Guidance

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.

Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off-label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

1.1 Intractable nausea and vomiting

1.1.1Consider nabilone as an add-on treatment for adults (18 years and over) with chemotherapy-induced nausea and vomiting which persists with optimised conventional antiemetics.

1.1.2When 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.

To find out why the committee made the recommendations on intractable nausea and vomiting and how they might affect practice, see .

1.2 Chronic pain

1.2.1Do not offer the following to manage chronic pain in adults:

  • nabilone
  • dronabinol
  • THC (delta-9-tetrahydrocannabinol)
  • a combination of cannabidiol (CBD) with THC.

1.2.2Do not offer CBD to manage chronic pain in adults unless as part of a clinical trial.

1.2.3Adults who started cannabis-based medicinal products to manage chronic pain in the NHS before this guidance was published[1] should be able to continue treatment until they and their NHS clinician think it appropriate to stop.

To find out why the committee made the recommendations on chronic pain and how they might affect practice, see .

1.3 Spasticity

1.3.1Offer a 4-week trial of THC:CBD spray 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 spray according to its pay-for-responders scheme[2].

    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.

1.3.2Treatment 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.

To find out why the committee made the recommendations on spasticity and how they might affect practice, see .

1.4 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.

To find out why the committee made the research recommendations on CBD, and THC in combination with CBD for severe treatment-resistant epilepsy, see .

1.5 Prescribing

Who should prescribe?

1.5.1Initial prescription of cannabis-based medicinal products[3] must be made by a specialist medical practitioner (a doctor included in the register of specialist medical practitioners [the Specialist Register][4]). They should also have a special interest in the condition being treated[5]. For children and young people under the care of paediatric services, the initiating prescriber should also be a tertiary paediatric specialist.

Shared care

1.5.2After the initial prescription, subsequent prescriptions of cannabis-based medicinal products may be issued by another prescriber as part of a shared care[6] 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.

1.5.3Efficacy 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.

1.5.4A 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 transition to adult services).
To find out why the committee made the recommendations on who should prescribe and how they might affect practice, see .

Factors to think about when prescribing

1.5.5When 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[7].

1.5.6When prescribing cannabis-based medicinal products for babies, children and young people, pay particular attention to the:

  • potential impact on psychological, emotional and cognitive development
  • potential impact of sedation
  • potential impact on structural and functional brain development.

1.5.7When prescribing cannabis-based medicinal products, advise people to stop any non-prescribed cannabis, including over-the-counter, online and illicit products.

1.5.8Prescribers should record details of treatment, clinical outcomes and adverse effects for people prescribed cannabis-based medicinal products, using local or national registers if available.

1.5.9For more information on safe prescribing and use of cannabis-based medicinal products, see the recommendations in the NICE guideline on controlled drugs.

To find out why the committee made the recommendations on factors to think about when prescribing and how they might affect practice, see 

Supporting shared decision making

1.5.10Before prescribing cannabis-based medicinal products, discuss with people:

1.5.11When 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.

To find out why the committee made the recommendations on supporting shared decision making and how they might affect practice, see .

Terms used in this guideline

Cannabis-based medicinal products

In this guideline cannabis-based medicinal products include:

  • cannabis-based products for medicinal use as set out by the UK Government in the 2018 Regulations
  • the licensed products delta-9-tetrahydrocannibinol combined with cannabidiol (Sativex) and nabilone
  • plant-derived cannabinoids such as pure cannabidiol (CBD)
  • synthetic compounds which are identical in structure to naturally occurring cannabinoids such as delta-9-tetrahydrocannabinol (THC), for example, dronabinol.

Optimised conventional antiemetics

These are treatments that are commonly used in practice at an optimum tolerated dose to manage nausea and vomiting.


[1] November 2019.

[2] According to the terms of the pay-for-responders scheme, the company will fund the first 3 x10-ml vials of THC:CBD spray if there is an agreement for continued funding for people who experience at least a 20% reduction in spasticity-related symptoms on a 0 to10 patient-reported numeric rating scale after 4 weeks of treatment.

[3] This excludes nabilone, THC:CBD spray (Sativex) and cannabis-based medicines that are not classed as controlled drugs such as cannabidiol. See the relevant summaries of product characteristics for further information on prescribing. See recommendation 1.3.2 for information on prescribing of THC:CBD spray.

[4] See section 34D of the Medical Act 1983.

[7] Breastfeeding is a contraindication for Sativex and nabilone. There is limited evidence on the safety of cannabis-based medicinal products during pregnancy and breastfeeding.

 

 

Also Read more at Speciality Medical Dialogues: Use of Cannabis-based medicinal products: NICE guidelines

 https://speciality.medicaldialogues.in/use-of-cannabis-based-medicinal-products-nice-guidelines/