In June 2018 the UK government announced a review of the use of cannabis and cannabis-based products for medicinal purposes (CBPM).

The first part of this review involved Professor Dame Sally Davies, the Chief Medical Officer (CMO) and Chief Medical Advisor to the UK government, assessing the evidence for the medicinal benefit of these products. She concluded that there was “conclusive evidence of therapeutic benefit for certain medical conditions, and reasonable evidence in several other medical conditions”. The CMO advised that the whole class of CBPM be moved from schedule 1 of the Misuse of Drugs Regulations 2001.

Following this evidential review the Advisory Council on the Misuse of Drugs (ACMD) then recommended that “cannabis-derived medicinal products of the appropriate standard” should be moved out of Schedule 1 into Schedule 2. Moving these medicines into Schedule 2 enables these products to be prescribed medicinally where there is an unmet clinical need, although this move requires further clarification of the definition of CBPM.

 Cannabis-based products for medicinal use

In order to satisfy the government definition of a CBPM the product is required to meet three key criteria:

• It needs to be a preparation or product which contains cannabis, cannabis resin, cannabinol or a cannabinol derivative;
• It is produced for medicinal use in humans and;
• Is a medicinal product, or a substance or preparation for use as an ingredient of, or in the production of an ingredient of, a medicinal product

Under the revised guidelines additional criteria must be met to enable these products to be prescribed:

• Prescriptions can only be written by clinicians listed on the Specialist register of the General Medical Council.  Other prescribers may continue prescribing once the decision to prescribe has been made by a specialist, for more information click here
• Prescriptions should only be written where the prescriber is acting within their area of practice and training i.e. within their area of clinical expertise.
• CBPM should only be prescribed where there is clear evidence of benefit and where the identified clinical need cannot be met by a licensed medicine
• Unlicensed products or “specials” can only be prescribed on a “named patient” basis

The GMC Specialist Register

Inclusion of a doctor on the GMC Specialist Register will be listed as part of their entry on the medical register, including details of their speciality and the date of joining the Specialist Register

Checks on doctors listed in the GMC Specialist Register can be made on the GMC ‘List of Registered Medical Practitioners’ Link here

The law has been drafted such that a specialist needs to be responsible for the decision to prescribe.  However, the law does allow other prescribers to continue prescribing once the decision to prescribe has been made by a specialist.

There are existing arrangements permitting doctors not on the specialist register but working under the direction of a specialist within a hospital setting (e.g. specialist registrars, supplementary prescribers, non-medical independent prescribers etc.) to continue prescribing, once patients have become established on a particular treatment with no problems.

In general, however it is expected that patients receiving these products to remain under the direct care of a specialist doctor (i.e. initiation and continued prescribing) in the first instance.  For full details click here.

Products exempted from the revised legislation

The revised legislation does not cover synthetic cannabinoids. Consequently there is no change in the licensing or use of nabilone, which is licensed for use in the treatment of treatment resistant nausea and vomiting induced by chemotherapy, or to the unlicensed use of dronabinol which is used outside of the UK as an appetite stimulant in HIV patients suffering from cachexia.

The revised legislation also does not affect Sativex which is licensed within the UK for the relief of spasticity in patients with Multiple Sclerosis.

Impact of the revised legislation on pharmacists

It is predicted that relatively few prescriptions for CBPM will be issued, however it is possible that patients will present such prescriptions to community pharmacy contractors.

Registered pharmacies are included in the list of persons authorised to procure unlicensed CBPMs within the UK. Guidance from MHRA¹ on the supply, manufacture, importation and distribution of unlicensed cannabis-based products for medicinal use in humans “specials” has several key requirements for community pharmacy teams, these are summarised below:

Notification-The MHRA guidance[1] states that all persons involved in the supply chain should be aware of the unlicensed status of the CBPM. It should be apparent from the product packaging that the product is unlicensed as there will be no marketing authorisation or product licence number included. The guidance advises that before a CBPM is ordered or administered the pharmacist should ensure that the prescriber is fully aware of the unlicensed status of the CBPM.

Record keeping-The MHRA guidance¹ advises that any person who sells or supplies an unlicensed CBPM in the UK must maintain records detailing the following information:

• Product name, brand/supplier, cannabis strain and content of THC/CBD (and the ratio of THC/CBD where relevant)
• Source from which the product was obtained and the date
• Person to whom the product was supplied, and the date of supply
• Quantity of the sale or supply
• Batch number of the product
• Details of any suspected adverse reaction

These records must be retained for at least 5 years following the supply. All records must be available for inspection by MHRA on request.

In addition contractors must comply with record keeping requirements of the Misuse of Drugs Regulations- all unlicensed CBPM will be Schedule 2 controlled drugs.

Adverse Drug Reactions- Prescribers or pharmacists supplying the unlicensed CBPM should report all adverse drug reactions through the electronic Yellow Card Scheme, the Yellow Card app or paper based form.

Storage requirements- The storage requirements for all CBPM will be the same as for other Schedule 2 controlled drugs i.e.:

• They will be subject to safe custody requirements and must be kept in a locked CD cabinet or approved safe that can only be opened by a pharmacist or person authorised by the pharmacist
• A register must be kept for Schedule 2 CDs that must comply with relevant regulations
• Destruction of out of date Schedule 2 CDs must be authorised by an appropriate witness, whilst it is good practice for the destruction of patient returned Schedule 2 CDs to be witnessed by a member of pharmacy staff. Appropriate records of destruction must be kept.
• All Schedule 2 CDs for destruction must be denatured.

Product labelling- CBPM may impair a patient’s ability to drive safely, and all patients supplied a CBPM should be advised of this risk. The product label should detail the following information:

• “WARNING” This medicine may make you feel sleepy. If this happens do not drive or use tools or machinery. Do not drink alcohol
• Do not drive while taking this medicine until you know how it affects you
• Do not drive if you feel sleepy, dizzy, unable to concentrate or make decisions, or if you have blurred or double vision.

Drug driving legislation- The current drug driving legislation prohibits driving with a blood level of THC above 2mcg/ml. However where the patient’s driving has not been impaired in spite of their blood THC level exceeding the prescribed limits they may be able to claim a statutory medical defence, further details of this medical defence are explained in the CPD article Drug-Drive Legislation

Supply chain checklist- MHRA have produced a supply chain checklist as Appendix 4 of their guidance.  Community pharmacy contractors may find this checklist useful when ordering and supplying CBPM.

Clinical use of CBPM

Treatment of intractable epilepsy- The British Paediatric Neurology Association has acknowledged that there is good evidence to support the use of CBD in the treatment of two severe epilepsy syndromes (Dravet syndrome and Lennox-Gastaut syndrome). However they also advise that when considering the use of CBPM for the treatment of epilepsy syndromes in children pure CBD (Epidiolex, a product licensed by the US Food and Drug Administration) should be the default choice where prescribers are considering a prescription for intractable epilepsy, even though at present it does not have an EMA licence.

Chemotherapy induced nausea and vomiting- there is good evidence supporting the use of cannabinoids in the treatment and prevention of nausea and vomiting[2] induced by chemotherapy (CINV). Cannabinoids, specifically nabilone, have trial data that demonstrates efficacy in the prevention of CINV. Cannabinoids should be considered as a second line option for CINV where standard treatment has failed.

Pain-there is limited research available to support the benefits of using CBPM for pain relief in a palliative care context. Studies have shown mixed results or results of uncertain clinical significance. Considering this evidence base and the adverse effects associated with CBPM the role of these medicines in relieving pain in palliative care is both unclear and not recommended in routine clinical practice.

There is also a lack of sound clinical evidence to support the use of CBPM in the treatment of neuropathic pain.

Other potential uses for CBPM

The US National Academies of Sciences, Engineering and Medicines (NASEM) review[3] on the available evidence for the use of cannabis and cannabinoids advised that there is moderate evidence that CBPM are effective for improving short term sleep outcomes in patients with sleep disturbance associated with obstructive sleep apnoea, fibromyalgia, chronic pain and MS.

They further reported limited evidence to support the use of CBPM in increasing appetite and decreasing weight loss in patients with HIV, improving symptoms of Tourette syndrome, post-traumatic stress disorder and also specific forms of anxiety symptoms.

Further research and clinical trial data will be needed to support the use of products for these and other conditions and to also support the licensing of cannabis- based medicinal products.

NICE guidelines-NICE has been commissioned to produce formal guidelines on the use of CBPM for the following groups:

• People with chronic pain
• People with intractable nausea and vomiting
• People with spasticity
• People with severe treatment- resistant epilepsy

This guidance is not expected to be available until October 2019, in the interim many professional bodies, including the Royal Pharmaceutical Society, Royal College of Physicians, NHS England and the British Paediatric Neurology Association, have produced guidance to support healthcare professionals involved in the sourcing, prescribing, supply and administration of unlicensed CBPM.