analgesics for outpatient use. The REMS program requires that training be made available to all healthcare providers involved in managing patients with pain, including nurses and pharmacists (FDA, 2021). Prescribers are strongly encouraged to do all of the following: ● Complete a REMS-compliant education program offered by an accredited continuing education (CE) provider or another education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain. ● Use the patient counseling guide (PCG) to discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients and their caregivers. ● Emphasize to patients and their caregivers the importance of reading the medication guide provided by their pharmacist every time an opioid analgesic is dispensed to them. ● Consider using other tools to improve patient, household, and community safety, such as patient–prescriber agreements that reinforce patient–prescriber responsibilities. Give special safety instructions to patients with young children, especially toddlers, and those who live with a child or adult who is cognitively impaired. For example, prescribing a controlled substance to a patient with Alzheimer’s disease or other cognitive impairments must involve instructions to a responsible adult in the home. Family members should also have a plan for accidental overdoses, including poison control (1-800-222-1222) for unintentional ingestion of a known or unknown substance. Family members should call 911 and initiate emergency services if the individual is in respiratory distress.
Healthcare Consideration: A review of current guidelines or online references provides updated recommendations for managing acute pain following dental or surgical procedures or common emergency medical conditions. See, for example, recommendations developed by the University of Michigan (2022) at https://opioidprescribing.info/. To reduce the overall burden of opioids, clinicians should consider nonopioid treatment modalities such as regional anesthesia, massage, or physical therapy. Follow-up within three to five days of initial treatment is essential. Reevaluate any severe pain that continues beyond the expected duration to adjust the pain management regimen appropriately. Consider a stepwise approach with the least invasive and least powerful pain management therapies appropriate for the patient (see Table 5). Counsel patients regarding common adverse effects of opioids used for acute pain. Upon initiation of opioid therapy, it is common for patients to experience sedation, nausea or vomiting, and pruritus. In most cases, these effects resolve within a few days. It is important to note that opioid-induced itching does not always indicate an allergic reaction, as opioids induce the release of histamine. Treatment with antihistamines usually resolves the itching but may increase sedation. Ensure patients are aware of the risk of oversedation, respiratory depression, and overdose, and recommend that they not take more medication than prescribed without discussing it with their prescriber. The FDA approved the Opioid Analgesic Risk Evaluation and Mitigation Strategies (REMS), which apply to all opioid
Table 5: Oral Opioids for Acute Pain in Opioid-Naïve Adults
Available Oral Strengths Tablets: • 15 mg/300 mg • 30 mg/300 mg • 60 mg/300 mg
Medication
Moderate Pain Severe Pain
Clinical Considerations
Codeine- acetaminophen • Tylenol with Codeine
1 to 2 tablets every four hours as needed for pain.
Incremental efficacy decreases and increases in adverse reactions with increasing doses. Limit codeine to no more than 60 mg/dose. Do not exceed codeine 360 mg/24 hours. The maximum dose of acetaminophen is 4,000 mg/day (from all sources). Metabolism of codeine to morphine (its active form) varies between patients; drug interactions may affect response. Dosage limited by acetaminophen maximum dose (4,000 mg/day [from all sources]).
Hydrocodone- acetaminophen
Tablets: • 2.5 mg/325 mg • 5 mg /300 mg • 5 mg/325 mg • 7.5 mg/300 mg • 7.5 mg /325 mg • 10 mg/300 mg • 10 mg/325 mg Oral solution: • 7.5 mg/325 mg per 15 mL • 10 mg/300 mg per 15 mL • 10 mg/325 mg per 15 mL Tablets: • 2.5 mg/325 mg • 5 mg/325 mg • 7.5 mg/325 mg • 10 mg/325 mg Oral solution: • 5 mg/325 mg per 5 mL
1 to 2 tablets PO every six hours as needed.
1 to 2 tablets PO every four to six hours as needed.
• Lorcet • Lortab • Norco • Vicodin
Oxycodone- acetaminophen*
1 to 2 tablets PO every six hours as needed.
1 to 2 tablets PO every four to six hours as needed.
Dosage limited by acetaminophen maximum dose (4,000 mg/day [from all sources]).
• Endocet • Percocet • Primlev • Roxicet • Xolox
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