Am Fam Physician. 1998;58(3):786-789
Panelists for the National Institutes of Health (NIH) have issued a report recommending a reduction in U.S. Food and Drug Administration (FDA) regulations for methadone maintenance programs. The report, which was prepared at the Consensus Development Conference on treatment for opiate addiction, states that current federal regulations make it difficult, if not impossible, to tailor treatment to the needs of the individual patient. The FDA's treatment regulations for methadone were written in 1972.
In a call to loosen the regulatory reins, the report states, “By prescribing MMT (methadone maintenance treatment) procedures in minute detail, FDA's regulations limit the flexibility and responsiveness of the programs, require unproductive paperwork, and impose administrative and oversight costs greater than what are necessary for many patients. We know of no other area where the Federal government intrudes so deeply and coercively into the practice of medicine.” The report notes that therapeutic doses of methadone are now known to be higher than previously thought, but FDA regulations discourage the use of such higher doses.
The panelists of the consensus conference recommend elimination of the federal regulations and establishment of alternative means of oversight, such as accreditation, for improving methadone maintenance treatment programs. The report states that the Department of Health and Human Services “can more effectively, less coercively, and much more inexpensively discharge its statutory obligation to provide treatment guidance. . . by means of publications, seminars, Web sites, continuing medical education and the like.”
The panelists also recommend that current laws and regulations be revised to eliminate the extra level of regulation of methadone as compared with other schedule II narcotics. Under the current law, methadone can be dispensed only from facilities that obtain an extra license and comply with regulatory requirements. According to the consensus statement, “These extra requirements are unnecessary for a medication that, when diverted at all, is not often diverted for recreational or casual use but to individuals with opiate addiction who lack access to clinically administered methadone.” The panelists believe that by eliminating the extra levels of regulation, more physicians could prescribe methadone, making such treatment available in many more locations.
The two-and-one-half day conference focused on five key questions regarding the treatment of opiate addiction: What is the scientific evidence to support the concept that opiate addiction is a medical disorder? What are the consequences of untreated opiate addiction to individuals as well as society? What is the efficacy of current treatment modalities? What are barriers to effective use of opiate agonists in the treatment of opiate addiction? And, finally, what are the future research areas and recommendations for improving opiate agonist treatment and access to such treatment?
The report states that opiate addiction has been proved to be a medical disorder characterized by predictable signs and symptoms and by a strong tendency to relapse after long periods of abstinence. The opiate addict's craving for opiates induces continued use despite a strong motivation to stop. In addition, research has shown that pathophysiologic changes in the brain occur with continuous exposure to opiates.
According to the report, the consequences of untreated opiate addiction exact a great cost to society. The financial costs of untreated opiate addiction to individuals, families and society are estimated to be approximately $20 billion a year. Health care costs related to opiate addiction are estimated to be $1.2 billion a year. From 1991 to 1995, in major metropolitan areas, the annual number of emergency department visits for opiate-related problems increased from 36,000 to 76,000. During this four-year interval, the annual death rate from opiate-related problems increased from 2,300 to 4,000. Multiple studies have shown that effective treatment of persons addicted to opiates markedly reduces the crime rate. According to the consensus statement, data from 1993 indicate that more than one fourth of inmates in state and federal prisons were incarcerated because of drug offenses. More than 95 percent of opiate addicts report committing crimes during an 11-year at-risk interval.
While methadone is the most commonly used agent for the treatment of opiate withdrawal and maintenance of abstinence, other agents available for detoxification and maintenance include LAAM (levoalpha acetyl-methadol), buprenorphine and naltrexone. The consensus statement points to evidence that access to treatment of opiate addiction is limited and that large numbers of patients have no access to treatment. Of the 600,000 opiate addicts in the United States, only 115,000 are known to be in methadone maintenance programs. To increase the availability of effective treatment, the consensus panel recommends wider participation by physicians trained in substance abuse and additional funding for the treatment of opiate addiction. “All primary care medical specialties (including general practice, internal medicine, family practice, obstetrics and gynecology, geriatrics, pediatrics and adolescent medicine) should be taught the principles of diagnosing and treating patients with opiate addiction.”
The NIH consensus statement on opiate addiction concludes with 11 recommendations for improving the treatment of opiate addiction, as follows:
Leadership is needed within the Office of National Drug Control Policy (ONDCP) and related federal and state agencies to inform the public that addiction is a medical disorder that can be treated, resulting in significant benefits to patients and society.
Our society must make a commitment to offer effective treatment of opiate addiction to everyone who needs it.
Opiate-addicted persons under legal supervision should have access to methadone maintenance treatment. The ONDCP and the Department of Justice should implement this recommendation.
Training in the diagnosis and treatment of opiate addiction should be improved for physicians and other health care professionals.
Regulations should be reduced for methadone maintenance programs as well as other treatment programs.
Funding of methadone maintenance treatment programs should be increased.
Methadone maintenance treatment should be required as a benefit in public and private insurance programs.
Pregnant women with opiate addiction should be a target population for involvement in methadone maintenance treatment.
Methadone maintenance treatment must be culturally sensitive to enhance a favorable outcome for African-American and Hispanic persons.
Patients, underrepresented minorities and consumers should be included in bodies charged with policy development.
The availability of opiate agonist treatment should be expanded in those states and programs where this treatment option is currently not available.