CBD: Medical Miracle or Just Another Fad? - Michigan Pharmacists ...
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CBD: Medical Miracle or Just Another Fad?
By Vanesa Muratovic, Pharm.D. candidate 2019, Ferris State University College of Pharmacy,
Clinton Township, Mich.
Target Audience
This activity was developed specifically for pharmacists and pharmacy technicians.
Disclosure Statement
The author has indicated that she does not have any conflicts of interest, nor does she have financial
relationships with a commercial interest related to this activity.
Learning Objectives
By the end of this activity, participants should be able to:
1. Explain the difference between cannabidiol (CBD), tetrahydrocannabinol (THC) and
marijuana
2. Identify the reason(s) why patients might utilize CBD
3. Describe the legal and medical concerns healthcare practitioners might have with CBD use
Current Events
The legalization of marijuana has been a controversial topic since the first state, California,
passed legislation to allow medical marijuana in 1996.1 On Nov. 6, 2018, Michigan passed a ballot
proposal to make recreational marijuana use legal, with medical marijuana being legal since 2008.1
Pharmacists and other healthcare professionals are experiencing chaos in their workplaces due to the
recreational legalization of marijuana and the impact it will have on caring for patients. One of the
biggest issues, however, has to do with the misunderstanding of the different chemicals that make
up marijuana and what their effects are on the human body. This paper aims to provide a non-
biased, comprehensive overview of the topic.
Introduction to Marijuana
The nomenclature surrounding marijuana can often lead to confusion in the topic. The
terms cannabis, hemp and marijuana can all be used interchangeably to refer to the physical plant.2
However, when it comes to common lingo, the public has separated the three terms to be associated
with different implications. Cannabis is the term used by the scientific community for research
purposes, whereas hemp is associated with products such as fibers and textiles, and marijuana is
commonly coupled with medicinal effects. For the purposes of this paper, which focuses on the
medication component, the term marijuana will be used.
There are three different species of marijuana: c. indica, c. sativa, and c. ruderalis; the former
two being the most common.3 Once again with nomenclature, the “c” in front of each species
refers to cannabis, while the name distinguishes physical traits of the plants. Often times c. indica
and c. sativa are marketed as producing different affects in the body, c. indica being more sedating
and c. sativa being more invigorating.3 While a simple Google search on “indica vs. sativa” will yield
numerous results on the difference between the two, scientists have aimed to disprove this theory.
According to Dr. Ethan Russo, a cannabis research pioneer, there is no physical way to tell what
kind of effect a person will achieve by using indica or sativa.4 Since the effects are produced by thechemicals found in marijuana, the only way to tell if a strain would cause relaxation or euphoria is by
performing a biochemical assay.4
Hemp, one of the synonyms discussed, was cultivated to grow taller and denser for
production of textiles and construction purposes.5 Hemp, by definition, must not be able to cause a
psychoactive effect because it is used for manufacturing purposes.5 Even so, hemp has been illegal
in the United States since the Marijuana Act of 1937, which placed a tax on the plant and regulated
the importation, cultivation, possession and distribution of it so much so that hemp became
uneconomical to grow.6 Since then, the 2014 Farm Bill included a provision that stated that
individuals could cultivate hemp for research purposes under pilot programs done with universities
and agricultural departments.7 Most recently, the Hemp Farming Act of 2018 was introduced in
early April in both the House and Senate to take the place of the 2014 Farm Bill, which expired
Sept. 30, 2018 but was extended until Dec. 7, 2018 in order for the bill to be assessed during the
lame-duck session.8 On Dec. 20, 2018, President Trump signed the 2018 Farm Bill into law, which
removed hemp from a schedule 1 controlled substance and legalized it as an industrial crop.9
Agriculture aside, the restrictions placed on marijuana, good or bad, are because of the
psychoactive effect it provides. The science behind the “high” is critical because it explains what is
going on economically, legally and socially in the world of marijuana. Marijuana contains over 400
different chemicals, known as cannabinoids, making it a complex plant.10 The chemical that leads to
the psychoactive “high” associated with marijuana, delta-9-tetrahydrocannabinol (THC), is only one
of over 400 found in the plant.11 While THC will most likely always be controversial due to its
psychoactive properties, many are focusing on the cutting-edge hot topic in the world of marijuana,
cannabidiol (CBD). CBD, just like THC, is only one out of the hundreds of cannabinoids found in
the marijuana plant. Unlike THC, however, CBD does not cause a psychoactive high.11 Instead, the
chemical has been introduced to the nation as a natural medicinal product that can allegedly be used
to relieve multiple ailments.
Legal Issues
Claims that CBD can be used to treat various disease states is problematic due to multiple
factors, with legal problems being at the top. Due to the fact that CBD is a component of
marijuana, the status of CBD depends on the status of marijuana, even though it does not lead to a
psychoactive effect.
On the federal level, marijuana is illegal. In fact, marijuana is considered a schedule 1
substance, placing it in the same realm as ecstasy, heroin and LSD.12 According to the U.S. Drug
Enforcement Administration (DEA), these substances do not currently have accepted medical use
and are considered criminal possession.12 As mentioned earlier, the passage of the 2018 Farm Bill
changed the way that the Federal government views hemp and hemp products, which must contain
less than 0.3 percent of THC to be categorized as hemp. While hemp is now a legal crop, the DEA
and FDA both state that CBD companies must gain approval from the government before their
CBP products are recognized as legal for medicinal purposes.13
Closer to home, Michigan voters passed Proposal 1, making recreational marijuana use legal
in the state, as mentioned previously.14 However, both those pleased and displeased with the results
will have to wait a minimum of one year in order for the state to set up policies and procedures
regarding the new proposal, leaving many with lingering questions that are yet to be answered.14
Regarding CBD in the Michigan, CBD has been available to medical marijuana card holders sincethe passing of medical marijuana in the state, following the same protocol as marijuana
containing THC.15 Since the state’s Department of Licensing and Regulatory Affairs (LARA)
treats any extracts of the marijuana plant as marijuana, CBD has been illegal in Michigan without
a medical marijuana card and will continue to be illegal until the new regulations are defined that
allow recreational use, expected to be done in early 2020.15
On Dec. 31, 2018, legislation was signed to revise the definition of “industrial hemp” to
include industrial hemp commodities and products and topical or indigestible animal and consumer
products derived from the plant Cannabis sativa L. with a delta-9 tetrahydrocannabinol (THC)
concentration of not more than 0.3 percent on a dry weight basis. The legislation also required the
Michigan Department of Agriculture and Rural Development (MDARD) to establish, operate and
administer an industrial hemp licensing and registration program. The legislation was signed with
immediate effect and prohibits a person from growing industrial hemp in the Michigan, unless he or
she was registered as a grower. Furthermore, the legislation prohibited a person from processing,
handling, brokering or marketing industrial hemp in Michigan unless the person was licensed as a
processor-handler.
It is important to note that whether or not marijuana is legal nationwide or statewide,
employers reserve the right to make their own decisions about drug testing and tolerance at the
workplace. Since CBD is considered a marijuana derivative by both the federal and state
governments, using products that contain CBD, especially products that are ingested, should be
proceeded with caution until there is more clarification on the subject.
FDA Approved CBD?
The rising popularity of CBD is important for pharmacists to be aware of because
patients will most likely be trying to obtain and experiment with CBD products, legal issues aside.
As healthcare professionals, it is vital to be informed about the implications of CBD use and to
understand any possible side effects or adverse reactions that may be associated with the
chemical. As of June 2018, the only legal form of CBD that is FDA approved is Epidiolex, a
prescription medication used to treat certain seizure disorders.16 All other forms of CBD have not
been FDA approved for treatment of any ailments, and many have not even been scientifically
tested, but are already available online and in stores across the country.
While the exact mechanism of action of Epidiolex® is unknown, it is indicated for the
treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients
two years of age and older. Lennox-Gastaut syndrome is a rare, severe form of early childhood
epilepsy without an exact definition. It is composed of atonic, tonic and absence seizures and can be
difficult to treat because it is often resistant to many anti-seizure medications.17 Dravet syndrome is
another type of seizure disorder that occurs in the first year of life and is caused by a genetic
mutation.18
Like Lennox-Gastaut syndrome, it is also resistant to many anti-seizure medications. For patients
and families suffering with these conditions, Epidiolex® seems like an answer to their needs. The
active ingredient in Epidiolex® is made from natural CBD. The medication contains 100 mg/mL of
the active ingredient and is dosed by weight. From studies done for FDA approval of Epidiolex®, it
is known that CBD can increase serum ALT and AST levels and therefore should be used with
caution in patients with hepatic impairment.16 In addition, interactions with certain cytochrome
p450 enzymes has been established, specifically CYP3A4 and CYP2C19, confirming that drug
interaction analysis should be run before dispensing medications along with Epidiolex®.16 While
this medication seems like a miracle to those suffering with Lennox-Gastaut and Dravet syndromes,
the price tag of the medication will likely turn away many patients. At $32,500 per year for the
medication, many might question if there is a difference between Epidiolex® and other lessexpensive CBD products on the market.
While FDA approval is a common process to healthcare providers since all prescription
medications must be FDA approved, it should be very important to consumers due to what it
means for medication safety. FDA approved drugs go through a rigorous process where they are
reviewed by the Center for Drug Evaluation and Research (CDER). Drugs must be proven effective
and the effectiveness must outweigh any of the side effects.19 FDA approval ensures that the
government protects the people and that drug creators and drug manufacturers cannot just do as
they please including varying the amount of active ingredient per batch of medication produced.
One of the largest concerns with CBD products not being FDA approved is the actual
amount of CBD per product. While there is concern about the amount of CBD in topical products,
the real apprehension has to do with oils and other ingestible goods because they act internally. A
study done on CBD oils sold in Europe found rather large discrepancies with the amount of CBD
advertised and the amount actually found by terpene fingerprint analysis.20 This could be dangerous
to people taking the products because not only is there a lack of knowledge about CBD in general,
but there is also a lack of certainty in the contents of the CBD containing products as well.
STOP AND
REFLECT
A patient comes to the pharmacy counter and states that he has heard that marijuana can help
with his epilepsy disorder. He states that he would rather go the natural route, if possible, than
continue taking his prescription medications. He states that internet searches have brought up a
lot of good data saying that marijuana can help him and asks the pharmacist’s opinion on this.
Feedback
First, it is important to tell the patient to never abruptly stop taking his prescribed medications
without consulting a healthcare professional especially because discontinuing the medication could
cause rebound seizures.
Second, it is important to explain the difference between marijuana, CBD and THC to the
patient. It seems as though the patient is confusing the marijuana plant with all the chemicals the
plant contains, specifically CBD. The pharmacist should counsel the patient on the differences
between these chemicals as well as discuss the “natural”, FDA approved medication on the
market, Epidiolex®, explaining that it is only approved for two specific types of seizure disorders.
Finally, the pharmacist should explain to the patient that FDA approval is important because
many safety measures are taken into place before a medication is approved for human use, and
marijuana products have not yet gone through this process. Furthermore, the exact mechanism of
action of CBD is unknown and therefore drug interactions have not yet been fully established,
making concomitant use potentially dangerous.Various Forms of CBD
CBD is sold in a variety of dosage forms including oils, capsules, balms, butters, and
even cartridges used for e-cigarettes.21 The large number of various dosage forms available
indicates the market for this product is growing making it is important for healthcare
professionals to be familiar with the products in order to best serve patients.
What makes CBD so attractive to consumers? The answer to this question is quite
complex because it has to do with the numerous claims that companies producing CBD-
containing products make, most of which are not backed up by scientific data. These claims
include that CBD can help with pain, anxiety, depression, cancer-related symptoms, acne and
even heart health, among many others.21 Additionally, the natural product movement, with
consumers caring more about where food and products come from and under what conditions
they are manufactured, has driven an immense change in the economy. Sales of organic foods
worldwide topped 90 billion in 2016, up from just 15 billion in 1999.22 One of the biggest ways
that producers of CBD are getting patients to use their products is by talking about how CBD
comes from a plant and therefore is a natural and thus a better solution to prescription
medications. Endless websites make claims about the dangers of traditional solutions to pain,
including Nonsteroidal anti-inflammatory drugs (NSAIDS) and opiates. Websites like
“cbdoilreview.org” talk about how NSAIDS increase the risk of ulcers, stroke and myocardial
infarctions, as well as how opiates are highly addictive and have led to the opioid crisis.23 While
some elements of these claims are true, sites like these only report the negatives of traditional
pain solutions and emphasize the alleged positives of CBD products. They want the patient to
believe that because CBD is natural, it does not come with risks or side effects, and because of
the lack of research, these statements cannot be disproven, yet.
Looking at claims made by CBD producers, analysis of the 2012 National Health Interview
Survey (NHIS), conducted by the National Institutes of Health (NIH), found that 25.3 million or 11
percent of Americans suffer from pain every day.24 With this staggering number in mind, it does not
come as a surprise that the CBD market would cater to this subset of the population. In fact, one of
the largest targets for CBD products is the pain market. From lotions to creams to ointments, the
topical CBD products are just beginning to become readily available. While all CBD containing
products are marketed as helping with pain, among other ailments, the topicals along with the oils
are branded as being the most effective delivery method. Manufacturers even promote different
dosages of CBD and how they can be used for different types of pain. These range from back, joint
and muscle pain to chronic pain and even disease related pain. Some manufacturers make confusing
claims about how their products are “FDA approved”.25 A naïve consumer might not read the fine
print that indicates that the other ingredients found in the products, such as menthol and camphor,
are the actual components that are FDA approved. The CBD they try to falsely advertise as being
FDA approved is definitely not, since it is still considered illegal by the Federal Government.
Another sizeable target population that CBD producers market to are patients suffering
from mental health disorders, most predominantly, anxiety. Statistics from the Anxiety and
Depression Association of America (ADAA) revealed that over 40 million Americans, more than
18 percent of the population, over the age of 18 suffer with anxiety, making it the most common
mental illness in the United States.26 With these numbers, it is easy to see why producers of CBD
are willing to invest significant dollars to market their products to those suffering from anxiety and
other related issues. Consumers who are desperate for answers to their issues will rely on these
claims and purchase these products in order to get the help they seek. Having healthcare
professionals who understand that these claims need further research can at least give patients more
information and help guide them to achieving the best outcomes for all involved.While there is some evidence to show that THC containing marijuana helps with pain, hence
the use of medical marijuana in patients with cancer, there seems to be minimal research on the
effects of CBD alone, with pain, anxiety and any other ailment. Most of the research that has been
released recently has to do with the effect of cannabinoids on these disease states, which means that
they include the illegal and psychoactive THC. Sativex, for example, is an oromucosal spray that
contains both THC and CBD in a 1:1 ratio and is approved in Europe for muscle pains associated
with multiple sclerosis.27 While Sativex is approved in other countries, it is still illegal in the
United States because of the THC content. So, while there is research and there are products in the
pipeline, the ones that are out now contain multiple cannabinoids and not just CBD, making it
difficult to back the claims that CBD itself, alone, can do what so many manufacturers say it can do.
STOP AND REFLECT
One of your long-term patients tells you that she doesn’t feel comfortable taking her Norco anymore because of all the
news about addiction and overdoses. She says that one of her family members has heard about CBD oil and
recommended it to her for her pain instead of the opioid. When she went on the internet, she discovered a plethora of
CBD products and claims about it helping people get their lives back. What would you tell your patient about her
discovery?
Feedback
When it comes to things found on the internet, it’s important to distinguish whether or not the resource is credible. This
can be difficult with many CBD manufacturers because they make their websites look legitimate. They use endings like
“.org” instead of “.com” and fill the pages with “facts” and “statistics” about CBD benefits. Inform your patient that
these websites are trying to sell a product, which is why they try too hard to convince patients about the efficacy of their
products. Inform her that at this point in time, there is not scientific research on CBD, and the only research that exists
is done in combination with THC, which she wants to avoid.
Conclusions
Recent trends in the CBD marketplace have shown nothing but growth, meaning that
healthcare workers, especially, need to prepare for what is to come. Projections expect that by 2020,
the CBD industry will be valued at over 1 billion USD.28 Expecting to have plenty of patients using
CBD, at the least, is reasonable and that is why having an understanding is critical now. It is better
to be prepared in the long run long than to be surprised by something that is almost inevitable.
In order to best prepare, pharmacists need to be educated on CBD and marijuana, what
makes them different and the legal battles between state and federal government. Independent
pharmacy owners, especially, need to be aware of companies trying to sell them CBD products,
making false claims of FDA approval, among other things, and the legal consequences this could
bring to their businesses.
As more and more research is expected to be done on both marijuana and CBD,
pharmacists and other healthcare professionals need to keep up with the data and be able to apply it
to patient care. Undertaking continuing education, attending conferences, reading journals and
general upkeep with the topics is essential as more clinical information becomes available.Reference:
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