Prescription of Medical Cannabis

Welcome to the sixth edition of Insider Cannabis Q&A, where we do a deeper dive into the market, trends, innovation, failures, and successors of operating and building a medical cannabis business. The goal of this newsletter is to bring to light open-source knowledge for an industry that is starting to standardize itself and bring news of consolidation of a maturing sector.?

In this newsletter, we will be diving more profound into the world of prescription medicinal cannabis. 1. What does prescription look like in Germany, Australia, and the UK? 2. What products are being prescribed and at what price to the patient? 3. What does a healthcare professional face when prescribing the right product? Full transparency in that I am not involved in this space, nor do we have any brands or products being prescribed. I am curious about what is happening in that space as a supplier of the APIs and contract private label manufacturer.

Medicinal Cannabis For Prescription

A medicinal cannabis product is the use of a Cannabis sativa L-based product with the primary active components, CBD, and THC. This product is used as a therapy to alleviate symptoms. With the development of pharmaceutical-quality products and their availability globally, reliable clinical data has been generated and presented allowing medicinal cannabis to be another therapeutic toolbox. ?

Just as the body has an opioid system that reacts to opioids, human beings have a receptor system called the Endocannabinoid system (ECS). The ECS is structured with Cannabinoid Receptors (CB). Endocannabinoids are cannabinoids produced within the body. Phytocannabinoids found in Cannabis sativa L. are structurally similar to the endocannabinoids produced in the body and activate the CB receptors that ultimately provide homeostasis to the ECS.

Indications that have supporting clinical promise include:

·??????Pain and muscle spasms associated with multiple sclerosis

·??????Chronic pain that is particularly focused on the central nervous system

·??????Nausea associated with chemotherapy

·??????Appetite loss and vomiting associated with chemotherapy

·??????Cachexia in HIV/AIDS

·??????Childhood epilepsy

Potential side effects would include:

·??????Lowering of blood pressure

·??????Dizziness

·??????Increased heart rate

·??????Dry mouth

·??????Increased appetite (often desired)

·??????Mild euphoria

As other traditional medicines, they can be available in different dose forms (e.g., inhalation, oral, transdermal or sublingual) to satisfy different patient requirements. Important differences exist between inhalation and ingestion. It is dependent on the patient as to one type of product will address different therapeutic outcomes.

The importance of dosage form consists of the following points:

·??????Bioavailability

·??????Duration of effects

·??????Onset of action

·??????Accuracy of dosing

·??????Reproducibility

·??????Safety

The following figures illustrate the various types of methods of administration: Ingestion vs Inhalation vs Sublingual

Question 1. What does prescription look like in Germany, Australia, and the UK?

Germany

As of 2017, it has been legal under the law for every German doctor to be able to prescribe cannabinoid-based medicines. These medicines include cannabis flowers, formulated extracts, and isolates. Depending on the type of medical condition and product prescribe, health insurance companies are required to cover the costs of the therapy. This does not however come with its challenges. Due to the expensive nature of the novel therapies that are cannabinoid-based now, many patients cannot afford this therapy when reimbursement is not performed. This high price has also made it unattractive for doctors as they typically have a limited drug budget which ultimately can lead to patients struggling to find doctors who want to prescribe.

Australia

Any doctor in Australia can prescribe medicinal cannabis with approval from the Therapeutic Goods Administration (TGA). Since most medical cannabis products are unapproved products, this means that you simply cannot go to a doctor and obtain a prescription and get it at a pharmacy as one would with conventional registered medicines. Firstly, a medical doctor or practitioner who would like to have access to these therapies must choose to do so through the Special Access Scheme (SAS) or the Authorised Prescriber Scheme. Medicinal cannabis products in Australia are not reimbursed by health insurers and the patient bares the costs of the therapy 100%.

United Kingdom

In the UK, medical cannabis cannot be prescribed by a General Practitioner (GP), but can be filled out by specialists if they feel that this is the right course of action. These decisions are mostly made on a case-by-case basis and by law, a medical cannabis prescription can only be given out “when the patient has an unmet special clinical need that cannot be met by licensed products”.

Question 2. What products are being prescribed and at what price to the patient?

To answer this question, I won’t waste much time and use the internet to find resources on what doctors are prescribing.

Germany:

In Germany only two methods of administration and two product categories exist:

1.????Inhalation

a.?????Cannabis Flower??

i.????THC/CBD percentage is shown, cultivar and strain name

2.????Ingestion

a.?????Oily Base

i.????THC/CBD percentage is shown, cultivar and strain name

?

Australia:

To keep up to date with the latest products being prescribed, I actually tend to head to where this is group that has ±20k members who are posting their products online and how it is treating their symptoms.

In Australia three methods of administration exist and six product types:

1.????Inhalation

a.?????Cannabis Flower

i.????THC/CBD percentage is shown, cultivar and strain name

b.????510 Cartridges/Pods

i.????THC/CBD percentage is shown, cultivar and strain name

c.?????Hash/Resin

i.????THC/CBD percentage is shown, cultivar and strain name

2.????Ingestion

a.?????Oily drops

i.????THC/CBD percentage is shown, cultivar and strain name

b.????Gummies

i.????THC/CBD percentage is shown, cultivar and strain name

3.????Sublingual

a.?????Emulsion drops

i.????THC/CBD percentage is shown, cultivar and strain name

Doctors are also prescribing flowers and as by the heading I pose above – What strain is this? This would potentially make things difficult for the doctor in wanting to understand the terpene profiles to detail and as well as the cultivar’s heritage.?

UK:

In the UK two methods of administration exist and three product types:

1.????Inhalation

a.?????Cannabis Flower

i.????THC/CBD percentage is shown, cultivar and strain name

b.????510 Cartridges/Pods

i.????THC/CBD percentage is shown, cultivar and strain name

2.????Ingestion

a.?????Oily drops

i.????THC/CBD percentage is shown, cultivar and strain name

Question 3. What does a healthcare professional face when prescribing the right product?

For a healthcare practitioner or specialist prescribing a medicinal cannabis product, it will be extremely important to understand the complexities of the various types of products.

The most important aspect is understanding what dose or equivalent daily dose a patient will be prescribed. To get an accurate dose of the product, it would most certainly be dosing oily drops with the method of administration being that of ingestion. This is an extremely accurate way of dosing as this could be done with a number of drops using a graduated syringe. However, if you observe the above tables comparing this, the bioavailability is low, and finding an optimal dose is difficult due to the onset time being extremely slow and unpredictable.

Inhalation of flowers and extracts does have a much faster onset and therefore allowing the doctor to have a shorter period of finding the optimal dose.?

The most important aspect it seems for a healthcare practitioner is understanding the origin of the medicine if it is still full-spectrum or flower. This is that of the sativa vs indica debate.

While there is still no scientific evidence to distinguish sativa or indica and still being referred to as Cannabis sativa L., there still exists an opportunity for companies to innovate in this space making it easier for doctors to know that when they are prescribing a dose of CBD/THC they are also prescribing a certain dose of terpene terpenes in mg/mg or mg/g for example. The century of crossbreeding has led to most cultivars being of hybrid variations between sativa and indica. Some medical cannabis users believe that sativa varieties tend to be more energizing and indica to be more sedative.

Healthcare practitioners would need a significant amount of education around the complexity of this type of therapeutic use this and will unlikely result in fast adoption by healthcare practitioners due to this complexity.

Imagine being a doctor who has a formulated product that has an agglomeration of terpenes including myrcene, pinene, caryophyllene, limonene, and terpinolene at different concentrations and ratios on top of that being called a name such as Mutant Alien Cookies (MAC).

You now have a patient that has severe anxiety and is looking for a medicine that will be sedative and assist with pain. You remember being told that limonene could be energizing and give further anxiety but this brand of MAC is Indica (don’t hold me to it, I am just thought writing) and you need to understand if the patient can take this medicine or not – you might get anxiety yourself!

For this, I believe there lies an opportunity for clinical evaluation of terpenes at various forms of inhalation after different times of extraction or curing of flowers or methods of administration. This would allow the industry to build a chart of terpenes with CBD/THC to have a carefully tailored prescription plan.