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OPINION: The highs and lows of prescribing medical cannabis down under

Dr Mark Smith is a UK-trained GP who has prescribed medical cannabis to more than 200 patients in Australia.

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Dr Mark Smith has prescribed to more than 200 medical cannabis patients in Australia

Dr Mark Smith, is a UK-trained GP and member of the Medical Cannabis Clinicians Society (MCCS), who has been practicing in Western Australia since 2015. Here, he shares his experience prescribing medical cannabis to more than 200 patients. 

First, a bit of history. In February 2016 Australia legalised the growing of cannabis for the first time as long as it was for medical use and research purposes, and by 2017 specialists were allowed to prescribe. 

Dr Mark Smith has been practicing in Australia since 2015

Then, state-by-state, non-specialists (GPs like myself) were allowed to prescribe too (as in the US, each state has different laws for everything). Here in Western Australia it wasn’t allowed until late 2019.

Although I knew the rules had been relaxed, the process looked intimidating. How do I apply? What do I prescribe and what doses are needed for all the different conditions? Some of us might have had our interest piqued but it was still daunting. 

But it wasn’t long before a patient came to ask about it. 

I’d never met him before, but with cerebro-spinal degeneration he was suffering from fear, anxiety and dreadful insomnia. I promised to look into the process. I didn’t realise then how time consuming the application for one prescription would be.

Prescribing in general in Australia is quite different from the UK. The equivalent of the NHS is Medicare, but this system doesn’t cover everything either. 

If medicines are covered by the Pharmaceutical Benefits Scheme (PBS) the maximum prescription charge for a month’s supply is around £22 until you reach an annual cost cap. 

However if PBS doesn’t cover the medicine, as with cannabis products, then the patient must pay the whole cost. 

The big difference is that GPs can still prescribe it safely, but the process for prescribing ‘unapproved’ medicines like cannabis is still cumbersome. 

A document justifying the prescription with a description of the condition and what medicines have been tried and failed has to be uploaded to the Special Access Scheme application website and the application will be assessed in the capital Canberra over several days. 

Sometimes it will get refused, but most are allowed as long as the patient isn’t under the age of 18 and wanting access to THC. 

This approval then gets sent to the state authorities in Western Australia for another level of bureaucracy.

Starting out I got great support from Little Green Pharma (LGP) who are based here in Perth.

After several months experience, the company helped me through the ‘Approved Prescriber’ process which allows me to prescribe on the spot without needing to apply through SAS. 

All within a 45 minute appointment, a patient can be assessed, fully briefed on how to take it and leave with a prescription for immediate dispensing from the pharmacy downstairs. 

It’s a vastly streamlined and efficient process compared with the UK. I am already up to over 200 individual patients and there is no sign of demand slowing, especially since the QUEST research study launched in early 2021.

Not dissimilar to Project Twenty21 in the UK, QUEST is run by the University of Sydney in partnership with LGP and allows patients discounted access to cannabis medicines in return for their participation in a study monitoring their progress.

For monthly emailed questionnaires a 50ml bottle (2500mg) is discounted to $165/£90 including postage, whether it’s the CBD 50 (usual price $225/£122) or the THC products that are usually $175/£95 (it’s worth noting that all products dropped in retail price this year anyway).

There are now over 200 Authorised Prescriber GPs in Australia, and many others prescribe too but we are still in the minority (Australians can be pretty conservative).

In 2020, 60 percent of prescriptions were for THC containing products but this year it’s been quite different. 

Many more anxious patients have been presenting, resulting in 80 percent of prescriptions being written for CBD only.

My impression is that early seekers of cannabis medicines were pain sufferers, hence the greater demand for THC containing oils. But it is clear to me that CBD is a tremendous breakthrough for anxiety patients. Most people will also report better sleep. 

THC has its place for pain, but the local drawback is that the law still bans anyone from driving with THC in their system.

With random alcohol breath and saliva drug stops a common sight here (they even have their own TV show) anyone using THC oil in the morning is likely to test positive within six hours of ingestion.

The law is also very strict regarding manufacturing (GMP) and only reliable products can get approved for prescription. There has to be a guarantee of no detectable THC. LGP estimates 40 percent of the cost of the product is growing and manufacturing – 60 percent is testing and compliance.

Many people will still get success for chronic pain, headache and migraines from CBD only, but the dose has to be right. 

Everyone is different but it will usually need to be at least a 25mg dose twice daily. 

A few months ago CBD was finally legalised for pharmacy sales in Australia, with the Government allowing a daily dose of 150mg of over the counter CBD. 

I suspect sales will take off, but it will be imperative for patients to know how much to take, in milligrams. Take too little to try and save money and it is not going to work.

My original patient? He did very well from the off, reporting significant improvements in his sleep, depression and mood and appetite.

Here’s a few other success stories taken from my notes:

Female, 20, CBD only for anxiety reporting a vast improvement in anxiety and sleep

Male, 62, CBD only for chronic headache reported reduced headaches, spells with no pain and improved sleep 

Female, 64, CBD, brilliant response to 0.5ml, best ever sleep and pain doesn’t need paracetamol any more

Female, 41, CBD only reported a vast improvement in endometriosis pain. No longer needing time off work. Migraines eased too, easier to cope all round. Halved analgesic use. 

Male, 72, was prescribed 10:10 balanced CBD:THC for chemotherapy symptoms. Appetite great, rested after sleep and done away with Norspan opiate patch with no detriment. Very pleased. 

You’ll note that the majority of patients are treated with CBD only, due to the random roadside drug testing laws and 80 percent of this years consults have finished with a CBD prescription. What this could suggest, is that medicinal quality, full-spectrum CBD has a lot of value – so much so that THC isn’t always needed.

Dr Mark Smith hopes to return to the UK early next year where he plans to use his prescribing experience to help improve access for patients. 

Find out more about joining the MCCS here

READ MORE  Why we need to reframe CBD as good nutrition

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“Three years on, disabled people need a solution”

PLEA’s advocacy director highlights how disabled patients are still suffering three years since the law change.

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Sajid Javid was Home Secretary when medical cannabis was legalised in 2018

Almost three years since the rescheduling of medical cannabis, disabled patients are still suffering, writes Lucy Stafford, advocacy director at PLEA (Patient-Led Engagement for Access).

In November 2018, current Health Secretary (and then Home Secretary) Sajid Javid ruled that medical cannabis would be made legally available for patients with chronic conditions.

At the time, he claimed the government had “now delivered on our promises.”

Today, the UK is the world’s leading producer of medical cannabis products, yet the overwhelming majority of eligible UK patients are still unable to access legal NHS prescriptions that could vastly improve their quality of life.

Instead, people suffering from chronic pain, Tourette’s disorder and other conditions have found themselves shackled with serious debt or even risking arrest as they attempt to seek treatment. Some patients report having to sell all possessions and even homes to fund private prescriptions.

Lucy Stafford medical cannabis patient

Lucy Stafford

A new report published in the British Medical Journal (BMJ) identifies barriers to access for patients with Ehlers Danlos syndrome, as well as solutions to breaking the deadlock for patients with numerous conditions.

Javid returned as Health Secretary earlier this year. Patients and patient groups now demand that he revisit his decision on medical cannabis, and quickly address all obstacles, allowing meaningful access for the people who need it.

Disabled patients across the United Kingdom are demanding that Health Secretary Sajid Javid fully delivers on the government’s 2018 promises and makes legal medical cannabis accessible to patients with chronic and life-limiting conditions. Then Home Secretary, Javid’s November 2018 decision permitted legal prescriptions of the drug. And in these three years, the United Kingdom has emerged as the largest producer of medical cannabis, identified as such in research conducted by the United Nations.

But very little has changed for the majority of patients with chronic and life-limiting conditions. Many barriers to NHS access remain. And in fact, only three patients have been able to access ‘full spectrum’ (or ‘full plant’) medical cannabis via the NHS, since the medicine was made legal.

Kayleigh Ross, a patient working group member at PLEA, said: “The government has not ‘delivered on its promises’ as Javid stated. In 2021, this important treatment remains inaccessible to hundreds, if not thousands of people whose lives could be transformed but are instead encountering huge problems as they try and afford private prescriptions. Enough waiting. We need more than just words, we need things to change.”

READ MORE  UK medical cannabis company GW Pharma sells for $7.2 billion

BMJ Report identifies barriers to access – as well as solutions

On the 9 September 2021, the BMJ published clinical practice guidance for the provision of non-inhaled medical cannabis for patients living with moderate to chronic pain, including people with neuropathic and cancer-related pain.

This follows the publication by the BMJ in July of a new case report, highlighting the barriers which still remain for patients with chronic and life-limiting disorders, including a lack of physician knowledge on the topic and education on medical cannabis use, restrictive guidelines and cost and supply issues.

Specifically relating to Ehlers Danlos syndrome – an inherited disorder that affects the body’s tissues – the report identifies ways of breaking the deadlock for patients, with solutions that include increasing UK production of medication and bulk importation of medical cannabis from around the world.

As highlighted in the BMJ’s case report, a lack of NHS access means that UK patients using legal medical cannabis are often having to pay for expensive private prescriptions. And those that can do this will often have to borrow from friends and family, sell possessions or go into long-term debt, in order to fund their treatment.

Lara Bloom, president and CEO at The Ehlers-Danlos Society said: “We hope that this report will support clinical expertise of this treatment option and expand research into this area. It’s unacceptable that patients are forced to resort to illegal routes of access when they cannot afford private healthcare – patients need NHS access to treatment, including cannabis-based medicinal products where appropriate.”

Patients are receiving life-changing treatment, but at what cost?

Jim Finch and his wife are having to sell their family home in order to pay for an ongoing prescription that has cost upwards of thousands of pounds for just ten days worth of treatment.

Jim Finch

Jim Finch developed Tourette’s after a serious car accident

A 2018 car accident that was no fault of his own resulted in serious injuries and trauma and left Jim with complex neurological conditions including Tourette’s Syndrome, fibromyalgia and functional neurological disorder. He went from a healthy, 29-year-old dad to being unable to walk or communicate properly and suffering dozens of fits and seizures a day.

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Jim was prescribed ‘hundreds of pills’ to manage his symptoms including Tramadol, Morphine, Diazepam, Codeine, amitriptyline, Lorazepam and Sertraline, which left him (in his own words) a ‘vegetable’. Now, he uses a vape of privately prescribed medical cannabis to help control his pain, tics and seizures.

Jim said: “It has changed me from bed-bound to housebound and I can now be a proper father to my young children. Before, that simply would not have been possible. I’m as close to my old self as I have been since before the crash. There’s the injustice that people are going to prison for trying to get help for themselves.

“There’s also an injustice that people have to pay so much for private prescriptions. My partner and I sold both our cars, used all our savings and have borrowed thousands from family in the past two years. We are now having to sell my house and move in with my in-laws, along with our children to be able to continue this life-changing treatment. And all of it just so I can be present as a father.’’

Building the UK evidence base

In November 2019, the UK scientific charity Drug Science launched Project Twenty 21 – an observational study of 1,500 patients to date, which aims to create the largest body of evidence for the efficacy of medical cannabis in the UK.

The study covers a range of primary conditions, the most common being anxiety and chronic pain, and has the ultimate aim of providing enough evidence to bring about better patient access for medical cannabis on the NHS. With the help of funding from industry producers, Project Twenty21 provides patients with medical cannabis products at a capped price, whilst collecting patient data to feed the UK evidence base with the goal of influencing the NICE guidelines.

Having spent my teenage years in severe pain, dependent on opiates and a feeding tube, my quality of life has been ‘transformed’ by medical cannabis.

Now aged 21, I am one of the few patients able to legally access medical cannabis in the UK. I do this through Project Twenty 21, which provides me with a subsidised private prescription that costs £450 a month, previously having paid £1,450 each month.

READ MORE  The stress-free route to accessing prescribed cannabis medicines 

Three years ago my life was a blur of excruciating pain from dislocating joints at the smallest of movements, needing support from full-time carers to even use a bedpan as I couldn’t get out of bed safely. I had countless injections of incredibly powerful opioid drugs to try and reduce my pain. They never worked and as I became weaker, the pain medications became stronger. I felt like a shell and had no hope or idea how I could keep living in that state – that’s what constant severe pain does to you.

Three years ago Sajid Javid saw the suffering of disabled people and the benefits that medicinal cannabis could bring. Thankfully, he changed the law to allow legal prescriptions. My doctor and I were thrilled. This was my last hope for a life-changing treatment, after which I would be referred to palliative care. But when my doctor wrote me such a prescription, it was denied funding and I was told I could not access the treatment on the NHS. I was devastated.

So like millions of other unwell people, I had no option but to break the law to find help. I was scammed, sent contaminated cannabis, left in vulnerable situations during drug deals and I was terrified of being caught. This was one of the lowest points of my life.

Today, as I am fortunate enough to be supported by my family to have a legal prescription, my health has never been better or more stable. I can now walk, sit, live independently, focus, study for a degree and live a generally normal life, away from hospitals and endless medical interventions. But funding life-saving medication is unsustainable as a disabled student on a very limited income, even at the heavily subsidised rate I receive as a patient with Project Twenty21. And I live in fear of losing access and getting sick again.

The current situation helps no one. Established medications, such as those that I was given, cost the NHS a great deal and can come with terrible side effects. The toll on the mental health of ineffectively treated chronic conditions, like my own, can make patients feel suicidal. And private prescriptions are expensive so people either can’t afford them or can be forced to choose between being in pain and being able to eat.

That’s barbaric, and something the NHS was created to prevent.

For more information visit PLEA (Patient-Led Engagement for Access)

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“Ireland has the most restrictive medical cannabis programme in the world”

Peter Reynolds on the issues facing the MCAP programme in Ireland

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Ireland: A doctor in a white lab coat with out stretched hands holding one cannabis leaf and another holding a bottle of oil

The HSE announced the first products available through Ireland’s medical cannabis access programme (MCAP) this week, but the system has been “sabotaged” by a medical establishment “hostile to cannabis”, argues Peter Reynolds.

Peter Reynolds is an advisory board member of Ireland Medical Cannabis Council.

Peter Reynolds is an advisory board member of the Irish Medical Cannabis Council.

Ireland has the most restrictive medicinal cannabis programme anywhere in the world and it’s still not operational more than four years after it was announced.

What’s even worse, as demonstrated by the letter, nine leading neurologists have sent to Minister for Health Stephen Donnelly, is the four products that the Health Products Regulatory Authority (HPRA) have selected are unsuitable for the conditions they are supposed to treat.

The story of how this has unfolded is a lesson in how not to regulate medicinal cannabis, or, indeed, any medicine. The programme is the result of public demand based on increasing recognition of the value and safety of cannabis when used responsibly under medical supervision. But it has been sabotaged by an Irish medical establishment that is hostile to cannabis, and officials who have refused to take expert advice, preferring the opinions of clinicians who know nothing about it.

The problems started right at the beginning with a report compiled by the HPRA early in 2017 described as from an ‘expert working group’, yet not one person in the group is an expert in cannabis. It’s not clear that any of them had any knowledge about the use of cannabis as medicine when they were appointed.

Ireland and cannabis

Unsurprisingly the report is full of errors and misunderstandings. It claims there is “an absence of scientific data” on the efficacy of cannabis and not enough information on safety. This is palpable nonsense.

READ MORE  ‘As doctors we need to listen to our patients’

History records cannabis being used as medicine for more than 5,000 years and ironically, it was an Irishman, William Brookes Shaughnessy, who published the first scientific paper on it in the Lancet, in 1840. Since then it has been one of the most studied medicines on the planet. It has over 26,000 references on Pubmed, the foremost source for medical literature whereas paracetamol has around 12,000.

California has had a medicinal cannabis program since 1989, the Netherlands since 2001 and its use is now widespread throughout the world. Millions of people are using medicinal cannabis safely and effectively. There is a vast amount of information and evidence available.

The most glaring error in the report is the omission of pain as a condition for which cannabis should be available. Pain is the condition for which cannabis is most often used and is most effective. In 2020 the global market was valued at around $9 billion, this is expected to reach $47 billion by 2027 and over 60% of this is for treating pain. Yet the HPRA’s supposed experts thought it best to leave it out.

The HPRA started work on MCAP in March 2017. Officials claim to have sought “solutions to the supply of products from Denmark, UK, Canada and further afield”, which has included at least some officials going on international trips. It has taken four years to select four products, one of which is for epilepsy in adults and the other three are, as anyone with any expertise will confirm, best suited to treating pain!

READ MORE  A study testing CBD on large animals shows positive results in blood tests

Responsibility for this situation lies squarely with the HPRA. It is matched by its corresponding failure to deal with many attempts to set up a medicinal cannabis industry in Ireland. At least a dozen serious proposals have been presented offering multimillion euro investments in Ireland, promising the creation of hundreds of new jobs.

Irish Cannabis industries

Professor David Finn at NUI Galway is one of the world’s leading researchers into cannabinoid medicines and even his participation has failed to galvanise the HPRA into action.

Medicinal cannabis is the fastest growing business sector in the world. It is coming to Ireland, irrespective of the negative and Luddite attitudes that prevail amongst the establishment.

What is clear is that public health, the Irish people and the Irish economy are missing out in a big way and many of the opportunities have now been lost for good.

Read more: HSE to offer first cannabis-based products on MCAP program from October

 

Peter Reynolds is president of CLEAR Cannabis Law Reform in the UK and an advisory board member of the Irish Medical Cannabis Council.

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Is it time for a T (tolerance)-break?

A medical cannabis prescriber explains why it’s important to take a break

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Medical cannabis users may experience their treatment becoming less effective

How do you know if it’s time to take a tolerance break? Dr Niraj Singh, a consultant psychiatrist and member of the Medical Cannabis Clinicians Society, explains.

Dr Niraj Singh

Dr Niraj Singh

Medical cannabis is used increasingly for a range of conditions including anxiety, depression, PTSD, ADHD, pain, fibromyalgia and others.

But we all need a break from time to time, and so it seems do our cannabinoid receptors. 

Readers will be familiar with the issue of tolerance developing with continuous use of medical cannabis. The definition of tolerance is “a person’s diminished response to a drug, which occurs when the drug is used repeatedly and the body adapts to the continued presence of the drug.”

The cannabinoid receptor 1 lies mainly within the brain and spinal cord. THC binds directly to this and CBD indirectly. With continuous binding of THC, CB1 become ‘down regulated’ ; this means a decrease in the number of receptors on the surface of target cells, making the cells less sensitive to THC binding. 

Medical cannabis users may experience this as their treatment becoming less effective and the requirement to take more for symptomatic relief.

Timing for development of tolerance will depend on one’s history of cannabis use, the chemovar of the product itself and other physiological factors. 

At times therefore the CB1 receptors need a rest. With reduced consumption, this gives the ‘overworked’ receptors a break, giving them a chance to expand in number again, a term called ‘up regulation’. 

The idea of reducing consumption can be anxiety provoking for users and not an easy one, however the benefits are unquestionable. With up regulation, a lesser amount of medical cannabis product is required for the same effect. Using less product, also means less financial expense. 

There is no specific guidance on the time frame for how long a tolerance break should be. Up regulation is said to take place 48-72 hours hours after stoppage and levels out between 21 days and 4 weeks after, so this is the range after which most benefits can take place. This is because THC clears the system completely within this latter period.  

A T-break has to be balanced with the patient’s circumstances, current symptoms, as well as risk of any deterioration in health. Treatment dosages can also be reduced gradually rather than sudden stoppage.

It’s important therefore that any tolerance breaks take place during periods of less stress. Alongside ensuring regular exercise and a healthy diet to boost the endocannabinoid system (ECS) is important. 

One can still use CBD and terpenes during the tolerance break periods. If there are any problems with sleep, natural supplements can be used.

Once medical cannabis is re-started, it’s important that this is gradually built up rather than starting back on the dosage used prior to the tolerance break.

It’s vital that the doctor and patient discuss the tolerance break and agree on a plan.  It’s important that patients discuss this with people in their household and those in close proximity as irritability and frustration can occur particularly in the early stages.

A few things to remember:

  • A T-break should be planned and measures put in place to ease it as best possible. Decide on a realistic time frame. Doctors and patients need to discuss and agree this also.
  • Ensure it happens at a time of fewer stressors but at the same time ensure a good level of activity is taking place to ensure the mind is focused elsewhere.
  • Ensure a healthy diet and adequate exercise. Connect with the natural environment.
  • Use natural supplements for sleep where required.
  • If needs be use CBD oil which is broad spectrum with a good range of terpenes.
  • Stay resolute but also realistic. Remember any break above 72 hours will be beneficial.
  • Build up the dosage gradually after re-starting.

Find out more about joining the MCCS here

If you’d like to share your experience and insight as a medical cannabis prescriber or patient, we’d love to hear from you. Please email sarah@handwmedia.co.uk

READ MORE  The stress-free route to accessing prescribed cannabis medicines 
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