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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
© 2015 CannTrust Inc.™ All Rights Reserved.
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.
© 2015 CannTrust Inc.™ All Rights Reserved.
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
© 2015 CannTrust Inc.™ All Rights Reserved.
Key Objectives of Marijuana for Medical
Purposes Regulations (MMPR)
© 2015 CannTrust Inc.™ All Rights Reserved.
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)
© 2015 CannTrust Inc.™ All Rights Reserved.
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
© 2015 CannTrust Inc.™ All Rights Reserved.
Medical Cannabis Users in Canada
(2011)
© 2015 CannTrust Inc.™ All Rights Reserved.
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)
© 2015 CannTrust Inc.™ All Rights Reserved.
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
© 2015 CannTrust Inc.™ All Rights Reserved.
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
© 2015 CannTrust Inc.™ All Rights Reserved.
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
© 2015 CannTrust Inc.™ All Rights Reserved.
Medical Cannabis Survey Results
© 2015 CannTrust Inc.™ All Rights Reserved.
Source: CCSN survey 2014
Medical Cannabis Survey Results
© 2015 CannTrust Inc.™ All Rights Reserved.
Source: CCSN survey 2014
Medical Cannabis Survey Results
© 2015 CannTrust Inc.™ All Rights Reserved.
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
© 2015 CannTrust Inc.™ All Rights Reserved.
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.
© 2015 CannTrust Inc.™ All Rights Reserved.
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
© 2015 CannTrust Inc.™ All Rights Reserved.
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
© 2015 CannTrust Inc.™ All Rights Reserved.
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
© 2015 CannTrust Inc.™ All Rights Reserved.
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
© 2015 CannTrust Inc.™ All Rights Reserved.
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
Source: http://www.hc-sc.gc.ca/dhp-mps/marihuana/med/infoprof-eng.php
© 2015 CannTrust Inc.™ All Rights Reserved.
Abuse/Dependence
SOURCE: Bostwick, 2012
© 2015 CannTrust Inc.™ All Rights Reserved.
It is prohibited to seek
or obtain cannabis
from more than one
source at a time from
the same Medical
Document
© 2015 CannTrust Inc.™ All Rights Reserved.
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
© 2015 CannTrust Inc.™ All Rights Reserved.
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)
© 2015 CannTrust Inc.™ All Rights Reserved.
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
© 2015 CannTrust Inc.™ All Rights Reserved.
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
© 2015 CannTrust Inc.™ All Rights Reserved.
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 ● ● ●
© 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)
© 2015 CannTrust Inc.™ All Rights Reserved.
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
© 2015 CannTrust Inc.™ All Rights Reserved.
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.
© 2015 CannTrust Inc.™ All Rights Reserved.
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
© 2015 CannTrust Inc.™ All Rights Reserved.
Source: CFPC, "Authorizing Dried Cannabis for Chronic Pain or Anxiety: Preliminary guidance,"
Mississauga, 2014.
Questions?
ktalachian@canntrust.ca
info@canntrust.ca
647-872-2300
© 2015 CannTrust Inc.™ All Rights Reserved.

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

  • 1. 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.
  • 2. 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 © 2015 CannTrust Inc.™ All Rights Reserved.
  • 3. 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. © 2015 CannTrust Inc.™ All Rights Reserved.
  • 4. 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 © 2015 CannTrust Inc.™ All Rights Reserved.
  • 5. Key Objectives of Marijuana for Medical Purposes Regulations (MMPR) © 2015 CannTrust Inc.™ All Rights Reserved.
  • 6. 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) © 2015 CannTrust Inc.™ All Rights Reserved.
  • 7. 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 © 2015 CannTrust Inc.™ All Rights Reserved.
  • 8. Medical Cannabis Users in Canada (2011) © 2015 CannTrust Inc.™ All Rights Reserved. Source: http://www.hc-sc.gc.ca/hc-ps/drugs-drogues/stat/_2011/summary-sommaire-eng.php
  • 9. 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) © 2015 CannTrust Inc.™ All Rights Reserved.
  • 10. 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 © 2015 CannTrust Inc.™ All Rights Reserved.
  • 11. 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 © 2015 CannTrust Inc.™ All Rights Reserved.
  • 12. 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.
  • 13. Medical Cannabis Survey Results Source: CCSN survey 2014 © 2015 CannTrust Inc.™ All Rights Reserved.
  • 14. Medical Cannabis Survey Results © 2015 CannTrust Inc.™ All Rights Reserved. Source: CCSN survey 2014
  • 15. Medical Cannabis Survey Results © 2015 CannTrust Inc.™ All Rights Reserved. Source: CCSN survey 2014
  • 16. Medical Cannabis Survey Results © 2015 CannTrust Inc.™ All Rights Reserved. Source: CCSN survey 2014
  • 17. 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 © 2015 CannTrust Inc.™ All Rights Reserved.
  • 18. 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. © 2015 CannTrust Inc.™ All Rights Reserved.
  • 19. 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 © 2015 CannTrust Inc.™ All Rights Reserved.
  • 20. 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 © 2015 CannTrust Inc.™ All Rights Reserved. Source:www.hc-sc.gc.ca/dhp-mps/marihuana/med/infoprof-eng.php
  • 21. 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 © 2015 CannTrust Inc.™ All Rights Reserved.
  • 22. 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 © 2015 CannTrust Inc.™ All Rights Reserved.
  • 23. 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 Source: http://www.hc-sc.gc.ca/dhp-mps/marihuana/med/infoprof-eng.php © 2015 CannTrust Inc.™ All Rights Reserved.
  • 24. Abuse/Dependence SOURCE: Bostwick, 2012 © 2015 CannTrust Inc.™ All Rights Reserved.
  • 25. It is prohibited to seek or obtain cannabis from more than one source at a time from the same Medical Document © 2015 CannTrust Inc.™ All Rights Reserved.
  • 26. 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 © 2015 CannTrust Inc.™ All Rights Reserved.
  • 27. 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) © 2015 CannTrust Inc.™ All Rights Reserved.
  • 28. 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)
  • 29. 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 © 2015 CannTrust Inc.™ All Rights Reserved.
  • 30. 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 © 2015 CannTrust Inc.™ All Rights Reserved. Most strains are a hybrid of Indica and Sativa, with one or the other dominant. Hybrids can yield a balancing combination of effects.
  • 31. Terpenoids Myrcene Caryophyllene Linalool D-Limonene 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
  • 32. 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) © 2015 CannTrust Inc.™ All Rights Reserved.
  • 33. 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 © 2015 CannTrust Inc.™ All Rights Reserved.
  • 34. 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. © 2015 CannTrust Inc.™ All Rights Reserved.
  • 35. 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 © 2015 CannTrust Inc.™ All Rights Reserved. Source: CFPC, "Authorizing Dried Cannabis for Chronic Pain or Anxiety: Preliminary guidance," Mississauga, 2014.

Editor's Notes

  1. During this presentation I will be using the term cannabis instead of marijuana which is the more appropriate terminology. Prior to 1910, “marijuana” didn’t exist as a word in North American culture. Rather, “cannabis” was used, most often in reference to medicines and remedies for common ailments. Supporters of the Pancho Villa first used the name marijuana in 1895 in Sonora, Mexico. During this presentation we will review the basic principles of MMPR compared to the preceding regulations or MMAR Discuss statistics on cannabis usage in Canada and CCSN survey on medical cannabis Discuss licensed producer compared to a dispensary Review basic information on potential use of medical cannabis as well as contraindications and adverse effects Brief discussion on cannabis varieties, THC, CBD and Terpenoids And finally how to legally access medical cannabis
  2. Cannabis is a common subspecies of Industrial hemp, or simply hemp, which is commonly known for fiber-production and hemp seed oil. It grows wild in many of the tropical and temperate areas of the world Cannabis contains numerous chemical compounds. The main active constituents of cannabis are known as cannabinoids, with THC and CBD being the most studied cannabinoids. THC is the only cannabinoid with psychoactive effects. y.[
  3. . - See more at: http://adai.uw.edu/marijuana/factsheets/cannabinoids.htm#sthash.J3TK1tq4.dpuf Cannabinoids are a class of diverse chemical compounds that act on cannabinoid receptors on cells that repress neurotransmitter release in the brain. These receptor proteins include the endocannabinoids (produced naturally in the body by humans and animals),[1] the phytocannabinoids (found in cannabis and some other plants), and synthetic cannabinoids (manufactured chemically). The most notable cannabinoid is the phytocannabinoid ∆9-tetrahydrocannabinol (THC), the primary psychoactive compound of cannabis.[2][3] Cannabidiol (CBD) is another major constituent of the plant.[4] There are at least 85 different cannabinoids isolated from cannabis, exhibiting varied effects.[5] Synthetic cannabinoids are laboratory-synthesized molecules or extracted compounds that bind to cannabinoid receptors Nabilone (0.25 – 1mg) : Oral capsule, approved for CHIV Nabiximols (2.5 mg THC + 2.7 mg CBD) : Oromucosal spray , approved for multiple sclerosis-associated neuropathic pain, spasticity and advanced cancer pain Clinical endocannabinoid deficiency may underlie the pathogenesis of migraine, fibromyalgia, idiopathic bowel syndrome, and numerous other painful conditions that defy modern pathophysiological explanation or adequate treatment
  4. The Marihuana for Medical Purposes Regulations were announced on June 10, 2013. It was Intended to address public health and safety concerns that existed under the Marihuana Medical Access Program (MMAR). MMPR is intended to provide access to quality-controlled cannabis produced by licensed producers for medical purposes to Canadians who need it, while giving program participants more choices of strains and suppliers. It introduced comprehensive production, licensing, personal and physical security and inspection regulations. It was also intended to prevent diversion, improve record keeping and simplify and expedite access to medical cannabis
  5. MMAR Form A - Application for Authorization to Possess Marihuana for Medical Purposes Form B1 - Medical Practitioner 's Form for Category 1 Applicants Form B2 - Medical Practitioner 's Form for Category 2 Applicants Form C - Application for Licence to Produce Marihuana by Applicant Form D - Application for Licence to Produce Marihuana by a Designated Person Form E1 - Application to Obtain Dried Marihuana Form E2 - Application to Obtain Marihuana Seeds Form F - Consent of Property Owner http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/marihuana/how-comment/forms_complete-eng.pdf
  6. MMAR had two categories of authorization: General and Compassionate end of life care.
  7. There were 2.3 M Canadians using cannabis according to the published data from Health Canada. 17.7% (420,000) of cannabis users reported using it for medical purposes or 1.6% of the Canadian population aged 15 years and older These numbers do not in any way measure or reflect enrolment in the federal Medical Marijuana Access Program." there were only 40,000 registered patients under MMAR. Prevalence of use for medical purposes was similar between male and female (17.3% versus 18.4%, respectively) More than 21.8% cannabis users aged 25 years and older reported using it for medical purposes 49.7% mainly use cannabis for chronic pain caused by conditions such as arthritis, back pain and migraines The remaining 50.3% used cannabis primarily for one of a variety of conditions that included insomnia, depression and anxiety Canada has one of the highest rates of cannabis use in the world. More than 40% of Canadians have used cannabis in their lifetime and about 10% have used it in the past year. 1 No other targeted drug is used by more than 1% of Canadians every year. HC 2013 Most people who use cannabis do not use other illegal drugs, and cannabis use alone does not increase the likelihood that a person will progress to using other illegal substances (Room R. 2010)
  8. The notice will have to specify the activities for which the license is sought and the address of the site where activities conducted The notification must be addressed to a senior official of the local authority (municipality, fire and law enforcement)
  9. Sativex is contraindicated in patients: • With hypersensitivity to cannabinoids or to any of the excipients listed in section 6.1. • With any known or suspected history or family history of schizophrenia, or other psychotic illness; history of severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition. • Who are breast feeding (in view of the considerable levels of cannabinoids likely in maternal breast milk and the potential adverse developmental effects in infants).
  10. This may create problems in carrying out everyday activities. Driving and operating heavy or complex machinery or activities requiring alertness or coordination are not recommended From Initial Use: Patient may experience mood reactions such as anxiety, paranoia, agitation, amnesia, delusions or hallucinations. If this happens they should stop consuming marijuana immediately. Fast heartbeat; this may be more of a problem in patients with heart disease. Facial flushing or red eyes. Right after consuming marijuana, patients may get dizzy or feel faint when they get up from a lying or sitting position. Inhaling cannabis with a high content of THC increases the risk of psychological side-effects. This can be avoided by choosing a variety with a low content of THC or through oral administration (tea) when cannabis is used for the first time (2).   From Long-term use: Wheezing or a chronic cough, if the product is smoked. May impair short-term memory attention and concentration. These effects continue after patient stops using marijuana and increase with longer periods of use. Cognitive impairment may be greatly increased when cannabis is consumed along with alcohol or other drugs (3) which affect the activity of the nervous system (e.g. opioids, sleeping pills, other psychoactive drugs)   The use of cannabis can reduce the ability to react and can cause a lower concentration. This may create problems in carrying out everyday activities. Driving and operating heavy or complex machinery or activities requiring alertness or coordination are not recommended for 24 hours or longer after consumption (3). Asthenia: Weakness. Lack of energy and strength What is ataxia? Ataxia describes the lack of muscle coordination when a voluntary movement is attempted.
  11. Absorption The absorption of cannabinoids in the body is dependent on the method of administration. When cannabis is inhaled, cannabinoids are absorbed into the blood within minutes via the lungs and are transported to the brain. Maximum cannabinoids concentration in the brain is achieved within 15 minutes, which corresponds with the peak of the psychological and physiological effects. Absorption differs per individual and is based on various factors, including the heating of the cannabis, the number of inhalations, the waiting time between two inhalations, the inhalation period and lung capacity(4).   When cannabis is taken orally, absorption of cannabinoids in the blood is slow and more unpredictable. This results in effects being delayed 30 to 90 minutes with the maximum effect being experienced two or three hours later. The effect lasts four to eight hours. The result of THC concentration in the blood with oral intake is 25-30% compared to inhalation. This is partly caused by the large first-pass effect in the liver (4).    
  12. British Journal of Pharmacology (2011) 163 1344–1364 Patients with no prior experience with cannabis and initiating cannabis therapy for the first time are cautioned to begin at a very low dose and to stop therapy if unacceptable or undesirable side effects occur Under the Marijuana for Medical Purposes Regulations individuals who are registered with a licensed producer may possess the lesser of a 30-day treatment supply of dried marihuana or 150 grams of marijuana. Smoking is not recommended.
  13. Although cannabis can be addictive, a smaller proportion of people who try cannabis ever become dependent on it when compared to other substances listed on the table. A major reason that such a low percentage of people who try cannabis ever become addicted is that such a large number of people try the drug but are not heavy users. This statistic should not be read to indicate that cannabis is not addictive; just that many people who try the drug never become heavy users. According to 1999 IOM report “A distinctive marijuana [cannabinoid botanicals] withdrawal syndrome has been identified, but it is mild and short-lived. The syndrome includes restlessness, irritability, mild agitation, insomnia, sleep EEG disturbance, nausea, and cramping.” – Multiple references support mild short lived withdrawal symptoms; but not the physical dependence seen with heroin or alcohol – Minority of cannabis users find it psychologically difficult to moderate use or quit – Experience comparable to nicotine withdrawal • Stronger modern strains of cannabis suggested by some as more dangerous (avg 3.7% THC in 1988) • Actually higher THC strains will reduce the amount smoked and therefore reduced tar = harm reduction • Studies have shown no increase harm with higher THC (Earlywine, 2005) • Risk of addiction greater for recreational users, seeking euphoria
  14. If necessary, bring a friend or family member to your appointment as moral support, this makes it easier on you if you are too nervous to bring up the subject with your doctor. Medical cannabis is not beneficial for all patients; therefore, do not pressure your physician for a prescription Do not expect to receive a ‘medical document’—the document that gives you permission to receive medical cannabis— after only one appointment with your physician. Your physician may need to complete a health assessment or conduct some tests to evaluate your potential risks and benefits before they decide whether you are a candidate to receive medical cannabis. Download and bring required forms such as the ‘medical document’ to your appointment.
  15. Cannabis is generally considered to have three main varieties: Indica Known for its calming benefits. Commonly used to relieve inflammation, glaucoma, arthritis and muscle tension. Helps promote a good night’s sleep. Occasional side effects reported by some users include lethargy and difficulty concentrating. Sativa This category is known for its stimulating properties. Generally good for energizing daytime use. Can reduce migraines, pain and nausea and help stimulate appetite. Occasional side effects reported by some users include anxiety and hyperactivity. Hybrid Most strains are a hybrid of Indica and Sativa, with one or the other dominant. Hybrids can yield a balancing combination of medical uses and effects. Hybrid strains can potentially produce effects that are typically associated with either Indica or Sativa strains. New users should start with low doses until they know how each particular strain affects them. There is reason to believe that cannabis with a high CBD content provides effective relief for pain and muscle spasms in patients with Multiple Sclerosis (MS). Because of the anti-inflammatory properties of CBD, a high CBD variety may be more effective than others for patients with inflammatory conditions. Cannabis with High levels of THC is preferred for Gilles de la Tourette syndrome, therapy-resistant glaucoma and symptoms like weight loss, nausea and vomiting. In case of chronic neuropathic pain, a close ratio of THC to CBD is often prescribed first for inhalation. If this provides insufficient relief, a variety with a higher THC content is substituted. It is also possible to start with a high THC strain (as tea) or combine varieties and methods of administration.
  16. Relatively little is known about the pharmacological actions of the various other compounds found within cannabis (e.g. terpenes, flavonoids). However, it is believed that some of these terpenes may have a broad spectrum of action (e.g. anti-oxidant, anti-anxiety, anti-inflammatory, anti-bacterial, anti-neoplastic, anti-malarial), but this information comes from a few in vitro and in vivo studies and no clinical trials exist to support these claims. It is proposed that cannabinoids and terpenoids may form a metabolic “entourage” that is responsible for the bioactivity of cannabis: British Journal of Pharmacology (2011) 163 1344–1364