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 age 18 and restricted use of cough and cold products containing hydrocodone to adults older than age 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 stating that the risks of these products outweighed the benefits in children and adolescents under 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). Codeine, chlorpheniramine
Table 2. Prescription Cough Medications Containing Codeine or Hydrocodone Active Ingredients
Representative Brand Names (not inclusive of all available products)
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,
chlorpheniramine, pseudoephedrine
Zutripro
Hydrocodone, homatropine
Only generic products are available.
Morphine milligram equivalent (MME) Morphine milligram equivalent (MME) thresholds help the practitioner assess 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 a patient as part of state legislation, Medicare/Medicaid regulations, and other payers’ guidelines. The CDC recommends calculating the daily dose of opioids (as MMEs) to identify patients who may benefit from closer monitoring, reduction or tapering of opioids, a prescription for 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 1 to <20 MME/day, 50 to <100 MME/day dosages 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).
Table 3. Selected Opioid Oral MME Conversion Factors Oral Opioids (doses in mg/day, except where noted) Conversion Factor Codeine 0.15 Fentanyl transdermal (mcg/hour) 2.4 Hydrocodone 1 Hydromorphone 4 Methadone: 1–20 mg/day 4 21–40 mg/day 8 41–60 mg/day 10 61–80 mg/day 12 Morphine 1 Oxycodone 1.5 Oxymorphone 3 Tramadol 0.1 Important : Do not use the MME conversion factor or the MME amount determined for conversion from one opioid to another or to guide dosing medication or assisted treatment for opioid use disorder. The MME conversion factor and amount may overestimate the amount for conversion, resulting in serious adverse effects such as respiratory depression or death.
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