United States Government Oversight and Regulation of Medication Assisted Treatment for the Treatment of Opioid Dependence

Abstract

The federal government has a fundamental as well as critical role in the successful development, implementation and utilization of controlled medications for the treatment of opioid abuse and dependence. The development and implementation of a federal regulatory structure establishes minimum standards which provide the basis for the development of treatment policies and medical best practices for the treatment of drug abuse and dependence. In the United States, the use of pharmacotherapies in combination with counseling, behavior therapies and other core services including primary medical care provide a comprehensive therapeutic approach termed as an evidence-based best practice termed "Medication Assisted Treatment" (MAT). Federally supported research studies have shown that the most efficacious treatment for opioid abuse and dependence comprises treatment programs that utilize pharmacotherapies and include psychosocial counseling, financial, legal, educational services as well as wrap around social services (NIDA, 2000). Federal programs catalogue such evidence-based best medical practices and promote their implementation in the care and treatment of patients to optimize good medical outcomes. In a non regulatory role, federal programs can also mandate medical education and training as well as support the piloting of treatment improvement projects to develop national implementation strategies. Drug treatment programs that utilize MAT are regulated by the federal government in their adherence to treatment standards through accreditation and in their record keeping requirements for use of controlled pharmaceuticals. Thus, multiple federal agencies combine to support MAT in the treatment of opioid dependence throughout the treatment continuum from drug discovery to patient care and treatment outcome. Salient policy issues that involve MAT as a direct result of the federal regulatory structure(s) include the provision and integration of medical services into Opioid Treatment Programs (OTPs), infectious diseases prevention counseling, the availability of opioid treatment using either buprenorphine or methadone, the limited use of Suboxone/Subutex in OTPs and which health care providers can prescribe as well as the number of patients prescribed Suboxone/Subutex in an office based setting.