Physician Assistance (PAs) PAs are authorized to prescribe Schedule II-V in 44 states and DC. Five states allow III-V. However, PAs are not authorized to prescribe in Kentucky. Physicians directly oversee these practitioners, but PAs are considered “mid-level” practitioners. This designation allows PAs and other healthcare providers to prescribe controlled substances. State by state requirements can be accessed here https://deadiversion.usdoj.gov/drugreg/ practioners/mlp_by_state.pdf
Self-Assessment Quiz Question #1 If there is accidental ingestion of a known or unknown substance with no respiratory distress, who should you call? a. Poison Control (1-800-222-1222). b. Emergency Services (911). c. American Medical and Lawyer Referral Service (411- PAIN). d. CVS or local pharmacist.
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 a 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 (LaBruyere, 2022). 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 However, in January 2018, this memo was rescinded (DOJ, 2018), and now the status of state-level legalization of medical marijuana is uncertain. The medical marijuana debate has highlighted the issue of state rights versus the federal government. Since 2018, another 19 states have legalized recreational marijuana, and 39 states have legalized medical marijuana. 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].” 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 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 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 1). Two 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 one year and older patients. 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 (HB6095, 2021).
Table 1: Marijuana-Derived Pharmaceutical Products
FDA -Approved or Under Review Indications Appetite stimulant in the 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
Synthetic delta-9- tetrahydrocannabinol (delta-9-THC) is the primary active compound of marijuana. Derivative of cannabinol, a nonpsychoactive constituent of marijuana. Plant-derived cannabidiol (CBD) accounts for 40% of cannabis extracts. Combination of delta‑9‑THC, the primary active compound, and cannabidiol, a nonpsychoactive component of marijuana.
FDA-approved controlled substance Schedule Ill.
THC
Syndros (capsules)
Nabilone
Cesamet (capsules)
FDA-approved controlled substance Schedule II. Descheduled by the DEA; no longer subject to the CSA.
Cannabidiol (CBD)
Epidolex (oral solution)
Cannabidiol (CBD) and delta-9- tetrahydrocannabinol
Sativex (oro-mucosal spray)
Under investigation in the United States, Phase II/III trials.
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Book Code: DFL3024
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