Table 12. Buprenorphine-Containing Products FDA-Approved for Opioid Use Disorder
Product Name
Available Strengths
Route(s) of Administration
Buprenorphine 1 mg/naloxone 0.2 mg Buprenorphine 2.1 mg/naloxone 0.3 mg Buprenorphine 4.2 mg/naloxone 0.7 mg Buprenorphine 6.3 mg/naloxone 1 mg
Bunavail buccal films
Buccal
Probuphine implant
Buprenorphine 74.2 mg
Subdermal
Sublocade extended-release solution for injection
Buprenorphine 100mg/0.5 mL Buprenorphine 300 mg/1.5 mL Subcutaneous
Buprenorphine 2 mg Buprenorphine 8 mg
Subutex sublingual tablets
Sublingual
Buprenorphine 2 mg/naloxone 0.5 mg Buprenorphine 8 mg/naloxone 2 mg Buprenorphine 2 mg/naloxone 0.5 mg Buprenorphine 4 mg/naloxone 1 mg Buprenorphine 8 mg/naloxone 2 mg Buprenorphine 12 mg/naloxone 3 mg Buprenorphine 0.7 mg/naloxone 0.18 mg Buprenorphine 1.4 mg/naloxone 0.36 mg Buprenorphine 2.9 mg/naloxone 0.71 mg Buprenorphine 5.7 mg/naloxone 1.4 mg Buprenorphine 8.6 mg/naloxone 2.1 mg Buprenorphine 11.4 mg/naloxone 2.9 mg
Suboxone sublingual tablets
Sublingual
Suboxone sublingual films
Sublingual, buccal
Zubsolv sublingual tablets
Sublingual
This followed Section 1262 of the Consolidated Appropriations Act, 2023 (also known as the Omnibus bill), that removed the federal requirement for practitioners to submit a Notice of Intent (have a waiver) to prescribe medications, like buprenorphine, for the treatment of OUD. All practitioners who have a current DEA registration that includes Schedule III authority may now prescribe buprenorphine for OUD in their practice if permitted by applicable state law. 28 Naltrexone As mentioned previously, naltrexone is considered first-line therapy for individuals with moderate or severe alcohol use disorder but is also an option for treatment of OUD via its effects on the mu receptor. Efficacy of naltrexone has been mixed in some studies when compared to traditional treatment for opioid use in particular; its use should be customized to the individual. 130 Different in mechanism from methadone or buprenorphine, naltrexone is an opioid antagonist medication available in both PO and IM formulation. It can be prescribed by any licensed provider without the need for special requirements linked to buprenorphine or methadone. There is no abuse potential. It is currently approved for the treatment of both OUD and for the treatment of alcohol abuse. As opposed to methadone and buprenorphine, naltrexone is not a controlled substance, so it can be prescribed by any healthcare provider who is licensed to prescribe
medications. However, as an opioid antagonist, use of naltrexone must be monitored closely to prevent serious acute withdrawal symptoms. BEFORE MOVING ONTO THE NEXT SECTION, PLEASE COMPLETE CASE STUDY 5 ON THE NEXT PAGE. Prescribing Practices for Controlled Substances Multiple providers including physicians, dentists, podiatrists, veterinarians, or advanced practice providers (i.e., chiropractor, nurse practitioner, midwife, optometrist, pharmacist) may issue a prescription for a controlled substance. Others may issue a prescription under the following conditions. • They are authorized to prescribe controlled substances by the jurisdiction of practice. • They are registered with the DEA or exempted from registration (e.g., U.S. Public Health Service, Federal Bureau of Prisons, or military practitioners); to obtain a DEA registration, the clinician must complete DEA Form 224 (www.DEAdiversion.usdoj.gov). • Effective May 11, 2022, DEA now requires all registration applications and renewal forms to be submitted electronically. • They are an agent or employee of a hospital or other institution acting in the normal course of business or employment under the
registration of the hospital or other institution that is registered instead of the individual practitioner being registered, provided additional requirements as outlined in the Code of Federal Regulations . 93 DEA registration grants federal authority to practitioners to handle controlled substances as part of their professional practice or research. A clinician may prescribe controlled substances only under the laws of the state where their practice is located. When federal and state laws differ, the practitioner should follow the more stringent aspects of both the federal and state requirements. This principle has led to much concern related to the state legalization of medical marijuana, despite the DEA maintaining its controlled substance Schedule I status. The DEA may deny, suspend, or revoke a clinician’s DEA registration upon finding the registrant has done any of the following: • Materially falsified any application filed • Been convicted of a felony relating to a controlled substance of a Schedule I chemical • Had their state license or registration suspended, revoked, or denied • Committed an act that would render the DEA registration inconsistent with the public interest • Been excluded from participation in the Medicaid or Medicare program
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