Table 1: Marijuana-Derived Pharmaceutical Products
FDA -Approved or Under Review Indications
Generic Name
Brand Name
FDA Status
Pharmacology
Dronabinol
Marinol
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.
Synthetic delta-9- tetrahydrocannabinol (delta-9-THC) is the primary active compound of marijuana. Derivative of cannabinol, a nonpsychoactive constituent of marijuana.
FDA-approved controlled substance Schedule Ill.
THC
Syndros (capsules)
Nabilone
Cesamet (capsules)
FDA-approved controlled substance Schedule II.
Cannabidiol (CBD)
Epidolex (oral solution)
Descheduled by the DEA; no longer subject to the CSA.
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.
Cannabidiol (CBD) and delta- 9- tetrahydro- cannabinol
Sativex (oro-mucosal spray)
Under investigation in the United States, Phase II/III trials.
PRESCRIBING PRACTICES FOR CONTROLLED SUBSTANCES
● Had their state license or registration suspended, revoked, or denied. ● Committed an act that would render the DEA registration inconsistent with the public interest. ● Been excluded from participation in the Medicaid or Medicare program. Clinicians who are agents or employees of a hospital or other institution (e.g., interns, residents, staff physicians, advanced practice providers) may, in the normal course of their duties, administer, dispense, or prescribe controlled substances under the registration of the hospital or other institution provided that: ● The dispensing, administering, or prescribing is in the ordinary course of practice. ● Practitioners are authorized by the state in which they practice. ● The hospital or institution has verified that the practitioner is permitted to dispense, administer, or prescribe controlled substances within the state. ● The practitioner acts within the scope of employment in the hospital or institution. ● The hospital or institution authorizes the practitioner to dispense or prescribe under its registration and assigns a specific internal code for each practitioner so authorized. In response to the opioid epidemic, many states have enacted policies to address the crisis yet still provide access to appropriate pain management. Procedures include guidelines for or limits on opioid prescriptions in Title 21 of the CFR, Sections 1308.11 through 1308.15 (DEA, 2018c). The DEA (2010a) defines a prescription as an order for medication dispensed to or for an end user. Furthermore, to be effective, a prescription for a controlled substance must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of their professional practice. The responsibility for properly prescribing and dispensing controlled substances is upon the prescribing
A physician, dentist, podiatrist, veterinarian, or advanced practice provider (i.e., chiropractor, nurse practitioner, midwife, optometrist, pharmacist) may issue a prescription for a controlled substance. Others may give a prescription under the following conditions: ● Authorized to prescribe controlled substances by the jurisdiction of practice. ● Registered with the DEA or exempted from registration (e.g., U.S. Public Health Service, Federal Bureau of Prisons, or military practitioners); to obtain a DEA registration, the clinician must complete DEA Form 224 (http://www.DEAdiversion.usdoj.gov). ● Effective May 11, 2022, DEA now requires all registration applications and renewal forms to be submitted electronically. ● An agent or employee of a hospital or other institution acting in the normal course of business or employment under the registration of the hospital or other institution that is registered instead of the individual practitioner being registered, provided additional requirements as outlined in the CFR (DEA, 2018c). DEA registration grants federal authority to practitioners to handle controlled substances as part of their professional practice or research. A clinician may prescribe controlled substances only under the state laws where their practice is located. When federal and state laws differ, the practitioner should follow the more stringent aspects of both the federal and state requirements. This principle has led to much concern about the state legalization of medical marijuana, despite the DEA maintaining its controlled substance Schedule I status. The DEA may deny, suspend, or revoke a clinician's DEA registration upon finding the registrant has: ● Materially falsified any application filed. ● Been convicted of a felony relating to a controlled substance or a Schedule I chemical.
EliteLearning.com/Dental
Page 51
Powered by FlippingBook