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 de- pression, and death to codeine- and hydrocodone-containing cough and cold products. The FDA strengthened and added these warnings following recommendations from the FDA Pedi- atric 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 Codeine, promethazine
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, pro- methazine
Only generic products are available. Only generic products are available.
Codeine, pseudoephedrine, triprolidine
Triacin C.
Hydrocodone, guaifenesin Obredon. Hydrocodone, pseudoephed- rine, guaifenesin
Hycofenix, Rezira.
Hydrocodone, chlorphenira- mine Hydrocodone, chlorphenira- mine, pseudoephedrine
Tussionex, Pennkinetic, Vituz.
Zutripro.
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 mil- ligram conversion factor analyzes and normalizes opioid prescrip- tion 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, pre- scribing naloxone (Narcan) or other measures to reduce the risk of overdose. MME calculations omit buprenorphine and other opi- oids 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 clini- cians 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 treat- ment for opioid use disorder. The MME conversion factor and amount may overestimate the amount for conversion, resulting in serious adverse effects such as respiratory de- pression or death.
Page 112
Book Code: RPUS3024
EliteLearning.com/Pharmacy
Powered by FlippingBook