Medical Cannabis in Minnesota: overview of program and implications for hospitals Manny Munson-Regala Tom Arneson, MD, mph Presentation to Minnesota Hospital Association March 11, 2015 OFFICE OF MEDICAL CANNABIS Status of Cannabis Laws Source: Marijuana Policy Project Minnesota History • 1980 Therapeutic Research Act • 2009 Legislature passed SF97 allowing access for terminal patients; vetoed • HF1818 and SF1641 Introduced 2014 • March 2014; intense lobbying by parents of kids with severe epilepsy • Governor meets with families; directs MDH to work on proposal. MDH crafts clinical trial approach similar to Therapeutic Research Act • Compromise reached May 2014 • Bill signed by Governor May 29, 2014; Minnesota Laws 2014, Regular Session, Ch. 311 General Requirements • 2 licensed manufacturers • 1 manufacturing site (cultivation and processing) • 4 distribution sites • Pills, oils or vaporizers but no dried leaves or plants • New criminal and civil penalties and protections created • Limited qualifying conditions • Patients agree to provide access to medical data for purposes of observational studies Manufacturers • Annual Registration • Pharmacist must dispense • Technical Expertise • Laboratory Testing • Qualified Employees • Subject to Inspections • Financial Stability • Security Measures • Product Requirements • Ability to Meet • Limited forms Patient Needs • One location • Fees Charged • Monthly Report • Fees must be reasonable • Amount and dosages • Composition • Tracking Number • Security Standards Patients • Qualifying medical conditions • Cancer* • Seizures • Crohn’s disease • Glaucoma • Severe and • Terminal illness • HIV/AIDS persistent with life expectancy • Tourette’s muscle of under one year* spasms • ALS • Participates in a patient registry and provide access to medical records. • MDH can add additional conditions ; must look at Intractable Pain first Health Care Practitioners • Physicians, APRNS or PAs • Determine patient qualification • Agree to continue treatment and report medical findings to commissioner • Provide health records to commissioner • Data protected under state law but may be used in aggregated, non-identifiable form for publishing research or creation of summary data Overall Timeline Minnesota Medical Solutions •Dr. Kyle Kingsley CEO and Dr. Jon Thompson, Scientific Director • Otsego, MN • Moorhead • Minneapolis • Rochester • Maple Grove Leafline Labs •Peter Bachman, President with co-founders Dr. Gary Starr and Dr. Andy Bachman • Cottage Grove • Eagan • Hibbing • St. Cloud • St. Paul Patient: HCP: Patient: MDH: Patient: Visits HCP for Registers Completes Application Reviews Visits a Distribution Site to Condition Certifies Condition Submits Fee Approves acquire medical cannabis Assessment Application $ June 2015 July 2015 HCP = Health Care Practitioner Medical Cannabis Therapies in MN • Extraction/Refining process • Extract components • Product composition • Administration Forms • Laboratory testing • Packaging Extraction/Refining Process •Drying •Cutting/shredding •Supercritical CO2 extraction (high pressure liquid CO2) •Refining - to isolate specific cannabinoids Note: Sativex – approved for use in Canada, UK, Europe, and elsewhere is a cannabis extraction product Extract Components • Cannabinoids • >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 • Pharmacologically active. Some evidence of synergistic action with cannabinoids, but much more study needed to define clinical role. • Other (flavonoids, fats, more) Product Composition •Different medical cannabis products in MN will be characterized by different ratios of THC:CBD •Likely to range from something like 99:1 to 1:99 (THC:CBD) •The two manufacturers will each determine their product line, which could evolve over time Laboratory Testing •Content – cannabinoid profile •Contamination: •Metals •Pesticides •Microbials •Residual solvents •Consistency and stability Packaging •Plain (minimize appeal to children) •Tamper evident •Child-resistant •Names reflect medical cannabis nature •Label • Chemical composition • Dosage/directions • Date of manufacture/batch number • Patient name/DOB/address • Caregiver name (if any) Clinical Trials • Summary of clinical trials relevant to MN qualifying conditions and cannabis extraction products or synthetic THC posted on Office of Medical Cannabis web site http://www.health.state.mn.us/topics/cannabis/ practitioners/dosage.pdf • Number and quality of trials varies by condition • General insights from reviewing the literature: • Serious adverse events rare • Individual variability • Effective for only portion of patients • Side effects common and generally mild and dose-related Learning from participants’ experience • Observational study from patient reported data • Focused studies incorporating medical record information – as feasible – a year into the program • Adverse event reporting • Opinions of patients and health care practitioner Still to Do • IT Development • Additional Rulemaking • Business Processes • Forms • Data Requirements • Billing • Legislative Reports • Outreach and Education • Intractable Pain Study Resources http://www.health.state.mn.us/topics/cannabis/ http://www.lcc.leg.mn/mctrtf/ http://www.house- leg.state.mn.us/hrd/pubs/medcannabis.pdf [email protected] [email protected].