MINNESOTA S MEDICAL CANNABIS PROGRAM

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1 MINNESOTA S MEDICAL CANNABIS PROGRAM OFFICE OF MEDICAL CANNABIS MICHELLE LARSON DIRECTOR OCTOBER 20, 2016

2 What is medical cannabis? Material from the cannabis plant used for a therapeutic purpose In MN, must be liquid/oil Cannabis is the genus name for the plant. One species or 3? controversial, but many, many varieties Appears to have first developed in Central Asia Trichomes glandular structures that produce the pharmacologically active substances. Especially abundant on calyx of flowering structures on female plants

3 Cannabis as Medicine Cannabinoids thought to be most important constituent for therapeutic use: >80 types of these 21-carbon molecules Main cannabinoids: THC (tetrahydrocannabinol) psychoactive. Analgesic, anti-nausea/vomiting, more. CBD (cannabidiol) - not psychoactive. Anti-inflammatory, anti-epileptic, analgesic, more Terpenes: Aromatic compounds give distinctive aromas Some evidence of synergistic action with cannabinoids, but much more study needed to define clinical role Endocannabinoid System (new knowledge over last 30 years) Endocannabinoids are molecules produced by the body that are similar to the phytocannabinoids found in the cannabis plant (e.g. THC, CBD). ECS impacts appetite, metabolism, pain sensation, inflammation, thermoregulation, vision, mood and memory

4 Legal Marijuana Sales 2015 Topped $5.4 billion last year over $1 billion in medical marijuana sales in California, nearly $1 billion in legal marijuana sales in Colorado, and more than a half-billion dollars in sales in Washington state.

5 2014: MN became 22 nd state with full medical cannabis program Recreational and Medical (4) Medical (21) Low THC/High CBD Products (17)

6 Current Federal Law Marijuana remains classified as Schedule I drug under the Controlled Substances Act (CSA) (1970) No currently accepted medical use High potential for abuse Cannot prescribe Cultivation, manufacture, sale, distribution, and use of medical cannabis violates CSA Two most recent spending bills: cannot use federal $ to prevent state implementation of medical cannabis program Different federal agencies take different approaches; mixed signals

7 Minnesota s Medical Cannabis Program

8 Minnesota Medical Cannabis Program Minnesota Laws 2014, Chapter 311 Codified at Minn.Stat to There are two objectives of state law: allow therapeutic use of medical cannabis, and prevent its misuse or diversion. July 1, 2015 Medical cannabis distributed to enrolled patients

9 Changes for 2016 Qualifying medical conditions: Intractable Pain added Ulcerative colitis added (inflammatory bowel disease) Permits: Remote consultation between pharmacist and patient 1 person to transport to testing lab or disposal facility Task Force moved to MDH

10 Minnesota s program is different from most No smokeable or plant form marijuana (only liquids and oils in capsule, tincture, or vaporized form) Two vertically-integrated manufacturers (cultivation-productiondistribution supply chain) Commitment to learning from experience with the program (reports and observational studies on effectiveness, side effects, etc.) Patients agree to provide access to medical data

11 Patients - Requirements Must be Minnesota resident with qualifying medical condition No program i.d. card No reciprocity with other jurisdictions Must enroll in registry and agree that data in registry can be used for aggregate reports and research $200 annual enrollment fee ($50 reduced fee if receiving assistance) Cost of medical cannabis is out of pocket

12 Patients -- Qualifying Medical Conditions Cancer or its treatment, with severe or chronic pain, or severe nausea, or severe wasting Glaucoma HIV/AIDS Tourette s Syndrome Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig s Disease) Seizures, including those characteristic of epilepsy Severe and persistent muscle spasms, including those characteristic of multiple sclerosis Inflammatory Bowel Disease, including Crohn s Disease Terminal Illness with life-expectancy < 1 year - with severe or chronic pain, or severe nausea, or severe wasting) Intractable Pain

13 Public Petitions to Add Qualifying Medical Conditions Acquired absence of limb/phantom limb pain Arthritis Autism/ASD Depression, treatment-resistant Diabetes (blood sugar control) Ehlers-Danlos Syndrome Insomnia Post-Traumatic Stress Disorder (PTSD) Schizophrenia Decision by December 1

14 Health Care Practitioners - Duties Certify diagnosis Certify need for caregiver, if applicable Provide ongoing treatment Allow MDH access to health records Recertify annually Participation is voluntary

15 Registered caregivers Will only be registered if the certifying health care practitioner has also certified the patient needs one Must apply to and register with the Dept of Health separately from the patient (after being invited by a patient) Must be > 21 years old and pass a background check Limit of one patient per caregiver, unless patients share same address

16 Health Facilities Employees may possess medical cannabis while carrying out employment duties Health care facilities = health care facilities licensed under chapter 144A, boarding care homes licensed under section , assisted living facilities, and facilities owned, controlled, managed, or under common control with hospitals licensed under chapter 144. Includes home care (see Laws 2016, Chapter 179, subd. 14)

17 Medical Cannabis Manufacturers

18 Manufacturers Two registered grower/manufacturer/distributors, each with one growing/manufacturing site and 4 distribution locations. Security requirements and restrictions on location and advertising Regular MDH inspections

19 Manufacturers - Products Manufacturers each determine their own product line Products range from: high CBD/low THC -- 1:1 -- low CBD/high THC Different medical cannabis products in MN are characterized by different ratios of THC:CBD and mode of delivery Packaging and labeling requirements Insurance does not cover cost of medical cannabis

20 Independent Laboratory Testing Content Cannabinoid Profile Contamination: Metals Pesticides Microbials Residual Solvents Consistency and Stability (Random Audits) Laboratory must be approved by MDH

21 Manufacturers - Distribution requirements At each of the manufacturers distribution locations, there must be a MN-licensed pharmacist who is responsible for dispensing medical cannabis to the patients enrolled in the registry. The pharmacist must consult with the patient and recommend the formulation and dosage of medical cannabis for the patient. There is a maximum 30-day supply limit. Consumption of medical cannabis onsite is prohibited.

22 Cannabis Patient Center Locations: 1 per congressional district Eagan St. Paul St. Cloud Hibbing Minneapolis Bloomington Rochester Moorhead

23 Crimes It is a felony to divert medical cannabis: ( , subds. 1 and 2) Manufacturer or agent of manufacturer Registered patients, parents/legal guardians, caregivers Gross misdemeanors and misdemeanors created

24 Other Prohibitions (Minn.Stat ) Even if enrolled in the registry, a person may not: possess or use: On a school bus or van On the grounds of a pre-, primary, or secondary school In any correctional facility operate auto, boat, plane while under influence do something under influence that would constitute negligence or professional malpractice vape on public transport, in a public place or place of employment, or where vapor could be inhaled by non-patient child

25 Program Statistics and Survey Results

26 Program Statistics 2920 patients are currently approved (as of Oct 7) 3569, including those no longer active 706 health care practitioners approved to certify patients (as of Oct 7) Most frequently certified conditions: Intractable Pain Severe and persistent muscle spasms, including M.S. Cancer or its treatment (w/ associated pain, nausea, or wasting) Seizures, including epilepsy Others combined < 10%

27 Patients Active in Registry (n=2806 as of 9/30/16) /7/2015 8/7/ /7/ /7/2015 2/7/2016 4/7/2016 6/7/2016 8/7/2016

28 Health Care Practitioners in Registry (n=696 as of 6/30/16) /7/2015 8/7/ /7/ /7/2015 2/7/2016 4/7/2016 6/7/2016 8/7/2016

29 Who s in the Registry? (September 30 data) Conditions: Intractable pain 43% Muscle spasms/ms 31% Cancer/treatment 18% Glaucoma + HIV/AIDS + Tourette syndrome + ALS = 4.5% Average age = 48.6 years (On June 30, average age = 44.2 years)

30 Patients age group profiles Prior to Intractable Pain October 10, 2016 Percent Percent Less than 18 yrs 11.5% Less than 18 yrs 4.9% 18 yrs to 30 yrs 13.2% 18 yrs to 30 yrs 10.8% 31 yrs to 50 yrs 33.8% 31 yrs to 50 yrs 33.0% 51 yrs to 70 yrs 35.6% 51 yrs to 70 yrs 41.2% 71 yrs and older 5.9% 71 yrs and older 10.1% Male/Female 57%/43% Male/Female 52.5%/47.5%

31 Patient Enrollment Fee Types June 30, 2016 September 30, 2016 Reduced Fee 57% Full Fee 43% Reduced Fee 52% Full Fee 48%

32 Learning from Participants Experience Observational study from patient reported data/transactions Opinion surveys of patient and their certifying health care practitioner Adverse event reporting Potential for focused studies incorporating medical record information

33 Patient Surveys self-reported perceived benefits 120 Patient-Perceived Benefit first quarter 48% % 10% 12% 20 5% 4% 3% 0 1- No Benefit Some Benefit Great Benefit

34 Medical provider surveys - Perception of Benefit 35 HCP-Perceived Benefit No Benefit Some benefit A great deal of benefit

35 Questions? Website: OR Phone numbers: Michelle Larson Director Minnesota Department of Health Office of Medical Cannabis (office)

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