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Calls for cannabis medicines to be added to NHS drug dictionary

Their exclusion could lead to potentially “dangerous” contraindications

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NHS
Unlicensed cannabis products are not listed in the NHS dictionary of medicines and devices

Patients have joined calls for cannabis-based medicines to be added to the NHS drug dictionary, saying their exclusion could lead to potentially “dangerous” contraindications.

Patient organisation PLEA (Patient-Led Engagement for Access) has joined clinics in the sector and MPs, calling for cannabis-based products to be added to the NHS dictionary of medicines and devices.

As most cannabis medicines are unlicensed in the UK, they are not listed in the database, with only the licensed cannabis-based medicines Nabilone, Epidyolex and Sativex currently included.

This means that those who have legal prescriptions for medical cannabis currently have no record of this in their GP notes, other than any letters which have been sent from their private clinic.

Experts have highlighted the “danger” this poses, with patients at risk of being prescribed medications with known contraindications if their doctors are not aware they are taking cannabis.

Scottish National Party MP, Alyn Smith, raised the issue in a parliamentary debate on Thursday 4 November. 

Smith, whose Stirling constituency is home to Scotland’s first medical cannabis clinic, also highlighted that bringing all cannabis prescriptions into the NHS drug dictionary would allow for “better assessment of the scale of prescriptions already in existence, along with “better analysis”.

Smith, who was himself diagnosed with arthritis nine years ago, said: “What it has given me is a really keen awareness that pain management and chronic medical conditions are life-defining for millions and millions of the people that we serve. Medical cannabis, anything that can help and alleviate those conditions surely needs to be properly worked through for the benefit of those millions of people… it shouldn’t be held back by outdated thinking.”

Smith has been working closely with Sapphire Medical Clinics, which opened its Stirling clinic earlier this year. 

Speaking at the summary event of Medical Cannabis Awareness Week on Sunday 7 November, Sapphire’s head of communications, Beth Sweet-Escott said: “One thing that we can push for immediately is for NHS Digital to add cannabis-based medicines –  all the different types of medicines – to the NHS drugs dictionary.  

“At the moment they’re not included and that is actually really dangerous and has impacts for things like contraindications. This is something that needs to happen very quickly… so that it’s transparent and on the record.”

Sweet-Escott, also highlighted that this would help with clinician education around medical cannabis.

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She continued: “One of the main focuses is to increase education awareness. The Primary Care Cannabis Network carried out research on GPs earlier this year, and found that there’s still a huge kind of lack of awareness, even though GPs asked on a daily basis about CBD and cannabis by patients.

“All healthcare professionals have so much to learn when they are starting out, but this is a vastly growing patient community who are being helped and there’s no other option but to provide education and support conditions, on safety data, on efficacy data, on adverse events. Cannabis is a very complex medicine.”

Also on the panel, medical cannabis patient Lex Wolfe, revealed that they were almost prescribed an antidepressant with known contraindications with cannabis, due to their prescription not being in their medical records. 

“Nowhere on my health records – other than a couple of letters from my cannabis clinic – does it state that I’m a medical cannabis patient,” said Lex.

“I’ve had GPs try to prescribe me tricyclic antidepressants, which have known contraindications with cannabis products. They can cause tachycardia and as a patient that already has tachycardia issues that can be really dangerous.”

A spokesperson for NHS Business Services Authority, which manages the NHS dictionary of medicines and devices, told Cannabis Health that products would be added once they received regulatory approval from the Medicines and Healthcare Products Regulatory Agency (MHRA).

They added that the “lack of standardised information” creates challenges when authoring in the dictionary of medicines and devices.

“The NHS dictionary of medicines and devices (dm+d) aims to include any regulatory approved licensed medicine that has undergone robust assessment by the Medicines and Healthcare Products Regulatory Agency (MHRA) to support prescribing and dispensing purposes. Regulatory approved documentation is aligned with credible standards (e.g., Pharmaceutical form) that helps support inclusion of product profiles in dm+d,” they said.

“Many cannabis-based products are not licensed in this country and in the absence of more products not being approved by the national regulatory agency, the lack of reputable and standardised information creates challenges for authoring on dm+d.

 “We’ll continue to review products and as soon as any achieve a reputable regulatory approved status they will be added to the NHS dictionary.”

The Department of Health said that “the majority” of products containing THC and CBD products, are unlicensed and have not demonstrated “clear evidence of their safety, clinical and cost effectiveness”.

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They added that they continue to back further research and look at how to minimise the costs of these medicines.

A spokesperson said: “Three cannabis-based medicines have been made available for prescribing on the NHS for patients with multiple sclerosis or hard to treat epilepsies, where clinically appropriate.

“The NHS dictionary of medicines and devices aims to include information on licensed medicines approved by the UK’s independent regulator, the MHRA, to support both prescribing and dispensing – including Nabilone, Epidyolex and Sativex.

“Currently, many cannabis-based products are not licensed. This means there is a lack of standardised information on these products, which creates challenges for adding them to the dictionary. We are working closely with the NHS and the National Institute of Health Research to establish clinical trials to develop the evidence base to support further commissioning decisions.”

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US Congresswoman speaks out about how cannabis helped her depression

Nancy Mace spoke out about using cannabis to help her depression after experiencing a traumatic event as a teenager

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Image credit: Nancy Mace/Instagram

A Republican congresswoman who has proposed a federal bill to legalise cannabis has spoken out about her experience using cannabis to combat depression.

Nancy Mace, a republican politician from South Carolina appeared on Fox Business’s ‘Kennedy’ show to talk about the bill which would legalise cannabis but would also focus on veteran access.

It also includes expungement for non-violent cannabis crimes and imposes a revenue tax that would support reinvestment into communities hurt by the war on drugs.

Bill: A banner for always pure organics

The bill titled the States Reform Act would federally legalise and tax cannabis has been proposed ahead of competing Democrat proposed bills. While the bill was originally proposed in July, Mace shared her story after officially filing the State Reform Act in November.

At the end of the discussion, host, Lisa “Kennedy” Montgomery asked the congresswoman if she smoked cannabis.

Nancy replied: “When I was 16, I was raped. I was given prescription medication that made the feelings I had of depression worsen, and I stopped taking those prescription drugs and I turned to cannabis for a brief period of time in my life.”

She added that she believed her experience with cannabis made her more sympathetic to veterans who may use cannabis for conditions such as post-traumatic stress disorder (PTSD).

Bill protection for veterans

The congresswoman explained that the new bill is “particularity protective of veterans, ensuring they are protected, not discriminated against and that the US Department of Veteran Affairs can utilise cannabis for their PTSD.”

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She added: “When I talk to vets and I see that pain, it hurts because I felt that pain before in my life. Veteran suicide, we see every single day.”

One other provision in the bill is that cannabis would be under the Treasury Department’s Alcohol and Tobacco Tax and Trade Bureau (TTB) instead of the Food and Drug Administration (FDA). The FDA would have some involvement similar to its current control over the alcohol industry.

Bill history

Mace has already won an exception for rape and incest victims in a fatal fetal heartbeat bill. She mentioned her history when it came to proposing that bill in 2019.

She said: “I’ve had family that have overdosed from hardcore opiates and prescription drugs. And I’ve mentioned part of this in 2019, at the time I got the exception for rape and incest in the fetal-heartbeat bill I told my story about being raped when I was 16, but I’ve never said this part publicly before: I was prescribed antidepressants afterwards, and it made my feelings a lot worse. And so I started using cannabis for a brief moment, for a time in my life. It helped me. It cut down on my anxiety and helped me get through some dark periods.”

 

Fibromyalgia: A banner advert for cannabis health news

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First patient set to receive cannabis products on Ireland’s MCAP programme

CannEpil is the first drug available through the programme but has yet to be prescribed

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Ireland HSE offer medical cannabis
CannEpil was announced as the first drug to be made available through the programme

Earlier this year, the Irish Health Service Executive (HSE) has announced that the first cannabis-based products will be available through the Medical Cannabis Access Programme from mid-October.

Despite an update from the Irish health service (HSE) and Health Products Regulatory Authority (HPRA) that CannEpil would be prescribed by the middle of October, the first prescription has been delayed.

People before Profit TD for Dublin Mid-West Gino Kenny tweeted that the first prescription should be available from next week.

The HSE has yet to confirm that the products will be available from next week but says they would not be aware until the consultant neurologist has issued claims at the end of the month.

In a statement to Cannabis Health News, a press officer at the HSE stated: “The HSE has registered three patients under the MCAP in recent days. We would not be aware whether the consultant neurologist has proceeded with prescribing for an individual until claims were submitted from pharmacies at the end of the month.”

He also raised the issue in the Dáil earlier this month to Taoiseach, Michael Martin.

“Many families would have been very joyous during the summer when the medical cannabis access programme was to commence. But sadly, in a PQ response today, not one patient has been given access thus far. That is a huge disappointment to those families that this treatment could make life-changing benefits,” he said.

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“So what do you say to families that feel let down by the program and now they have to look at other treatments and probably getting no treatment at all?” He asked.

Michael Martin replied that a lot of patients have been facilitated by the original ‘imported license’ but he was unsure as to why patients had not availed of the MCAP. He promised to follow up with the Minister for Health, Stephen Donnelly of Fianna Fáil.

Gino announced changes to the Cannabis Regulation and Control bill that he is due to submit. It will now take place next year with a focus on production and consumption for personal use.

HSE committee meeting

In a joint committee meeting held in September, CannEpil was announced as the first drug to be made available through the program from mid-October.

Ireland’s Health minister Stephen Donnelly announced funding for the Medical Cannabis Access Programme (MCAP) in January, almost two years since the legislation was signed off in June 2019.

The programme will offer access to cannabis-based medicines to people living with one of three qualifying conditions. These include intractable nausea and vomiting associated with chemotherapy, severe treatment-resistant epilepsy and spasticity associated with multiple sclerosis (MS) where patients have failed to respond to authorised treatments.

The meeting saw officials from the Department of Health and the Health Products Regulatory Authority (HPRA) outline the current state of the MCAP programme and the Ministerial License system.

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The suppliers of two products, CannEpil and Tilray are said to have confirmed their prices to the HSE, but Tilray has yet to announce its availability date.  Two more cannabis-based products have been added to the schedule but suppliers are not thought to have current plans to supply the Irish market.

Morris O’Connor, the assistant national director of primary care reimbursement, announced that two additional products were expected to be added to the schedule in the coming weeks and that the programme may be extended for longer than the initial five year pilot period.

He stated: “There are currently four cannabis products on the schedule and two more to be added to schedule one of the regulations in the coming weeks. I understand that one of the products in the schedule namely CannEpil is expected to be available in October, subsequent to the introduction of the necessary legislation.”

According to Lorraine Nolan the chief executive of HPRA, since the MCAP regulations came into force in June 2019, 34 applications have been made for cannabis-based products.

Of these four cannabis oils have been placed in schedule one of the regulations, and two dry herb products have completed the final HPRA review and are awaiting a ministerial decision. Five are currently under active review.

Nolan commented: “The first cannabis-based products are expected to be made available to Irish patients through MCAP in October 2021. Once these are accessed by Irish patients, the HPRA will receive any reports of suspected adverse events and review them for any signals of concern regarding the safety of the product.

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“The HPRA will also have a role in investigating any quality issues that may arise and coordinate any action that might be subsequently required.”

Doctors are asked to register patients who may benefit from this treatment to the HSE including the condition they are being prescribed for.

The HPRA will be monitoring patients for adverse effects over the coming weeks once the medication is available.

The MCAP programme has been criticised by patients who are still waiting for access to products despite the introduction of the scheme in 2019 under then Minister for Health, Simon Harris.

O’Conner also highlighted that 192 ministerial licenses have already been issued for 67 individuals who access medication from the Netherlands.

In July a direct funding scheme was announced to remove the need for patients to pay for these prescriptions up front and then apply for reimbursement from the Government.

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Irish politicians receive cannabis in mail to mark National Legalise Cannabis day

The letters outlined the reasons why legalising cannabis in Ireland needs to be a top priority for government officials.

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Irish: A banner advert for National Legalise cannabis day

Two hundred Irish TDs received a letter outlining the reasons for cannabis legalisation and a roll-up in the post sparking an investigation

The cannabis was sent by An Póst by leading cannabis activists to mark National Legalise Cannabis Day in Ireland. The cannabis was accompanied by a letter outlining ten reasons why cannabis should be legalised and made accessible. Cannabis activists including Cannabis Activist Alliance, ReLeaf CBD Café, and Martin Condon from the podcast Martin’s World shared images of the letters online before sending them to ministers.

Two hundred letters containing cannabis roll-ups and edibles were sent to ministers including the President of Ireland, Michael D Higgins. A further forty were sent to members of the media and senators. Mary Lou McDonald of Sinn Fein was even sent a tricolour roll-up.

In a statement online, those involved encouraged other cannabis consumers and activists to get involved in the action.

“To mark the 20th anniversary of this event the Martins World Podcast, The Cannabis Activist Alliance and the ReLeaf Cafe have teamed up to recreate this event. Cannabis containing joints will again be posted to every TD and Senator in Ireland. With the joint, we will include a letter about the campaign and 10 reasons why Cannabis prohibition should be ended (there are thousands to choose from). We encourage anyone who wants to get involved to do so. It will only cost you the price of a stamp and envelope.”

Some of the benefits listed in the letters included the creation of jobs, open access for patients and researchers, the end to the discrimination faced by patients and also the protection of minors with the introduction of regulation.

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Irish cannabis market

While the letter highlighted the reasons why cannabis should be legalised in Ireland, it also gave a stern warning about the dangers of buying cannabis from an unregulated market.

“As this product was sourced from an unregulated market, you as a consumer have very little protection. There is no guarantee that this joint contains any cannabis. If it does contain cannabis you as a consumer have no idea as to the potency of the cannabis. This makes dosing incredibly difficult and could put you at risk.”

The action has sparked an investigation by Irish authorities after scanners at the ministerial buildings failed to recognise the substance. It was reported that nearly all of the Green party received a letter along with members of Fianna Fáil and Fine Gael.

Irish ministers response

Most of the ministers have not confirmed if they have or have not received the letters. However, Cathal Crowe, a Fianna Fáil TD for Clare posted a photo of the letter on Twitter confirming he had received one.

Irish Green party councillor, Oliver Moran also received a letter and tweeted his response. “Many thanks for including me in this action—and for the prudent warning that potency and content are unknown when drugs are purchased from an underground market.”

November 5 was declared  National Legalise Cannabis Day by Independent TD, Luke Ming Flanagan back in 2001. The letters campaign was created to mark the 20th anniversary of this.

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Ireland’s cannabis reform

The campaign comes amidst criticism that the Medical Cannabis Access Programme is still not functioning despite reassurances that Cannephil would be available from mid-October.

People before Profit TD for Dublin Mid-West, Gino Kenny raised the issue in the Dáil to Taoiseach, Michael Martin.

“Many families would have been very joyous during the summer when the medical cannabis access programme was to commence. But sadly, in a PQ response today, not one patient has been given access thus far. That is a huge disappointment to those families that this treatment could make life-changing benefits,” he said.

He added: “So what do you say to families that feel let down by the program and now they have to look at other treatments and probably getting no treatment at all?”

Michael Martin replied by saying that a lot of patients have been facilitated by the original ‘imported license’ but was unsure as to why patients had not availed of the MCAP. He promised to follow up with the Minister for Health which is currently Stephen Donnelly of Fianna Fáil.

Gino also announced changes to the Cannabis Regulation and Control bill that he is due to submit. It will now take place next year with a focus on production and consumption for personal use.

Image credit : Martin’sWorld

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