Methadone Methadone is one of the most common medicines to treat OUD. It is an opioid agonist and can only be prescribed and dispensed in licensed methadone clinics for the treatment of OUD. Methadone therapy for OUD typically requires frequent visits in conjunction with an established opioid treatment program and may be inconvenient or feel stigmatizing for some patients. Methadone was first developed and used as a pain reliever in 1947. Methadone maintenance has been evaluated since its development in 1964 as a medical response to the post–World War II heroin epidemic in New York City. 124 Prior to the release of buprenorphine, methadone was the gold standard for treatment of opiate addiction. Methadone is a full opioid agonist and retains most of the undesirable effects associated with opioids, including respiratory depression, thereby making it necessary to be managed by a trained health professional. Currently, methadone is typically dosed daily and through an approved clinic. In limited cases patients may be allowed to take methadone at home between program visits. The length of methadone treatment should be a minimum of 12 months with some patients requiring long-term maintenance. 125 Buprenorphine Buprenorphine is an increasingly popular treatment for OUD. It was approved in 2002 for the treatment of OUD and differs from methadone in that buprenorphine is only a partial agonist and has less potential for side effects and overdose injury as compared to methadone. One of the most important advantages of buprenorphine is its ceiling effect on respiratory depression. As described earlier, respiratory depression frequently leads to hypoxia and arrest in many opioid overdoses. Buprenorphine has very little risk for respiratory depression, and this has made it increasingly favored and more suitable for its initiation in the outpatient arena. Unlike methadone, the lack of required daily visits to a treatment center can also be an advantage. Another advantage of
buprenorphine is the availability of long-acting injectable or implantable formulations that carry a low risk of diversion and can be managed as a monthly visit. Some patients still prefer methadone over buprenorphine. Both methadone and buprenorphine are first line agents for the treatment of OUD in pregnancy. 126 Previously, buprenorphine could only be prescribed and dispensed by a certified provider who has a Drug Enforcement Agency license and has undergone training and/or qualifies for a Drug Addiction Treatment Act of 2000 (DATA 2000) waiver. This list included physicians, nurse practitioners (NPs), physician assistants (PAs), clinical nurse specialists (CNSs), certified registered nurse anesthetists (CRNAs), and certified nurse-midwifes (CNMs). This license was commonly referred to an “x-waiver” as, after a successful application was submitted, a new DEA card was provided with an “x” before the number, designating the provider as approved to prescribe buprenorphine. It is important to note that any DEA licensed practitioner could order buprenorphine during treatment of OUD during inpatient hospitalization, as the x-waiver was only necessary for prescription authority. The x-waiver is no longer necessary to prescribe buprenorphine for the treatment of OUD . On December 29, 2022, the Consolidated Appropriations Act of 2023 enacted a new one-time, 8-hour training requirement for all DEA-registered practitioners on the treatment and management of patients with opioid or other substance use disorders. 127 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
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
Suboxone sublingual tablets
Sublingual
Page 78
Book Code: MDCO1025
Powered by FlippingBook