Cannabis Industry And Medical Cannabis Clinics Need Regulation

There is little transparency about the clinical practices of medical cannabis clinics. To our knowledge, Canadian cannabis clinics have not published the indications, contraindications, or dosing protocols for the products they prescribe. The College of Family Physicians of Canada, in its 2014 guidance document,25 recommends restricting the prescribing of dried cannabis to patients with severe neuropathic pain unresponsive to all first-line medications. It also recommends a maximum dose of 700 mg of dried cannabis with 9% THC per day. However, in 2017, the average daily dose of prescribed medical cannabis in Canada was 2.3 g,1 well in excess of this recommended maximum. The average concentration of THC prescribed has not been reported, but many of the industry’s cannabis products contain concentrations of THC that are far above the 9% recommended by the guidance document, with some containing concentrations of 20% or more. To discourage inappropriate prescribing, some US states have imposed medical requirements on cannabis clinics, including mandatory training in cannabis prescribing, prescriptions lasting no more than 30 days, and a requirement to closely follow the patient to ensure the safety and effectiveness of the cannabis prescription.26

The provincial regulatory colleges have put out position statements on medical cannabis. For example, the College of Physicians and Surgeons of Ontario position statement27 advises physicians that they must do a comprehensive assessment before prescribing cannabis and identify patients at high risk of cannabis-related harms, such as psychosis or mood disorders. The college also recommends that prescribers use a low dose. Monitor for complications such as cannabis use disorder (CUD).

However, evidence from the United States suggests that physicians frequently prescribe medical cannabis to patients who have conditions for which cannabis is contraindicated, such as CUD. In a US survey study, family doctors reported that 31% of their patients who were prescribed medical cannabis by another doctor had a medical condition that could be worsened by cannabis.28 Another large-scale epidemiologic study found that, out of a total of 3784 respondents with past-year cannabis use, 32% of medical cannabis users had past-year CUD, compared with 25% of recreational cannabis users.29 A US study of at-risk youth in Denver and San Francisco found that CUD was significantly ( 2 = 22.8, P < .001) associated with having a medical cannabis card.30 A review of US medical cannabis programs noted that

in many states people receive authorizations for medical marijuana from physicians whom they have seen for a single visit …. Initial studies have shown that the typical medical marijuana patient in these states is a young male with a nonspecific indication of chronic or severe pain and a history of recreational marijuana use.26

Health Canada is responsible for ensuring that pharmaceutical products are safe and effective. It approves products for sale after rigorous review of their safety and effectiveness, and it requires companies to develop a product monograph containing the indications, contraindications, and dosing for the product. Companies are not allowed to promote “off-label” uses of their product (ie, for nonindicated conditions). Physicians are expected to be consistent with the product monograph in their prescribing of the product and in their educational presentations on the product. However, Health Canada does not require cannabis companies to produce and abide by a product monograph, listing the indications, contraindications, and dosing of their products. As a result, the educational programs the industry sponsors have no restrictions on their claims about their product. Furthermore, Health Canada has allowed the companies to produce cannabis with THC concentrations of 20% or more. Industry involvement in medical cannabis marketing and education has a very dangerous precedent: Purdue’s marketing of OxyContin.

Health Canada failed in its obligation to protect the public in the OxyContin epidemic. Health Canada approved Purdue’s product monograph even though it contained misleading and inaccurate information. An affidavit, submitted to the court as part of the successful national class-action lawsuit against Purdue,31 concluded that Purdue’s 2009, 2010, and 2011 OxyContin monographs contained inaccurate statements that encouraged physicians to prescribe very high doses of OxyContin to patients at high risk of addiction, overdose, and other harms. The monographs suggested that OxyContin is indicated for all types of pain; they did not provide a therapeutic range or an upper dose limit; they did not warn physicians that high opioid doses are associated with an increased risk of overdose and addiction; and they did not warn physicians that certain patient groups were at high risk of these harms. This allowed Purdue, in its many publications, conferences, and workshops, to tell physicians that OxyContin could be “dosed to effect,” with no upper limit; that it was effective for all types of pain; and that addiction was rare in pain patients. Purdue’s campaign profoundly changed physicians’ prescribing practices and directly or indirectly caused the deaths of many thousands of people across North America. Health Canada also allowed Purdue to produce tablets containing up to 80 mg of oxycodone, 16 times the amount contained in an acetaminophen-oxycodone tablet, with the result that physicians began prescribing high doses of oxycodone even for benign pain conditions.

While medical cannabis will not lead to overdose deaths, it could potentially cause harm and disability for many. Health Canada has put strict limits on advertising, and has set the minimum legal age for cannabis purchase at 18, but much more needs to be done. Canadians were given access to medical cannabis because of a Supreme Court decision, not because of Health Canada regulatory approval. Nonetheless, it has the regulatory authority, and the public health obligation, to regulate medical cannabis just as it does with other pharmaceutical products. Health Canada should require the industry to produce a product monograph, stating the evidence-based indications, precautions, contraindications, and dosing protocols for medical cannabis. Health Canada should also prevent the industry from making products containing levels of THC higher than those used in trials (ie, 9%).