News Updates

Follow today’s news updates in the field of medicinal cannabis. Here you will find a selection of articles that appeared in our newsletter. For a complete overview, go to our Archive.

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The importance of standardised cannabis

Standardised cannabis enables doctors to monitor the dose and the effect of medicinal cannabis in the same way as for other certified medication.

Unlike other medication, cannabis does not have a fixed chemical/molecular composition. A cannabis plant contains hundreds of different substances and each individual plant is different in terms of its composition. THC and CBD are the best known substances, but there are dozens to hundreds of other known and unknown substances in the plant that may have an effect. No two cannabis plants are the same. Even if the levels of THC and CBD are the same, the substances around them can produce a different effect for the patient; this known as the ‘entourage effect’. There have been various studies of this entourage effect. Ultimately, the complete ‘fingerprint’ of the plant determines its effect.

Plant standardisation – Four crucial reasons why medicinal cannabis should be standardised

In the Netherlands, there are now five medicinal cannabis varieties available. Each variety has a unique, fully standardised genetic composition that is and remains the same each time, for every batch, year in, year out, because of the unique production process. The result is that the CBD and THC levels are always the same, but the other substances are also always present in the same ratio. The reproducible chemical profile enables doctors to monitor the dose and the effect on the disorder in the same way as for other certified medication. Furthermore, it makes these varieties suitable for carrying out scientific medical research.

1. PATIENTS

Standardised cannabis is extremely important to the patient

Just like ‘normal’ medication, all patients are ‘set’ on a certain variety. Sometimes it can take a long time to get patients on the right variety with exactly the right dose on the basis of the existing five varieties. The same applies to the use of cannabis oil. Changing the dose or administering medication with a different genetic composition can have adverse consequences for individual patients.

2. DOCTORS

Standardised cannabis is extremely important to the doctor

Quite rightly, doctors want to know exactly what they give to their patients and what its effects are. It takes a lot of time and effort for doctors to become used to prescribing cannabis. The reproducible chemical profile of standardised medicinal cannabis enables doctors to monitor the dose and the effectiveness in the same way as for other certified medication. As this medicinal cannabis is also produced in accordance with pharmaceutical standards (GMP), quality and safety are guaranteed as much as possible. As doctors have prescribed the same products from the Office of Medicinal Cannabis for years, they know what it does and they feel comfortable with it. The same applies to the pharmacists who ultimately hand over the product.

3. RESEARCHERS

Standardised cannabis is extremely important to researchers and clinical research

For the first time, there is now larger scale serious clinical research into the effect of medicinal cannabis. In December 2018, the first results were published of a placebo-controlled, comparative study of 3 of the 5 varieties available in the Netherlands, carried out by the Leiden University Medical Centre. Different doctors, pharmacists, and study groups are now preparing further clinical research. They prefer to work with standardised medicinal cannabis that has a guaranteed quality, safety and availability.

In order to obtain permission for medical scientific research with humans, you need a detailed statement of the product that is studied. At the end of the study, the outcomes only say something about the specific plant, and its unique genetic composition, that was used in the study. Clinical research that is carried out with an existing product, can only be carried out with that product. Changing variety in the meantime is not possible from a substantive point of view, it is legally impossible, and certainly not desirable. If there were to be a change to a plant variety with only comparable THC and CBD levels, permission for the research would have to be applied for again. THC and CBD may well be comparable, but the chemical and genetic composition of the plant and the presence of other substances changes. So therefore, in essence the product used for the research changes too. It means the outcomes that were gathered up to that point are no longer usable, because they do not apply to this new, different plant.

4. MEDICINE DEVELOPERS

Standardised cannabis is extremely important to developers of medication and medical devices

At the moment, medicinal cannabis only applies as a medical raw material, i.e. an API or Active Pharmaceutical Ingredient. Various companies around the world are working on developing medication or medical devices on the basis of this active pharmaceutical ingredient. One example is an extremely advanced inhaler, which was developed by using standardised products from the Netherlands from the beginning. This inhaler is so advanced that it detects even the slightest change in the form and composition of the product to be administered. For the device to work correctly, the same percentage of THC and CBD and exactly the same genetic and chemical composition of the product are important. Any change in plant will produce high modification costs and months, if not years, of delay in its further development.

Scientific research with standardised cannabis

The importance of standardising the complete chemical composition of the plant is supported by various scientific studies. Below is a list of a number of studies into other substances in the cannabis plant and the entourage effect they cause:

  1. From Cultivar to Chemovar II—A Metabolomics Approach to Cannabis Classification

The study considered the ‘cultural’ designation of cannabis varieties, how to distinguish them in terms of effect and how they can be separated chemically and scientifically. The chemical difference is expressed in THC and CDB values, but also in other cannabinoids and terpenoids. This means that clinical research and anecdotal evidence could be used to study the various therapeutic effects of cannabis and/or certain varieties of cannabis could be prescribed to patients on the basis of the complete chemical profile.

More information>

  1. Taming THC: Potential Cannabis Synergy and Phytocannabinoid-Terpenoid Entourage Effects

This study introduces the ‘entourage effect’, which assumes interaction between cannabinoids and terpenes. This interaction may lead to positive effects regarding treatment of pain, inflammation, depression, anxiety, addiction, epilepsy, cancer, fungal and bacterial infections. Unique therapeutic properties are ascribed to terpenes, the odour and flavour substances in cannabis.

More information>

  1. Terpenes and Derivatives as a New Perspective for Pain Treatment: A Patent Review

This study deals with the role of terpenes in pain relief and is particularly focused on the role those terpenes could play in developing new analgesics.

More information>

  1. Synergy Between Cannabidiol, Cannabidiolic Acid, and Δ⁹-Tetrahydrocannabinol in the Regulation of Emesis in the Suncus Murinus (House Musk Shrew)

This study demonstrated that a combination of THC, CBD, and CBDA (cannabidiolic acid) produced better control of vomiting and fewer side effects. This combination was administered to shrews. These effects are also expected to occur in humans.

More information>

  1. Beyond Cannabis: Plants and The Endocannabinoid System

Not just the substances in cannabis have an effect on the endocannabidoid system. This article deals with a number of other plants that could produce similar effects. It also deals more in-depth with the ‘entourage effect’.

More information>

  1. Cannabis Pharmacology: The Usual Suspects and a Few Promising Leads

This article aims to answer the question as to the synergy between cannabinoids and terpenes in the therapeutic treatment of pain, psychiatric complaints, cancer and various other disorders. It also considers the therapeutic effects of substances in cannabis roots, leaves and seeds.

More information>

  1. Cannabis Constituent Synergy in a Mouse Neuropathic Pain Model

This animal study demonstrated that CBD strengthens the pain-killing power of THC during the treatment of neuropathic pain. The results suggest that a combined low dose of THC and CBD is the best option for dealing with neuropathic pain.

More information>

  1. Single and Combined Effects of Δ⁹-Tetrahydrocannabinol and Cannabidiol in a Mouse Model of Chemotherapy-Induced Neuropathic Pain

This study in mice demonstrated that really small doses of CBD or THC – administered separately – do not have an effect on reducing neuropathic pain caused by chemotherapy. However, when THC and CBD are administered in combination, these two substances have a synergetic effect and can be effective in dealing with pain.

More information>

  1. Appraising the “Entourage Effect”: Antitumor Action of a Pure Cannabinoid Versus a Botanical Drug Preparation in Preclinical Models of Breast Cancer

This animal study demonstrated that a full extract of cannabis has a better effect on treating tumours (breast cancer) than pure THC.

More information>

  1. The Case for the Entourage Effect and Conventional Breeding of Clinical Cannabis: No “Strain,” No Gain

This article proposes to stop categorising cannabis varieties by strains and to categorise them by chemical properties (‘chemovars’) instead. Furthermore, according to this article it is assumed that the combination of substances has a better therapeutic effect than the active substances alone – the ‘entourage effect’.

More information>

  1. An Experimental Randomized Study on the Analgesic Effects of Pharmaceutical-Grade Cannabis in Chronic Pain Patients With Fibromyalgia

This clinical study demonstrated that administering a combination of THC and CBD demonstrated a synergetic effect in patients, whereby the CBD increased the amount of THC in the bloodstream.

More information>

Our endocannabinoid system explained

Like in the case of the opioid system reacting to opioids (morphine, codeine), humans have a distinct receptor system for cannabinoids. The endocannabinoid system contains cannabinoid receptors and influences the activity of many other body systems. The phytocannabinoids of the cannabis plant work in a similar way to our naturally produced endocannabinoids.

Cannabinoid receptors

The human brain and other organs contain naturally occurring cannabinoid (CB) receptors and the chemicals that bind to them. This is called the human endocannabinoid system (ECS). The system’s role is to maintain our body’s ability to function normally by influencing the functioning of other systems. It plays a critical role in our nervous system, and regulates multiple physiological processes. This includes the adjustment of our response to pain, appetite, digestion, sleep, mood, inflammation, and memory.

The endocannabinoid system also influences seizure thresholds (i.e. in epilepsy), coordination, and other processes such as the immune system, heart function, sensory integration (touch, balance, sense of space), fertility, bone physiology, the central stress response system (the HPAA), neural development, and eye pressure.

Cannabinoid receptors

Endocannabinoids

Humans produce their own cannabinoids, the endocannabinoids. These endocannabinoids act on, or stimulate, the cannabinoid receptors. These compounds act in a similar way to phytocannabinoids which also bind to the receptors. The plant cannabinoids are called phytocannabinoids. They are the unique constituents of the cannabis plant. Tetrahydrocannabinol (THC) and cannabidiol (CBD) are the main constituents. There are other cannabinoids, but currently far less is known about them.

For example, the CB1 receptor is located in a number of regions of the brain which control various physical and behavioural functions. As a result, cannabinoids influence sensory and motor responsiveness (movement), heart rate, emotional reactions, appetite and nausea/vomiting, sensitivity to pain, learning and memory, and high-level decision making. As our knowledge of the human endocannabinoid system develops so will our understanding of how the phytocannabinoids, THC, CBD and other cannabinoids work. This understanding will lead to better medicines.

Endocannabinoidsystem (EDS)

GPCRs

Cannabinoid receptors are G-protein-coupled receptors (GPCRs). GPCRs are found on the surface of our cells. These receptors are said to ‘act like an inbox for messages, talking with cells and therefore our body’. GPCRs have a great number of functions in the human body. As a result, many medicines, including medicinal cannabis, work on GPCRs. Humans produce endocannabinoids which interact with the GPCRs CB1 and CB2. We know the most about the endocannabinoids anandamide (AEA) and 2-arachidonoylglycerol (2-AG).

Bedrocan develops new practice for cannabis cultivation

Bedrocan has developed a new practice for medicinal cannabis cultivation. The practice is already in use at Bedrocan’s facilities and is called GMCCP: Good Medicinal Cannabis Cultivation Practice. According to Bedrocan, GACP is not sufficient for cannabis intended for medicinal use, hence the need for a special practice for the cultivation of medicinal cannabis.

At the moment, Good Agricultural and Collection Practice (GACP) is the only set of requirements available to companies within the EU for the cultivation of medicinal cannabis. This GMCCP standard exceeds the requirements as defined in GACP. The ultimate purpose is to increase the quality of medicinal cannabis cultivation and to get it as close as possible to GMP, while simultaneously taking into consideration the complexity of cultivating the cannabis plant for medicinal and scientific use.

The introduction of GMCCP has gone smoothly within Bedrocan. Actually, not much has changed because Bedrocan already had strict rules in place for growing cannabis. For example, Bedrocan has a quality management system (QMS) to guarantee product quality and continuous process improvement. It ensures that all cultivation operations are carried out in a correct and consistent manner.

White Paper

A white paper promoting novel standards for the cultivation of pharmaceutical-quality cannabis for medicinal and scientific use.

 

Cannabis cultivation: GMP certificate

Until recently, these stricter cultivation rules were covered by Bedrocan’s GMP certificate, which was obtained in 2017, the first of its kind for a cannabis grower in the world. However, the Dutch inspector then drew a line after the cultivation of plants. Cultivation, including the making of cuttings, the vegetative and generative phase, and the harvest were no longer subject to GMP, but to the less stringent GACP. The reason for this change was that GMP requirements cannot be applied to the cultivation of plants. “Working in cleanrooms is a requirement for GMP, but it is not realistic to grow plants, with all its microorganisms in a GMP cleanroom,” says CEO, Jaap Erkelens, in an explanation. The processing phase, including drying, primary processing, and packaging, remained GMP certified.

GACP is not sufficient

However, growing pharmaceutical grade medicinal cannabis requires a clean and controlled environment. According to Bedrocan, GACP is not sufficient for cannabis intended for medicinal use, especially when inhaled. Erkelens says: “You want to prevent the end product from being contaminated with micro-organisms and other contaminants, such as pesticides that can be harmful to the patient. This is only possible in an environment where everything is checked, validated, and documented.”

Bedrocan, therefore, applies the strictest possible hygiene regulations for cultivation, and checks and validates all steps to ensure that the end product is free of pesticides, molds, and other contaminants. “These are more demanding requirements than those that are defined within the GACP, the practice used by the big majority of other medicinal cannabis growers worldwide. Although GACP is intended for the cultivation of medicinal plants, it allows outdoor cultivation and does not require advanced and high-quality indoor cultivation, which Bedrocan has been applying for years. As a result, the global market is overloaded with cannabis products of questionable quality that often have to be recalled because they are contaminated with pesticides and other types of contaminants”, says Erkelens.

To prevent this contamination, Bedrocan is advocating for a new, better quality practice that applies to the entire sector.

What is the difference between GACP and GMCCP?

The main difference is that GACP leaves far too much room for interpretation. It does mention many things which we also mention in GMCCP but does not clearly state what are the exact requirements and how extensive their implementation must be. In that sense, GMCCP is a much stricter practice because it leaves little to no room for interpretation and flexibility.

 

GMCCP GACP
Indoor Outdoor / Greenhouse
GMP QMS Basic QMS
Training performed and documented Training performed but not necessarily documented
Gowning procedure must be established Workers should wear protective clothing to prevent contact with toxic and potentially allergenic substances
Cleaning and sanitation must be recorded, validated, and performed according to established procedures and cleaning schedules Buildings used in the processing of harvested medicinal plants/herbal substances must be clean
Acceptance criteria for residues and the choice of cleaning procedures and cleaning agents also must be defined and justified n/a
Cleaning validation n/a
Validation procedures documented n/a
Calibration of equipment involved in the cultivation process n/a
Critical Quality Attributes and Critical Process Parameters should be identified n/a
Batch Records n/a
Good Documentation Practice n/a
Cultivation process has to be standardised in order to ensure reproducible results n/a
Deviation, CAPA & Change Control n/a
Vendor and Material Qualification n/a
Risk Management n/a

Real-World Data can help to understand better how medicinal cannabis works

For years, doctors and researchers have been calling out ‘we need more evidence’ regarding the effect of medicinal cannabis. The Dutch-German company MYCB1 says it can now provide this proof by using data from actual patients. It is called Real-World Data (RWD), a new term that is popping up more and more in the medical world.

Real-World Data approach

In a Real-World Data approach, drug efficacy data is not extracted from traditional controlled clinical trials but comes directly from patients. For example, a patient keeps track of his health status via an online app on a daily basis. This data is then processed and made available via an online platform. More and more drug agencies, including the US FDA and the European EMA, are using this type of data to support drug decision-making and approval.

Uruguay-born Ernesto Diringuer started the pharmaceutical technology company MYCB1 five years ago with the aim of collecting scientifically useful data from real patients. The starting point was to demonstrate the effect of medicinal cannabis with the help of patients. To collect the data, MYCB1 has developed the ALETTA platform, named after Aletta Jacobs, the first female doctor in the Netherlands.

High-quality Real-World Data

Doctors and researchers can use ALETTA to gather high-quality Real-World Data on patients under cannabinoid-based treatment. This data can then be used to optimize patient treatment results or for research purposes.

The ALETTA stands out from all other apps in the market. “We are not a purely technological company, because we also produce cannabis oil ourselves from Bedrocan raw materials. This oil is standardised and that is the basis of the whole concept. Without standardised oil, you cannot collect scientifically sound evidence about the effect of medicinal cannabis. The ingredients of cannabinoid-based medicines must always be the same, just like with any other medicine.”

MYCB1 produces three different types of medicinal cannabis oil that doctors can prescribe to patients.

Real-World Evidence and Covid

The Covid-19 vaccines from AstraZeneca, among others, have been developed with evidence collected through Real-World Evidence (RWE) studies. In an article approved by the International Society for Pharmacoepidemiology, scientists state that RWE has “quickly provided compelling evidence on drug safety, vaccine safety and effectiveness.” The European Medicines Agency expects that by 2025 the use of RWE will have become commonplace.

Amsterdam pharmacy

In the Netherlands, the products of MYCB1 are registered with Z-index, the drug database of the Netherlands. The oil is manufactured under GMP in their Amsterdam pharmacy. For the German market, production takes place in Steinheim. Per default, the oil comes with the ALETTA application in which patients indicate any side effects and how they are feeling through a validated, internationally recognised questionnaire. Diringuer: “These are not random questions but standardised questions that are used by scientists worldwide to assess someone’s quality of life, the so-called EQ-5D. It has been used to gather evidence in trials, population studies, and real-world clinical settings for over 25 years.”

The patient plays a crucial role in the concept. Data about his well-being must be captured in the app. Diringuer: “The patient who is prescribed our oil can keep control over their own medication. They can look for the dose that works best and has the least side effects. Side effects can be reported immediately, and the patient gains insight into their own Quality of Life.” Doctors can then use this data to make more informed medical decisions.

Researchers also see the value of the availability of the Real-World Data. “The drug agencies, including the European Medicines Agency, increasingly want to see Real- World Evidence (RWE) studies, which provide insight into medications outcomes on patients’ daily drug use. It is a new development from which there is no escaping, and it seems RWE will be the new gold standard for clinical research in the near future,” says Diringuer.

Real World Data - self reported health status through ALETTA
The Real-World Data management platform ALETTA

How MYCB1 started

“In 2017, it became clear to me that the only way going forward on the cannabis space in the Netherlands was on prescription-only cannabis extracts manufactured only with Bedrocan GMP-grade standardised cannabis flos.

We found out in our journey that, on one side, many patients are benefiting from cannabis. However, there is a serious lack of high-quality scientific evidence on the other side. We also found out that this is not an exclusive problem of cannabinoids, but the insufficient evidence also applies to register medicines when used in the Real-World setting. Control studies results as Randomized Control Trials, with strict exclusion criteria, do not represent the results of the same drug in Real-World use by “real patients”  with varied comorbidities, poor adherence, ethnicities, using many medications with complex interactions, and so on.

The problem of lack of scientific evidence also extends into supplements and vitamins, and other OTC drugs, but also into all kinds of behavioral interventions.

MYCB1 is developing tools and technologies such as ALETTA, our Real-World Data management platform, to gather high-quality Real-World Evidence to help optimise patients’ outcomes. Starting with cannabinoids but moving into all prescription medications, OTCs, and also behavioural interventions. ”

MYCB1 Apotheek + ALETTA is ISO27001, NEN7510, ISO9001 and HKZ certified.

Ernesto Diringuer  - about
Ernesto Diringuer

Bedrocan presents: A clinical primer

Bedrocan is happy to present the new booklet ‘A clinical primer’. Following on from the introductory text ‘A primer to medicinal cannabis’, the ‘clinical primer’ draws on clinical research, clinical observations, and professional experiences to provide useful, real-world insights into the rational use of cannabis-based medicines. It aims to equip prescribers, pharmacists, and nurses with practical, evidence-based guidance to support decision-making and improve communication of these medicines’ benefits and risks with their patients.

clinical primer

About the authors and editor

The authors are Dr Jürgen Fleisch (MD, PhD) and Martin Woodbridge (MPHC, DPH). The editor is Professor Emeritus Dr Carl Burgess (MB ChB, MD, MRCP, FRACP, FRCP).

Dr Jürgen Fleisch (MD, PhD) has practised anaesthesiology and pain therapy since 2007 at the Leiden University Medical Centre (LUMC), Netherlands. His close cooperation with the Department of Oncology of the LUMC allowed him to regularly treat pain and related symptoms in cancer patients using classic medications and interventional pain treatments. He also has considerable experience prescribing cannabis-based medicines.

Martin Woodbridge (MPHC, DPH) is a pharmacologist, policy analyst, and clinical educator. In 2007, he wrote New Zealand’s medicinal cannabis clinical and regulatory guidelines for the Ministry of Health. Since then, he has advised on the development of cannabis medicine programmes in Oceania and Asia and for the United Nations International Narcotics Control Board’s regulatory guidance on cannabis intended for medical and scientific use. He is also the author of the complimentary text ‘A primer to medicinal cannabis’.

Professor Emeritus Dr Carl Burgess (MB ChB, MD, MRCP, FRACP, FRCP) is a member of the New Zealand Order of Merit for Services to Pharmacology. He taught internal medicine and clinical pharmacology from 1982 to 2013 at the University of Otago’s Wellington School of Medicine while also a consultant hospital physician to Capital and Coast Health, New Zealand. He has been involved in clinical pharmacology research since 1976.

Martin has worked with Dr Carl Burgess and Dr Jürgen Fleisch on different projects relating to the rational use of medicines.

Contributions

The clinical primer is also the result of the contribution of several healthcare professionals, who agreed to share their experience with prescribing, handling and working with cannabis-based medicines for patients with different conditions.

Bedrocan also proudly supports the development of this brochure under the policy of education without commercial bias.

Go to our Downloads page to download a free copy.

Talking with Lucy Haslam, co-founder of the Australian UIC Medicinal Cannabis Symposium

The Australian  United in Compassion symposium (UIC) started in 2014. UIC is well attended by industry, health professionals, government regulators and patient advocacy groups. Bedrocan Australia caught up with Lucy Haslam – UIC co-founder – to see where it all started and what lies ahead.

Bedrocan Australia first attended UIC in 2016. Then, the industry was fledgling in status. All health practitioners were new to prescribing, and the Australian TGA was preparing to publish TGO93 (quality standard) and SAS prescribing guidance. What did UIC represent back in 2016?

“UIC represented patients struggling not to be forgotten in the political arena. The discussion had changed from exercising compassion to enforcing regulations. We were still very much trying to battle the mantra that harped on constantly about the lack of evidence, and the devaluation of the lived patient experience.”

In 2022 UIC is back! There is strong support from the industry. The speaker line-up is diverse, as are the topics. What role does UIC represent today?

 “In some ways, our position hasn’t changed much. We continue to struggle to ensure that barriers to access are removed.

In 2022, we have a rapidly evolving industry where many participants are not even aware of the patient-led campaign that went before the birth of the industry.  Some in the industry have a determined focus on profits; they undervalue the patient as their customers and only give them recognition when it relates to their bottom line.

UIC today tries to remind the industry that patients should come first, and that ethical industry practice will be rewarded in the longer term. UIC still promotes education because that is a void that has remained since the change in legalisation. The regulation around advertising and the lack of public information demonstrate the failure of government to accept the reality of medicinal cannabis use in the broader community.”

Lucy Haslam and son
Lucy Haslam and her son Dan

Since 2016 you have been in a leadership role and the face of UIC. What have been the key achievements for UIC, and what are you most proud of?

“It has been a hard road. The key achievements would be raising public awareness and acceptance of medicinal cannabis, but with the knowledge that there is still much to be done in removing the stigma and ongoing barriers.

Changing the law in Australia was briefly rewarding until the legislation revealed the potential for many problems. These problems, predicted in 2016, have indeed emerged. These unnecessary obstacles have impacted most heavily on patients, who were the very reason for changing the legislation in the first instance.”

UIC is pretty focused on (a) ensuring access to quality herbal material and full-spectrum extracts medicines, and (b) engagement with health professionals – indeed, UIC has supported health professional education… regarding this:

Are there unmet needs with regard to patient access?

“Many eligible patients still rely on the ‘green market’ [illegal market] because of cost and ease of the process. The price disparity is improving, but cannabis remains outside the reach of many due to the regulatory limbo which sees it  as ‘approved yet unapproved’ in Australia. Consequently, it is not able to be subsidised by the Government.

Paediatric epilepsy patients who are not suitable for Epidiolex (the only registered product) cannot afford the exorbitant costs of the quantities they require. They are frequently still relying on the ‘green market’.

Patients who need to drive still have to choose between ‘driving and risking criminal prosecution’ or ‘not having medicinal cannabis as medicine’. That should never be the reason to make a health determination, and the laws need urgent fixing as they are discriminatory and unscientific. Many cancer patients are using cannabis in ways unapproved by the TGA. The regulations do not reflect reality, which puts patients outside the care of their doctors when that care is most needed.”

Are there unmet needs with regard to medicine quality?

 “Australia opted for allowing cheaper imports to fill the need until the local industry was established. That created a dual system whereby local producers were held to a higher standard than imported products, which is now being addressed following many complaints.”

 Are there unmet needs with regard to education?

“Education is beginning to be sought out, and there is progress in the number of prescribers accessing it.

The roadblocks here seem to be more at the College level [health professional societies], and one can only assume that this is political and based on the vested interests and/or personal biases of individuals.”

Cannabis-based medicines are increasingly being prescribed in Australia. Do you think cannabis is now being seen as a medicine? From your perspective, are we almost there, or are we still on a long path ahead?

“For many people, cannabis is a very valuable medicine. Additionally, for many like me, it represents the battle for truth that seems so readily diluted when vested and commercial interest is involved.

Patients who use cannabis are still largely struggling for respect and recognition that their choice of medicine is validated scientifically.

We are on the road, but far from where we should be – which is where patients can easily access affordable medicine and not be punished or discriminated against for doing so. I still hold the belief that once human interference is removed from the mix, cannabis will one day be considered a wonder drug by the medical community and not just by the patients who use it.”

Find out more

Interested in attending UIC? There are still tickets available for the sunny Queensland symposium.

Bedrocan Australia will host an industry booth, and will also speak at the General Symposium on the topic of ‘quality in cultivation’, Saturday 21 May 2022.

The important role of pharmacists and medicinal cannabis

The role of pharmacists is as important as prescribers. Pharmacists discuss the risks of a drug with patients and help to minimize drug harm. They also provide information about safety, effectiveness and side effects.

As a pharmacist Salma Boudhan dispenses cannabis flos, and oil extracts (with CBD and THC) for named patients throughout the Netherlands. She dispenses high quality whole cannabis oil, including CBD oil Bedrolite®, for sublingual use since 2015. A typical patient arriving at her pharmacy are those suffering from cancer pain, nausea and vomiting, neuropathic pain or epilepsy.

Salma Boudhan
Salma Boudhan

What is the safest cannabis oil and CBD oil dose?

“In accordance with their doctor’s prescription, we suggest that patients start low and go slow. As a starting dose for oil (e.g. Bedrolite), we recommend to use two drops (0,05ml) under the tongue, three times a day and increase the dose until the desired effect is achieved. The maximum dosage is ten drops (0,25ml), three times a day.

The ‘steady state’ concentration of THC/CBD and the active metabolite is reached after one or two weeks. This time span should be taken into account for the assessment of the medicines effectiveness for the patient.”

What is your dosing advice on vaporization?

“We recommend patients inhale one or two times a day until the desired effect is achieved or until (psychotropic) side effects occur. This means they have had too much. Per inhalation, we recommend patients wait at least five minutes between the inhalations.

Patients should take into account that inhaling cannabis results in a higher uptake than when using other administration routes. Patients have to dose carefully when changing to a different variety, especially if they have previously used cannabis with a lower content of THC/CBD.

The ‘steady state’ concentration of THC/CBD and the active metabolite is reached after one to two weeks. Like oral dosing, this time span should be taken into account for the assessment of the medicines effectiveness for the patient.”

A primer to medicinal cannabis

This is an abridged version of the interview taken from the booklet A primer to medicinal cannabis. Interested in the full version and more information about the use of medicinal cannabis? Then download the booklet A primer to medicinal cannabis.

Does cannabis interact with other medicines?

“We know that cannabis is metabolised by CYP450 enzymes. When taken together with other medicines metabolised by the same enzymes, there may be the potential for drug-drug interactions. We discuss with patients about the risk of using such medicines concurrently, or recommend alternative medications.”

What are the actual and potential complications with medicinal cannabis?

“The biggest risk is getting high and triggering psychoses (especially with psychiatric patients) or worsening current depression. There are risks in prescribing in the elderly, and the potential long-term effects on children are still unknown.”

What are the key risks of patients who have other conditions, and are using cannabis as a therapeutic product?

“The only known contra-indications include schizophrenia, arrhythmia and other heart conditions. We work closely with prescribing doctors and also provide adequate instructions to patients about the benefits and risk of their medicines.”

Bedrocan at the Australian United in Compassion Medicinal Cannabis Symposium

The Australian United in Compassion symposium is a highly publicised medicinal cannabis conference attended by industry, health professionals, government regulators and patient advocacy groups. Bedrocan will host a booth and present at the Symposium from Friday 20 to Sunday 22 May 2022.

United in Compassion symposium

The United in Compassion (UIC) began five years ago as a patient-led movement that actually managed to change the law in Australia. Where are we now?

The Australian federal law changed in 2016, permitting the prescribing of pharmaceutical-quality medicinal cannabis. Quickly, State legislators – Australian states set their own laws – quickly followed suit.

Currently, most medicinal cannabis products in Australia are unregistered, meaning prescriptions require a rapid online application (i.e. 24–48 hours) under a Special Access Scheme (SAS) and medicines must be dispensed by a pharmacy. Data from the Therapeutic Goods Administration reveals that in 2017, 248 applications were approved for medicinal cannabis products. That number soared toward 123,131 approved applications by the end of 2021.

Prescribing occurred among more than 2,700 doctors, with most prescribing in General Practice (Family Medicine). The prescriptions are mainly for chronic non-cancer pain, anxiety, cancer-related symptoms, epilepsy, sleep disorder and other neurological disorders.

Dried cannabis flower and whole extracts

The UIC’s primary mission is advocating for ‘patient access to full-spectrum herbal medicinal cannabis extracts and dried herb cannabis’. There are currently over 200 different cannabis products available on prescription. Most are full-spectrum oral preparations (oils) containing THC or CBD, or the dried cannabis flower. Last year, around 26% of SAS applications were for herbal dried products for pulmonary administion (inhalation).

The full range of Bedrocan products are available on prescription to Australian patients. Novachem, the distributor, faces fierce competition, despite that other companies cannot guarantee pharmaceutical-quality products on an ongoing basis.

Bedrocan Australia attends UIC

This year Bedrocan will host an information booth at the United in Compassion Medicinal Cannabis Symposium. Bedrocan’s booth is a viewing window to our newest services for health professionals, regulators, industry, and patient advocacy groups. At the booth, delegates can:

  • Take a 3D interactive tour of our first-in-class cultivation facilities (Oculus 3D googles),
  • Learn more about our Australian health professional guidance, and the education resources we support.
  • Gain access to our regular, enlightening articles on diverse topics on cannabis-based medicines.

Bedrocan will also present at the symposium on the topic ‘GACP, GMP and Quality in cultivation’. This presentation will discuss Bedrocan’s draft ‘White Paper’ on standards for the cultivation of pharmaceutical-quality medicinal cannabis. Bedrocan’s Good Medicinal Cannabis Cultivation Practices (GMCCP) standards align with current global thinking on clearly separating pharmaceutical from recreational.

Cost to patients and education for health professionals

The UIC continues the push for affordable medicines as cost to patients remains the biggest issue in Australia. Like many countries, there is no pharmaceutical subsidy for cannabis products, meaning patients pay out-of-pocket for all of their medication.

Another hurdle is education. Prescribers are the gate keepers. The recent and rapid introduction of cannabis-based medicines to modern practice means there is still a lot to understand and discover. Australian prescribers and pharmacists are concerned about the correct dosing regimens for the condition being treated, the quality of the medicines themselves, and accountability for treatment-related decisions.

According to Bedrocan, high quality, easy to access, free education is therefore required. Bedrocan is supporting the production of a Clinical Primer text which provides health professionals valuable insights to the rational use of cannabis-based medicines. This compliments the text A primer to medicinal cannabis, an other free text written for health professionals, regualtors, and policy makers. See download button below.

Bedrocan makes Vietnamese translation available on medicinal cannabis

Bedrocan provides a Vietnamese translation of the informative booklet on medicinal cannabis: Nhập môn về cần sa y tế. A request for a Vietnamese version came from the Vietnamese community in North America because accurate information on this subject in the Vietnamese language is scarce. Bedrocan’s goal is always to provide scientific information about medicinal cannabis in as many languages as possible.

Initially drafted in English, the booklet is now available in German, Thai and Vietnamese. It aims to provide doctors, regulators and policy makers with an understanding of the medical and scientific aspects of Cannabis sativa L. and how this plant fits into the range of therapeutic options. As in many other Asian countries, Vietnam currently does not allow medicinal cannabis. This translation is expressly not intended to change or influence the Vietnamese government policy.

Enjoy reading!

Nhập môn về cần sa y tế

Một văn bản giới thiệu về các ứng dụng trị liệu của cần sa

Hiện trạng về khả năng tiếp cận nguồn thông tin đáng tin cậy, dựa trên bằng chứng vẫn còn gây trở ngại cho hoạt động kê đơn cần sa đạt chất lượng dược phẩm vì mục đích trị liệu.

Cuốn sách nhỏ này bàn luận về ứng dụng trị liệu của cần sa. Tức là chúng ta sẽ không bàn về cần sa ở góc độ sử dụng cho mục đích giải trí để đạt được trạng thái ‘phê’. Sách chỉ hoàn toàn hướng đến cần sa y tế. Mục đích của sách là cung cấp cho các chuyên gia y tế, cơ quan quản lý và bệnh nhân những hiểu biết chi tiết từ khía cạnh khoa học và y tế của loài cây Cannabis sativa L., cũng như vị thế của nó trong chuỗi các lựa chọn trị liệu.

Cuốn sách này được thực hiện với sự tài trợ của Bedrocan International – đơn vị giữ bản quyền.

A fully standardised product, but with different prices. How come?

Since 2006, medicinal cannabis produced by Bedrocan for the Dutch Office of Medicinal Cannabis has become available to patients in various countries. Bedrocan is the only company in the world that has the proven capability of producing standardised cannabis flos (whole, dried flower) – containing consistent levels of cannabinoids, every time. Products used by patients in Australia or Italy are identical to the products used by patients in the Netherlands or Germany. However, one difference is the price of the products in different countries. In the Netherlands, patients pay €5.50 per gram (excluding prescription fee and VAT, price as of September 1, 2021) in the pharmacy, while in some other countries prices can go up to €25 or more. Why do these prices differ so much. In this article, we explain why.

How come patients in other countries pay more than €5.50?

The Dutch OMC sells all products for the same price to anyone. However, the rules and regulations in other countries differ a lot, resulting in very different prices in each country. The price difference (from €5.50 per gram) for which the product is sold in another country is caused by the cost of transportation and import fees, permits and licensing fees, taxes and additional regulatory steps in the chain. Until March 2020, for instance, German pharmacies were obliged by German law to increase the price of their raw (cannabis) material by 100% in order to be allowed to deliver a final product to patients. This is just one of many examples showing Bedrocan and the OMC have no control over the final price of the product in other countries.

Prices for medicinal cannabis in the Netherlands

How does Bedrocan feel about the huge price difference?

We do not like it. It is our mission to produce affordable, constantly available, high quality, safe and standardised medicinal cannabis for patient use. In The Netherlands, we have succeeded in this mission. It is now our goal to improve patient affordability worldwide. We feel that it is not fair to patients that such high prices are set in other countries. With the harmonisation of international rules and regulations, we hope prices will become more equal and, most importantly, more affordable for patients.

What about the price for cannabis oil?

Bedrocan does not produce or sell cannabis oil. Nor does the OMC. Medicinal cannabis oil extracted from Bedrocan’s standardised products is currently available in the Netherlands, Italy and Germany among others. It is extracted by third parties for patient’s use only. The companies extracting and producing an oil dose form, like compounding pharmacies, decide the final price to patients. Bedrocan therefore has no control over the prices of oils based on our products, currently.

Bedrocan and adult-use cannabis legalization in Germany

The new German government is set to legalize some form of adult-use cannabis. Bedrocan has been supplying cannabis to German patients for years. Lately, we have often been asked: ‘Will you soon also be supplying German recreational users?’ That is a very understandable question. However, the answer is simple: No.

Bedrocan does not supply cannabis for recreational use. We do not do that anywhere in the world, not even in the Netherlands, and soon also not in Germany.

Why does Bedrocan not want to enter the recreational market?

Bedrocan believes in a strict separation of medicinal cannabis and cannabis for recreational use. We are committed to providing a pharmaceutical product that is available on prescription to patients who benefit from it. We want to focus one hundred per cent on this assignment. This means that we cannot and do not want to be involved with cannabis for recreational use.

In other countries, we have (unfortunately) seen patients that use medicinal cannabis become the victims of the legalization of recreational use. Not so much because of the legalization itself, but because of the fact that producers were tempted to jump into this market. The quality requirements are lower, the rules are easier, controls are less strict, and yields (they hoped) higher. Result: medicinal cannabis received less (or no) attention, and patients were left without the product. We want to avoid that at all costs.

Moreover, it is true that there can indeed be adverse effects from the use of cannabis. That’s why we want our products to be available only to patients who use them with a prescription and under the supervision of a pharmacist. We also only want to use our many years of knowledge and experience in the field of cannabis cultivation for this purpose.

Are you approached by companies or users who would like to work with Bedrocan towards the recreational market?

Yes, very often, in fact. The answer is and will always be ‘no.’ At first, that may sound strange. But change the resource and the players. Suppose the government legalizes Ecstasy pills. Would a pharmaceutical company that now makes antidepressants or rheumatism drugs show up there? No, of course not. They would stay far from it. The same goes for us. Medicinal cannabis and cannabis for recreational use are two different products with completely different target groups. You shouldn’t want to mix them up.

Will you continue to supply German patients?

The current supply system via the Dutch Office of Medicinal Cannabis (OMC) will not be impacted. Therefore, German patients will continue to have access to our pharmaceutical-grade products.

Cannabidiol, the popular component of cannabis

Cannabidiol, abbreviated as CBD, is getting a lot of attention these days, and everyone knows someone who uses it. But what is CBD, and how does it compare to THC?

CBD is a cannabinoid and is only found in the cannabis plant. There are currently more than 100 different identified cannabinoids, of which THC is the best known. These two substances are very similar in their chemical structure but have very different effects.

CBD has medicinal properties but cannot make the user feel ‘high’. THC can. Some studies suggest that CBD may be effective in treating symptoms of rheumatoid arthritisdiabetes, PTSD, anxiety disorder, and antibiotic-resistant infections, among others.

CBD and epilepsy

More recently, CBD has been used in children with treatment-resistant epilepsy, and a subsidy has been made available by the Dutch government for further research. This study will not only look at CBD, but cannabis products in general, including THC.

CBD molecuul

THC is more likely to be used to reduce nausea, vomiting, pain and muscle spasms and improve sleep and appetite and the scientific evidence for its effectiveness in these conditions is more sound than the one available for CBD.

Ideal THC:CBD ratio

It has been shown that CBD can influence the effects of THC. However, it is still difficult to say which THC:CBD ratio is the most ideal for a specific medical condition. As an example, a study into the pain experienced by fibromyalgia patients showed that the combination of CBD and THC had a better effect on pain reduction than a product with THC alone. Conversly, CBD alone had no effect on pain. In a follow-up study, the researchers are now looking if a THC:CBD balanced ratio cannabis is better than opiates in reducing  fibromyalgia pain.

However, the ultimate medicinal effect of cannabis does not depend solely on CBD or THC.

CBD and driving

When using CBD and driving it is important to avoid combining CBD with THC. A study of the effects of THC on driving ability showed that cannabis containing both THC and CBD had a worse effect on driving performance than cannabis with only THC. Further, when participants received both THC and CBD, they had slightly higher levels of THC in their blood compared with when they had just received THC. CBD alone and driving, on the other hand, do go together. No evidence has been found that CBD negatively affects driving behaviour on its own.

Terpenes refine the therapeutic effect

Terpenes are the substances that give cannabis its characteristic smell and taste. So far, over 120 different terpenes have been found in cannabis, with unusual names such as myrcene, alpha-pinene and beta-caryophyllene.

Unlike cannabinoids, terpenes can be found everywhere in nature. For example, they are present in lavender, roses and pine trees. Some studies suggest that terpenes may counteract certain undesirable effects of THC, such as feelings of restlessness or loss of short-term memory, although thorough research on this topic is still lacking.

Certain terpenes may also have medicinal properties of their own: some are antibiotics, while others have analgesic or anti-inflammatory effects. Terpenes are therefore often used in aromatherapy.

Because there are many different terpenes, there are also many different combinations in which they can occur in a cannabis plant. As with cannabinoids, each specific mix of terpenes can lead to a unique medicinal effect. The terpenes are suspected to work with cannabinoids to modify or amplify their effects. This is known as the ‘entourage effect’.

Trichomes

CBD, like other ingredients, is produced by tiny glandular hairs that are present all over the cannabis plant. Also known as trichomes, these hairs produce a sticky resin that accumulates as tiny droplets at the end of each glandular hair. Trichomes are so small that you can only see them with a magnifying glass.

CBD zit als CBD-zuur in trichoom

Trichomes are found on both male and female plants, but they are particularly concentrated in the tips of the female flower.

Acidic and neutral cannabinoids

THC and CBD are not present in the cannabis plant in ready-to-use form but must first be heated to a temperature of at least 180°C.

The plant only contains ‘acidic’ cannabinoids. THC is, therefore, primarily THC acid (THCA), and CBD from the plant is CBD acid (CBDA, also known as cannabidiolic acid). When these substances are sufficiently heated, the cannabinoid acids are converted into a neutral form known as THC and CBD. This chemical process is called decarboxylation.

Decarboxylation also occurs spontaneously in cannabis as a result of exposure to light and room temperature, although at a slower pace. However, cannabis can be kept for a very long time in the freezer.

CBD acid

Until recently, scientists thought that the acidic cannabinoids had no medicinal properties. However, these substances can indeed be interesting as medicines. For example, it appears that CBDA bactericidal properties and seems promising as an anti-inflammatory substance. Additionally, THC acid seems to have a strong effect on the human immune system.

 

 

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Vietnamese version of the primer of medicinal cannabis
Pharmacist Selma Boudhan