From morphine clinics to buprenorphine: regulating opioid agonist treatment of addiction in the United States

doi:10.1016/S0376-8716(03)00055-3

Drug and Alcohol Dependence

Volume 70, Issue 2, Supplement, 21 May 2003, Pages S3-S11

https://doi.org/10.1016/S0376-8716(03)00055-3 Get rights and content

Abstract

The practice of prescribing opioid drugs for opioid dependent patients in the U.S. has been subjected to special government scrutiny for almost 100 years. From 1920 until 1964, doctors who used opioids to treat addicts risked federal and/or state criminal prosecution. Although that period ended when oral methadone maintenance was established as legitimate medical practice, public concern about methadone diversion and accidental overdose fatalities, combined with political pressure from both hostile bureaucracies and groups committed to drug-free treatments, led to the development of unprecedented and detailed Food and Drug Administration (FDA) regulations that specified the manner in which methadone (and later, levo-alpha-acetyl methadol, or levomethadyl acetate, (LAAM)) could be provided. In 1974, Congress gave the Drug Enforcement Administration (DEA) additional oversight of methadone treatment programs. Efforts to liberalize the FDA regulations over the past 30 years have been resisted by both the DEA and existing treatment providers. Additional flexibility for clinicians may evolve from the most recent effort to create an accreditation system to replace some of the FDA regulations. The development of buprenorphine, a partial opioid agonist, as an effective treatment for opioid addiction reopened the possibility for having a less burdensome oversight process, especially because of its reduced toxicity if ingested by non-tolerant individuals. New legislation, the Drug Addiction Treatment Act (DATA) of 2000, created an opportunity for clinicians with special training to be exempted from both federal methadone regulations and the requirement to obtain a special DEA license when using buprenorphine to treat addicts. Some details of how the DATA was developed, moved through Congress, and signed into law are described.

Section snippets

Early history of opioid-addiction treatment

The federal regulation of medical prescribing of opioids in the U.S. began with the Harrison Act of 1914. While the Harrison Act did not actually prohibit physicians from prescribing opioids for addicted patients within a legitimate medical context, the Treasury officials who were empowered to implement the Act vigorously opposed the practice and were successful in deterring physicians from engaging in it. By 1920, the American Medical Association (AMA) also condemned prescribing opioids to

Evolution of methadone treatment

The current system of opioid treatment regulations, as well as American attitudes towards addicts, were influenced not only by this history, but also by other equally important elements and events. These included a heroin epidemic that accelerated in the early 1960s; the rise of the therapeutic community movement, which convincingly demonstrated that heroin addicts were not beyond redemption; the Narcotic Addict Rehabilitation Act (NARA) of 1966, which established a federal civil commitment

Opioid-agonist treatment regulations—recent changes

The number of patients in methadone treatment programs has grown since the early 1970s, from about 20,000 to about 180,000 (Kreek and Vocci, 2002). Some states still do not permit methadone or other opioid agonist treatment regulated by the NATA. In 1993, when the FDA finally approved LAAM for the treatment of heroin addiction, multiple state and local legislative and regulatory barriers still prevented it from being used. Even where it was permitted its utility was compromised because the FDA

Buprenorphine: a new pharmacotherapy for opioid addiction

A major justification for the regulation, accreditation, and separate DEA registration was to minimize the diversion of opioid drugs from treatment programs. Among the most important concerns about diversion are the serious toxic consequences that ensue when non-tolerant individuals ingest dosages of methadone or LAAM typically used in treatment. As early as Jasinski et al. (1978) had noted the possible clinical utility of buprenorphine, a partial opioid agonist. By the early 1990s, it became

A need for new legislation

Reckitt and Colman was convinced by the history of efforts to modify the methadone regulations that amending treatment program regulations through administrative change would be a long and cumbersome process unlikely to reach the goal of moving treatment into the mainstream of medicine and expanding access for new patients. The company therefore chose to seek a change in the law. The original aim of the proposed legislative solution seemed simple and straightforward: to change the law to waive

The drug addiction treatment act of 2000

The new law, the DATA of 2000, offers an opportunity to make significant changes in the way addiction treatment is delivered. The change could be of benefit to hundreds of thousands of patients addicted to opioids. Perhaps as result of this legislation, other companies will see more opportunity in the development of new pharmaceuticals to treat addiction. The last hurdle was the final approval of the buprenorphine NDA by the FDA.

Buprenorphine for the treatment of opioid dependence was approved

Future challenges

It is not clear at this time how these two concurrent systems will interact and what the impact will be on patient access to treatment or the array of services provided. It is anticipated that the changes in the older system (the hybrid–hybrid) and the availability of buprenorphine in the offices of qualified physicians will serve both to increase access to treatment and to ease the compliance burdens on patients, and that both of these conditions will result in substantial benefits to the

Acknowledgements

Charles O'Keeffe is President of Reckitt Benckiser Pharmaceuticals. Jerome Jaffe retired from his position as Director of OESAS in CSAT in 1997. He was a consultant to Schering Corporation, in 2000–2001, which is licensed by Reckitt Benckiser to market buprenorphine in several countries around the world. In the early 1990s, he provided consultation to drug manufacturers Roxane and Mallinckrodt, which manufacture and distribute methadone and LAAM. Support for this work was provided through

References (17)

D.T. Courtwright
A century of American narcotic policy
V.P. Dole
Hazards of process regulations; the example of methadone maintenance
J. Am. Med. Assoc.
(1992)
Glasscote, R., Sussex, J.N., Jaffe, J.H., Ball, J., Brill, L. 1972. The treatment of drug abuse-programs, problems,...
J.H. Jaffe
The maintenance option and the Special Action Office for Drug Abuse Prevention
Psychiatr. Ann.
(1975)
Jaffe, J.H., 1997. The history and current status of opiate agonist treatment. In: Effective medical treatment of...
D.R. Jasinski et al.
Human pharmacology and abuse potential of the analgesic buprenorphine
Arch. Gen. Psychiatry
(1978)
R.E. Johnson et al.
A controlled trial of buprenorphine treatment for opiate dependence
J. Am. Med. Assoc.
(1992)

There are more references available in the full text version of this article.

Cited by (124)

Insufficient Impact: Limited Implementation of Federal Regulatory Changes to Methadone and Buprenorphine Access in Arizona During COVID-19
2024, AJPM Focus
This study examined the impact of federal regulatory changes on methadone and buprenorphine treatment during COVID-19 in Arizona.
A cohort study of methadone and buprenorphine providers from September 14, 2021 to April 15, 2022 measured the proportion of 6 treatment accommodations implemented at 3 time periods: before COVID-19, during Arizona's COVID-19 shutdown, and at the time of the survey completion. Accommodations included (1) telehealth, (2) telehealth buprenorphine induction, (3) increased multiday dosing, (4) license reciprocity, (5) home medications delivery, and (6) off-site dispensing. A multilevel model assessed the association of treatment setting, rurality, and treatment with accommodation implementation time.
Over half (62.2%) of the 74-provider sample practiced in healthcare settings not primarily focused on addiction treatment, 19% practiced in methadone clinics, and 19% practiced in treatment clinics not offering methadone. Almost half (43%) were unaware of the regulatory changes allowing treatment accommodation. Telehealth was most frequently reported, increasing from 30% before COVID-19 to 80% at the time of the survey. Multiday dosing was the only accommodation substantially retracted after COVID-19 shutdown: from 41% to 23% at the time of the survey. Providers with higher patient limits were 2.5–3.2 times as likely to implement telehealth services, 4.4 times as likely to implement buprenorphine induction through telehealth, and 15.2–20.9 times as likely to implement license reciprocity as providers with lower patient limits. Providers of methadone implemented 12% more accommodations and maintained a higher average proportion of implemented accommodations during the COVID-19 shutdown period but were more likely to reduce the proportion of implemented accommodations (a 17-percentage point gap by the time of the survey).
Federal regulatory changes are not sufficient to produce a substantive or sustained impact on provider accommodations, especially in methadone medical treatment settings. Practice change interventions specific to treatment settings should be implemented and studied for their impact.
Adoption of methadone take home policy by U.S. state opioid treatment authorities during COVID-19
2024, International Journal of Drug Policy
Patients face well documented problems accessing methadone from opioid treatment programs (OTPs) in the U.S., yet addressing these barriers has proven difficult due in part to the sheer number of actors governing treatment, including state authorities. Changes in federal methadone regulations during COVID-19 offer an opportunity to study the timing and extent of U.S. state opioid treatment authority (SOTA) adoption of policies expanding take home dosing for methadone treatment since March 2020.
We completed a policy scan between February 23 and May 2, 2023 on state adoption and subsequent rescinding of federal regulatory exemptions for expanded take-home dosing. This scan involved three components: a policy survey of SOTAs, a freedom of information act (FOIA) request of SAMHSA, and outreach to members of National Survivors Union (NSU)’s methadone work group.
Of the 39 of 50 (78 %) SOTAs that responded, only 2 states (HI and MT) indicated that they never adopted federal exemptions for expanded take-home dosing. Of the 37 adopting states, all adopted the exemptions within the first month after the agency's announcement. Additionally, four SOTAs (OH, IN, FL, MS) indicated that their state subsequently rescinded expanded take-home dosing for methadone.
Among responding states, regulations expanding take-home dosing appear to have been adopted by U.S. SOTAs in a widespread and rapid manner at the start of the COVID-19 pandemic, but some states have begun to rescind such policies. Our findings suggest that state regulators can rapidly modify OTP regulations in response to federal policy changes. SOTA policies are likely to become critical factors in the adoption of methadone treatment innovations if new federal regulatory flexibilities become permanent.
Expanding Buprenorphine Access: Outcomes of a Curricula With Opioid-Related Content
2023, Journal for Nurse Practitioners
A priority for addressing the opioid crisis is the expansion of the nurse practitioner (NP) workforce. A Mid-Atlantic school of nursing revised their Doctor of Nursing Practice (DNP) curricula to augment the federally required 24 hours of specialized training with the goal of increasing the number of NPs eligible to prescribe buprenorphine. On the basis of a survey of those NP alumni, 17% reported they were prescribing buprenorphine. Continuing to provide opioid-related content and clinical opportunities for NP students is essential for increasing their knowledge and skills in providing evidence-based and nonjudgmental, nonstigmatized care to this patient population.
Enhancing engagement between legislators and nursing to increase buprenorphine access
2023, Nursing Outlook
History of the discovery, development, and FDA-approval of buprenorphine medications for the treatment of opioid use disorder: Buprenorphine medications for opioid use disorder
2023, Drug and Alcohol Dependence Reports
Buprenorphine-based medications were first approved by the United States Food and Drug Administration in 2002 for the treatment of opioid dependence, or opioid use disorder (OUD) as the condition is presently known. This regulatory milestone was the outcome of 36 years of research and development, which also led to the development and approval of several other new buprenorphine-based medications. In this short review, we first describe the discovery and early development stages of buprenorphine. Second, we review key steps that led to the development of buprenorphine as a drug product. Third, we explain the regulatory approval of several buprenorphine-based medications for the treatment of OUD. We also discuss these developments in the context of the evolution of regulations and policies that have progressively improved OUD treatment availability and efficacy, although challenges remain in removing system-level, provider-level, and local-level barriers to quality treatment, to integrating OUD treatment into routine care and other settings, to reducing disparities in access to treatment, and to optimizing person-centered outcomes.
State-level regulations and opioid-related health outcomes
2022, Drug and Alcohol Dependence
Due to the ongoing opioid use disorder crisis, improved access to opioid treatment programs (OTPs) is needed. However, OTPs operate in a complex regulatory environment which may limit their ability to positively affect health outcomes. The objective of this study was to examine how the number and type of state OTP regulations are associated with opioid-related deaths, hospitalizations, and emergency department visits.
Cross-sectional data capturing information about OTP state-level regulations collected by Jackson et al. was combined with other secondary sources. OTP regulations were categorized based on the nature of their focus. Analyses include bivariate and multivariable regressions that controlled for region and other state laws that can affect opioid outcomes.
In bivariate analysis, a greater number of OTP regulations was positively correlated with both deaths and emergency visits. Moreover, a greater number of regulations in the Physical Facilities Management category (e.g., rules related to restrooms, lighting, and signage) was positively correlated with both deaths and hospitalizations. The number of regulations in the Staffing Requirement category was positively associated with emergency visits. In adjusted analysis, the number of regulations in the Physical Facilities Management category was positively associated with opioid-related deaths.
States with a higher number of regulations had poorer opioid-related outcomes. Additional research is needed to support policy decisions that can improve access to OTPs and reduce avoidable deaths, hospitalizations, and emergency visits.

View all citing articles on Scopus

View full text

ReviewFrom morphine clinics to buprenorphine: regulating opioid agonist treatment of addiction in the United States

Abstract

Section snippets

Early history of opioid-addiction treatment

Evolution of methadone treatment

Opioid-agonist treatment regulations—recent changes

Buprenorphine: a new pharmacotherapy for opioid addiction

A need for new legislation

The drug addiction treatment act of 2000

Future challenges

Acknowledgements

A century of American narcotic policy

Hazards of process regulations; the example of methadone maintenance

J. Am. Med. Assoc.

The maintenance option and the Special Action Office for Drug Abuse Prevention

Psychiatr. Ann.

Human pharmacology and abuse potential of the analgesic buprenorphine

Arch. Gen. Psychiatry

A controlled trial of buprenorphine treatment for opiate dependence

J. Am. Med. Assoc.

Review
From morphine clinics to buprenorphine: regulating opioid agonist treatment of addiction in the United States