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Medical Marijuana: Clinical Concepts Jennifer Kapur, Pharm.D

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Medical Marijuana: Clinical Concepts Jennifer Kapur, Pharm.D 11/3/2015 MEDICAL MARIJUANA: CLINICAL CONCEPTS JENNIFER KAPUR, PHARM.D. NOVEMBER 21, 2015 OBJECTIVES Compare and contrast federal law and state laws regarding marijuana List different dosage forms of medical marijuana Discuss the pharmacologic effects of marijuana Describe the risks and benefits of medical marijuana use Summarize the role of the pharmacist in the care of patients using medical marijuana CASE: MARILYN 68yo female with breast cancer metastatic to the lungs and thoracic and lumbar spine Meds: Doxorubicin Ondansetron and prochlorperazine Acetaminophen 1000mg q8h Oxycodone 5-10mg QHS prn Complains of very low energy, minimal appetite, substantial pain in spine She asks you about the possibility of using marijuana to help with nausea, pain and fatigue What advice will you offer regarding the use of marijuana to alleviate her current symptoms? Do you believe the the overall medicinal benefits outweigh the risks? NEJM. 2013;368(9)866-868. 1 11/3/2015 HISTORY OF MEDICAL MARIJUANA William Brooke O’Shaughnessy Introduced marijuana to Western medicine in the mid-1800s From www.en.Wikipedia.org HISTORY OF MEDICAL MARIJUANA 1851: Marijuana added to US Pharmacopeia 1942: Marijuana removed from US Pharmacopeia 1970: Marijuana classified as Schedule 1 under Controlled Substances Act 1996: California becomes first state to legalize medical marijuana 1998: Alaska, Oregon and Washington legalize medical marijuana Currently 23 states and the District of Columbia have legalized medical marijuana 2 11/3/2015 MEDICAL MARIJUANA IN WASHINGTON STATE HEALTHCARE PROVIDERS WHO MAY RECOMMEND MEDICAL MARIJUANA* Medical doctors (MDs) Physicians assistants (PAs) Osteopathic physicians (DOs) Osteopathic physician assistants (OAs) Naturopathic physicians (NDs) Advanced registered nurse practitioners (ARNPs) *Must be licensed in Washington state Healthcare providers must NOT PRESCRIBE marijuana. It is prohibited under federal law to distribute, dispense or possess marijuana. MEDICAL MARIJUANA IN WASHINGTON STATE BEFORE PROVIDING A RECOMMENDATION TO A PATIENT A PROVIDER MUST: Complete a physical exam Determine that the patient has a qualifying condition Document qualifying condition in the medical record Inform the patient of other treatment options Document other treatment options attempted in the medical record Advise patients of risks and benefits of medical marijuana PROVIDER MAY NOT: Practice solely to authorize medical marijuana Advertise that they authorize medical marijuana Hold economic interest in a business that produces, processes or sells MJ 3 11/3/2015 MEDICAL MARIJUANA IN WASHINGTON STATE QUALIFYING CONDITONS (must be severe enough to interfere with ADLs and ability to function) Cancer Intractable pain* HIV Glaucoma, acute or chronic* Multiple sclerosis Crohn’s disease with debilitating symptoms* Epilepsy or other seizure disorder Hepatitis C with debilitating nausea/intractable pain* Spasticity disorders Chronic renal failure requiring hemodialysis Posttraumatic stress disorder (added 7/24/15) Traumatic brain injury (added 7/24/15) Diseases, including anorexia, which result in NV, wasting, appetite loss, cramping, seizures, muscle spasms or spasticity* *unrelieved by standard medical treatments and medications MEDICAL MARIJUANA IN WASHINGTON STATE DOCUMENTATION OF AUTHORIZATION MUST: Be on tamper-resistant paper and be signed/dated Effective 7/24/15, all new authorizations must be on form developed by DOH Authorizations given before 7/24/15 are valid until 6/30/16 DOCUMENTATION OF AUTHORIZATION MUST INCLUDE: Patient’s name, address, DOB Health care provider’s name, address, phone number, license number The date of issuance and expiration CHANGES TO MEDICAL MARIJUANA LAW IN WASHINGTON Outgoing Rules Cannabis Patient Protection Act (2015) Authorization* None >18yo: 12 months Expiration <18yo: 6 months Authorizations must be renewed in person Possession 24 oz usable; 15 plants 8 oz usable; 6 plants (provider may authorize up to 15 plants) Amounts** If DO NOT join voluntary registry: limited to 6 oz usable and 4 plants Collective Up to 10 Collectives NOT allowed; phased out by July 2016 Gardens** patients/designated providers may grow Cooperatives allowed: 4 patients/60 plants collectively Retail Locations** Not regulated Licensed stores w/medical endorsement Registry patients exempt from sales tax *Changed 7/24/15 **Change beginning 7/1/16 4 11/3/2015 CANNABIS PATIENT PROTECTION ACT: DEPARTMENT OF HEALTH REQUIREMENTS Contract a third party to create and administer a medical marijuana authorization database Develop rules to regulate database operation Develop rules regarding medical marijuana products sold to patients Consult with Liquor and Cannabis Board about requirements for retail store to get a medical marijuana endorsement Create a medical marijuana consultant certification Develop and approve continuing education for providers who authorized medical marijuana Make recommendations to the legislature about establishing medical marijuana specialty clinics DEFINITIONS Endocannabinoids Phytocannabinoid Botanicals: Cannabis-Derived MEDICAL MARIJUANA Pharmaceuticals (Cannabis) Produced in human tissues Illegal/illicit Prescription Drugs Endogenous cannabinoids Cannabinoids found in Cannabis Synthetic version of one specific sativa or Cannabis indica phytocannabinoid: •Dronabinol (Marinol®) •Nabilone (Cesamet®) Cannabis-derived liquid extract: •Nabiximols (Sativex®)* *Not currently available in the US: undergoing Phase III trials for cancer pain DEFINITIONS Phytocannabinoids Cannabidiol (CBD) (>70 found in marijuana) •major nonpsychoactive ∆9-tetrahydrocannabinol (THC) component •primary psychoactive •decreases psychotropic component CBD activity of THC •used as measure of potency •may have anti-inflammatory, THC neuroprotective and antipsychotic effects 5 11/3/2015 CANNABIS-DERIVED PHARMACEUTICALS: DRONABINOL (MARINOL®, C-III) Synthetic THC Available as capsules: 2.5mg, 5mg, 10mg INDICATIONS: Chemotherapy-induced NV HIV-associated anorexia with weight loss ADVANTAGES: FDA approved; pharmaceutical grade product DISADVANTAGES: Doesn’t work rapidly Amount of drug that reaches the bloodstream varies from person to person Difficult to titrate to effect CANNABIS-DERIVED PHARMACEUTICALS: NABILONE (CESAMET®, C-II) Synthetic cannabinoid similar to THC Available as capsules: 1mg INDICATIONS: Chemotherapy-induced NV HIV-associated anorexia with weight loss ADVANTAGES: FDA approved; pharmaceutical grade product DISADVANTAGES: Doesn’t work rapidly Amount of drug that reaches the bloodstream varies from person to person Difficult to titrate to effect CANNABIS-DERIVED PHARMACEUTICALS: NABIXIMOLS (SATIVEX®, PHASE III TRIALS IN US) Approved in 27 countries Cannabis-derived extract of THC and cannabidiol (“liquid cannabis”) Available as oral mucosal spray: 2.7mg THC-2.5mg CBD/spray INDICATIONS (in Canada): Relief of spasticity in patients with multiple sclerosis who have not responded to other therapies Relief of neuropathic pain in patients with multiple sclerosis Adjunct in patients with advanced cancer who experience moderate to severe pain during highest tolerated dose of strong opioid therapy ADVANTAGES: Pharmaceutical grade product Contraindications (in Canada) include: Contains both THC and CBD -significant hepatic/renal impairment -serious CVD Less variability in absorption than dronabinol and nabilone -h/o schizophrenia/psychotic disorder 6 11/3/2015 MARIJUANA DOSAGE FORMS CANNABIS HASH HASH OIL Flowering tops/leaves/stalks of mature Dried cannabis resin Oil based extract of hash female plant THC content: THC content: THC content: -historically 0.5-5% -2-20% or higher -15-50% or higher -WA recreational pot: 16% (average) MARIJUANA DOSAGE FORMS INHALATION ORAL (aka “Edibles”) TRANSDERMAL Smoking Capsules Ointment Vaporizers Cooking oils (olive, coconut, etc) Balm Butter Patch Soda Mints Candy Baked goods Peak Blood [THC] Reached Crackers INHALED: within 10 minutes ORAL: up to 4 hours EXAMPLES OF EDIBLES www.legalmarijuanadispensary.com From www.dea.org www.marijuanasuckers.com 7 11/3/2015 MARIJUANA DOSAGE FORMS From Department of Colorado Public Health & Environment Report Typical marijuana cigarette (joint) in Colorado contains: About 0.5gm of marijuana with THC content of 12-23% Between 60-115mg of THC Typically a “dose” of recreational marijuana is considered to be 10mg THC Marijuana from pre-1960s contained more equal proportions of THC and CBD Marijuana currently available has been bred to contain higher concentrations of THC Monitoring Health Concerns Related to Marijuana in Colorado: 2014 https://www.colorado.gov/pacific/cdphe/retail-marijuana-public-health-advisory-committee MARIJUANA DOSAGE FORMS: ACCURACY OF PRODUCT LABELING FOR EDIBLES Accurately Labeled Underlabeled Overlabeled Overall (3 cities) Products tested, N=75 13 (17%) 17 (23%) 45 (60%) THC (mg) label range 15-200 20-1000 2-325 THC (mg) actual range 15-183 34-1236 <1-267 Seattle, WA Products tested, N=23 1 (4%) 4 (17%) 18 (78%) THC (mg) label range 180 34-180 20-250 THC (mg) actual range 164 46-206 <1-136 JAMA. 2015;313(24):2491-2493. THERAPEUTIC USES OF MEDICAL MARIJUANA QUALIFYING CONDITIONS IN WASHINGTON STATE Intractable pain Most common uses of medical marijuana Muscle spasms Cancer HIV Glaucoma, acute or chronic THIS LIST IS NOT Multiple sclerosis Crohn’s disease with debilitating symptoms EVIDENCED BASE Epilepsy or other seizure disorder Hepatitis C with debilitating nausea/intractable
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