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Although is unlikely that CBD products would be added
to formulary or otherwise procured and distributed by the
health system, the health system may decide to allow patients
to bring in and use their own CBD products under a Patient's
Own Medication (POM) policy. In a recent survey within our
health system, providers indicated that they were generally
in favor of POM use of CBD products if deemed appropriate
by their medical provider and that they should be treated in
the same manner as herbals or dietary supplements. Joint
Commission standards dictate that products brought into the
institution by patients are to be identified prior to administration and visually inspected for their integrity.6 However,
there are unique challenges to identification of CBD products in that it is well documented that CBD product labeling
may not accurately reflect the CBD and THC content.7,8 In
addition, impurities such as pesticides and heavy metals have
been identified.9 This may unknowingly put a health system
at risk of penalties due to violation of state and federal regulations. Furthermore, caution should be taken to ensure that
POM use of CBD products is operationalized in a manner
that can be construed as prescribing. For example, if a provider places a POM order within the electronic medical
record so that the product shows up on the Medication
Administration Record (MAR) and can be documented as
given, that may technically be interpreted as prescribing and
administering a product which may be a violation of the CSA
depending on the THC content of the product. Beyond an
institution's POM policy, a CBD-specific policy may be warranted to address these unique challenges as well as to outline appropriate storage and disposal requirements to ensure
that products are handled in a secure manner as some CBD
products come in forms (i.e., cookie, gummy bears) that may
unknowingly lead to inadvertent exposure. Although it is
likely that pharmacy will take a primary role in CBD-related
policy development, it is imperative that other stakeholders
such as regulatory and risk departments be involved to
address the unique challenges regarding the use of non-FDA
approved CBD products within the health system.
On June 25, 2018, the FDA approved CBD (Epidiolex)
for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients at or
above 2 years of age.10 This marks the first FDA-approved
drug with an active ingredient derived from cannabis.11
Epidiolex contains trace amounts of THC (≤0.1% w/w;
≤0.01% in final product)12 and is classified as Schedule V
under the CSA.10 Consequently, the FDA has taken a clear
stance that CBD products do not meet the definition of a
dietary supplement as under the FD&C Act a dietary supplement cannot contain the same active ingredient as an
FDA-approved drug.3 This approval provides an opportunity for better characterization of possible drug interactions, adverse effects, and monitoring requirements that
may be associated with the use of CBD products. For example, Epidiolex labeling requires serum transaminase and
total bilirubin levels be monitored prior to and throughout

Hospital Pharmacy 55(1)
treatment for early identification and management of possible hepatocellular injury which is more common with
concomitant use of valproate and clobazam.10 However, it
must be considered that non-FDA approved CBD products
may likely contain unlabeled ingredients and impurities
that may lead to unknown risks.
To effectively advise the health care team as to the appropriate use of CBD products for specific indications, use in
special populations, management of drug interactions, and
identification of possible adverse reactions, pharmacists will
be called upon to apply their expertise in evaluating the rapidly growing body of medical literature beyond the use of
traditional drug information resources. In addition, pharmacists should be prepared to counsel patients with evidencebased information to inform them of possible risks and
counter the marketing messages that so prevalently tout CBD
products as a cure-all without risk.3,9
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect
to the research, authorship, and/or publication of this article.

Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iD
Jennifer L. Dill

https://orcid.org/0000-0002-5292-3064

References
1. National Academies of Sciences, Engineering, and Medicine.
The Health Effects of Cannabis and Cannabinoids: The
Current State of Evidence and Recommendations for Research.
Washington, DC: The National Academies Press; 2017.
2. Comprehensive Drug Abuse Prevention and Control Act, Pub
L 91-513, 84 Stat 1236 1970.
3. Food and Drug Administration. FDA regulation of cannabis
and cannabis-derived products: questions and answers. https://
www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-questions-andanswers. Accessed June 12, 2019.
4. Kansas Legislature. Senate Bill No. 282. http://www.kslegislature.org/li_2018/b2017_18/measures/SB282/. Accessed June
12, 2019.
5. Kansas Legislature. House Bill. No. 2244. http://www.kslegislature.org/li/b2019_20/measures/HB2244/. Accessed June 12,
2019.
6. The Joint Commission. MM.03.01.05. https://e-dition.jcrinc.
com/MainContent.aspx. Accessed July 17, 2019.
7. Food and Drug Administration. Warning letters and test results
for cannabidiol-related products. https://www.fda.gov/newsevents/publichealthfocus/ucm484109.htm. Accessed April 8,
2019.
8. Bonn-Miller MO, Loflin MJE, Thomas BF, Marcu JP, Hyke
T, Vandrey R. Labeling accuracy of cannabidiol extracts sold
online. JAMA. 2017;318(17):1708-1709.

https://www.orcid.org/0000-0002-5292-3064 https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-questions-and-answers https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-questions-and-answers https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-questions-and-answers https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-questions-and-answers http://www.kslegislature.org/li_2018/b2017_18/measures/SB282/ http://www.kslegislature.org/li_2018/b2017_18/measures/SB282/ http://www.kslegislature.org/li/b2019_20/measures/HB2244/ http://www.kslegislature.org/li/b2019_20/measures/HB2244/ https://e-dition.jcrinc.com/MainContent.aspx https://e-dition.jcrinc.com/MainContent.aspx https://www.fda.gov/newsevents/publichealthfocus/ucm484109.htm https://www.fda.gov/newsevents/publichealthfocus/ucm484109.htm

Hospital Pharmacy - February 2020

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