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By Janel Miller for Healio Primary Care
Americans for Safe Access recently issued the Patient’s Guide to CBD to provide background on cannabidiol and recommendations regarding its dosing and handling.
The Americans for Safe Access is an organization consisting of medical professionals, scientists, patients and others who promote safe and legal access to cannabis for therapeutic uses and research, according to the guide. Researchers used data gleaned from nearly 100 journal articles, committee opinions and websites to come up with the guide’s contents.
The FDA has only approved one product containing cannabidiol, commonly referred to as CBD — Epidiolex (GW Research Ltd.) — for the treatment of seizures in patients aged 2 years and older with Dravet and Lennox-Gastaut syndromes. But patients use CBD to treat anxiety, sleep, inflammation and immune responses and many forms of cancer, according to Americans for Safe Access.
However, there is a significant amount of uncertainty about CBD, Ethan Russo, MD, director of research and development at the International Cannabis and Cannabinoids Institute, wrote in the guide’s foreword.
“There has been a corresponding profusion of confusion in relation to cannabidiol. Myths and misconceptions abound,” he wrote, adding that the guide seeks to “emphasize the facts, rather than the falsehoods” regarding CBD.
“It is hoped that the information contained in this publication will be shared widely with patients and their families, enabling greater access to CBD, a therapeutic modality of unparalleled versatility and safety,” he added.
To help medical professionals understand more about CBD, Healio Primary Care provides a summary of the guide’s information on dosing and packaging below. In addition, we asked C. Michael White, PharmD, FCP, FCCP, of the department of pharmacy practice at the University of Connecticut, and Brooke Worster MD, an associate professor of internal medicine and palliative care at Thomas Jefferson University Hospitals — to discuss the Patient’s Guide to CBD’s strengths and weaknesses. They also provided additional tips when treating patients with CBD.
Both the potency of the CBD product and the medical history of the person taking it should be considered to provide the “optimal” dose, the Americans for Safe Access wrote.
“Individuals taking products made with purified forms of CBD must be more precise and deliberate when finding the right dosage because not only will they find too little CBD ineffective, they will also find too much CBD ineffective. Patients who are able to take a full-spectrum product may be able to start with a higher dosage and titrate more rapidly as they do not risk overshooting the therapeutic target,” the organization stated.
“Nevertheless, individuals using a full-spectrum product should attempt to find the smallest dose that provides maximum therapeutic effect in order to minimize potential for side effects and unnecessary expenditures,” they continued.
The organization suggested that patients should keep a journal for at least 1 week that provides the following information regarding their CBD intake:
- adverse events/therapeutic benefits;
- cannabinoid and terpene content;
- cultivar (also known as the strain of CBD);
- mood and feelings after the dose was taken;
- mode; and
- time until first therapeutic benefit and peak of pain relief, as well as how long until pain “noticeably dissipates” and pain relief is completely gone.
“Some conditions may require repeated administrations over time before efficacy can be observed,” the Americans for Safe Access cautioned.
Labels of FDA-approved products must indicate all ingredients. However, CBD products, except for Epidiolex, are not FDA-regulated. Several studies suggest some of these products are not properly labelled.
Just 26 of 84 CBD products purchased online were labeled correctly (the product had 90 to 110% of the labeled value, whereas 36 were underlabeled (the product had 110% or more of labeled value) and 22 were overlabeled, (the product had less than 90% of the labeled value, a report concluded.
In addition, researchers who analyzed the contents of 14 CBD oils available in Europe found that what was in the product deviated from declared amount on the packaging between 4.44% and 38.4%.
Another study indicates the potency of CBD also varies among products. Of the 38,681 samples of cannabis preparations that a group of researchers received and analyzed between Jan. 1, 1995 and Dec. 31, 2014, the CBD content fell from approximately 0.28% in 2001 to less than 0.15% in 2014. This, along with other data researchers collected, showed a change in the ratio of THC to CBD from 14 times in 1995 to approximately 80 times in 2014.
The Americans for Safe Access also acknowledged some of these discrepancies.
“Due to a current lack of adequate governmental regulation with regard to hemp-derived CBD products, consumers purchasing CBD products from a source other than a medical cannabis dispensary must be wary of unscrupulous actors and poor production processes. It should also be noted that not all medical cannabis dispensaries are the same.
Product safety testing is not required by all states, and patients should be aware of the testing that is done on the products they are consuming,” the organization wrote.
Patients using CBD products should check the labels to ensure they contain all of the following, according to Americans for Safe Access.
- appropriate warnings for use, including any individuals for whom the product is contraindicated;
- batch, lot or control number;
- cannabinoid content;
- dosing guidance;
- identity of the product;
- instructions for appropriate storage and use;
- name and place of business of the manufacturer or distributor;
- net quantity of contents in terms of weight, numerical count or other applicable measure; and
- production date or expiration date, with products vulnerable to spoilage bearing a “use by” date and/or a “freeze by” date.
The organization continued that CBD edible product labels should include:
- cannabinoid content;
- cannabis ingredients;
- cholesterol (when more than 2 mg per serving);
- dietary fiber, protein, sugars and/or total carbohydrates (when greater than 1 g per serving);
- sodium (when greater than 5 mg per serving);
- total calories and fat calories (when greater than 5 calories per serving);
- total fat, saturated fat and trans fat (when greater than 0.5 g per serving); and
- vitamin A, vitamin C, calcium and iron (when present at greater than 2% of the recommended daily intake).
The Americans for Safe Access offered other considerations for clinicians and patients regarding how products containing CBD are packaged and stored.
“Light, heat, and oxygen affect, and can degrade, cannabinoids and terpenes. Excessive moisture in a product can promote spoilage and fungal growth. Generally, cannabis floral material and products derived therefrom should be packaged in a manner that minimizes exposure to these factors and should be stored in a climate-controlled setting to avoid elevated temperatures,” the organization wrote.
“To protect the contents within, containers should be rigid, airtight, and made out of a non-absorptive material (eg, glass, stainless steel) that is appropriate for the type of product in question,” they continued.
Experts weigh in
White told Healio Primary Care that although the data are “skimpy when it comes to showing benefit in humans,” the guide is a “valuable addition to the literature for health professionals.”
He also discussed the importance of telling patients that any product claiming to contain CBD to be tested before use.
“Patients should be encouraged to have these products tested by an independent outside lab to ensure the amount of CBD that is listed on the label is accurate, that the THC level does not exceed legal amounts, and that there is no adulteration or contamination (pesticides, fungi, bacteria, heavy metals). If they tell you that the lab report found something that would be suspicious in most other everyday products, encourage your patient to not buy or use that product,” White said in the interview.
He also stressed the magnitude of telling patients to only buy products with CBD from licensed vendors.
“In most licensed medical marijuana dispensaries, there are people to help patients through the packaging, buying and dosing process that you cannot consult if they buy CBD on their own. These locations can also help in the titration process since most of the outcomes people are going to try CBD for — sleep, anxiety and/or pain — are prone to the placebo effect and so patients might portend benefits that are not biologically based,” White said.
He also pointed out where the guide falls short.
“There is no mention of how a rare side effect of Epidiolex is raising liver function tests,” he said. “Since CBD was not known previously to have this adverse event, it underscores that there may be other risks associated with prolonged use that are unknown at this time that people should expect. They also did not clearly specify strongly enough that in epilepsy, small changes in the concentrations from dose to dose can induce breakthrough seizures. This is important because previous research has found that even switching between a brand and generic antiepileptic can cause clinical instability for several days afterwards.”
White added that except for the data that led to Epidiolex’s approval, there is paucity of reliable research regarding using CBD for medical purposes.
“The human data for using CBD for pain relief, spasticity, movement disorders, inflammatory diseases, acne and Parkinson’s disease is so limited it is impossible to say whether or not it has any worthwhile effects at all. For comparison, the data for the anti-inflammatory effects of the curcumin extract of turmeric in humans is much better established than with CBD,” he said. .
Worster said the Patients Guide to CBD does a “respectful job” of addressing the confusing, ever-changing medical story surrounding CBD.
“Considering that there is a lot we don’t know yet about CBD, the guide is a very good starting point for physicians to learn more about, and educate their patients about, CBD,” she told Healio Primary Care.
She concurred with the authors that CBD dosing varies by patient but added that physicians should also consider THC concentration.
“The higher the THC percentage in a product, the higher chance your patient needs to steer away from that product,” Worster said.
“This is because CBD is metabolized by the P450 system in the liver. So ingesting CBD can prolong the half-life of other drugs. Patients on antiplatelet agents or blood-thinning agents who want to take CBD should be particularly mindful of this,” she continued.
Although data indicate that CBD edibles like brownies and gummy bears are one of the most common forms of CBD products, Worster said providers should steer their patients away from them.
“There is no medical indication to support your patients consuming CBD edibles. Furthermore, if your patients mix CBD or THC into whatever they are making, the CBD strength is likely affected, meaning most of the data in the diary you’ve kept goes out the window. In addition, most edibles are in forms that are appealing to pets and children who may not alert you to their adverse reactions to CBD until it’s too late,” Worster continued.
Prepare for questions
Worster agreed that patients should keep a dosing diary, and added that physicians should also ask their patients about the symptoms they are trying to treat with CBD.
“Taking the answer you get and the information in the diary, and reviewing the patients’ other medical conditions, medications and age will allow you to have a greater sense of what dose of CBD works and in what formulation CBD might be most helpful,” Worster said in the interview.
Physicians need to prepare themselves for patients’ questions about CBD, according to Worster.
“Provide a lot of appointment time to these patients. I can assure you that most patients who are usually silent will become a lot more talkative when CBD is brought up,” she said. – by Janel Miller