Use of Cannabis-based medicinal products: NICE guidelines
NICE has released guidelines for use of Cannabis-based medicinal products. The guideline covers prescribing of cannabis-based medicinal products for people with intractable nausea and vomiting, chronic pain, spasticity and severe treatment-resistant epilepsy.
1. Intractable nausea and vomiting
- Consider nabilone as an add-on treatment for adults (18 years and over) with chemotherapy-induced nausea and vomiting which persists with optimised conventional antiemetics.
- When considering nabilone for adults with chemotherapy-induced nausea and vomiting, take into account potential adverse drug interactions, for example, with central nervous system depressants and other centrally active drugs.
2. Chronic pain
- Do not offer the following to manage chronic pain in adults:
- THC (delta-9-tetrahydrocannabinol)
- a combination of cannabidiol (CBD) with THC.
- Do not offer CBD to manage chronic pain in adults unless as part of a clinical trial.
- Adults who started cannabis-based medicinal products to manage chronic pain in the NHS before this guidance was published should be able to continue treatment until they and their NHS clinician think it appropriate to stop.
- Offer a 4-week trial of THC: CBD sprays to treat moderate to severe spasticity in adults with multiple sclerosis, if:
- other pharmacological treatments for spasticity are not effective (see the recommendations on spasticity in NICE's guideline on multiple sclerosis in adults)
- the company provides THC: CBD sprays according to its pay-for-responders scheme. After the 4-week trial, continue THC: CBD spray if the person has had at least a 20% reduction in spasticity-related symptoms on a 0 to 10 patient-reported numeric rating scale.
- Treatment with THC: CBD spray should be initiated and supervised by a physician with specialist expertise in treating spasticity due to multiple sclerosis, in line with its marketing authorisation.
4. Severe treatment-resistant epilepsy
NICE has made research recommendations on the use of cannabis-based medicinal products for severe treatment-resistant epilepsy.
NICE is developing technology appraisal guidance on cannabidiol with clobazam for treating seizures associated with Lennox-Gastaut syndrome and Dravet syndrome.
Who should prescribe?
- Initial prescription of cannabis-based medicinal products must be made by a specialist medical practitioner (a doctor included in the register of specialist medical practitioners [the Specialist Register]). They should also have a special interest in the condition being treated. For children and young people under the care of paediatric services, the initiating prescriber should also be a tertiary paediatric specialist.
- After the initial prescription, subsequent prescriptions of cannabis-based medicinal products may be issued by another prescriber as part of a shared care agreement under the direction of the initiating specialist prescriber, if:
- shared care is appropriate and in the person's best interest
- the person's clinical condition is stable
- the other prescriber is confident to make a fully informed prescribing decision about cannabis-based medicinal products.
- Efficacy and safety of cannabis-based medicinal products should be monitored and evaluated, and doses should be adjusted by the initiating specialist prescriber as part of the shared care agreement.
- A shared care agreement for a person prescribed a cannabis-based medicinal product should include:
- the responsibilities of all parties [the initiating specialist prescriber, the other prescriber(s), the patient, family and/or carers]
- the nature and frequency of monitoring and how this will be recorded
- when treatment might be stopped, for example, if it is not effective
- how suspected or known adverse reactions will be managed
- how communication will be managed between the initiating specialist prescriber, the other prescriber, the patient, family and/or carers
- how the treatment will be funded
- how care will be maintained when the patient, initiating specialist prescriber or other prescriber moves location (including a transition to adult services).
Factors to think about when prescribing
- When prescribing and monitoring cannabis-based medicinal products, take into account:
- current and past use of cannabis (including any over-the-counter and online products)
- history of substance misuse including the illicit use of cannabis
- potential for dependence, diversion and misuse (in particular with THC)
- mental health and medical history, in particular, liver impairment, renal impairment, cardiovascular disease
- potential for interaction with other medicines, for example, central nervous system depressants and other centrally active drugs, antiepileptics and hormonal contraceptives
- pregnancy and breastfeeding.
- When prescribing cannabis-based medicinal products for babies, children and young people, pay particular attention to the:
- the potential impact on psychological, emotional and cognitive development
- the potential impact of sedation
- the potential impact on structural and functional brain development.
- When prescribing cannabis-based medicinal products, advise people to stop any non-prescribed cannabis, including over-the-counter, online and illicit products.
- Prescribers should record details of treatment, clinical outcomes and adverse effects for people prescribed cannabis-based medicinal products, using local or national registers if available.
- For more information on safe prescribing and use of cannabis-based medicinal products, see the recommendations in the NICE guideline on controlled drugs.
Supporting shared decision making
- Before prescribing cannabis-based medicinal products, discuss with people:
- the potential benefits and harms, including any risk of dependence or interaction with other medicines
- the licensing status of the medicines
- how long they might take the medicine
- how long it will take to work
- what it has been prescribed for and how to take it
- how it may affect their ability to drive (see the advice from the Department of Transport on drug driving and medicine)
- the need to seek advice before travelling abroad about the legality of cannabis-based medicinal products in other countries (see the UK Government's advice on travelling with medicine containing a controlled drug).
- the importance of not allowing others to use the prescribed medicine.
- When discussing cannabis-based medicinal products with patients and their families and carers, follow the recommendations on shared decision making in the NICE guideline on patient experience in adult NHS services.
For more details click on the link: nice.org.uk