SAOIRSE O'SULLIVAN, PHD PROVIDES FAMILIES 4 ACCESS WITH A CONSIDERED ASSESSMENT ON THE ACMD'S LATEST LETTER
September 13, 2018
Saoirse O'Sullivan, PhD, a prominent cannabinoid researcher and Associate Professor at The University of Nottingham, provided a considered response for Families 4 Access with her assessment of the ACMD’s latest letter with their recommendations to the government.
On September 11th, the Advisory Council on the Misuse of Drugs (ACMD) issued a number of recommendations to the government on cannabis-derived medicinal products (CDMPs) based on their review in collaboration with representatives of the Home Office, Department of Health and Social Science (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA). Although the exact definition of what a CDMP is (and the devil will be in the detail), the recommended access routes appear broad including both ‘special’ unlicensed products and those without marketing authorisation (approval), and will not be limited to those already licensed cannabis-based products such as Sativex, Epidiolex or Marinol. Importantly, the ACMD recommends that when these CDMPs have been defined, that they should be exempt from the Misuse of Drugs Order 2015, meaning they would no longer be illegal for patients or their carers. Of course, these are just recommendations, and the government may not take on all the ACMDs advice, or at least in its current format. In some areas, it seems like much work is yet to be done and that the provision of CDMPs will take some time to finalise.
A strong recommendation from the ACMD is that any CDMPs should meet defined safety and quality assurance standards, with products that are manufactured to an acceptable medicinal standard with accurate content description of the products (including the amount of the main active ingredients of cannabis, Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD) present). Effectively, this means that they are requesting that any CDMPs been produced according to good manufacturing practice (GMP). GMP certified cannabis products do exist, although this would limit the number of suppliers of future CDMPs in the UK. In my opinion, this is an entirely reasonable request to ensure the safety, quality and consistency of any medicinal product that would be a minimum requirement in any other licensed medication. Because there are therapeutic benefits of many other compounds found within cannabis, it would be worth expanding the recommendation of content description (at least for whole plant products) to include information on the content of some of the other active ingredients like terpenes and flavonoids. In the long-term capturing of the clinical outcomes from CDMPs, it is crucial that we understand all the active ingredients that are being used in any given product. The ACMD also recommends that this content description should include dosing instructions. However, considering the extreme heterogeneity of the limited high quality clinical evidence (i.e. phase 3 randomised controlled trials) with CDMPs (different products with different levels and ratios of cannabinoids, different routes of administration in different disease indications), I think it would be almost impossible to dissect out any meaningful recommendation of dosing instructions.
Because of the lack of education and clinical evidence in the area of CDMPs, it is crucial that substantial guidance be put in place to support practitioners in prescribing CDMPs. In addition to the urgent recommendations of the ACMD (with inputs from the Home Office, DHSC, MHRA and NICE) for clinician and pharmacist education, I would suggest that this guidance be extended to other healthcare practitioners such as nurses and carers, and also law enforcement officers. Modules on cannabinoid pharmacology and medicines could be immediately added to the curriculum of medical schools in the UK to ensure future doctors are fully educated in this area. This could aid with the normalisation of CDMPs if doctors are taught from an early stage about the science behind, and benefits of, CDMPs. The ACMD recommends that in the first instance that the prescription of CDMPs be by specialist clinicals on the register of the General Medical Council (GMC) i.e. consultants. I think this could be extended to include specialist GPs (a program for which would need to be developed) to widen patient access. This is particularly important as not all patients that would be looking for a CDMP would be under consultant care.
As a researcher, I was very happy to see the recommendation from the ACMD that we need to build on our understanding of the benefits and harms of CDMPs by capturing clinical outcomes from patients that are prescribed CDMPs. As mentioned, there is a paucity of information in this area that will make it very difficult for clinical decision making. However, allowing the increased use of CDMPs will mean that we can begin to gather evidence in the UK on the effectiveness of CDMPs in a range of disorders and whether this is affected by factors such as age, gender and ethnicity. Given the known number of genetic variants and gender differences in the endocannabinoid system, it is likely that there will be a heterogeneity of responsivity to CDMPs that we can begin to understand and use in prescribing practices. It will also be crucial to fully capture any short or long-term side effects of CDMPs. People may argue that humans have been using cannabis-based products safely for thousands of years, but we are now altering the level and ratios of cannabinoids in products (for example CBD) to levels that humans would not previously have been exposed. I also really welcome the recommendations that the government should encourage developing CDMPs for MHRA marketing authorisation. I would extend this to recommend that the government increases dedicated funding streams for basic and clinical researchers based in this area through special calls from research councils.
To me, some elements of the ACMD recommendations may limit the patient’s choice in how they use a CDMP. For example, the ACMD recommend that CDMPs should only be used as a ‘product of last resort’ when no other drug meets the clinical need. However, many patients choose to use CDMPs over currently available medication because of a preferred side effect profile (for example versus opioids in pain management) or personal preference over other pharmaceutical products (for example versus anti-anxiety, anti-depressant or sedation medications). ACMD also suggest that smoking would not be a permissible route of administration. However, many patients enjoy the immediate (smoking is a better route of administration for cannabinoids) and relaxing or euphoric effect of smoking cannabis that contributes to the overall improvement in quality of life and symptoms reported by patients. While the ACMD may argue that there are health risks with smoking, clinicians and patients could decide whether the benefits outweigh risks in their particular circumstances. This is particularly pertinent in the palliative care setting. Overall, I think there could be an increased consideration and consultation of patient’s choice of how they use CDMPs.
The opinion is that of the author and does not necessarily reflect the views and position of Families 4 Access team.