SCHEDULES III–V CONTROLLED SUBSTANCE PRESCRIBING CONSIDERATIONS 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 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, Active Ingredients Zutripro.
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).
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).
chlorpheniramine, pseudoephedrine
Hydrocodone, homatropine Only generic products are available.
Morphine milligram equivalent (MME) Morphine milligram equivalent (MME) thresholds guide the risk of overdose when prescribing opioids for pain. The morphine milligram conversion factor analyzes and normalizes opioid prescription data to determine a daily MME value (see Table 3). MME defines limits for the total amount of opioid analgesics prescribed to the patient as part of state legislation, Medicare/Medicaid, and other payers. The CDC recommends calculating the total daily dose of opioids (as MMEs) to identify patients who may benefit from closer monitoring, reduction, or tapering of opioids, prescribing naloxone (Narcan) or other measures to reduce the risk of overdose. MME calculations omit buprenorphine and other opioids used to treat opioid use disorder.
Compared to dosages of 1 to <20 MME/day, dosages of 50 to <100 MME/day increase the risks of opioid overdose by factors of 1.9 to 4.6 (Dowell et al., 2016). CDC guidance states that clinicians should carefully assess patients when considering increasing dosage to >50 MME/day and should avoid or carefully assess and justify a decision to increase the total opioid dose >90 MME/day (AAFP, 2021). While the CDC has not explicitly stated that opioids should not be used in quantities >90 MME/day, many states and payers limit opioid prescriptions to <90 MME/day regardless of the underlying condition (CDC, 2021) (see Table 4).
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