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Medicinal Cannabis: Pharmacologic and Regulatory Considerations and Dispensary Requirements Iadelisse Cruz-González PharmD, BCGP, GCG Professor School of Pharmacy This Photo by Unknown Author is licensed under CC BY-ND University of Puerto Rico CFPR Convention- August 2021 1 Faculty Disclosure ▪ Iadelisse Cruz- Gonzalez, declares no conflict of interest ▪ This presentation has been prepared FOR EDUCATIONAL PURPOSES ONLY. It is not intended to be used for clinical decision making or patient assessment. ▪ The attendees must consult current applicable regulations, guidelines, clinical studies, expert opinions and exercise their professional judgment in order to fulfill their responsibilities and in the best interest of each patient and the profession. 2 This Photo by Unknown Author is licensed under CC BY-NC-ND 1.Describe the evolution of medicinal cannabis use Objectives 2.Explain legal implications regarding medicinal At the end of the CPE activity the cannabis at national and local level participants will be able to: 3.Describe the initial operation requirements for medical cannabis dispensaries 4.List training requirements for medical cannabis dispensaries employees 5.Identify the indications for medicinal cannabis according to regulations in Puerto Rico 6.Discuss the pharmacologic and safety considerations regarding patients using medicinal cannabis 3 Evolution of Medicinal Cannabis Use Objective 1 4 Medicinal Cannabis BC This Photo by Unknown Author is licensed under CC BY-SA-NC Year Country Fact / Comment 2737 B.C. China Legendary Chinese Emperor Shennong - Catalog of 365 Species of Medicinal Plants and “discover” the healing properties of marijuana. The Divine Farmer or God of Herbal Chinese Medicine Uses: malaria, constipation, rheumatic pains, and childbirth and mixed with wine as a surgical analgesic 600 B.C. India Bhang: drink of cannabis and milk, is used widely as an anesthetic. Other uses: analgesic, anticonvulsant, sedative-hypnotic, and anti- inflammatory, antibiotic, antiparasitic, antispasmodic, digestive, appetite stimulant, diuretic, aphrodisiac or anaphrodisiac, antitussive, and expectorant. 1500 B.C. Egypt Medical Papyri from Egypt mention marijuana as a cure for sore eyes and inflammation. Encyclopedia Britannica Available online: https://www.britannica.com Accessed: April 16, 2018 Zuardi AW. History of cannabis as a medicine: a review. Braz J Psychiatry .2006;28(2):153-157. Ben Amar M. Cannabinoids in medicine: a review of their therapeutic potential. JEthnopharmacology. 2006;105(1-2):1-25. 5 Mikuriya TH. Marijuana in medicine: past, present and future. California Med.1969;110(1):34-40. Medicinal Cannabis AD This Photo by Unknown Author is licensed under CC BY-SA Year Country Fact / Comment 79 A.D. Italy Roman naturalist, Pliny the Elder – Natural History, cites boiled cannabis roots as a treatment for gout, pain and cramped joints. 800 A.D. Islamic Islamic physicians prescribe cannabis for a variety of ailments, countries although some decry it as a “lethal poison”. 1542 A.D. Germany German physician Leonhart Fuchs names the plant Cannabis sativa. 1839-42 United British army surgeon from Irish descent, William Brooke A.D. Kingdom O’Shaughnessy introduces marijuana into medical practice as a treatment for pain, nausea and convulsions. 6 Encyclopedia Britannica Available online: https://www.britannica.com Accessed: April 16, 2018 Medicinal Cannabis Year Country Fact / Comment This Photo by Unknown Author is licensed under CC BY-NC-ND 1850 US The United States Pharmacopeia, which issues the official handbook for dispensing medications, classifies marijuana as a legitimate medical compound. 1906 US Pure Food and Drug Act required drug labels to list dangerous drugs, Encyclopedia Britannica Available online: https://www.britannica.com cannabis was included Accessed: April 16, 2018 1925 Geneva, A League of Nations and Opium Conferences Treaty limits cannabis use Mahvan TD et al., Marijuana use in Switzerland the Elderly: Implications and to medical or scientific purposes. Aspirin and other newly developed considerations The Consultant drugs begin to replace cannabis as treatments for pain. Pharmacist 2017; 32: 341-349. Cydney Adams CBS News November US 17, 2016, 5:45 PM The man behind 1930 Harry J. Anslinger is appointed commissioner of the Federal Bureau of the marijuana ban for all the wrong Narcotics. He considers marijuana a corrupting influence and helps to reasons turn public opinion against the drug. 1937 US Marihuana Tax Act; Federal Marihuana prohibition 1942 US Removed from the United States Pharmacopeia. 7 Medicinal Cannabis Image available: Year Country Fact / Comment https://www.unodc.org/unodc/frontpage/2015/un70.html 1961 United United Nations, New York - Single Convention on Narcotic Drugs (Print States 1962) 1964 Israel Raphael Mechoulam, the “father of cannabis research” (co-discovered THC) 1967 - 1969 United Hippie culture States 1969 United Summer of Love, Woodstock States 8 Mahvan TD et al., Marijuana use in the Elderly: Implications and considerations The Consultant Pharmacist 2017; 32: 341-349. Medicinal Cannabis This Photo by Unknown This Photo by Unknown This Photo by Unknown Author Author is licensed under Author is licensed under CC is licensed under CC BY-SA CC BY-SA BY-SA Year Country Fact / Comment 1971 United States President Richard Nixon declares “War on Drugs” 1972 United States National Commission on Marijuana and Drug Abuse recommended decriminalization 1973 United States President Richard Nixon creates the Drug Enforcement Administration (DEA) 1986 United States President Ronald Regan - Anti Drug Abuse Act 1989 United States President George Bush - National Control Drug Policy and 1st Drug Czar - William Bennett 1996 United States California was the first state to legalize cannabis - Compassionate Use Act 1998 United States Medicinal cannabis use was approved - Alaska, Washington and Oregon 9 Mahvan TD et al., Marijuana use in the Elderly: Implications and considerations The Consultant Pharmacist 2017; 32: 341-349. Among ancient cannabis uses there is… a. Treatment of inflammation and pain b. Rituals c. Psychedelic effects d. Alternative a and b are correct 10 Cannabaceae family (170 species,11 genera) Cannabis Plants Cannabis (C sativa, C indica, and C Hemp ruderalis) More than 2500 strains Cannabinoids including Terpenes Flavonoids CBD & THC Products Dietary Drugs Foods Cosmetics supplements This Photo by Unknown Author is licensed under CC BY-NC FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD). Available at: https://www.fda.gov/news-events/public-health-focus/fda- 11 regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd . Accessed Jul 14, 2021 United $17.5 billion (2020)# 46% increase from 2019 States Current Cannabis Use population 332.9 M * 96 millions Dept. Hacienda de PR+ *Macro trends. U.S. Population 1950-2021Available at: https://www.macrotrends.net/countries/USA/united- states/population#:~:text=The%20current%20population%20of%20U.S.,a%200.58%25%20in Marijuana use has Blacks 4.7 to 12.7% crease%20from%202020. Accessed Jul 23, 2021. increased in 10 years ^^ #U.S. Cannabis Sales Hit Record $17.5 Billion As Americans Consume More Marijuana Than Ever Before https://www.forbes.com/sites/willyakowicz/2021/03/03/us-cannabis-sales-hit- record-175-billion-as-americans-consume-more-marijuana-than-ever-before/ . Accessed Jul (2001-2002 and 2012-2013) 23, 2021. Hispanics 3.3 to 8.4% +Noticentro Edición Estelar 4:00pm. WAPA TV. Jul 30, 2012 #McVey E. Exclusive: US retail marijuana sales on pace to rise 40% in 2020, near $37 billion by 2024. Marijuana Business Daily. https://mjbizdaily.com/exclusive-us-retail-marijuana- sales-on-pace-to-rise-40-in-2020-near-37-billion-by-2023/. Published June 30, 2020.Accessed Older adults the prevalence increased from 2.4% to Jul 15, 2021. of past-year use from 2015 ^^ AHasin DS, Saha TD, Kerridge BT, et al. Prevalence of Marijuana Use Disorders in the 4.2% United States Between 2001-2002 and 2012-2013. JAMA Psychiatry. 2015;72(12):1235–1242. to 2018 ^ doi:10.1001/jamapsychiatry.2015.1858p ^ Older adults and medical marijuana: Reduced stigma and increased use (2020) Available at: https://www.health.harvard.edu/blog/older-adults-and-medical-marijuana-reduced-stigma- and-increased-use-2- th 2020040119321#:~:text=According%20to%20a%20recent%20study,4.2%25%20from%20201 2019 – Children marijuana 8 - 11.8% 5%20to%202018. Accessed Jul 23, 2021. use in the past year @ @NIDA. 2021, April 20. What is the scope of marijuana use in the United States?. Retrieved th from https://www.drugabuse.gov/publications/research-reports/marijuana/what-scope- 10 – 28.8% marijuana-use-in-united-states Accessed Jul 23, 2021. 12th - 35.7% 12 Legal Implications regarding Medicinal Cannabis at National Level Federal Regulations Objective 2 13 Federal Law: Cannabis is illegal Schedule I substance The term ’marihuana’ means all parts of the plant Cannabis sativa L Drug Enforcement Administration (DEA) Medicare Medicaid Universities and schools' regulations Up to now, no legal charges has been presented Image available at: https://www.campusdrugprevention.gov/content/cannabis-campus-not- 14 allowed FDA Regulation of Cannabis and Cannabis-Derived Products CBD Federal Food, Drug and The use in human food of Not been evaluated or FDA approved Cosmetic Act hemp seed-derived food approved by FDA (FD&C Act) ingredients is LEGAL • ONLY cannabidiol in • Other CBD products • It is ILLEGAL to market • hulled hemp seed
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