Federal regulation of methadone treatment / Richard A. Rettig and Adam Yarmolinsky, editors ; Committee on Federal Regulation of Methadone Treatment, Division of Biobehavioral Sciences and Mental Disorders, Institute of Medicine.

Format:

Book

Contributor:

Rettig, Richard A.

Yarmolinsky, Adam.

Institute of Medicine (U.S.). Committee on Federal Regulation of Methadone Treatment.

Language:

English

Subjects (All):

Methadone maintenance--Government policy--United States.

Methadone maintenance.

Drug monitoring--Government policy--United States.

Drug monitoring.

Methadone hydrochloride.

Physical Description:

1 online resource (250 p.)

Edition:

1st ed.

Place of Publication:

Washington, D.C. : National Academy Press, 1995.

Language Note:

English

Summary:

For nearly three decades, methadone hydrochloride has been the primary means of treating opiate addiction. Today, about 115,000 people receive such treatment, and thousands more have benefited from it in the past. Even though methadone's effectiveness has been well established, its use remains controversial, a fact reflected by the extensive regulation of its manufacturing, labeling, distribution, and use. The Food and Drug Administration regulates the safety and effectiveness of methadone, as it does for all drugs, and the Drug Enforcement Administration regulates it as a controlled substance. However, methadone is also subjected to a unique additional tier of regulation that prescribes how and under what circumstances it may be used to treat opiate addiction. Federal Regulation of Methadone Treatment examines current Department of Health and Human Services standards for narcotic addiction treatment and the regulation of methadone treatment programs pursuant to those standards. The book includes an evaluation of the effect of federal regulations on the provision of methadone treatment services and an exploration of options for modifying the regulations to allow optimal clinical practice. The volume also includes an assessment of alternatives to the existing regulations.

Contents:

Federal Regulation of Methadone Treatment

Copyright

Acknowledgments

Contents

Federal Regulation of Methadone Treatment

Executive Summary

HOW METHADONE IS REGULATED

SCOPE OF THE REPORT

BALANCING THE BENEFITS AND RISKS OF METHADONE

RECOMMENDATIONS TO MODIFY AND SUPPLEMENT THE REGULATIONS

Diagnosing Addiction and Determining Dose Levels

Habilitative and Rehabilitative Services

Treating Pregnant Opiate Addicts

Replacing "Detoxification" with "Medically Supervised Withdrawal

Inpatient Hospital Admissions

Treating Opiate Addiction and Treating Pain

ENFORCEMENT OF THE REGULATIONS

GUIDELINES AND QUALITY ASSURANCE

PROCESS EVALUATION AND OUTCOME EVALUATION

FEDERAL GOVERNMENT LEADERSHIP

REFERENCE

1 Introduction

THE CHARGE TO THE COMMITTEE

OBJECTIVES OF OPIATE ADDICTION TREATMENT

EFFECTIVENESS OF METHADONE MAINTENANCE TREATMENT

Beneficial Outcomes

Factors Limiting Effectiveness

Multiple Problems of Methadone Maintenance Patients

Variability among Methadone Maintenance Programs

WHY METHADONE IS REGULATED DIFFERENTLY FROM OTHER DRUGS

THE COMMITTEE'S VIEW

REPORT ORGANIZATION

STUDY METHODS

A NOTE ON TERMINOLOGY

REFERENCES

2 Pharmacology and Medical Aspects of Methadone Treatment

THE RATIONALE FOR PHARMACOTHERAPY

History and Practice

Basic Science

PHARMACOKINETICS OF METHADONE

METHADONE MAINTENANCE

Treatment Regimen

Effects, Side Effects, and Special Pharmacological Issues

Physiological Functions Disrupted During Heroin Addiction

INTERACTIONS OF METHADONE WITH OTHER DRUGS

IMPACT OF METHADONE MAINTENANCE ON INFECTIOUS DISEASES

3 Who are the Recipients of Treatment?

HEROIN USE AND DEPENDENCE

Prevalence of Heroin Use

From Use to Dependence

How Persistent is Heroin Dependence?.

Age, Gender, and Ethnicity

Age

Gender

Ethnicity

What Other Substances Do Heroin Users Consume?

Other Medical and Social Problems of Heroin-Dependent Persons

How Likely Are Heroin Addicts to Use Treatment?

CHARACTERISTICS OF UNTREATED AND TREATED HEROIN ADDICTS

METHADONE PATIENT CHARACTERISTICS

Historical Trends

Current Patient Characteristics

Methadone in Drug Treatment: General

Use of Methadone in Detoxification

Use of Methadone in Maintenance Treatment

Contrast between Detoxification and Maintenance Patient Admissions

Maintenance Patients in New York State

1992

Maintenance Patients in California, 1992

Differences Between New York and California

SUMMARY

4 Methadone Diversion Control

EARLY CONCERN OVER DIVERSION

THE NARCOTIC ADDICT TREATMENT ACT OF 1974

MORE RECENT OFFICIAL VIEWS ON DIVERSION

House Select Committee Hearings

Perspective of the Drug Enforcement Administration

THE DATA ON DIVERSION

Drug Abuse Warning Network Data

Harris County, Texas

Harris County Medical Examiner Data

Methadone Maintenance Treatment Data

Independent Pathologists' Review

Drug Abuse Warning Network (DAWN) Medical Examiner Data

Other Data on Diversion

Drug Use Forecasting Data

National AIDS Demonstration Research (NADR) Data

HOW IS METHADONE DIVERTED?

Production and Distribution System

Sale by Patients: Who Sells and Why?

WHO USES DIVERTED METHADONE AND WHY?

CONSEQUENCES OF METHADONE DIVERSION

Public Safety Issues

Public Health Issues

Is Diverted Methadone Dangerous?

Is Diverted Methadone a Major Drug of Abuse?

APPENDIX

5 Federal Regulation of Methadone Treatment

THE 1960S

THE NIXON ADMINISTRATION

1970 Legislation

Special Action Office for Drug Abuse Presentation.

DEFINING THE REGULATORY REGIME: 1970-1974

Research, Treatment, and Regulation

Methadone IND Regulations

1972 Regulations

Legal Challenge to the FDA

Narcotic Addict Treatment Act of 1974

Summary: 1970-1974

THE CURRENT REGULATORY REGIME

1980 Revision of the Regulations

1989 Revision of the Regulations

1983 Regulatory Reform Initiative

1987 Notice of Proposed Rule-Making

1989 Final Rule

1989 Guidance Document

1989 Interim Methadone Maintenance Proposal

Assessment of Program Performance

LEVO-ALPHA-ACETYL-METHADOL

6 Methadone Treatment

THE PROVIDER COMMUNITY

Number of Treatment Facilities

Regional Variation

Number of Patients

Capacity and Utilization Rate

Waiting Lists

Facility Ownership

FINANCING OF METHADONE TREATMENT

Department of Veterans Affairs

Out-of-Pocket and Private Insurance

STATE SUBSTANCE ABUSE AGENCIES

New York

Financing

Regulations

California

Florida

Illinois

Massachusetts

7 Treatment Standards and Optimal Treatment

DEFINITION OF TERMS

PATIENT EVALUATION AND ADMISSION CRITERIA

Admission to Medically Supervised Withdrawal

Admission to Maintenance Pharmacotherapy

Proper Patient Placement

Two Conclusions

MAINTENANCE PHARMACOTHERAPY

Dosing

Comprehensive Treatment Services

Take-Home Medication

Urine Testing

Implications for Regulations

Opiate Addiction in Pregnant Women

MEDICALLY SUPERVISED WITHDRAWAL

INPATIENT TREATMENT

Maintenance Pharmacotherapy in Hospital Inpatient Settings

Inpatients with Untreated Opiate Addiction

PAIN MANAGEMENT

Non-Opiate-Addicted Pain Patients

Methadone Patients.

''Recovering" Opiate and Other Substance Dependent Patients

CONCLUDING COMMENTS

8 Implementing Standards-and Beyond

REGULATIONS AND THEIR ENFORCEMENT

CLINICAL PRACTICE GUIDELINES

FORMAL QUALITY ASSURANCE SYSTEMS

WHAT CAN BE DONE NOW?

Process Evaluation

Outcome Evaluation

Research Issues

Clinical Research

Health Services Research

Federal-State Relations

Financing of Treatment

Policy Guidance

REFERENCES.

Notes:

Bibliographic Level Mode of Issuance: Monograph

Includes bibliographical references.

ISBN:

9786610193035

9780309176583

0309176581

9781280193033

1280193034

9780309598620

0309598621

9780585154572

0585154570

OCLC:

44960724