feelings of euphoria, relaxation, altered time perception, lack of concentration, and impaired learning. Memory and mood changes such as panic and paranoid reactions have also been reported. Physiological effects include rapid changes in heart rate and diastolic blood pressure, conjunctival Medical marijuana legislation Medical marijuana refers to using the whole, unprocessed marijuana plant or its essential extracts to treat symptoms of illness and other conditions. The FDA has neither recognized nor approved the marijuana plant as medicine. The DEA considers marijuana a Schedule 1 controlled substance due to the lack of scientific research. However, a growing body of literature (scientific and anecdotal) has led to the increasing use of medical marijuana for various conditions, including pain, seizures, posttraumatic stress disorder (PTSD), and other disorders. The DEA considered rescheduling marijuana to Schedule II in August 2017 but decided against it. 60 The DEA has agreed to support additional research on marijuana and make the process easier for researchers. However, despite the lack of scientific confirmation, over 50% of the states and the District of Columbia have legalized marijuana, while other states maintain restricted access. In 2013, the federal government took a lenient approach to federal law enforcement regarding marijuana and provided guidance allowing states to legalize medical marijuana. However, in January 2018, this memo was rescinded, and now the status of state-level legalization of medical marijuana is uncertain. The medical marijuana debate has highlighted the issue of states rights versus the federal government. Since 2018, another 19 states have legalized recreational marijuana, and 39 states have legalized medical marijuana. More recently, in 2022, the current attorney general, Merrick Garland, has reiterated that the Department of Justice will not prioritize prosecuting marijuana use “given the nation’s ongoing opioid and methamphetamine epidemic[s]” 61 . Medical marijuana is the same as or similar to the plant used for recreational purposes but is prescribed by an authorized clinician. Each state has regulations Table 6: Marijuana-derived Pharmaceutical Products Generic Name Brand Name FDA Status
suffusion, dry mouth and throat, increased appetite, vasodilatation, and decreased respiratory rate. Cannabis also affects the immune and endocrine system, and its abuse is associated with lung damage and EEG alterations. 59
regarding qualified practitioners who can recommend medical marijuana and the recommendations for types of legal medical marijuana. In addition, states may require individuals to obtain a medical marijuana card, allowing them to purchase medical marijuana from a dispensary. 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
FDA-Approved or Under Review Indications Appetite stimulant in management of anorexia associated with AIDS Treatment of chemotherapy- induced nausea/ vomiting
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)
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Book Code: MI24CMEB
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