LEADER 09860nam 2200793Ia 450 001 9910973826103321 005 20251017110113.0 010 $a9786610193035 010 $a9780309176583 010 $a0309176581 010 $a9781280193033 010 $a1280193034 010 $a9780309598620 010 $a0309598621 010 $a9780585154572 010 $a0585154570 035 $a(CKB)110986584751592 035 $a(OCoLC)44960724 035 $a(CaPaEBR)ebrary10057046 035 $a(SSID)ssj0000153929 035 $a(PQKBManifestationID)11946761 035 $a(PQKBTitleCode)TC0000153929 035 $a(PQKBWorkID)10406227 035 $a(PQKB)11311572 035 $a(MiAaPQ)EBC3376768 035 $a(Au-PeEL)EBL3376768 035 $a(CaPaEBR)ebr10057046 035 $a(CaONFJC)MIL19303 035 $a(OCoLC)923265953 035 $a(Perlego)4735180 035 $a(DNLM)788420 035 $a(BIP)1883231 035 $a(EXLCZ)99110986584751592 100 $a19941206d1995 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt 182 $cc 183 $acr 200 00$aFederal regulation of methadone treatment /$fRichard A. Rettig and Adam Yarmolinsky, editors ; Committee on Federal Regulation of Methadone Treatment, Division of Biobehavioral Sciences and Mental Disorders, Institute of Medicine 205 $a1st ed. 210 $aWashington, D.C. $cNational Academy Press$d1995 215 $a1 online resource (250 p.) 300 $aBibliographic Level Mode of Issuance: Monograph 311 08$a9780309052405 311 08$a0309052408 320 $aIncludes bibliographical references. 327 $aFederal 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 -- REFERENCES -- 3 Who are the Recipients of Treatment? -- HEROIN USE AND DEPENDENCE -- Prevalence of Heroin Use -- From Use to Dependence -- How Persistent is Heroin Dependence?. 327 $aAge, 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 -- REFERENCES -- 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? -- SUMMARY -- APPENDIX -- REFERENCES -- 5 Federal Regulation of Methadone Treatment -- THE 1960S -- THE NIXON ADMINISTRATION -- 1970 Legislation -- Special Action Office for Drug Abuse Presentation. 327 $aDEFINING 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 -- SUMMARY -- REFERENCES -- 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 -- Financing -- Regulations -- Florida -- Financing -- Regulations -- Illinois -- Financing -- Regulations -- Massachusetts -- Financing -- Regulations -- SUMMARY -- REFERENCES -- 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. 327 $a''Recovering" Opiate and Other Substance Dependent Patients -- CONCLUDING COMMENTS -- REFERENCES -- 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 -- FEDERAL GOVERNMENT LEADERSHIP -- Research Issues -- Clinical Research -- Health Services Research -- Federal-State Relations -- Financing of Treatment -- Policy Guidance -- SUMMARY -- REFERENCES. 330 $aFor 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. 606 $aMethadone maintenance$xGovernment policy$zUnited States 606 $aDrug monitoring$xGovernment policy$zUnited States 606 $aMethadone hydrochloride 615 0$aMethadone maintenance$xGovernment policy 615 0$aDrug monitoring$xGovernment policy 615 0$aMethadone hydrochloride. 676 $a353.0084/29 701 $aRettig$b Richard A$01803761 701 $aYarmolinsky$b Adam$0675792 712 02$aInstitute of Medicine (U.S.).$bCommittee on Federal Regulation of Methadone Treatment. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910973826103321 996 $aFederal regulation of methadone treatment$94354272 997 $aUNINA