Part D: Critical Questions and Links to Information Regarding Clinical and Regulatory Requirements for Implementing Methadone Maintenance Programs: Examples of Approaches

Question 1: How are methadone programs approved or registered for operation?

Answer:

United States
Methadone maintenance programs must go through an accreditation process in order to operate. The Substance Abuse and Mental Health Services Administration (SAMHSA) (www.samhsa.gov/) is the lead agency responsible for Federal methadone treatment oversight and the accreditation of methadone programs. Through its Center for Substance Abuse Treatment (http://dpt.samhsa.gov/), SAMHSA has guidelines for program accreditation (http://dpt.samhsa.gov/pdf/001218accred.pdf) that address each critical legal, clinical, safety, and program management area related to the treatment of patients using methadone maintenance therapy.

All accredited methadone programs operate under the authority of the Drug Enforcement Agency (DEA) regulations that govern the dispensing of controlled substances. The DEA regulations (www.deadiversion.usdoj.gov/pubs/manuals/narcotic/narcotic.pdf) stipulate requirements for the type of registration required, qualifications for physicians who dispense methadone, and rules for physician record-keeping.

Canada
In Canada, treatment practitioners and the hospitals providing methadone treatment must be registered to dispense methadone and are exempt from the control regulations set forth in the Controlled Drug and Substances Act (laws.justice.gc.ca/en/C-38.8/C.R.C.-c.1041/211220.html?noCookie).

Australia
In Australia, methadone programs are approved by the Director-General of Health and treatment practitioners must complete and pass a Methadone Prescriber’s Accreditation Course before they are allowed to dispense methadone (http://opiateaddictionrx.info/pdfs/methadone_clinicalpractice_guidelines.pdf).

New Zealand
The Minister of Health has designated the Director of Mental Health as the authority to determine what organization can be specified as a methadone treatment service (www.moh.govt.nz/moh.nsf/49ba80c00757b8804c256673001d47d0/
43c7fe2ae5863e39cc256cf30002b8ad/$FILE/Opioid%20Substitution%20Treatment.pdf). In addition, New Zealand will only approve practitioners who agree to establish and maintain a direct relationship with the local treatment services provider. Local programs are required to provide a letter of support for the practitioner to dispense methadone and to work collaboratively as a team (www.moh.govt.nz/moh.nsf/49ba80c00757b8804c256673001d47d0/
43c7fe2ae5863e39cc256cf30002b8ad/$FILE/Opioid%20Substitution%20Treatment.pdf).