Cannabis Based Medicine Life Science and Healthcare Treatment Life - - PowerPoint PPT Presentation

Cannabis Based Medicine

Life Science and Healthcare Treatment

Life Science

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What Medical Cannabis isn’t

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What Medical Cannabis isn’t Medical cannabis is NOT about getting high, it is about the therapeutic benefits of the 2 most researched cannabinoids, CBD and THC

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What Medical Cannabis isn’t

This is Karen, she has epilepsy

She takes FDA approved CBD (still awaiting a licence in EU)

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Cannabidiol (CBD)

CBD is non- psychoactive

(does not alter brain function)

CBD* is already used for:

• Pain Relief and Inflammation
• Epilepsy
• Anxiety and Depression
• Nausea and vomiting from chemotherapy

*(usually in oil format)

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Cannabidiol (CBD)

e

• n)

CBD is being researched for :

• Drug withdrawal (from nicotine to opioids)
• Diabetes
• Anti-tumour effects
• Improving quality of life for those with Parkinson’s
• r Alzheimer’s

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Side Effects of CBD

• Side effects of CBD based

pharmaceuticals are substantially more mild than other Epileptic pharmaceuticals

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Cannabidiol (CBD)

• CBD is non-psychoactive cannabinoid i.e. it

does not alter brain function

• Studies show it provides a safer more natural

treatment than many other medications used to

• therwise treat epilepsy such as steroids
• Research has found no significant side effects
• n the central nervous system, the

cardiovascular system or mood, even among people who used high dosages.

• The most common side effect is tiredness.

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Methods of Administration & Properties of CBD

Methods of Administration

• Oral solution (Epidolex)

Properties of CBD

• Non psychoactive
• Non addictive

NOT LIKE TOBACCO

NOT LIKE TOBACCO

It is an oral solution, is tolerated well and has a good safety profile.

NOT LIKE OPIOIDS

“The evidence from well controlled human experimental research indicates that CBD is not associated with abuse potential” World Health Organisation

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What Medical Cannabis looks like

This is John, he has uncontrolled nausea and vomiting from chemotherapy

He has a choice of two medications: Dronabinol capsules or oil, structurally identical to THC Nabilone capsules, a synthetic cannabinoid that mimics THC

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What is Tetrahydrocannabinol (THC)?

• THC is the active component of

cannabis and results in temporary changes in perception, mood consciousness and behaviour THC is already used for :

• Loss of appetite in people with AIDS
• To treat nausea and vomiting caused

by chemotherapy

• Treatment of spasticity in patients with

Multiple Sclerosis

• Pain control
• PTSD

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What is Tetrahydrocannabinol (THC)?

THC is being researched for :

• Chronic and neuropathic

pain

• Protecting brain cells and

brain growth (can treat/slow down Alzheimers)

• Treating antibiotic resistant

pathogens such as MRSA

• Asthma and COPD

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Side Effects of THC

• Side effects of THC based

pharmaceuticals are substantially more mild than

• ther nausea suppressing or

anti-spasticity pharmaceuticals

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Methods of Administration & Properties of THC

Methods of Administration

• Tablet

Properties of THC

• Neuroprotectant
• Natural pain relief
• Effective for PTSD
• Psychoactive

NOT LIKE TOBACCO

NOT LIKE TOBACCO

They are tablets, not smoked

NOT LIKE OPIOIDS

• Prescription only given when all
• ther avenues exhausted
• Addictive potential is

considerably lower than opioids.

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What Medical Cannabis looks like

This is Kathleen, she has MS

She takes Sativex, that contains both CBD and THC in a 1:1 ratio, to reduce spasticity caused by MS which affects her muscles Nabilone capsules, a synthetic cannabinoid that mimics THC

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What Medical Cannabis looks like

Studies have shown that almost 75% of patients reported a pain reduction after using Sativex

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Entourage Effect

Evidence has shown that CBD modulates the effect

• f THC therefore limiting

the risks of THC Products have been created containing both CBD and THC

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Side Effects of CBD and THC Combined

• Side effects of CBD and THC

Combined based pharmaceuticals are substantially more mild than other epileptic pharmaceuticals

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Methods of Administration & Properties of CBD & THC

Methods of Administration

• Sub-lingual

Properties of CBD Properties of CBD and THC combined

• The benefits of CBD seem to wear off after a few months

unless a little THC is added

• Combining CBD and THC reduces the psychoactive side effects of the

latter cannabinoid

• CBD can also lessen the sedative and appetite-inducing effects of THC
• Combining CBD and THC can improve the pain-fighting properties of both

NOT LIKE TOBACCO

Sub-lingual, not smoked

NOT LIKE OPIOIDS

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Process of approval

Approval of medications containing CBD or THC are subject to the same process as any other drug Research Pre-clinical Phase 1 Phase 2 Phase 3 Pre- registration

Entre in to humans Marketing authorisation application

Duration (years) Probability

• f reaching

launch

0.1% 1% 5% 10% 50% 75%

• Understand disease

mechanisms

• Identity targets and

compounds against them

Stage

• bjectives
• Test candidate drugs

in laboratory and animals for toxicity side-effects and therapeutics value

• Test safety healthy

volunteers (20-200 people)

• Test efficacy in

larged desease (in 200-300 people)

• Determine

appropriate dose

• Confirm efficacy in

larger patient populations (300 – 3000 people)

• Monitor side effects
• FDA/EMEA reviews

100.000 pages application and decides whether to great approval 3-5 1-2 1-2 1-2 2-3 1-2

Launch

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US Pharmaceutical Warnings

FDA Black Box Warnings are added to drug literature if:

• If an adverse event is so serious (death or a permanently

disabling reaction) in proportion to the potential benefit from the drug that it is essential to consider when weighing the risks and benefits of the drug

• If a serious adverse reaction can be prevented, reduced

in frequency, or made less severe by following certain guidelines, such as patient selection, careful monitoring,

• r taking into account other medication that the person

might be taking

• If there are mandatory restrictions for prescribing the drug.

Some medication may only be administered in certain settings (supervised or inpatient) or may require the doctor to complete extra training in order to prescribe

There are no FDA black box warnings on any

• f the cannabis derived

products, synthetic

• r natural

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EU Pharmaceutical Warnings

• The EU does not have an equivalent Black

Box Warning because all of the information around risk and adverse reactions is written within the Summary of Product Characteristics (SmPC) and Patient Information Leaflet.

• In the EU there is scheme for the additional

monitoring of medicines, known as the black triangle. It shows that the medicine is being closely monitored by European regulatory authorities and is usually applied to new medicines.

There are no black triangles

• n any of

the cannabis derived products, synthetic

• r natural

Cannabis Based Medicine

Life Science insurance implications

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Clinical trial Liability

A participant to a clinical trial suffers injury as a result of participation to the trial

Life Science - Liability exposures

Product Liability

Product - after being approved by the authorities - does not provide the safety

• ne can expect. Product

include package, container, label and instructions.

Professional Indemnity

Errors and omissions in providing service to pharmaceutical companies resulting in property damage, bodily injury or pure financial loss

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Appetite for

• GMP manufactured
• Prescribed by a healthcare professional
• Approved by FDA or EMA for specific indications
• Clinical Trials

No appetite for

• Stand alone cultivators
• Hemp products
• Recreational use
• Nutraceuticals

Life Science - appetite

Healthcare Treatment

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What Medical Cannabis products can be prescribed?

Sativex

Indicated for symptom improvement in adult patients with moderate to severe spasticity due to Multiple Sclerosis who have not responded to

• ther anti-spasticity medication

Dronabinol

Indicated to treat loss of appetite in people with AIDS and to treat severe nausea and vomiting caused by chemotherapy in patients with inadequate response to conventional anti-sickness medication.

Nabilone

Indicated for nausea and vomiting caused by chemotherapy, if patient is unresponsive to conventional anti-sickness medication

Epidiolex

Indicated for Lennox-Gastaut Syndrome or Dravet Syndrome (severe epilepsy) in patients 2 years

• f age and older. (FDA approved,

awaiting EU approval)

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Types of cannabis based medicinal products

Licensed Medicines

(Prescriptions)

Non‐Licensed Medicines

(Prescriptions)

Non Licensed Non Prescribed

(Nutraceuticals)

1 2 3

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What are the prescribing guidelines in U.K?

Cannabis based products can only be prescribed:

• where there is an unmet need and
• by clinicians listed on the Specialist Register of the GMC and
• taking GMC guidance into account .

In the U.K. a cannabis based product for medicinal use in humans is defined as: (a) Is or contains cannabis, cannabis resin, cannabinol or a cannabinol derivative (b) Is produced for medicinal use in humans; and— (c) Is— (i) a medicinal product, or (ii) A substance or preparation for use as an ingredient of,

• r in the production of an ingredient of, a medicinal product.

There is very strict guidance in the UK and since the law changed in Nov 2018 still only a handful of people have got prescriptions.

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Prescribing guidelines in other countries

France

Doctors can only prescribe a cannabis based medication that has marketing authority. The country is still to make a decision on unlicensed products.

Germany

Doctors can prescribe licensed and unlicensed cannabis based medication if the patients have attempted other treatments without

• success. i.e. medical cannabis is

legal in Germany.

Netherlands

Doctors can prescribe licensed and unlicensed cannabis based

• medication. The Office of Medicinal

Cannabis run by the Dutch Ministry

• f Health has an absolute monopoly
• n all medicinal cannabis, the only

company to be licensed to produce cannabis is Bedrocan.

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Prescribing guidelines in Canada

• Cannabis was legalised for recreational use in

October 2018 but it is not an approved therapeutic product unless it has a drug identification number (DIN) and a notice of compliance (NOC.)

• The legality of cannabis is unlikely to eliminate

the need for a Government medical cannabis programme which is regulated through the Access to Cannabis for Medical Purposes Regulations (ACMPR)

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Prescribing guidelines in Canada

Licensed Healthcare Practitioners can only prescribe medical cannabis if they are the primary treating physician for the condition for which it is being prescribed If medical cannabis is agreed the healthcare practitioner will issue a medical document that contains specific information as set out in the ACMPR It is common for patients to be asked to complete a treatment agreement that sets out the risks of medical cannabis The patient can then obtain medical cannabis by:

• Submitting the medical document to a federally

licensed provider or

• Registering with Health Canada to produce a

limited amount of cannabis themselves or

• Designating a 3rd party to grow it for them

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Doctors prescribing cannabis based products

Doctors in countries where it is legal to prescribe medical cannabis must show they have exhausted other options A doctor’s professional liability would not be affected for prescribing unlicensed cannabis as long as it was in accordance with their national prescribing regulations

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How the patient accesses the prescription (e.g. the bud)

Patient Doctor Prescription Company Pharmacist

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Informed Consent and Cannabis Based Medications

Doctors must follow the same process of obtaining informed consent that they must for any

• ther prescribed medication

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Medical use cannabis preparations – Bud/Flos or Oil

There is a global cultural ingrained concern when the term “bud” is used

HOWEVER

Bud that is legally prescribed as an unlicensed medicine is a strictly standardised, pharmaceutical grade cannabis product.

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Source of Bud or Oil

One of the main manufacturers of producers of bud or oil is the company Bedrocan based in the Netherlands. They produce standardised medicinal cannabis bud(flos) and oil with a constant composition of cannabinoids.

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Prescribing medical use cannabis preparations

Prescribed bud can be: Vaporised Made into tea

Cannabis oil can be extracted from this flos and can be administered in drop form under the tongue or swallowed.

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Prescribing medical use cannabis preparations

In the EU no country that permits medical use of cannabis preparations recommends smoking

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U.K. Child Patient example

• Alfie Dingley, suffered up to 30 violent

seizures a day due to rare form of epilepsy

• CBD can reduce seizures but Alfie's

condition was so severe it did not respond to CBD alone.

• Now he is able to get on prescription from

Bedrocan (Netherlands) standardised, medical grade cannabis oil, that contains THC as well as CBD.

• He takes 3 drops daily

Cannabis Based Medicine

Medical Professional Liability insurance implications

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Healthcare: Medical Professional Liability

Medical Professional Liability Bodily injury arising from a negligent act, error or omission of a medical practitioner, allied health professional or medical institution.

It is worth noting that there have been court rulings that have actually upheld the “duty of care” principle, against a medical institution when they have failed to provide an un-licensed drug.

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Healthcare: Medical Professional Liability

Appetite for

Medical institutions and allied health providers, including medical practitioners, that adhere to the local regulatory framework, guidelines and best practice for the use of Medicinal Cannabis products in the treatment of a patient. These could include:

• Pain management clinics
• Epilepsy clinics
• Cancer treatment/ oncology
• Multiple sclerosis treatment
• Nausea treatment in hospitals

No appetite for

The absence of medical indication;

• Recreational use
• Weight loss/gain establishments
• Or any individual or facility not adhering to regulatory

guidelines

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Conclusion

• Unmet Medical need
• Research underpins safety
• No black box warnings or black triangles
• Often superior alternative due to lack of

serious side effects

• Production to pharmaceutical standards
• Approved products qualify for our Life Science

insurance solutions

• Strict guidelines allow for our Healthcare

insurance solutions for both approved and unapproved products

Although we have no appetite for administration through smoking and for non medical use We are committed to the Healthcare industry and support to insure Medical Cannabis