Demerol (meperidine oral tablet, oral solution), Meperitab (oral tablet)

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1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Subsection: Analgesics and Opioids Original Policy Date: May 8, 2015 Subject: Meperidine Page: 1 of 5 Last Review Date: June 19, 2015 Meperidine Description Demerol (meperidine oral tablet, oral solution), Meperitab (oral tablet) Background Meperidine is a Schedule II narcotic analgesic prescribed to treat acute episodes of moderate to severe pain. Meperidine has multiple actions qualitatively similar to those of morphine. Meperidine produces both its therapeutic and adverse effects by interaction with one or more classes of specific opioid receptors in the central nervous system to cause the therapeutic actions of analgesia and sedation. In addition to analgesia, the adverse effects of meperidine include lightheadedness, confusion, respiratory depression, nausea, vomiting, sweating, and mood changes. Meperidine should not be used for treatment of chronic pain due to the risk of toxicity (1-4). Meperidine is a Schedule II controlled substance and can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing meperidine in a situation where misuse, abuse, or diversion are a concern (1). Regulatory Status FDA-approved indications: Meperidine hydrochloride is indicated for the relief of moderate to severe pain (1-3). Meperidine oral tablets and syrups should only be used in the treatment of acute episodes of moderate to severe pain, not for treatment of chronic pain (1). Prolonged meperidine use may increase the risk of toxicity from the accumulation of the meperidine metabolite, normeperidine, which may cause CNS excitement and convulsions. If these events preclude adequate pain relief, another opioid agent should be substituted (1-3).

2 Subject: Meperidine Page: 2 of 5 All patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use. The risk for opioid abuse increases in patients with a personal or family history of substance abuse or mental illness. Patients should be assessed for the risk of developing abuse prior to the start of treatment and should be routinely monitored during therapy (1-4). Meperidine hydrochloride is contraindicated in patients who are receiving monoamine oxidase inhibitors or have recently received such agents, patients with respiratory depression, and those with hypersensitivity to meperidine or any of its ingredients. Respiratory depression is the chief hazard of opioid agonists, including morphine sulfate, which if not immediately recognized and treated, may lead to respiratory arrest and death. To reduce the risk of respiratory depression, proper dosing, titration, treatment duration, and monitoring are essential (1-4). The safety and effectiveness of meperidine hydrochloride in pediatric patients below the age of 18 have not been established (1). Related policies Abstral, Actiq, Duragesic, Embeda, Fentanyl Powder, Fentora, Hysingla ER, Lazanda, Methadone, Morphine drug class, Nucynta, Onsolis, Oxycodone, Subsys, Tramadol, Xartemis XR, Zohydro ER Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims. Meperidine hydrochloride may be considered medically necessary in patients that are 18 years of age and older with moderate to severe acute pain when alternative treatment options have been ineffective, not tolerated or inadequate for controlling pain; no dual therapy with other immediate release opioid analgesics. Meperidine hydrochloride may be considered investigational in patients that are under the age of 18 and patients that do not have moderate to severe acute pain. Prior-Approval Requirements Prior authorization is not required if prescribed by an oncologist Age 18 years of age or older

3 Subject: Meperidine Page: 3 of 5 Diagnosis Patient must have ALL of the following: Moderate to severe acute pain AND the following: 1. Alternative treatment options have been ineffective, not tolerated or inadequate for controlling the pain a. These include: non-opioid analgesics and immediate release analgesics 2. No dual therapy with other immediate release opioid analgesic(s) AND the following requirements: Answers to the following are for data collection only and are not used in the determination of the medical necessity. 1. Care plan / agreement for opioid therapy has been established 2. Patient has been advised of risks of opioid therapy and has provided informed consent 3. Patient is an appropriate candidate for opioid therapy 4. Prescriber will continue to monitor for signs of misuse, abuse and addiction during therapy Prior Approval Renewal Requirements None Policy Guidelines Pre - PA Allowance Age Quantity 18 years of age or older Meperidine 50mg/ 5ml oral solution Meperidine 50mg tablets Meperidine 100mg tablets Prior - Approval Limits Quantity Meperidine 50mg/ 5ml oral solution 360 ml per 90 days, OR 90 tablets per 90 days OR 90 tablets per 90 days 3600 ml per 90 days, OR

4 Subject: Meperidine Page: 4 of 5 Meperidine 50mg tablets Meperidine 100mg tablets Max combination 720 tablets per 90 days OR 360 tablets per 90 days 400mg per day Duration 3 months Rationale Summary Meperidine is a Schedule II narcotic analgesic with multiple actions similar to those of morphine. Meperidine is prescribed to treat acute episodes of moderate to severe pain and should not be used to manage chronic pain. The principal therapeutic actions of meperidine are analgesia and sedation. All patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use. The safety and effectiveness of meperidine hydrochloride in pediatric patients below the age of 18 have not been established (1-3). Prior approval is required to ensure the safe, clinically appropriate and cost effective use of meperidine hydrochloride while maintaining optimal therapeutic outcomes. References 1. Demerol [package insert]. Bridgewater, NJ: Sanofi-Aventis U.S. LLC; October Meperidine hydrochloride tablets Meperidine hydrochloride oral solution [package insert]. Columbus, OH: Roxane Laboratories, Inc.; March Meperidine [package insert]. Deerfield, IL: Baxter Healthcare Corporation; American Pain Society. Principles of Analgesic Use in the Treatment of Acute Pain and Cancer Pain, 6th ed. Glenview, IL: American Pain Society, Policy History Date May 2015 Action Addition to PA

5 Subject: Meperidine Page: 5 of 5 Keywords This policy was approved by the FEP Pharmacy and Medical Policy Committee on June 19, 2015 and is effective July 1, Signature on file Deborah M. Smith, MD, MPH

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