Change in regulations for cannabis-based products for medicinal use

Background

In June 2018, the Home Office launched a review into the scheduling of cannabis and cannabis-based products for medicinal purposes; it found that there is conclusive evidence of therapeutic benefit for certain medical conditions, and reasonable evidence in several other medical conditions.

The Chief Medical Officer (CMO), Professor Dame Sally Davies then recommended that the whole class of cannabis-based products for medicinal use be moved out of Schedule 1 of the Misuse of Drugs Regulations 2001 (MDR). This was backed up by The Advisory Council on the Misuse of Drugs (ACMD).

Considering this, the Government has decided to lay regulations which will move cannabis-based products for medicinal use out of Schedule 1 and into Schedule 2 of the MDR, with the exception of synthetic cannabinoids which were specifically excluded from this and reserved for further consideration.

Prescribing cannabis-based products for medicinal use

The Government has defined a cannabis-based product for medicinal use in humans as follows:

A preparation or other product, other than one to which paragraph 5 of part 1 of Schedule 4 [of MDR] applies, which:

• Is or contains cannabis, cannabis resin, cannabinol or a cannabinol derivative (not being dronabinol or its stereoisomers)
• Is produced for medicinal use in humans and is either 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 new regulation, all cannabis-based products for medicinal use apart from Sativex® would be unlicensed medicines.

Due to the limited evidence base and their unlicensed nature, the Government has decided to restrict the decision to prescribe cannabis-based products for medicinal use to only those clinicians listed on the Special register of the General Medical Council.

As with any unlicensed medicines, the prescribing of such products must be on a “named patient” basis. It is therefore expected that rigorous and auditable safeguards around prescribing of an unlicensed product will be followed, alongside existing protocols on controlled drugs. This applies to both those working within the NHS and non-NHS settings.

In addition, prescribers are expected to only prescribe a product where they are certain of its content and quality. Products will be expected to fulfil the requirements of the Medicines and Healthcare products Regulatory Agency (MHRA) special guidance and the additional cannabis guidance. For example, a product should not be prescribed where the content of cannabinoid constituents in the product is not known or not declared on the product label.

Monitoring

The Department of Health and Social Care along side the Controlled Drug Accountable Officers (CDAOs) have a statutory responsibility to secure the safe management and use of controlled drugs. Together they are currently exploring options for national data collection on prescribing of cannabis-based products for medicinal use in the NHS and private sector. Further details of this will be made available in due course.

Clinical Guidelines

The Department of Health and Social Care will be producing a clinical guideline on prescribing cannabis-based products for medical use in humans. However, this guidance is not expected until October 2019 at the latest.

In the interim, the British Paediatric Neurology Association (BPNA) has developed clinical advice on the use of cannabis-based products for medical use in paediatric patients with certain forms of severe epilepsy. In addition, the Royal College of Physicians (RCP) has developed advice around prescribing of cannabis -based products for medicinal use in intractable chemotherapy induced nausea and vomiting and chronic pain. For more information go to http://www.nhs.uk/conditionas/medical-cannabis.

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