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

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

• 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

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

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, Presidentwith co-founders Dr. Gary Starr and Dr. Andy Bachman

• Cottage Grove

• Eagan

• Hibbing

• St. Cloud

• St. Paul

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

$

Medical CannabisTherapies 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 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

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

Manny.munson-regala@state.mn.us

Michelle.larson@state.mn.us