Bedrocan sponsors ICRS scientific congress

There are more and more cannabis-related conferences worldwide. Bedrocan chooses only meetings about the medicinal use of cannabis or where we can tell our story about GMP-quality medicinal cannabis. The ICRS symposiums is close to our heart.

This year it will be held in Leiden, the Netherlands (30 June to 5 July). ICRS, the peak International Cannabinoid Research Society, is an independent organisation promoting scientific research in cannabinoids, the most important components of cannabis.

ICRS provides impartial information about cannabis and cannabinoids. It is also provides a forum for research discourse, and a platform to share scientific the latest studies. This year the global scientific community meet in Leiden where Bedrocan is one of the principal sponsors.

During the year, you can catch up with Bedrocan, when we present at the following international conferences:

What Where When
Cannabis Europe Cannabis Europe London, United Kingdom 22 May
World Cannabis Congres World Cannabis Congress New Brunswick, Canada 10 – 12 June
Medical Cannabis Medical Cannabis ‘Controversies in Cannabis-Based Medicines’ Vienna, Austria 24 & 25 June
ICRS ICRS Leiden, the Netherlands 30 June – 5 July

Dr Hřib: ‘Don’t be afraid of medicinal cannabis’

When a science student stepped into his office and explained about the medicinal use of cannabis, Dr Radovan Hřib developed a serious interest in cannabis as a medicine in the Sint Anna University Hospital, Brno city of Czech Republic. Prescribing since May 2015 under state registration, he currently treats around 80 patients experiencing pain of different origin. Dr Hřib has a message for reluctant doctors: “Do not be afraid about cannabis for medicinal use. It will surprise you pleasantly.”

According to Dr Hřib there are three types of patients in his hospital. The first already has some good experience with cannabis, and wants to the use it under his medical supervision. The second patient type is already taking a number of analgesics such as non-steroidals, paracetamol, anti-rheumatics and opioids. They only receive partial response. With the third type, current treatment using classical medications hardly work and cannabis is their last hope.

He prescribes fully standardised cannabis flos, the whole dried flower, as it is the only pharmaceutical-quality product available in the Czech Republic. His patients take their medicine either prepared by the hospital pharmacy, as capsules containing a single dose of cannabis flos and are taken by mouth, or are dispensed cannabis flos for inhalation by vaporization. Just recently the Sint Anna Hospital has set up a special area where pain and cancer patients learn how to operate a vaporizer.

Dr Hřib

Why do you prescribe medicinal cannabis to patients? Is there a personal motivation?

I prescribe medicinal cannabis to patients for one simple reason: because it is helping them. This is driven by my professional curiosity and the intention to provide the best outcomes for my patients. An overwhelming majority of patients are actively interested in possibility using it as a treatment for pain. However, there will always be a few patients with strong opinions against its use.

What are the key benefits of medicinal cannabis?

I still have many benefits to discover. However, the longer I prescribe it, the more I am fascinated. In the treatment of pain, cannabinoids act in several modalities, apart from a

good analgesic effect, it significantly improves sleep and its use is accompanied by a reduction in anxiety. In this way, the so called vicious circle of chronic pain can be broken in several places.

What are the risks of prescribing medicinal cannabis?

The very individual character of dosing poses a disadvantage for many physicians. In Czech Republic we prescribe cannabis as an individually prepared medical product. Therefore you need a collaborating pharmacist who understands what is needed. I am lucky that I can rely on the great support of our hospital pharmacist Monika Pecháčková. As a prescribing doctor I would like to point out that my work with medicinal cannabis would not be possible without the support and tolerance of my faculty superiors, my family, colleagues and co-workers at the workplace and in the hospital.

Why is that?

There is great stigma around medicinal use of cannabis and this is also present in the Czech medical community. It is still tightly regulated, it is risky because there are still unknowns. As opposed to other work places, the hospital I work at has been openly supporting me from the very beginning.

How do you decide the best dose for individual patients?

Mostly, this being specific for the Czech Republic, I use oral administration through capsules. Mainly for financial reasons as patients appreciate that this method does not significantly increase the price of already expensive plant material. The body is offered the whole herb, and we let the human organism to choose what to absorb from it.

At the moment, I am using two dosing schemes for capsules. First one is according to my own empirical experience. We start at a dose of 0.125 gram of cannabis decarboxylated by heat, presented in a gelatine capsule, per night (which makes up to 18 – 25 mg THC depending on variety). If the patient experiences difficulties, the patient can call me immediately, at any time of the day. Within 7 days I want to hear from the patient, also if they only benefit from the treatment. When there are significant side effects, usually it is dizziness, we reduce the dose or we try to encourage the patient to keep trying. The dose is increased at the earliest after one month from the beginning of the therapy.

I also started using the second scheme according to neurologist Ethan Russo. Starting with a dose of 2.5 mg THC per night. After about 5 days we gradually increase the dose by 2.5 mg THC.

When vaporizing, I teach the patient about gradual titration. In the near future, I would like to combine oral capsule administration with vaporization. Now that we have opened our user centre, we will try to introduce the gradual titration directly in the hospital, or during hospitalisation.

Do you encounter diversion for misuse or the abuse of medicinal cannabis?

So far, I was lucky to have disciplined patients, and I did not have to deal with this problem with regards to medicinal cannabis.

How do you identify this issue in your practice?

Given the fact that I have been prescribing highly addictive opioids to my patients for over 18 years, I have quite a lot of experience with diversion for misuse or the abuse. Fortunately, with patients experiencing chronic pain, this problem is minimal. Mostly, patients with this problem identify themselves. For example, they often “lose” medications, are not disciplined in treatment or check-ups, and so on. I believe that the best way to prevent and deal with abuse is to have an individual and personal approach to the patient.

If a doctor wants to know more about prescribing medicinal cannabis, what would be a good information source?

I recommend two basic resources to doctors.

Furthermore I recommend the following websites:

  • IPVZ – the Institute of Post Gradual Education in Healthcare. They are holding already a third training seminar on cannabis.
  • ICCI – International Cannabis and Cannabinoids Institute based in the Czech capital Prague. Our hospital is also now offering the opportunity to organize seminars in cooperation with ICCI.
  • SAKL – State Institute of Cannabis for medicinal use
  • KOPAC – Czech Patient Association

As the doctor’s experience grows, they can much more rely on their own experience, and only use the internet occasionally.

Do you have any advice for doctors starting out prescribing?

Do not be afraid of medicinal cannabis and try it in your therapeutic practice.

What would you like to say to doctors that are reluctant to prescribe cannabis because there is not enough clinical evidence that medicinal cannabis actually works?

I will only repeat myself. Do not be afraid about cannabis for medicinal use. It will surprise you pleasantly. On the contrary, you will be able to contribute to the creation of scientific evidence. And I mean this as criticism towards the almost exclusively strict use of evidence-based medicine, which is well described, and the tendency to adhere to prescribing only this, rather than being open to new methods and treatments. Trying out new treatments and creating your own opinion… only then you will discover yourself what the real art of medicine is.

Dutch patients’ daily cannabis dose remains stable

The average daily dosage for prescribed medicinal cannabis among Dutch patients has remained remarkably stable over the past years. The average daily dose has risen slightly from 0.64 to 0.73 gram of cannabis per day during two study periods. This can be concluded from a recent study carried out by researcher Bas de Hoop. We asked him why is this important?

Where does the data for this study come from?

The Dutch Foundation for Pharmaceutical Statistics (SFK). SFK is an independent organisation who collects 90% of all prescription data from Dutch pharmacies. This includes the prescriptions for medicinal cannabis, but excludes pharmacies that are located in care homes or hospitals.

All manner of information can be collected from these prescription details. For example, the issue date, the amount of cannabis dispensed, the specialty of the prescribing doctor, and importantly the age and gender of the patient. On the basis of this raw data we produced calculations that provide an approximation, such as patients’ average daily dose and the total duration of use.

Is there an increase in the number of users in the Netherlands?

Certainly, you can observe a gigantic increase in users between the study periods 2003-2010 and 2011-2016. During the first eight years we identified 5,601 people. Six years later we identified 10,826. That is only for prescriptions of cannabis flos. In 2015, cannabis oil became available as a dosage form. In the year after Transvaal Apotheek in The Hague introduced cannabis oil, there are now 6.720 patient prescribed the oral dose form.

We also calculated how many patients there were in relation to the total Dutch population. Those figures are spectacular. In 2003, 6.4 patients per 100,000 inhabitants used a medicinal cannabis product. By 2010,this had moved up to 6.9, which is not exactly a gigantic leap in use. However, by 2016 we note that 24.6 patients per 100,000 inhabitants are prescribed medicinal cannabis, either as cannabis flos or oil.

The introduction of cannabis oil at the end of 2015 had a significant impact on the figures? 

OMC

Dutch patients have been able to obtain medicinal cannabis on prescription from their GP for 15 years. The medicinal cannabis programme is supervised by the Dutch Ministry of Health’s Office for Medicinal Cannabis (OMC) . A programme which supplies pharmaceutical-quality medicinal cannabis. Since the start of the programme in 2003, medicinal cannabis has been prescribed a total of 170,000 times to more than 15,000 patients.

The availability produced an enormous increase. In 2016 alone, the number of patients prescribed oil was much higher than for cannabis flos. Unfortunately, cannabis oil was introduced too recently to provide reliable data on the average daily use or other interesting aspects. However, those data demonstrate that patients prescribed oil were often older and more often female compared to patients who prescribed cannabis flos.

What do the figures say about the age structure and gender distribution of the average patient?

The largest group of patients is over 40 years of age. Eighty percent of the flos users are older than forty years, and this number is 88 percent for the patients who are prescribed cannabis oil. About the same number of men and women are prescribed cannabis flos. In relation to oil, women have a slight majority (60%). Most prescriptions are among patients aged between 41 and 60 years old (42.9%), followed by the category of 61-80 year olds (30.9%). So they are an older group, on average.

In this study we compared the current data with previously published material. The age distribution of patients remained virtually the same for the two study periods. However, there was a slight shift in the gender split – the percentage of female patients fell from 57.1%  to 51.4%.

Why should we care about these figures?

We have been gathering data about medicinal cannabis use in the Netherlands for more than 15 years. We can learn a lot about actual usage. As far as I know, there is nowhere else in the world where these figures are collected centrally. Not even in Canada, which was the first country in the world to start with a medicinal cannabis programme. In other words, these figures are fairly unique and, particularly when it concerns a daily dose of 0.7 gram. The Netherlands has a prescriber-pharmacy model, where guidance for using medicinal cannabis is actively provided. This is important because not every patient has the same course of treatment meaning a doctor and patient and pharmacy work together to find the correct dose and improve patient safety.

On prescription

In the Netherlands, medicinal cannabis is only available on prescription and can be issued by any pharmacy in the country. Currently, only Bedrocan products are available. Five different products of pharmaceutical quality and standardised composition are available.

This data provides a framework for a doctor to take into account when considering prescribing for their patient.

Can you say something about the duration of use?

The figures demonstrate that as the patient gets older, the number of days they use medicinal cannabis reduces. While it is possible to calculate an average duration, but it is difficult to interpret, given the average duration of use is likely to be affected by deaths in the highest age category.

The daily dose in the Netherlands has been around 0.7 gram for more than 10 years. What does that tell us?

This shows clearly that there is no increase in the consumption of medicinal cannabis in the Netherlands. Policymakers may have fears that the introduction of medicinal cannabis will lead to an increased patient tolerance, physical addiction and dependency. In the Netherlands, policymakers fears are laid to rest with these figures; over a period of 10 years we cannot find an indication for unwarranted increased in medicinal cannabis use.

Can you say something about what conditions Bedrocan products are prescribed?

Unfortunately I cannot provide an accurate answer to this question. The reason is that we do not have the right information. The disease or complaint of the patient is not stated on the prescription, it just says who prescribed it. More than half of the prescribing doctors are GPs (59.2%), followed by specialists (27.1%). The data refer to specialisations, but when it says surgery, cardiology, or internal medicine you don’t know enough to identify the complaint.

Bedrocan donates vaporizers to Czech hospitals

Bedrocan has donated ten medical vaporizers to two Czech hospitals. They concern the Volcano Medic®, and they are used in the Sint Anna University Hospital and the Masaryk Cancer Institute in the Czech city of Brno. Under the guidance of trained personnel, pain and cancer patients learn how to operate and dose the device. The Sint Anna Hospital has set up a special area for this purpose, which was put into use officially on 17 April.

Jaap Erkelens (Bedrocan) & Dr Martin Pavlík (Sint Anna University Hospital)

The Czech Republic has had a medical cannabis programme for many years. However, as in the Netherlands, cannabis and expensive vaporizers are no longer reimbursed by health insurance policies, causing a major problem for patients with low incomes in particular. Bedrocan hopes that by donating the vaporizers, patients are able to familiarize themselves with vaporization as a method of administration before they purchase the vaporizers. Vaporizing is generally regarded as the most efficient dosage form because the active substances are absorbed quickly into the body. It is also safer than smoking because there is no release of toxic substances, such as carbon monoxide, ammonia or polycyclic aromatic hydrocarbons (PAHs).

Capsules

Bedrocan has been working with one of the doctors of the St. Anna hospital, doctor Radovan Hřib, for many years. As a pain specialist, he prescribes medicinal cannabis for patients with chronic or acute pain. The special user space was his idea.

Doctor Hřib commented “Now patients often have to rely on capsules that are compounded by the pharmacy, but it is not the best dosage form in pain management. Vaporizing is preferable above all else, because the vapour is absorbed immediately into the bloodstream and the effect is felt immediately. ”

In addition to his work in the hospital, Dr Hřib is associated with the Czech patient organization KOPAC. In the Czech Republic he is regarded as the medical expert in the field of medicinal cannabis. He cooperates with government bodies to increase the availability of cannabis for medicinal use to the patients and to simplify administration for doctors.

Dr Radovan Hřib

He was also involved with the registration of medical vaporizers in the Czech Republic. The user area with the vaporizers is intended to teach patients to dose. Doctor Hřib said “Unfortunately there is no universal dosage. Every patient reacts differently to cannabis. Here they learn which dosage suits them best. Under expert guidance, they also discover any possible side effects occur and how to deal with those.”

Cannabis ointment for skin diseases based on Bediol

Recently the Dutch Transvaal Apotheek in The Hague started marketing cannabis cream alongside cannabis oil. This cream is a new dosage form for patients. It is based on the cannabis variety Bediol and is intended for treating skin conditions.

According to Arwin Ramcharan, pharmacists QA of Transvaal Apotheek, the cream was developed at the request of a dermatologist in The Hague. “I won’t mention names, but it is a dermatologist with whom we have worked before. He was already familiar with the cannabis oil we have been preparing on the basis of the Bedrocan varieties since 2015 and which he prescribes from time to time. He wanted to try out a cream based on Bediol for group of approximately 40 patients. If the trial is positive, the group of patients will be expanded. For the time being, other patients can buy the cream from us on prescription.”

With the cream, for which a patient pays 60 Euro (per 20 gram), a new dosage form has been added to the range of cannabis products based on Bedrocan varieties. The Transvaal Apotheek will leave it at that for the time being. Ramcharan: “Occasionally we receive requests for capsules, but they are more difficult to make. Furthermore, it is a significantly different administration method as capsules go via the stomach where substances are broken down; it means you need to increase the dose.”

Apotheek SMA in Rosmalen, which prepares oil from Bedrocan varieties, also has a cream available for various skin conditions. However, this Cannabinoid Cream is made on the basis of CBD crystals.

Vaporizing presents minimal risk of second-hand exposure

Hospital staff or researchers are at low risk of exposure to patient’s exhaled cannabis vapour. An Australian study demonstrated staff who administer vaporized cannabinoid medication to patients in a clinical environment will not be exposed to THC. The active substance THC was not found in the blood after staff had been exposed to environmental vapours.

A vaporizer medical device is considered to be a safe administration method for patients. There is no exposure to harmful substances like from smoking. The medicinal effects occur sooner with vaporizing than with other administration forms, because the cannabinoids are absorbed into the blood almost immediately after inhalation. It is also a user-friendly method for patients who struggle with swallowing. However, until recently there was little or no knowledge of whether the exhaled vapour would be harmful to other people in the same environment. In other words, could someone else be exposed to THC?

The conclusion is therefore that vaporizing is safe for staff who administer medicinal cannabis to patients. However, a more comprehensive study of this subject is warranted. A study including more participants, room sizes, cannabis varieties, and types of vaporizers would be beneficial.

Denmark permits medicinal cannabis, but doctors are reluctant

Since 1st January 2018, cannabis for medicinal use is permitted in Denmark. How did the first weeks work out? If we are to believe the stories in the media, Denmark will be cultivating cannabis on a major scale next year. Doctors on the other hand are sceptical, because there is insufficient scientific evidence. Meanwhile, a public pain clinic is unable to meet demand and patients are on a one-year waiting list.

Odense, the third largest city in Denmark, aims to become the European capital of cannabis cultivation. That was the heading of a newspaper article from early 2018 about the developments in what is known as the centre of Danish horticulture. At the end of last year, a local tomato grower and a hemp grower entered into cooperation with two major Canadian cannabis producers. The Canadians bring money and knowledge, whilst the growers supply the greenhouses and the land. Peppers and orchids are being exchanged for ‘green gold’ and thousands of square metres of old greenhouses are transformed into high-tech businesses.

Cannabis cultivation

According to the Danish medicines agency, which issues licences for cannabis cultivation, 12 Danish businesses have received permission to start cultivating. They may only do so within the context of a four-year pilot project. After two years there will be an interim evaluation and the Danish government will decide whether to continue the project or not. According to Henrik Uth of the company CannGros, currently the only importer of medicinal cannabis in Denmark, obtaining a growers licence does not mean you can start selling medicinal cannabis. “In principle, you just need to present a plan to the authorities. You don’t even need facilities. It will be interesting to see how the production, and the regulation on quality control on Danish grown medicinal cannabis, will come together. There is still little clarity on that point.”

Tina Horsted & Jens Thau

Either way, government rules prescribe that the new growers must be able to produce standardised and consistent cannabis. The levels of active substances must be the same for every harvest. This has been Bedrocan’s speciality for years, and for doctors who wish to prescribe medicinal cannabis it is simply essential. Pain specialist Tina Horsted is familiar with the issue. She runs a pain clinic in Copenhagen where she treats 90 patients a day. Tina Horsted comments:  “Standardisation is essential. Patients must have the guarantee that with every inhalation, drop of cannabis oil or capsule they receive the same amount of THC or CBD. It is about safety and quality. That makes the difference between going to a doctor or obtaining cannabis on the black market.”

In Denmark, Tina Horsted is the only doctor who specialises in prescribing medicinal cannabis. Two years ago, she started the public pain clinic Min Smerte. A loophole in the law enabled her to prescribe cannabis to patients, because cannabis was considered to be a natural medicine. “It had to be a hand-written prescription and the end product had to be compounded by a pharmacist”, commented Horsted. She found one pharmacist who was prepared to produce oil and capsules with cannabis components. He lawfully obtained the CBD-containing cannabis from Austria and the THC was added separately.

At the moment, she treats 1,200 patients in her clinic who suffer from chronic pain, MS, RA and cancer. The change in legislation now enables her to prescribe Bedrocan products lawfully and everything is done electronically. In principle, a patient can take a valid prescription to any Danish pharmacy. At the moment, the Danish government has permitted two products – Bedrocan® and Bediol®, which are the most commonly prescribed cannabis products in the world.

Danish doctors

However, a majority of Danish doctors opposes the change in legislation. They argue there is insufficient scientific evidence to support the effect of cannabis. There is also little known about the correct dose, side effects and possible risks of combining cannabis with other medication. Danish patients are struggling to find a doctor who is prepared to write the prescription. Jens Thau is in charge of Clinic Horsted that is privately run and he is confronted with the doctors’ reluctance on a daily basis. “Each day we receive some 20 calls from patients all over the country who do not receive any assistance from their own doctor.” These patients, except for terminal cancer patients, end up on a one-year waiting list because of the high demand. “According to Danish rules we may only employ one doctor in our clinic and that is Tina.” The costs of treatment in the public clinic are reimbursed in full by the Danish government. Patients who do not want to wait, or who cannot wait, can attend the private clinic that has an open surgery every Friday. Patients pay for their treatment themselves or have it reimbursed by additional insurance. Thau comments: “Most pain patients do not have insurance, they are 65 or older and often did heavy labour. That is the saddest part of the story.”

Book

The couple Hosted and Thau are  convinced of the beneficial effect of cannabis and in their evenings they travel around the country to convince Danish doctors and parliamentarians. A book about their experiences with prescribing medicinal cannabis, which will be published this year, is also intended to contribute to more knowledge transfer. Until then doctors will have to make do with the guidelines of the Danish medicines agency, which are available online. Information about the two Bedrocan products that have been included in the trial, comes from importer Uth. “We are bound by rules and may not provide information that encourages the sales of the cannabis product. The only thing that is permitted is a general leaflet with advice about administration and doses. It is in high demand.” As in the Netherlands, the recommendation is vaporizing with a vaporizer or drinking tea. Smoking is not recommended due to the ‘risk of lung and airways infections’ according to Danish guidelines. It is also recommended to start with a low dose. According to the Danish government, it is ultimately the doctor who decides on the dose and the correct usage method.

Bedrocan stays away from recreational use

Before the turn of the millennium ‘producing cannabis of pharmaceutical quality’ was a self-imposed task. Today it is nothing less than a tour de force for Bedrocan. Operating across the globe, Bedrocan is keeping abreast of the growing demand for the highest quality medicinal cannabis.

The will to move cannabis to the level of a licensed medicine came from Tjalling Erkelens, founder and chairman/CEO of Bedrocan. From the start he envisaged a specialised cultivation process. He made a three-fold promise to the Dutch government (in 2003 – ed.) – to be patient inspired, science driven, and regulatory compliant. Since then, Bedrocan has been the sole supplier to the Dutch prescriber-pharmacy medicinal cannabis programme.

“The cannabis varieties we supply now are based on years of knowledge and experience, and on patient need,” clarifies Erkelens. “In conjunction with our client, the Dutch government, we translated that into a number of standardised varieties of cannabis flos (the whole dried flower). These days there is more and more scientific research into the effect of the active substances in cannabis on the human body, to ensure the approach to medicinal cannabis moves from empirical and anecdotal to scientifically sound. We support this development wholeheartedly. Bedrocan continues to undertake and support scientific research. The same applies to studies of administration methods, such as our patient-friendly vaporizer. Input from patients continues to be essential, because they are the reason for our efforts. We have now come to a point where we initiate and support clinical trials. If your aim is to have cannabis registered as medicine, you can only achieve that on the basis of scientific evidence.”

Recreational use

In the area of compliance, Bedrocan has always taken a clear course. Erkelens continues: “From the start we have worked in accordance with applicable legislation and regulations. That is beyond dispute as far as we’re concerned.

Bedromedic® - Bedrocan's patient-friendly vaporizer

Outside the Netherlands, we only wish to focus on countries where the production and use of medicinal cannabis is enshrined in law. We continue to focus on the medicinal application of cannabis; intended for patients.

We are never party to the global discussion about legalisation, we stay away from recreational use, and only seek to cooperate with partners that share our vision of compliance.”

This choice means that Bedrocan and its licensees are bound by increasingly stringent requirements in the area of quality and safety. Compliance, again. This time a commitment to pharmaceutical requirements. “Fair enough”, says Erkelens. “We are a pharmaceutical company. So you need to comply with strict requirements and be tested for those. That is why we were the first manufacturer to have the entire production process – including cultivation – good manufacturing practice (GMP) certified. It is why we invest in people, equipment and processes in that area.”

Cannabinoid therapeutic products

Globally there is increasing interest in the medicinal application of cannabis. Not only as pharmaceutical cannabis flos for vaporization, but also as an active ingredient for cannabinoid therapeutic products. Bedrocan keeps pace with those developments.

In 2016, we started with controlled cultivation, and that led to a larger, more streamlined organisation, where botany joins forces with pharmaceutical knowledge. In 2017, a new state of the art production site was commissioned. “This enables us to meet the growing demand in the Netherlands and abroad”, continues Erkelens, who realises that the interest in medicinal cannabis will increase across the world.

What is medicinal cannabis?

When medicinal cannabis has to be defined, there is always a discussion about the difference between the medicinal and recreational use of cannabis. The Dutch Office for Medicinal Cannabis (OMC) has final responsibility for the medical and scientific use of cannabis in the Netherlands. The OMC describes medicinal cannabis on its website as follows: “Cannabis distributed by pharmacies is of pharmaceutical quality and complies with the strictest requirements. This cannabis is intended for medicinal use only. That is why we refer to medicinal cannabis.”

It is all about cannabis that is meant for people who can’t function properly due to a certain condition. Often these people have a low level of resistance and that makes product safety crucial. The cannabis that is supplied by the OMC to pharmacies in the Netherlands and exported to some countries, is produced by Bedrocan Nederland in accordance with strict protocols in a standardised, predictable process. That is the only way to standardise the product – the same amount of active substances per variety in each and every batch. This happens in a conditioned environment and – from cultivation to packaging – in accordance with the strict requirements of good manufacturing practice (GMP). The cannabis is free from contamination and is tested for this continuously, as for its standardisation.

“The number of countries that are active in the area is increasing and that is all to the good. However, it is important that we express clearly who we are, what we do, and why we do it this way. Anyone can address us on that.”

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.

 

 

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