Medical marijuana products vary from plant to extracted oils or edible products (e.g., cookies, butters, lozenges, and others). It is important to note that the FDA does not oversee or regulate medical marijuana as it does with prescription medications. Therefore, the quality of medical marijuana, including purity, strength, and ingredients, may vary significantly depending on where and when it is purchased. The FDA has approved marijuana-derived prescription medications (see Table 6). Two of the products are synthetic derivatives: Dronabinol is synthetic delta-9-tetrahydrocannabinol, while nabilone is a derivative of cannabinol, one of the many chemical constituents of marijuana. The FDA approved Epidiolex, which contains cannabidiol (CBD) purified from marijuana plants, in 2018 as a Schedule I. While Epidiolex is FDA-approved for treating seizures related to Lennox-Gastaut syndrome and Dravet syndrome, it also treats other off-label conditions. In 2020, Epidiolex was approved to treat seizures associated with tuberous sclerosis complex (TSC) in patients one year and older. Under the CSA, CBD is
currently a Schedule I controlled substance because it is a chemical component of the cannabis plant. The FDA has submitted a medical and scientific analysis of CBD, including data from studies to assess the abuse potential of CBD, to the DEA to change the scheduling of CBD. In 2020, the DEA removed Epidiolex from a downgraded Schedule V and descheduled it entirely, meaning Epidiolex is no longer subject to the CSA and its tracking and monitoring requirements. 62 BEFORE MOVING ONTO THE NEXT SECTION, PLEASE COMPLETE CASE STUDY 3. Opioids Both “opiate” and “opioid” have commonly been used interchangeably in the past, but current accepted practice is to specifically use the term “opioids” to refer to all natural, semisynthetic, and synthetic forms of this centuries-old agent of pain control.
Fentanyl, the most prevalent synthetic opioid today, is included in this category along with naturally occurring opioid formulations such as heroin, morphine, and codeine. The popularity of this drug class stems from its powerful ability to control pain and induce euphoria. Opioid use disorder (OUD) has reached epidemic proportions with substantial negative impacts on society. OUD is a chronic, relapsing disease influenced by genetics, stress response, and prior experimentation or exposure. 63 Mu opioid receptors (MORs) modulate nociception, stress, temperature, respiration, endocrine activity, memory, mood, and motivation. MORs bind opioids and delta opioids, kappa opioids, and nociception receptors to increase drug tolerance. Physical dependence can develop between 2 and 10 days of continuous use with withdrawal symptoms occurring when stopped abruptly. 64
Table 6. Marijuana-Derived Pharmaceutical Products
FDA-Approved or Under Review Indications Appetite stimulant in management of anorexia associated with AIDS Treatment of chemotherapy-induced nausea/vomiting Treatment and prevention of chemotherapy-induced nausea/vomiting Treatment of Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex Clinical trials for pain treatment in cancer patients who experience inadequate analgesia during optimized chronic opioid therapy
Generic Name
Brand Name
FDA Status
Pharmacology
Dronabinol
Marinol
FDA-approved controlled substance Schedule Ill
Synthetic delta-9-tetrahydrocannabinol (delta-9-THC) is the primary active compound of marijuana
THC
Syndros (capsules)
Nabilone
Cesamet (capsules) FDA-approved
Derivative of cannabinol, a nonpsychoactive constituent of marijuana
controlled substance Schedule II Descheduled by the DEA; no longer subject to the CSA Under investigation in the United States, Phase II/III trials
Cannabidiol (CBD) Epidolex (oral solution)
Plant-derived cannabidiol (CBD), accounting for 40% of cannabis extracts
Cannabidiol (CBD) and delta-9-
Sativex (oro- mucosal spray)
Combination of delta-9-THC, the primary active compound, and cannabidiol, a nonpsychoactive component of marijuana
Instructions: Spend 5-10 minutes reviewing the case below and considering the questions that follow. Case Study 3
Mr. and Mrs. Jones bring in their teenage son for evaluation. His school performance has declined recently, and Mrs. Jones is concerned that he “vapes” and reports that he admitted occasionally using marijuana in the vape device. He states that he uses it to “relax” sometimes and that he would be doing worse without it. He states that it is legal, so that it must not be that bad.
1. What information could you share with the Joneses and their son regarding the potential risks of marijuana in all its forms?
2. The Joneses have questions regarding the legality of the use of marijuana and ask whether a prescription for medical marijuana would be appropriate. Would it?
32
Powered by FlippingBook