CPC Qualicare / DocWeb | Doctor's Online resource for South African Doctors

April 2019 Newsletter

Guidelines for prescribing Medical Cannabinoids – No Panacea!!!

We have all seen the sudden expansion of the availability of medical cannabis oil at pharmacy level and no doubt, your patients are asking you to script it for a variety of reasons, which you may find unclear.

Much of this stems from the Constitutional Court judgement of Sept 18 2018, which declared the existing legislation criminalising the use, possession and cultivation of cannabis, as unconstitutional.

It would thus, from 18 Sept 2018, no longer be an offence for an adult person to possess and use cannabis for their personal consumption, privately.

This has resulted in a plethora of products flooding onto the market containing the extracts of cannabinol and cannabidiol. The South African Health Products Regulatory Authority (SAHPRA) however stresses that unless a product is registered by them, such products may not be sold to the public and are, in fact, illegal.

It would therefore also be unethical for a Medical Practitioner to prescribe or suggest a product to a patient, which product may not be registered i.t.o. the SAHPRA. This should be carefully understood by Medical Practitioners who could be under extreme patient pressure to prescribe medication which may not yet be registered.

A Recent article in the Canadian Family Physician Feb 2018 volume 64, gives an excellent set of guidelines for the use of Medical Cannabis in General Practice.

There are 2 main extracts of Cannabis, namely tetrahydrocannabinol (THC), which is hallucinogenic, and cannabidiol (CBD) which is not overtly hallucinogenic.

They clearly point out that there are only 3 clear indications for the use of the products containing Cannabidiol (CBD). In RSA all of the cannabis derived products may only contain CDB and no product may contain the hallucinogenic THC (Tetrahydrocannabinol).

I have attached the table of recommendations from the article for your closer inspection and understanding, however, in summary:

  • Use of CBD should be limited in general practice.
  • A patient centred approach with shared, informed, joint decision making is recommended.
  • The use should be restricted to conditions where there is some clinical evidence of efficacy which has been researched.
  • < p>Only the following conditions warrant further consideration of the use of CBD:

    • Neuropathic pain
    • Palliative and end of life pain
    • Chemotherapy induced nausea and vomiting
    • Spasticity due to Multiple sclerosis
    • Spasticity due to spinal cord injuries

    Remember that these guidelines are merely suggestions to Family Practitioners and do not dictate your behaviour

    Box 1. Recommendations summary

    General Recommendation

    • We recommend against use of medical cannabinoids for most medical conditions owing to lack of evidence of benefit and known harms (strong recommendation)
    • Potential exceptions are reviewed below: some types of pain, CINV, and spasticity due to MS or SCI

    Management of pain

    • Acute pain: We strongly recommend against use of medical cannabinoids for acute pain management owing to evidence of no benefit and known harms (strong recommendation)
    • Headache: We recommend against use of medical cannabinoids for headache owing to lack of evidence and known harms (strong recommendation)
    • Rheumatologic pain: We recommend against use of medical cannabinoids for pain associated with rheumatologic conditions (including osteoarthritis and back pain) owing to lack of evidence and known harms (strong recommendation)
    • Neuropathic pain: We recommend against medical cannabinoids as first-or second-line therapy in neuropathic pain owing to limited benefits and high risk of harms (strong recommendation)

    -Clinicians could consider medical cannabinoids for refractory neuropathic pain, with the following considerations (weak recommendations):

    • A discussion has taken place with patients regarding the benefits and risks of medical cannabinoids for pain
    • Patients have had a reasonable therapeutic trial˟ of ˃3 prescribed analgesics⁺ and have persistent problematic pain despite optimized analgesic therapy

    Medical cannabinoids are adjuncts to other prescribed analgesics

    • Palliative (end-of-life) cancer pain: We recommend against use of medical cannabinoids as first-or second-line therapy for palliative cancer pain owing to limited benefits and high risk of harms (strong recommendation)
    • Clinicians could consider medical cannabinoids for refractory pain in palliative cancer patients, with the following considerations (weak recommendation):
    • -a discussion has taken place with patients regarding the risks and benefits of medical cannabinoids for pain
    • -patients have had a reasonable therapeutic trial˟ of ˃2 prescribed analgesics and have persistent problematic pain despite optimized analgesic therapy -medical cannabinoids are adjuncts to other prescribed analgesics

    Types of medical cannabinoids for pain:

    • -If considering medical cannabinoids, we recommend a pharmaceutically developed product (nabilone or nabiximols) as the initial agent (strong recommendation)
    • Nabilone is off-label for pain and has limited evidence of benefit. However, it is less expensive that nabiximols and dosing is more consistent than for smoked cannabis
    • Nabiximols is expensive and, in some provinces, only available through specialist prescribing or special authorization.

    However, nabiximols has better evidence than nabilone does -If considering medical cannabinoids, we recommend against medical marijuana (particularly smoked) as the initial product (strong recommendation)

    • Evidence for smoked cannabis has a very high risk of bias, and long-term consequences are unknown
    • Products available can have far higher concentrations of THC and CBD than those researched

    Management of nausea and vomiting

    • General: We recommend against use of medical cannabinoids for general nausea and vomiting owing to the lack of evidence and known harms (strong recommendation)

    -We strongly recommend against medical cannabinoids for nausea and vomiting in pregnancy or hyperemesis gravidarum owing to the lack of evidence, known harms, and unknown harms (strong recommendation)

    • CINV: We recommend against use of medical cannabinoids as first-or second-line therapy for CINV owing to limited comparisons with first-line agents and known harms (strong recommendation)

    -Clinicians could consider medical cannabinoids for treatment of refractory CINV, with the following considerations (weak recommendation):

    • A discussion has taken place with patients regarding the risks and benefits of medical cannabinoids for CINV

    • Patients have had a reasonable therapeutic trial of standard therapies⁺ and have persistent CINV
    • Medical cannabinoids are adjuncts to other prescribed therapies
    • Types of medical cannabinoids for CINV:

    -If considering medical cannabinoids, we recommend nabilone (strong recommendation)

    • We recommend against nabiximols and medical marijuana (smoked, oils, or edibles), as it is inadequately studied (strong recommendation)
    • While dronabinol has been studied, it is no longer available in Canada

    Management of spasticity

    • General: We recommend against use of medical cannabinoids for general spasticity owing to lack of evidence and known harms (strong recommendation)
    • Spasticity in MS or SCI: We recommend against use of medical cannabinoids as first-or second-line therapy for spasticity in MS or SCI owing to limited evidence and known harms (strong recommendation)
    • Clinicians could consider medical cannabinoids for refractory spasticity in MS and SCI, with the following considerations (weak recommendation):
    • A discussion has taken place with patients regarding the benefits and risks of medical cannabinoids for spasticity
    • Patients have had a reasonable therapeutic trial of standard therapies (including non-pharmaceutical measures) and have persistent spasticity
  • Types of medical cannabinoids for spasticity:
  • -If considering medical cannabinoids, we recommend nabiximols (strong recommendation)

    • We recommend against medical marijuana (smoked, oils, or edibles), as it is inadequately studied (strongly recommendation)
    • Clinicians could consider nabilone owing to its lower cost; however, it is off-label and lacks evidence for this use (weak recommendation)

CBD-Cannabidiol, CINV-chemotherapy-induced nausea and vomiting, MS-multiple scleroisis, SCI-spinal cord injury, THC-tetrahydrocannabinol. ˟Reasonable therapeutic trial is defined as 6 wk of therapy with an appropriate dose, dose titration, and monitoring (eg. Function, quality of life).

⁺Other prescribed therapies for neuropathic pain management include, but are not limited to (in no particular order), tricyclic antidepressants (eg, amitriptyline, nortriptyline), gabapentinoids (gabapentin, pregabalin), or selective norepinephrine reuptake inhibitor antidepressants (duloxetine, venlafaxine). The committee believed that ˃ 3 medications should be trialed before considering cannabinoids or opioids. ˟Other prescribed therapies for CINV include, but are not limited to (in no particular order), serotonin antagonists (eg, ondansetron), neurokinin-1 receptor antagonists (aprepitant, fosaprepitant), corticosteroids (dexamethasone), and dopamine antagonists (prochlorperazine, metoclopramide).

˟Other therapies for spasticity in MS include, but are not limited to (in no particular order), daily stretching, range-of-movement exercises, baclofen, gabapentin, tizanidine, dantrolene, benzodiazepine, or botulinum toxin.

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