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

© 2015 CannTrust Inc.™ All Rights Reserved.

MMPR & MMARUpdate

Marijuana for Medical Purposes Regulations

(MMPR)What do I need to know?

Speaker:Kaivan Talachian Pharm. D., R.Ph.Vice President, Professional ServicesCannTrust Inc.


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.

http://www.hc-sc.gc.ca/dhp-mps/marihuana/med/infoprof-eng.php



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)

Source: http://www.hc-sc.gc.ca/dhp-mps/marihuana/med/infoprof-eng.php




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

Production1)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 contractRegulate LPs, including licensing, audit and

inspection

DistributionHealth Canada supply sent through secure courier;

designated producer can distribute in person or by mailLicensed Producer (LP) (secure direct delivery)


Medical condition(s) and symptom(s) for application

+ compassionate end-of-life careThe 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)Source: http://www.hc-sc.gc.ca/dhp-mps/marihuana/med/infoprof-eng.php


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 minutesSource: http://www.hc-sc.gc.ca/dhp-mps/marihuana/med/infoprof-eng.php



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.

TerpenoidsMyrcene

Caryophyllene

Linalool

D-Limone

ne Humulene Pinene

Improve memory ●Anti-Tumor ● ● ●

Anti-Inflammatory ● ● ● ●Spasm ●

Insomnia ● ●

Pain ● ● ●

Anti-bacterial ● ●Bronchodilator ●Anxiety & Depression ● ● ●

© 2015 CannTrust Inc.™ All Rights Reserved.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.


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Health & Medicine

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