Marijuana for Medical Purposes Regulation - What Do I Need to Know?

MMPR & MMAR
Update
Marijuana for Medical Purposes
Regulations (MMPR)
What do I need to know?
Speaker:
Kaivan Talachian Pharm. D., R.Ph.
Vice President, Professional Services
CannTrust Inc.
© 2015 CannTrust Inc.™ All Rights Reserved.

Presentation Objectives
 Basic understanding of Marijuana for Medical Purposes
Regulations (MMPR)
 Review statistics on cannabis usage and results of the
CCSN medical cannabis survey
 Differences between licensed producers and dispensaries
 Basic information on medical cannabis usage, adverse
effects, potential use and contraindications
 Cannabis varieties
 How to legally access medical cannabis

What is Cannabis?
 Dried flowers of the female plant is generally used
 Contains a number of active substances, such as
 ∆9-tetrahydrocanabinol (THC)
 Cannabidiol (CBD)
 THC is mainly responsible for the effects of the plant,
but other cannabinoids like CBD may also influence the
effectiveness of cannabis
Source: http://www.hc-sc.gc.ca/dhp-mps/marihuana/med/infoprof-eng.php
Cannabis sativa L. Scientific drawing from Franz
Eugen Köhler's Medizinal-Pflanzen. Published and
copyrighted by Gera-Untermhaus, FE Köhler in
1887 (1883–1914). The drawing is signed W.
Müller.

What are cannabinoids?
 Cannabinoids are chemical
compounds that act on
cannabinoid receptors in human
body
 Phytocannabinoids are produced only
by marijuana plant
 THC, CBD, CBC, CBG,THCV, CBN
 Synthetic cannabinoids are
laboratory-synthesized molecules or
extracted compounds that bind to
cannabinoid receptors
 Endocannabinoids are naturally
produced cannabinoids in the body
 Anandamide, 2-
Arachidonylglycerol (2-AG)

Key Objectives of Marijuana for Medical
Purposes Regulations (MMPR)

What are the main differences between
MMAR and MMPR?
MMAR(old program) MMPR(new program)
Support for Access Physician pre-defined Physician or nurse practitioner*
Authorization Complex application to Health Canada Simple registration with Licensed Producer
Production
1)Purchase from Health Canada
2) Personal use production
3) Designated-person production
Licensed Producer only
Health Canada Mandate
Authorize and license individuals with medical support;
administer production contract
Regulate LPs, including licensing, audit and
inspection
Distribution
Health Canada supply sent through secure courier;
designated producer can distribute in person or by mail
Licensed Producer (LP) (secure direct delivery)

Medical condition(s) and symptom(s) for application
+ compassionate end-of-life care
The MMPR does not contain any limitations on the conditions for which a
health care practitioner can support the use of cannabis for medical purposes.
MMAR
MMPR

Medical Cannabis Users in Canada
(2011)
Source: http://www.hc-sc.gc.ca/hc-ps/drugs-drogues/stat/_2011/summary-sommaire-eng.php

Licensed Producers (LPs)
Activities and Requirements
• LPs are licensed and operate under the supervision
of Health Canada and shall comply with local By-
laws and regulations.
• LP’s are allowed to dispense medical cannabis in the
following forms:
• Dried Cannabis
• Oil/Extract
• Fresh cannabis buds or leaves
• Cannabis can be produced only indoor (secure
environment)

What are the benefits of medical cannabis
produced by a licensed producer?
 Pharmaceutical grade strains
 Laboratory tested and quantified THC and CBD concentrations
 Consistent cannabinoids content
 Contamination free
 Mold
 Bacteria: e.g. E.coli, Salmonella
 Heavy Metals: Arsenic, cadmium, cobalt, mercury and lead
 Pesticide
 Cheaper, legal and safer than illegal sources
 Can be claimed as a medical expense

Who may benefit from Medical Cannabis?
 Chronic Pain
 Treatment of resistant nausea and vomiting
 Wasting Syndrome and Loss of Appetite
 Muscle spasm due to Multiple Sclerosis, Amyotrophic Lateral Sclerosis(ALS) & Spinal Cord
Injury
 Epilepsy (seizures)
 Arthritis and Musculoskeletal Disorders
 Movement disorders ( i.e. Parkinson’s disease, Tourette’s syndrome & Huntington’s
Disease)
 Glaucoma
 Anxiety and Depression
 Sleep Disorders
 Post-Traumatic Stress Disorder (PTSD)
 Alzheimer’s Disease and Dementia
 Inflammatory Bowel Diseases (IBD. i.e. Crohn’s disease and ulcerative colitis )
 Irritable Bowel Syndrome (IBS)

What is the evidence?
 “Use of marijuana for chronic pain, neuropathic pain, and spasticity due to
multiple sclerosis is supported by high-quality evidence”.
 “Six trials that included 325 patients examined chronic pain, 6 trials that
included 396 patients investigated neuropathic pain, and 12 trials that
included 1600 patients focused on multiple sclerosis”.
 “Several of these trials had positive results, suggesting that marijuana or
cannabinoids may be efficacious for these indications”.
 “There was low-quality evidence suggesting that cannabinoids were associated
with improvements in nausea and vomiting due to chemotherapy, weight gain in
HIV infection, sleep disorders, and Tourette syndrome. Cannabinoids were
associated with an increased risk of short-term AEs”.
Source:
Hill KP. Medical Marijuana for Treatment of Chronic Pain and Other Medical and Psychiatric Problems: A Clinical Review. JAMA.
2015;313(24):2474-2483. doi:10.1001/jama.2015.6199.
Whiting PF, Wolff RF, Deshpande S, et al. Cannabinoids for Medical Use: A Systematic Review and Meta-analysis. JAMA. 2015;313(24):2456-
2473. doi:10.1001/jama.2015.6358.

Medical Cannabis Survey Results
Source: CCSN survey 2014

Patient Scenario 1:
Maria (74 years old)
 Never used Cannabis until she turned 61
 First used to improve her appetite during chemotherapy for breast cancer
 Cancer has returned and metastasized to her spine
 Conventional painkillers didn’t work
 Now she uses Medical cannabis for pain relief

Patient Scenario 2:
Marilyn (68-year-old)
 Metastatic breast cancer
 currently undergoing chemotherapy
 Very low energy, minimal appetite, and substantial pain
 Severe nausea and vomiting cannot be controlled with ondansetron
 Taking 1000 mg of acetaminophen every 8 hours for the pain. Sometimes at night she
takes 5 mg or 10 mg of oxycodone to help provide pain relief.

Who is not a good candidate for Medical Cannabis?
 Allergy to any cannabinoid or to smoke
 History of serious mental disorder such as schizophrenia, psychosis, bipolar
disorder in patient or family
 Serious liver, kidney, heart or lung disease
 Pregnancy or planning to get pregnant or nursing
 Patients under the age of 18 years
 Men who wish to start a family
 History of alcohol or drug abuse or substance dependence

What would be side effects?
 Most common
 Dizziness, Dry mouth & Drowsiness
 The use of cannabis can reduce the ability to react and can
cause a lower concentration
 Common
 Euphoria/”high”, blurred vision, postural hypotension, red
eyes & headache
 Rare
 Anxiety, depression, ataxia, asthenia, cognitive effects &
tachycardia
Source:www.hc-sc.gc.ca/dhp-mps/marihuana/med/infoprof-eng.php

How fast cannabis work?
Inhalation Oral
Onset Less than 5 Min 30-90 Min
Maximum effect Less than 15 Min 2-3 hours
Duration 3-4 hours 4-8 hours

Cannabinoids Biosynthesis
 Cannabinoids are produced by the cannabis plant as carboxylic
acids
 The carboxyl group is not very stable and is easily lost under
the influence of heat (vaporizing, smoking, cooking) or light,
resulting in the corresponding neutral cannabinoids
 Cannabis preparations require heat to be activated

Dosage
 The optimal dose should improve pain relief and function,
while causing minimal euphoria or cognitive impairment.
 Approximately 1 - 3 g of cannabis per day
 Dosing remains highly individualized and relies to a great
extent on titration
 Consumption of smoked/inhaled or oral cannabis should
proceed slowly, waiting between puffs for a few minutes
and waiting 30 - 60 min between consumption of
cannabis-based oral products (e.g. tea) to gauge for
strength of effects or for possible overdosing
 Tea: ½ gram cannabis in ½ liter of water, brewed for 15
minutes

Abuse/Dependence
SOURCE: Bostwick, 2012

It is prohibited to seek
or obtain cannabis
from more than one
source at a time from
the same Medical
Document

How to communicate with your physician?
 Medical cannabis is not beneficial for all patients; therefore, do not pressure your
physician for a Medical Document
 Do not expect to receive a Medical Document after only one appointment:
 You need to try traditional medications if you have not
 Your physician needs to do assessment and tests
 Share the symptoms that are not being managed successfully with your current
treatment protocol and how it impacts your quality of life
 Make a list of medicines and therapies you have tried previously, identifying the
ones that have worked and those that have not

How to communicate with your physician?
 Bring credible information (i.e. past medical records) to your appointments
 If you already use medical cannabis, let your doctor know about:
 Length of usage
 Dosage (in grams per day)
 Frequency of usage
 Route of administration (orally or inhalation).
 If you have never used cannabis before, get informed
 Speak to others who use it to manage their symptoms
 Contact LPS to ask questions
 Check reliable websites (i.e. Health Canada, CCSN)

Medical Document
 Physician's information
 Can be entered once and
used for all patients
 Patient’s information
 The prescription
 Number of Gram/day
 Number of month
authorized
 THC/CBD percentage or
strain (Optional)
 Medical diagnosis
(Optional)

Registration Forms
I. Form A: For applicants with
a residence
II. Form B: For applicants with
no residence
III. Form C: Medicine delivery
to your Health Care
Practitioner
• Filled and signed by patients
• Patient's information
• Mailing and shipping address
• Physician’s information

Cannabis Variety
 There are three main species of cannabis
 Indica
 Sativa
 Ruderalis
 There are many varieties of medicinal cannabis which have
different strengths, compositions and thus different effects
Most strains are a hybrid of Indica and Sativa, with one or the other
dominant. Hybrids can yield a balancing combination of effects.

Terpenoids
Myrcene
Caryophyllene
Linalool
D-Limonene
Humulene
Pinene
Improve memory ●
Anti-Tumor ● ● ●
Anti-Inflammatory ● ● ● ●
Spasm ●
Insomnia ● ●
Pain ● ● ●
Anti-bacterial ● ●
Bronchodilator ●
Anxiety &
Depression ● ● ●
British Journal of Pharmacology (2011) 163 1344–1364

Shipping and Packaging
 Packaging
 Not more than 30 g of dried cannabis in each dispensed container is allowed
 Tamper-evident packaging is required
 Packaging shall be child-resistant
 Shipping
 Physical transfer of cannabis is only done through shipping direct from LP to registered
client, health care provider or designated shipping address
 Must be traceable during transport
 Must be packaged so that contents cannot be identified (i.e. no smell, no release of
content)
 No more than 150 g/shipment
 Storage and handling
 should be stored in the original packaging at room temperature (15 - 25°C)

Proof of Legal Possession under MMPR
 Patient label or shipping invoice serve as proof of legal possession for client
 Client-specific label MUST contain:
 Full name of client
 Full name of the HCP who provided the medical document
 Name of the LP
 Daily dose (g)
 Expiry of the client’s registration/medical document
 Law enforcement and police officials may:
 Request to see a piece of photo identification when validating proof of authority to possess
 Verify legal possession of dried marihuana by contacting the LP, In the course of an investigation

Traveling with medical cannabis
 Within Canada:
 You may travel within Canada keeping your documentation with you at all times.
 Outside of Canada:
 patients must contact the embassy or the consulate of the country they are visiting
to inquire about permission to bring the medicinal cannabis with them.
 Some countries, such as USA, does not allow medical cannabis to be transported
into the country.

Cannabis & Driving
 Patients using dried cannabis should be advised
not to drive for at least:
 4 hours after inhalation
 6 hours after oral ingestion
 8 hours after inhalation or oral ingestion if the patient
experiences euphoria/high
Source: CFPC, "Authorizing Dried Cannabis for Chronic Pain or Anxiety: Preliminary guidance,"
Mississauga, 2014.

Questions?
ktalachian@canntrust.ca
info@canntrust.ca
647-872-2300

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