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Bedrocan’s founder speaks at cannabis product quality workshop

An international workshop on cannabis product quality will be hosted on December 7th and 8th by ASTM and USP. Bedrocan will share her knowledge in this free online workshop. During these two days, standards and guidelines from USP, PhEur, ASTM and other relevant organizations will be discussed to help address the challenges related to cannabis quality. Science-based resources from these standards development organisations will be discussed to explore opportunities to harmonise the varying national requirements for cannabis quality for products intended for medical use and scientific research.

Harmonisation

Currently, around the globe, there is inconsistency in the development and adoption of analytical methods for cannabis materials and products intended for medical use.  The globalisation of production and trade means industry must meet varying standards to enter markets. Harmonisation across the Americas and Europe is the first step toward reducing technical barriers to trade and improving the quality of cannabis intended for medical and scientific use around the globe.

Addressing common challenges through harmonisation and alignment of quality standards across jurisdictions would serve to protect patients and promote research and improve public health across the globe. The start of the harmonisation process has already begun with Bedrocan meeting both the Dutch and German monograph, which soon will be superseded by the European monograph.

The workshop

The international workshop on cannabis product quality will be held on the 7th and 8th of December from 8.00 am – 12.15 pm ET (2:00pm – 6:15pm CET). There is no fee to attend this event, registration is required and now open.

The objectives and scope of this workshop include:

  • Obtain awareness of the existing data, regulatory framework and public policy for cannabis quality, public quality standards, and policy guidance documents on defining cannabis product quality attributes globally – initially from an American and European perspective.
  • Understand the scientific basis for standards to explore potential harmonization among standards groups.
  • Facilitate discussions between stakeholders to identify needs and challenges related to cannabis quality.
  • Identify areas of global data gaps to inform future standards and research needs.

The workshop will also include four panel sessions across both days. Bedrocan founder, Tjalling Erkelens, will be one of the panelist in the industry panel on day two, the 8th of December. Tjalling will share information on the industry experiences in meeting regulatory requirements and in utilizing the available standards for medical cannabis quality.

If you want to read more about this workshop and the participating organisations, click here. To register, click here.

About the ASTM

ASTM International is a leading international standards development organization with over 12,800 standards operating globally. ASTM formed Committee D37 on Cannabis in 2017 to develop and maintain standards and guidance materials for cannabis products and processes.

About USP

USP is an independent, scientific organization focused on building trust in the supply of safe, quality medicines by setting public quality standards and publishing a pharmacopeia. USP formed an Expert Panel of Medical Cannabis in 2016 to develop quality standards for cannabis used for medical purposes.

How Do They Do It about medicinal cannabis

Have you seen the episode How Do They Do It? at Bedrocan? If not, it is now on our YouTube channel. In this episode, presenter Joep van Deudekom and Bedrocan founder Tjalling Erkelens go through the production process: from cuttings to cannabis flos. The video is subtitled in English and Dutch. Curious? Click on the image  below.

How Do They Do It?

How Do They Do It? is a television series produced by Wag TV for Discovery Channel. It is one of the world’s best-known and highest-rating pop-science/engineering shows. Each programme explores how two or three ordinary objects are made and used. The series is broadcast throughout the world on various Discovery-owned networks including Discovery Channel in the Netherlands.

In the Netherlands, the programme is presented by Tim Senders and Joep van Deudekom.

(source: Wikipedia & Wag Entertainment)

Join us at CPhI Frankfurt 2022

Bedrocan is present again at world’s largest pharmaceutical API & raw materials fair: CPhI Frankfurt 2022, Germany. Our team is happy to tell you everything about our standardised medicinal cannabis API. Will we you  see you in Frankfurt?

Register now and receive a FREE Early Access Pass

Book your ticket for this 3-day international pharma industry event by clicking on the below banner.

Advisor Commercial Strategy & Development Varun Arora and Market Research Analyst Thanh Nguyen-Kim will represent our organisation and our cannabis products together with Corporate Strategy Analyst Andrew Kraszewski.

Promoting our products at CPhI Frankfurt 2022

Last year, we focused on our five varieties of standardised cannabis as an API and the trichome powder and placebo product forms.  Although there is no production line for the trichome powder yet, Bedrocan will produce them on a larger scale in the future. Especially for companies from countries in which the import of cannabis flos is not allowed, having our products in a different form that can be used as raw material would be very valuable.

Additionally, Bedrocan team will also promote our unique cultivation techniques and excellent quality management system, which could also be applied to the production of other medicinal plant products.

The importance of a standardised cannabis product

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

Unlike other medication, the cannabis plant does not have a fixed chemical/molecular composition. Cannabis  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.

Four crucial reasons why cannabis should be standardised

Bedrocan produces five medicinal cannabis varieties. 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

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:

Cannabis - from cultivar to chemovar

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.

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.

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.

Synergy between cannabidiol, cannabidiolic acid, and Δ⁹-tetrahydrocannabinol in the regulation of emesis in the Suncus murinus

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.

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’.

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.

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.

Single and combined effects of Δ 9 -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.

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.

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’.

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.

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

Documentary ‘The Doctor- Franjo Grotenhermen’ to be premiered

On 3 June, the documentary The Doctor – Franjo Grotenhermen will be premiered. It’s about the life of a pioneering physician in Germany and the first in the healthcare sector to foster the therapeutic potential of medicinal cannabis in Europe.

Meet Franjo Grotenhermen in person

The premiere will be held in Amsterdam, at the LAB111 cinema at 7.30 pm. Franjo Grotenhermen will also be present at the event, offering a unique opportunity to meet The Doctor in person.

Do you want to go to the premier? You can use this discount code to get 50% off tickets.

Discount Code: MYCB1DS

Franjo Grotenhermen

The documentary takes place during the 10th Conference on Cannabinoids in Medicine in Berlin in 2019, organised by the International Association for Cannabinoids in Medicine (IACM), which Franjo co-founded and directed for several years.

This award-winning documentary is a journey through his life and work over the last 30 years with interviews with his colleagues and fellow scientists like Raphael Mechoulam, Mark Ware, Kirsten R Müller-Vahl and Manuel Gúzman. Our CEO Tjalling Erkelens is also featured in an interview as one of the people Franjo met in his journey.

About the film director

Edu Hernández, born in Spain, is a filmmaker and photographer focused on journalism and documentaries.

With a passion for journalism, it is his obsession to tell what happens in social conflicts and to reflect true stories of almost unlikely characters. One of his documentaries, Refugees, has already won awards at five film festivals. It has also been nominated at six other festivals, and it was also selected to raise awareness among the world leaders during the World Government Summit 2017 in Dubai.

Since 2017 he has been working as an independent filmmaker. As a photographer, he worked for local as well as international artists, such as Concha Buika, Miguel Poveda, Fuel Fandango and Nynke Laverman.

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 Real World Data
Founder & Director 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.

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Discovery Channel - How Do They Do It?