Almost six years since the law changed, children still struggle to access a consistent supply of cannabis-based medicine in the UK.
With families now facing national shortages of other anti-epileptic drugs, it’s time the sector stepped up, writes co-founder and director, Matt Hughes, Medcan Family Foundation.
Medcan Family Foundation is a patient organisation working on behalf of families living with complex neurological disorders for whom the new generation of cannabis-derived medications represent a lifeline for their children.
Medcan’s founding principle is that no child should have their life cut short when there is simple and safe treatment available which might benefit them and improve their quality of life.
Although our primary goal is to see NHS access, we cannot ignore that the UK medical cannabis sector plays a pivotal role in that becoming a reality.
We are here to bridge the gap between industry, government, NHS and patients. To collectively work together in helping some of the most vulnerable families receive what might be the only medication which brings relief from hundreds or thousands of seizures per week.
Unfortunately, just weeks into the new year we have seen an influx of messages from concerned and worried parents being told prescriptions cannot be filled, or will be delayed with advice to change products.
The importance of consistent medication in epilepsy
Severe treatment resistant epilepsy by definition is difficult to control and those diagnosed are sensitive to change.
The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute of Health Care Excellence (NICE) both have guidance for clinicians on considering the potential loss of seizure control, increased side effects and impact on quality of life when changing brands between generic licensed anti-epileptic medicines.
Changing medications when a patient suffers from severe, treatment-resistant epilepsy is a delicate and intricate process. Parents grappling with this form of epilepsy often find themselves in pursuit of an effective medication regimen that can bring their child’s seizures under control.
However, the sensitivity of altering medications cannot be overstated, as it significantly influences seizure control, side effects, and ultimately, the overall quality of life of the child.
READ MORE: It is “highly unsafe” to switch children’s cannabis medicines, says leading epilepsy expert
We are approaching six years since the change in law, those providing cannabis based medicines for this cohort have had enough time to understand the potential weaknesses and delays in supply and have appropriate measures in place to maintain a consistent supply.
As Alice Salisbury Jones, mum to 13-year-old Jasper, explains: “My son has complex epilepsy. Producers and importers need to understand that a tiny adjustment to his medications can be the difference between no seizures a day and ten seizures in an hour.
“We get emails from the pharmacy saying ‘this is not available, ask your doctor about an alternative’ and all I read is ‘get ready with the rescue meds and have the ambulance on speed dial’.
“I am trying to keep my son alive and it is not in any way an exaggeration to say his medication not being available makes it less likely he will make it.”
Ongoing issues with inconsistent supply for paediatrics
January 2024 has brought uncertainty for epilepsy patients with announcements from leading epilepsy charities that the supply of three licensed anti-epileptics are in short supply across the UK.
Charities are calling on DHSC for urgent action and to bring a resolution. However shortages are generally rare and resolved without delay or interruption in the medicine regime.
Prescription cannabis is a controlled drug in the UK, which means it comes with its own set of regulatory hurdles with licences at every point in the manufacturing process required to handle raw or finished product.
We’ve seen issues arise outside the control of producers and distributors. In 2021, UK prescriptions were no longer valid in the EU, although unique to medicines via Transvaal pharmacy in the Netherlands, prevented access.
More recently a change in EU initiatives have delayed the issuing of permits to allow for distribution. Crop failures and cancellations of transit have all contributed to a delay. However, supply chains should be resilient to unexpected events and in general five years on, it shouldn’t remain an ongoing monthly concern.
This has to be addressed.
Clinical perception of cannabis
We have seen medications of epileptic children abruptly stopped, delayed or changed, with adverse events, loss of control leading to hospital admissions. NHS neurologists will be made aware that changes were made due to supply, not a clinical need. The perception in the use of prescribed cannabis for severe epilepsy here in the UK is beginning to shift.
In January, the annual British Paediatric Neurology Association conference took place with several epilepsy charities in attendance. The agenda saw an hour focused on the use of cannabinoids.
Only five years ago when the medical use of cannabis was mentioned, we were sadly told that many in the room laughed at the mere mention of the word. Today it’s taken seriously, and questions are being raised on enabling access to patients in the most need.
However, these positive steps can be easily undone if the industry doesn’t support a consistent supply.
Why can the UK sector not sustain uninterrupted supply?
Prohibition Partners has forecast the number of cannabis patients in the UK to reach 70,000 by the end of this year, but paediatric numbers are set to remain at a fraction of that with only 50 patients currently receiving legal prescriptions.
Is this part of the issue?
Patient numbers will always be low in rare diseases. Treatment-resistant epilepsy has not seen a decrease in diagnoses in over 40 years, in part because focus has been on bringing medicines to market which cater for those who have well controlled epilepsy.
Rare diseases are not profitable, in the case of cannabis it’s a trend seen across the world with childhood epilepsy catering for only 1% of the market.
Despite having an NHS prescription for her son for almost six years, Hannah Deacon, co-founder and chair of Medcan Family Foundation, says the uncertainty around supply still causes ‘a huge amount of anxiety’.
“Alfie has now been prescribed medical cannabis via the NHS for nearly six years,” Hannah says.
“In that time we have had to fight for access to his medication due to Brexit and more recently because of changes in EU legislation which delayed his medication, and we saw him down to just a few bottles. The day we won Alfie’s prescription should have been the end, but sadly it was only the beginning of spending the last five years trying to legitimise his prescription and ensure it continues to be safely supplied to him each month.
“Alfie has now been seizure free for over 1,300 days, not only has this given him a life worth living, but it has taken a huge burden off our local NHS hospital, where he spent most of his life prior to his prescription of medical cannabis.
“I have fought for years to give my son a safe and happy life, and to continue to feel that even his NHS prescription is not safe at times causes a huge amount of anxiety and fear. I want to see the UK build a world-class medical cannabis industry, the way it moves to this is to work with public health to offer a solution.
“If the current supply chain issues continue without enough focus or attention, this industry is just not ready to provide a large number of patients a service and products that would be needed. Self -regulation and looking to work in best practice must be of paramount focus for all companies but especially for those who wish to supply medical products to children and their families.”
Personalised medicine – how can we make an informed decision?
Unlicensed cannabis medicines fall into the category known as special medicines, these are deemed as unlicensed medicinal products manufactured in the UK for human use which have been specially prepared to meet a prescription ordered for individual patients without the need for the manufacturer to hold a marketing authorisation for the medicinal product concerned.
Specials do not require the same level of patient information to be supplied in comparison to those with marketing authorisation.
It’s common for clinician and parent to only know the CBD:THC concentration, ratio and nothing more. The very basics of non-active ingredients should be available alongside a full cannabinoid profile as a minimum.
Industry has to play its part in going above and beyond the standard for best patient outcomes. The requirement must be for self-regulation if the industry is to withstand the test of time and become a world class industry which caters for all patients not just some.
Cannabis is a personalised treatment plan, without the relevant information everyone involved in the child’s care is planning from ignorance, not information, which means the clinicians cannot make informed choices for their most vulnerable patients.
In situations where parents are told stock is unavailable, the phrase ‘please speak with your clinician to arrange an alternative’ sends parents into panic.
How can they make an informed choice with no information?
Dr Bonni Goldstein, a paediatric consultant specialising in personalised cannabinoid treatments in the US, explains: “I routinely recommend cannabis-based medicines to paediatric patients with severe epilepsies and have found that, despite having similar diagnoses, these patients require customised medication regimens.
“For instance, one of my young patients with Dravet syndrome is virtually seizure-free on a high dose of cannabis oil with a CBD:THC ratio of 27:1. Another child with the same diagnosis required a 15:1 CBD:THC ratio at a lower dose to achieve seizure reduction. Same diagnosis, different treatment personalised to their response.”
Dr Goldstein adds: “These children must have numerous tested cannabinoid-based medicine options available as there is no ‘one size fits all’ for cannabis medicines. This is not any different from other medications; in fact, there are over 30 types of anti-seizure pharmaceuticals available.
“We cannot deny these vulnerable children a chance at a better quality of life by limiting their options.”
Placing children at risk
Professor Mike Barnes is one of only two doctors currently prescribing for paediatric epilepsy in the UK. Working with families at the forefront of this issue, he shares their frustrations alongside his own.
“As one of the two prescribers for children I can confirm that the supply chain issue is a major problem,” he says.
“It is not uncommon to have to write two or even three scripts for each child each month simply due to products going in and out of stock. It is frankly awful and really dangerous for these children.”
Professor Barnes adds: “If the NHS would prescribe then we would have bigger numbers and better supply.”
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Author: Opinion editor
