Can Suboxone and methadone be legally prescribed for pain

Can Suboxone and methadone be legally prescribed for pain, and if so, is this considered off label?

Methadone carries two FDA labeled indications: (1) chronic pain and (2) detoxification. Initial inpatient detoxification of opioids by a licensed trained provider with methadone and supportive care is appropriate. A methadone maintenance provider must have special credentialing and training as required by state and federal governments. Methadone can be written for pain management purposes; however, any outpatient prescription for pain should indicate “for pain” on the prescription in order to avoid any miscommunication or misperceptions. Continuation of methadone maintenance from an outside provider while the patient is inpatient for another condition is appropriate.

Patients with a history of opioid abuse disorder can legally receive methadone by prescription for analgesic purposes if written and monitored appropriately. The provider should use risk mitigation strategies discussed in this chapter to help reduce the risk of abuse and/or misuse. Suboxone requires providers to register for a specific DEA number in order to prescribe Suboxone for the treatment of substance abuse. This required certification obtained through the medical boards, percludes unregistered practitioners from prescribing Suboxone for any other indication.

Specifically, according to 21 CFR § 1308.13(e)(2)(i), all controlled substances (including all of the buprenorphine products), may only be “prescribed, administered, or dispensed for a legitimate medical purpose by a DEA-registered practitioner acting in the usual course of professional practice and otherwise in accordance with the Controlled Substances Act (CSA) and DEA regulations.” The general registration requirement applicable to all practitioners (registration under 2 1 U.S.C. § 823(t)) applies to a practitioner who prescribes buprenorphine for the legitimate treatment of pain in the usual course of professional practice. No additional DEA registration is required for such purpose.

Subutex is a sublingual tablet of single entity buprenorphine FDA approved for opioid abuse disorder. Bunavail and Zubsolv are other products available similar to Suboxone.

More specifically, if a buprenorphine product is prescribed for maintenance or detoxification, the prescribing practitioner must obtain an identification number that the DEA issues to the practitioner under 21 CFR § 1301.28(d). Unlike Suboxone, Bunavail, Zubsolv, and Subutex, both Belbuca and Butrans, and even injectable Buprenex (all three of which are specifically FDA approved for analgesia), do not require anything more than a DEA license and of course are all consistent with FDA labeling when prescribed for pain management. For maintenance and detoxification, however, certification requires that the prescribing clinician “hold a subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties or a subspecialty board certification in Addiction Medicine from the American Osteopathic Association OR an addiction certification from the American Society of Addiction Medicine, and have the capacity to provide or to refer patients for necessary ancillary services, and agree to treat no more than the new limit of 275 patients at any one time in their individual or group practice.”


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