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Medicinal Marihuana


Cannabis indica, cannabis sativa, cannabis americanus, Indian hemp and marijuana (or marihuana) all refer to the same plant.


Medical cannabis, or medical marijuana, can refer to the use of cannabis and its cannabinoids.


Cannabis is not an approved therapeutic product and the provision of this information should not be interpreted as an endorsement of the use of this product, or cannabis generally, by Health Canada.


What the product may be used for


Health care practitioner may authorize the use of cannabis (marihuana, marijuana) for the relief of one or more of the following symptoms associated with a variety of disorders which have not responded to conventional medical treatments. These symptoms (or conditions) may include: severe refractory nausea and vomiting associated with cancer chemotherapy; loss of appetite and body weight in cancer patients and patients with HIV/AIDS; pain and muscle spasms associated with multiple sclerosis; chronic non-cancer pain (mainly neuropathic); severe refractory cancer-associated pain; insomnia and depressed mood associated with chronic diseases (HIV/AIDS, chronic non-cancer pain); and symptoms encountered in the palliative/end-of-life care setting. This is not an exhaustive list of symptoms or conditions for which cannabis may be authorized for use by your health care practitioner.


The potential therapeutic and adverse effects associated with cannabis use may vary depending on the amount of cannabis used and the concentration of cannabinoids in the cannabis product, the frequency of cannabis use, the patient's age and medical condition, previous experience with cannabis or cannabinoids, and the use of other prescription or non-prescription drugs. For more detailed information on potential therapeutic uses and adverse effects, please consult the "Information for Health Care Professionals: Cannabis (marihuana, marijuana) and the Cannabinoids". (http://www.hc-sc.gc.ca/dhp-mps/marihuana/med/infoprof-eng.php)


Cannabis (marihuana, marijuana) and the cannabinoids Dried plant for administration by ingestion or other means Psychoactive agent (Reference: Prepared by Health Canada, February 2013)


Primary medical conditions and associated secondary end-points (if any) for which benefits were observed
  • HIV/AIDS-associated weight loss

  • HIV/AIDS-associated weight loss; disease-associated mood and insomnia

  • Multiple sclerosis-associated pain and spasticity

  • Central and peripheral chronic neuropathic pain (various etiologies)

  • Chronic neuropathic pain from HIV-associated sensory neuropathy

  • HIV-associated chronic neuropathic pain refractory to other medications

  • Chronic post-traumatic or post-surgical neuropathic pain refractory to other medications and associated insomnia

  • Chronic pain of various etiologies (musculoskeletal, post-traumatic, arthritic, peripheral neuropathy, cancer, fibromyalgia, migraine, multiple sclerosis, sickle cell disease, thoracic outlet syndrome)


Furthermore, among the goals of palliative care described by the World Health Organization (WHO) are relief from pain and other distressing symptoms, and the enhancement of quality of life. While integration of cannabis into mainstream medical use can be characterized as extremely cautious, its use appears to be gaining some ground in palliative care settings where the focus is on individual choice, patient autonomy, empowerment, comfort and especially quality of life. Nevertheless, establishing the effectiveness of cannabis as a viable treatment option in a palliative care context requires a careful assessment of its effects in a wide range of conditions; such evidence is not yet abundant and further research is needed. In addition, while prescription cannabinoids demonstrate an acceptable safety profile according to some studies for certain medical conditions, the use of cannabis and cannabinoids in the clinic is known to be limited by their psychotropic effects. Certain patient populations (e.g. the elderly or those suffering from pre-existing psychiatric disease) may be also be more sensitive or susceptible to experiencing adverse psychotropic, cognitive, psychiatric or other effects.


The Cannabis plant has a history of medicinal use dating back thousands of years across many cultures. Its current use is controversial. In Chinese medicine cannabis is one of the fundamental herbs. Writings from ancient India confirm that its psychoactive properties were recognized, and doctors used it for a variety of illnesses and ailments. These included a whole host of gastrointestinal disorders, insomnia, headaches and as a pain reliever frequently used in childbirth. In the 1970s, a synthetic version of THC, the primary active ingredient in cannabis, was synthesized to make the drug Marinol.


Wherever the use of marijuana for medicinal purposes is legal, doctors tend to recommend it to treat chronic diseases and conditions. Examples of what medical marijuana is used for include AIDS, cancer, ADHD, multiple sclerosis, nausea resulting from chemotherapy, Crohn's disease, glaucoma, epilepsy, insomnia, migraines, arthritis and lack of appetite. Doctors have also used medical marijuana on terminally ill patients, as a way to alleviate some of their pain and improve their overall quality of life.





Medicinal Marihuana Chemistry


"The chemistry of Cannabis is quite complex, and the isolation and extraction of the active ingredient are challenging even today. There are over 400 chemicals in marihuana, but to date only about 86 endo-cannabinoids have been identified in nature and others have been synthesized chemically.


Endocannabinoids have an effect on the human body because our bodies produce a group of ‘cannabis-like’ chemicals called endogenous cannabinoids, endocannabinoids.


The major psychoactive ingredient in marihuana is Δ9-tetrahydrocannabinol, commonly referred to as THC (although other naming systems refer to it confusingly as Δ9-THC). The mode of action of THC is still not properly understood, although it is known that of the two stereoisomers (mirror images), the (-)-form (the left-handed form of the molecule) is 10-15 times more potent than the (+)-form.


how cannabis works

Other cannabinoids, in addition to THC, have medicinal or psychoactive elements; Cannabidiol (CBD), cannabinol (CBN), cannabavarin (THCV), cannabigerol (CBG), cannabichromene (CBC), delta-8-THC, cannabicyclol (CBL), cannabitriol (CBT), and cannabielsoin are among the many different naturally-occurring cannabinoids. Most are known to have psychoactive and/or pharmacological properties.



how cannabis works

Because of Δ9-THC’s psychoactive nature in marihuana, it is regularly used to measure the herb’s potency. THC typically occurs in concentrations of less than 0.5% for inactive hemp, 2 to 3% for marihuana leaf, and 4 to 20% for higher-grade marihuana. In seedless buds, known as sinsemilla the highest concentrations of THC in the plant can be found at 10 to 20% or more. Higher concentrations of THC can also be found in extracts, tonics, and hashish (i.e., concentrated cannabis resin).


THC will not naturally occur in its active form in the cannabis plant. Instead, it occurs in an acidic form called tetrahydrocannabinolic acid or THC acid (THCa). When burned in a cigarette or heated, the THCA is rapidly converted to active THC in a heat-propelled reaction called decarboxylation. THCa is not psychoactive, but it has been discovered to have immune-modulatory properties akin to other cannabinoids.


Cannabidiol (CBD) is the next most common cannabinoid and is very prevalent in hemp varieties of cannabis. CBD and THC acid (THCA) are produced simultaneously. In the marihuana plant, a cannabinoid called cannabigerolic acid is the precursor for both CBD and THCA.


CBD also occurs in an acidic form called Cannabidiolic acid or (CBDa). CBD actually lacks any noticeable psychoactive affects and does not really interact with the body’s cannabinoid receptors. Despite that, plenty of evidence is starting to show that CBD has valuable medicinal properties. It works in concert with THC, augmenting its medical effects and moderating its psychoactive effects. Some researchers believe that CBD has anti-psychotic properties which tend to reduce anxiety and panic reactions to THC. It is also considered to improve wakefulness and to supplement THC’s activity against pain and spasticity. Pretreatment with CBD in mice nearly tripled the levels of THC in their brains which is an indication that it can increase the action and effectiveness of other drugs. Studies claim CBD on its own has anti-inflammatory anti-anxiety, anti-epileptic, sedative, and neuro-protective properties. It’s also quite a powerful anti-oxidant and can protect against chemical damage due to oxidation. Lab and animal tests have suggested that CBD could even protect against the incurrence of the following diseases: diabetes; certain types of cancer; rheumatoid arthritis; brain and nerve damage as a result of a stroke; alcoholism; Huntington’s disease; and even prion infections like “Mad Cow.” Other evidence suggests that CBD is biphasic, meaning that its effectiveness diminishes if the does is too high or too low.


The third most common cannabinoid is Cannabinol (CBN), which is more or less a byproduct of the chemical breakdown of THC. CBN lacks the strong psychoactive and medicinal qualities of THC and is usually found in degraded or poorly-preserved marihuana.


Marihuana also contain over 100 Terpenoids which are aromatic chemicals that can also be found in pine trees, citrus flora, and other odoriferous plants. Terpenoids produce the unique aroma and flavor of marihuana, but many researchers believe that terpenoids might have significant medicinal effects. In comparison to the cannabinoids, little is really known about terpenoids in cannabis.


Cannabis also has over 20 Flavonoids which are chemicals common to most plant life. Some flavonoids (known as cannaflavins) are exclusive to cannabis. Most flavonoids are considered to have anti-inflammatory and antioxidant properties and could help prevent cancer and other major diseases.


Marihuana-using veterans have reported different highs and medical effects for different types of cannabis. This effect is largely produced by the different chemical concentrations of cannabinoids, terpenoids, and flavonoids in every different type of marihuana.



Mandatory Testing of Medicinal Marihuana


Health Canada Technical Document


PDF

Health Canada is stepping away from being the provider of Medical Marihuana and focusing on their role as the regulatory body. Medical Marihuana being treated much more like a true pharmaceutical in the way that it's going to be controlled and accessed by licensed patients.


In order to achieve purity and quality of the finished dried marihuana product, Good Production Practices as outlined in the “Repealed” Marihuana for Medical Purposes Regulations (MMPR) in must be followed at all stages of production, packaging, labelling and storage of the marihuana. However, as of August 24, 2016, the Marihuana for repealed Medical Purposes Regulations (MMPR) are no longer in effect and have been archived. Never the less the information under MMPR can be used for the reference, research, or record-keeping purposes only


The MMPR regulation is now replaced by the new Access to Cannabis for Medical Purposes Regulations (ACMPR).


As specified in the ACMPR, each batch or lot of dried marihuana must be approved for release by the LP's Quality Assurance person, who must have the training, experience and technical knowledge relating to the activity conducted and the requirements of Division 4 of the repealed MMPR. This means that the Quality Assurance person must have the ability to evaluate the operations of the LP to ensure compliance with Division 4, of Health Canada’s guidance document for Technical Specifications for Testing Dried Marihuana for Medical Purposes, and the technical knowledge to be able to assess analytical testing results in order to be able to make the determination of whether the dried marihuana is suitable for sale. The Quality Assurance person is also responsible for investigating quality-related complaints and taking corrective and preventive actions, if necessary.


Visual inspection should confirm the absence of pests or extraneous substances. The microbial and chemical contaminants of dried marihuana must be within generally accepted tolerance limits for herbal medicines for human consumption. LPs must maintain consistent specifications for their products, and assess each lot or batch of dried marihuana against those specifications before approving the release of a lot or batch for sale.


Analytical testing for those contaminants and for the percentages of Δ9-tetrahydrocannabinol (Δ9-THC) and cannabidiol (CBD) referred to in these Regulations must be conducted using validated methods.


Testing of dried marihuana can only be performed by the holder of a producer's licence under the MMPR or of a dealer's licence under the Narcotic Control Regulations, and must be performed according to validated methods.


Marihuana must not be treated - before, during or after the drying process - with a pest control product that has not been registered under the Pest Control Products Act for use on marihuana for medical purposes. Dried marihuana must not contain any residue of a pest control product in excess of any maximum residue.


Analysis for cannabinoid profiles is a very important piece of the Cannabis Quality Assurance for any medical marihuana patient.


Health Canada provides licenses to medical marihuana producers who are inspected and found in compliance with applicable sections of the following Canadian acts and regulations:


  • Food and Drug Act (FDA)

  • Controlled Drugs and Substances Act (CDSA)

  • Food and Drug Regulations (FDR)

  • Natural Health Product Regulations (NHPR)

  • Narcotic Control Regulations (NCR)

  • Marihuana Medical Access Regulations (MMAR) (In effect until March 31, 2014)

  • “Repealed” Marihuana for Medical Purposes (MMPR) “Repealed” (introduced June 19, 2013)

  • Access to Cannabis for Medical Purposes Regulations (ACMPR) (introduced August 24, 2016)

Under MMAR, licensed marihuana producers must also abide by standards set in Good Manufacturing Practices (GMP), ensuring a controlled, procedure-driven cultivation, processing and testing systems. For instance, if a question of safety or potency is raised, a licensed, GMP-compliant grower should be able to fully trace a specific product or dose, and answer concisely to the medical community and patients.