Medical Cannabis in Minnesota - MHA > · PDF fileMedical Cannabis in Minnesota: ......
Transcript of Medical Cannabis in Minnesota - MHA > · PDF fileMedical Cannabis in Minnesota: ......
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OFFICE OF MEDICAL CANNABIS
Manny Munson-RegalaTom Arneson, MD, mphPresentation to Minnesota Hospital AssociationMarch 11, 2015
Medical Cannabisin Minnesota: overview of program andimplications for hospitals
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Status of Cannabis Laws
Source: Marijuana Policy Project
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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
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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
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Manufacturers
• Annual Registration
• Technical Expertise
• Qualified Employees
• Financial Stability
• Security Measures
• Ability to Meet Patient Needs
• Fees Charged
• Fees must be reasonable
• Pharmacist must dispense
• Laboratory Testing
• Subject to Inspections
• Product Requirements
• Limited forms
• One location
• Monthly Report
• Amount and dosages
• Composition
• Tracking Number
• Security Standards
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Patients• Qualifying medical conditions
• Cancer*
• Glaucoma
• HIV/AIDS
• Tourette’s
• ALS
• Crohn’s disease
• Terminal illness with life expectancy of under one year*
• Participates in a patient registry and provide access to medical records.
• MDH can add additional conditions ; must look at Intractable Pain first
• Seizures
• Severe and persistent muscle spasms
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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
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Overall Timeline
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Minnesota Medical Solutions
•Dr. Kyle Kingsley CEO and Dr. Jon Thompson, Scientific Director
• Otsego, MN
• Moorhead
• Minneapolis
• Rochester
• Maple Grove
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Leafline Labs•Peter Bachman, Presidentwith co-founders Dr. Gary Starr and Dr. Andy Bachman
• Cottage Grove
• Eagan
• Hibbing
• St. Cloud
• St. Paul
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Patient:Visits HCP for
Condition Assessment
HCP = Health Care Practitioner
HCP:Registers
Certifies Condition
Patient: Completes Application
Submits Fee
MDH: Reviews
Approves Application
Patient: Visits a Distribution Site to acquire medical cannabis
July 2015June 2015
$
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Medical CannabisTherapies in MN
•Extraction/Refining process
•Extract components
•Product composition
•Administration Forms
• Laboratory testing
•Packaging
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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
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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)
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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
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Laboratory Testing
•Content – cannabinoid profile
•Contamination:•Metals•Pesticides•Microbials•Residual solvents
•Consistency and stability
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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)
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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
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Learning fromparticipants’ 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
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Still to Do
• IT Development
• Additional Rulemaking
• Business Processes• Forms • Data Requirements• Billing
• Legislative Reports
• Outreach and Education
• Intractable Pain Study
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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