Medical Cannabis in Iowa
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4/9/2021 Kevin T. Schleich, PharmD, BCACP Clinical Pharmacy Specialist, Department of Family Medicine University of Iowa Hospitals and Clinics Objectives • Review historical context of medical cannabis and literature that addresses efficacy of cannabis for multiple medical conditions • Discuss safety concerns from both an acute and chronic use standpoint • Compare and contrast available formulations of medical cannabis in Iowa • Highlight the process by which patients in Iowa can receive medical cannabis United States' "Dealers” https://www.ncsl.org/research/health/state-medical-marijuana-laws.aspx 1 4/9/2021 Weed 101 • Marijuana contains numerous extractable substances – Steroidal components – Volatile compounds • 60 cannabinoids can be isolated – Delta-9-tetrahydrocannabinal (THC): main psychoactive cannabinoid – Cannabidiol (CBD): main non-psychoactive cannabinoid Brand Name Active Ingredient FDA-Indication DEA Schedule Epidiolex® Cannabidiol (plant derived extract) Seizures V Marinol®, Syndros® Dronabinol (Synthetic THC) III AIDS: loss of appetite Cancer: chemotherapy-induced n/v Cesamet® Nabilone (Synthetic THC-analog) II Herman, Ronald A. (2018). Current Iowa Medical Cannabis Regulations. Weed 101 • Two main cannabinoid receptors throughout the human body – CB1: brain, spinal cord, some periphery – CB2: intestinal tract, peripheral organs, immune system • Neither CBD or THC directly agonize either the CB1 or CB2 receptor – THC a partial agonist of CB1 – CBD influences endogenous cannabinoids Herman, Ronald A. (2018). Current Iowa Medical Cannabis Regulations.. http://sensipharma.com/ecs Weed 101 • CBD antagonizes the effects of THC at the CB1 receptor THC THC + CBD • CBD + THC CBD – Pain relief – Anti-spasmodic • CBD only – Epilepsy Herman, Ronald A. (2018). Current Iowa Medical Cannabis Regulations. www.analyticalcannabis.com 2 4/9/2021 Iowa Qualifying Conditions • Cancer, AIDS/HIV, or any • Crohn’s disease/ulcerative colitis terminal illness if: – Severe/chronic pain • Chronic pain* – Nausea/severe vomiting – Cachexia or severe wasting • Severe autism, intractable with self-injurious/aggressive • Neuromuscular disorders: behavior (pediatric and adult)* – Multiple sclerosis (with severe/persistent muscle spasms) • Post-Traumatic Stress Disorder – Amyotrophic lateral sclerosis (PTSD)* (ALS; Lou Gehrig’s Disease) – Parkinson’s disease • Corticobasal degeneration* • Seizures (including those characteristic of epilepsy) * Update since original legislation https://idph.iowa.gov/omc/For-Patients-and-Caregivers Does the Stuff Work? www.google.com/images Efficacy Data • The National Academies of Sciences, Engineering, and Medicine (NASEM) – “The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research” – Comprehensive report highlighting the health effects of recreational/therapeutic cannabis use – Published in 2017 – Cannabis still DEA Schedule I substance • Limited research capability (federal funding) • 194 current trials on ClinicalTrials.gov http://www.nationalacademies.org/hmd/Reports/2017/health-effects-of-cannabis-and-cannabinoids.aspx 3 4/9/2021 Efficacy Data • Chronic Pain – “…there is substantial evidence that cannabis is an effective treatment for chronic pain in adults” – NASEM cites 5 systematic reviews (n=2454) • Low-quality evidence • 2 studies focused on fibromyalgia • Pain scores decreased by ~30% on average – Generally, higher THC content = greater pain relief – 49 active trials on ClinicalTrials.gov Herman, Ronald A. (2018). Current Iowa Medical Cannabis Regulations. http://www.nationalacademies.org/hmd/Reports/2017/health-effects-of-cannabis-and-cannabinoids.aspx www.clinicaltrials.gov Efficacy Data Demonstrated ~# of Current Clinical Condition Efficacy Trials Chronic Pain 115 Cancer/HIV-Related Symptoms 176* Seizures 14 MS Spasticity Symptoms 29 Parkinson’s 6 Crohn’s/UC/IBD 8 Autism 1 PTSD 17 *Majority are associated with pain control Herman, Ronald A. (2018). Current Iowa Medical Cannabis Regulations. http://www.nationalacademies.org/hmd/Reports/2017/health-effects-of-cannabis-and-cannabinoids.aspx www.google.com/images 4 4/9/2021 Short-Term Adverse Effects • Marijuana inhalation/ingestion Impaired motor coordination Short-term memory Paranoia/psychosis impairment Dry mouth Tachycardia Hypertension Nausea/ vomiting www.google.com/images N Engl J Med. 2014;371(9):879 Long-Term Adverse Effects Addiction* Altered brain • 9%: overall development* • 17%: begin as adolescent • 25-50%: daily user Worsening educational Cognitive outcomes* impairment* Diminished life Increased risk of satisfaction* chronic psychosis disordersΩ * = effect strongly Ω = in those with a associated with initial use predisposition to such in adolescence disorders “Pharmacy stuff… pharmacy stuff… pharmacy stuff… pharmacy stuff… pharmacy stuff” www.google.com/images 5 4/9/2021 Pharmacokinetics Sublingual Trans- Inhaled Oral /Buccal cutaneous Onset Seconds 5-15 min ? 60 min Time to Peak 30 min 4 hours ? 4-6 hours Duration 2-4 hours ? ? > 8 hours Absorption < inhaled 10-35% CBD> THC ~5% Bioavailability > oral • Distributes readily into well-vascularized organs (lung, heart, brain, liver) Distribution • Chronic use accumulates in adipose tissue • THC highly lipophilic crosses placenta; excreted into breast milk Metabolism THC CYP2C9, CYP3A4 Active CBD CYP2C19, CYP3A4 (by CYP enzymes) metabolite (2x as potent) Inactive metabolite Routeof Elimination Half-Life THC: 22 hours Excretion Feces: 70% (5% unchanged) CBD, occasional use: 24-31 hours Urine: 30% CBD, frequent use: 2-5 days Ku, Jennifer. (2018). Cannabis Can Do What? Pharmacological Considerations with Cannabinoids. Drug-Drug Interactions www.google.com/images What Effects Cannabis Increase Cannabinoid Decrease Cannabinoid Levels Levels • Grapefruit • Rifampin • Azole antifungals • Carbamazepine • Clarithromycin • St. John’s Wort • Amiodarone • Barbiturates • HIV Antivirals • Common offenders for drug-drug interactions when utilizing the CYP enzyme system • Current manufacturers recommend monitoring efficacy and safety if administering concurrently with above drugs • No preemptive dose adjustments necessary Ku, Jennifer. (2018). Cannabis Can Do What? Pharmacological Considerations with Cannabinoids. 6 4/9/2021 What Cannabis Effects Cannabis Induces Cannabis Inhibits CYP2C8, CYP2C9, CYP2C19, UGT1A9, Enzymes CYP1A2, CYP2B6 UGT2B7 Decreases efficacy of the following Increases efficacy of the following Effect drugs drugs Neuro/psych: • Citalopram Neuro/psych: • Diazepam • Duloxetine • Lamotrigine • Haloperidol • Lorazepam • Olanzapine Platelet inhibitors: Musculoskeletal/analgesia: • Clopidogrel • Cyclobenzaprine Drugs Musculoskeletal/analgesia: • Naproxen • NSAIDS • Tizanidine Lipid-lowering: Opioids: • Fibrates • Methadone Anti-hyperglycemic: Hormones: • Sulfonylureas • Estradiol Opioids: • Morphine Ku, Jennifer. (2018). Cannabis Can Do What? Pharmacological Considerations with Cannabinoids. www.google.com/images Products in Iowa 20:1 2:1 1:1 1:20 (CBD:THC) (CBD:THC) (CBD:THC) (CBD:THC) 5 mg:5 mg 0.25 mg:5 mg Capsule 600 mg:30 mg/cap 0.5 mg:10 mg 10 mg:10 mg 1 mg:20 mg 5 mg:0.25 mg/0.25 mL Tincture ~5 mg:5 mg/0.25 mL 0.25 mg:5 mg/0.25 mL 25 mg:2 mg/0.25 mL 17.5 mg:8.75 mg/0.5 tsp* 17.5 mg:8.75 mg/0.5 tspΩ Cream 3.75 mg:1.875 mg/pump* 3.75 mg:1.875 mg/pumpΩ Vaporizer 215 mg: 10 mg/inhalation pediatric formulation; * = no scent; Ω = rosemary extract scent • Rectal and vaginal suppositories allowable (not currently supplied) www.medpharmiowa.com/products www.google.com/images 7 4/9/2021 What’s In Recreational? Product Weight/Size THC (mg) Pretzels 0.18 oz (5 g) 3 Honey 1 tsp: 0.2 oz (7 g) 8 Cookie 0.56 oz (16g) 10 Gummy Bear 0.09 oz (2.5 g) 25 Green Tea 0.07 oz (1.9 g) 40 ChocolateBar 1.5 oz(43 g) 200 Brownie 3.5 oz (100 g) 250 www.latimes.com/projects/la-me-weed-101-1hc-calculator/ www.google.com/images Can Anyone Afford This? • Insurance does not cover – Cash and debit cards only form of payment accepted – Credit card not permitted due to “federal regulations” • Price of all products published on MedPharm website • Cost obviously varies widely based on dose utilized/product www.medpharmiowa.com/products www.google.com/images www.google.com/images 8 4/9/2021 Prescribing Review Amoxicillin 500 mg Take 2 caps 3 times daily x 10 days #60 0 refills www.google.com/images “Attesting” Review You have a condition Dr. XYZ My high school degree and 2- week training course leads me to believe your child needs this dose of cannabis. www.google.com/images Application/Registration • Patients submit a three-page application to the Iowa Department of Public Health (IDPH) to receive a medical cannabidiol registration card – Available online at IDPH website – $100 non-refundable application fee – $25 non-refundable reduced application fee for low-income – Electronic application now accepted (https://idph.iowa.gov/cbd) • Patient must be > 18 years of age – Caregiver can obtain card for those < 18 years of age 9 4/9/2021 Application/Registration • Provider Attestation Requirements (page 3) – Established patient-provider relationship with the patient – A primary care provider of the patient involved in the diagnosis and treatment of the debilitating medical condition – Confirmation that the patient suffers from a qualifying condition – Have counseled patient (including guided patient to IDPH website) about benefits/risks of medical cannabidiol – Agree to annually evaluate continuing need Dispensary Sites Sioux City Waterloo Windsor Heights **Davenport