This month, we provide responses to frequently asked questions on the use and access to products containing cannabidiol (CBD). With the legalizing of medical marijuana (cannabis) in many states and the explosion of products openly marketed with claims of containing CBD, this has become a popular patient and caregiver inquiry of hospice professionals. We encourage you to download this month’s case study to share with your colleagues or continue reading below.
WHAT IS CANNABIDIOL (CBD)?
Cannabidiol (CBD) is a phytocannabinoid and is 1 of over 100 identified cannabinoids extracted from cannabis plants, accounting for up to 40% of a plant’s extract. Phytocannabinoids are naturally occurring chemical compounds secreted by plants with potential medical benefits.1
WILL CBD CAUSE EUPHORIA IN MY PATIENT?
CBD lacks the euphoric, properties that are characteristic of tetrahydrocannabinol (THC), which is the main psychoactive substance in marijuana.2
WHAT IS THE DIFFERENCE BETWEEN “HEMP” AND “MARIJUANA”?
Hemp and marijuana are both types of cannabis plants. Both varieties contain CBD, but marijuana plants contain higher amounts of THC. Until recently, both variations of cannabis were classified as Schedule 1 Controlled Substances (CIs) by the U.S. Drug Enforcement Administration (DEA). Substances classified as CI have a high abuse potential and have no currently accepted medical use in the U.S. In late 2018, the Agriculture Improvement Act of 2018 (a.k.a., farm bill),2 incorporating provisions of the proposed Hemp Farming Act of 2018 (H.R. 5485), became law and allows for legal production, sale and consumption of CBD in the U.S. The act defined “industrial hemp” as containing less than 0.3% THC and allowed for its removal from the list of CIs.3
WHAT IS THE DIFFERENCE BETWEEN “CBD OIL” AND “HEMP SEED OIL”?
CBD is commonly supplied as an oil with cannabidiol as the only active ingredient. CBD oil that is considered legal in all 50 states is produced from hemp plants. However, CBD oil can be produced from THC and non-THC containing cannabis. Hemp oil is produced by pressing hemp seeds and collecting the oil contained within the seed. Hemp seed oil and CBD oil are not equivalent products; hemp seed oil does not contain any appreciable amount of cannabidiol. In addition, a high-quality CBD oil, from a reputable manufacturer, will be more expensive than hemp seed oil.4
IS IT LEGAL FOR MY PATIENT TO USE PRODUCTS THAT CONTAIN CBD?
Yes. CBD-containing products are currently legal to purchase and consume in all 50 states because of the Agriculture Improvement Act of 2018 (a.k.a., farm bill). The law states that federally legal CBD containing products must be produced from “industrial hemp”, or a cannabis plant that naturally contains less than 0.3% THC.2
ARE CBD-CONTAINING PRODUCTS REGULATED BY THE FDA?
As of April 2020, the U.S. Food & Drug Administration (FDA) has approved only one CBD-containing product, Epidiolex®, for treatment of seizures in pediatric patients with either Lennox-Gastaut syndrome or Dravet syndrome. Aside from Epidiolex®, the FDA does not regulate CBD or hemp production. As such, it is unlawful for CBD product labeling to make claims suggesting the potential to prevent, treat or cure disease or manage symptoms. For patients wishing to use CBD for its perceived health benefits, it is important to discuss these intentions with the patient’s prescriber before proceeding.5 It is recommended that prescribers do their research on the websites of CBD product makers, ensuring a certificate of analysis is posted and updated regularly.6
WHAT ARE THE POTENTIAL BENEFITS FROM USING CBD?
It is important to note that while CBD is believed to palliate several symptoms experienced by patients with advanced illness, it is only indicated (as determined by the FDA) for treatment of seizures in pediatric patients. Nevertheless, it is most commonly utilized for its potentially anti-inflammatory and anxiolytic properties and has several other proposed benefits:3
- Opioid dependence
ARE THERE RISKS ASSOCIATED WITH CBD?
The safety and efficacy of CBD have not been evaluated by large scale studies. Potential risks associated with its use are derived from small studies, case reports and expert opinions and include the side effects nausea, fatigue and irritability. Like any vitamin or supplement, it is important to consult with a physician, nurse or pharmacist before making CBD part of a treatment plan.7
WHAT ARE POTENTIAL DRUG INTERACTIONS ASSOCIATED WITH CBD?
CBD is an inhibitor of one or more enzymes of the cytochrome P450 system that plays a key role in metabolism of drugs and other substances in the liver. CBD has been shown to slow the metabolism of certain medications causing them to have an increased level in the body. For example, patients using clobazam (Onfi®) or valproate (Depakene®) should not take CBD. CBD also has the potential to slow the metabolism of warfarin (Coumadin®).8
WHAT DOSE OF CBD IS RECOMMENDED?
The FDA-labeled dosage range of Epidiolex® to manage pediatric seizures is 5mg/kg/day to 20mg/kg/day.9 However, the optimal dose of CBD for unlabeled symptoms or conditions is unknown. Currently, there are no dose-confirming studies for pain, nausea, or anxiety. Data from some studies suggest a range from 15mg to 900mg, in various formulations. When initiating CBD it is suggested to start at a low dose and slowly increase until symptom relief is attained.10
- Alcohol & Drug Abuse Institute at the University of Washington. Learn About Marijuana. Updated June 2013. Available from: https://adai.uw.edu/marijuana/factsheets/cannabinoids.htm
- gov. H.R.2 – Agriculture Improvement Act of 2018. Updated December 12, 2018. Available from: https://www.congress.gov/bill/115th-congress/house-bill/2
- Ohio Marijuana Card & The Ohio Medical Alliance. What is THC & CBD in Marijuana? Updated 2020. Available from: https://www.ohiomarijuanacard.com/thc-vs-cbd
- Johnson J. Hemp Oil Benefits List. Medical News Today. Published February 14, 2019. Available from: https://www.medicalnewstoday.com/articles/324450
- S. Food & Drug Administration (FDA). What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD. Updated March 5, 2020. Available from: https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis
- Coombs A, Martinez DM. A Physician’s Guide to the Cannabidiol Craze. Medscape Perspective – Columbia University Psychiatry. Published May 31, 2019. https://www.medscape.com/viewarticle/913273
- Grinspoon, P. Cannabidiol (CBD), what we know and what we don’t. Harvard Health Publishing, Harvard Medical School. Published August 24, 2018. Available from: https://www.health.harvard.edu/blog/cannabidiol-cbd-what-we-know-and-what-we-dont-2018082414476
- Alsherbiny, MA. Guang Li, C. Medicinal Cannabis – Potential Drug Interactions, Medicines. 2019;(6)1:3.
- Epidiolex® Full Prescribing Information. Carlsbad, CA: Greenwich Biosciences Inc, 2018. https://www.epidiolex.com/
- Christensen A, Pruskowski J. Fast Facts and Concepts #370: The role of cannabidiol (CBD) in palliative care. Published December 2018. Available from: https://www.mypcnow.org/fast-fact/the-role-of-cannabidiol-cbd-in-palliative-care/