MEDICAL MARIJUANA UPDATE FOR HEALTH CARE PRACTIONERS PRAK NAIK, PHARM.D. THE DRUG STORE OF PERRYSBURG NOVEMBER 10, 2017

CONFLICT OF INTEREST Owner and Operator of The Drug Store of Perrysburg Owner and Operator of Drugstore Solutions No other commercial or financial relationship Off-label use may be discussed No ownership in Cultivator, Processor or Dispensary

CANNABIS ADMINISTRATION, DOSING, INDICATIONS, ADVERSE EFFECTS, ETC DESCRIBE LAW AND COMPLIANCE INFORMATION IN THE STATE OF OHIO REVIEW DATA REGARDING CLINICAL USES OF MEDICAL MARIJUANA OBJECTIVES

BOTANY/PHARMACOGNOSY

Cannabis sativa

Cannabis sativa and THC Over 60 Cannabanoids identified THC (delta-9-tetrahydrocannabinol) most active Synthesized in 1964 Average THC content highly variable depending on the strain, climate, soil and growing conditions, and handling Weak acid, very high lipid solubility Binds to glass, diffuses into plastic, and is photo labile and susceptible to heat, acid, and oxidation

DEFINITIONS – CANNABIS THC (tetrahydrocannabinol) Psychoactive CBD (cannabinol) Non-Psychoactive www.livescience.com

PHARMACOLOGY

CANNABINOID RECEPTORS Two types of cannabinoid receptors: CB1 and CB2 superfamily of G-protein-coupled receptors CB1 receptor is mainly expressed in the brain and spinal cord Modulation of synaptic plasticity, cell migration, and neurite remodeling – regulate neurotransmitters CB2 receptor is predominantly expressed in cells of the immune and hematopoietic systems Controls immune cell migration both within and outside the central nervous system Prog Neuropsychopharmacol Biol Psychiatry. 2012 Jul 2; 38(1): 4–15.

FDA APPROVED PRODUCTS

FDA APPROVED PRODUCTS MARINOL® (DRONABINOL) – CAPSULE CHEMO INDUCED N/V, ANOREXIA & WEIGHT LOSS DUE TO AIDS SYNDROS® (DRONABINOL) – SOLUTION CESAMET® (NABILONE) – CAPSULE, SYNTHETIC, SIMILAR CHEMICAL STRUCTURE AS THC CHEMO INDUCED N/V https://www.fda.gov

INVESTIGATIONAL PRODUCTS Sativex® (nabiximols) composed of CBD and THC and administered as a metered dose oro-mucosal spray Use: spasticity (muscle stiffness/spasm) due to Multiple Sclerosisy and pain including chronic cancer pain Epidiolex® (cannabidiol) a liquid formulation of pure plant- derived CBD Use: treatment-resistant epilepsy syndromes including Dravet syndrome, Lennox-Gastaut syndrome (LGS), Tuberous Sclerosis Complex (TSC) and Infantile Spasms (IS) https://www.gwpharm.com

MEDICAL HISTORY OF CANNABIS

HISTORY OF CANNABIS One of the oldest psychotropic drugs in human history Originating from central Asia then spread to China and India First description by an Irish physician (O’Shaughnessy) in 1839 United States Dispensary in 1854: analgesic, sedative, anti- inflammatory, antispasmodic, anti-asthmatic, and anticonvulsant U.S. government and popular media began condemning the use of smoked cannabis in the 1930s, linking its use to homicidal mania www.ama-assn.org

HISTORY OF CANNABIS Marihuana Tax Act of 1937 introduced the first federal restrictions Law required industrial or medical users to register 38 and pay a tax on marijuana of $1/ounce Recreational or other purposes were required to pay a tax of $100/ounce www.ama-assn.org

AMERICAN MEDICAL ASSOCIATION & CANNABIS

AMA AND MARIJUANA AMA was alone in opposing passage of Marihuana Tax Act Objective data were lacking on the harmful effects, and passage would impede future investigations Due to governmental pressures, marijuana was removed from the U.S. Pharmacopoeia in 1942 AMA believes Marijuana should move from Schedule I to II or III www.ama-assn.org

AMA AND MARIJUANA AMA recommends increase in research in marijuana and THC and CBD to better understand benefit NIH to better administer procedures for access and grants NIDA to be involved in distribution for research projects NIH to create a smoke-free distribution method To ensure free access to patients and providers where appropriate www.ama-assn.org

LEGAL & REGULATORY

DEA AND MARIJUANA THC AND MARIJUANA ARE SCHEDULE I SYNTHETICS AND DERIVATIVES ARE ALSO SCHEDULE I Schedule I: has a high potential for abuse has no currently accepted medical use in treatment in the US lack of accepted safety for use under medical supervision www.deadiversion.usdoj.gov

WHERE CAN I SCORE SOME WEED?

2016 https://www.brookings.edu/blog/brookings-now/2016/04/11/map-medical-marijuana-laws-state-by-state/

2017 http://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2017/01/27

STATE MEDICAL MARIJUANA LAWS 29 states, the District of Columbia, Guam and Puerto Rico now allow for comprehensive public medical marijuana and cannabis programs 18 states allow use of "low THC, high cannabidiol (CBD)" products for medical reasons in limited situations or as a legal defense  In October of 2009, the Obama Administration sent a memo to federal prosecutors encouraging them not to prosecute people who distribute marijuana for medical purposes in accordance with state law http://www.ncsl.org/research/health/state-medical-marijuana-laws.aspx

STATUS IN OHIO

OHIO ADMINISTRATIVE CODE (OAC) 3796: MEDICAL MARIJUANA CONTROL PROGRAM RULES AND RESPONSIBILITIES – ADVISORY COMMITTEE BOARD STANDARDS DEFINITION OF LICENSING - RESTRICTIONS REGISTRATION – ID CARD PAYMENT – CLOSED LOOP SYSTEM QUALIFYING CONDITIONS ACCEPTABLE PRODUCTS http://codes.ohio.gov/oac/3796

OAC 3796: QUALIFYING CONDITIONS Acquired immune deficiency syndrome Alzheimer's disease Amyotrophic lateral sclerosis Cancer Chronic traumatic encephalopathy Crohn's disease Epilepsy or another seizure disorder Fibromyalgia Glaucoma Hepatitis C Inflammatory bowel disease Multiple sclerosis http://codes.ohio.gov/oac/3796

OAC 3796: QUALIFYING CONDITIONS Pain - Chronic and severe Pain - Intractable Parkinson's disease Positive status for HIV Post-traumatic stress disorder Sickle cell anemia Spinal cord disease or injury Tourette's syndrome Traumatic brain injury Ulcerative colitis Any other disease or condition added by the state medical board under section 4731.302 of the Revised Code http://codes.ohio.gov/oac/3796

OAC 3796: PERMISSIBLE FORMS OILS TINCTURES PLANT MATERIAL EDIBLES PATCHES ANY OTHER FORMS APPROVED BY STATE BOARD OF PHARMACY NOTE: VAPORIZATION IS ALLOWED, SMOKING IS NOT http://codes.ohio.gov/oac/3796

OAC 3796: THC CONTENT TETRAHYDROCANNABINOL (THC) PLANT MATERIAL <35% EXTRACTS <70% http://codes.ohio.gov/oac/3796

OAC 3976: LICENSING CULTIVATOR PROCESSOR DISPENSARY CULTIVATE PRODUCT AND SELL TO PROCESSOR PROCESSOR PACKAGE AND LABEL AND SELL TO DISPENSARY (CHILD- RESISTANT, LABELING THC CONTENT) DISPENSARY VALIDATE ID, VERIFY WRITTEN PRESCRIPTION, DISPENSE PRE- PACKAGED PRODUCT (MAX=90 DAY SUPPLY), CLOSE-LOOP http://codes.ohio.gov/oac/3796

OAC 3796: DISPENSARY LICENSE LIMITS BASED ON POPULATION LUCAS (2), WOOD (1) RESTRICTIONS ON LOCATION WITHIN 500 FEET OF A SCHOOL, CHURCH, PUBLIC LIBRARY, PUBLIC PARK, OR PUBLIC PLAYGROUND EXCEPTIONS: STATE UNIVERSITY, ACADEMIC CENTER, PRIVATE R&D ORGANIZATON, http://codes.ohio.gov/oac/3796

HOUSE BILL 523 (HB 523) GENERAL ASSEMBLY: 131 SHORT TITLE: AUTHORIZES THE USE OF MARIJUANA FOR MEDICAL PURPOSES PRIMARY SPONSOR: REPRESENTATIVE HUFFMAN COMMITTEES: SENATE GOVERNMENT OVERSIGHT AND REFORM, HOUSE SELECT COMMITTEE ON MEDICAL MARIJUANA www.legislature.ohio.gov

MEDICAL MARIJUANA CONTROL PROGRAM DEPT OF COMMERCE AND STATE BOARD OF PHARMACY ADVISORY COMMITTEE MAKES RECOMMENDATIONS PERMITS PATIENT TO USE MEDICAL MARIJUANA BOARD OF PHARMACY REGISTER PATIENT AND PROVIDER – ALSO REGULATES RETAIL DISPENSARIES DEPT OF COMMERCE LICENCES TO CULTIVATORS, PROCESSORS AND TESTING LABS AUTHORIZES MEDICAL BOARD TO CERTIFY PROVIDERS www.legislature.ohio.gov

WHAT IF I WANT TO “PRESCRIBE” (READ “RECOMMEND”) MEDICAL MARIJUANA?

PHYSICIAN RESPONSIBILITIES WRITTEN RECOMMENDATION AFTER OBTAINING CERTIFICATE FROM STATE BOARD OF MEDICINE THIS RECOMMENDATION IS A MAIN COMPONENT ON AN AFFIRMATIVE DEFENSE BY PATIENT AND PARENTS/GUARDIANS OF MINORS IN MARIJUANA- RELATED CRIMES IMPORTANT FOR PROVIDER IS CONSULT WITH LEGAL COUNSEL AND EMPLOYER Medicalmarijuana.ohio.gov/physicians

WHAT QUANTITY LIMITS ARE THERE FOR MEDICAL MARIJUANA?

DISPENSARY RESPONSIBILITIES 2.83g plant material 295mg THC – patch, lotion, cream or ointment 110mg THC – oil, tincture, capsule or edible 590mg THC – oil for vaporization Maximum dispensed is 90 day supply – can be as mixed products Codes.ohio.gov/oac/3796

CLINICAL USE

EVIDENCE-BASED DATA (MAYO CLINIC) CATEGORY GRADE CHRONIC PAIN B MULTIPLE SCLEROSIS AMYOTROPHIC LATERAL SCLEROSIS (LOU GEHRIG’S DISEASE) C APPETITE STIMULATION ATOPIC DERMATITIS BRAIN INJURY CHEMOTHERAPY RELATED NAUSEA/VOMITING DERMATITS EPILEPSY https://www.mayoclinic.org

EVIDENCE-BASED DATA (MAYO CLINIC) CATEGORY GRADE GLAUCOMA C HUNTINGTON’S DISEASE NEUROMUSCULAR DISEASE RHEUMATOID DISEASE SCHIZOPHRENIA SLEEP DISORDER TOURETTE’S SYNDROME EATING DISORDER https://www.mayoclinic.org

DOES MEDICAL MARIJUANA DECREASE THE AMOUNT OF OPIOID USE IN PATIENTS?

MARIJUANA AND OPIOID USE THEORY IS THAT USE REDUCES OPIOID ADDICTION RESEARCH FOCUSING ON CBD (NON-PSYCHOACTIVE) – THOUGHT IS REDUCED ANXIETY AND CRAVINGS Journal of Neuroscience: CBD decreased heroin cravings in rats that had previously been trained to self-administer heroin www.livescience.com

DRONABINOL AND OPIOID USE www.clinicaltrials.gov SPONSOR: New York State Psychiatric Institute and NIDA Two-year study is to test the efficacy of dronabinol as an adjunct to maintenance treatment with naltrexone in opioid-dependent individuals Randomized, double-blind, placebo controlled, parallel-groups, 8 week study of relapse prevention in opioid-dependent individuals Participants will be randomized into one of two conditions (1) Naltrexone and Placebo (N=20) and (2) Naltrexone and dronabinol 15 mg bid (N=40)

MARIJUANA AND OPIOID USE June H. Kim et al. “State Medical Marijuana Laws and the Prevalence of Opioids Detected Among Fatally Injured Drivers”, American Journal of Public Health 106, no. 11 (November 1, 2016): pp. 2032-2037. Objectives: To assess the association between medical marijuana laws (MMLs) and the odds of a positive opioid test, an indicator for prior use Results: State-specific estimates indicated a reduction in opioid positivity for most states but not statistically significant age-stratified analyses indicated a significant reduction in opioid positivity for drivers aged 21 to 40 years (P < .001)

MARIJUANA AND OPIOID USE Powell D, Pacula RL, Jacobson M. Do Medical Marijuana Laws Reduce Addiction and Deaths Related to Pain Killers? RAND Corporation; 2015. (funded by NIDA) Objectives: To study the impact of medical marijuana laws on problematic opioid use Results: evidence using difference-in-differences, event study, and synthetic control group methods that states providing legal access to marijuana through dispensaries experience lower treatment admissions for addiction to pain medications potential unintended benefit of these laws: a reduction in the misuse of prescription opiates.

MARIJUANA AND OPIOID USE Bradford AC, Bradford WD. Medical Marijuana Laws Reduce Prescription Medication Use In Medicare Part D. Health Affairs;  2016 Jul 1;35(7):1230-6. Project HOPE—The People-to-People Health Foundation, Inc Objectives: Review data about whether medical marijuana is being used clinically in Medicare population Results: data on all prescriptions filled by Medicare Part D enrollees from 2010 to 2013, we found that the use of prescription drugs for which marijuana could serve as a clinical alternative fell significantly overall reductions in Medicare program and enrollee spending when states implemented medical marijuana laws were estimated to be $165.2 million per year in 2013

WHAT DOES THE FUTURE HOLD?

FUTURE DIRECTION NEW INDICATIONS NEW FORMULATIONS HEALTH OUTCOME STUDIES COST-BENEFIT ANALYSIS LEGAL UPDATE COMMERCE

TAXATION NEWS ARTICLE Michael Blood, Associated Press November 5, 2017 New Taxation for California Market in 2018 Recreational: costs about $35 to buy a small bag of good quality medical marijuana in LA Same purchase will be up to $60 due to taxes (state, city) higher taxes for businesses and consumers give the state's thriving illicit market a built-in advantage Medical: increase in price will be less, but there will be increase in taxes

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