● Practitioners prescribing Schedule II controlled substances for residents of long-term care facilities may transmit a prescription by facsimile to the dispensing pharmacy. The practitioner’s agent may also transmit the prescription to the pharmacy. ● A practitioner prescribing a Schedule II narcotic-controlled substance for a patient enrolled in a hospice care program certified and paid for by Medicare under Title XVIII or a hospice program licensed by the state may transmit a prescription to the dispensing pharmacy by facsimile. The practitioner or agent may transmit the prescription to the pharmacy and will note on the prescription that it is for a hospice patient.
The DEA has granted three exceptions to the facsimile prescription requirements for Schedule II controlled substances. As a result, the facsimile of a Schedule II prescription may serve as the original prescription as follows. Regardless of the method of transmission of a controlled substance prescription—by hand delivery, facsimile, phone call, or electronically—DEA regulations make it clear that the legal responsibility for issuing a valid prescription that “conform[s] in all essential respects to the law and regulations” rests upon the prescribing practitioner. However, a pharmacist is responsible for properly prescribing and dispensing controlled substances: ● A practitioner prescribing Schedule II controlled substances to be compounded for direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion may transmit the prescription by facsimile. A prescription for controlled substances in Schedules III, IV, and V may be communicated verbally, written, or by facsimile to the pharmacist. It may be refilled if authorized on the prescription or by call-in. The CSA provides that a pharmacy may dispense Schedules III and IV controlled substances according to a “written or oral prescription.” DEA regulations further specify that a pharmacist may dispense a Schedule III, IV, or V controlled substance according to “either a paper prescription signed by a practitioner [or] a facsimile of a signed paper prescription transmitted by the practitioner or the practitioner's agent to the pharmacy.” Accordingly, an authorized agent may transmit such a practitioner-signed paper prescription via facsimile to the pharmacy on behalf of the practitioner (DEA, 2018c).
As electronic prescribing of controlled substances becomes more widespread, the need to fax or call in a Schedule II controlled substance (or any other controlled substance) will decrease. SCHEDULES III–V CONTROLLED SUBSTANCE PRESCRIBING CONSIDERATIONS
Schedules III and IV controlled substances may be refilled if authorized on the prescription. However, the prescription may only be refilled up to five times within six months of the date it was issued. After five refills or six months, whichever occurs first, a new prescription is required. Prescriptions for Schedules III through V controlled substances may be transmitted by facsimile from the practitioner, or an employee or agent of the individual practitioner, to the dispensing pharmacy. The facsimile is equivalent to the original prescription (DEA, 2020a). In addition, a pharmacist may dispense a controlled substance listed in Schedules III, IV, or V according to an oral prescription made by an individual practitioner. The pharmacist must promptly reduce writing of the oral prescription containing all information required for a valid prescription, except for the practitioner’s signature. Table 2: Prescription Cough Medications Containing Codeine or Hydrocodone Representative Brand Names (not inclusive of all available products) Codeine, chlorpheniramine Tuxarin ER, Tuzistra XR. Codeine, phenylephrine, promethazine Only generic products are available. Codeine, promethazine Only generic products are available. Codeine, pseudoephedrine, triprolidine Triacin C. Hydrocodone, guaifenesin Obredon. Hydrocodone, pseudoephedrine, guaifenesin Hycofenix, Rezira. Hydrocodone, chlorpheniramine Tussionex, Pennkinetic, Vituz. Hydrocodone, Zutripro.
FDA warning for codeine- and hydrocodone-containing cough and cold products In 2018, the FDA further limited codeine-containing cough and cold products to adults older than 18 and restricted the use of cough and cold products containing hydrocodone to adults older than 18. Additionally, the FDA added black box warnings about the risks of misuse, abuse, addiction, overdose, respiratory depression, and death to codeine- and hydrocodone- containing cough and cold products. The FDA strengthened and added these warnings following recommendations from the FDA Pediatric Advisory Committee that stated the risk of these products outweighed the benefits in children and adolescents less than 18 years of age (FDA, 2022b). It is important to note that codeine-containing cough medicines are available over the counter in some states (see Table 2). The FDA is also considering regulatory action for these products (FDA, 2022e). Active Ingredients
chlorpheniramine, pseudoephedrine
Hydrocodone, homatropine Only generic products are available.
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