Recent trends in medical cannabis use in Canada

Recent trends in medical cannabis use in Canada Paul Grootendorst Faculty of Pharmacy, University of Toronto Department of Economics, McMaster University

Cannabis therapeutic effects Cannabis has been used therapeutically for centuries http://cann-can.ca/resources/history/

Cannabis therapeutic effects There is renewed interest in its therapeutic use Some RCTs indicate that cannabis effective for treating neuropathic pain and various other disorders

Cannabis therapeutic effects Some evidence that US states that have allowed medical cannabis use have seen reduced opioid death rates https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1898878

Cannabis therapeutic effects Physicians generally reluctant to prescribe given that cannabis is not formally approved for use by Health Canada Also an unconventional treatment

Patients/advocates are more enthusiastic https://www.leafly.com/start-exploring

Regulations governing medical cannabis access in Canada, over time Pre 2001: Section 56 of the Controlled Drug and Substances Act Who grants access to MC? Discretion of Federal Minister of Health Physician documentation required Extensive. "By its very nature, a Section 56 exemption may be granted only in exceptional circumstances" Number of patients given access: 2 patients in 1999. http://www.mapinc.org/drugnews/v99.n614.a03.html Legal sources of supply Not specified in CDSA; Minister allowed the 2 patients to cultivate their own

Why did the policy change? Litigation culminating in Canada vs Parker, Ontario Court of Appeal (July 2000) Terrance Parker has since childhood suffered from a very severe form of epilepsy. He has found conventional therapies ineffective. By smoking marijuana he can substantially reduce the incidence of seizures. He did not seek Section 56 approval and was charged with marijuana possession, contrary to CDSA Court found that Section 56 did not provide sufficient exemption for medical use of marijuana

Regulatory systems, over time 2001-2013: Marihuana Medical Access Regulations (MMAR) 2014-2016: Marihuana for Medical Purposes Regulations (MMPR) 2016-present: Access to Cannabis for Medical Purposes Regulations (ACMPR)

Regulatory systems, over time 2001-2013: Marihuana Medical Access Regulations (MMAR) Patient authorization & eligibility MMAR: Health Canada granted access to severely ill patients; physicians provided documentation Legal sources of supply: MMAR: Home cultivation or purchase from Health Canada

Regulatory systems, over time 2001-2013: Marihuana Medical Access Regulations (MMAR) 2014-2016: Marihuana for Medical Purposes Regulations (MMPR) Patient authorization & eligibility MMPR: physicians and nurse practitioners, at their discretion, subject to regulations of provincial professional regulatory body Legal sources of supply: MMPR: Licensed Producers, commercial vendors approved and regulated by Health Canada

Regulatory systems, over time 2001-2013: Marihuana Medical Access Regulations (MMAR) 2014-2016: Marihuana for Medical Purposes Regulations (MMPR) 2016-present: Access to Cannabis for Medical Purposes Regulations (ACMPR) Patient authorization & eligibility ACMPR: physicians and nurse practitioners Legal sources of supply: ACMPR: Licensed Producers. Home cultivation.

summary Patient authorization & eligibility MMAR: Health Canada granted access to severely ill patients; physicians provided documentation MMPR: physicians and nurse practitioners, at their discretion, subject to regulations of provincial professional regulatory body ACMPR: same as MMPR Legal sources of supply: MMAR: Home cultivation or purchase from Health Canada MMPR: Licensed Producers, commercial vendors approved and regulated by Health Canada ACMPR: Licensed Producers. Home cultivation.

MMPR created concern among medical associations and regulators

restrictions on physician cannabis prescribing, by province, April 2016 prescribing physician must province bc ab sk mb on pq nb ns pe nl meet with patient at least every 3 months 3 3 register with regulator as cannabis prescriber 2 review patient's medicines use 2 2 send in Medical Document to LP 1 be patient's primary physician 3 3 meet patient in person to prescribe 1 1 1 have patient sign written treatment agreement 1 1 1 have patient enroll in research study 2 create and maintain registry of patients using cannabis 4 have patient sign consent form 1 1 1 assess patient risk of addiction using standardized tool 1.5 1.5 1.5 1.5 implement process to identify patient misuse 2 2 2 2 2 2 keep medical documents separate for inspection by regulator 1 1 1 1 specify THC percentage on Medical Document 0.5 specify medical condition on Medical Document 0.5 0.5 0.5 total restriction score 7.5 11 5.5 6.5 5 13 0 1 4 4.5 restriction category 4 4 3 3 2 5 1 1 2 2 1= least restrictive, 5 = most restrictive

Research questions What impact did the change in rules in 2014 have on patient and physician participation in the medical access program? What is the effect of the provincial College prescribing restrictions on access to medical cannabis? What are the trends in dosing & potency of medical cannabis? What are the trends in the prices of cannabis sold by regulated vendors? Implications for coming legalization of recreational cannabis.

Research questions What impact did the change in rules in 2014 have on patient and physician participation in the medical access program?

Number of client registrations by month, in thousands, 2003-5 to 2014-3 (MMAR) and 2013-11 to 2017-06 (MMPR/ACMPR) # of registered clients, in 1000s 0 50 100 150 200 MMAR MMPR/ACMPR 2002m1 2004m1 2006m1 2008m1 2010m1 2012m1 2014m1 2016m1 2018m1 month

# of unique medical cannabis prescribers by month, 2003-5 to 2014-3 (MMAR) and 2014-4 to 2017-06 (MMPR/ACMPR) # of cannabis prescribers 0 2,000 4,000 6,000 8,000 MMAR MMPR/ACMPR 2002m1 2004m1 2006m1 2008m1 2010m1 2012m1 2014m1 2016m1 2018m1 month

# of registered clients per prescriber, by month, 2003-5 to 2014-3 (MMAR) and 2014-4 to 2017-06 (MMPR/ACMPR) # of clients per cannabis prescriber 0 20 40 60 80 MMAR MMPR/ACMPR 2002m1 2004m1 2006m1 2008m1 2010m1 2012m1 2014m1 2016m1 2018m1 month

http://www.cannabisclinics.ca/medical-marijuana-canada-clinic/

Research questions What is the effect of the provincial College prescribing restrictions on access to medical cannabis? To answer, examine association between provincial College prescribing restriction score and LP shipments (a measure of # prescriptions dispensed)

Number of cannabis shipments from Licensed Producers per 100,000 population (average over March to May 2016) and composite cannabis prescribing restriction score (April 2016), by province. Shipments per 100,000 population 0 100 200 300 NB NS ON PE NL SK MB BC AB QC 0 2 4 6 8 10 12 14 Composite prescribing restriction score

Research questions Of course, College rules could reflect underlying provincial sentiment towards cannabis use Solution: find rates of regulated medical cannabis use among those using cannabis regularly examine association between provincial College prescribing restriction score and fraction of regular cannabis users who are using under auspices of medical access program Regular use (daily or weekly) can be estimated using the 2015 Statistics Canada Canadian Tobacco, Alcohol and Drugs Survey (CTADS)

Estimated proportion of regular (daily or weekly) cannabis users (2015 CTADS) registered in medical access program Province Estimated number of regular users Fraction of population aged 15+ Percentage of regular users: who report using registered in for medical medical access purposes program Newfoundland 16,990 4% 31% 2.4% P.E.I. 3,660 3% 51% 3.6% Nova Scotia 48,364 6% 50% 3.5% New Brunswick 21,121 3% 41% 8.2% Quebec 243,288 3% 35% 0.4% Ontario 607,652 5% 40% 2.5% Manitoba 53,600 5% 48% 1.1% Saskatchewan 39,382 4% 47% 2.0% Alberta 154,291 5% 49% 1.8% British Columbia 334,630 9% 46% 0.5% All provinces 1,522,978 5% 42% 1.7%

Fraction of regular cannabis users who are using under auspices of medical access program and composite cannabis prescribing restriction score, by province. Fraction of reg users enrolled in MAP 0.02.04.06.08 NB NS PE NLON SK MB BC AB QC 0 5 10 15 Composite cannabis prescribing restriction score

# shipments from Licensed Producers per 100,000 population, by province and month, 2013-11 to 2017-06 LP shipments per 100,000 pop. 0 200 400 600 800 AB MB BC PQ 2013m7 2014m7 2015m7 2016m7 2017m7 month

Estimated # of Health Canada approved marijuana plants per 1,000 population 25+ as of December, 2013 Number 0 200 400 600 BC AB SK MB ON PQ NB NS PE NF Province

Research question What are the trends in cannabis prescribing? Grams per day Potency (THC, CBD)

Mean daily cannabis amounts (grams/day) authorized under MMAR and MMPR mean grams/day 0 5 10 15 20 MMAR MMPR 2000 2005 2010 2015 year

Trends in potency of cannabis authorized under MMAR and MMPR two primary active ingredients in cannabis: 9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD). THC produces the psychoactive effects of marijuana. It also has analgesic, anti-nausea, appetite stimulant and anti-spastic effects. CBD does not cause psychoactive effects. It has neuroprotective, antiinflammatory, anti-anxiety, anti-epileptic and anti-psychotic properties. http://www.cannabisclinics.ca/medical-marihuana-clinics-canada/#1438630914290-b4437a91-0007 Concentrations of THC & CBD vary

Trends in potency of cannabis authorized under MMAR and MMPR There is no administrative data available We can, however, look at the types of cannabis that Licensed Producers are selling under MMPR

prices and potency of dried cannabis available from Licensed Producers

prices and potency of dried cannabis available from Licensed Producers, June 2015 % THC content 0 5 10 15 20 25 30 4 4.5 4.5 4.5 4.2 4.6 2 24.5 3.6 2.5 3.5 4.75 1.75 1.75 Price per gram <$5 $7-$9 $11-$13 >=$15 0 5 10 15 20 25 30 % CBD content

prices and potency of dried cannabis available from Licensed Producers, June 2016 % THC content 0 5 10 15 20 25 30 4 4 4.5 4.5 4.46 3.5 4.75 2.5 4.5 Price per gram <$5 $7-$9 $11-$13 >=$15 0 5 10 15 20 25 30 % CBD content

prices and potency of dried cannabis available from Licensed Producers, June 2017 % THC content 0 5 10 15 20 25 30 4.25 4 4 4.46 2.5 4 Price per gram <$5 $7-$9 $11-$13 >=$15 0 5 10 15 20 25 30 % CBD content

prices and potency of dried cannabis available from Licensed Producers, November 2017 % THC content 0 5 10 15 20 25 30 4 4.46 4.25 4 4.25 Price per gram <$5 $7-$9 $11-$13 >=$15 0 5 10 15 20 25 30 % CBD content

prices and potency of cannabis oil available from Licensed Producers

prices and potency of cannabis oil available from Licensed Producers, June 2016 % THC content 0 10 20 30 4 1.3 4.2 1.1 Price per ml <$1.5 $2-$2.5 $3-$3.5 >=$4 0 5 10 15 20 25 30 35 40 45 % CBD content

prices and potency of cannabis oil available from Licensed Producers, December 2016 % THC content 0 10 20 30 4 4.2 1.3 1.3 5 1.3 1.3 Price per ml <$1.5 $2-$2.5 $3-$3.5 >=$4 0 5 10 15 20 25 30 35 40 45 % CBD content 4

prices and potency of cannabis oil available from Licensed Producers, June 2017 % THC content 0 10 20 30 1.3 1.3 1.3 4.3 Price per ml <$1.5 $2-$2.5 $3-$3.5 >=$4 4 5 5.3 0 5 10 15 20 25 30 35 40 45 % CBD content

prices and potency of cannabis oil available from Licensed Producers, November 2017 % THC content 0 10 20 30 5.9 1.2 1.2 1.3 Price per ml <$1.5 $2-$2.5 $3-$3.5 >=$4 4 5 5 0 5 10 15 20 25 30 35 40 45 % CBD content

Research questions What is the trend in prices of cannabis sold by Licensed Producers?

Prices of dried cannabis available from Licensed Producers, June 2015- November 2017 CBD 10%, THC 2% CBD > 10%, THC 2% THC 10%, CBD 5% 5 10 15 5 10 15 mean price per gram 5 10 15 10 < THC 15%, CBD 5% 15 < THC 20%, CBD 5% 20 < THC 25%, CBD 5% THC > 25%, CBD 5% THC > 2%, CBD > 5% 2015 2016 2017 2018 2015 2016 2017 20182015 2016 2017 2018 Graphs by THC and CBD concentration month

Prices of cannabis oil available from Licensed Producers, June 2015- November 2017 CBD 10%, THC 5% 10 < CBD 20%, THC 5% 20 < CBD 30%, THC 5% 1 2 3 4 5 1 2 3 4 5 mean price per ml 1 2 3 4 5 CBD > 30%, THC 5% THC 10%, CBD 5% 10 < THC 20%, CBD 5% 20 < THC 30%, CBD 5% THC > 5%, CBD > 5% 2016 2017 2018 2016 2017 20182016 2017 2018 Graphs by THC and CBD concentration month

some research questions re legalization of recreational cannabis use, anticipated July 1, 2018

1. will there be a separate medical cannabis market? Unclear how the 200,000+ Canadians registered in the medical access system will obtain cannabis after legalization Primary self reported medical uses are pain, depression, anxiety Ideally physicians will continue to supervise medicinal cannabis use

2. size of regulated & unregulated recreational cannabis markets Rates of annual cannabis use relatively high in Canada. United Nations Office on Drugs and Crime, World Drug Report 2017 (ISBN: 978-92-1-148291-1, eisbn: 978-92-1-060623-3, United Nations publication, Sales No. E.17.XI.6).

2. size of regulated & unregulated recreational cannabis markets Rates of cannabis use relatively high in Canada. Estimated percentage of residential population that uses cannabis, by frequency of use, sex, and age, 2005. fraction using cannabis at least: age group once a year once a month once a week once a year once a month once a week females males 15-19 0.18 0.07 0.04 0.23 0.13 0.1 20-24 0.26 0.12 0.08 0.33 0.20 0.16 25-34 0.19 0.07 0.05 0.25 0.18 0.16 35-44 0.09 0.04 0.04 0.17 0.08 0.07 45-64 0.05 0.02 0.02 0.09 0.06 0.05 65+ 0.01 <0.01 <0.01 0.02 0.01 0.01 Data Source: 2015 Statistics Canada Canadian Tobacco, Alcohol and Drugs Survey. (Public use version. Sampling weights used.)

size of cannabis markets Appears to be large production capacity to serve the gray market Also 100+ retail outlets known as dispensaries or compassion clubs Online vendors

size of cannabis markets According to PBO, prices are less than $10/gram In 2015-16, the average price of illicit cannabis ranged between $8.32 and $9.36, with a mid - point estimate of $8.84 per gram. There were also considerable discounts associated with purchases of larger quantities. Legalization will likely put downward pressure on prices of illicit cannabis. Will the price/quality combinations on offer in the regulated market be sufficiently attractive to attract current recreational users?

size of cannabis markets Appears that Ontario regulated price will be about $10/gram Competitive with current recreational prices Unclear what the THC/CBD concentrations will be. Unclear what will happen to cannabis dispensaries

3. Impact of legalization on initiation of cannabis use? Since it is so widely prevalent in Canada, unclear what impact legalization will have