There was a degree of frustration in Deputy Montfort Tadier’s recent email concerning medician cannabis, and the current position recommending against prescribing it. It is worth therefore reviewing recent changes which have taken place in the UK, where very much the same problems arise.
It should be noted that the legalisation of medical cannabis in the first instance has not opened the doors to a flood of prescriptions in the UK, but a mere trickle. But what it has done of significance is to allow products when licenced to come into Jersey with rapid effect, and also in the UK, to facilitate medical trials which can now be conducted without the previous legal restraints.
To understand what was the position, a very succinct précis is given in the Open Access Government website:
“The medical benefits of cannabis – including pain management, seizure remediation, muscle spasms management and others – have been well known for centuries. However, over the past century, cannabis has become a proscribed substance and treated as a law-enforcement challenge. As a result, it has become difficult for researchers to get approval and funding for properly controlled cannabis studies and users are unable, or unwilling, to share their experiences. Consequently, doctors and other practitioners lack trusted information on which to base clinical decisions.”
“Altogether, these factors have led to significant under-prescription of medical cannabis, there has been a large, unfilled demand for quality research, new product delivery methods and consumer information on the uses and effects of this substance.”
The change in the law means that when we look at the Pharmaceutical Journal for 16 January 2019,, we note significant changes in protocols and monitoring. As the market is very much an emerging one, monitoring programmes are key to successful prescriptions:
“A system to monitor the prescribing of cannabis-based products for medicinal use has been established, despite prescribing appearing to be incredibly low. NHS England has established a system to monitor the prescribing of cannabis-based products for medicinal use, with the first data expected by the end of March 2019, health minister Steve Brine has said. Brine was responding to a question from Jim Cunningham MP, following concerns that despite the legal change to the status of medical cannabis, very few, if any, NHS prescriptions have been written.”
“NHS-commissioned interim guidance on the use of cannabis-derived medical products, produced by the British Paediatric Neurology Association (BPNA) and the Royal College of Physicians (RCP), has been criticised as too restrictive, leaving consultant doctors — the only doctors allowed to prescribe the drugs — unwilling to do so. Genevieve Edwards, director of external affairs at charity the MS Society, told The Pharmaceutical Journal that, as far as the Society was aware, no patient with multiple sclerosis has been able to access a cannabis-based medicine since the law changed — a situation she described as “incredibly frustrating”.
It is clear that the same frustration felt by Deputy Tadier is also felt by others, such as Genevieve Edwards. But meanwhile, a wider analysis, also looking beyond the UK, has produced new guidance as reported in the 21 March 2019 edition of The Pharmaceutical Journal:
“New guidance has identified conditions for which it says there is strong or weak evidence of efficacy of medical cannabis treatment. Guidance for the prescription of medical cannabis has been issued by the by the Medical Cannabis Clinicians’ Society (MCCS) and the All-Party Parliamentary Group (APPG) for Medical Cannabis under Prescription. Published on 20 March 2019, the guidance identifies conditions for which it says there is “conclusive or substantial”, “moderate”, and “limited” evidence of efficacy of medical cannabis treatment — as well as those for which it says there is “no conclusive evidence”.
“In the conclusive category, the guidance lists spasticity, pain, chemotherapy-related nausea and vomiting, and epilepsy. It says there is currently no conclusive evidence for efficacy in a range of conditions, including behavioural control in dementia, depression and cancer.”
“The MCCS recommends that “given that there are few doctors familiar with cannabis medicine, a specialist does not refuse prescription based on their own lack of understanding but seeks to work with an expert cannabis physician”. To date, there have been no recorded NHS prescriptions for the drug and only a handful of private prescriptions since medical cannabis products were rescheduled in November 2018.”
Part of the reason for resistance to prescription is that it is an emerging medical market, and enough evidence for prescribing, as well as contra-indications, reactions with existing drug regimes etc (a cancer patient may be on multiple drug regimes), does not really exist in detail, and that the manufacturers seem to be reluctant to engage with trials.
This was the frustrating aspect cited by Keith Ridge, chief pharmaceutical officer for England, on 28 March 2019:
“Evidence for the prescribing of medical cannabis is lacking, Keith Ridge, chief pharmaceutical officer for England, has told MPs. Robust, randomised controlled trials (RCTs) are “top of the list”, he added.”
“Baroness Blackwood, under secretary of state for health and social care, told the committee that “pressure should be put on the industry” to fund RCTs, echoing sentiments previously expressed by Dame Sally Davies, chief medical officer for England. Committee chair Sarah Wollaston asked Blackwood what could be done if manufacturers refused to supply a medical cannabis product for trials. She said the British Paediatric Neurology Association had told the committee that they “haven’t been able to secure an agreement from [medical cannabis producer] Tilray to provide the product for a trial that they are proposing to conduct”.
“Blackwood replied that such a response was “completely unacceptable” from a cannabis company. “We obviously need to develop the clinical evidence. I can’t understand for the life of me why a cannabis company wouldn’t want to develop the evidence base in order for their drug to be more prescribed and for there to be more confidence in it,” she said.”
Meanwhile on 9th March 2019, a specialist clinic, staffed by professionals opened in the UK:
“Britain's first medical cannabis clinic opened in Manchester this week despite only just four patients having successfully obtained cannabis-based treatments since their use was legalised in the country late last year. The private clinic is Manchester will deal with patients suffering from chronic pain conditions, neurological condition such as epilepsy, Alzheimer's and Parkinson's disease and psychiatric problems including depression, anxiety and post-traumatic stress disorder.”
"The legalisation of prescription cannabis has given people with chronic illnesses hope; the next step is to ensure the availability of medical cannabis to offer those without other alternatives the treatment they need," Hannah Simon from European Cannabis Holdings — the private investment group behind the new clinics — said in a statement. Two other clinics are also expected to open in London and Birmingham later this spring.
The Open Government Access site has more details:
“The first clinic will open at The Beeches Consulting Centre in Manchester in March and will be led by Dr David McDowell, a Consultant in Pain Management who issued the first prescription for medical cannabis in December. Clinics will then open in London across multiple disciplines including neurology and psychiatry in addition to chronic pain, on Harley Street, and in Birmingham later this spring.”
“Professor Mike Barnes, a consultant neurologist, will serve as the Clinical Director of the Clinics. Prof Barnes was responsible for obtaining the first medicinal cannabis licence for Alfie Dingley. He is also one of the world’s foremost experts in medical cannabis whose 2016 report ‘Cannabis: The Evidence for Medical Use’ helped pave the way for legalisation of medical cannabis.”
And finally, Jersey also has a mention in the 26 March edition of Pharmaceutical Journal:
“The Jersey government should support doctors on the island to prescribe medical cannabis, a member of the States Assembly of Jersey has said. Speaking to the Jersey Evening Post on 18 March 2019, Rowland Huelin, deputy for the Parish of St Peter, Jersey, said the government should work with doctors to “hopefully, accelerate its usage” after all doctors on the island were given permission to prescribe medical cannabis.”
“The law came into effect on 28 February 2019, but on 1 March 2019, Nigel Minihane, chair of the Jersey Primary Care Body, which represents Jersey GPs, told Channel 103, a local radio station, that GPs had been asked not to prescribe the drugs. Minihane said there were “lots of reasons” why GPs would not currently be able to prescribe medical cannabis, but highlighted the risk of a negligence claim being brought against a doctor.”
“Naomi Mews, a prescribing support pharmacist and a Jersey Local Practice Forum lead, speaking to The Pharmaceutical Journal in a personal capacity, said she was not aware of any licensed or unlicensed cannabis-based medical products having been added to the Prescribed List, which details the medicines available for prescription to Jersey residents. “For a medicine to be considered for addition to the list it must be recommended by a registered medical practitioner or pharmacist contractor, and be reviewed by a committee that has oversight over changes to the limited list,” said Mews, adding that any proposed additions then have to be ratified by the minister for social security.
"Mews said this was one of the “potential barriers to the provision of cannabis products through primary care at this time”, also citing GPs’ concerns about insurance and “a lack of clinical knowledge or experience in use in the practice of medicine of cannabis-based products”.
This brings us full circle, and very much highlights the dilmemnas of cannabis prescription. While patients may be eager to have the benefits of medical cannabis, the issue of a litigation against a doctor is a very real one.
Perhaps one way round the impasse might be for medics and politicians alike to work towards engaging with manufacturers and prescribing in accordance with the UK guidelines, but setting up and arranging medical trials for the manufacturer. As trials always contain a degree of risk, patients in would have to give consent and sign a waiver to acknlowlegde it was an experimental trial. This is, however, a complex process, as can be seen from such literature as “Clinical trials litigation: Practical realities as Seen from the Trenches” (2005)
The creation of private clinics in the UK are also worth investigation, in order to see what protocols they follow, and how they deal with the potential claims for negligence. That would also be worth investigation, so as to benefit from understanding what best practice is being followed there.
In the meantime, small comfort though it is, the fact that the recent legislation of medical cannabis has thrown open the doors to an emerging multimillion pound market means that the number of trials will rise exponentially over the next few years, and probably no more than one or two years down
References
https://www.openaccessgovernment.org/how-trusted-data-is-helping-to-liberate-the-power-of-medical-cannabis/44954/
https://www.pharmaceutical-journal.com/news-and-analysis/news/data-on-nhs-medicinal-cannabis-prescribing-expected-by-end-of-march-2019/20205989.article?firstPass=false
https://www.pharmaceutical-journal.com//news-and-analysis/news/medical-cannabis-clinicians-society-publishes-guidance-for-prescribers/20206324.fullarticle?firstPass=false#cxrecs_s
https://www.pharmaceutical-journal.com//news-and-analysis/news/medical-cannabis-industry-should-be-told-to-provide-evidence-if-it-wants-products-prescribed-mps-hear/20206346.fullarticle?firstPass=false#cxrecs_s
https://www.euronews.com/2019/03/09/first-medical-cannabis-clinic-opens-in-the-uk
https://www.openaccessgovernment.org/ech-uk-medical-cannabis-clinics/60046/
https://www.pharmaceutical-journal.com//news-and-analysis/news-in-brief/support-jerseys-gps-to-prescribe-medical-cannabis-deputy-says/20206313.fullarticle?firstPass=false#cxrecs_s
https://www.researchgate.net/publication/7722524_Clinical_trials_litigation_Practical_realities_as_Seen_from_the_Trenches
It should be noted that the legalisation of medical cannabis in the first instance has not opened the doors to a flood of prescriptions in the UK, but a mere trickle. But what it has done of significance is to allow products when licenced to come into Jersey with rapid effect, and also in the UK, to facilitate medical trials which can now be conducted without the previous legal restraints.
To understand what was the position, a very succinct précis is given in the Open Access Government website:
“The medical benefits of cannabis – including pain management, seizure remediation, muscle spasms management and others – have been well known for centuries. However, over the past century, cannabis has become a proscribed substance and treated as a law-enforcement challenge. As a result, it has become difficult for researchers to get approval and funding for properly controlled cannabis studies and users are unable, or unwilling, to share their experiences. Consequently, doctors and other practitioners lack trusted information on which to base clinical decisions.”
“Altogether, these factors have led to significant under-prescription of medical cannabis, there has been a large, unfilled demand for quality research, new product delivery methods and consumer information on the uses and effects of this substance.”
The change in the law means that when we look at the Pharmaceutical Journal for 16 January 2019,, we note significant changes in protocols and monitoring. As the market is very much an emerging one, monitoring programmes are key to successful prescriptions:
“A system to monitor the prescribing of cannabis-based products for medicinal use has been established, despite prescribing appearing to be incredibly low. NHS England has established a system to monitor the prescribing of cannabis-based products for medicinal use, with the first data expected by the end of March 2019, health minister Steve Brine has said. Brine was responding to a question from Jim Cunningham MP, following concerns that despite the legal change to the status of medical cannabis, very few, if any, NHS prescriptions have been written.”
“NHS-commissioned interim guidance on the use of cannabis-derived medical products, produced by the British Paediatric Neurology Association (BPNA) and the Royal College of Physicians (RCP), has been criticised as too restrictive, leaving consultant doctors — the only doctors allowed to prescribe the drugs — unwilling to do so. Genevieve Edwards, director of external affairs at charity the MS Society, told The Pharmaceutical Journal that, as far as the Society was aware, no patient with multiple sclerosis has been able to access a cannabis-based medicine since the law changed — a situation she described as “incredibly frustrating”.
It is clear that the same frustration felt by Deputy Tadier is also felt by others, such as Genevieve Edwards. But meanwhile, a wider analysis, also looking beyond the UK, has produced new guidance as reported in the 21 March 2019 edition of The Pharmaceutical Journal:
“New guidance has identified conditions for which it says there is strong or weak evidence of efficacy of medical cannabis treatment. Guidance for the prescription of medical cannabis has been issued by the by the Medical Cannabis Clinicians’ Society (MCCS) and the All-Party Parliamentary Group (APPG) for Medical Cannabis under Prescription. Published on 20 March 2019, the guidance identifies conditions for which it says there is “conclusive or substantial”, “moderate”, and “limited” evidence of efficacy of medical cannabis treatment — as well as those for which it says there is “no conclusive evidence”.
“In the conclusive category, the guidance lists spasticity, pain, chemotherapy-related nausea and vomiting, and epilepsy. It says there is currently no conclusive evidence for efficacy in a range of conditions, including behavioural control in dementia, depression and cancer.”
“The MCCS recommends that “given that there are few doctors familiar with cannabis medicine, a specialist does not refuse prescription based on their own lack of understanding but seeks to work with an expert cannabis physician”. To date, there have been no recorded NHS prescriptions for the drug and only a handful of private prescriptions since medical cannabis products were rescheduled in November 2018.”
Part of the reason for resistance to prescription is that it is an emerging medical market, and enough evidence for prescribing, as well as contra-indications, reactions with existing drug regimes etc (a cancer patient may be on multiple drug regimes), does not really exist in detail, and that the manufacturers seem to be reluctant to engage with trials.
This was the frustrating aspect cited by Keith Ridge, chief pharmaceutical officer for England, on 28 March 2019:
“Evidence for the prescribing of medical cannabis is lacking, Keith Ridge, chief pharmaceutical officer for England, has told MPs. Robust, randomised controlled trials (RCTs) are “top of the list”, he added.”
“Baroness Blackwood, under secretary of state for health and social care, told the committee that “pressure should be put on the industry” to fund RCTs, echoing sentiments previously expressed by Dame Sally Davies, chief medical officer for England. Committee chair Sarah Wollaston asked Blackwood what could be done if manufacturers refused to supply a medical cannabis product for trials. She said the British Paediatric Neurology Association had told the committee that they “haven’t been able to secure an agreement from [medical cannabis producer] Tilray to provide the product for a trial that they are proposing to conduct”.
“Blackwood replied that such a response was “completely unacceptable” from a cannabis company. “We obviously need to develop the clinical evidence. I can’t understand for the life of me why a cannabis company wouldn’t want to develop the evidence base in order for their drug to be more prescribed and for there to be more confidence in it,” she said.”
Meanwhile on 9th March 2019, a specialist clinic, staffed by professionals opened in the UK:
“Britain's first medical cannabis clinic opened in Manchester this week despite only just four patients having successfully obtained cannabis-based treatments since their use was legalised in the country late last year. The private clinic is Manchester will deal with patients suffering from chronic pain conditions, neurological condition such as epilepsy, Alzheimer's and Parkinson's disease and psychiatric problems including depression, anxiety and post-traumatic stress disorder.”
"The legalisation of prescription cannabis has given people with chronic illnesses hope; the next step is to ensure the availability of medical cannabis to offer those without other alternatives the treatment they need," Hannah Simon from European Cannabis Holdings — the private investment group behind the new clinics — said in a statement. Two other clinics are also expected to open in London and Birmingham later this spring.
The Open Government Access site has more details:
“The first clinic will open at The Beeches Consulting Centre in Manchester in March and will be led by Dr David McDowell, a Consultant in Pain Management who issued the first prescription for medical cannabis in December. Clinics will then open in London across multiple disciplines including neurology and psychiatry in addition to chronic pain, on Harley Street, and in Birmingham later this spring.”
“Professor Mike Barnes, a consultant neurologist, will serve as the Clinical Director of the Clinics. Prof Barnes was responsible for obtaining the first medicinal cannabis licence for Alfie Dingley. He is also one of the world’s foremost experts in medical cannabis whose 2016 report ‘Cannabis: The Evidence for Medical Use’ helped pave the way for legalisation of medical cannabis.”
And finally, Jersey also has a mention in the 26 March edition of Pharmaceutical Journal:
“The Jersey government should support doctors on the island to prescribe medical cannabis, a member of the States Assembly of Jersey has said. Speaking to the Jersey Evening Post on 18 March 2019, Rowland Huelin, deputy for the Parish of St Peter, Jersey, said the government should work with doctors to “hopefully, accelerate its usage” after all doctors on the island were given permission to prescribe medical cannabis.”
“The law came into effect on 28 February 2019, but on 1 March 2019, Nigel Minihane, chair of the Jersey Primary Care Body, which represents Jersey GPs, told Channel 103, a local radio station, that GPs had been asked not to prescribe the drugs. Minihane said there were “lots of reasons” why GPs would not currently be able to prescribe medical cannabis, but highlighted the risk of a negligence claim being brought against a doctor.”
“Naomi Mews, a prescribing support pharmacist and a Jersey Local Practice Forum lead, speaking to The Pharmaceutical Journal in a personal capacity, said she was not aware of any licensed or unlicensed cannabis-based medical products having been added to the Prescribed List, which details the medicines available for prescription to Jersey residents. “For a medicine to be considered for addition to the list it must be recommended by a registered medical practitioner or pharmacist contractor, and be reviewed by a committee that has oversight over changes to the limited list,” said Mews, adding that any proposed additions then have to be ratified by the minister for social security.
"Mews said this was one of the “potential barriers to the provision of cannabis products through primary care at this time”, also citing GPs’ concerns about insurance and “a lack of clinical knowledge or experience in use in the practice of medicine of cannabis-based products”.
This brings us full circle, and very much highlights the dilmemnas of cannabis prescription. While patients may be eager to have the benefits of medical cannabis, the issue of a litigation against a doctor is a very real one.
Perhaps one way round the impasse might be for medics and politicians alike to work towards engaging with manufacturers and prescribing in accordance with the UK guidelines, but setting up and arranging medical trials for the manufacturer. As trials always contain a degree of risk, patients in would have to give consent and sign a waiver to acknlowlegde it was an experimental trial. This is, however, a complex process, as can be seen from such literature as “Clinical trials litigation: Practical realities as Seen from the Trenches” (2005)
The creation of private clinics in the UK are also worth investigation, in order to see what protocols they follow, and how they deal with the potential claims for negligence. That would also be worth investigation, so as to benefit from understanding what best practice is being followed there.
In the meantime, small comfort though it is, the fact that the recent legislation of medical cannabis has thrown open the doors to an emerging multimillion pound market means that the number of trials will rise exponentially over the next few years, and probably no more than one or two years down
References
https://www.openaccessgovernment.org/how-trusted-data-is-helping-to-liberate-the-power-of-medical-cannabis/44954/
https://www.pharmaceutical-journal.com/news-and-analysis/news/data-on-nhs-medicinal-cannabis-prescribing-expected-by-end-of-march-2019/20205989.article?firstPass=false
https://www.pharmaceutical-journal.com//news-and-analysis/news/medical-cannabis-clinicians-society-publishes-guidance-for-prescribers/20206324.fullarticle?firstPass=false#cxrecs_s
https://www.pharmaceutical-journal.com//news-and-analysis/news/medical-cannabis-industry-should-be-told-to-provide-evidence-if-it-wants-products-prescribed-mps-hear/20206346.fullarticle?firstPass=false#cxrecs_s
https://www.euronews.com/2019/03/09/first-medical-cannabis-clinic-opens-in-the-uk
https://www.openaccessgovernment.org/ech-uk-medical-cannabis-clinics/60046/
https://www.pharmaceutical-journal.com//news-and-analysis/news-in-brief/support-jerseys-gps-to-prescribe-medical-cannabis-deputy-says/20206313.fullarticle?firstPass=false#cxrecs_s
https://www.researchgate.net/publication/7722524_Clinical_trials_litigation_Practical_realities_as_Seen_from_the_Trenches
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3 comments:
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