Medical Marijuana and the Workplace. Speaker Disclosures. Agenda 3/7/2018

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Medical Marijuana and the Workplace Douglas W Martin MD FACOEM FAADEP FAAFP UnityPoint Health St. Luke s Occupational Medicine Sioux City, Iowa Speaker Disclosures 1. Do not dispense, prescribe, refer or recommend MMJ 2. Have no financial interest in any entity that grows, procures, processes, sells or dispenses MMJ 3. Not receiving financial sponsorship for this presentation Agenda History Cannabinoids Medical Uses Medical Marijuana Policy and Workplace Issues 1

Ancient History Cannabis sativa plant origin in Central Asia/Himalayas 36 million years ago China Emperor Shen Nung described therapeutic properties 2737 BCE India widespread medicinal use 1000 BCE Spread throughout Asia, Middle East, Africa through 18 th Century 19 th Century Use in Western Medicine 1839 publication by O Shaughnessy: effective analgesic, appetite stimulant, antiemetic, muscle relaxant, anticonvulsive 1854 entered U.S. Dispensary; usually available as tincture 1860 Ohio State Medical Society sponsored conference on cannabis 1900 >100 scientific pubs. in U.S., Europe Marketed by Merck, Burroughs Wellcome, Bristol Myers Squibb, Parke Davis, Eli Lilly 2

20 th Century Challenges Difficulty with standardized dosing, water solubility; delayed onset when taken orally Newer medications introduced for primary indications 1937 Federal Marijuana Tax Act severely burdened use by high taxes (AMA opposed Act) 1942 removed from US Pharmacopoeia (AMA opposed this action) 1970 Controlled Substance Act banned use of MJ 1971 Nixon s War on Drugs led to plummeting research funding Recent Developments 1964 chemical structure of THC identified 1996 medical marijuana (MM) legalized in CA 1999 Institute of Medicine reported scientific and clinical basis for medical use 2015 MM legalized in 23 states & DC 2015 9 additional states approved use of CBD oil for childhood epilepsy, other conditions 2014 15 recreational use legalized in CO, WA, AK, DC with expected and unexpected effects 3

Iowa and Illinois Iowa CBD only Medical Cannabidiol Board Controlled Registry Certification of Medical Need (limited conditions) by MD Controlled dispensary (MedPharm LLC seeking apps) Illinois Any medical marijuana (limit of 2.5 oz per 2 weeks) Registry Card with application fees Limited conditions (advisory board authority) Medical certification by physician Patient must designate a dispensary 4

Marijuana Products More Marijuana Products Ever More Marijuana Products 5

Never Ending Variety Main Active Compounds Delta 9 Tetrahydrocannabinol (THC) Strong psychoactive effect and analgesic activity 11 Hydroxy THC Immediate metabolite; 4 times greater psychoactive and immunosuppressive effects Cannabidiol (CBD) Non psychoactive; modulates ion channels, receptors and enzyme targets Anti inflammatory, antiemetic, anti epileptiform, antiischemic, anxioytic, and anti psychotic effects Many other components: e.g., Cannabinol, Cannabigerol, Tetrahydro cannabivarian, Canabichromene Cannabis Components Cannabis contains >450 distinct compounds in 18 chemical classes Pyrolysis yields >2000 compounds THC is primary psychoactive ingredient THC and cannabidiol most abundant cannabinoids. THC/CBD ratios vary by strain, preparation, etc. Charlotte s Web: CBD, THC 6

Agricultural Hybridization THC content of cultivated cannabis has risen dramatically ~3% in 1980s ~12% in 2013 Potency responsible for growing number of ED visits over last decade (overdose) Exogenous Pharmaceuticals Dronabinol (Marinol) isomer of THC DEA Schedule 2 3 1985 FDA: nausea and vomiting (chemotherapy induced) 1992 FDA: anorexia and cachexia (AIDS) Nabilone (Cesamet) Schedule 3 More potent than synthetic THC FDA: Nausea and vomiting Nabiximols (Sativex) Approved in 20 countries, including Canada In Phase III trials in U.S. for cancer pain Cannador Orally administered cannabis extract with 2:1 THC:CBD Current research by European Institute for Clinical Research Pharmaceutical grade smoked or vaporized Cannabis Netherlands, Canada (NOT U.S.) Cannabinomimetics Drugs that stimulate cannabinoid receptors and can mimic some of their effects Dozens of chemically diverse compounds K2 Spice Bath Salts Warning: Benign sounding names highly toxic effects: have led to death and brain damage 7

Routes of Administration Pulmonary Smoking (high temp.) Vaporization (lower temp.) Oral Medication, e.g., capsule, tincture, oral spray Edible, e.g., brownie, cookie, pastry Tea Transdermal Skin patch 8

Current Medical Use Not primary drug of choice for any condition Recommended where standard therapies have been ineffective or intolerable Often used as adjunct with other medications or therapy (e.g., to lower opiate doses) Medical indications formalized by states (e.g., NY, CA, MI), Health Canada, Netherlands Indications for Medical Use 1 Nausea/vomiting from chemotherapy, radiation therapy, or medications for HIV and hepatitis C Pain and palliative Rx for Cancer, HIV/AIDS (stimulate appetite, avoid weight loss, reduce debilitation and wasting syndrome) Disorders of pain and spasticity (intractable spasticity, multiple sclerosis, spinal cord damage or injury, ALS) Indications for Medical Use 2 Chronic neuropathic pain (nerve damage, phantom limb, facial neuralgia, postherpetic neuralgia) Neurologic disorders (childhood epilepsy,* neuropathy, tics of Tourette syndrome, Parkinson s disease, possibly PTSD) Autoimmune disease (arthritis, lupus, inflammatory bowel disease, e.g. Crohn s) Treatment resistant glaucoma * Five upcoming clinical trials 9

Acute Side Effects* Respiratory irritation/cough (if smoked) Lightheadedness or dizziness (30 60%) Sedation/fatigue (5 40%) Dry mouth (10 25%) Muscle weakness (10 25%) Palpitations: tachycardia/hypotenstion (20%) Cognitive: attention, memory, reaction time *Dose dependent; rapidly reversible Risks (dose related) No established lethal dose Slower reaction time, diminished estimation of time and distance impaired vehicle operation and motor skills (especially with alcohol) Impaired thinking and memory Anxiety/panic attacks Exacerbation of underlying psychological/ psychiatric conditions (acute psychosis?, schizophrenia?) Adolescents: poorer educational outcomes Contraindications and Precautions Hypersensitivity to cannabinoids or smoke Psychosis personal or family history Age <18 years Severe cardiac or pulmonary disease Severe liver or renal disease Pregnancy or breastfeeding History of substance abuse Current Rx with CNS depressant 10

Addictive Potential 32% nicotine 23% heroin 17% cocaine 15% alcohol 9% recreational marijuana?? medical marijuana Medical Marijuana 11

Question?? Can doctors in medical marijuana states actually prescribe medical marijuana? No. Because MJ is still DEA Schedule 1 drug it cannot be prescribed. A licensed physician can only recommend or refer a patient. Person can then get medical cannabis ID card or license at a registry, and/or go to dispensary to obtain (varies by state). Medical Marijuana Laws 1 Some statutes have general language authorizing medical discretion. Examples: Patients whose physicians advise in writing that they "might benefit from the medical use of marijuana" (AK) Qualifying debilitating medical condition (CT) Debilitating condition; potential benefits would likely outweigh health risks (HI) 12

Economic Impact of Legalized Marijuana A mature marijuana industry could generate up to $28 billion in tax revenues for federal, state, and local governments, including $7 billion in federal revenue: $5.5 billion from business taxes and $1.5 billion from income and payroll taxes. A federal tax of $23 per pound of product, similar to the federal tax on tobacco, could generate $500 million per year. Alternatively, a 10 percent sales surtax could generate $5.3 billion per year, with higher tax rates collecting proportionately more. The reduction of societal risk in being engaged in the marijuana trade, as well as the inclusion of taxes, will combine to reduce profits (and tax collections) somewhat from an initial level after national legalization. Society pays all the costs regardless of legality but tax revenues help offset those costs. Policy Issues 1 Collision of Federal vs. State authority Illegal under federal law, even in 24 states with medical MJ statutes Federal law overrides state law, e.g., DHHS/DOT federally regulated drug testing 12/2014 Congress barred Justice Dept. from prosecuting patients and providers who use MM in accordance with state laws 13

Policy Issues 2 Federal vs. State Authority DEA Scheduling Currently Schedule 1 no accepted medical use Shift from Schedule 1 lower Schedule (2 5)?? Long urged by IOM, ACP, AMA (11/09) DEA Drug Rescheduling Criteria* 1. Chemistry must be known and reproducible 2. Adequate safety studies 3. Adequate, well controlled efficacy studies 4. Accepted by qualified experts (NDA to FDA or scientific consensus) 5. Scientific evidence must be widely available * Petitions for rescheduling of marijuana submitted to DEA in 1972, 1995 and 2002 American College of Physicians "ACP urges review of marijuana's status as a schedule I controlled substance and its reclassification into a more appropriate schedule, given the scientific evidence regarding marijuana's safety and efficacy in some clinical conditions... Supporting Research into the Therapeutic Role of Marijuana" February 2008 14

Policy Issues Federal vs. State authority DEA Scheduling Inadequate Research Most medical evidence is largely anecdotal Need randomized controlled clinical trials Explore other active components, e.g., CBD Systems of administration, doses Social research Unproven Myths Gateway drug theory Most MJ users do not use harder drugs 25% lower opioid OD mortality in states with MMJ laws (2014 JAMA). Is MJ substitute? Adjunct? Pulmonary harm 2014 JAMA: normal FEV1, FVC >20 yr. w small sample Adverse Immune effects Cognitive Impairment beyond acute use Addiction (dependence vs. addiction) Former U.S. Surgeon General "The evidence is overwhelming that marijuana can relieve certain types of pain, nausea, vomiting and other symptoms caused by such illnesses as multiple sclerosis, cancer and AIDS or by the harsh drugs sometimes used to treat them. And it can do so with remarkable safety. Indeed, marijuana is less toxic than many of the drugs that physicians prescribe every day. Joycelyn Elders, MD Editorial, Providence Journal March 26, 2004 15

Institute of Medicine Marijuana's active components are potentially effective in treating pain, nausea and vomiting, AIDS related loss of appetite, and other symptoms and should be tested rigorously in clinical trials. But a subpopulation of patients do not respond well to other medications and have no effective alternative to smoking marijuana. Marijuana and Medicine: Assessing the Science Base IOM Report, March 1999 American Psychiatric Association There is no current scientific evidence that marijuana is in any way beneficial for the treatment of any psychiatric disorder. Medical treatment should be evidence based and determined by professional standards of care; it should not be authorized by ballot initiatives. Further research on the use of cannabis derived substances as medicine should be encouraged and facilitated by the federal government. Position Statement on Marijuana as Medicine, 2013 Policy Issues Federal vs. State authority DEA Scheduling Inadequate Research MMJ Contamination (e.g., pesticides) Diversion to Other States 16

Policy Issues Federal vs. State authority DEA Scheduling Inadequate Research MMJ Contamination (e.g., pesticides) Diversion to Other States Medical Licensing Boards Need Bona Fide Physician Patient Relationship, not casual dispensing Mandatory CME for prescribers, parallel to mandatory opiate education? 17

Impairment with Marijuana? Slower reaction time, diminished estimation of time and distance impaired vehicle operation and motor skills. Impact on safety sensitive jobs, e.g., machinery, vehicles? Impaired thinking and memory Impact on mentally demanding tasks? State Laws CT, RI, ME prohibit discrimination against workers solely based on their status as MM patients AZ and DE bar discrimination against registered MM patients who test positive, with exception of employees who are impaired in the workplace Legal Appeals the ADA does not protect medical marijuana users who claim to face discrimination on the basis of their marijuana use 9th U.S. Court Circuit of Appeals Private employees are not protected from disciplinary action as a result of their use of medical marijuana, nor are private employers required to accommodate the use of medical marijuana in the workplace. 6th U.S. Court Circuit of Appeals Employees who lose jobs due to marijuana positive drug test are entitled to unemployment benefits IL & MI Courts of Appeals 18

Workplace Issues Potential Impact on Corporate culture Work quality and productivity Safety sensitive work functional impairment Even where medical MJ or recreational MJ legalized, most employers have right to ban Some states upheld firing MMJ users with + UDS (CA, MI, OR, WA) Other states prohibit discrimination against MMJ users with + UDS (AZ, DE, IL, MN) unless used or impaired on job Important not to discriminate against underlying disability MRO Reporting of Positive for Registered Medical Marijuana User Key is legitimate medical explanation DHHS/DOT always positive; no explanation Non federally regulated defer to employer s policy and instructions to MRO Vast majority of employers do not accept MMJ No states make MMJ an acceptable explanation Only 4% of employers accommodate medical marijuana (HireRight survey) Professional Society Guidance ACOEM/AAOHN Report as positive to employer, who must determine employment implications Marijuana in the Workplace, 2015 ACOEM MRO and Pharma Sections Determine whether the medical facts corroborate valid medical marijuana use. Make a written notation on their report whether donor has provided supporting documentation. Medical Marijuana in the Workplace, 2015 19

Subtleties Testing for marijuana provides way for employers to prohibit use on and off the job. Many employers have not adopted policies re: acceptability of medical marijuana and look to MRO for guidance. Difficult to assess appropriateness of use even in doctor patient relationship. Extremely challenging in brief MRO telephone interview. The Future Situation likely to remain complex. How will current employer discretion apply to state and municipal employees? What will happen if DEA shifts marijuana to Schedule 2? If no longer illegal, how will this affect employer options? Quick Web Based References Medical cannabis in the United States https://en.wikipedia.org/wiki/medical_cannabis_in_the_united_states Medical marijuana laws by state http://healthcare.findlaw.com/patient rights/medical marijuana laws bystate.html Pros and Cons Compilation of data, charts, arguments pro and con, 60 peer reviewed medical studies www.medicalmarijuana.procon.org Petition to Reschedule Cannabis filed with the DEA, October 9, 2002 www.drugscience.org Canada s Medical Marijuana Regulations, an overview http://www.raps.org/regulatory Focus/News/2015/08/26/23079/Canadas Medical Marijuana Regulations An Overview/ 20

Scientific Reference List 21