The National Institute for Health and Care Excellence (NICE) has published updated guidance on prescribing cannabis-based medicinal products for people with intractable nausea and vomiting, chronic pain, spasticity and severe treatment-resistant epilepsy.
Intractable nausea and vomiting
- Consider nabilone as an add-on treatment for adults (≥18 years) with chemotherapy-induced nausea and vomiting which persists despite optimised conventional antiemetics.
- When considering nabilone, take into account potential adverse drug interactions.
Chronic pain
- Do not offer the following for chronic pain in adults:
- Nabilone.
- Dronabinol.
- Delta-9-tetrahydrocannabinol (THC).
- Cannabidiol (CBD) with THC.
- Do not offer CBD unless as part of a clinical trial.
- Adults who started treatment for chronic pain before this guidance was first published (November 2019) should be able to continue until it is appropriate to stop.
Spasticity
- Offer a four-week trial of THC:CBD spray for moderate-severe spasticity in multiple sclerosis (MS), if other pharmacological treatments are ineffective.
- After the 4-week trial, continue THC:CBD spray after the trial if there is ≥20 per cent reduction in spasticity-related symptoms on a 0-10 patient-reported numeric rating scale.
Severe treatment-resistant epilepsy
- See NICE recommendations on the use of cannabis-based products for severe treatment-resistant epilepsy.
- See NICE guidance on cannabidiol with clobazam for seizures associated with Lennox-Gastaut syndrome and Dravet syndrome.
Prescribing
- Initial prescription of cannabis-based products must be made by a specialist medical practitioner, except for nabilone, THC:CBD spray (Sativex) and medicines not classed as controlled drugs, such as cannabidiol.
- Subsequent prescriptions may be issued by another prescriber as part of a shared care agreement.
- Efficacy and safety should be monitored and evaluated, and doses adjusted, if necessary, by the initiating prescriber.
- A shared care agreement should include agreement on:
- responsibilities of all parties;
- nature and frequency of monitoring;
- when treatment might be stopped;
- how adverse events will be managed;
- how communication will be managed between the initiating specialist prescriber, the other prescriber, the patient, family and/or carers;
- how treatment will be funded; and
- how care will be maintained when the patient, specialist prescriber or other prescriber moves location, including transition to adult services.
Factors to think about
- When prescribing and monitoring, take into account:
- current and past use of cannabis (including over-the-counter and online products);
- history of substance misuse;
- potential for dependence, diversion and misuse (in particular with THC);
- mental health and medical history, in particular, liver impairment, renal impairment and cardiovascular disease; and
- potential interaction with other medicines, e.g., central nervous system depressant, antiepileptics and hormonal contraceptives
- Breastfeeding is contraindicated for Sativex and nabilone.
- When prescribing for babies, children and young people, pay particular attention to the:
- potential impact on psychological, emotional and cognitive development;
- potential impact of sedation; and
- potential impact on structural and functional brain development.
- Record details of treatment, outcomes and adverse effects using local or national registers if available.
- For more information on safe prescribing and the use of cannabis-based medicinal products, see the NICE guideline on controlled drugs.
Supporting shared decision-making
- Discuss:
- the potential benefits and harms, including any risk of dependence or interaction with other medicines;
- the licensing status of the medicines;
- duration of treatment;
- time to effect;
- what it has been prescribed for and how to take it;
- how it may affect their ability to drive;
- the need to seek advice before travelling abroad; and
- the importance of not allowing others to use the medicine.
Research recommendations
- The following were highlighted as areas that require further research:
- Fibromyalgia or persistent treatment-resistant neuropathic pain in adults.
- Chronic pain in children and young people.
- CBD for severe treatment-resistant epilepsy.
- THC in combination with CBD for severe treatment-resistant epilepsy.
- Spasticity.
- Chemotherapy-induced intractable nausea and vomiting in adults.
- Chemotherapy-induced intractable nausea and vomiting in babies, children and young people.
- Intractable nausea and vomiting not caused by chemotherapy in adults.
- Intractable nausea and vomiting not caused by chemotherapy in babies, children and young people.
NICE has also issued a clarification on recommendations for the use of unlicensed cannabis-based products for severe treatment-resistant epilepsy. The clarification should be read alongside this guideline.
This article originally appeared on Univadis, part of the Medscape Professional Network.
