1st November 2018
Cannabis-based medicines available on prescription
Patients in special circumstances will now be able to access medicinal cannabis, after a decision by the Home Office to reschedule cannabis-based products for medicinal use.
This follows an outcry earlier this year relating to children with treatment-resistant epilepsy being denied access to the cannabis oil which had been helping to control their seizures.
Under the change, some specialist medical practitioners will be able to prescribe medicinal forms of cannabis.
The Home Office decision comes on the back of a two part review of the scheduling of cannabis, undertaken by the Chief Medical Officer, and the Advisory Council on the Misuse of Drugs. The review found strong evidence of a therapeutic benefit of cannabis-based medicinal products for certain medical conditions. It concluded that medicinal cannabis should be available for prescriptions “under controlled conditions by registered practitioners”.
Cannabis is listed as a class B substance under the Misuse of Drugs Act 1971. This means that it is generally illegal to possess, supply, produce, or import/export cannabis.
Under the Misuse of Drugs Regulations 2001 there are circumstances where it is legal to undertake these activities with certain controlled drugs. This depends which schedule a drug comes under.
Until now, cannabis has been a schedule 1 drug. Schedule 1 drugs are understood to have no therapeutic value and are only permitted for use in research under a Home Office licence. However from 1st November 2018 cannabis will become a schedule 2 substance. This means that cannabis is understood to have therapeutic value, though still needs strict control and special requirements relating to their prescription, due to being highly addictive and potentially harmful. Morphine is an example of another drug in this category.
Accessing these treatments
Normally, medical practitioners can only prescribe medicines which have been licensed for use in the UK, by either the Medicines and Healthcare products Regulatory Agency (MHRA) or the European Medicines Agency (EMA). Licences are only granted if strict safety and quality standards are met. At present there is only one cannabis-derived medicine licensed for use in the UK, Sativex. However it is not available on the NHS because it is deemed to be too expensive for the NHS to pay for.
Under the decision to allow patients to access medicinal cannabis, specialist clinicians will be allowed to prescribe unlicensed medicines. Off-label prescribing of unlicensed medicines – known as ‘specials’ – is governed by guidance produced by the MHRA, and guidance by the General Medical Council. This states that specialist clinicians must first consider whether any licensed medications could be effective. They will also need to make their own judgement on medical benefits and pharmaceutical quality of unlicensed cannabis derived medicinal products.
The decision to prescribe medicinal cannabis is restricted to registered medical practitioners on the General Medical Council’s specialist register.
NHS England has provided guidance to clinicians explaining what the regulatory change will mean in practice for clinicians working in the NHS and in private practice in England.
Additionally, guidelines for specialist clinicians to follow when making these prescribing decisions has been produced by the Royal College of Physicians, and The British Paediatric Neurology Association. These interim guidelines are a prelude to formal guidance being issued by the National Institute of Clinical Excellence in or around October 2019.
Conditions for which this these treatments can be prescribed
The changes do not limit the types of conditions that can be considered for treatment. However, the guidance available only covers three conditions. The Royal College of Physicians’ guidance covers cannabis-based medicines in the management of chronic pain and nausea from cancer treatment. The British Paediatric Neurology Association’s guidance covers the use of cannabis-based medicines in children and young people with epilepsy. There is significant concern within the neurology community that the guidance overlooks conditions such as MS for which the therapeutic benefits are well-known.
While the change has been welcomed by the neurology community, there is significant concern that that too few people who could benefit will actually get access to medicinal cannabis.
Over the longer-term the move is promising in improving the research evidence about the safety and effectiveness of different types of medicinal cannabis. At present there is a lack of evidence available.