treatment-resistant epilepsies. NICE has also issued guidelines on cannabis-based products for medicinal use ¹. The British Paediatric Neurology Association (BPNA) has specific guidance on the use of cannabis-based products for pediatric patients with certain severe forms of epilepsy. It recommends Epidiolex® (CBD) as the preferred choice for prescription within its licensed indications. The use of non-licensed cannabis-derived medical products, including artisanal cannabis oils, is not recommended ¹.

It is worth noting that the most robust evidence for the efficacy and safety of CBPMs in childhood epilepsy relates to pure cannabidiol (Epidyolex®). Products containing THC, another compound in cannabis, do not have sufficient evidence for safety or efficacy. There are concerns about the potential adverse effects of THC on the developing brain, particularly with chronic high exposure ¹.

Cannabis contains numerous chemical constituents, but two of the most researched are tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is the psychoactive component, responsible for the “high” associated with cannabis, while CBD is non-psychoactive ¹.

¹: Source: NHS England.

Learn more:

1. england.nhs.uk2. gov.uk3. gov.uk4. assets.publishing.service.gov.uk