Federal Regulation of Methadone Treatment (1995) / Chapter Skim
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Federal Regulation of Methadone Treatment
Federal Regulation of Methadone Treatment
Pages 120-150
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From page 120... ...
In 1970, these various statutes were consolidated and remodified as the Controlled Substances Act (CSA) , which has been amended several times since then.
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From page 121... ...
Congress ratified this joint responsibility of law enforcement and public health officials for methadone through this third set of rules in 1974 with the passage of the Narcotic Addict Treatment Act (NATA)
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From page 122... ...
of 1966-1967, and the Narcotic Addiction Rehabilitation Act of 1966. The 1965 Drug Abuse Control Amendments brought under strict federal control all nonnarcotic drugs capable of producing serious psychotoxic effects when abused.
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was created, which became the Drug Enforcement Administration in 1973. DHEW responsibilities for narcotic addiction treatment were lodged in the NIMH.
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From page 124... ...
To achieve this clarification, Title I, in Section IV, charged the Secretary of Health, Education, and Welfare, to "determine the appropriate methods of professional practice in the medical treatment of the narcotic addiction of various classes of narcotic addicts." This provision constitutes the initial statutory basis for treatment standards. More important, it clearly stated that the health establishment, not the law enforcement community, would determine the scope of the practice of medicine in this area.
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From page 125... ...
Since SAODAP also controlled federal funding of treatment programs, its role was very important in encouraging and nurturing the establishment and development of methadone treatment programs. DEFINING THE REGULATORY REGIME: 197~1974 The methadone regulatory regime the third set of rules governing methadone treatment was defined in the period 1970 through 1974 by the Comprehensive Drug Abuse Prevention and Control Act of 1970, the FDA methadone regulations for Investigational New Drugs of 1971, the FDA methadone regulations of 1972, and the Narcotic Addict Treatment Act of 1974.
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From page 126... ...
Its primary use in addiction treatment was to withdraw addicts fiom heroin, well before methadone maintenance treatment was developed. In 1962, Vincent Dole and Marie Nyswander at Rockefeller University began planning clinical studies to use methadone with carefully selected narcotic addicts in New York City.
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From page 127... ...
as the primary federal agency that might have regulatory authority over his proposed research, and the key question was whether research using methadone to maintain heroin addicts as part of a treatment program in New York City was within the domain of the professional practice of medicine or was another form of trafficl~ing, as FBN had claimed with respect to the morphine clinics some 40 years earlier (Dole, 1989~. After extensive consultation with university lawyers and officials, Dole concluded that prior Supreme Court decisions did not bar the use of methadone in "in the course of professional treatment." The FBN view, however, was that maintenance of narcotic addiction with any narcotic drug fell outside the normal course of professional treatment.
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It issued a proposed rule dealing with IND protocols for methadone treatment on June 11, 1970 (35 FR 9014~. On April 2, 1971, a final rule of 2 1/2 pages specified the conditions of investigational use; the rule also responded to a BNDD regulation on IND requirements for controlled substances (see below)
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From page 129... ...
Two types of treatment—detoxification and maintenance were defined. The former involved using methadone "as a substitute narcotic drug in decreasing doses to reach a drug free state in a period not to exceed 21 days" in order to "withdraw an individual who is dependent on heroin or other morphine-like drugs from the use of these drugs." Methadone maintenance, the provision of which was to be restricted to methadone treatment programs, involved using methadone "at relatively stable doses" for more than 21 days along with the appropriate social and medical services.
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From page 130... ...
A two-tiered system was stipulated. The first tier—"methadone treatment programs" provided comprehensive services using methadone for either detoxification or maintenance treatment of narcotic addicts, including initial patient evaluation.
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by treatment programs. Minimum dosage was described, both for detoxification treatment and for maintenance treatment.
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The Commissioner therefore concludes that it is essential to the public interest to prescribe detailed conditions for safe and effective use of methadone, utilizing the IND and NDA control mechanisms and the authority granted under the Comprehensive Drug Abuse Prevention and Control Act of 1970, to assure that the required additional information for assessing the safety and effectiveness of methadone is obtained, to maintain close control over the safe distribution, administration, and dispensing of the drug, and to detail responsibilities for such control.
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From page 133... ...
(See 37 FR 26807.) The controlled distribution established by this rule restricted dispensing of methadone to hospital pharmacies and treatment programs, required registration of physicians, thus limiting their ability to write prescriptions for methadone for heroin addicts, and required that methadone treatment services be provided only by authorized programs.
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From page 134... ...
It will not replace them in any way; it will simply make their enforcement much more readily obtainable." The purpose of the bill, the Senate committee report stated, was "to provide new authority for the regulation of the use of narcotic drugs in the treatment of narcotic addicts which are consistent with legitimate program objectives and the protection of the community at large." The House report expressed the belief that the bill would "complement the DEA and FDA regulations currently in force, and establish the basis for additional joint regulation of treatment programs by these two agencies." The intent of Congress was clear on the expectation that the law would be implemented by regulations. As had the methadone regulation, the NATA statute defined both maintenance and detoxification treatment.
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to issue standards of treatment for narcotic addiction treatment, specifically for the qualifications of practitioners and with respect to the quantities of methadone for take-home ("unsupervised use") , was embedded in the NATA provision for registration of practitioners by DEA.
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Finally, persons under 16 years of age were now admissible to maintenance treatment; previously only detoxification had been allowed. The rule retained mandatory urine testing for methadone maintenance patients of at least eight tests in the first year of treatment, at least quarterly tests for the second and successive years, and monthly tests for each six-day take-home patient.
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From page 137... ...
Doses over 100 mg required that the state authority and the FDA be notified in writing or by telephone within 72 hours of the dose, eliminating the requirement of prior approval. The final rule restricted take-home methadone to a liquid form for "responsible" patients.
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In transmitting the results of the review, the chairman of the review team cautioned that while all review team members concurred with the recommendations, the effort to select specific regulations for conversion to guidelines would reveal "unresolved policy issues." The 1983 review argued the case for guidelines on the following basis: Since 1972 when the first methadone regulations were issued and continuing into the present, the "state of the art" in the treatment and rehabilitation of narcotic addicts has been evolving and frequently changing. An often voiced criticism of
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From page 139... ...
The report noted that DEA staff had, informally, raised no objections to the recommended approach "as long as diversion does not increase." Thus, the review team recommended that the DHHS treatment standards "be basically in the form of guidelines." In response to this exercise, in 1983, the FDA and NIDA solicited comment on whether they should make portions of the methadone regulation into guidelines, and modify record-keeping and reporting requirements, and whether changing the requirements "would impair enforcement and compliance with the regulation, affect the quality of patient care, and increase the likelihood of the diversion of methadone for illicit use." Most of the comments viewed the methadone regulations as "generally neither unreasonable nor burdensome" and noose argued that they should not be substantially revised or converted to guidelines. 1987 Notice of Proposed Rule-Making The 1983 recommendations, though not adopted, did initiate another revision of the methadone regulations, which first found expression in a 1987
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From page 140... ...
and long-term (>21 and <180 days) treatment; that the minimum staffing ratio of one counselor to 50 patients be eliminated; that blood tests be allowed as ways to conduct initial drug screening or to meet the monthly testing requirements for six-day take-home patients; that the 72-hour notification of FDA and the pertinent state authority for methadone doses greater than 100 mg be eliminated; that special adverse reaction reporting requirements for methadone be eliminated and reliance placed upon general FDA reporting requirements; that a supervising counselor be allowed to conduct the annual review of the patient's treatment plan for "certain qualified patients" who had been in treatment for 3 years or longer; and that the requirement of an annual report of methadone treatment programs to the FDA be dropped.
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From page 141... ...
The major changes to the regulations as issued in 1980 included the following: detoxification was separated into short- and long-tenn, the former being a maximum of 30 days and the latter a maximum of 180 days; a specified counselor-patient ratio was deleted; treatment programs were allowed to use other procedures besides urinalysis, such as blood testing, to test for drugs of abuse; the 72-hour notification of FDA and state authority for doses above 100 mg was eliminated, but written justification in the patient record was still required; the review of a patient's annual treatment plan by a physician was not required for model patients in treatment for 3 years; the serology test for syphilis could be omitted if a patient's veins were so severely damaged as to preclude obtaining blood; expanded counseling for pregnant women was required; an inadvertently omitted requirement that a physician date and sign the patient record within 72 hours of first administration of methadone was reinstated; and the special adverse reaction reporting requirement for methadone and the annual report to FDA were eliminated. Some provider comments on the 1987 proposed rule reflected a fear that removal of rehabilitation services requirements would weaken the emphasis on rehabilitation.
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From page 142... ...
The guidance document dealt with services; hospital affiliation; medication units; current physiological dependence; drug screening urinalysis; contents of medical evaluation; admission evaluation; initial treatment plans and their periodic evaluation; pregnant patients, staffing; and initial, maintenance, take-home, and initial detoxification dosage; methadone formulation; and discontinuation of methadone use (both involuntary and voluntary)
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From page 143... ...
lIIV was "making massive inroads" among intervenous drug users; methadone treatment, by reducing the consumption of heroin by needle sharing, could therefore reduce the spread of HIV.6 Under the proposal, methadone maintenance treatment was to be categorized as "comprehensive" and "interim." The former was methadone maintenance treatment as defined in the existing regulations. Although "interim" treatment was to be provided only by comprehensive treatment programs (i.e., programs offering only interim treatment were prohibited)
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From page 144... ...
The polydrug use of injecting narcotic addicts argued for the counseling and rehabilitative services of a comprehensive program. Importantly, it was pointed out that the resources available to such programs would be reduced if treatment programs also devoted funds to interim maintenance.
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Simultaneously, the FDA was approving an NDA for LAAM.8 7This rule was issued jointly by the FDA and SAMHSA. LOAM had been developed originally in 1948 as a synthetic congener of methadone, had been tested in Germany as a narcotic analgesic, and had been examined in this country as a potential narcotic addiction treatment medication in the 1970s.
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From page 146... ...
The interim rule did revise 21 CFR 291.501, basically unchanged since 1972, which had served as the defacto "preamble" to the methadone regulation.9 The "need for farther research" language, which had provided the justification for the hybrid IND-NDA system, was finally replaced by an explicit recognition by the FDA, NIDA, and DEA "that the use of narcotic drugs in the prolonged maintenance of narcotic dependence has been shown to be an effective part of a total treatment effort in the management and rehabilitation of selected narcotic addicts." ~° The new section 291.501 noted the dangers of abuse if services and controls were inadequately applied. However, it simply indicated that interested professionals, municipalities, arid organizations "should be allowed to use narcotic drugs in the medical treatment of narcotic addiction within a framework of adequate controls designed to protect the individual patients and the community." The interim rule included the following LAAM-related provisions: talcehome medications were prohibited; programs were prohibited from admitting individuals into treatment who were under 18 years of age; women of childin securing its approval as an NDA.
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From page 147... ...
Comments on the interim rule challenged the assertion that treatment capacity would be increased by the longer duration of LAAM, criticized the prohibition on take-homes, sought clarification on dosage in relation to methadone doses, questioned the need for monthly pregnancy testing on grounds of costs, asked whether methadone treatment programs would be automatically approved to use LAAM, and complained that the FDA-approved label had not been published with the rule. California proprietary providers objected to the requirement that a physician complete and record initial patient evaluation findings before administering the medication, preferring that the physician either sign in advance or review the decision of a "health professional" within 72 hours of initial dose.
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From page 148... ...
That use of a narcotic drug to treat narcotic addiction is an unusual practice posing special risks to patients, both those truly addicted and those who might be more appropriately treated without narcotic drugs; 2. That the desirability and availability of methadone created an unusual potential for drug diversion to illicit uses, posing special risks to society (see chapter 4~; 3.
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From page 149... ...
Des Jarlais, D, Addicts Who Survived: An Oral History of Narcotic Use in America, 1923-1965, Knoxville, University of Tennessee Press 331-343. Draft Final Rule, Food and Drug Administration, National Institute of Drug Abuse, "Methadone in maintenance and detoxification treatment of narcotic addicts; human immunodeficiency virus counseling," unpublished, n.d.
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From page 150... ...
1974. Narcotic Addict Treatment Act Report No.
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