INFORMATION FOR HEALTH CARE PROFESSIONALS
INFORMATION FOR HEALTH CARE PROFESSIONALS
Cannabis (marihuana, marijuana) and the cannabinoids
Dried or fresh plant and oil administration by ingestion or other means Psychoactive agent
Health Canada is the federal department responsible for helping the people of Canada maintain and improve their health. Health Canada is committed to improving the lives of all of Canada 's people and to making this country's population among the healthiest in the world as measured by longevity, lifestyle and effective use of the public health care system.
?galement disponible en fran?ais sous le titre : RENSEIGNEMENTS DESTIN?S AUX PROFESSIONNELS DE LA SANT? Le cannabis (marihuana, marijuana) et les cannabino?des Plante s?ch?e ou fra?che et huile destin?es ? l'administration par ingestion ou par d'autres moyens Agent pyschoactif
To obtain additional information, please contact:
Health Canada Address Locator 0900C2 Ottawa, ON K1A 0K9 Tel.: 613-957-2991 Toll free: 1-866-225-0709 Fax: 613-941-5366 TTY: 1-800-465-7735 E-mail: hc.publications-publications.sc@canada.ca
? Her Majesty the Queen in Right of Canada, as represented by the Minister of Health, 2018
Publication date: October 2018
This publication may be reproduced for personal or internal use only without permission provided the source is fully acknowledged.
Cat.: H129-19/2018E-PDF ISBN: 978-0-660-27828-5 Pub.: 180312
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
iii
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:
o Fax toll-free to 1-866-678-6789, or o 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 MedEffectTM Canada Web site.
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TABLE OF CONTENTS
Page List of figures and tables.................................................................................................................................................................. 1 List of abbreviations ........................................................................................................................................................................ 2 Authorship and acknowledgements ................................................................................................................................................. 7 Overview of summary statements.................................................................................................................................................. 11
1.0 The Endocannabinoid System............................................................................................................................................... 18 1.1 Cannabis ............................................................................................................................................................................ 22 1.1.1 Chemistry and composition....................................................................................................................................... 22 1.1.2 Other constituents ..................................................................................................................................................... 22 1.1.3 Stability and storage.................................................................................................................................................. 22
2.0 Clinical Pharmacology........................................................................................................................................................... 24 2.1 Pharmacodynamics ............................................................................................................................................................ 24 2.2 Pharmacokinetics ............................................................................................................................................................... 29 2.2.1 Absorption ................................................................................................................................................................ 30 2.2.1.1 Smoked cannabis........................................................................................................................................... 30 2.2.1.2 Vapourized cannabis ..................................................................................................................................... 30 2.2.1.3 Oral ............................................................................................................................................................... 31 2.2.1.4 Oro-mucosal and intranasal........................................................................................................................... 33 2.2.1.5 Rectal ............................................................................................................................................................ 33 2.2.1.6 Topical .......................................................................................................................................................... 33 2.2.2 Distribution ............................................................................................................................................................... 34 2.2.3 Metabolism ............................................................................................................................................................... 34 2.2.3.1 Inhalation ...................................................................................................................................................... 35 2.2.3.2 Oral ............................................................................................................................................................... 35 2.2.4 Excretion ................................................................................................................................................................... 36 2.3 Pharmacokinetic-pharmacodynamic relationships ............................................................................................................. 36 2.4 Tolerance, dependence, and withdrawal symptoms ........................................................................................................... 39 2.5 Special populations............................................................................................................................................................ 43
3.0 Dosing ..................................................................................................................................................................................... 46 3.1 Smoking ............................................................................................................................................................................. 48 3.2 Oral .................................................................................................................................................................................... 51 3.3 Oro-mucosal ...................................................................................................................................................................... 52 3.4 Vapourization..................................................................................................................................................................... 52
4.0 Potential Therapeutic Uses.................................................................................................................................................... 54 4.1 Palliative care..................................................................................................................................................................... 56 4.2 Quality of life..................................................................................................................................................................... 57 4.3 Chemotherapy-induced nausea and vomiting .................................................................................................................... 59 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..................................................................................................................... 62 4.4.1 To stimulate appetite and produce weight gain in AIDS patients ............................................................................. 62 4.4.2 To stimulate appetite and produce weight gain in cancer patients ............................................................................ 63 4.4.3 Anorexia nervosa ...................................................................................................................................................... 64 4.5 Multiple sclerosis, amyotrophic lateral sclerosis, spinal cord injury and disease............................................................... 64 4.5.1 Multiple sclerosis ..................................................................................................................................................... 65 4.5.2 Amyotrophic lateral sclerosis.................................................................................................................................... 70 4.5.3 Spinal cord injury (or spinal cord disease) ................................................................................................................ 71 4.6 Epilepsy ............................................................................................................................................................................. 72 4.7 Pain .................................................................................................................................................................................... 78 4.7.1 Acute pain ................................................................................................................................................................. 80 4.7.1.1 Experimentally-induced acute pain ............................................................................................................... 81 4.7.1.2 Post-operative pain........................................................................................................................................ 82 4.7.2 Chronic pain.............................................................................................................................................................. 82
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4.7.2.1 Experimentally-induced inflammatory and chronic neuropathic pain ........................................................... 82 4.7.2.2 Neuropathic pain and chronic non-cancer pain in humans ............................................................................ 82 4.7.2.3 Cancer pain ................................................................................................................................................... 91 4.7.2.4 "Opioid-sparing" effects and cannabinoid-opioid synergy........................................................................... 93 4.7.2.5 Headache and migraine ................................................................................................................................ 98 4.8 Arthritides and musculoskeletal disorders ......................................................................................................................... 99 4.8.1 Osteoarthritis............................................................................................................................................................. 99 4.8.2 Rheumatoid arthritis................................................................................................................................................ 101 4.8.3 Fibromyalgia ........................................................................................................................................................... 102 4.8.4 Muscular pain ......................................................................................................................................................... 104 4.8.5 Osteoporosis............................................................................................................................................................ 104 4.9 Other diseases and symptoms .......................................................................................................................................... 105 4.9.1 Movement disorders ............................................................................................................................................... 105 4.9.1.1 Dystonia...................................................................................................................................................... 105 4.9.1.2 Huntington's disease ................................................................................................................................... 107 4.9.1.3 Parkinson's disease ..................................................................................................................................... 108 4.9.1.4 Tourette's syndrome ................................................................................................................................... 109 4.9.1.5 Spinocerebellar ataxias .............................................................................................................................. 110 4.9.2 Glaucoma ............................................................................................................................................................... 110 4.9.3 Asthma ................................................................................................................................................................... 111 4.9.4 Hypertension .......................................................................................................................................................... 111 4.9.5 Stress and psychiatric disorders.............................................................................................................................. 111 4.9.5.1 Anxiety and depression .............................................................................................................................. 112 4.9.5.2 Sleep disorders ........................................................................................................................................... 114 4.9.5.3 Post-traumatic stress disorder..................................................................................................................... 116 4.9.5.4 Alcohol and opioid withdrawal symptoms (drug withdrawal symptoms/drug substitution) ...................... 119 4.9.5.5 Schizophrenia and psychosis...................................................................................................................... 121 4.9.6 Alzheimer's disease and dementia.......................................................................................................................... 126 4.9.7 Inflammation .......................................................................................................................................................... 127 4.9.7.1 Inflammatory skin diseases (dermatitis, psoriasis, pruritus)....................................................................... 128 4.9.8 Gastrointestinal system disorders (irritable bowel syndrome, inflammatory bowel disease, hepatitis, pancreatitis, metabolic syndrome/obesity).............................................................................................. 129 4.9.8.1 Irritable bowel syndrome ........................................................................................................................... 129 4.9.8.2 Inflammatory bowel diseases (Crohn's disease, ulcerative colitis) ............................................................ 131 4.9.8.3 Diseases of the liver (hepatitis, fibrosis, steatosis, ischemia-reperfusion injury, hepatic encephalopathy) ..................................................................................................................................................... 135 4.9.8.4 Metabolic syndrome, obesity, diabetes ...................................................................................................... 137 4.9.8.5 Diseases of the pancreas (diabetes, pancreatitis) ........................................................................................ 141 4.9.9 Anti-neoplastic properties....................................................................................................................................... 142 4.9.10 Emerging potential therapeutic uses ..................................................................................................................... 146
5.0 Precautions ........................................................................................................................................................................... 147
6.0 Warnings .............................................................................................................................................................................. 148 6.1 Tolerance, dependence, and withdrawal symptoms......................................................................................................... 149 6.2 Drug interactions ............................................................................................................................................................. 149 6.3 Drug screening tests......................................................................................................................................................... 151
7.0 Adverse effects ..................................................................................................................................................................... 152 7.1 Carcinogenesis and mutagenesis ..................................................................................................................................... 153 7.2 Respiratory tract .............................................................................................................................................................. 154 7.3 Immune system................................................................................................................................................................ 156 7.4 Reproductive and endocrine systems............................................................................................................................... 158 7.5 Cardiovascular system ..................................................................................................................................................... 162 7.6 Gastrointestinal system and liver ..................................................................................................................................... 163 7.6.1 Hyperemesis ........................................................................................................................................................... 163 7.6.2 Liver ....................................................................................................................................................................... 164 7.7 Central nervous system.................................................................................................................................................... 164
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7.7.1 Cognition ................................................................................................................................................................ 164 7.7.2 Psychomotor performance and driving................................................................................................................... 168 7.7.3 Psychiatric effects................................................................................................................................................... 174
7.7.3.1 Anxiety, PTSD, depression, and bipolar disorder ...................................................................................... 174 7.7.3.2 Schizophrenia and psychosis...................................................................................................................... 182 7.7.3.3 Suicidal ideation, attempts, and mortality .................................................................................................. 189 7.7.3.4 Amotivational syndrome ............................................................................................................................ 190 8.0 Overdose/Toxicity ................................................................................................................................................................ 191 References................................................................................................................................................................................... 193
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List of figures and tables
Figures Figure 1 The Endocannabinoid System in the Nervous System................................................................................................................... 21 Figure 2 Pharmacokinetics of THC.............................................................................................................................................................. 29 Figure 3 A Proposed Clinical Algorithm for Physicians Considering Supporting Therapeutic Use of Cannabis for a Patient with Chronic, Intractable Neuropathic Pain ........................................................................................................................................... 86 Tables Table 1 Selected Pharmacologic Actions of Cannabis/Psychoactive Cannabinoids ................................................................................... 27 Table 2 Recommendations for the Evaluation and Management of Patients .............................................................................................. 48 Table 3 Relationship between THC Percent in Plant Material and the Available Dose (in mg THC) in an Average Joint ........................ 50 Table 4 Comparison between Cannabis and Prescription Cannabinoid Medications ................................................................................. 50 Table 5 Published Positive, Randomized, Double-Blind, Placebo-Controlled, Clinical Trials on Smoked/Vapourized Cannabis and Associated Therapeutic Benefits ............................................................................................................................. 55
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