Information for Health Care Professionals: Cannabis (marihuana, marijuana) and the cannabinoids

Dried or fresh plant and oil for administration by ingestion or other means
Psychoactive agent

This document has been prepared by the Cannabis Legalization and Regulation Branch at Health Canada to provide information on the use of cannabis (marihuana) and cannabinoids for medical purposes. This document is a summary of peer-reviewed literature and international reviews concerning potential therapeutic uses and harmful effects of cannabis and cannabinoids. It is not meant to be comprehensive and should be used as a complement to other reliable sources of information. This document is not a systematic review or meta-analysis of the literature and has not rigorously evaluated the quality and weight of the available evidence nor has it graded the level of evidence. Despite the similarity of format, it is not a Drug Product Monograph, which is a document which would be required if the product were to receive a Notice of Compliance authorizing its sale in Canada.

This document should not be construed as expressing conclusions or opinions from Health Canada about the appropriate use of cannabis (marihuana) or cannabinoids for medical purposes.

Cannabis is not an approved therapeutic product, unless a specific cannabis product has been issued a drug identification number (DIN) and a notice of compliance (NOC). The provision of this information should not be interpreted as an endorsement of the use of this product, or cannabis and cannabinoids generally, by Health Canada.

Prepared by Health Canada

Date of latest version: Spring 2018

Reporting Adverse Reactions to Cannabis (marihuana, marijuana) Products

Reporting adverse reactions associated with the use of cannabis and cannabis products is important in gathering much needed information about the potential harms of cannabis and cannabis products for medical purposes. When reporting adverse reactions, please provide as much complete information as possible including the name of the licensed producer, the product brand name, the strain name, and the lot number of the product used in addition to all other information available for input in the adverse reaction reporting form. Providing Health Canada with as much complete information as possible about the adverse reaction will help Health Canada with any follow-ups or actions that may be required.

Any suspected adverse reactions associated with the use of cannabis and cannabis products (dried, oils, fresh) for medical purposes should be reported to the Canada Vigilance Program by one of the following three ways:

1. Report online
2. Call toll-free at 1-866-234-2345
3. Complete a Canada Vigilance Reporting Form and:
   • Fax toll-free to 1-866-678-6789, or
   • Mail to: 
     Canada Vigilance Program 
     Health Canada 
     Postal Locator 0701D 
     Ottawa, Ontario K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site.

Table of contents

• List of figures and tables
• List of abbreviations
• Authorship and acknowledgements
• Overview of summary statements
• 1.0 The Endocannabinoid System
  • 1.1 Cannabis
    • 1.1.1 Chemistry and composition
    • 1.1.2 Other constituents
    • 1.1.3 Stability and storage
• 2.0 Clinical Pharmacology
  • 2.1 Pharmacodynamics
  • 2.2 Pharmacokinetics
    • 2.2.1 Absorption
      • 2.2.1.1 Smoked cannabis
      • 2.2.1.2 Vapourized cannabis
      • 2.2.1.3 Oral
      • 2.2.1.4 Oro-mucosal and intranasal
      • 2.2.1.5 Rectal
      • 2.2.1.6 Topical
    • 2.2.2 Distribution
    • 2.2.3 Metabolism
      • 2.2.3.1 Inhalation
      • 2.2.3.2 Oral
    • 2.2.4 Excretion
  • 2.3 Pharmacokinetic-pharmacodynamic relationships
  • 2.4 Tolerance, dependence, and withdrawal symptoms
  • 2.5 Special populations
• 3.0 Dosing
  • 3.1 Smoking
  • 3.2 Oral
  • 3.3 Oro-mucosal
  • 3.4 Vapourization
• 4.0 Potential Therapeutic Uses
  • 4.1 Palliative care
  • 4.2 Quality of life
  • 4.3 Chemotherapy-induced nausea and vomiting
  • 4.4 Wasting syndrome (cachexia, e.g., from tissue injury by infection or tumour) and loss of appetite (anorexia) in AIDS and cancer patients, and anorexia nervosa
    • 4.4.1 To stimulate appetite and produce weight gain in AIDS patients
    • 4.4.2 To stimulate appetite and produce weight gain in cancer patients
    • 4.4.3 Anorexia nervosa
  • 4.5 Multiple sclerosis, amyotrophic lateral sclerosis, spinal cord injury and disease
    • 4.5.1 Multiple sclerosis
    • 4.5.2 Amyotrophic lateral sclerosis
    • 4.5.3 Spinal cord injury (or spinal cord disease)
  • 4.6 Epilepsy
  • 4.7 Pain
    • 4.7.1 Acute pain
      • 4.7.1.1 Experimentally-induced acute pain
      • 4.7.1.2 Post-operative pain
    • 4.7.2 Chronic pain
      • 4.7.2.1 Experimentally-induced inflammatory and chronic neuropathic pain
      • 4.7.2.2 Neuropathic pain and chronic non-cancer pain in humans
      • 4.7.2.3 Cancer pain
      • 4.7.2.4 “Opioid-sparing” effects and cannabinoid-opioid synergy
      • 4.7.2.5 Headache and migraine
  • 4.8 Arthritides and musculoskeletal disorders
    • 4.8.1 Osteoarthritis
    • 4.8.2 Rheumatoid arthritis
    • 4.8.3 Fibromyalgia
    • 4.8.4 Muscular pain
    • 4.8.5 Osteoporosis
  • 4.9 Other diseases and symptoms
    • 4.9.1 Movement disorders
      • 4.9.1.1 Dystonia
      • 4.9.1.2 Huntington’s disease
      • 4.9.1.3 Parkinson’s disease
      • 4.9.1.4 Tourette’s syndrome
      • 4.9.1.5 Spinocerebellar ataxias
    • 4.9.2 Glaucoma
    • 4.9.3 Asthma
    • 4.9.4 Hypertension
    • 4.9.5 Stress and psychiatric disorders
      • 4.9.5.1 Anxiety and depression
      • 4.9.5.2 Sleep disorders
      • 4.9.5.3 Post-traumatic stress disorder
      • 4.9.5.4 Alcohol and opioid withdrawal symptoms (drug withdrawal symptoms/drug substitution)
      • 4.9.5.5 Schizophrenia and psychosis
    • 4.9.6 Alzheimer’s disease and dementia
    • 4.9.7 Inflammation
      • 4.9.7.1 Inflammatory skin diseases (dermatitis, psoriasis, pruritus)
    • 4.9.8 Gastrointestinal system disorders (irritable bowel syndrome, inflammatory bowel disease, hepatitis, pancreatitis, metabolic syndrome/obesity)
      • 4.9.8.1 Irritable bowel syndrome
      • 4.9.8.2 Inflammatory bowel diseases (Crohn’s disease, ulcerative colitis)
      • 4.9.8.3 Diseases of the liver (hepatitis, fibrosis, steatosis, ischemia-reperfusion injury, hepatic encephalopathy)
      • 4.9.8.4 Metabolic syndrome, obesity, diabetes
      • 4.9.8.5 Diseases of the pancreas (diabetes, pancreatitis)
    • 4.9.9 Anti-neoplastic properties
    • 4.9.10 Emerging potential therapeutic uses
• 5.0 Precautions
• 6.0 Warnings
  • 6.1 Tolerance, dependence, and withdrawal symptoms
  • 6.2 Drug interactions
  • 6.3 Drug screening tests
• 7.0 Adverse effects
  • 7.1 Carcinogenesis and mutagenesis
  • 7.2 Respiratory tract
  • 7.3 Immune system
  • 7.4 Reproductive and endocrine systems
  • 7.5 Cardiovascular system
  • 7.6 Gastrointestinal system and liver
    • 7.6.1 Hyperemesis
    • 7.6.2 Liver
  • 7.7 Central nervous system
    • 7.7.1 Cognition
    • 7.7.2 Psychomotor performance and driving
    • 7.7.3 Psychiatric effects
      • 7.7.3.1 Anxiety, PTSD, depression, and bipolar disorder
      • 7.7.3.2 Schizophrenia and psychosis
      • 7.7.3.3 Suicidal ideation, attempts, and mortality
      • 7.7.3.4 Amotivational syndrome
• 8.0 Overdose/Toxicity
• References

Authorship and acknowledgements

Author: Hanan Abramovici Ph.D.
Co-authors: Sophie-Anne Lamour, Ph.D.: and George Mammen, Ph.D.

Affiliations:
Cannabis Legalization and Regulation Branch, Health Canada, Ottawa, ON, Canada K1A 0K9
Email: hanan.abramovici@canada.ca

Overview of Summary Statements

The following bullet-point statements are meant to summarize the content found within sections 4.0 (Potential Therapeutic Uses) and 7.0 (Adverse Effects) and their respective subsections. The bullet-point statements can also be found in their respective sections and sub-sections in the body of the document itself. Note: most, but not all, clinical studies of cannabis (experimental or therapeutic) have been conducted with dried cannabis containing more THC than CBD and typically, but not always, with lower-potency THC (< 9% THC). Furthermore, the majority of the clinical studies of cannabis (experimental or therapeutic) have administered dried cannabis by smoking. Lastly, the findings from clinical studies of cannabis for therapeutic purposes may not be applicable to other chemotypes of cannabis or other cannabis products with different THC and CBD amounts and ratios.

References

See source: https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/information-medical-practitioners/information-health-care-professionals-cannabis-cannabinoids.html