Wednesday March 29, 2017

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1 NYMCIA AND GNHYA Wednesday March 29,

2 AGENDA Medical Marijuana 101 Stephen Dahmer MD - Chief Medical Officer (Vireo Health) Quality Assurance Process Seed to Sale and Labeling Regulatory Requirements Chris Diorio -Director of Research & Development (Pharmacannis) Dispensary Accessibility to Hospital Providers - Sang Choi R.Ph Dispensary Director (Etain) Questions with Panel Discussion: Chris Diorio -Director of Research & Development (Pharmacannis); Hillary Peckham Chief Operations Officer (Etain), Jeff Fontale - Director of Patient Resource Centers (Bloomfield Industries), Nicholas Vita Chief Executive Officer and Vice Chairman (Columbia-care), Stephen Dahmer MD - Chief Medical Officer (Vireo Health) 2

3 MEDICAL CANNABIS 101 STEPHEN DAHMER MD Chief Medical Officer, Vireo Health of New York 3

4 GENERAL AND HISTORIC AL BACKGROUND The cannabis plant (Cannabis sativa, C. indica and C. ruderalis) is an annual flowering herb It has more than 60 unique compounds (~480 total) Δ-9-tetrahydrocannabinol (THC) is intoxicating Cannabidiol (CBD) is not ; may ameliorate some THC effects Earliest recorded use of medicinal cannabis ( ma ) dates back to 2900BC Emperor Fu Hsi 4

5 WHAT IS DIFFERENT ABOUT NY? Physician/Provider recommendation Precision of final product (Wadsworth Lab) Formulation/ Real Dose 3 rd Party testing (Heavy metals, bacteria, etc) CO2 Extraction Only active ingredients matter (major cannabinioids) No popularized names/strains No advertising Licensed Pharmacist PMP/iSTOP 11 Qualifying/5 Associated Conditions

6 QUALIFYING CONDITIONS Prescribers must be qualified to treat 1 of the following chronic health conditions: 1. Cancer 2. HIV/AIDS 3. Epilepsy 4. Neuropathies 5. Amyotrophic lateral sclerosis (ALS) 6. Huntington s disease 7. Parkinson s disease 8. Multiple sclerosis (MS) 9. Inflammatory bowel disease (IBD) 10.Damage to spinal cord nervous tissue with intractable spasticity 11.Chronic Pain (Recently Added) The Commissioner may add or remove approved conditions

7 DISEASE-ACCOMPANYING SYMPTOMS One or more of the conditions must include: 1. Severe or chronic pain causing a substantial limitation of function 2. Severe nausea 3. Seizures 4. Cachexia or wasting syndrome 5. Severe or persistent muscle spasms The Commissioner may add or remove diseaseaccompanying symptoms 7

8 WHAT S DIFFERENT ABOUT THE MEDICATION: ENTOURAGE

9 BIOLOGICAL COMPONENTS OF CANNABIS Cannabinoids THC* CBD* Minor Cannabinoids CBC, CBG*, CBN*, THC-V*, CBD-V*, THCA*, CBDA*, CBC-V, Terpenes trans-caryophyllene #, α-caryophyllene #, α-pinene, β-pinene, terpinolene, myrcene, limonene, linalool phytol, squalene Carotenoids β-carotene # Fatty Acids Linoleic acid, Palmitoleic acid, Linolenic acid, Palmitic acid, Oleic acid, Stearic acid, Myristic acid, Arachidonic Sterols Β-sitosterol, campesterol, stigmasterol Vitamins Vitamin E Triglycerides

10 ECS (ENDOC ANNABINOID SYSTEM)

11 ENDOC ANNABINOIDS orelax oeat osleep oforget oprotect Thermoregulatory, perception, cognition, motor functions, synap plasticity, braindevelopment, dynorphin relsease, blood pressure, heart rate. (Marzo, 1998)

12 ENDOCANNABINOID IMBALANCE o Migraine o Fibromyalgia o Causalgia o Post-traumatic stress disorder (PTSD) o Bipolar disease o Autism o Epilepsy o Neurodegenerative disease (Russo 2004)

13 DETAILED LIST OF MORE THAN 150 PEER- REVIEWED STUDIES

14 AT LEAST FIVE HIGH-QUALITY RANDOMIZED CONTROLLED CLINICAL TRIALS ESTABLISHING THE PAIN RELIEVING EFFIC ACY OF C ANNABIS Wilsey B, MarcotteT, Tsodikov A, Millman J, Bentley H, Gouaux B, Fishman S: A randomized, placebo-controlled, crossover trial of cannabis cigarettes in neuropathic pain. J Pain 9: , Ellis RJ, Toperoff W, Vaida F, van den Brande G, Gonzales J, Gouaux B, Bentley H, Atkinson JH: Smoked me- dicinal cannabis for neuropathic pain in HIV: A randomized, crossover clinical trial. Neuropsychopharmacology 34: , Wallace MS, MarcotteTD, Umlauf A, Gouaux B, Atkinson JH: Efficacy of inhaled cannabis on painful diabetic neuropathy. J Pain 16: , Ware MA, Wang T, Shapiro S, Robinson A, DucruetT, Huynh T, Gamsa A, Bennett GJ, Collet JP: Smoked cannabis for chronic neuropathic pain: A randomized controlled trial. CMAJ 182:E694-E701, Abrams DI, Jay CA, Shade SB, Vizoso H, Reda H, Press S, Kelly ME, Rowbotham MC, Petersen KL: Cannabis in painful HIV-associated sensory neuropathy: A randomized placebo- controlled trial. Neurology 68: , 2007

15 SYNERGY WITH OPIOIDS (Abrams, 2011) 15

16 PATIENTS WITH CHRONIC PAIN SUCCESSFULLY SUBSTITUTE MEDIC AL C ANNABIS FOR OPIOIDS (Boehnke 2016) 16

17 CANNABIS IS A BENEFICIAL ADJUVANT ON ALL STEPS OF ANALGESIC LADDER (Vargas-Schaffer 2010) 17

18 NNT PAINFUL SENSORY NEUROPATHY (AMA, 2013) 18

19 MORE C ANNABIS, FEWER OPIOID DEATHS o Time-series analysis: medical cannabis laws and state-level death certificate data in the United States from 1999 to 2010 o Reported age-adjusted opioid analgesic overdose death rate per population in each state. o Results showed states with medical cannabis laws had a 24.8% lower mean annual opioid overdose mortality rate (95% CI, 37.5% to 9.5%; P =.003) compared with states without medical cannabis laws. o The association between medical cannabis laws and opioid analgesic overdose mortality in each year after implementation of the law strengthened over time o Concluded that medical cannabis laws are associated with significantly lower state-level opioid overdose mortality rates. (Bachhuber 2014) 19

20 MORE C ANNABIS, FEWER OPIOID DEATHS 20

21 REDUCED PRESCRIPTION DRUG SPENDING Patient use of all varieties of prescription drugs is reduced when medical cannabis is an option Relationship assessed between medical marijuana legalization laws and physicians prescribing patterns in 17 states from Patients consumption of and spending on prescription drugs approved under Medicare Part D for nine domains/conditions Pharmaceutical use fell significantly in 7/9 domains 21 resulting in annual savings of $165.2 million

22 MEDICAL CANNABIS CAUTIONS

23 MEDIC AL C ANNABIS SAFETY Medical cannabis used for chronic pain over one year appears to have a reasonable safety profile (199 Patients; no difference in risk of serious adverse events). Ware MA1, Wang T2, Shapiro S3, Collet JP4; COMPASS study team. Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS). J Pain Dec;16(12): doi: /j.jpain Epub 2015 Sep 16. 0% of patients surveyed after one year reported a Great deal of Negative Physical Side Effects. 0% reported a Great Deal of Negative Mental Side Effects0 (241 Patients, 12 months) McGriff D, Anderson S, Arneson T. Early Survey Results from the Minnesota Medical Cannabis Program. Minn Med Jun;99(4):18-22.

24 LD50 1,

25 OPIOIDS AND THE BRAIN

26 QUALITY ASSURANCE INVENTORY CONTROL SYSTEMS LABELING AND PACKAGING CHRIS DIORIO, R.PH Director of Research and Development, PharmaCannis

27 QUALITY ASSURANCE Governed by SOPs and quality systems Third-party testing: Wadsworth Lab - Potency and reproducibility - Active cannabinoids - Potential contaminants - Stability/shelf life

28 QUALITY ASSURANCE - Active cannabinoids Tetrahydrocannabinol (THC), Tetrahydrocannabinol acid (THCA), Tetrahydrocannabivarin (THCV), Cannabidiol (CBD), Cannabinadiolic acid (CBDA), Cannabidivarine (CBDV), Cannabinol (CBN), Cannabigerol (CBG), Cannabichromene (CBC), any other cannabinoid component at > 0.1% - Potential contaminants E. coli, Klebsiella, Pseudomonas (for products to be vaporized) Salmonella, Streptococcus, Bile tolerant gram negative bacteria Aspergillus, Mucor species, Penicillium species, Thermophilic Actinomycetes species, Aflatoxin, Ochratoxin, Antimony, Arsenic, Cadmium, Chromium, Copper, Lead, Nickel, Zinc, Mercury, Any pesticide/herbicide/fungicide used during production of the medical marihuana product, Any growth regulator used during production of the medical marihuana product, Any other analyte as required by the commissioner

29 INVENTORY CONTROL Plant genetics and clone s life cycle Tracked in real time Encrypted, cloud-based, seed-to-sale tracking system Reconciled by hand on a weekly basis Product s life cycle Tracked through unique identifiers on barcoded tags on each plant through its grow cycle and harvest Tracking continues postharvest into conversion into oils, manufacturing of dosage form, packaging into the final product, transportation to the dispensaries and then finally, to the patient

30 LABELING AND PACKAGING Accuracy in labeling +/- 5% or 95% - 105% vs. Pharmaceutical tolerance = 10% or % Child-resistant and tamper-evident packaging CR vaporizer devices Dispensed with detailed safety inserts

31 PharmaCann 14 Hudson Crossing Drive Montgomery, NY MM0101M Qty: 1.0ml Date Pkgd: 02/14/2017 Use By: 02/14/2018 Lot: BVH17B14 Product Form: Vape Cart. Brand: Blue Single Dose: 0.04ml/dose THC (mg) 9.5 CBD (mg): <0.5 Store in a cool, dark place BVH17B14 WARNING! Medical Marijuana products must be kept in the original container in which they were dispensed and removed from the original container only when ready for use by the certified patient. This product is for medicinal use only. Keep secured at all times. This product might impair the ability to drive. May not be resold or transferred to another person. KEEP THIS PRODUCT AWAY FROM CHILDREN (unless medical marijuana product is being given to the child under a practitioner s care) Women should not consume during pregnancy or while breastfeeding except on the advice of the certifying practitioner, and in the case of breastfeeding mothers, including the infant s pediatrician.

32 EXPLORING ACCESS TO MEDICAL MARIJUANA DISPENSARIES IN NEW YORK SANG CHOI, R.PH Dispensary Director, Etain Health, LLC

33 WHO HAS ACCESS TO MMJ DISPENSARIES IN NEW YORK? Patients & Caregivers with a valid New York MMJ Registry Card, Photo ID, and Certification. Patient Card Caregiver Card

34 WHO CAN CERTIFY MMJ IN NEW YORK? MDS NPS PAS Must complete a four hour DOH Approved online course. Register with the NYS MMJ Program. Determine whether the patient meets the requirements for certification. Cancer, HIV/AIDS, ALS, Parkinson s Disease, MS, Spinal Cord Nerve Injury with Intractable Spasticity, Epilepsy, IBD, Neuropathy, Huntington Disease And the recently approved CHRONIC PAIN (3/22/17)

35 SAMPLE CERTIFICATION FORM

36 CONTINUED The Certification expires in one year unless the patient is terminally ill. At which point the Certifying Practitioner must recertify the patient. The patient may designate up to 2 caregivers. Caregivers can be a parent, family member, legal guardian, or appropriate guardian (nonfamily) Caregivers can have up to 5 certified patients at any time.

37 PRODUCTS OFFERED: LIQUID OR OIL PREPARATIONS Oral Capsule: Onset: 1-2 hours; duration 6-8 hours. Tincture Onset: 30 minutes; duration 4-6 hours. Oral Spray Onset: 30 minutes; duration 4-6 hours. Vaporization Onset: Immediate to 5 minutes; duration 2-4 hours.

38 PRODUCTS OFFERED: CONTINUED Note that brands vary by dispensary. 2 Ratios are REQUIRED as per regulation. A high CBD:Low THC and 1:1 THC/CBD Currently, dispensaries may have up to 5 brands. All Medical Marijuana Products produced are tested by a lab licensed by the DEA and approved for analysis of Medical Marijuana. The ROs MUST conform to GAPs (Good Agricultural Practices)

39 PHARMACIST'S EXPERIENCE: All counseling to patient or caregiver (use, administration, risks) must be done by a pharmacist with an active NYS license or a person under the direct supervision of pharmacist on site. Must check PMP before every dispense. Limited to a 30-day supply. Liability Malpractice insurance will cover as long as working as a pharmacist in any capacity

40 CASE STUDY #1 AJ, a 28 year old male diagnosed with Multiple Sclerosis, suffered from muscle spasms primarily in his face and arms. In addition, he experienced fatigue and anxiety resulting in trouble sleeping. First visit to RO was on 5/28/16. He started with the 1:1 ratio Capsules and the Vaporizer Pen. In addition his initial recommendation, the patient has been using the High CBD:Low THC Capsules. Current dose: Balance capsules- 1 capsule at bedtime Balance vaporizer-1-2 inhalations every 2-4 hours as needed Dolce capsules- 1 capsule daily in the morning

41 CASE STUDY #1 (CONTINUED) Current Medication: Tecfidera 240mg BID Zoloft 50mg QD Results to date: Significant reduction in muscle spasms Decrease in anxiety. Has discontinued Zoloft No longer late to/or missing work

42 CASE STUDY #2 JS is a 23 year old female suffering from Fibromyalgia, Lupus, and Carpal Tunnel Syndrome. Her qualifying condition is Neuropathy. JS first came to RO with her mother in September directly after discharge from the hospital. Started therapy on 1:1 capsules and vaporizer. Came back in October and started on the high CBD capsules and high THC vaporizer and capsules. She is stabilized on this combination. Giving her the relief that she needs. Patient takes 1 capsule twice daily of the high THC and high CBD twice daily and vaporizes as needed.

43 CASE STUDY #2 (CONTINUED) Current Medication Plaquenil Tramadol 50mg-1 tablet 3 times daily as needed Results to date: Pain has been significantly reduced Her mother stated that she has a better outlook on life She is thinking about re-enrolling in college

44 HOSPITALS Patients may bring in outside medications, which may not be on the formulary. MD may write an order that the patient may store and self-medicate.

46 STORAGE: Facilities can not store C-1. Though there are no provisions in the MMJ Regulations for Hospitals or Nursing Homes. Patient may store in room. In a single private room, patient may be able to self-medicate. Patients in shared rooms may consider utilizing a lockbox or a lockable drawer. Administration will be done by the patient or caregiver.

47 SAMPLE HOSPITAL POLICY :

48 QUESTIONS AND PANEL DISCUSSION

Stephen Dahmer, MD Chief Medical Officer Vireo Health. Assistant Clinical Professor Family Medicine & Community Health ICAHN

Stephen Dahmer, MD Chief Medical Officer Vireo Health Assistant Clinical Professor Family Medicine & Community Health ICAHN 1 Many Names 2 Stigma IF CANNABIS were unknown, and bioprospectors were suddenly