Medicinal Cannabis: Pharmacologic and Regulatory Considerations and Dispensary Requirements - Colegio de Farmacéuticos de Puerto Rico
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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
17, 2016, 5:45 PM The man behind
1930 US 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
Year Country Fact / Comment Image available:
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
10Cannabaceae 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, 2021United $17.5 billion (2020)# 46% increase from 2019
States
Cannabis Use Current
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
crease%20from%202020. Accessed Jul 23, 2021.
Marijuana use has Blacks 4.7 to 12.7%
#U.S. Cannabis Sales Hit Record $17.5 Billion As Americans Consume More Marijuana Than
increased in 10 years ^^
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
23, 2021.
(2001-2002 and 2012-2013) 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 4.2%
^^ AHasin DS, Saha TD, Kerridge BT, et al. Prevalence of Marijuana Use Disorders in the
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-
2020040119321#:~:text=According%20to%20a%20recent%20study,4.2%25%20from%20201
5%20to%202018. Accessed Jul 23, 2021.
2019 – Children marijuana 8th - 11.8%
use in the past year @
@NIDA. 2021, April 20. What is the scope of marijuana use in the United States?. Retrieved
from https://www.drugabuse.gov/publications/research-reports/marijuana/what-scope-
10th – 28.8%
marijuana-use-in-united-states Accessed Jul 23, 2021.
12th - 35.7%
12Legal Implications regarding
Medicinal Cannabis at National
Level
Federal Regulations
Objective 2
13Federal 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
allowedFDA Regulation of Cannabis and
Cannabis-Derived Products CBD
Federal Food, Drug and The use in human food of
Not been evaluated or Cosmetic Act
FDA approved 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
people one year and CBD and THC as… • hemp seed protein
older powder
• food additive • hemp seed oil
• Lennox Gastaut • use in human or animal
syndrome (LGS) food
• Dravet Syndrome (DS) • label these as dietary
• Tuberous Sclerosis supplements
Complex (TSC)
FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)Jan 22, 2021. Available at: https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived- 15
products-including-cannabidiol-cbd . Accessed Jul 14, 2021CBD products Quality Control and Labeling Inaccurate labeling 69% of the products did not contain the labeled amount of CBD* Corroon J, Kight R. Regulatory status of cannabidiol in the United States: A ✓36 products (43%) having >10% of the labeled content perspective. Cannabis Cannabiboid Res. 2018;3(1):190-194. ✓22 products (26%) having
FDA Regulation of Cannabis and
Cannabis-Derived Products CBD
• Precautions • Special populations
• Somnolence, irritability, agitation • NO COMPREHENSIVE RESEARCH
• GI distress (diarrhea - human studies) • Pregnancy - High doses
• Liver injury • Reproductive toxicity of developing
• Drug interactions male fetuses (animal studies)
• Pets • Breast feeding
• Reports of potential contaminants (e.g., • Some amount will be transferred to
pesticides, heavy metals, bacteria, and babies through breast milk
fungus)
FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD) Jan 22, 2021. Available at: https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-
cbd . Accessed Jul 14, 2021. 17
Epidiolex (cannabidiol) [package insert]. Carlsbad, CA: Greenwich Biosciences, Inc; 2020FDA Regulation of Cannabis and
Cannabis-Derived Products THC
• Dronabinol - synthetic versions of THC • Decreased plasma testosterone; decreased
• Marijuana smoke contains many of the same sperm count, concentration, and motility*
harmful components as tobacco smoke • Pregnancy
• It can enter the fetal brain from the
mother’s bloodstream
• Research suggests increased risk for
premature birth, low birth weight and
potentially stillbirth
• Breast feeding
• Breastmilk can contain THC for up to 6d
after use and may affect a newborn’s
brain development (hyperactivity, poor
cognitive function, others)
Dalterio SL, deRooij DG. Maternal cannabinoid exposure. Effects on spermatogenesis in male offspring. Int J Androl. 1986 Aug;9(4)
FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)Available at: https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd . Accessed Jul 14,
2021. 18
*National Academies of Science, Engineering and Medicine The health effects of cannabis and cannabinoids: committee conclusions. Published January 2017 Available online http://nationalacademies.org/hmd/~/media/Files/Report%20Files/2017/Cannabis-
Health-Effects/Cannabis-conclusions.pdf . Accessed: Jul 14, 2021DEA Continues to Prioritize Efforts to Expand
Access to Marijuana for Research in the United States
Date Comment
May 14, 2021 To increase opportunities for medical and scientific research.
Review of certain marijuana grower applications, to soon register additional entities authorized
to produce marijuana for research purposes.
Currently, the National Center for the Development of Natural Products at the University of
Mississippi is the only approved supplier of marijuana for research purposes in the US, and that
production has been exclusively for the National Institute on Drug Abuse.
DEA Continues to Prioritize Efforts to Expand Access to Marijuana for Research in the United States (May 14, 2021). Available at: https://www.dea.gov/press-releases/2019/08/26/dea-announces-steps-necessary-improve-access-
marijuana-research .Accessed Jul 14, 2021
19Agriculture Improvement Act “Farm Bill” December 20, 2018
• Industrial hemp - the plant Cannabis sativa L. and any part of
that plant, including the seeds thereof and all derivatives,
extracts, cannabinoids, isomers, acids, salts, and salts of
isomers, whether growing or not, with a delta-9 THC
concentration of not more than 0.3% on a dry weight basis. (not
controlled substance under federal Controlled Substance Act)
• Products
• Food or dietary supplements cannot contain CBD no matter
the source (hemp or marijuana) FD&C Act / FDA
• Market forces*
This Photo by Unknown Author is licensed under CC BY-NC-ND
*Hemp was supposed to boost farmers. It’s turned out to be a flop. Oversupply and a lack of federal rules led to trouble for the industry. (05/ 20/2020)Available at: https://www.politico.com/news/2020/05/25/hemp-
farmers-275046 Accessed Jul 2021
20DEA on
Marijuana Crops,
California
• Unregulated water use from
wells - Aggravates droughts
problems
• Waste lands
• Security
• Industrial growers are moving
to states w/o registering with
local governments and taking
the product out of state,
avoiding taxes
• Marijuana from Mexico
DEA Los Angeles SAC Bill Bodner speaks w/ ABC7 about illegal
Image available at: https://www.latimes.com/local/california/la-me-santa-barbara-pot-grows-20190612-htmlstory.html
marijuana grows & counterfeit Adderall. (June 29, 2021) 21
Available at: https://www.youtube.com/watch?v=poSXdo9VViI
. Accessed Jul 14, 2021.Cannabis Legal Status in United States
• Recreational use
• 19 states: Colorado, Washington, Alaska,
Oregon,, California, Maine, Massachusetts,
Nevada, Michigan, Vermont,, Illinois, Arizona,
Montana, New Jersey, South Dakota, New
York, Virginia, New Mexico, Connecticut
• DC, Guam
• Medicinal use
• 36 states, District of Columbia, Guam, Puerto
Rico and U.S. Virgin Islands have approved
comprehensive, publicly available medical
marijuana/cannabis programs
Image available at: https://www.cosmeticsdesign.com/Article/2019/01/24/Aurora-Cannabis-breaks-into-
Mexico-market-with-acquisition • Some states have laws that limit THC content
or allow CBD oil only
Hansen Claire, Alas Horus. Where Is Marijuana Legal? A Guide to Marijuana Legalization (June 30, 2021). Available at:
https://www.usnews.com/news/best-states/articles/where-is-marijuana-legal-a-guide-to-marijuana-legalization . Accessed Jul 23, 2021 22
State Medical Marijuana Laws. Available at: https://www.ncsl.org/research/health/state-medical-marijuana-laws.aspx . Accessed Jul 23, 2021Pharmacists and Cannabis:
Most states do not specify a defined role for pharmacists
• 7 states include mandated pharmacist involvement: Connecticut, Arkansas, Louisiana, Utah,
Minnesota, New York, and Pennsylvania
• Connecticut - only pharmacists can obtain a medical marijuana dispensary permit (MC -
Schedule II)
• Louisiana- specialty marijuana pharmacy licenses and the Board of Pharmacy providing
oversight (since 2018)
• Minnesota, New York, and Pennsylvania - require a pharmacist on site
• Arkansas - pharmacist consultant for each dispensary, but not necessarily on site
• Pennsylvania - pharmacist or physician on site at the dispensary. Allows a nurse practitioner
or physician assistant when a dispensary has multiple locations.
Vivian JC. Dispensing cannabis. US Pharmacist. https://www.uspharmacist.com/article/dispensing-cannabis .(April 14, 2016). Accessed Jul 11, 2021.
Marijuana pharmacies: the beginning of the licensure process. Louisiana Board of Pharmacy. http://www.pharmacy.la.gov/index.cfm?md=pagebuilder&tmp=home&pid=401 . Accessed Jul 11, 2021.
State of Arkansas. Arkansas Medical Marijuana Amendment of 2016. HB2190. https://www.arkleg.state.ar.us/Acts/Document?type=pdf&act=1024&ddBienniumSession=2017%2F2017R . (March 6, 2017). Accessed Jul 11, 2021.
Gubb SE. Pharmacists' role under Pennsylvania's medical marijuana law. https://cdn.ymaws.com/www.papharmacists.com/resource/resmgr/Legislative/Pharmacists%27_Role_Under_Penn.pdf . Accessed Jul 11, 2021.
Zheng Lili. DEA: Pharmacists dispensing marijuana would be in violation of federal law. (July 11, 2018). Available at: https://kfor.com/news/dea-pharmacists-dispensing-marijuana-would-be-in-violation-of-federal-
law/#:~:text=Marijuana%2C%20a%20schedule%201%20drug,to%20work%20at%20a%20dispensary .Accessed Jul 30, 2021.
Pharmacists tread carefully into the world of medical cannabis Pharmacy Today Available at: https://www.pharmlcytoday.org/article/S1042-0991(17)31966-7/fulltext .(JANUARY 2018) Accessed Jul 30, 2021. 23
Pharmacists and the future of cannabis medicine Schmitz, Natalie et al. Journal of the American Pharmacists Association, Volume 60, Issue 1, 207 - 211Even as several states and Washington - DC, allow medical marijuana
use, the federal government still strictly prohibits it
a. True
b. False
24Legal Implications regarding
Medicinal Cannabis at
Local Level
Ley #42 (9 de julio de 2017)
Ley para manejar el estudio, desarrollo e investigación del cannabis para la innovación, normas aplicables y límites
Reglamento #9038 (2 julio de 2018)
Reglamento para el uso, posesión, cultivo, manufactura, producción, fabricación, dispensación, distribución e
investigación del cannabis medicinal.
Objective 2
25Puerto Rico and Medicinal Cannabis
• Not allowed
• Smoking /exceptions Delito menos grave para aquellos
• Recreational use médicos que autoricen el uso de
• Driving under its effects cannabis medicinal a personas que
• Bona-fide relationship no sufren de una condición
• Patient’s monthly supply identificada por medio de
• Product presentation
reglamentación
• Patient’s follow-up
Ley #42 (9 de julio de 2017)
Ley para manejar el estudio, desarrollo e investigación del cannabis para la innovación, normas aplicables y límites
Reglamento #9038 (2 julio de 2018)
Reglamento para el uso, posesión, cultivo, manufactura, producción, fabricación, dispensación, distribución e investigación del cannabis medicinal.
26Initial Operation Requirements
for Medical Cannabis Dispensaries
in Puerto Rico
Objective 3
27Dispensario de Cannabis Medicinal
Permisología
Departamento de Salud Oficina de Sustancias Controladas
y Cannabis Medicinal
PO Box 70184
San Juan, PR 00936-8184
Tel: 787-765-2929
ext.3504, 3505, 6803 y 6809
Enlace
http://www.salud.gov.pr/dept-de-salud/pages/cannabis-medicinal.aspx
Correo Electrónico
cannabismedicinal@salud.pr.gov
confidenciascannabismedicinal@salud.pr.gov
28Dispensarios
Expedición de Licencia
Reglamento 9038 (2018) Cap. VIII Art 42, p35
La Junta Reglamentadora del Cannabis Medicinal podrá:
• Establecer la cantidad de licencias a expedirse • Recomendar cantidad de licencias a otorgar,
• Regular la cantidad de solicitudes a ser aceptadas velando por el interés del paciente, su oferta y
para dispensario/año natural corriente. Dicho demanda.
parámetro se publicará en o antes de las primeros 15 • Evaluar las licencias de dispensarios
días del año natural
• capacidad económica
• Basado en una proporción pacientes versus y
dispensario emitidas • acceso al paciente
• Considerando las limitaciones geográficas, de
transportación y de acceso que enfrenta la Isla
29Dispensarios
Expedición de Licencia
Reglamento 9038 (2018) Cap. VIII Art 42, p35 • Recomendar cantidad de licencias a otorgar
La Junta Reglamentadora del Cannabis • Interés del paciente
Medicinal (Junta) podrá: • Oferta y demanda
• Establecer la cantidad de licencias a
expedirse • Evaluar las licencias de dispensarios
• Regular la cantidad de solicitudes a ser • Capacidad económica
aceptadas para dispensario/año natural • Acceso al paciente
corriente
• Publicado en o antes de las primeros 15
días del año natural
• Proporción pacientes versus licencias de
dispensario emitidas
• Limitaciones geográficas, de
transportación y de acceso que enfrenta
la Isla
30Dispensario
Licencia/Autorización
Ley #42 (2017) - Cap. I Art 2, p7 Reglamento #9038 (2018) - Cap. XII, Art 58, p72
Reglamento #9038 (2018) - Cap. I Art 5, p8 • Vigencia de la licencia - 1 año
• Licencia o autorización
• emitida por la Junta
Reglamento #9038 (2018) - Cap. I Art 5, p5
• Dispensario autorizado
• toda propiedad comercial donde se
vende cannabis al detal a los pacientes o
a sus acompañantes autorizados e
incluyendo el servicio de entrega a los
pacientes autorizados
31Dispensario
Pago de Derechos
Reglamento #9038 Cap. XXV Art 129, p 148-150
• Los pagos de derechos se realizarán en sellos de rentas internas
• Solicitud de Licencia $5,000.00
• Licencia y Renovación $20,000.00
This Photo by Unknown Author is licensed under CC BY-NC-ND
32Dispensario
Documentación
Reglamento #9038 (2018) Cap. XII, Art 59, p75
• Tener visibles las licencias, permisos y certificaciones
expedidas para propósitos de su operación
• Mantener copia de los procedimientos operacionales
estandarizados internos y un programa de control de
calidad y garantía de calidad
• Protocolos y Procedimientos de Estándares Operacionales
(Standard Operation Procedures (SOP’s)
• Procedimiento sobre las medidas para evitar la
contaminación y mantener la seguridad del producto
33Dispensarios
Seguridad
Reglamento #9038 (2018) - Cap. XII Art
Ley # 42 (2017) - Cap. V Art 17, p 18
60, p 75-76; Cap. XII Art 58, p73
• Iluminación y Limpieza • Herramientas digitales de
• “No entre -Área de Acceso información del paciente
Restringido - Acceso limitado SOLO al • Facilitar la adquisición del cannabis
paciente de Cannabis Medicinal” medicinal en cualquier dispensario,
• Letreros de Entrada y Salida 12“ x pero garantizando que no se exceda
12” mínimo y letras ½”de altura de la cantidad dispuesta por dicho
mínimo reglamento
• Registro de Inventario
• Nombre del empleado que remueve
el producto, el día y hora, la
descripción del producto, nombre y
número de paciente o acompañante
autorizado
• Contrato del Sistema de Rastreo de
This Photo by Unknown Author is licensed under CC BY-SA
Inventario del Departamento de
Salud
34Dispensarios
Seguridad
Ley #42 (2017) - Cap. V Art 17, p18
o Sistemas de vigilancia electrónica
✓ Monitoreado y funcionando 24/7
✓ Transmitiendo video y fotos en vivo
o Centro de comando certificado
Reglamento #9038 (2018) - Cap. IX Art 50, p48; Cap. XII Art 58, p72
o Al menos 1 guardia de seguridad durante el horario de
operaciones y abierto al público
✓ Expediente delictivo
✓ Controlar/Autoriza el acceso al establecimiento
This Photo by Unknown Author is licensed under CC BY-NC-ND
✓ Verificar la tarjeta de identificación del patrocinador 35Dispensarios
Seguridad - Sistema de vigilancia
Mensajes de voz Grabación de El centro de comando Capacidad de
Monitoreo Alarmas
pregrabados videos/fotos 24/7 debe poder recibir… continuar funcionando
• Perímetro • Alarmas de pánico • Sistema programado • Incluyendo los • Transmisión con Pese a interrupción del
con activación para enviar estos a puntos de venta fecha y hora correcta servicio eléctrico
• Sensores de manual agencias de orden de los eventos (sin
movimiento público • Las grabaciones se que se obscurezca la
• "duress alarms” retendrán por un imagen)
• "holdup alarms" mínimo de 90 días
luego del suceso • Mensajes para
alertar sobre fallas
del sistema, dentro
de un máxima de 5
minutos (sistema de
notificación de fallas)
Reglamento #9038 (2018)- Cap. XII Art 58, p72 -73
36Dispensario
Localización y Áreas
Ley #42 (2017) - Cap. V Art 17, p16 Reglamento #9038 - Cap. XII, Art 58, p72 -73
• Localización o la presentación, promoción, • El dispensario debe tener al menos 2 accesos
rotulación o cualquier anuncio de un ÁREAS SEPARADAS CON CONTROLES DE
dispensario - no podrá estar a menos de cien ACCESO
(100) metros de una escuela pública o privada 1.acceso general
y/o centro de cuido
2.área de administración - todos los registros
del establecimiento incluyendo aquellos que
exige este reglamento y se almacenará la
bóveda con el dinero producto de las ventas
3.área de bóveda para almacenamiento de
cannabis medicinal y/o productos derivados
4.acceso restringido de dispensación
5.área de carga
37Dispensario Acceso Reglamento #9038 (2018) • Paciente o acompañante - registro para el uso del Cannabis Medicinal válido y vigente (Cap. II Art 8 p14) Ley #42 (2017) • Paciente residente en PR o acompañante autorizado - identificación emitida por la Junta (Cap. I Art 1, p6; Cap. III Art 13, p14) • Pacientes no residentes en PR - identificación de su jurisdicción (Cap. V Art 17, p16) • No se admiten menores de 21 años (Cap. III Art 10, p13) • No se permite consumir cannabis en el dispensario (MARCO LEGAL QUE This Photo by Unknown Author is licensed under CC BY-SA-NC PROVEE ESTA LEY, p6 y Cap. III Art 10, p13) 38
Medicinal cannabis dispensary requirements
in Puerto Rico include…
a. Tracking system
b. Vaults for money and cannabis
c. Security mechanisms
d. All alternatives are correct
39Training Requirements for Employees of
Medical Cannabis Dispensaries
in Puerto Rico
Objective 4
40Documento en WORD
Reglamento #9038- Cap. XII Art 59, p75 ; Cap. XXV Art 129, p150
Todo propietario de un dispensario de Cannabis Medicinal debe
obtener y retener copia de la documentación que evidencie que
Requisitos de cada dispensador posee
Capacitación de • Adiestramiento de Licencia Ocupacional
• 6 hrs. Educación (3 hrs. /año)
Técnico de • Curso sobre dispensación de Cannabis Medicinal (Curso de
Dispensario Técnico de Dispensario )
• 6 hrs. Educación (3 hrs. /año)
• Licencia ocupacional vigente (2 años)
41Reglamento #9038- Cap. XXV Art 129, p150
• Solicitud para Licencias Ocupacionales de Individuos
• Pago de derechos
• Gerencial $500.00
Requisitos de • Empleado $150.00
Capacitación de
Técnico de
Dispensario
42In Puerto Rico, budtenders or dispensary technicians must have
a minimum academic preparation of (check all that apply):
a. Fourth year of high school
b. Two years of post-secondary studies
c. Bachelor of Science degree
d. One year in some health-related job
43Indications for
Medicinal Cannabis
in Puerto Rico
Ley #42 (9 de julio de 2017)
Ley para manejar el estudio, desarrollo e investigación del cannabis para la innovación, normas aplicables y límites
Reglamento #9038 (2 de julio de 2018)
Reglamento para el uso, posesión, cultivo, manufactura, producción, fabricación, dispensación, distribución e investigación del
cannabis medicinal.
Objective 5
44Indicaciones para uso de Cannabis Medicinal
Condiciones Médicas Debilitantes
Reglamento #9038 - Cap. I Art 5, p 3
Alzhéimer • Desórdenes de Ansiedad (Diagnostic and
Statistical Manual of Mental Disorders)
• Anorexia • Desórdenes relacionados al Virus de la
• Artritis Inmunodeficiencia Humana (VIH)
• Autismo • Enfermedades degenerativas (Esclerosis
Lateral Amiotrófica, Esclerosis Múltiple,
• Cáncer y el tratamiento de quimioterapia para Enfermedad Inflamatoria Intestinal)
el Cáncer • Enfermedades incurables y avanzadas que
• Depresión requieran un cuidado paliativo
• Epilepsia
• Fibromialgia
45Indicaciones para uso de
Cannabis Medicinal, continuación…
• Glaucoma • Síndrome de Inmunodeficiencia Adquirida
• Hepatitis C (SIDA)
• Trastorno Bipolar
• Insomnio
• Lesiones en el Cordón Espinal • Cualquier otra condición que cause caquexia
• Migraña • Dolor crónico
• Náuseas severas o espasmos musculares
• Neuropatías Periferales
persistentes
• Parkinson
• otra que el Cuerpo Asesor Médico
• Síndrome de Estrés Postraumático recomiende y la Junta así lo exprese mediante
Determinación Administrativa.
46The following are heath conditions included in the #9038 bylaws,
except:
a. Anxiety
b. Hepatitis C
c. Chronic pain
d. Attention deficit/hyperactivity disorder
47Medicinal Cannabis
Pharmacologic and
Safety Considerations
Objective 6
48Cannabinoids Pharmacology
Endogenous cannabinoid > 100 cannabinoid
Endocannabinoid system Therapeutic effects
substances compounds*
• Anandamide Active cannabinoids: • Common to all vertebrates • G – Protein coupled
✓1964 - delta-9 and many invertebrates cannabinoid receptors
• 2-arachidonoyl-glycerol (2- tetrahydrocannabinol • CB1 – Central Nervous
AG) (THC) – partial agonist • Present in living organisms System (CNS), most
since 600 million years abundant
• Others: Noladin ether, ✓Cannabidiol ago • CB2 – Immune Cells,
Virodhamine, N- (CBD) – negative immune function,
arachidonyldopamine(NA allosteric modulator inflammation, CNS
DA), Oleamide • Other mechanisms of
action
Mahvan TD et al., Marijuana use in the Elderly: Implications and considerations The Consultant Pharmacist 2017; 32: 341-349.
*National Institutes of Health - National Institute on Drug Abuse. ¿Es la marihuana un medicamento? (July 2015): pages. 1-5.
Melton ST. Stirring the Pot: Potential drug Interactions with Marijuana Published: June 8, 2017. Available online: https://www.medscape.com/viewarticle/881059 Accessed: February 12, 2018. 49
Bianca Calderon, T. J. Sayre,. Cannabidiol Use in Older Adults. Published: March 19, 2020. US Pharmacist https://www.uspharmacist.com/article/cannabidiol-use-in-older-adults . Accessed September 11, 2020.Cannabinoids Receptors: CB1
o THC
Central and o Pain modulation (CNS)
peripheral o Antiemetic
neurons
o Appetite stimulant
GI system Liver o Psychoactivity
o CBD
Connective o Pain modulation (CNS)
tissues, Adipocytes o Anticonvulsant
muscles
CV system Gonads
Mahvan TD et al., Marijuana use in the Elderly: Implications and considerations The Consultant Pharmacist 2017; 32: 341-349.
National Institutes of Health - National Institute on Drug Abuse. ¿Es la marihuana un medicamento? (July 2015): pages. 1-5.
Levinsohn EA, Hill KP. Clinical uses of cannabis and cannabinoids in the United States. J Neurol Sci. 2020 Apr 15;411:116717. doi: 10.1016/j.jns.2020.116717. Epub 2020 Jan 30. PMID: 32044684. 50
Int J Mol Sci. 2018;(19):833. doi:10.3390/ijms19030833.Cannabinoids Receptors: CB2
o THC
o Process of inflammation (Inflammatory
bowel disease, Crohn’s disease)
o Pain pathways (e.g., neuropathic pain)
Immune
o CBD
cells o Process of inflammation
o Pain pathways (e.g., neuropathic pain)
o Mechanism not fully understood
Brain o Multiple Sclerosis - spasticity and
central pain (RCTs)
Mahvan TD et al., Marijuana use in the Elderly: Implications and considerations The Consultant Pharmacist 2017; 32: 341-349.
National Institutes of Health - National Institute on Drug Abuse. ¿Es la marihuana un medicamento? (July 2015): pages. 1-5.
Levinsohn EA, Hill KP. Clinical uses of cannabis and cannabinoids in the United States. J Neurol Sci. 2020 Apr 15;411:116717. doi: 10.1016/j.jns.2020.116717. Epub 2020 Jan 30. PMID: 32044684.
Int J Mol Sci. 2018;(19):833. doi:10.3390/ijms19030833. 51Epilepsy - CBD
Non-Cannabinoid MOAs
1. Decreasing synaptic release of
glutamate
2. Stimulating alpha-3 and alpha-1
glycine receptors
3. Activating 5-HT receptors
4. Altering GABA, adenosine and
norepinephrine signaling
5. Modulation of intra-cellular
calcium through GPR-55, TRPV,
and VDAC
Image available a: https://www.frontiersin.org/files/Articles/345007/fphar-09-00482-HTML/image_m/fphar-09-00482-g001.jpg. Accessed Jul
24, 2021 52Which of the following substances is an endogenous ligand for
the cannabinoid receptor?
a. 2-arachidonoyl-glycerol (2-AG)
b. Anandamide
c. Prostaglandin
d. There is no known endogenous ligand
53What to High quality evidence of cannabis
consider as a Patient’s history of adequate trials with FDA
pharmacist approved drugs
when taking Medical and psychiatric evaluation to identify risk
factors
care of a patient Discuss legal and logistical concerns with using
using Cannabis? cannabis
Challenges during hospitalization
“Start low – go slow – stay low” approach*
*MacCallum CA, Russo EB. Practical considerations in medical cannabis administration and dosing. Eur J Int Med. 2018;49:12-18
54Medicinal Cannabis: Formulations
Administration Labeling
Strength Purity
form Differences
• Inhalation •Different degrees of •Cryptococcus, Mucor, and • THC : CBD ratio might
• Oral strength depending on Aspergillus fungi, and not be specified
Escherichia coli, Klebsiella
• Oromucosal (spray) product and
pneumoniae, and
• Topical - creams, environmental factors Acinetobacter baumannii
ointments, patches, bacteria.
vaginal sprays, and rectal (e.g., bacteria and fungi in
suppositories marijuana samples from
• Food/drinks Northern California
dispensaries)
Mahvan TD et al., Marijuana use in the Elderly: Implications and considerations The Consultant Pharmacist 2017; 32: 341-349.
Barrett J, Assistant Editor. Fungal, Bacterial Contaminants Found in Some Medical Marijuana. Pharmacy Times. (February 15, 2017). Available at:
55
http://www.pharmacytimes.com/news/fungal-bacterial-contaminants-found-in-some-medical-marijuana . Accessed: February 5, 2018Dosage form Onset Duration Comments
Absorption Inhaled Rapid (5-10 min.)
Rapid time to peak and
2-4 hrs. Toxicity -rare
self titration*
Oral Slow (30 min. to 2 hrs.) 4-12 hrs. Toxicity -
Time to peak 1-2 hrs. that increased
can be delayed 6 hrs. due accidental
*Mahvan TD et al., Marijuana use in the Elderly: Implications and
to digestion* overdose*
considerations The Consultant Pharmacist 2017; 32: 341-349. (children and
N. Schmitz, L. Richert / Journal of the American Pharmacists Association 60
(2020) 207e211
adolescents)
Parmar JR, Forrest BD, Freeman RA. Medical marijuana patient counseling Oromucosal 15 to 40 min. 2 to 4 hrs.
points for health care professionals based on trends in the medical uses,
efficacy, and adverse effects of cannabis-based pharmaceutical drugs. Res
Social Adm Pharm. 2016 Jul-Aug;12(4):638-54. doi:
(CBD)
10.1016/j.sapharm.2015.09.002. Epub 2015 Sep 16. PMID: 2644347
Tincture 30 min. 4-6 hrs.
**National Academy of Sciences (Health and Medicine Division): The Health
Effects of Cannabis and Cannabinoids: The Current State of Evidence and (THC:CBD)
Recommendations for Research. January 12, 2017. Accessed at
https://www.nap.edu/catalog/24625/the-health-effects-of-cannabis-and-
cannabinoids-the-current-state
Rectal use 1-2 hrs. 4-8 hrs.
Suppositories
Topical use 15-30 min.** 2 hrs. CBD
• Patch accumulates in
• Cream adipose tissue
• Spray 56EFFECT OF CANNABINOIDS ON DRUG-METABOLIZING
ENZYME CYTOCHROME P450
Cannabinoid Substrate Inhibit Induce
THC 2C9 2B6 1A2
Distribution 2C19
3A4
2C9
2D6
95-99% protein bound 3A4
CBD 2C9 1A1
3A4 1A2
Metabolism 1B1
2B6
Liver 1st pass: 11-OH-THC and CBD 2C9
Interactions 2C19
2D6
3A4
Parmar JR, Forrest BD, Freeman RA. Medical marijuana patient counseling points for health care professionals based on trends in
the medical uses, efficacy, and adverse effects of cannabis-based pharmaceutical drugs. Res Social Adm Pharm. 2016 Jul-
Aug;12(4):638-54. doi: 10.1016/j.sapharm.2015.09.002. Epub 2015 Sep 16. PMID: 2644347
Cannabis 1A2
Bianca Calderon, T. J. Sayre. Cannabidiol Use in Older Adults. Published: March 19, 2020. US Pharmacist (smoked) 3A4
https://www.uspharmacist.com/article/cannabidiol-use-in-older-adults . Accessed September 11, 2020
57Elimination • THC - Occurs over several days
• THC
20% to 35% in urine
65% to 80% in feces
• CBD - most unchanged in feces
58
Lemberger L, Axelrod J, Kopin IJ. Metabolism and disposition of delta-9-tetrahydrocannabinol in man. Pharmacol Rev. 1971;23:371–380.
Goulle JP, Saussereau E, Lacroix C. Delta-9-tetrahydrocannabinol pharmacokinetics] Ann Pharm Fr. 2008;66:232–244.Adverse effects
to consider if a patient using Cannabis
CNS
anxiety, panic attacks, CARDIOVASCULAR
psychosis, dysphoria, EYES
tachycardia, bradycardia, Cannabis hyperemesis
drowsiness, dizziness, vertigo, Dry mouth reddened eyes, changes in
increased blood pressure, syndrome
ataxia, difficulty in visual perception
orthostasis
concentration, euphoria,
impaired motor skills
LOW RISK OF OVERDOSE AND
DEATH REPORTS:
RESPIRATORY SYSTEM increased risk of heart failure,
Immunosuppression Changes in blood glucose Increased risk of bleeding
cough and bronchitis (smoked) stroke, coronary artery disease,
sudden cardiac death, and
hypertension
Parmar JR, Forrest BD, Freeman RA. Medical marijuana patient counseling points for health care professionals based on trends in the medical uses, efficacy, and adverse effects of cannabis-based pharmaceutical drugs. Res Social Adm Pharm. 2016 Jul-Aug;12(4):638-
54. doi: 10.1016/j.sapharm.2015.09.002. Epub 2015 Sep 16. PMID: 2644347.
National Academies of Science, Engineering and Medicine The health effects of cannabis and cannabinoids: committee conclusions. Published January 2017 Available online http://nationalacademies.org/hmd/~/media/Files/Report%20Files/2017/Cannabis-Health-
59
Effects/Cannabis-conclusions.pdf . Accessed: Jul 14, 2021Medicinal Cannabis: Contraindications
Absolute contraindications Relative contraindications
• Allergies • Severe cardiovascular,
• Acute psychosis and immunological, liver, or
other unstable psychiatric kidney disease, especially
conditions in acute illness
• Cannabis may exacerbate
arrhythmia or a history of
arrhythmias
This Photo by Unknown Author is licensed under CC BY-ND
60
Perwee R. Handbook of Cannabis (Handbooks in Psychopharmacology) Reprint Edition 2015
Government of the District of Columbia, Department of Health. Medical Cannabis Adverse Effects & Drug Interactions. (Dec 22, 2015). Available at:
https://doh.dc.gov/sites/default/files/dc/sites/doh/publication/attachments/Medical%20Cannabis%20Adverse%20Effects%20and%20Drug%20Interactions_0.pdf Accessed Jul. 30, 2021FDA approved Cannabinoid Products
Cannabinoid Dosage Form Schedule Dose Indication
Synthetic delta-9-THC tablets /capsules III 2.5–10 mg oral chemotherapy induced nausea and
vomiting -
liquified dronabinol II l5 mg/mL oral cachexia related to HIV (AIDS) or
solution cancer
Nabilone capsules II 1 – 2 mg twice chemotherapy-induced nausea and
synthetic cannabinoid daily for adults vomiting
(similar to THC) 0.5 –1 mg twice cachexia related to HIV or cancer
daily for pediatric antiemetic and analgesic for
patients neuropathic pain
Cannabidiol pure plant derived 100 V weight-based childhood seizures (1yr. and older)
mg/mL of pure CBD dosing from Patient Medication Guide
extract (sesame oil) 5mg/kg/day to of
20 mg/kg/day max.
Mahvan TD et al., Marijuana use in the Elderly: Implications and considerations The Consultant Pharmacist 2017; 32: 341-349.
Levinsohn EA et al. Clinical uses of cannabis and cannabinoids in the United States. Journal of the Neurological Sciences 411 (2020) 116717
Rubin R. The path to the first FDA-approved cannabis-derived treatment and what comes next. JAMA. 2018;320(12):1227-1229.
Cannabidiol [package insert]. Carlsbad, CA: Greenwich Biosciences, Inc; 2020 61England and Canada approved
Cannabinoid Product
Cannabinoid Dosage Form Dose Indication
Nabiximols oromucosal spray 4-8 sprays daily neuropathic pain*, spasticity* and
standardized extract of 27mg/mL THC+ 25mg/mL CBD Most patients require 12 overactive bladder, among others
tetrahydrocannabinol sprays or less; dosage
(THC), cannabidiol should be adjusted as
(CBD), other minor needed and tolerated.
cannabinoids
Mahvan TD et al., Marijuana use in the Elderly: Implications and considerations The Consultant Pharmacist 2017; 32: 341-349.
GW Pharma LTD. PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION. (Rev. Dec 11, 2019) Available at: https://omr.bayer.ca/omr/online/sativex-pm-
en.pdf. Acceded Aug 3, 2021
62Evidence Based Medicine and Cannabis
Indication Evidence Comments
Chronic pain in adults (cannabis)* Conclusive/ Risk vs Benefit
Substantial Opiates vs Cannabis
* ** 64% reduction in use of opioids***
Medicare D
Depressive symptoms Ineffective
in patients with chronic pain*
(nabiximols, dronabinol, nabilone)
*National Academies of Science, Engineering and Medicine The health effects of cannabis and cannabinoids: committee conclusions. Published January 2017 Available online
http://nationalacademies.org/hmd/~/media/Files/Report%20Files/2017/Cannabis-Health-Effects/Cannabis-conclusions.pdf Accessed: February 14, 2018
**National Institutes of Health - Marijuana and Cannabinoids: A Neuroscience Research Summit. 2016 NIH Campus, Bethesda, Maryland Available online: https://www.drugabuse.gov/sites/default/files/briefmjsummitmeetingsummary.pdf
Accessed: April 16, 2018.
63
***Boehnke KF, Litinas E, Clauw, DJ. Medical cannabis use is associated with decreased opiate medication use in a retrospective cross-sectional survey of patients with chronic pain. J Pain. 2016;17(6):739–44Evidence Based Medicine and Cannabis
HIV related to
Neuropathic pain Diabetic neuropathy
neuropathic pain
• Vaporized cannabis • Inhaled cannabis • Smoked cannabis (1ry therapy)
• Central neuropathic pain • Spontaneous patient pain rating • Reduced central, peripheral and
(spinal cord injury and disease) • Dose-dependent reduction in HIV-associated neuropathic
• Reduced pain - rating scale pain pain
• No evidence of a dose- • RTCs • RTCs
dependent effect
• UNKNOWN effective analgesic
combination THC:CBD
• NO RTCs
WHO Expert Committee on Drug Dependence Pre-Review. Cannabis plant and cannabis resin
Section 4: Therapeutic use (2018). Available at: https://www.who.int/medicines/access/controlled-substances/Section4.CannabisPlant.TherapeuticUse.pdf . Accessed Jul 30, 2021. 64Evidence Based Medicine and Cannabis
This Photo by Unknown Author is licensed
under CC BY-NC
Indication Evidence Comments
Nausea/Vomiting Limited THC (dronabinol tablets, nabilone)
in HIV and cancer patients
Nausea/Vomiting due to Moderate Oral cannabinoids effective as anti-emetics *
chemotherapy Ondansetron vs Cannabis (survey: both effective) **
*National Academies of Science, Engineering and Medicine The health effects of cannabis and cannabinoids: committee conclusions. Published January 2017. Available online http://nationalacademies.org/hmd/~/media/Files/Report%20Files/2017/Cannabis-Health-
Effects/Cannabis-conclusions.pdf Accessed: February 14, 2018
*Olivier Beauchet. Medical cannabis use in older patients: Update on medical knowledge. Maturitas 118 (2018) 56–59
65
**Zikos, T.A., Nguyen, L., Kamal, A. et al. Marijuana, Ondansetron, and Promethazine Are Perceived as Most Effective Treatments for Gastrointestinal Nausea. Dig Dis Sci 65, 3280–3286 (2020). https://doi.org/10.1007/s10620-020-06195-5Evidence Based Medicine
and Cannabis - Multiple Sclerosis
https://www.webconsultas.com/esclerosis-multiple/sintomas-de-la-esclerosis-multiple-317
Painful spasms /
Spasticity Symptoms Central pain Bladder frequency**
Neuropathic pain**
Oral cannabis extract Conclusive evidence Limited evidence
(nabiximols) and patient reported* clinician measured*
orally administered,
THC appear to be the
most effective
cannabinoid
*National Academies of Science, Engineering and Medicine The health effects of cannabis and cannabinoids: committee conclusions. Published January 2017 Available online
http://nationalacademies.org/hmd/~/media/Files/Report%20Files/2017/Cannabis-Health-Effects/Cannabis-conclusions.pdf Accessed: February 14, 2018
National Institutes of Health - Marijuana and Cannabinoids: A Neuroscience Research Summit. 2016 NIH Campus, Bethesda, Maryland Available online:
https://www.drugabuse.gov/sites/default/files/briefmjsummitmeetingsummary.pdf Accessed: April 16, 2018. 66
**Schrot RJ, Hubbard JR. Cannabinoids: Medical implications. Ann Med. 2016;48(3):128-141.Evidence Based Medicine
and Cannabis - Epilepsy
Useful for 30% of
Limited evidence
refractory patients
Adults (-) Children (+)
Dravet Syndrome, Lennox- CB1 activity
Gastaut Syndrome, Doose Side effects: cognitive &
Syndrome behavioral
National Institutes of Health - Marijuana and Cannabinoids: A Neuroscience Research Summit. 2016 NIH Campus, Bethesda, Maryland Available online: https://www.drugabuse.gov/sites/default/files/briefmjsummitmeetingsummary.pdf Accessed: April 16, 2018. 67Evidence Based Medicine and Cannabis
Image available at:
http://seniorcarecorner.com/good-night-sleep-
seniors
Indication Evidence Comments
Improving short-term sleep Moderate Cannabinoids, primarily nabiximols
outcomes in individuals with sleep
disturbance associated with… The quality of sleep achieved with cannabis may be
• obstructive sleep apnea syndrome poor ***
• fibromyalgia
• chronic pain
• multiple sclerosis
Image available at: http://seniorcarecorner.com/good-night-sleep-seniors
National Academies of Science, Engineering and Medicine The health effects of cannabis and cannabinoids: committee conclusions. Published January 2017 Available online
http://nationalacademies.org/hmd/~/media/Files/Report%20Files/2017/Cannabis-Health-Effects/Cannabis-conclusions.pdf Accessed: February 14, 2018
*** WHO Expert Committee on Drug Dependence Pre-Review .Cannabis plant and cannabis resin. Section 4: Therapeutic use 2018 68Evidence Based Medicine and
Cannabis – Anorexia and Weight Loss
This Photo by Unknown Author is licensed under CC BY
Indication Study type Evidence Comments
AIDS associated RTC w Limited* ** Dronabinol and smoked cannabis
anorexia and placebo significantly greater weight gain than
weight loss (THC) n=67 ** administration of a placebo**
*National Institutes of Health - Marijuana and Cannabinoids: A Neuroscience Research Summit. 2016 NIH Campus, Bethesda, Maryland Available online:
https://www.drugabuse.gov/sites/default/files/briefmjsummitmeetingsummary.pdfF Accessed: April 16, 2018.
** WHO Expert Committee on Drug Dependence Pre-Review. Cannabis plant and cannabis resin
Section 4: Therapeutic use (2018). Available at: https://www.who.int/medicines/access/controlled-substances/Section4.CannabisPlant.TherapeuticUse.pdf . Accessed Jul 30, 2021.
69Evidence Based Medicine and
Cannabis - Opioids
Can cannabis treat opioid withdrawal and reduce opioids related deaths?**
Opioids or cannabis for pain control * ***
Approximately 9% of those who use cannabis will develop dependence****
Among those who use cannabis regularly, up to 30% percent would have
cannabis use disorder. (DSM-V) ****
* Olfson M. et al., Cannabis Use and Risk of Prescription Opioid Use Disorder in the United States. American Journal of Psychiatry January 2018, Vol. 175, No. 1, pp. 47 – 53
** Shover CL, Davis CS, Sanford C, et al. Association between medical cannabis laws and opioid overdose mortality has reversed over time. Proc Natl Acad Sci U S A. 2019;116(26):12624–6.
*** WHO Expert Committee on Drug Dependence Pre-Review .Cannabis plant and cannabis resin. Section 4: Therapeutic use 2018
****Hasin DS, Saha TD, Kerridge BT, et al. Prevalence of marijuana use disorders in the United States between 2001–2002 and 2012– 2013. JAMA Psychiatry. 2015;72(12):1235–42.
70Other Indications Indication Study type Administration Form Evidence Comment
with Limited PTSD RCT w placebo2 Smoked cannabis Poor No significant difference
Evidence Systematic review6 Various Very
scant
evidence
Prospective study Various Poor Insufficient evidence
Cannabis users vs
non users3
1 National Academies of Science, Engineering and Medicine The health
A Review of Clinical Nabilone Limited 72% reported total
effects of cannabis and cannabinoids: committee conclusions. Published
January 2017 Available online
Effectiveness and cessations or lessening of
http://nationalacademies.org/hmd/~/media/Files/Report%20Files/2017/Can
nabis-Health-Effects/Cannabis-conclusions.pdf Accessed: February 14, 2018
Guidelines4 severity of recurrent
2 Bonn-Miller MO, Sisley S, Riggs P, Yazar-Klosinski B, Wang JB, Loflin MJE, et
nightmares
al. (2021) The short-term impact of 3 smoked cannabis preparations versus
placebo on PTSD symptoms: A randomized cross-over clinical trial. PLoS ONE Tourette’s Small trials1 THC 10mg max., Limited therapeutic effects of
16(3): e0246990. https://doi.org/10.1371/journal.pone.0246990
syndrome THC capsules THC capsules on tic
3 Marcel O. Bonn-Miller, Megan Brunstetter, Alex Simonian, Mallory J. Loflin,
Ryan Vandrey, Kimberly A. Babson, and Hal Wortzel. Cannabis and capsules/placebo severity and global
Cannabinoid Research.ahead of print http://doi.org/10.1089/can.2020.0056
clinical outcomes
4 Cowling T, MacDougall D. Nabilone for the Treatment of Post-Traumatic
Stress Disorder: A Review of Clinical Effectiveness and Guidelines [Internet]. Anxiety Systematic review 5 CBD capsule or Limited General anxiety disorder,
Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019
Feb 20. PMID: 31553551. and sublingual spray as social anxiety disorder,
5 Skelley, Jessica W. et al. Use of cannabidiol in anxiety and anxiety-related anxiety- either monotherapy anxiety related to PTSD
disorders (2019) Journal of the American Pharmacists Association, Volume 60,
Issue 1, 253 – 261 DOI: https://doi.org/10.1016/j.japh.2019.11.008 related or adjunctive
6 O'Neil ME, Nugent SM, Morasco BJ, Freeman M, Low A, Kondo K, Zakher B, disorders therapy 400mg max
Elven C, Motu'apuaka M, Paynter R, Kansagara D. Benefits and Harms of
Plant-Based Cannabis for Posttraumatic Stress Disorder: A Systematic Review.
Ann Intern Med. 2017 Sep 5;167(5):332-340. doi: 10.7326/M17-0477. Epub
2017 Aug 15. PMID: 28806794. 71Potential for Drug Diversion
Marijuana Effects in Children and Adolescents
https://www.drugabuse.gov/video
s/reward-circuit-how-brain-
responds-to-marijuana
Addiction
https://youtu.be/s27f7Jzy2k0
• Cannabis has addictive
potential and may lead
Cognitive to other drug use
Impairment ** disorders***
Mental Illness* • Greater cognitive
impairment if cannabis
• Decreased memory use is frequent and
Potentially • Decreased attention early in life
detrimental to • Lower IQ
• Impaired decision
fetus making
• THC – mice
*National Institutes of Health - The Adolescent Brain Cognitive Development (ABCD) Study. Available online: https://www.drugabuse.gov/news-events/nida-notes/2017/06/researchers-speak-abcd-study Accessed: April 16, 2018.
**Poulton, R., Moffitt, T. E., & Silva, P. A. (2015). The Dunedin Multidisciplinary Health and Development Study: overview of the first 40 years, with an eye to the future. Social Psychiatry and Psychiatric Epidemiology, 50(5), 679–693. http://doi.org/10.1007/s00127-015-
1048-8
*** National Institutes of Health - Marijuana and Cannabinoids: A Neuroscience Research Summit. 2016 NIH Campus, Bethesda, Maryland Available online: https://www.drugabuse.gov/sites/default/files/briefmjsummitmeetingsummary.pdf Accessed: April 16, 2018.72
***Levinsohn EA, Hill KP. Clinical uses of cannabis and cannabinoids in the United States. J Neurol Sci. 2020 Apr 15;411:116717. doi: 10.1016/j.jns.2020.116717. Epub 2020 Jan 30. PMID: 32044684.Marijuana and ethanol
Binge drinking
Substance use disorder
(especially alcoholism)
Major depressive disorder This Photo by Unknown Author is licensed under CC BY-NC-ND
National Institutes of Health - Marijuana and Cannabinoids: A Neuroscience Research Summit. 2016 NIH Campus, Bethesda, Maryland Available online: 73
https://www.drugabuse.gov/sites/default/files/briefmjsummitmeetingsummary.pdf Accessed: April 16, 2018.Motor Vehicle Accidents and Marijuana Use
WHO
8,700 traffic deaths worldwide (JAMA April 2018)
Cannabis is the most common illicit Blood level as low as 1-2 mcg/L
drug identified in motor vehicle
crashes and fatalities in US* Cannabis 1.5 -2,5 x motor vehicle crashes or deaths**
Cannabis + Alcohol The THC threshold is under study
*National Highway Traffic Safety Administration, National Forensic Laboratory Information System- Marijuana –Impaired Driving: A Report to the Congress. Published: July 2017. Available online: https://www.nhtsa.gov/sites/nhtsa.dot.gov/files/documents/812440-marijuana-impaired-driving-report-to-
congress.pdf .Accessed: April 16, 2018.
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