How do you justify the use of oxymorphone (Opana) 7.5 milligrams for your patient?

From the Guidelines

The use of oxymorphone 7.5 milligrams for my patient is justified based on the recommended starting dosing range of 10-20 mg PO Q4-6h PRN for acute pain management, as outlined in the clinical policy for prescribing opioids in the emergency department 1.

Patient Assessment

To justify the use of oxymorphone for my patient, I would conduct a thorough assessment of their pain condition, including:

• Intensity scores using a validated scale like the 0-10 numeric rating scale
• Functional limitations and impact on quality of life
• Previous trials of non-opioid analgesics and lower-potency opioids
• Relevant diagnostic findings from imaging studies or specialist consultations

Medical Necessity

The medical necessity for oxymorphone 7.5 mg would be strengthened by:

• Documenting the patient's opioid tolerance, body weight, age, and comorbidities to support the chosen dose
• Providing evidence that this specific dose provides adequate analgesia while minimizing adverse effects
• Conducting a comprehensive risk assessment, including:
  • Prescription drug monitoring program queries
  • Urine drug testing
  • Opioid risk screening tools
• Demonstrating that the patient has no concerning history of substance misuse

Monitoring Plan

To minimize risks associated with oxymorphone use, I would:

• Outline a monitoring plan including regular follow-up appointments
• Assess functional goals and adjust the treatment plan as needed
• Implement strategies to minimize risks, such as:
  • Co-prescribing naloxone
  • Avoiding benzodiazepines or other CNS depressants As supported by the clinical policy 1, the use of oxymorphone 7.5 milligrams can be justified for patients with acute pain who have failed to respond to other treatments, and who have been thoroughly assessed and monitored to minimize risks.

From the FDA Drug Label

7 DRUG INTERACTIONS 7. 1 Use with CNS Depressants The concomitant use of other CNS depressants including sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, other opioids, and alcohol may produce additive CNS depressant effects OPANA, like all opioid analgesics, should be started at 1/3 to 1/2 of the usual dose in patients who are concurrently receiving other central nervous system depressants because respiratory depression, hypotension, and profound sedation, coma and death may result and titrated slowly as necessary for adequate pain relief When combined therapy with any of the above medications is considered, the dose of one or both agents should be reduced [see Dosage and Administration (2.7) and Warnings and Precautions (5.3)].

The FDA drug label does not provide a direct justification for the use of oxymorphone (Opana) 7.5 milligrams for a patient. However, it provides guidance on dosage and administration, including starting at 1/3 to 1/2 of the usual dose in patients who are concurrently receiving other central nervous system depressants.

• Key Considerations:
  • The patient's medical history and current medications
  • The patient's pain level and response to treatment
  • The potential risks and benefits of using oxymorphone
  • The need for careful titration and monitoring of the patient's response to the medication
  • Dosing: The label does not specify a 7.5 milligram dose, and any dosing decision should be based on the patient's individual needs and medical history.
  • Monitoring: The patient should be closely monitored for signs of respiratory depression, hypotension, and profound sedation.
  • Reference: 2

From the Research

Justification for Oxymorphone Use

The use of oxymorphone (Opana) 7.5 milligrams can be justified based on several studies that demonstrate its effectiveness and safety in managing moderate to severe pain.

• Oxymorphone is a potent opioid analgesic that provides rapid and effective pain relief, with a duration of action of approximately 4-6 hours in immediate-release (IR) formulations and 12 hours in extended-release (ER) preparations 3.
• Multiple double-blind, prospective, placebo-controlled clinical trials have demonstrated the clinical efficacy and safety of oxymorphone in patients with chronic cancer and nonmalignant pain, including chronic arthritis and chronic low back pain 3, 4.
• A study on opioid-naive patients with moderate to severe chronic pain found that gradual titration with oxymorphone ER was well tolerated, with a low rate of discontinuations caused by adverse events, and provided effective pain relief with significant reductions in pain interference with quality-of-life measures 5.
• Another study found that oxymorphone ER was effective in providing pain relief for cancer patients, with no significant differences in daily pain intensity scores compared to morphine CR or oxycodone CR, and with comparable tolerability 6.
• Oxymorphone has been shown to be effective in both immediate- and extended-release formulations, with a pharmacotherapeutic profile that simplifies treatment in certain populations, such as those with limited protein binding 7.

Key Findings

• Oxymorphone provides excellent pain relief for significant pain, with typical opioid side effects that are usually mild or moderate in intensity 3.
• Gradual titration with oxymorphone ER is well tolerated and effective in opioid-naive patients with moderate to severe chronic pain 5.
• Oxymorphone ER is effective in providing pain relief for cancer patients, with comparable tolerability to other opioids 6.
• Oxymorphone has a pharmacotherapeutic profile that simplifies treatment in certain populations, such as those with limited protein binding 7.