On 1 November 2018, following considerable popular pressure surrounding a select number of young children with treatment-resistant epilepsy who responded well to medicinal cannabis (and medicinal cannabis alone), regulations in the UK came into force to reschedule cannabis‑derived medicinal products to schedule 2 of the Misuse of Drugs Regulations 2001 and to allow prescribing of these products, but only by a doctor on a specialist register.
It is widely acknowledged that expectations were raised, both for families who have children living with very severe forms of epilepsy and for a number of other conditions. The Health and Social Care Committee held a two part hearing in March 2109 to explore some of the wider issues that lie behind the decision and how well the current regulations are working.
Drug Science’s statement can be found below, and the videos for the full sessions can be found here.
1. Executive summary
- There are several established indications for the use of medical cannabis and medical cannabis may have efficacy in many other disorders.
- The previous status of cannabis in schedule 1 resulted in a lack of high quality research, meaning that essential information on the health implications of medical cannabis use is often lacking.
- The current procedures for enabling the use of medicinal cannabis in appropriate cases are failing patients.
- Practitioners often lack the knowledge and products available to them to confidently prescribe medicinal cannabis.
- There is a lack of training for prescribers and insufficient collaboration between different stakeholders.
- No clear and widely accepted standards exist to help guide patients and clinicians to make decisions around if, when, where, and how to use cannabis safely and effectively.
- There is a need for collaboration between medical practitioners and pharmacists to provide supplies in different forms for different patients.
- Many patients in need are not able to get access to medical cannabis and are becoming disillusioned with current practises.
- Public opinion in general has become increasingly favourable towards medicinal cannabis, in part as a response to public interest stories in the media.
A range of recommendations for action are outlined.
2. The role of Drug Science
Drug Science wants to see a world where drug control is rational and evidence-based; where drug use is better informed and drug users are understood; and where drugs are used to heal not harm.
We provide an evidence base free from political or commercial influence, creating the foundation for sensible and effective drug laws, by delivering, reviewing and investigating scientific evidence relating to psychoactive drugs. DrugScience is asked frequently about medical cannabis – what it is, what it can be used for, who can prescribe it and how to regulate it. To address (at least some of) these questions, we recently organised the Drug Science Symposium – ‘Cannabis medicines: from principle to practice. How can we maximise clinical research and benefits?’ conference.
We submit evidence in order to continue to contribute to the current scientific, political and ethical discussions regarding medical cannabis. Drug Science is keen to establish a dialogue between different stakeholders in the debate, and create special interest groups who can work together to evaluate risks and benefits, developing a long-term network that can focus in detail on the implementation of medical cannabis.
3. What does the current evidence base tell us about the efficacy of medicinal cannabis?
There are several established indications already: epilepsy, pain, spasticity and arthritis. A range of other research and personal evidential data suggests that medical cannabis may have efficacy in many other disorders, such as Crohn’s disease, ulcerative colitis and PTSD, to name a few. However, access for these indications is denied patients. The previous status of cannabis in Schedule 1 resulted in a lack of high quality research, meaning that essential information on the health implications of medical cannabis use is often lacking. NASEM (2017) provides a range of research conclusions on the health effects of cannabis and cannabinoids which are based on substantial or moderate evidence. These are presented here with some additions by Drug Science. There is conclusive or substantial evidence that cannabis or cannabinoids are effective: for the treatment of chronic pain in adults (cannabis), as antiemetics in the treatment of chemotherapy-induced nausea and vomiting (oral cannabinoids), for improving patient-reported multiple sclerosis spasticity symptoms (oral cannabinoids), and epilepsy (cannabinoids). There is moderate evidence that cannabis or cannabinoids are effective for: improving short-term sleep outcomes in individuals with sleep disturbance associated with obstructive sleep apnea syndrome, fibromyalgia, chronic pain, and multiple sclerosis (cannabinoids, primarily nabiximols).
4. What plans are there for research into the medicinal use of cannabis, and what challenges are faced by that research?
Many medical researchers wish to study cannabis but access is still very difficult as current research supplies are from overseas. The previous status of cannabis in Schedule 1 resulted in a lack of high quality research, meaning that essential information on the health implications of medical cannabis use is often lacking.
5. How suitable are the current procedures for enabling the use of medicinal cannabis in appropriate cases?
The current procedures are failing patients badly as the specialist gatekeepers are generally not adequately informed about the value of medical cannabis and many still believe the misinformation perpetuated for decades by successive governments that it is a dangerous drug. Further, current procedures fail to avoid the “last resort option” for medical cannabis, prescribing it only when other medicines (which are often more harmful) have failed.
6. Do practitioners have the knowledge and products available to them to confidently prescribe medicinal cannabis?
No. To date, there is a lack of training for prescribers and insufficient collaboration between different stakeholders. Concerns by physicians when deciding if and how to prescribe medical cannabis need to be addressed urgently so that the medicine can reach patients in need. Currently, prescribing medical cannabis only as a ‘last resort’ means that patients may lose out on effective treatment.
7. Is the current guidance around prescribing CDMPs fit for purpose?
No. There is an urgent need to clarify and improve current guidance so that physicians are better supported in their prescribing decisions and feel confident to prescribe the medicine as required. To date, no clear and widely accepted standards exist to help guide patients and clinicians to make decisions of if, when, where, and how to use medicinal cannabis safely and effectively.
8. What can we learn from the legalisation of medicinal cannabis and its practical implementation in other countries?
There is a need for collaboration between medicinal practitioners and pharmacists to provide supplies in different forms for different patients. A special category for medical cannabis in the medicines act would be advisable. Many countries now allow or are considering allowing the medical use of cannabis or cannabinoids in some form, and the approaches taken to prescribing and dispensing cannabis medicine vary greatly in terms of the products allowed and the regulatory frameworks employed. For example, in contrast to the restrictive UK system at present, the Netherlands offer a long-established system that allows relatively broad access to medical cannabis, with any doctor able to prescribe. The Netherlands-Nabiximol-containing medicinal products (such as Sativex) are available as medicines. Doctors are also permitted to prescribe medical cannabis for conditions such as (but not limited to): MS, HIV, cancer, pain, Tourettes Syndrome. Produced and distributed in commission by the Ministry of Health-Generally, the doctor is allowed to judge whether cannabis might beneficial to treat a condition. However, cannabis should only be prescribed when the standard treatments have not helped or cause too many side effects. Cannabis is produced by Bedrocan to meet quality standards, then dispensed by a pharmacist to patients with medical prescription. A few pharmacies prepare cannabis oil and dispense it to their “own”patients.
9. Have recent changes in the scheduling and availability of CDMP, and media attention around this, affected public opinion and behaviours in the UK?
On the one hand, it appears that patients are becoming more and more disillusioned – they thought that the problem of access was solved by the rescheduling but it seems to be if anything no better and maybe worse. Many patients in need are not able to get access to medical cannabis. On the other hand, public opinion in general seems to have become increasingly favourable towards medical cannabis, as a response to current research and development trends as well as public interest stories, such as the media representations of the case of Billy Caldwell.
10. Recommendations for action
Drug Science recommends to:
- Develop clear and widely accepted standards to help guide patients and clinicians make decisions on if, when, where, and how to use medical cannabis safely and effectively
- Clarify what types of medicinal products or cannabis preparations should be allowed
- Propose a special category for medical cannabis in the medicines act.
- Highlight the medical indications for which treatment is permitted and the routes of administration allowed
- Investigate how cannabinoids fit into any existing treatment
- Highlight when treatment is permitted – this should avoid prescribing cannabis only as a ‘last resort’ and allow patients a degree of choice
- Develop a hierarchy of evidence to see where cannabis medicines sit. This might be indication-specific, in order to avoid patients having to explore other treatments which may be less useful, and indeed, may be more harmful
- Address the reluctance by physicians to prescribe by providing clear guidelines and training from an early career stage onwards
- Provide clear guidelines and training for prescribers
- Agree on who is to train the specialists on the Specialist Register in cannabis medicine
- Assess how much of the cost is to be met by patients or whether it can it be covered by the NHS
- Monitor patient outcomes and adverse effects
- Establish an international monitoring base
- Develop a medical cannabis network that can address further issues as soon as they arise