March 2018
The Evolution of Federal Drug Control Policy and its Impacts on Treatment for Opioid Use Disorder: A brief history
Understanding the development of federal drug policy will aid clinicians in navigating the treatment constraints (often invisible) for their patients. There are six critical pieces of federal legislation: a) the 1914 Harrison Narcotic Act, b) the 1929 Narcotic Farms Act, c) the 1966 Narcotic Addict Rehabilitation Act, d) the 1970 Controlled Substances Act, e) the 1972 Drug Abuse Office and Treatment Act, and f) the Drug Abuse Treatment Act of 2000. This article is a brief summary of a chapter from the 2018 Annual Review of Public Health (now available on-line in advance of print and scheduled for publication in April) (McCarty, Priest, & Korthuis, 2018).
Passed over a century ago, the 1914 Harrison Narcotic Act is the foundation for contemporary drug control policy. The Act aligned US policy with European policy, began federal oversight and regulation of controlled substances (e.g., raw opium, morphine, diacetylmorphine, and cocaine), and criminalized the “non-medical” use of opioids. Physicians and pharmacist who handled and dispensed narcotics were required to register with the federal government and keep records of the medications prescribed and dispensed (Musto, 1973). At the time, the primary treatment for opioid dependence was diacetylmorphine (aka heroin) or morphine maintenance. States and communities operated “narcotic” maintenance clinics.
However, in 1919, the U.S. Supreme Court (Webb v. US), affirmed the rulings of the lower courts finding that physicians treating opioid dependence with opioids were in violation of the Act, consequently by the mid-1920s all publicly funded maintenance clinics were closed and publicly funded treatments for morphine, opium, and heroin use disorders were largely unavailable.
Also known as the Porter Act, the legislation authorized construction of two “Narcotic Farms” for treatment and incarceration of Federal narcotic offenders. The facility in Lexington Kentucky opened in 1935 to serve voluntary patients and federal offenders east of the Mississippi; the Fort Worth Texas institution served individuals west of the Mississippi and opened in 1938. The US Public Health Service and the US Bureau of Prisons co-managed the institutions. Moral therapy provided the structure for therapeutic services – fresh air and hard work (Campbell, Olsen, & Walden, 2008). Following withdrawal management, residents grew food, managed dairies, sewed clothing, and took classes toward degrees. Between 1935 and 1974, the hospitals provided the only federally funded residential care for opioid use disorder. Upon leaving, individuals usually returned to use because structured continuing care outside of the farm was not available in their home communities. In 1974, the programs were closed as hospitals and continued to operate as federal correctional institutions.
Learn more in the upcoming webinar:
Treatment and Prevention of Opioid Use Disorder: Overview
Tuesday, April 3, 2018
11AM PT, 12PM MT, 1PM CT, 2PM ET
Presented by Dr. Dennis McCarty, topics in this 90-minute webinar include the history of federal initiatives for OUD treatment, efffective therapies for OUD, the chronic nature of OUD, and the role of naloxone distribution.
To register, click here.
NARA authorized civil commitment instead of prosecution for individuals charged with federal drug offenses. The initial four to six months of the 36-month civil commitment were served at one of the two narcotic farms. Following hospital release, individuals received supervision in the community. Outpatient services developed with federal funds to provide ongoing care for the recently released individuals (Besteman, 1992). Those services were guided by self-help philosophies because there was little research to guide training of counselors.
The Controlled Substances Act provides the current drug control framework. Drugs with abuse potential are categorized into five schedules based on acceptable medical uses and the perceived potential for abuse: Schedule I substances have no acceptable medical use (e.g., heroin); Schedule II substances have strong abuse potential (e.g., methadone, morphine); Schedule III substances have lower abuse potential (e.g., buprenorphine); Schedule IV and V substances have less abuse potential. The Act repealed and replaced the 1914 Harrison Narcotic Act and explicitly prohibits the prescription of opioids for the treatment of opioid addiction. (The legislation defines all controlled substances as narcotics and in addition to opioids, includes cocaine, cannabis, amphetamine and other substances with abuse potential.)
The Food and Drug Administration (FDA) approved naltrexone as an opioid antagonist therapy for treatment of opioid dependence in 1984.
The Act authorized the Special Action Office for Drug Abuse Prevention (SAODAP) in the Whitehouse as part of President Nixon’s “War on Drugs.” Under Dr. Jerry Jaffe’s leadership, SAODAP promoted the development of methadone clinics as a medical intervention for the nation’s heroin problem and elevated crime rates. Congress was reluctant to embrace the use of opioid agonist therapy and SAODAP’s authorizing legislation required development of an opioid antagonist medication. SAODAP and its successor the National Institution of Drug Abuse partnered with pharmaceutical companies and eventually developed naltrexone. The Food and Drug Administration (FDA) approved naltrexone as an opioid antagonist therapy for treatment of opioid dependence in 1984.
By the late 1990s, it was apparent that buprenorphine was heading towards FDA approval but language in the Controlled Substances Act would not permit physicians to prescribe it to patients (Jaffe & O'Keefe, 2003).
Buprenorphine (and many other controlled substances) was tested on residents at the Lexington Public Health Hospital through the research wing of the hospital—the Addiction Research Center. Researchers observed the potential for buprenorphine to be used for maintenance in this population and suggested it as a potential long-term opioid agonist therapy (Jasinski, Pevnick, & Griffith, 1978). By the late 1990s, it was apparent that buprenorphine was heading towards FDA approval but language in the Controlled Substances Act would not permit physicians to prescribe it to patients (Jaffe & O'Keeffe, 2003). Thus, DATA 2000 explicitly addressed this barrier through the creation of a regulatory program for buprenorphine prescribers.
This program, in place today, includes a waiver process requiring prescriber education, a request for a waiver from the SAMHSA and the DEA, a unique DEA registration number and a patient panel limit. The requirements were designed to inhibit the creation of clinics that carelessly prescribed the medication. Buprenorphine received FDA approval in 2002. Over time, the regulations have been updated to expand access to treatment by increasing the number of patients on a panel, and in 2016 nurse practitioners and physician assistants were authorized to request waivers to prescribe buprenorphine.
These six pieces of legislation reflect a long and complex societal history with opioid use disorder. Doctors, experts, and society at large have simultaneously viewed opioids as medicine and as a menace, and those that use opioids have been viewed as patients and as criminals. Over the last century, patients had few treatment options – isolation in rural correctional-based facilities, untrained counselors, and heavy restrictions on access to evidence-based opioid agonist therapies. A criminal justice perspective shaped federal and local policy, constrained the development and use of effective therapies, and continued a legacy of stigma that inhibited integration into primary care settings. In the 21st century, science based approaches to care will continue to develop providing more care options, and foster more understanding and support from primary care clinicians and the medical community. Clinicians will support patient choices to use agonist and antagonist medications and will advocate for federal and state policies that promote recovery and reduce stigma.