New vaporizer tested by patients

A group of some 20 Dutch patients is about to test the new Bedrocan vaporizer. Recently, a call was made in the Dutch media and through patient associations. More than 70 patients have said they would like to participate. The purpose of the study is to collect feedback about, among other things, the user-friendliness of this medical device. The vaporizer will be marketed under the name Bedromedic®.

With a Bedromedic it is possible to inhale Bedrocan’s medicinal cannabis products safely. Heating cannabis releases vapours with active components. The vapour is inhaled by means of a mouthpiece and absorbed into the body via the lungs. It does not involve any tobacco. Temperatures are lower than during smoking, which prevents the release of harmful substances that are produced during burning.

The study is carried out by Bedrocan’s own research department, which screens patients in advance. Participants must have medicinal cannabis from Bedrocan prescribed by a doctor. It is also important that a participant has at least six months of experience with using cannabis as medication. Experience with using vaporizers is not necessary. Participants have the Bedromedic® vaporizer sent to their home and can try it out in their home environment. Afterwards, they complete a comprehensive online questionnaire.

Discourse with doctors – Dr Jürgen Fleisch provides his insights…

Insights from experienced health professionals prescribing cannabinoids.

There is a place for cannabinoids in the therapeutic toolbox. So how should they be prescribed? Discourse with doctors is a series of interviews with experienced doctors prescribing cannabinoids. This article highlights prescribing realities and strategies to improve patient safety, dispels some myths, and aims to encourage self-driven inquiry.

Trained as an anaesthesiologist in Germany, Dr Fleisch then undertook a fellowship in pain medicine (Portland, Oregon).

He now practices anaesthesiology and pain therapy in Holland at the Leiden University Medical Centre.

For the last decade, his close cooperation with the department of oncology means he regularly treats patients experiencing pain from cancer.

Dr Jürgen Fleisch

Do you have any advice for doctors starting out prescribing?

My advice for clinicians who are starting to prescribe cannabinoids is to stick to specific indications where there is a solid foundation of evidence for its use, e.g. multiple sclerosis, patients experiencing central neuropathic pain, or cancer patients. This allows us to gain experience with the effects of this medication in a specific patient population.

Recreational cannabis users are, in my opinion, not a good patient category to start with. They may put considerable pressure on the clinician to prescribe for dubious indications.

Prescribing experience

How long have you prescribed cannabinoid therapeutics?

I have prescribed cannabinoids, mainly for patients with cancer, since I started working here in Holland ten years ago.

Can you describe a typical patient who you would prescribe products containing cannabinoids?

There are two typical types of patients where I would initiate cannabinoid therapeutics. These are in patients with:

  • advanced cancer experiencing loss of appetite and possibly nausea and vomiting. Often many other medications have been tried before.
  • central neuropathic pain (after unsuccessful trials of more common medications).

Prescribing cannabinoid therapeutics

How is prescribing cannabinoid therapeutics different to prescribing other medicines?

They are like any other medicine. However, many patients will have an opinion about cannabis [and cannabinoid products]. For some it has a rather negative connotation as being a substance of abuse.

What are the key benefits of cannabinoids as a therapeutic product?

There are three main advantages of cannabinoid therapeutics in general over other medicines used in my field of pain medicine, these include that:

  • there are analgesic effects on neuropathic pain syndromes and, depending on the medicine type, anti-emetic and appetite stimulating effects. This is especially important for cancer patients with pain.
  • there are no known organ damaging side effects in the adult patient. As compared to, for example, those linked with using NSAID’s.
  • some cannabis flos variants have a soothing effect, which some patients greatly appreciate.

What do you think are prescribing practices that improve patient outcomes?

For patients with no experience using cannabinoid products, the possible psychological side effects can be distressing. In order to avoid this we advise patients’ to start with low dosage and use the medicine in a quiet and relaxing environment.

In our experience, it is advantageous to prescribe cannabis flos as an inhalational agent, administered by vaporization, as it creates more rapid analgesic effects and has a more reliable absorption profile.

Are there any special considerations you make when prescribing a ‘herbal’ medicine (cannabis flos)?

With cannabis flos, the prescribing clinician needs to be aware that in many countries the standards are different with respect to ‘regular’ medicines: concerning the quality control of the active ingredient, and toxicological contamination.

What is cannabinoid therapeutics?

Medicinal cannabis is a term used to describe the use of cannabis to treat or manage illness. It hails from a time when the products used where typically marijuana and patients smoked joints. Since that time, there have been major developments in cultivation techniques, product quality and controls. Today, the sympathetic regulatory environment favours standardised products (e.g., Bedrocan cannabis flos, Sativex) and safer modes of administration (sublingual, oral and vaporization). A prescriber-pharmacy model now offers patients better communication of risks and benefits, and the safety of health professional oversight. Standardised products and clinical research means plant-based products are closer to achieving full medicine registration. The use of the term ‘medicinal cannabis’ in these circumstances seems redundant.

In this article, we talk about the therapeutic use of cannabinoids. The class of medicines containing cannabinoids (e.g., THC and CBD) and other chemical compounds secreted by cannabis plant (e.g., terpenes) that are intended to be used in, or on human beings for a therapeutic purpose. This change in terminology from ‘medicinal cannabis’ to ‘cannabinoid therapeutics’ reflects our knowledge and understanding of the endocannabinoid system, the cannabinoid receptors, endogenous (human) cannabinoids, and exogenous (plant) cannabinoids.

For more information, please download the booklet An Introduction to Medicinal Cannabis by Dr Arno Hazekamp.

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Using cannabis flos originating from controlled producers means patients are assured there is no biological or toxicological contamination.

In the Netherlands cannabis flos is produced under strict quality conditions by the government licenced company Bedrocan.

Administration by vaporization

Aside from eliminating the harms from smoking, what are the benefits of administration by vaporization?

With vaporization cannabis flos is heated to a specific temperature without burning it. Cannabinoids and terpenes are released in a vapour which is directly inhaled.

There are three main advantages of administration by vaporization is that it:

  • allows for exact dosing,
  • leads to a rapid effect, and
  • avoids the disadvantages of smoking (i.e., no tar, ammonia, carbon monoxide).

What do patients say about the administration of cannabis flos by vaporization?

Using vaporized cannabis flos is the preferred means of use by most patients, especially when compared with an oral application. This is due to the more rapid effect by inhalation.

For some years the vaporizers where reimbursed by Dutch health insurance, thereby eliminating the threshold of a financial burden for the patient.

Patient considerations

Thinking about a first consultation with a patient, how do you start a conversation about cannabinoid therapeutics?

There are two types of discussion around the use of cannabinoids:

The elderly, cannabis naive patient:

An elderly cancer patient may be hesitant to use cannabis as a medication. This likely is related to prejudices about cannabis being a product for ‘recreational’ use. With these patients, I rarely discuss the use of these medicines during a first consult. If the patient is eligible and several other therapies did not provide sufficient pain relief, I then mention cannabinoid therapeutics as a possible option. This allows the patient and his/her family to contemplate that treatment option until the next appointment.

The experienced patient:

There may be patients who have extensive experience using cannabis recreationally. They may be actively looking into cannabinoid therapeutics as a potential adjunct to their pain therapy. These patients emphasise the ineffectiveness or side effects of other therapies, and may push clinicians towards prescribing a cannabis product. With these patients the topic must be discussed fully during a first consult. The main question during this consult is are they at all eligible to receive cannabinoid products.

Are you aware of patients experiencing interactions with cannabinoid therapeutics and other medicines?

Indeed, we do see patients who experience drug interactions using cannabinoids alongside other CNS depressant medications (e.g. opioids).

Sedative effects can be enhanced especially in the geriatric population. Severe drowsiness and hallucinations can also be provoked.

Aside from drug interactions, the smoking of cannabis is related to an increased risk of myocardial infarction and stroke. Cannabis as a trigger of myocardial infarction is plausible, given its cardio-stimulatory effects, which may cause ischemia in susceptible hearts. Carboxy-hemoglobinemia from the smoking of cannabis may also contribute to ischemia. Smoking is never recommended.

Do you encounter diversion for misuse or the abuse of cannabinoids? How do you identify this issue in your practice?

During the period when Dutch health insurers widely reimbursed medicinal cannabis, we had frequent discussions with patients, best described as ‘recreational users’, about their eligibility.

Patients of this group, who were already using large amounts of cannabis, were requesting access for rather dubious indications. Some patients were seeing it as a cheap way to get a ‘recreational drug’ which they were already abusing.

How do you deal with diversion for misuse or abuse in your practice?

This patient group can be quite challenging. They may put pressure on clinicians to prescribe cannabinoids as the only means to relieve their pain. Mentioning misuse and abuse can provoke abrupt reactions.

Clinicians should be coherent in prescribing cannabinoids only for indications with enough evidence for beneficial effects (e.g. analgesic for neuropathic pain, appetite stimulation etc). Misuse and abuse should be discussed openly if they become apparent.

Bedrocan releases new corporate movie

Bedrocan has for decades been a household name as a brand and company when it comes to the development and production of standardised, medicinal cannabis of pharmaceutical quality. Based on the knowledge that a picture is worth a thousand words, a short film has been made showing the unique combination of growing, harvesting and production (in accordance with good manufacturing practice) and research & development. The film explains in just three minutes and thirty one seconds precisely what we mean by ‘beyond pioneering’.

 

 

Bedrocan - beyond pioneering

New Dutch Bedrocan production site GMP certified

As of November 2017, the new Dutch Bedrocan production facility officially manufactures in accordance with good manufacturing practice (GMP). This guarantees that Bedrocan meets international pharmaceutical quality and safety requirements.

It is the second time that a Bedrocan production site has been made compliant with the GMP requirements for an active pharmaceutical ingredient. Earlier this year, the manufacturer of standardised medicinal cannabis acquired a GMP certificate for the existing Dutch production site. This made Bedrocan the first manufacturer in the world where the entire production process – including cultivation – complies with the international requirements imposed on the production of pharmaceutical raw materials and end products.

On 15 September 2017, the new Bedrocan production site harvested the first batch of standardised medicinal cannabis and handed it over to the Office for Medicinal Cannabis. The new site, outfitted with state-of-the-art finishings and fittings, has a surface area of 10,000 m2, half of which is in use at the moment. With this significant increase in production capacity, Bedrocan meets the growing demand for standardised medicinal cannabis of pharmaceutical quality.

 

 

No clear evidence of ancestry differences between Sativa- and Indica-labelled cannabis

Cannabis labelled ‘Sativa’ and ‘Indica’ may not come from distinct ancestries, according to a study performed by the Canadian Dalhousie University in cooperation with Bedrocan on the genetic differences between the two types and their hybrids. In this study 149 Dutch cannabis samples were analysed, correlating the genotype and chemotype to their reported ancestries. Indica- and Sativa-labelled samples were not as distinct as sub species would be assumed to be, but the genetic differences between them do correlate to their terpene profile (resin fragrance), which could explain the variation between them. Results of this new study have been presented on the International Association for Cannabis as Medicine (IACM) congress in Cologne, Germany, September 2017.

There is perhaps no debate in the world of cannabis more contentious than that of species. The genus Cannabis sativa L. is the only official species, but the terms ‘Sativa’, ‘Indica’ and ‘Hybrid’ have been widely adopted by cannabis breeders and cultivators as a way of advertising their product’s effects, aromas or purported pedigree. The degree to which these labels correspond to their actual ancestry, however, is dubious, and how this informal classification scheme relates to genotype or phenotype has been largely unexplored.

In the study an analysis of 149 cannabis samples was performed, correlating the genotype and chemotype (based on terpene and cannabinoid content of the flowers) to their reported ‘ancestry’.  The researchers then compared the reported labels to new scales they generated by reclassifying the samples based on their genetic and chemical similarity.

The Indica/Sativa classification of Dutch cannabis does not correspond to distinct genetic lineages or to cannabinoid type, but there are genetic and chemical similarities that explain the variation between the groups. Deconvolution of the Indica-Sativa ancestry showed a strong relationship between the chemical and genetic profiles, suggesting that the distinct terpene contents of the types are heritable and important to the identity of these two groups. It is likely that strains are classified by their distinct aromas, and not their lineages, which has a direct impact on the genetics of this crop.

Bedrocan, worldwide producer of standardised medicinal cannabis, is already working on the terpene profiles that are associated with the current Bedrocan products. Hugo Maassen, head of the phyto engineering department at Bedrocan: “This study shows that the Indica/Sativa differences could be largely based on terpene content, which instead of the current Indica/Sativa labelling might require for more insight in the terpene profiles related to the Bedrocan products available for patient use.”

The terpene profiles of the Bedrocan products are expected to be announced in the near future.

Bedrocan now available in Australia

Used by patients in the Netherlands since 2003, Bedrocan® standardised cannabis flos is now available for patients in Australia. This includes the same cannabis flos currently used in the NSW palliative care clinical trial.

Administered by vaporization, the consistent chemical profile of the flos better allows doctors to monitor dosage, condition progress, and reduce the risk of overdosing and unwanted side effects.

Being free of microbial contaminants (molds, fungi, and bacteria), pesticides, and heavy metals, Bedrocan cannabis flos is safe for vaporization and inhalation into the lungs. These qualities are especially important for people with weakened immune systems.

The recently published Prescribing Bedrocan provides information to assist health professionals on dosing, safety, and side effects. Our portal now allows doctors to report adverse events online.

Novachem, a specialist import and distribution agent, will supply flos and vaporization technology to licensed pharmacies in Australia.

Bedrocan International visit to Australia and New Zealand

A lot has happened in Australia and New Zealand to improve patient access to cannabis-based medicines. In this region, Bedrocan maintains is mission – to bridge the gap between patients need for cannabis and the requirements of modern medicines.

Reaching out to Oceania

Bedrocan have built strong academic and private partnerships across the globe. Our experienced international team, networks and collaborations are being strengthened here in Australia and New Zealand. Our international team are set to meet with leading researchers and practitioners who seek a better understanding of medicinal properties, the medicines safe and effective use, and education without commercial bias.

Steadfast, not a start-up

Bedrocan Australia draws on our 20+ years’ experience and global network. As the world’s most experienced producer of legal medicinal cannabis, our intention has always been for cannabis flos to achieve official medicine registration.

The first step is good manufacturing practice (GMP). Achieving a major industry milestone, Bedrocan is the only cannabis cultivator with end-to-end GMP. This guarantees seamless GMP production of finished dose forms – just like any other medicine.

Bedrocan’s founders – Tjalling Erkelens and Wupke Bruining – will be in Australia and New Zealand during late June and early July 2017.

LUMC starts clinical study on fibromyalgia and cannabis

Can herbal cannabis be used to treat fibromyalgia symptoms that are not properly managed with standard therapy?

This year marks the start of a worldwide series of double-blind, placebo controlled clinical trials with standardised, pharmaceutical grade medicinal cannabis. The first trial is being conducted in Leiden, The Netherlands, where prof. dr. Albert Dahan of the department of Anesthesiology of the Leiden University Medical Center (LUMC) is leading a study on the effects of inhaled medicinal cannabis on fibromyalgia symptoms.

Fibromyalgia is a disorder characterised by widespread musculoskeletal pain and sensitivity to touch. These symptoms are frequently accompanied by chronic fatigue, sleep disturbance, and emotional changes. It is estimated that around 3 to 5 percent of the general population is affected by this disease. Interestingly and for unknown reasons, the majority (80 to 90 %) of patients diagnosed with this condition are women.

Commonly used pharmacologic treatments for fibromyalgia include the central nervous system depressant pregabalin (Lyrica®) and the selective serotonin and norepinephrine reuptake inhibitor duloxetine (Cymbalta®), both of which have received regulatory approval in multiple countries for the treatment of this disorder. However, while these medicines have been shown in clinical trials to be effective and relatively safe, not all patients have responded to treatment. In addition, in some patients they have been found to produce a variety of side-effects, including dizziness, drowsiness, or emotional changes which may lead to depression or even, in severe cases, suicidal thoughts.

Cannabis as an alternative treatment

Research shows that cannabinoids – the active compounds present in the cannabis plant – can have a beneficial effect on fibromyalgia symptoms by reducing pain and improving sleep quality. Although cannabis has not been established as an approved medicine for this medical condition, surveys indicate that fibromyalgia patients already self-medicate using cannabis. Moreover, some patients have reported cannabis to produce fewer side-effects than the available conventional treatments and, most importantly, to be effective.

Clinical study

Bedrocan International – licensor for production of standardised, pharmaceutical-grade medicinal cannabis – hypothesises that herbal cannabis can be used to treat fibromyalgia symptoms that are not properly managed with standard therapy. For that reason, the LUMC is conducting a study that evaluates how the symptoms of fibromyalgia are affected by the two major cannabinoids (the active pharmaceutical ingredients) of the cannabis plant: delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Specifically, a group of patients is being administered these two compounds in the form of vaporized herbal cannabis. The three different investigated drug products are Bedrocan®, Bediol® and Bedrolite®, which are standardised medicinal cannabis varieties that are legally available in The Netherlands. During the study, patients are being subjected to different established measurements and tests that will provide information about the efficacy of the medication in reducing both the physical, as well as cognitive and affective, symptoms of fibromyalgia. It is hoped that the obtained information will push standardised medicinal cannabis forward as a possible alternative treatment for fibromyalgia, particularly for patients who do not respond, or do not respond sufficiently, to existing treatments.

Bedrocan becomes world’s first GMP producer

Following a rigorous inspection by the Dutch Health Care Inspectorate, Bedrocan in the Netherlands has become the world’s first producer of medicinal cannabis to be compliant with the European Medicines Agency’s good manufacturing practice (GMP) standards. This is the first time a medicinal cannabis producer has reached such a high level of compliance. Bedrocan’s production facilities in Canada and the Czech Republic are expected to become fully compliant next year.

GMP is the highest standard a medicine manufacturer must meet in its production process. Bedrocan’s GMP status is a guarantee of the highest quality in both its cultivation and packaging process.

Tjalling Erkelens, Chairman of Bedrocan International, said: “This is a significant recognition. We have always aimed to meet the highest pharmaceutical standards. Now our way of working is officially recognised by the authorities.”

Since 2003, Bedrocan has produced standardised medicinal cannabis as an active pharmaceutical ingredient (API). It is the only company in the world to produce cannabis flos (the whole, dried flower) with a constant composition of cannabinoids and terpenes.

Bedrocan’s Dutch-made medicinal cannabis supplies patients and researchers in the Netherlands, Germany, Finland, Israel, Italy, Macedonia and Poland. In Australia it is used in Australia’s first clinical trial of vaporized cannabis flower bud.

Perry Davidson, CEO and founder of Israel’s Syqe Medical, which incorporates Bedrocan’s medicinal cannabis in its metered-dose inhaler said: “Syqe Medical has developed the world’s first inhaler that delivers medicinal cannabis with the level of precision of traditional medicines. A key factor in our ability to provide a pharmaceutical-grade solution is Bedrocan’s standardised product and uncompromising quality. The GMP compliance achieved by Bedrocan marks a major leap forward for medicinal cannabis, and its acceptance as a mainstream treatment by the medical community.”

In Canada and the Czech Republic, Bedrocan’s unique production methods are licensed to exclusive partners.

Bedrocan’s cannabis used in clinical trial Australia

The first of its kind in Australia, Bedrocan’s cannabis flos and placebo will be used in a cancer palliative care clinical trial. Led by Professor Meera Agar, the double-blind randomised controlled trial will explore whether vaporized medicinal cannabis flos can promote appetite and improve quality of life. For people with cancer, the pathways that promote appetite are disrupted. Their quality of life is reduced due to fatigue, low mood, nausea and insomnia – aspects critical to health and wellbeing.

Researchers are now recruiting patients. Approximately 30 adult patients with advanced cancer will be included in the trials undertaken at Sydney’s St Vincent’s Sacred Heart Health Service and Newcastle’s Calvary Mater Hospital. The results may lead to a further trial, enrolling up to 250 patients from metropolitan and regional hospitals across the state.

The New South Wales Minister for Medical Research, the Hon. Pru Goward, fully supports the trial as part of the state Government’s $21 million funding commitment to medicinal cannabis clinical trials and reforms. To learn about the NSW Government’s Centre for Medicinal Cannabis Research and Innovation and the trial see www.medicinalcannabis.nsw.gov.au.

For more on vaporization as a way of administering cannabis flos, read our article Not all vaporizers are the same.

Placebo for use in clinical studies

Modern clinical trials are typically performed as double-blinded, placebo-controlled studies. To meet these needs, Bedrocan now offers placebo versions of all of our strains for use in clinical studies. Each placebo contains the precise terpene profile of the original strain, with all cannabinoids removed.

The method we use to turn active cannabis into placebo uses homogenised cannabis as the starting material. We do this through a process called granulation, where the cannabis is broken up into smaller particles. For that reason, placebo material only comes in the form of granulate.

Full HPLC (high-performance liquid chromatography) and GC (gas chromatography) profiles are available on request, showing detailed information about cannabinoid and terpene content of all varieties.

Click here for more information about our placebo.

placebo-medicinal-cannabis-by-bedrocan-6

Towards a clearer classification of medicinal cannabis varieties

Detailed chemical analysis shows clear differences between Sativa and Indica types of cannabis.

The terms Sativa and Indica have been used for centuries by cannabis cultivators and end users to identify certain types of cannabis. Patients have learned to use these terms to navigate their search for their favorite variety, but it was unclear how this reflected actual differences in chemical composition and medicinal effects.

A recently completed study, commissioned by Bedrocan International, shows that certain terpenes are the chemical markers that distinguish Sativa from Indica type cannabis. The use of biochemical markers is a useful addition to the commonly used classification system based on popularized vernacular or ‘cultivar’ classification names such as Amnesia Haze or Purple Kush. A more advanced scientific approach makes it easier to discover varieties with chemical composition (‘chemovars’) that better match patients’ pharmacological needs.

In his study, titled ‘From cultivar to chemovar II’, Dr Arno Hazekamp analysed the largest collection of cannabis samples (460) reported in scientific literature. Samples were chemically mapped and divided into clusters with similar composition. The study showed that Sativa and Indica samples were clearly different on a chemical level, with certain terpenes as the main markers. Hydroxylated terpenes (also known as terpenoids) were significantly more prevalent in Indica type samples. Opposite to common belief, Sativa and Indica types did not differ in their average content of THC or CBD.

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