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MEDICAL IN MARYLAND

PAUL W. DAVIES, M.D. NATALIE M. LAPRADE COMMISSION, CHAIRPERSON KURE PAIN MANAGEMENT, CHAIRPERSON

DISCLAIMER OBJECTIVES

• My comments and slides are only informational, and not authoritative. • History and background of medicinal cannabis • Basic pharmacology and physiology • You should not rely upon these slides or my comments as an authoritative • Review of clinical evidence statement of the law or the regulations. • Medical Cannabis in Maryland • The Commission and Regulations

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HISTORY OF USE OF MEDICAL CANNABIS WHAT IS MEDICAL CANNABIS? • Traditional Chinese medicine -- one of the 50 "fundamental" herbs • Medical marijuana, refers to the use of cannabis and its • Ancient Egypt, Ebers Papyrus (ca. 1550 BCE) -- used in suppositories to treat disease or improve symptoms for hemorrhoid pain Medical cannabis can be administered: • • Ancient India -- insomnia, headaches, gastrointestinal disorders, and • Vaporizing or smoking dried buds pain (including childbirth) • Consuming extracts • Ancient Greece -- dress wounds and sores, nose bleeds, and expel • Taking capsules tapeworms • Using oral sprays • Medieval Islamic world -- diuretic, antiemetic, antiepileptic, anti- inflammatory, analgesic and antipyretic properties

MODERN HISTORY OF CANNABIS

• William Brooke O'Shaughnessy (1809-1889), an Irish physician introduced cannabis to Western medicine -- muscle spasms, stomach cramps and general pain • Albert Lockhart and Manley West studied the health use in Jamaican communities – in 1987 introduced the pharmaceutical Canasol • In the 1970s, a synthetic version of THC was produced and approved for use in the United States as the drug Marinol

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MEDICAL CANNABIS IN THE US MEDICAL CANNABIS IN THE WORLD

• Medical cannabis legalized throughout the world: • Austria, Belgium, Canada, Czech Republic, Finland, Israel, Netherlands, Spain, the UK • 23 states and DC in the US, although it is illegal under US federal law • In the United States: • While federal law outlaws all cannabis use, legalized states no longer prosecute individuals for the possession or sale of marijuana, as long as the individuals are in compliance with the state's marijuana sale regulations

PHARMACOLOGY

• Genus Cannabis • Psychoactive Species • • , • Less Psychoactive Species • • 460+ compounds (80+ cannabinoids)

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PHARMACOLOGY ENDOCANNABINOID SYSTEM • Psychoactive • THC (or delta-9-tetrahydrocannabinol) • Other less psychoactive cannabinoids • Cannabinoid receptors • (CBD) • Predominantly located in the brain • (CBN) • (CBL) • Cell membrane receptors (G protein-coupled receptor) • (CBC) • (CBG) • Synergy produces effect • Different from our classic thinking of pharmaceuticals

ENDOCANNABINOID SYSTEM (CON’T) ENDOCANNABINOID SYSTEM (CON’T)

• Activators • Receptor Subtypes • Endocannabinoids (Mammillary body) • CB1 receptor • Brain (predominantly) • Plant cannabinoids • Lungs, liver and kidneys • (Marinol) • CB2 receptor • Immune system • Hematopoietic cells • Novel cannabinoid receptors (non-CB1 and non-CB2) • Endothelial cells

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ENDOCANNABINOID SYSTEM (CON’T) ENDOCANNABINOID SYSTEM (CON’T)

• Gastrointestinal • Physiology • Gastrointestinal activity reduced • Central Nervous System • Cardiovascular • Psychoactive • Cardiomyocytes • Coronary artery endothelial and inflammatory cells in humans and • Pain perception rodents • Appetite • Bone • Mood • Osteoblasts, osteocytes, osteoclasts • Memory • Osteoporosis

CANNABINOIDS FOR MEDICAL USE: CANNABINOIDS FOR MEDICAL USE: A SYSTEMATIC REVIEW AND META-ANALYSIS A SYSTEMATIC REVIEW AND META-ANALYSIS PENNY F. WHITING, PHD ET AL. PENNY F. WHITING, PHD ET AL. • Moderate/Low quality evidence • Meta-analysis of randomized controlled studies • Fibromyalgia; • HIV-related sensory neuropathy • High quality evidence • HIV-related weight loss • Chronic pain • Multiple sclerosis • Involuntary movements • Nausea and vomiting caused by chemotherapy • Muscle spasms • Rheumatoid arthritis • Sleep disorders; • Tourette syndrome

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CANNABINOIDS FOR MEDICAL USE: A SYSTEMATIC REVIEW AND META-ANALYSIS RESEARCHERS CONCLUDED PENNY F. WHITING, PHD ET AL.

• No Evidence Benefits... judged against the risks of potential side effects, such as: • Anxiety disorder • Dizziness • Depression • Dry mouth • Eye pressure • Euphoria • Psychosis • Fatigue • Nausea

MEDICAL MARIJUANA FOR TREATMENT OF CHRONIC PAIN AND OTHER MEDICAL AND PSYCHIATRIC PROBLEMS: A BACKGROUND OF MMCC CLINICAL REVIEW KEVIN P. HILL MD, MSH • Critical Leadership • Review 28 randomized Clinical Trials approx 6,500 patients. • Delegates Dan Morhaim, M.D., and Cheryl Glenn • Senator Jamie Raskin • High Quality Evidence • Chronic Pain • 2013 Natalie M. LaPrade Medical Cannabis Commission (DHMH) • Neuropathic Pain • Spasticity Associated with MS

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BACKGROUND OF MMCC (CON’T) THE COMMISSION

• 2013 Initial law created an academic medical center model • An independent Commission

• 2014 Program expanded to include non-academic physicians • Develops policies, procedures, guidelines and regulations to • 2013-2015 Development of regulations implement medical cannabis program

• 2015 (September) Regulations effective • Chair appointed by the Governor

• Latest version available on Commission website: mmcc.maryland.gov

THE COMMISSION OVERVIEW OF LICENSEES

16 members: • Commission is responsible for Secretary of DHMH 1 law enforcement 2 patient representatives 1attorney • Development of regulations 1 Nat’l Council on Alcohol and Drug Dependence 1 Maryland Department of Agriculture • Issue licenses 3 physicians 1 University of Maryland Extension 1 nurse 1 Office of the Comptroller • Continuous monitoring and oversight 1 pharmacist 1 Maryland States Attorneys Association 1 research scientist

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OVERVIEW OF LICENSEES (CON’T) OVERVIEW OF LICENSEES (CON’T)

• 15 licensed growers initially • Independent testing laboratories to inspect all products to • Also eligible for dispensary license confirm specifications: • Licensed processors • Cannabinoid content • leaf and flowers ointments, salves, lotions, and • THC concentration vaporizable extracts • Contaminants • 2 licensed dispensaries per State senatorial district

OVERVIEW OF LICENSEES (CON’T) OVERVIEW OF LICENSEES (CON’T)

•Growers •Growers (con’t) • Secure building, green house or secure • Facilities and operations inspected by Commission outdoor field • Independent Testing Laboratory • Detailed security requirements • Certificate of analysis for each batch • Strict controls/standard operating • Strict inventory control procedures • Report annually minority owners and employees • Product quality and consistency

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OVERVIEW OF LICENSEES (CON’T) OVERVIEW OF LICENSEES (CON’T)

•Dispensaries •Dispensaries (con’t) • Separate from growing/processing facility • Label active components and their strength • Strict security and inventory controls • Obtained from dispensary by patient and caregivers • Package plain, opaque and tamper-evident • Delivered to patient and caregivers by dispensary agents

OVERVIEW OF LICENSEES (CON’T) FEES – PROGRAM NOT PAID FOR BY TAXPAYERS

•Dispensaries (con’t) • Applications Grower application: • Patient education encouraged • • Stage 1: $2,000; Stage 2: $4,000 Record dispensing in Commission • • Processor application: database • Stage 1: $2000; Stage 2: $4000 • Adverse events reporting • Dispensary application: • Stage 1: $1000; Stage 2: $4000

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FEES – PROGRAM NOT PAID FOR BY TAXPAYERS PLAN FOR LICENSE APPLICATION (STAGE 1) (CON’T) • September 2015 Applications and instructions released • Annual Fees: • Grower -- $125,000 • 45 day Application period • Processor -- $40,000 • Dispensary -- $40,000 • Reviewed and ranked according to published rubric by independent • Agent registration -- $200 review team • (Grower, Processor, Dispenser, laboratory) • December 2015 likely Pre-approval of licenses • Independent Testing Laboratory -- $100 registration

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LICENSE APPLICATION (STAGE 2) QUALIFYING PATIENTS

• Finalizes capitalization, closes on real estate, • “Bona fide physician-patient relationship” zoning and planning approval, constructs • Register with the Commission facility, installs equipment, finishes Standard Operating Procedure, hires staff, trains staff • Establish identity • Registration number issued • Inspection, license issued, operations commence • No charge to register • Identification card, if requested, costs $50

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QUALIFYING PATIENTS (CON’T) CERTIFYING PHYSICIAN REQUIREMENTS

• Limited to 30-day supply with written certification • Register with Commission • 120g "usable cannabis" or 36g of Delta 9-THC in • Register online at Commission website infused products • No registration fee • Dispensary tracks quantity dispensed • Valid for two years

CERTIFYING PHYSICIAN REQUIREMENTS (CON’D) CERTIFYING PHYSICIAN REQUIREMENTS (CON’D)

• Physician Attestation • Bona fide physician patient relationship • Active Medical License • Issue “Written Certification” • Unrestricted • In good standing • Registered to prescribe controlled dangerous substances in Maryland

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CERTIFYING PHYSICIANS ARE ENCOURAGED TO REGISTER TO TREAT CERTAIN CONDITIONS PHYSICIAN GENERAL REGISTRATION Chronic or debilitating disease or medical condition, or treatment, that cause: • Cachexia Certifying Physicians may register to treat a patient who has a • Anorexia condition: • Wasting Syndrome • That is severe • Severe or chronic pain • Severe nausea • For which other medical treatments have been ineffective • Seizures • For which symptoms can reasonably be expected to be • Severe or persistent muscle spasm relieved by medical use of cannabis • Glaucoma • Post Traumatic Stress Disorder (PTSD)

CERTIFYING PHYSICIAN ISSUES WRITTEN QUALIFYING PATIENT GOES TO THE DISPENSARY CERTIFICATION • 30 day supply • Log on to Commission website • Dispensary checks identification • Provide certifying physician's name, license number, telephone number • Goes to Commission website to determine that patient has been issued a • Provide qualifying patient's name, date of birth, address, county of residence written certification Dispensary may counsel patient • Condition(s) requiring medical cannabis • • Written certification good for 30-day supply, up to 120 g. usable cannabis or 36 • Dispensary records batch, lot number, amount on Commission database -- this enables patient to go to any dispensary and obtain what they need up to 30 g. of Delta 9-THC in a medical cannabis-infused product day supply • Physicians can monitor patients on database

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VIOLATIONS OF MARYLAND MEDICAL CANNABIS LAW

• General Assembly concerned

• Possessing, distributing or using diverted medical cannabis punishable by up to 5 years in prison and up to $10,000 fine

• Health Law penalties in addition

CONTACT

• mmcc.maryland. gov • [email protected]

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