THERAPEUTIC USE OF CANNABIDIOL

To support continued research and to provide education on the therapeutic uses, adverse effects, and drug interactions of cannabidiol (CBD); further,

To oppose use of CBD-containing products not regulated by the Food and Drug Administration; further,

To advocate for enhanced public education regarding safe use of CBD-containing products. 

Rationale

In June 2018, the Food and Drug Administration (FDA) approved Epidiolex, an oral solution containing cannabidiol (CBD), for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. Epidiolex is the first prescription formulation of highly purified component of the Cannabis sativa plant. Because it does not contain a significant amount of tetrahydrocannabinol, the intoxicating substance in Cannabis sativa, in September 2018 the Drug Enforcement Administration placed Epidiolex in schedule V of the Controlled Substances Act (CSA), the least restrictive schedule of the Act.

Given the patchwork of state legislation regarding recreational and medical cannabis, there is a robust but largely unregulated industry in cannabis derivatives, including products promoted as containing CBD. These formulations range from lotions for topical application to oils for enteral consumption, and their components and CBD concentrations vary, leading to questions about their safety. FDA has issued over 40 warning letters to firms marketing products that allegedly contain CBD. As part of these actions, FDA has tested the chemical content of cannabinoid compounds in some of the products, finding that many do not contain the levels of CBD claimed.

With CBD’s easy availability came spurious claims regarding its efficacy in treating a number of maladies. Faced with the unique challenge of regulating an approved drug and widely available formulations of a similar product, FDA is currently considering a two-pronged approach that would:

1. regulate products that make therapeutic claims as new drugs, evaluating them for both safety and efficacy (e.g., Epidiolex); and
2. allow the continued marketing of CBD-containing products that do not make therapeutic claims, with limited regulation for safety (e.g., as dietary supplements).

ASHP opposes use of CBD-containing products not regulated by FDA in research and patient care. Further, due to concerns that patients may substitute unapproved cannabis-derivative products for the FDA-approved drug or confuse the two, ASHP advocates for enhanced patient and public education regarding safe use of CBD-containing products, and encourages pharmacists take a leadership role in those efforts. ASHP encourages research on the potential therapeutic uses, adverse effects, and drug interactions of CBD, and is committed to providing education to pharmacists and other healthcare providers on those topics.