A Day in the Life of a Medical Marijuana Pharmacist. Disclosure

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1 A Day in the Life of a Medical Marijuana Pharmacist Presenters Arrow Alternative Care Dispensary Pharmacists Angelo DeFazio, RPh Evan Bishop, PharmD Camden E. Svec, PharmD 1 Disclosure The presenters Angelo DeFazio, Dr. Evan Bishop, Dr. Camden Svec have no actual or potential conflict of interest associated with this presentation. 2 1

Objectives At the completion of this activity, the participant will be able to: 1. Describe the process of selecting medical marijuana products and dosage forms for individual patients 2.

2 Objectives At the completion of this activity, the participant will be able to: 1. Describe the process of selecting medical marijuana products and dosage forms for individual patients 2. Discuss how the individual components of marijuana relate to the treatment of specific diseases 3. Describe the outcomes you are measuring/observing in your patients 3 Physician Patient 4 2

3 5 6 3

7 Connecticut Palliative Use of Marijuana Connecticut General Statutes

17th state to enact a law permitting the legal use of marijuana for

Provides legal protections to qualified, registered patients for

debilitating medical condition; Requires a caregiver only if a physician

qualifying patients and primary caregivers to register with the

4 7 Connecticut Palliative Use of Marijuana Connecticut General Statutes Chapter 420f, Section 21a 408 HISTORY In 2012, Connecticut became the 17th state to enact a law permitting the legal use of marijuana for palliative, medical purposes. Provides legal protections to qualified, registered patients for possession and use; Allows a physician to certify that a patient has a debilitating medical condition; Requires a caregiver only if a physician believes the patient will benefit from having one; and Requires qualifying patients and primary caregivers to register with the Department of Consumer Protection, which can be done online with the Connecticut Medical Marijuana Registry System. SOURCE: DCP Program Materials 8 4

Qualifications for a Registration Certificate Connecticut resident.

Disease Wasting Syndrome Crohn's Disease Cerebral Palsy Cystic Fibrosis Ulcerative Colitis Post Traumatic Stress Disorder Post Laminectomy Syndrome with Chronic Radiculopathy Severe Psoriasis and

5 Qualifications for a Registration Certificate Connecticut resident. At least eighteen (18) years of age or older or; Qualifying Minor very specific qualifications Cannot be an inmate confined in a correctional institution or facility under the supervision of the Connecticut Department of Corrections. Qualifying Medical Condition QUALIFYING S PRIMARY CAREGIVERS MINORS 9 Qualifying Debilitating Medical Conditions Cancer Glaucoma Parkinson's Disease Multiple Sclerosis Epilepsy Cachexia Sickle Cell Disease Wasting Syndrome Crohn's Disease Cerebral Palsy Cystic Fibrosis Ulcerative Colitis Post Traumatic Stress Disorder Post Laminectomy Syndrome with Chronic Radiculopathy Severe Psoriasis and Psoriatic Arthritis Amyotrophic Lateral Sclerosis Complex Regional Pain Syndrome Irreversible Spinal Cord Injury with Objective Neurological Indication of Intractable Spasticity Terminal Illness Requiring End Of Life Care Uncontrolled Intractable Seizure Disorder Positive Status for Human Immunodeficiency Virus or Acquired Immune Deficiency Syndrome Damage to the Nervous Tissue of the Spinal Cord with Objective Neurological Indication of Intractable Spasticity Approved Qualifying Medical Conditions for Minors Severe Epilepsy 10 5

6 Physician Requirements and Eligibility Possess an active Connecticut medical license issued by the Ct Dept of Public Health Practice within the State of Connecticut. Possess an active controlled substance registration issued by the CT DCP that is not subject to limitation. Possess an active Drug Enforcement Administration (DEA) controlled substance registration that is not subject to limitation. Be registered with, and able to access, the Connecticut Prescription Monitoring Program. Physicians must also have a bona fide relationship with the patient in order to register them with the program. 11 Producers Dispensary Facilities Producers Advance Grow Labs, LLC West Haven, CT Connecticut Pharmaceutical Solutions LLC Portland, CT Curaleaf, LLC Simsbury, CT Theraplant, LLC Watertown, CT Dispensary Facilities Arrow Alternative Care Hartford CT Arrow Alternative Care Milford CT Bluepoint Wellness of Connecticut, Branford, CT Compassionate Care Center, Bethel, CT Prime Wellness of CT, South Windsor, CT Thames Valley Alternative Relief, Uncasville, CT The Healing Corner, Bristol, CT Southern CT Wellness, Milford, CT Caring Nature, Waterbury, CT 12 6

7 Producers Dispensary Facilities

The Science Behind Medical Marijuana What Makes Cannabis Medicine? Cannabinoids and Terpines Endocannabinoid System Piotr Paczyński Dreamstime.

Cannabinoids and Terpines Chemical compounds secreted by cannabis flower that provides relief to an array of symptoms including pain, nausea, and inflammation

8 The Science Behind Medical Marijuana What Makes Cannabis Medicine? Cannabinoids and Terpines Endocannabinoid System Piotr Paczyński Dreamstime.co m 15 What make Marijuana Medicine? Cannabinoids and Terpines Chemical compounds secreted by cannabis flower that provides relief to an array of symptoms including pain, nausea, and inflammation Work by imitating compounds our bodies naturally produce, endocannabinoids, which activate to maintain internal stability and health 480 chemical compounds in the cannabis plant Most popular Cannabinoids: 9 tetrahydrocannabinol THC Cannabidiol CBD Cannabinol CBN Cannabigerol CBG Cannabichromene CBC 16 8

9 Cannabis: Top Five Cannabinoids Delta 9 Tetrahydrocannabinol ( 9 THC) Δ 9 tetrahydrocannabinol (commonly referred to as Δ9 THC, D9 THC, d9 THC or simply THC ) is a neutral cannabinoid, well known for being strongly psychoactive. Of all the scientific discoveries that have been made about THC, probably the single most important was how THC enabled scientists to discover the existence of the endocannabinoid system in vertebrate animals (including humans): a critical part of physiology that, up until then, was unknown. THC has been shown to be effective in the treatment of a variety of ailments and disorders including pain, tumors and nausea. 17 Cannabis: Top Five Cannabinoids Cannabis: Top Five Cannabinoids CANNIBIDIOL (CBD) CBD has no psychoactive effects Calming effect on the nervous system Epilepsy, seizure disorders, nerve pain, cancer, multiple sclerosis, chronic pain, anxiety, diabetes, arthritis, dystonia, Chrohn s disease, and inflammation. CANNABINOL (CBN) Produced by the oxidization of THC If cannabis is exposed to too much air or heat, over time the oxidization of THC will create CBN. Mild psychoactive effects When combined THC and CBN produce that couch lock feeling Insomnia Antiemetic and anticonvulsant Source:

10 Cannabis: Top Five Cannabinoids Cannabis: Top Five Cannabinoids CANNABIGEROL (CBG) Building block for both THC and CBD More Common in Hemp Antibacterial and anti tumor properties Reduces intraocular pressure in glaucoma patients Reduces nausea Reduces temper anxiety Relieve inflammatory bowel disease. CANNABICHROMENE (CBC) Second most common cannabinoid (after THC) No psychoactive effects Eases pain Arrests tumor growth Regenerates bones and brain cells Puts you in a better mood Antibacterial and antifungal properties Source: 19 Cannabis: Terpenes Terpenes are found in many plants 120 terpenes found in cannabis Chemicals that give a plant its aroma and flavor Different levels of terpenes in different strains of cannabis are what give it a more earthy, fruity, or skunky smell and taste Stimulates senses Many have medicinal effects. Source:

Cannabis: Cannabis: Top Five Terpenes Terpenes For Healing BETA MYRCENE Beta myrcene is the most common terpene in cannabis, and it is also found in hops, eucalyptus, mango, bay leaves, and

11 Cannabis: Cannabis: Top Five Terpenes Terpenes For Healing BETA MYRCENE Beta myrcene is the most common terpene in cannabis, and it is also found in hops, eucalyptus, mango, bay leaves, and lemongrass. Its aroma has been described as herbal, balsamic, rooty, or spicy. Ease pain and inflammation, and it relaxes muscles Source: 21 Entourage Effect Cannabinoids and Terpenes While each cannabinoid and terpenes has its own medicinal benefits, they work best in concert. Working together (and with other cannabis compounds) they create the entourage effect, multiplying the benefits of each individual compound. In cannabis, the sum is so much more than its parts. For example, the combination of [Beta] Myrcene with D9 THC for pain, with THCA for inflammation, with CBD and Linalool as an antipsychotic, and with THC, THCA, and CBD in the treatment of muscle spasms

and immune cells Two most common receptors Role is to maintain

12 Cannabinoid Receptors Embedded in specific cell membranes throughout the body: brain, organs, connective tissues, glands, and immune cells Two most common receptors Role is to maintain Internal Stability and Health: a homeostasis state 23 Endocannabinoid System 24 12

Activating Cannabinoid Receptors 1. Our bodies release cannabinoids to regulate, regain or maintain a healthy body and mind (for example, anandamide) 2.

Manufactured cannabinoids such as Marinol, Cesamet, Sativex, Epidiolex 25 Anandamide, phytocannabinoid, THC.

13 Activating Cannabinoid Receptors 1. Our bodies release cannabinoids to regulate, regain or maintain a healthy body and mind (for example, anandamide) 2. Introduction of plant based cannabinoids such as Cannabis 3. Manufactured cannabinoids such as Marinol, Cesamet, Sativex, Epidiolex 25 Anandamide, phytocannabinoid, THC. Cannabis Pharmacology: Cannabis Affect on CB Receptors Endocannabinoids The other main endocannabinoid is (2 AG) which is active at both cannabinoid receptors, 2 AG and CBD are involved in the regulation of appetite, immune system functions and pain management. Anandamide 2 Arachidonylglycerol (2 AG) 26 13

to CB1 and CB2 Brain s Chemical Drug Anandamide THC

14 Cannabis Pharmacology: Cannabis Affect on CB Receptors Anandamide and THC Bind relatively equally to CB1 and CB2 Brain s Chemical Drug Anandamide THC 27 Cannabis Pharmacology: Cannabis Affect on CB Receptors 28 14

Cannabis Pharmacology: Cannabis Affect on CB Receptors Other cannabinoids found in the plant are

The cannabinoid that has sparked the most interest is a non psychoactive component called

Little binding affinity to CB1 and CB2 Suppresses enzyme fatty acid amide hydroxylase ( FAAH )

15 Cannabis Pharmacology: Cannabis Affect on CB Receptors Other cannabinoids found in the plant are also providing effects. The cannabinoid that has sparked the most interest is a non psychoactive component called cannabidiol (CBD). Little binding affinity to CB1 and CB2 Suppresses enzyme fatty acid amide hydroxylase ( FAAH ) the enzyme that breaks down anandamide Opposes THC at CB1 receptor Stimulates release of 2 AG TRPV 1 receptor agonist 5 HT1A receptor activation GPR55 antagonist Epilepsia 2014;55(6): Accessed 5/12/

Potential Physiologic Responses to Cannabis Improves sleep Reduces intraocular pressure Bronchodilator Anti inflammatory Anti proliferative Anti viral Anti seizure effects and neuroprotection Reduces

cancer.gov/cancert 11/17/14. 31 Marijuana Plant Types Sativa strains originated in an area around the equator and can be found in countries like Colombia, Mexico, Thailand and several African Nations.

16 Potential Physiologic Responses to Cannabis Improves sleep Reduces intraocular pressure Bronchodilator Anti inflammatory Anti proliferative Anti viral Anti seizure effects and neuroprotection Reduces anxiety and psychotic symptoms/ptsd Prevents nausea and stimulates appetite Relaxes muscles and reduces muscle spasms Relieves pain (especially neuropathic) Minnesota Medicine 2014:4: /17/ Marijuana Plant Types Sativa strains originated in an area around the equator and can be found in countries like Colombia, Mexico, Thailand and several African Nations. Grow taller than Indica s > 6 feet Indica strains originated from a higher altitude and can be found predominantly in countries known for their hash culture such as Morocco, Afghanistan, Nepal and Turkey. Shorter and fuller than Sativa< 3 feet Hybrid = Indica + Sativa 32 16

17 Learning Objectives Revisited998 What are the two principle endogenous endocannabinoids? A. THC and CBD B. Anandamide and 2-AG C. Dopamine and Serotonin D. CBD and CBN

18 Medical Marijuana Dispensary Pharmacist Patient Care Process SELF ASSESSMENT TREATMENT GOALS DISPENSARY PHYSICIAN EDUCATION MARIJUANA 35 Medical Marijuana Dispensary Pharmacist Patient Care Process Initial Patient Consultation First Visit SELF TREATMENT Medical History ASSESSMENT GOALS Current Medications Prescription Monitoring Program DISPENSARY PHYSICIAN Certifying Physician Instructions / Specialist Instructions Treatment Goals Desired Outcomes, Target Symptom Relief Physical, Social, Environmental Factors Marijuana Use History EDUCATION MARIJUANA 36 18

19 Medical Marijuana Dispensary Pharmacist Patient Care Process EDUCATION Identify Treatment Goals Disease Specific Symptom Relief Nausea Tremors Pain Relief SELFNerve Pain Muscle Spasms ASSESSMENTPoor Appetite Insomnia Depression Anxiety Siezures DISPENSARY PHYSICIAN Disease Management Quality of Life Day Time vs Night time End of Life Care MARIJUANA TREATMENT GOALS 37 Medical Marijuana Dispensary Pharmacist Patient Care Process Identify Factors Influencing Methods of Ingestion Physical Constraints Environmental Factors SELF Vape, Edibles, Topical, Capsule ASSESSMENT Identify Factors Influencing Strength DISPENSARY Tolerance THC Current / Historical Usage/ Tolerance Medication Contraindications EDUCATION Weight / Metabolism PHYSICIAN MARIJUANA TREATMENT GOALS 38 19

20 Medical Marijuana Dispensary Pharmacist Patient Care Process SELF ASSESSMENT Patient History EDUCATION /Feedback Product and Dosage Form Recommendation Based on Patient Consultation and Treatment Goals Strain Identification: Sativa, Indica, Hybrid Identify ideal Cannabinoid Profile Dosage Form Method of Ingestion DISPENSARY Considerations: Affordability Dynamic Product Inventory PHYSICIAN MARIJUANA TREATMENT GOALS 39 Medical Marijuana Dispensary Pharmacist Patient Care Process SELF ASSESSMENT TREATMENT GOALS DISPENSARY PHYSICIAN EDUCATION MARIJUANA 40 20

Medical Marijuana Dispensary Pharmacist Patient Care Process Determine Strain Type Sativa Indica Generally stimulating, energizing, uplifting Generally more

introvert Best for Daytime use Increases alertness Consider with depression Pain relief, muscle relaxant DISPENSARY Better after work is done, bedtime

EDUCATION Source: The Cannabis Health Index, Uwe Blesching, PH. D. www.thecannabisindex.

21 Medical Marijuana Dispensary Pharmacist Patient Care Process Determine Strain Type Sativa Indica Generally stimulating, energizing, uplifting Generally more mental/emotional SELF ASSESSMENT Usually more extrovert Generally sedating, relaxing, grounding Generally more TREATMENT physical GOALS Usually more introvert Best for Daytime use Increases alertness Consider with depression Pain relief, muscle relaxant DISPENSARY Better after work is done, bedtime PHYSICIAN Sleeping Aid Consider with anxiety Pain relief, muscle relaxant THC binds both CB1 and CB2 receptors CBN MARIJUANA has a greater affinity for CB2 EDUCATION Source: The Cannabis Health Index, Uwe Blesching, PH. D Medical Marijuana Dispensary Pharmacist Patient Care Process Lab Reports Current Inventory Future Producer Product Information SELF ASSESSMENT Determine Cannabinoid Profile TREATMENT GOALS DISPENSARY PHYSICIAN EDUCATION MARIJUANA 42 21

22 Medical Marijuana Dispensary Pharmacist Patient Care Process Dosage Forms SELF ASSESSMENT TREATMENT GOALS DISPENSARY PHYSICIAN EDUCATION MARIJUANA 43 Cannabis and Pediatrics Cerebral Palsy Cystic Fibrosis Severe Epilepsy Uncontrolled Intractable Seizure Disorder Irreversible Spinal Cord Injury with Objective Neurological Indication of Intractable Spasticity Terminal Illness Requiring End Of Life Care PD AGL Cannabidiol D CBD Tinct 1x 200mg V1 (02637) PD AGL Cannabidiol D CBDA Tinct 1x 200mg V1 (02639) PD AGL Hybridol A THC Tinct 1x 200mg V1 (02638) PD AGL Hybridol A THCA Tinct 1x 200mg V1 (02640) PD CC CPS Oral CBD Spray C290 (02702) PD CC CPS Oral THCA Spray T295 (02703) CPS Oil C250 Syringe (1ml) (02754) 44 22

23 Drug Interactions with Cannabis Opioids: may need to decrease opioid dose Anxiolytics: may need to decrease anxiolytic dose Tricyclic antidepressants: try to avoid concurrent use Amitriptyline Clomipramine Desipramine Doxepin Nortriptyline Protriptyline SSRIs: monitor for increased side effects of SSRI Citalopram (Celexa) Escitalopram (Lexapro) Paroxetine (Paxil, Pexeva) Fluoxetine (Prozac) Anti retroviral: may need to decrease cannabis dose Anti seizure meds: may need to decrease dose Imipramine Sertraline (Zoloft) Vilazodone (Viibryd) 45 Medical Marijuana Dispensary Pharmacist Patient Care Process Documentation: Electronic and Centralized Online Patient Information and Dispensary Facility Data Detail Patient Profile, Medical History, Current Medications ETC SELF Treatment Goals ASSESSMENT and Plans Documented Notes from each Follow Up are maintained Patient Self Assessment recorded DISPENSARY Patient Product History Maintained PHYSICIAN TREATMENT GOALS EDUCATION MARIJUANA 46 23

24 Medical Marijuana Dispensary Pharmacist Patient Care Process Patient Education Understanding Strain Types, Cannabinoid Profiles How to administer dosage form How to titrate, adjust, self titrate SELF TREATMENT Importance of ASSESSMENT monitoring efficacy and recording GOALSfor follow up consultation Side Effects / Toxicity DISPENSARY PHYSICIAN 75% 80% of Dispensary Time dedicated to Patient Education EDUCATION MARIJUANA 47 Medical Marijuana Dispensary Pharmacist Patient Care Process SELF ASSESSMENT Assessing / Refining Recommendations Patient Feedback Essential Patient maintains information to bring to follow up consultation appointment TREATMENT GOALS Journals recommended DISPENSARY PHYSICIAN EDUCATION Patient Completes Self Assessment Form MARIJUANA 48 24

25 Medical Marijuana Dispensary Pharmacist Patient Care Process Follow Up Patient Consultation with Dispensary Patient Self Assessment SELFis completed and reviewed to TREATMENT determine efficacy of ASSESSMENT GOALS products recommended during previous visit Product Purchase History Reviewed by Dispensary and Patient DISPENSARY PHYSICIAN Treatment Goals and Desired Outcomes Evaluated with Patient Self Assessment information Physician Included in Assessment when required / requested EDUCATION Patient Care Cycle Continues with updated recommendations MARIJUANA 49 Medical Marijuana Dispensary Pharmacist Patient Care Process SELF ASSESSMENT TREATMENT GOALS DISPENSARY PHYSICIAN EDUCATION MARIJUANA 50 25

26 Impact of MMJ on Opioid Use When used in conjunction with opioids, cannabinoids can lead to greater cumulative relief of pain and potential reduction of opiate use Comparisons in analgesia 10 mg THC less effective than 60 mg codeine 20 mg THC more effective than 120 mg codeine Prevent development of tolerance to and withdrawal from opiates and potentially rekindle opiate analgesia after a prior dosage has become ineffective Potentially less dangerous than opiates (no direct death) Source: J Psychoactive Drugs 2012;44: Examples Outcomes Documented Anecdotal and Substantiated Reduced Opiod Use Reduction In Seizures Multiple Sclerosis Patients Increased Mobility SELF Symptomatic Pain ASSESSMENT Relief Increased Appetite (Weight Stable / Gain) DISPENSARY PHYSICIAN MARIJUANA TREATMENT GOALS Cancer patients reports of diminished side effects of treatments, pain reduction and some cases tumor reduction Parkinson s Patients improved sleep, pain, quality of life Improved Sleep, Decrease in Anxiety especially in PTSD patients EDUCATION Drug Interactions 52 26

27 Learning Objectives Revisited998 As part of the Patient Care Process that a Dispensary Pharmacist engages in which of the following is FALSE? A. Discussing individual patient treatment goals B. Marijuana strain and cannabinoid profile and dosage form determination C. Intake of pertinent patient history including medication history and PMP Verification. D. Certification of approved disease state with the state of Connecticut. 53 Cannabinoid Patent 1998? 54 27

28 Cannabinoid Patent Our Dispensary Pharmacists

29 References 1998 References 1.Devinsky O, Marsh E, Friedman D, et al. Cannabidiol in patients with treatment resistant epilepsy: an open label interventional trial. Lancet neurology Tzadok M, Uliel Siboni S, Linder I, et al. CBD enriched medical cannabis for intractable pediatric epilepsy: The current Israeli experience. Seizure : the journal of the British Epilepsy Association 2016;35: Gattone PM, Lammert W, and Devinsky O. Epilepsy Foundation of America Position Statement Medical Marijuana in Epilepsy [online]. 4.Devinksy O, Cilio MR, Cross H, et al. Cannharmacology and potential therapeutic role in epilepsy and other neuropsychiatric disorders.epilepsia Patel, Anup MD Medical Marijuana and Epilepsy, Epilepsy Foundation of America Position Statement Medical Marijuana in Epilepsy [online]

PATIENT INTAKE FORM. Name: Address: Town: State: Zip Code: MMJ Card #: Exp. Date: Drivers License #: Exp. Date: Home Phone: Cell:

PATIENT INTAKE FORM. Name: Address: Town: State: Zip Code: MMJ Card #: Exp. Date: Drivers License #: Exp. Date: Home Phone: Cell: PATIENT INTAKE FORM Name: Last Name First Name Date of Birth: / / Gender: Male Female Address: Town: State: Zip Code: MMJ Card #: Exp. Date: Drivers License #: Exp. Date: Home Phone: Cell: Email: Primary