12.The rescheduling of cannabis-based products for medicinal use in humans (CBPM) on 1 November 2018 from Schedule 1 to Schedule 2 has been welcomed by patients and their families. The rescheduling recognises that there is a therapeutic benefit to cannabis-based products.
13.Following the change from Schedule 1 to Schedule 2, it is now easier to carry out research into such products. Products in Schedule 1 are deemed to have no therapeutic benefit and cannot be obtained and stored by researchers without a Home Office licence. Medicinal cannabis is now in Schedule 2, which allows researchers access to medicinal cannabis products without a Home Office licence. The products in Schedule 2 are still strictly controlled and subject to special requirements relating to their prescription, dispensing, recording and safe custody.
14.Medicinal cannabis is not readily available as the vast majority of products are unlicensed. Patient and families’ expectations were raised when medicinal cannabis was rescheduled. The rescheduling was influenced by high-profile cases, but there was poor communication from the Home Office and Department of Health and Social Care about who would be able to access CBPMs in practice. Many people believed that CBPMs would be easily available for a wide range of conditions. The media attention around the subject added to these expectations. The Cambridge University Trust Hospital said:
Following changes in the scheduling of CBMP in November 2018 we have observed a noticeable increase in requests for CBMP that we receive in our clinical practice. Parents of children with a variety of epilepsies and/or spectrum of disease burden have requested the drug. Unfortunately, parents often have a number of misperceptions about the effectiveness and tolerability of CBPMs. In many cases this seems to reflect the gaps in the media attention around CBMPs.
15.The high-profile nature of the rescheduling and well-known cases have led to misinformation, whereby the public believe CBPMs work in several areas where the evidence to support this is lacking. As the Royal College of Physicians told us, “there is a perception that CBMPs work in areas where there is little or no evidence and some patients feel they are being denied access to an efficacious drug.”
16.The raised expectations also had an impact on patient-doctor relationships, as patients expected ready access to prescriptions. The expectations have led to increasingly difficult relationships between doctors and patients where, as consultant psychiatrist Dr Imran Malik told us, doctors are having to “thrash” patients’ hopes. Doctors are having to spend time clarifying misconceptions about access to CBPMs, which has led to both public mistrust in the regulatory system and angry patients. We heard Professor Helen Cross, The Prince of Wales Chair of Childhood Epilepsy at UCL Institute of Child Health, Great Ormond Street Hospital, say that:
With the initial announcement in July last year, and then the subsequent change in legislation and the announcements in November, there came a real expectation on the part of the families, and not just the 16 families we have heard about but every family in my clinic, that we could just prescribe it. It was a natural treatment, and therefore that is what they wanted because it was different from what they were on. Probably 70% to 80%, if not more, of my clinics now are taken up with explaining the position.
17.The NHS website is a resource for information on CBPMs. However, it is not always easy for clinicians to refer patients to a website. We heard that clinicians do not have a comprehensive patient information leaflet summarising accurate information, as the previous British Paediatric Neurology Association (BPNA) leaflet has been withdrawn. It would be helpful if doctors had an agreed and consistent resource to hand out to patients.
18.We heard that the Government needed to communicate the reality of the rescheduling better. Professor Finbar O’Callaghan, president of the British Paediatric Neurology Association, told us:
When the Home Secretary announced the intention to reschedule the products, there was a lot of good publicity surrounding that statement. What was then needed was communication with the public about exactly what that meant; that it did not mean that these products were now going to be freely available to be prescribed on the NHS, because that is not the case, and it did not mean that clinicians in particular areas were necessarily going to think it appropriate to prescribe these products, given the evidence base. There could have been some management of how that was dealt with at the time.
19.It is apparent that the Government did not have a communications plan to ensure that the public and patients were not misinformed about the availability of CBPMs. The Government should have recognised the high-profile nature of the rescheduling and the possibility for the move to be misinterpreted. Whilst the Home Office Minister said he “ … would be very sensitive to any charge that we over-egged expectation as a Government”, it is apparent that the Government did not manage the expectations of the public. The Government made a concerted effort to emphasise that recreational cannabis was not being legalised but failed to communicate important points about the availability of what it was rescheduling. Patients and their wellbeing should be at the forefront of considerations when decisions are made and in this case, it was patients and their families who felt the repercussions of the Government’s poor expectation management.
20.There has also been poor communication since the rescheduling. Once it became apparent that there was a degree of misunderstanding about the rescheduling, it would have been feasible for the Government to step in to clarify the situation. Whilst clinicians have been issued guidance in the interim by their professional bodies, the Government has done little to correct the widespread misconceptions regarding CBPMs. Patients have had their expectations raised unfairly and doctors are handling the backlash of poor Government handling.
21.The situation remains that the vast majority of CBPMs are unlicensed and are therefore subject to stringent prescribing regulations. Under the current regulations, CBPMs can only be prescribed by a specialist doctor on the General Medical Council’s (GMC) register. Prescribing unlicensed products is often referred to as “off-licence” or “specials”. The GMC’s guidance on prescribing unlicensed products requires doctors to:
a)Be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy
b)Take responsibility for prescribing the medicine and for overseeing the patient’s care, monitoring, and any follow up treatment, or ensure that arrangements are made for another suitable doctor to do so
c)Make a clear, accurate and legible record of all medicines prescribed and, where they are not following common practice, their reasons for prescribing an unlicensed medicine.
In the first instance, doctors must be satisfied that there is a sufficient evidence base for prescribing the unlicensed product. If there is an insufficient evidence base, doctors are reluctant to prescribe knowing that they are taking personal responsibility for doing so and that there could be serious professional and legal consequences if there are adverse outcomes for their patient. Prescribing a product without a clear evidence base and on the basis of anecdote can be harmful to patients and the history of medicine has numerous examples of interventions that were introduced with the best of intentions but later turned out to be harmful.
22.The reality of the change in law was that medicinal cannabis products were rescheduled, which allowed them to be prescribed. However, most medicinal cannabis products are unlicensed, and therefore remain governed by a restrictive prescribing process. The Government failed to communicate this point, and unduly raised the hopes and expectations of patients and their families.
23.The Home Office, Department of Health and Social Care and NHS England should consult relevant patient and professional organisations and form a communications plan to relay clear information to patients and the wider public about the availability of CBPMs and the need for further research.
7 Epilepsy Action ()
10 All-Party Parliamentary Group on Medical Cannabis under Prescription ()
12 Royal College of Physicians ()
13 Cambridge University Hospitals NHS Trust ()
14 Royal College of Physicians ()
16 Royal College of Physicians ()
18 Cambridge University Hospitals NHS Trust ()
21 Royal College of Physicians ()
22 General Medical Council ()
Published: 3 July 2019