Despite legal restrictions and insufficient regulation, the market for CBD oil is booming.
CBD-cannabidiol-is suddenly everywhere and is being touted as a cure-all ingredient in lotions, tinctures, salves and balms. The dramatic proliferation of CBD products has led analysts at the Brightfield Group to predict the market will reach $22 billion by 2022, “outpacing the rest of the cannabis market combined.”
CBD oil is a booming business, but is it legal? That depends. Should pharmacists recommend CBD oil? That depends, too.
The variables involved in answering both questions includes the evolving and often puzzling patchwork of state and federal laws that govern products made from the cannabis plant. “You’ve got all sorts of state laws with some states approving marijuana, some only medically, some medically and recreationally, and some approving only certain products ” said Timothy Welty, PharmD, professor of pharmacy practice at the College of Pharmacy and Health Sciences, Drake University in Des Moines, IO. “The other confusing part is the whole issue of licensure that varies from state to state. Then we have the 2018 Farm Bill. Everyone still trying to sort out what that means. It’s extremely confusing.”
Medical marijuana is now legal in 33 states, with 10 states and Washington DC, also legalizing recreational use. Legislation varies regarding the role pharmacists can-or have to-play in dispensing marijuana. In Arkansas, Connecticut, Minnesota, Pennsylvania and New York, pharmacists must play a role in dispensaries, while in other states they are excluded by law.
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Whether a pharmacist can recommend CBD oil also depends on the state.
“In Iowa there are two state-approved manufacturers of CBD products, but a pharmacist cannot be involved with dispensing or selling these state-approved products,” said Welty. “Over the border in Minnesota, the law is different. They actually require pharmacists to be in the dispensary.” Pharmacists have to be careful about what states allow with the range of CBD products. “In some states it’s clearly a violation that could lose them their license,” he adds.
In 2018, the Agriculture Improvement Act-the Farm Bill-removed the hemp plant from the Controlled Substances Act. Cannabis derivatives with less than 0.3% of the psychoactive compound delta-9-tetrahydrocannabinol (THC) are no longer considered an illegal substance. CBD is derived directly from hemp plant, a close cousin of the marijuana plant, but which usually contains a low percentage of THC, so the act may not cover all CBD products.
“If CBD is derived from a U.S.-grown hemp plant that has a license to be grown and a company that has a permit to manufacture CBD, then that is legal,” said Alex Capano, DNP, a faculty member at The Lambert Center for the Study of Medicinal Cannabis and Hemp at Thomas Jefferson University in Philadelphia, and medical director for Ananda Hemp, which manufactures hemp-based products. As part of the Farm Bill, hemp was permanently removed from the controlled substance list. “However, if CBD is derived from a marijuana plant or flown from overseas or comes from an unlicensed hemp plant then it’s Schedule 1,” she said. Months before the bill passed, the FDA approved Epidiolex (cannabidiol) to treat seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. Epidiolex is the first FDA-approved drug containing a purified drug substance derived from marijuana.
What Are the Uses?
Research continues into the use of cannabis-derived drugs to treat degenerative diseases such as Parkinson’s disease and multiple sclerosis, or to decrease symptom severity and the frequency of flares associated with autoimmune diseases. Cannabidiols might also be useful in treating opioid addiction. So far, double-blind randomized controlled studies are scant and, except for the studies supporting Epidiolex, much evidence remains anecdotal. But anecdotal evidence carries some weight.
“I deal with patients every day and I’ve observed people having pretty profound responses across the board,” said Capano. Not everybody has had the opportunity to see those kinds of results, she adds.
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The FDA does not regulate the safety or purity of CBD products sold as supplements, making it harder for consumers to know what they’re getting. CBD products are commonly used to alleviate pain, induce sleep, and improve mood, but some products being marketed might not have been extensively tested.
“Pure CBD is really expensive,” said Jacci Bainbridge, PharmD, FCCP, professor of clinical pharmacy at the University of Colorado. “If you’re getting what they say you’re getting, you’re paying a lot of money for it. What we’ve seen in Colorado many times is that what they say is in there is not actually in there.”
If a pharmacy plans to carry CBD products that are not FDA- or state-approved, it’s essential to consider the source, Capano says. Work with a reliable company that can guarantee their product and provide counseling on how to use it. Always advise customers to start with a low dose and inform them about potential interactions.
What About Bioavailability?
Bioavailability must be considered when dealing with CBD products.
“The bioavailability of CBD in a tablet is less than 10% of whatever CBD you might have taken,” said Welty. “ If you put it in oil like Epidiolex or into a tincture, then the bioavailability may go up as high as 20%, which is still pretty low. How much are you actually getting into your blood? With topical application, CBD has to go through the skin’s fat layers and that slows absorption. The whole issue of being able to give a high enough dose to be absorbed is a concern.”
Taking a significant dose of purified CBD may subject patients to potential interactions with drugs such as cyclosporine, benzodiazepines, calcium channel blockers, atorvastatin, and simvastatin. “We don’t know about all of them, but most of the interactions we can find in the package insert of Epidiolex,” said Bainbridge. “Everything we know for sure is on that label.”
It’s hard to know how much CBD oil is too much without well-controlled toxicology studies, and given the lack of regulation there’s no way to know if the products or the plants they’re derived from are contaminated with herbicides, pesticides, heavy metals, or fungus.
To add another concern into the mix, CBD products are not supposed to contain more than 0.3% THC, but some formulas do, and that THC may register on a pre-employment drug test.
“You do have to worry about very sensitive drug testing, say for law enforcement,” said Bainbridge. “Since it’s absorbed systemically, a person can test positive for THC.”
If a pharmacy plans to carry CBD products, the important first step is learning what the state regulations are.
“A lot depends on what the state board approved and what is going to potentially get a pharmacist in trouble,” said Welty. “Even a foot balm with CBD in it can technically be a controlled substance.”
What Are the Options?
Pharmacists can offer patients safe options. Although Epidiolex is FDA-approved for only two rare syndromes, doctors can prescribe it for other things. “They are not restricted to treating seizures. It’s up to a physician. If they feel it’s appropriate, they can prescribe it for Parkinson’s, pain, you name it” says Welty. “My feeling is that if you’re going to recommend it, the safest way is with Epidiolex, a product that we know has been monitored for quality. If that’s not an option, go with a state-approved product like you can get in Iowa or Minnesota, where there’s some control.” Be suspicious of “artisanal” CBD products, he wards. “Some commercial products are reputable, but you don’t always know what you’re getting.”
Despite concerns, patients are likely to experiment with CBD on their own, without the benefit of any professional counseling. “The reality is people are going to use CBD. It’s out there; the industry is booming. If people are going to use it, there’s a benefit to getting counseling from a licensed pharmacist,” said Capano. “If patients are going to be using it they might as well use it well.”