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Product recall after reports of medical cannabis contaminated with mould

Two batches of medical cannabis products have been recalled while investigations are carried out.

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The pharmacy is requesting that all patients discontinue their use of the products

Two batches of medical cannabis products have been recalled by regulators as investigations are carried out, following reports they may be contaminated with mould.

Medical cannabis pharmacy, Dispensary Green and the Medicines and Healthcare products Regulatory Agency (MHRA) have issued a ‘precautionary’ product recall since being made aware of ‘defects’ in patient’s medication.

Concerns were initially raised after a number of medical cannabis patients spotted what they believed to be mould spores in their prescriptions. 

Last week Dispensary Green released a statement confirming that ‘inconsistencies’ were found in two batches of NOIDECS indica and sativa flower. 

The batches, identified as NOIDECS T20:C4 Sativa – 14NS2021002 and NOIDECS T20:C4 Indica – 14NI2021002 are said to have been placed in quarantine while investigations are carried out by the MHRA and manufacturer, Bol Pharma.

The pharmacy is requesting that all patients discontinue their use of these products and processes have been put in place for both opened and unopened packs to be returned. 

One patient, speaking to Cannabis Health anonymously, believes she has been unknowingly inhaling mould for at least a month. 

“I noticed a slight wheeze on my chest, which I thought was hayfever. After I got my jeweler’s loupe out and checked my batch under a microscope, you can see it has a little bit of mould on it,” she says.

“I have vaped most of it as I wasn’t aware it was happening and over the last month my pain has been massively improving. I have an autoimmune disease so you might expect to be really ill from inhaling mould, but I haven’t really had any adverse effects.”

Another patient, who had never used cannabis before being prescribed, said they felt they were “naive” to trust that the medication would be completely safe. 

“As a patient who never used cannabis previously, I feel like I was a bit naive to think that a pharmaceutical grade botanical product would never have a bad batch and that I could just fully trust the medication. But there are recalls in numerous countries for similar problems so it can and does happen, and you just need to be prepared,” they said.

They told Cannabis Health they would now be purchasing a USB microscope to check their medication after it arrives, and before use to ensure it hasn’t become mouldy in storage. 

The patient added: “I trust that the producers will be implementing additional QC procedures after they determine where in the supply chain this occurred, and hopefully this will lead to better quality in general for all UK medical patients.

Patient advocacy group Patient-Led Engagement for Access (PLEA) said substandard quality, such as mould in any medicinal product was “unacceptable”.

Quality and consistency is vital to medicinal cannabis treatment, with Good Manufacturing Practice (GMP) standards providing assurance that medication is produced to a pharmaceutical grade,” the PLEA management committee said in a statement.

“Substandard quality, such as mould, is unacceptable in a medicinal product. As a plant-based medicine, variation and degradation can occur during the manufacturing and importation process. As with all manufactured foods and medicines, a recall process exists and ensures that any faulty products will be pulled from use.”

The organisation called for more transparency from producers and for a “robust” UK supply chain to ensure more control over processes. 

“Trust in the system is important, and at present the MHRA regulates how producers meet GMP standards and this information is not shared with patients,” they added.

“Patients would like to see more transparency from licensed producers, providing a certificate of analysis for each batch that confirms it is free from contamination at the point of testing and cannabinoid and terpene profiling. 

“In future, having a robust supply chain within the UK will allow more control over farm to patient processes as well as employment and investment opportunities. PLEA will continue to work with the industry to ensure standards are patient-centred and that concerns are heard.”

Dispensary Green, which is run by Lyphe Group, told Cannabis Health that the welfare of patients is its “priority”, with staff working “around the clock” to contact anyone who has received these medications and provide the appropriate support. 

The company said in a statement: “Since we were made aware of a few patients spotting possible defects in medication from two batches of NOIDECS T20:C4, we have been working closely with our warehouse partner and MHRA to put a precautionary product recall (patients can choose whether they would like to return affected product) into place swiftly. 

“The manufacturer, Bol Pharma, and the MHRA continue to investigate these two batches and we expect to hear the results in the coming weeks.

“Our team at Dispensary Green pharmacy are working around the clock to call all patients that have received medicine from these two batches and can provide support as needed.

“We are requesting that all patients discontinue use if they have medicine from these two batches, and return all packs in their possession. This includes unopened packs and opened packs.

“There is minimal risk for any patients that have taken the affected medical cannabis products, highlighted by the ‘precautionary’ recall from the MHRA. Our priority at Dispensary Green has always been the welfare of our patients and we shall continue to act transparently and closely with patients to resolve this matter.”

It also warned that some activists were using the incident as an opportunity to “push an agenda” which promotes illicit cannabis use.

“It is deeply concerning that some grow-your-own activists are using this event as an opportunity to degrade the hard-work of the medical cannabis community and push an agenda focused on the illegal consumption of product sourced from clandestine black market cannabis growers. The legal medical market is priced competitively and built to safeguard patients so we can rid the country of black market dealers,” the statement continued.

“As always, it’s important to ensure that medical cannabis is stored correctly by patients. For natural flower products the direction is for pouches not to be opened until consumed, and then kept in the sealed pouch and stored away from light at room temperature.

The manufacturer, Bol Pharma, which is based in Israel, commented: “The issue in subject is under thorough investigation by us, throughout all required quality assurance and processes.

“Being one of the country’s leading medical cannabis companies, BOL Pharma is committed to its patients and to provide the highest manufacturing standards under the strictest regulatory and manufacturing environments, hence following the strictest protocols, particularly when patients and quality complaints are involved.

 “Samples from the batches in discussion are being examined. A process that normally takes up-to 10 working days. The results and conclusions are then submitted to our importer and distributors in the UK.”

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Weekend digest: Six big stories from the cannabis world you might have missed

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Another week, another rollercoaster in the fast-moving world of cannabis.

At Cannabis Health, our in depth coverage of the ongoing growth of cannabis as a medical and wellness product continues

Meanwhile, over at Cannabis Wealth, we’ve been following all the big industry and policy news in a week which has seen some important developments..

Been busy and want to get caught up in a hurry?

Here are the six things you need to read to stay in the loop this week.

1. Products pulled from shelves

Two batches of medical cannabis products have been recalled by regulators as investigations are carried out, following reports they may be contaminated with mould.

Medical cannabis pharmacy, Dispensary Green and the Medicines and Healthcare products Regulatory Agency (MHRA) have issued a ‘precautionary’ product recall since being made aware of ‘defects’ in patient’s medication.

Concerns were initially raised after a number of medical cannabis patients spotted what they believed to be mould spores in their prescriptions.

Full story here.

2. NFL turns to medical cannabis

The National Football League (NFL) in America is providing $1 million in funding for research into pain management and cannabinoids.

The NFL is funding research into medical cannabis.

The pain management committee of the NFL and the NFL Players Association announced it would stump up the funding on Tuesday 8 June.

According to the organisation’s news platform, the move is the next step in a shifting attitude towards players who use medicinal cannabis to manage pain from injuries.

You can read more here.

3. More medical cannabis evidence

Researchers have found that the cannabinoids CBD and CBG, when used in combination, are beneficial for treating inflammation in the lungs.

Scientists at King’s College London, working in collaboration with Sativa Wellness Group have published the first results from a study into the impact of cannabinoids on respiratory diseases.

It aimed to investigate the anti-inflammatory effects of the two non-psychotropic cannabinoids alone and in combination, in a model of pulmonary inflammation.

Full details here.

4. Germany to vote for reform?

Germany’s national election on September 26 could be a landmark moment for Europe’s cannabis industry.

As Chancellor Angela Merkel prepares to leave the stage, the European Union’s most influential country looks destined for a political shakeup.

Annalena Baerbock could become Germany’s first pro-drug reform Chancellor.

It could mark a huge moment for the cannabis industry as Germany’s parliament might swing in favour of legislation.

Here’s everything you need to know about it.

5. Adapt or fail

The pro-drug reform lobby must accept it has failed and change to push its agenda ahead, leading experts have warned.

Speaking at a Global Cannabis Intelligence event about the state of advocacy in the UK, three leading policy advocates set out how they think greater access can be achieved.

The discussion comes week after the 50-year anniversary of the passage of the The Misuse of Drugs Act.

Read the full story here.

6. Isle of Man steps up

The Isle of Man government has declared it is open for business to the medical cannabis industry.

In a big to create 250 new jobs and generate £3m a year for the island, policymakers want it to become ‘a world-leading exporter’.

Applications are now open for licences to produce and distribute treatments on the island, as well as to use it as an export base.

Full details here.

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News

New tracking app launches for UK medical cannabis patients

Through the app patients will be able to monitor their own symptoms and medication usage

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The free health monitoring app is already being used elsewhere in the world.

UK medical cannabis suppliers Grow Pharma have teamed up with an Australian tech firm to launch a new app for patients.

The partnership with OnTracka will see them launch Calyx, a free health monitoring app already being used elsewhere in the world.

Users will be able to monitor their own symptoms and medication usage, speak securely with their doctor and contribute to gathering evidence about the use of medical cannabis.

The app will also be available in Ireland and the Channel Islands after successful launches in Australia, the US and South America.

Users will be able to monitor their own symptoms and medication usage

Pierre Van Weperen, CEO of Grow Pharma said: “Grow Pharma is currently fulfilling around a third of all prescriptions for the UK’s medicinal cannabis patients.

“Our prominent role gives us a significant advantage to building data insights into how patients are managing their health.

“This is integral to pave the way towards increasing access for patients in the UK through providing doctors with confidence around the safety and efficacy of these products.

“Using the app will generate important insights to provide real-time evidence to doctors and regulators.”

Grow Pharma hopes the app will help ‘rapidly accelerate an understanding of the safety, quality, and efficacy’ of medical cannabis.

Insights gained via the app will ‘advance the industry forward in the service of patients, shaping future legislation and policy based on patient experiences’ by providing real-world data to regulators.

Grow is in the process of raising £6 million worth of capital via a private funding round expect to be completed later this month.

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Industry

Isle of Man launches medical cannabis export sector

The Isle of Man is open for business to the medical cannabis industry.

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The move could 250 new jobs and generate £3 million a year for the island

The Isle of Man government has declared it is open for business to the medical cannabis industry.

In a big to create 250 new jobs and generate £3 million a year for the island, policymakers want it to become ‘a world-leading exporter’.

Applications are now open for licences to produce and distribute treatments on the island, as well as to use it as an export base.

The island’s regulator – the Gambling Supervision Commission – has set out conditions for the licensing of high-THC cannabis and hemp.

Enterprise minister Laurence Skelly said: “The growing global medicinal cannabis market provides significant opportunity for economic development in the Isle of Man, and the new regulatory framework and guidance will offer stringent and flexible licensing of a broad range of cannabis products, which ranges from outdoor grown industrial hemp to indoor grown medicinal products.

“The Isle of Man Government has every confidence that the GSC will provide a world class regulatory structure required to regulate this new and complex industry.

The Isle of Man wants to be a major player in Europe’s growing medical cannabis industry.

“I am delighted to welcome licence applications and look forward to attracting quality businesses to the Island, transforming the cannabis export sector into a key contributor to the Isle of Man’s post-Covid economic recovery.”

The self-governing British Crown Dependency, which has a population of 83,000, approved new medical cannabis laws in January.

The island’s parliament – the Tynwald – moved to attract the industry to its shores after a public consultation showed 95 percent of residents were in favour of the policy.

Mark Rutherford, director of policy at the island’s regulator, said: “The GSC already has a sophisticated framework for supervising gambling.

‘We have worked carefully to apply the best of that framework to the risks in the new sector and we have educated ourselves in the technical areas that are new to us.

“What we now have will ensure that all stakeholders will be competent, crime free and capable of building a sector that is safe, trusted and efficient.

“As regulators, we aspire to put our regulatory umbrella above as many consumers as possible so that they can benefit from regulations that are well thought out and properly supervised.

“Years of prohibition mean that the markets in which our licensees will be participating are still in their infancy and still contain many uncertainties.

“To address this situation, it is our aim to ensure that consumers who purchase Isle of Man products will be able to understand exactly what their product contains through accurate labelling and independent testing.

“The GSC recognises there are many stakeholders in this newly created field and intends to extend its ethos of cooperation with other government authorities into its approach to cannabis regulation.”

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