This briefing is for England only.
NHS England and NHS Improvement undertook a review of barriers to accessing cannabis based products for medicinal use on NHS prescription in August 2019. The published report contains a number of recommendations for clinicians, researchers and policy makers.
Which types of cannabis-based medicines are available in the UK?
There are broadly speaking three types of cannabis-based medicines available in the UK: licensed; unlicensed ('specials') and non-pharmaceutical grade.
1. Licensed cannabis-based medicinal products
1a. Cannabidiol (CBD) only containing product
Epidyolex® (cannabidiol) oral solution has been developed to a pharmaceutical grade and has undergone clinical trials.
In September 2019 Epidyolex® received EU marketing authorisation as adjunctive therapy for seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome (DS), in conjunction with clobazam, for patients 2 years of age and older. Epidyolex® may contain a trace of THC (tetrahydrocannabinol), meaning it is regulated as a Controlled Drug (Schedule 2).
In November 2019 the National Institute for Health and Care Excellence (NICE) issued a guideline (NG144) on the use of cannabis-based medicinal products in various conditions, though this specifically excluded consideration of the use of cannabidiol as adjuvant treatment for LGS and DS.
In December 2019 NICE published technology appraisal guidance on the use of cannabidiol with clobazam for the treatment of Lennox Gaustat Syndrome (TA615) and Dravet Syndrome (TA614). It is now possible to prescribe this medication in combination with clobazam in these two epilepsy syndromes. Prescriptions can now be obtained from designated regional paediatric centres. All the patients who were receiving epidyolex on the previous expanded access scheme will be able to continue receiving this medicine.
1b. Cannabidiol (CBD) plus Tetrahydrocannabinol (THC) containing products
Sativex oromucosal spray is licensed for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.
Sativex is not recommended for use in children or adolescents below 18 years of age, although clinical studies in children have been undertaken. Any child who continues to receive this medication should be under the care of a paediatric neurologist.
1c. Licensed synthetic cannabinoids
Nabilone is a synthetic cannabinoid used in adults for the management of nausea and vomiting caused by cytotoxic chemotherapy, unresponsive to conventional anti-emetics. It is used infrequently.
2. Unlicensed cannabis-based medicinal products (‘Specials’- specially manufactured or imported to the order of a specialist doctor for the treatment of individual patients)
An unlicensed medicine should not be used where a medicine is available and licensed within the UK and meets the patient's need. Where a licensed medicine is not available there see the MHRA guidance on choosing an appropriate product.
There is no good quality research in the form of randomised controlled trials supporting use of these products. National associations such as the British Paediatric Neurologist Association produce guidance to support clinicians in decision making. THC is the principal psychoactive constituent of cannabis. Unlicensed cannabis-based medicinal products may contain varying proportions of CBD and THC. THC may carry additional potential risks beyond cannabidiol.
The main theoretical risks of THC-containing cannabis products are:
- Psychosis – there is evidence that regular cannabis use increases your risk of developing a psychotic illness such as schizophrenia although this evidence relates to recreational users rather than those exposed to cannabis based medicinal products1 .
- Dependency on the medicine – although scientists believe this risk is probably small when its use is controlled and monitored by a specialist doctor1 . Generally, the more THC the product contains, the greater these risks are.
There is also evidence to suggest that THC-containing cannabis products can have:
- Effects on cognition – there is evidence from animal and human data that THC containing products affect cognition and memory2 .
- Pro-convulsant effects – whilst some animal studies have shown THC to have an anticonvulsant effect, some have also shown it to be pro-convulsant3 .
3. Non-pharmaceutical grade cannabis including food supplements
These are readily available to buy in health stores and online. These products are not classed as medicines and are not licensed. They have varying levels of ingredients, may contain impurities as they are not pharmaceutical grade, and as they tend to have variable amounts of CBD, it is unclear how effective they are and what the side effects may be.
Some products have been demonstrated to contain none of the specified active ingredient and may contain THC4 . Not all products are clearly identified as food supplements and this may lead to confusion for patients and families. In addition, drug-supplement interactions may potentially occur and cannot be predicted.
Which medicine do UK doctors prescribe?
Epidyolex® is the only licensed product that can be prescribed. Rarely, other unlicensed high quality products may be prescribed and sourced in line with Home Office Guidance.
Why is cannabis-based medicine readily prescribed in some other countries?
In some countries, cannabis based medicines are more readily available. However, there is not enough research for these products to be deemed safe or effective and therefore they are only prescribed in the UK under very specific conditions.
The National Institute for Health Research (NIHR), on behalf of the Department for Health and Social Care (DHSC), made a call for evidence on the effectiveness of other cannabis based medicines.
Paediatricians always act in the best interest of their patients. Clinicians, patients and their families must be confident that any prescribed medication is both safe and effective.
What is RCPCH calling for?
Despite an expectation that cannabinoid based drugs for treatment of epilepsy would become freely available following the Home Secretary’s announcement in November 2018 this has not been the case, as the rescheduling meant that these products would only be made available under certain circumstances; the RCPCH concurs with the findings of the NHSE/NHSI report5 , in particular the call for expedited good quality research on these products.
The RCPCH requests industry and academic research programmes on the use of these products in complex childhood epilepsies and other appropriate areas.
Other points to note
The RCPCH is unable to comment on individual cases as we do not have the information to hand that the treating clinician will have.
For cannabis-based medicinal products the MHRA requires reporting of all suspected adverse reactions (serious and non-serious, whether the product is licensed or unlicensed), including reports of failure of efficacy. Report using the electronic Yellow Card, the Yellow Card app or using a paper form stating the manufacturer and indicating that the product is unlicensed.
- 1 a b NHS. Medical Cannabis (and cannabis oils): https://www.nhs.uk/conditions/medical-cannabis/
- 2Borgan F, Beck K, Butler E, et al. The effects of cannabinoid 1 receptor compounds on memory: a meta-analysis and systematic review across species. Psychopharmacology 2019 doi: 10.1007/s00213-019-05283-3[published Online First: Epub Date]|
- 3Rosenberg EC, Patra PH, Whalley BJ. Therapeutic effects of cannabinoids in animal models of seizures, epilepsy, epileptogenesis, and epilepsy-related neuroprotection. Epilepsy & behavior : E&B 2017;70(Pt B):319-27 doi: 10.1016/j.yebeh.2016.11.006[published Online First: Epub Date]]
- 4CBD in the UK June 2019. Gibbs B, Yates A, Liebling J. Centre for Medicinal cannabis irp-cdn.multiscreensite.com/51b75a3b/files/uploaded/Report%20%7C%20CBD%20in%20the%20UK%20-%20Exec%20Summary.pdf
- 5Barriers to accessing cannabis-based products for medicinal use on NHS prescription. Findings and recommendations. NHSE and NHSI. Gateway Reference number: 000842 Published August 2019. www.england.nhs.uk/wp-content/uploads/2019/08/barriers-accessing-cannabis-based-products-nhs-prescription.pdf