Federal Regulation of Methadone Treatment (1995) / Chapter Skim
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Executive Summary
Executive Summary
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From page 1... ...
The two factors limiting methadone's effectiveness are the multiple health and social problems of methadone maintenance patients, and the variability in quality of treatment programs. HOW METHADONE IS REGULATED Even though the effectiveness of methadone for treating opiate addiction has been well-established, its use has long been controversial, a fact reflected in its extensive regulation.
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From page 2... ...
Methadone treatment of opiate addiction is often restricted still further by many state governments, a fourth level of regulation, a matter beyond the scope of this report. To complicate the picture even further, a fifth tier of regulatory authority over methadone treatment programs is sometimes found at the county and municipal level.
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From page 3... ...
Unfortunately, a comprehensive description of the authorities and agencies of the states that govern opiate agonists used for treatment of opiate addiction does not exist. The limits of the charge and available data restricted the committee's evaluation of state regulation.
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From page 4... ...
Further, there is no apparent evidence of organized crime involvement in the street market for the drug. At the same time, the committee finds that the current regulations produce unintended results: addicts who cannot obtain a treatment program tailored to their individual circumstances, physicians who are unable to exercise professional judgment in treating individual patients, programs that are isolated from mainstream medical care (thus depriving patients of important ancillary services)
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From page 5... ...
Therefore, the committee recommendations to modify the regulations are ones that can be acted upon now, on the basis of existing empirical data. These recommendations include a number of changes in terminology, which emphasize that methadone and now LAAM involve the use of opiate agonist pharmacotherapy to treat opiate addiction, not the more pejorative and less descriptive "narcotic addiction," and that it is the addiction, not the addict, that is being treated.
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From page 6... ...
termination of treatment, or discharge of patients for whatever reason, and provide rights of due process to ensure safe and humane treatment: Should not arbitrarily restrict clinical practice; Should not promote withdrawal from methadone maintenance treatment without regard to the probability that the patient will return to opiate addiction; Should prohibit basing medication dose level on patient participation in or compliance with the treatment program. In what follows, we describe some of the ways we applied these principles in recommending changes in the regulations (discussed in chapter 7~.
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From page 7... ...
The implementation of this recommendation requires that methadone maintenance treatment programs be restored to a level of funding and professionalism commensurate with the severity of the disorders toward which they are directed. In the absence of such funding, however, a requirement to provide habilitative and rehabilitative services could very well impose an economic burden on many treatment programs that would force them to cease providing services at all.
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From page 8... ...
On the basis of these and other conclusions drawn from research findings, the committee recommends that regulations require that treatment programs establish rapid admission procedures to facilitate prompt treatment for pregnant opiate addicts; assure alternative ways to provide maintenance treatment for pregnant opiate addicts where treatment is not otherwise available; and allow providers to give maintenance pharmacotherapy for pregnant opiate addicts outside of a licensed narcotic treatment program, in settings such as a hospital, pharmacy, clinic, and individual practitioner's office. Special arrangements may be needed for patients in geographic areas where there are no licensed programs; dosage, treatment plan, and the acceptable time of treatment after conclusion of the pregnancy should be determined by consultation with addiction treatment experts, the treating physician, and the patient, in accordance with specific guidelines.
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From page 9... ...
This issue is appropriately addressed by guidelines for hospital staff, which should reflect the following general principles: on admission of a methadone maintenance patient as a hospital inpatient, hospital staff should notify the patient's treatment program and confirm the individual's enrollment, methadone dose, and time and date of last dose; during an inpatient stay, the hospital staff should ensure the continuity of methadone pharmacotherapy through its own pharmacy or by arrangement with the patient's treatment program; before discharge, hospital staff should notify the methadone treatment program of the time of discharge and the time and amount of last dose of methadone to ensure resumption of outpatient pharmacotherapy without interruption; if the patient is discharged to continuing care facilities, arrangements for continued provision of methadone should be part of the discharge plan. In addition to the issue of how hospital staff care for methadone patients, there are problems of how the restrictions of the federal regulations affect the treatment of hospitalized opiate addicts in general.
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From page 10... ...
Opiate addicts who also have chronic pain conditions may require coordinated treatment in both clinical settings, which sometimes may exist within in a single organization. To address the problem of inappropriate referrals of pain patients who may be opiate-dependent but not opiate-addicted to methadone pharmacotherapy, the IOM committee proposes that the regulations establish a clear distinction between opiate addiction and opiate dependence and that any guidelines developed for methadone treatment incorporate this distinction.
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From page 11... ...
Steering a course between these two dangers requires that medical staff serving opiate addiction treatment programs provide guidance to physicians, dentists, and other practitioners treating methadone-maintained patients for acute pain. In addition to emphasizing the need for honest communication between patient and physician, this guidance should provide for continued methadone pharmacotherapy without interruption; adequate doses of appropriate short-acting opiate agonist drugs for pain; and contraindications to giving antagonist and mixed agonist-antagonist opiate drugs that may produce a serious withdrawal reaction in opiate-tolerant individuals.
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From page 12... ...
The way substance abuse treatment is currently financed, no single revenue stream offers enough incentive to service providers to generate the requisite data. The Methadone Treatment Quality Assurance System, sponsored by NIDA, designed to assess the feasibility of a performance-based reporting and feedback system for methadone treatment programs, offers the prospect of laying the foundation for a formal QA system in the future.
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From page 13... ...
Effectiveness must be defined not only in relation to the individual well-being of the patient but also the public health and public safety objectives for methadone maintenance treatment, namely, the elimination of illicit opiate use and reduction of nonopiate illicit drug use; the general increase in positive social behaviors and employment; and the reduction of AIDS-transmission behaviors, crime, social violence, and the disproportionate use of medical and social services. We believe that the achievement of these objectives can and should be measured in any outcomes evaluation.
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From page 14... ...
In the case of NIDA, compliance with this requirement will undoubtedly involve research on the delivery of substance abuse treatment services, some of which may involve methadone, LAAM, or other controlled substances. This research may involve such issues as treatment settings and take-home privileges.
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From page 15... ...
SAMHSA should be authorized and directed to tie compliance with this requirement to eligibility for block grant funding. Finally, the extent of state regulation of substance abuse treatment revealed in the case of LAAM, approved by FDA in 1993 for treating narcotic addiction, but not yet approved by many states is so great that the committee recommends that a comprehensive assessment of state substance abuse treatment regulations be undertaken, especially as they pertain to the treatment of opiate addiction, with an eye to developing a model state approach to the financing, treatment, and regulation of services.
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From page 16... ...
It may be expected that increased federal funds will flow to substance abuse treatment services as a result of these actions. Therefore, the committee recommends that DHHS conduct a review of its priorities in substance abuse treatment, including methadone treatment, in a way that integrates changes in regulations and the development of practice guidelines with decisions about treatment financing.
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