MINNESOTA S MEDICAL CANNABIS PROGRAM

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1 MINNESOTA S MEDICAL CANNABIS PROGRAM DARIN TESKE LEGAL AND POLICY ADVISOR OFFICE OF MEDICAL CANNABIS AUGUST 25, 2016

2 2014: MN became 22 nd state with full medical cannabis program Recreational and Medical (4) Medical (22) Low THC/High CBD Products (16)

3 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

4 Minnesota s Medical Cannabis Program

5 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

6 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

7 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

8 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

9 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

10 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

11 Medical Cannabis Manufacturers

12 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

13 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

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

15 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.

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

17 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

18 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

19 Program Statistics and Survey Results

20 Program Statistics 2,204 patients are currently approved (as of August 19) 659 health care practitioners are approved to certify qualifying patients (as of August 19) Prior to Intractable Pain, the 3 most frequent conditions certified were: Muscle spasms, including M.S. (43%) Cancer or its treatment (w/ associated pain, nausea, or wasting) (25%) Seizures, including epilepsy (23%)

21 Patients in Active in Registry (2,204 patients active as of 8/19/16) Number of Patients Active in Registry /7/2015 7/7/2015 8/7/2015 9/7/ /7/ /7/ /7/2015 1/7/2016 2/7/2016 3/7/2016 4/7/2016 5/7/2016 6/7/2016 7/7/2016 8/7/2016

22 Health Care Practitioners in Registry (659 providers as of 8/19/16) 700 Health Care Practitioners Active in Registry /7/2015 7/7/2015 8/7/2015 9/7/ /7/ /7/ /7/2015 1/7/2016 2/7/2016 3/7/2016 4/7/2016 5/7/2016 6/7/2016 7/7/2016 8/7/2016

23 Patients age group profiles (prior to Intractable Pain) Percent Less than 18 yrs: 11.5% 18 yrs to 30 yrs: 13.2% 31 yrs to 50 yrs: 33.8% 51 yrs to 70 yrs: 35.6% 71 yrs and older: 5.9% Male/Female 57%/43%

24 Patient Enrollment Fee Types Active Patients by Fee Type SSI 9% SSD 16% Reduced fee Full fee 58% 42% MN Care 18% Medicaid 14% CHAMPVA 1%

25 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

26 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

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

28 Questions? Website: OR Phone numbers: Darin Teske Legal & Policy Analyst Minnesota Department of Health Office of Medical Cannabis (office)

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