oversight

Methadone Maintenance: Some Treatment Programs Are Not Effective; Greater Federal Oversight Needed

Published by the Government Accountability Office on 1990-03-22.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

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                                                              -   !

            United   States   General   Accounting   Office
            Report to the Chairman, Select
GAO         Committee on Narcotics Abuse and
            Control, House of Representatives


March1990
            METHADONE
            MAINTENANCE
            Some Treatment
            Programs Are Not
            Effective; Greater
            Federal Oversight
            Needed
Human Resources    Division

B-234388

March 22, 1990

The Honorable Charles B. Range1
Chairman, Select Committee
  on Narcotics Abuse and Control
House of Representatives

Dear Mr. Chairman:

In response to your request, we reviewed the activities of a number of methadone
maintenance treatment programs. This report focuses on the (1) extent of drug use by
patients in methadone maintenance treatment programs; (2) the goals, objectives, and
approaches of the treatment programs; and (3) the types of services available to patients in
treatment. It also presents information on federal oversight of the effectiveness of treatment
programs and the status of proposed regulations to allow methadone to be dispensed without
counseling or other supportive services that are required under current federal methadone
maintenance treatment regulations.

Copies of this report are also being sent to the Secretary of Health and Human Services;
Commissioner, Food and Drug Administration; Director, National Institute on Drug Abuse;
Director, Office of Management and Budget: and other interested parties.

The major contributors to this report are listed in appendix II.

Sincerely yours,




Mark V. Nadel
Associate Director, National
  and Public Health Issues
                           Executive Summary




                           Research indicates methadone maintenance can be an effective treat-
Results in Brief           ment for heroin addiction. In practice, however, the continued use of
                           heroin that GAO found among patients in 24 methadone maintenance
                           treatment programs indicates that many programs are not effectively
                           treating heroin addiction. The use of heroin by patients in treatment for
                           more than 6 months ranged from 1 percent at one program to 47 percent
                           two others. (See pp. 17-20.)

                           GAO found that policies, goals, and practices varied greatly among the 24
                           methadone maintenance treatment programs. None of the 24 programs
                           evaluated the effectiveness of their treatment. There are no federal
                           treatment effectiveness standards for treatment programs. Instead, fed-
                           eral regulations are process oriented in that they establish administra-
                           tive requirements for programs. Even with regard to these
                           requirements, federal oversight of methadone maintenance treatment
                           programs has been very limited since 1982. (See pp. 27-28.)

                           Recent federally sponsored research found that interim maintenance
                           would not significantly reduce intravenous (IV) heroin use and the corre-
                           sponding risk of acquired immunodeficiency syndrome (AIDS). GAO also
                           did not find clear evidence of an overall serious shortage of methadone
                           treatment slots that would justify interim maintenance.

                            ______-

Principal Findings

Program Treatment Goals,   Heroin use continued among a number of patients, with significant dif-
Policies, and Results      ferences among the 24 methadone maintenance treatment programs we
                           visited. At 10 of the 24 clinics more than 20 percent of the patients con-
Differed                   tinued to use heroin after 6 months of treatment-a    higher percentage
                           than experts believe should occur among patients in treatment. At two
                           programs, almost one-half the patients continued to use heroin. GAO
                           found that many of the patients also used other drugs, primarily
                           cocaine. (See pp. 17-20.)

                           GAO found that programs established their own goals, policies, and prac-
                           tices, which varied greatly. Program goals varied from treating only her-
                           oin addiction to treating abuses of all drugs with the goal of freeing the
                           patient of all drug use. including methadone. A wide variance also
                           existed among program policies with respect to urine testing, dismissing
                           patients, counselor staffing levels, and methadone dosage levels. Urine


                           Page 3                                   GAO/HRD90104 Methadone Maintenance
                    Executivr Summary




                    would not significantly     reduce heroin use.’ The VA researchers stated
                    that:

                    “methadone   by itself does not guarantee clinical improvements or reduced AIDS
                    risk.”

                    The report concluded that merely increasing the availability of metha-
                    done in the absence of administrative, counseling, and rehabilitative ser-
                    vices may not adequately protect the majority of patients from
                    continued drug use and the risk of AIDS. Given this research and the lack
                    of evidence of an overall shortage of methadone treatment slots, GAO
                    does not believe that interim maintenance will achieve its stated pur-
                    pose. (See pp. 30-33.)


                    To better monitor and assess methadone maintenance treatment pro-
Recommendationsto   grams, GAO recommends that the Secretary of Health and Human Ser-
the Secretary of    vices direct FDA or NIDA, as appropriate, to (1) develop result-oriented
Health and Human    performance standards for methadone maintenance treatment pro-
                    grams, (2) provide guidance to treatment programs regarding the type
Services            of data that must be collected to permit assessment of the programs’
                    performance, and (3) increase program oversight oriented toward per-
                    formance standards

                    GAO also recommends that the Secretary withdraw     the proposed interim
                    maintenance regulations until such time as (1) documented evidence
                    demonstrates that demand greatly exceeds treatment capacity for meth-
                    adone maintenance treatment programs and (2) research demonstrates
                    that interim maintenance is significantly better than no treatment at all
                    in preventing IV drug use and the corresponding risk of AIDS. (See p. 34.)


                    GAO did not obtain official agency comments on this report. However,
Agency Comments     GAO did obtain the views of FDA and NIDA officials and incorporated their
                    views where appropriate.




                    ‘Childress,Anna Rose,A. ThomasMcLellan,GeorgeE. Woody,and CharlesP. O’Brien,“Are There
                    Minimum ConditionsNecessaryfor MethadoneMaintenanceto ReduceIntravenous Drug IJseand
                    AIDS-RiskBehaviors?”



                    Page 6                                          GAO/HRD9@-104Methadone Maintenance
Table 2.2: Percentage of Heroin, Cocaine, and Overall                     19
     Drug Use Among Patients in Methadone Maintenance
    Treatment for 6 Months or Longer
Table 2.3: Percentage of Patients That Missed a Daily                    21
     Dose of Methadone in a 30-day Period
Table 2.4: Retention of Patients at 21 Methadone                          23
     Maintenance Treatment Programs
Table 2.5: Average Patient Caseloads and Number of                        26
     Counseling Sessions for the 24 Methadone
     Maintenance Treatment Programs




Abbreviations

ADAMHA      Alcohol, Drug Abuse, and Mental Health Administration
AIDS        acquired immunodeficiency syndrome
DF.A        Drug Enforcement Administration
FDA         Food and Drug Administration
GAO         General Accounting Office
HHS         Department of Health and Human Services
HIV         human immunodeficiency virus
IV          intravenous
LAAM        levo-alpha-acetylemthadol
w7          milligrams
NIAAA       National Institute on Alcoholism and Alcohol Abuse
NIDA        National Institute on Drug Abuse
VA          Department, of Veterans Affairs


page 7                                    GAO/HRD-90.104Methadone Maintenance
                        Chapter1
                        Introduction




                        An ongoing philosophical debate has surrounded the use of methadone
                        maintenance since its development as a treatment method. Some treat-
                        ment practitioners believe drug-free treatment is the only valid treat-
                        ment method. They discount the efficacy of methadone maintenance on
                        the grounds that it merely substitutes one narcotic drug for another. In
                        contrast, other treatment practitioners view methadone as a medication
                        for treating heroin addiction, and some compare it to taking insulin for
                        diabetes.

                        Research studies have demonstrated the effectiveness of methadone
                        maintenance. NIDA and the National Institute on Alcoholism and Alcohol
                        Abuse and Alcoholism (NIAAA), the federal government’s two primary
                        agencies for researching drug and alcohol abuse issues, respectively,
                        have concluded that methadone is the most effective method available
                        for treating heroin addiction.


                        Methadone maintenance programs are more effective when linked with
Program Effectiveness   comprehensive treatment services, according to a major NIDA-sponsored
Linked to Counseling    study.’ This in-depth 3-year study of six methadone maintenance treat-
and Rehabilitative      ment programs noted that effective programs reduced intravenous (IV)
                        drug use and needle sharing among most heroin addicts; thus reducing
Services                the risk of contracting or spreading the human immunodeficiency virus
                        (HIV) that causes acquired immunodeficiency syndrome (AIDS) through
                        needle use. However, the study folmd marked differences in the effec-
                        tiveness of various programs in reducing IV drug use.

                        Among the six programs, IV drug use varied from less than 10 percent to
                        over 57 percent of patients that were in treatment longer than 1 year.
                        The difference in the programs’ effectiveness to reduce IV drug use was
                        related both to the length of the patient’s stay in treatment as well as
                        the quality of the treatment provided. The more effective programs had
                        high patient retention rates; adequate methadone doses; high rates of
                        scheduled attendance; a close, consistent, and enduring relationship
                        between staff and patients; and year-to-year stability of treatment staff.
                        The research study concluded that:

                         “Although both the short-term pharmacological and the long-term rehabilitative
                         aspects of methadone maintenance are significant in successful treatment, the latter
                         seem more important with respect to reducing IV use.”

                         ‘Ball, John C.,W. RobertLange.C. Patrick Myers,and SamuelR. Friedman,“Reducingthe Riskof
                         AIDS Through MethadoneMaintenanceTreatment.” Journal of Health and SocialBehavior 1988,Vol.
                         29 (Sept.),1988,pp. 214-26



                         Page 9                                            GAO/HRD-90104 Methadone Maintenance
                        Chapter 1
                        Introduction




Objectives, Scope,and   Control, requested that we assess the effectiveness of methadone main-
Methodology             tenance treatment. In subsequent discussions with the committee staff,
                        we agreed to visit a limited number of methadone maintenance treat-
                        ment programs to determine (1) the extent of drug use by patients in
                        such programs; (2) the goals, objectives, and approaches of the treat-
                        ment programs; and (3) the types of services available to patients during
                        and after methadone maintenance treatment. We also agreed to obtain
                        information on current federal efforts with regard to (1) developing
                        alternative nonaddictive drug therapies to methadone,” (2) oversight
                        and monitoring of program effectiveness, and (3) the status of efforts to
                        alter federal methadone regulations to allow the dispensing of metha-
                        done without rehabilitative services.

                        We used a case-study approach to gather information concerning 24
                        methadone maintenance treatment programs in eight states. We selected
                        states that had large numbers of IV drug users, methadone maintenance
                        treatment programs receiving public funds, and that provided geo-
                        graphic variability. Seven of the states are among the top 10 states in
                        the country that have the largest IV drug-using populations and one
                        state is ranked twelfth. The eight states we selected are California, Flor-
                        ida, Illinois, Maryland, New Jersey, New York, Texas, and Washington.

                        We selected the 24 programs using criteria based on program size
                        (greater than 200 patients in treatment where possible) and years of
                        operation (those operating for at least 5 years). We collected data on all
                        active patients in methadone maintenance treatment at 21 of the 24 pro-
                        grams we visited. Because of large patient populations at three pro-
                        grams, we collected data on a random sample of active patients! In
                        total, we collected data on 5,600 active patients at the 24 programs. The
                        patient data included the length of time in treatment, methadone dosage
                        in milligrams, most recent urinalysis test results, age, race, sex, employ-
                        ment status, method of payment, and the number of days patients
                        missed their appointments at the clinics to take their prescribed metha-
                        done within a 30.day period immediately preceding our visit at each
                        program.

                        We interviewed treatment officials at the 24 programs. We obtained
                        information from them regarding each program’s operations, including

                        “This information is presented1x1
                                                        appendix 1.
                        .&Activepatients include thoseIII treatment for morethan 30 days.They do not include patients who
                        were hospitalized,incarcewted.or in the processof beingremovedfrom treatment.



                         Page 11                                              GA0/HRD90104 Methadone Maintenance
Methadone Maintenance Treatment Programs
Vary in Approach and Effectiveness

                           Research indicates that a well-managed methadone maintenance pro-
                           gram can be an effective treatment method for heroin addiction. But,
                          judging from the continued use of heroin among patients, in practice,
                           nearly one-half the programs we visited are not effective in treating her-
                           oin addiction.

                          There were significant differences in heroin use among the 24 metha-
                          done maintenance treatment programs we visited. At 10 of the 24 clin-
                          ics, more than 20 percent of the patients continued to use heroin after 6
                          months of treatment-a     higher percentage than experts believe should
                          occur among patients in treatment. At two clinics almost one-half the
                          patients continued to use heroin. We also found that many of the
                          patients used other drugs, primarily cocaine.

                          The 24 methadone maintenance treatment programs we visited estab-
                          lished their own treat,ment policies, goals, and practices, which varied
                          greatly among the programs, A wide variance also existed among pro-
                          grams with respect to staffing levels, the extent of rehabilitative ser-
                          vices provided to patients, and the availability of aftercare.

                          There are no federal performance standards for methadone maintenance
                          treatment programs (see ch. 3). Further, none of the methadone mainte-
                          nance treatment programs we visited evaluated the effectiveness of
                          their treatment. Given the wide variation of approaches and results,
                          there is a need for greater federal leadership in assessing methadone
                          treatment and determining components of effective treatment.


                          Research indicates that treatment goals influence program objectives.
Treatment Goals and       The programs we visit.crd developed their own treatment goals, which
Policies Differed         varied widely.
Among Programs        0 Five programs sought to treat only heroin addiction, and did not treat
                        patients for abuse of other drugs. Directors of some of these programs
                        told us that methadone maintenance treatment is only intended to treat
                        heroin addiction.
                      l Eleven programs sought to treat all drug abuse. Although methadone
                        treatment is only effective for treating heroin and other opiates, these
                        programs used other treatment approaches to address the abuse of
                        other drugs. Some program directors told us that it was appropriate to
                        provide methadone treatment indefinitely unless the patient requested
                        treatment be terminated. One clinic director said that a totally drug free



                           Page 13                                  GAO/HRlNO-104   Methadone   Maintenance
                                  Chapter 2
                                  Methadone Maintenance    Treatment
                                  Programs Vary in Approach
                                  and Effectiveness




Table 2.1: Methadone Dose Among
Patients at the 24 Methadone      Fiaures are milllarams
Maintenance Treatment Programs    Program                                                     Mean        Median-          Mode
                                  Cal,forn,a
                                     A                                                           47                50             50
                                     E                                                           52                50             80
                                     I                                                           50                50             80
                                    J                                                            51                55             70
                                    K                                                            64                66             80
                                    L                                                            68                70             80
                                    M                                                            51                55             70
                                  New York
                                     N                                                         -31                 50             50
                                     0                                                           58                60             60
                                     P                                                           58                60             70
                                     Q                                                           56                55             50
                                      Z                                                          55                60             60
                                  FlorIda
                                       D                                                         49                50             so
                                      H                                                          33                30             25
                                  lllinols
                                       R                                                        21 ~~~~            20             30
                                                                            -~   -~~      ~~.~ ~_~~
                                      S                                                          27                30             30
                                  Texas
                                     ,-.
                                     L                                                           36                35             40
                                     G                                                           31                30             25
                                  Maryland
                                    V                                                            36                40             40
                                    W                                                            67                70             80
                                  New Jersev                           .~
                                   T                                                             50                50             50
                                   U                                                             56                55             50
                                  Washlngton
                                                                            .~
                                     B                                                           38                40             50
                                     F                                                           49                50             60




                                  Page 15                                              GAO/HRDSC-104   Methadone    Maintenance
                              Chapter 2
                              Methadone Maintenance    Treatment
                              Programs Vary in Approach
                              and Effectiveness




                              program rules vary, different programs have different take-home poli-
                              cies. Most of the programs we visited would reduce or revoke take-home
                              privileges if a patient used heroin or other drugs. Two programs would
                              discharge any patient that was given take-home methadone if urinalysis
                              tests showed that the patient was not taking the methadone. One pro-
                              gram that did not treat cocaine or other nonopiate drug use, did not
                              reduce or eliminate take-home privileges for patients that tested posi-
                              tive for those drugs.


Cost and Payment              Funding for methadone programs varies by state and local government.
                              Public and nonprofit programs may receive funds from Medicaid, block
                              grants, and other assistance. The monthly income received from all
                              sources by the programs we visited ranged from $145 to $533 per
                              patient. The out-of-pocket costs to the patients for treatment ranged
                              from no charge to $280 per month. In most cases, costs to patients
                              depended in part on their ability to pay.


                              Just as program goals varied, we found great variation in patient
Substantial Variation         results, the kinds and amounts of services provided, program staffing
Found in Program              levels, and aftercare. None of the programs systematically evaluated
Results and Services          their effectiveness in treating patients.



Many Patients Continue   to   We found that many patients in treatment for more than 6 months-
Use Heroin and Other          ranging from 13 to 6’7 percent-continued      to use heroin and other
                              drugs. At 10 of the 24 programs we reviewed heroin use among these
Drugs                         patients exceeded 20 percent, ranging from 21 to 47 percent. For the
                              remaining 14 programs, heroin use among patients was less than 20 per-
                              cent and ranged from 1 to 13 percent. Drug treatment experts consider a
                              program to be ineffective if heroin is still being used by more than 20
                              percent of the patients in treatment longer than 6 months. The Deputy
                              Director for Demand Reduction, Office of National Drug Control Policy,
                              also believes that after patients have been in treatment 6 months, an
                              effective program should not have more than 20 percent, and possibly
                              as few as 10 percent, of patients who receive appropriate doses of meth-
                              adone and rehabilitative services using heroin.




                              Page 17                                 GAO/HRD-90.104   Methadone   Maintenance
                                      Chapter 2
                                      Methadone Maintenance    Treatment
                                      Programs Vary in Approach
                                      and Effectiveness




Table 2.2: Percentage 01 Heroin,
Cocaine, and Overall Drug Use Among                                                                              Drug Use
Patients in Methadone Maintenance     Program                                                       Heroin          Cocaine         OveralP
Treatment for 6 Months or Longer      Callfornla
                                        A                                                                47               0                   47
                                        E                                                                24               5                   29
                                        I                                                                21               3                   25
                                        J                                                                32               7                   35
                                        K                                                                30               5                   38
                                        L                                                                22               3                   24
                                        M
                                      -__~                                     ____-__.                  28               1                   33
                                      New York                                             ~--
                                        N                                                                 5              15                   21
                                        0                                                                 4              13                   15
                                         P                                                                5              40                   42
                                         a                                                                2               8                   20
                                         2                                                                4              21                   29
                                      Florlda                        ~~~ _~~__
                                          D                                                               6               6                   22
                                          H                                                              12              27                   45
                                      Illinois
                                      _~.___.~~_            ~                                    ____-
                                        R                                  -     ~_____-                 47               30                  67
                                        S                                                                 4               30
                                                                                                                        .___.      __~~       65
                                                                                                                                               ~.
                                      Texas
                                        C                                                                32              15                   49
                                        G                                                                 5              28                   32
                                      Maryland
                                         V                                                          -___ 22              23                   37
                                         W                                                                1               1                    2
                                      .New Jersey
                                             . __     _~
                                         T                                                                9              23                   27
                                         U
                                      ~~____.~_                                                           5              15                   26
                                       Washington
                                        B                                                                13
                                                                                                    __-___.              11                   20
                                        F                                                                11              10                   19
                                      aOverall drug use includes heroIn and other opiates. cocaine, benzodlazepmes, amphetamines. and
                                      barbiturates

                                      Although none of the 24 programs performed urinalysis tests for alcohol
                                      use, some program directors stated that they administered a
                                      breathalyzer test to patients suspected of being intoxicated before they
                                      would administer a daily dose of methadone. Most program directors
                                      believed that alcohol abuse remains a serious problem for many patients


                                      Page 19                                                    GAO/HID-90104     Methadone    Maintenance
                                         Chapter 2
                                         Methadone Maintenance Treatment
                                         Pro@mns Vary in Approach
                                         and Effectiveness




Table 2.3: Percentage of Patients That
Missed a Daily Dose of Methadone in a                                                                              Percent of patients
30-day Period                            Program                                                                   that missed a dose
                                         Callforma
                                            A                _~~~-                                      _-.~.                             27
                                         -E                                                                                               16
                                                                     --~-__.           __-
                                            I         _--~           --                                                                   16
                                            J                                  ~-.-              -                                        29
                                            K                                                                                             19
                                            L                                                                                             16
                                            M                                                                                             23
                                         New York
                                            N                                                                                             51
                                            0                                                                                             11
                                            P                                                                                             25
                                            Q                                                                                              9
                                            Z                                                                                             23
                                         Florida
                                             D                                                                                             6
                                             H                                                                                            30
                                         llltnois
                                             R                                        _.~                                                 49
                                             S                                                                                            46
                                         Texas
                                            C                                                                                          24
                                            G                                                                                         3,
                                         Maryland
                                           V                                                                                              43
                                           w                                                                                               4
                                         New Jersey
                                           T                                                                                              41
                                           U                                                                                              16
                                         Washinaton
                                          B                                                                                               14
                                           F                                                                                               8


                                         Research studies indicate that patient improvement-as      measured by
                                         decreased heroin and other drug use, decreased criminal activity, and
                                         increased social productivity-is  directly correlated to the length of
                                         time in treatment. While a necessary duration of methadone treatment
                                         has not been established, one research study demonstrated that patients
                                         who were in treatment less than 3 months did not differ significantly in
                                         drug use from addicts who received no treatment.


                                         Page 21                                             GAO/HRD-90-104     Methadone   Maintenance
                                         Chapter 2
                                         Methadone Maintenance   Treatment
                                         Progmms Vary in Approach
                                         and Effectiveness




Table 2.4: Retention of Patients at 21
Methadone Maintenance Treatment                                              Percentage of patients remaining in treatment
Programs                                 Program                                     after 3 months           after 6 months
                                         California
                                           A                                                    81                           67
                                           E                                                    84                           66
                                           I                                                    89                           76
                                           J                                                    77                           72
                                           K                                                     78                          56
                                           L                                                     83                          58
                                           M                                                     70                          47
                                         New York.
                                           N                                                     73                          59
                                           P                                                     91                          83
                                           Q                                                     90                          80
                                            2                                                    79                          62
                                         Flonda
                                              D                                                  69                          53
                                              H                                                  54                          43
                                         llllnois
                                              R                                                  78                              62
                                              S                                                  90                              66
                                         Texas
                                              C                                                  86                              61
                                              G                                                  81                              56
                                         Maryland
                                              V                                                  86                              69
                                            w                                                    84                              63
                                         New Jersey
                                           T                                                     45                              42
                                         WashIngton
                                            0                                                    68                              51




Programs Are Lax in                      Vocational and educational services, which are required by federal regu-
Providing Vocational and                 lation, are intended to assist patients in treatment programs to develop
                                         skills needed to function as productive members of society. They also
Educational Services                     help to refocus a patient’s attention away from drug use and more
                                         towards productive activities.

                                         Only 6 of the 24 programs offered educational services on site and only
                                         4 programs provided vocational services on site. For the programs that



                                         Page 23                                       GAO/HRDS@104    Methadone   Maintenance
chapter 2
Methadone Maintenance  Treatment
Pmgmms Vary in Approach
and Effectiveness




treatment. Since March 1989, the formerly mandated counselor/patient
ratio has been restated as a recommended practice.

All 24 programs provided counseling. However, at many of the pro-
grams the ratio of counselors to patients was higher than clinic counsel-
ors and directors believed it should be in order to provide effective
counseling. For the 24 programs, the ratio of counselors to patients
ranged from 1 counselor for every 15 patients to 1 for every 96 patients.
At 17 of the 24 programs counselor caseloads exceeded 35, and at 7 pro-
grams counselor caseloads were 50 or more. In many programs, counsel-
ors spent no more than half an hour twice a month per patient. Table 2.5
identifies counselor/patient ratios and the average number of counseling
sessions per month at the 24 programs.




Page 26                                 GAO/HR.D.S@1O4 Methadone   Maintenance
                           Chapter 2
                           Methadone Maintenance       Treatment
                           Pmgmm       Vary in Approach
                           and Effectiveness




                           meaningful counseling sessions, greater interaction between counselor
                           and patient, and increased rates of patient retention.


Programs Did Not Provide   An aftercare program should provide patients who detoxified from
Aftercare for Patients     methadone with counseling, recovery training, self-help meetings, and
                           recreational and social activities to assist in the recovery processes.
Detoxified From            Only 1 of the 24 programs we visited had a separate aftercare program.
Methadone                  Of the remaining 23 programs, 9 would allow patients to continue to
                           receive counseling even though they no longer were being maintained on
                           methadone. However, only a few patients chose to use the counseling
                           services from these programs. The remaining 14 programs did not allow
                           patients who detoxified from methadone to receive further services
                           from the program. Further, one official stated that they do not receive
                           public funding for a patient that no longer takes the drug methadone but
                           remains in treatment for counseling.


Treatment Programs Are     None of the 24 methadone maintenance treatment programs we visited
Not Assessing Their        systematically evaluated their effectiveness in treating patients. Data
                           related to urinalysis tests, patient attendance, or patient retention were
Effectiveness              not maintained at the program level except for three treatment pro-
                           grams. These three programs did summarize patient data, but did not
                           use the aggregate data to assess patient progress or program
                           effectiveness.




                           Page 27                                  GAO/HELWO-104   Methadone   Maintenance
-                                                    -.-~-
                            Chapter3
                            Improvements in FederalOversightof
                            MethadoneMaintenanwN~ed~d




                            FDA'S policy is to routinely
                                                      inspect each methadone program once every
FDA Inspections Have        2 years to determine whether programs are complying with federal
Been Infrequent and         methadone regulations. However, FDA'S inspections of methadone treat-
Do Not Ass&s                ment programs have been less frequent. At the time of our visits, the 24
                            programs we reviewed had not been inspected for over 5 years.
Program Performance
                            FDA officials told us that they had conducted biennial compliance inspec-
                            tions of methadone treatment programs before 1982. At that time, the
                            field resources for inspecting methadone treatment programs were
                            reduced because these inspections were considered a lower priority com-
                            pared with other FDA responsibilities. With field resources reduced, the
                            number of inspections declined. FDA inspected only 24 of the nation’s
                            668 methadone maintenance treatment programs in fiscal year 1988.

                            FDA's Associate Commissioner for Health Affairs told us that in May
                            1989, FDA established a new policy calling for increased methadone
                            treatment program compliance inspections. Inspections have become a
                            priority for FDA because of concerns of the FDA Commissioner and other
                            senior government officials involved in drug abuse issues that some pro-
                            grams may not be operating in accordance with federal regulations.

                            Additional resources under the Anti-Drug Abuse Act of 1988 provided
                            funding that, according to FDA, was used to acquire 21 additional inspec-
                            tors to assist in the inspection of methadone maintenance treatment pro-
                            grams. FDA again intends to inspect all such programs over the next 2
                            years.

                            However, the inspections carried out by FDA do not assess or evaluate
                            the effectiveness of the methadone maintenance treatment programs,
                            but, rather, are to insure that treatment programs are adhering to cur-
                            rent regulatory requirements.


    FDA Finds Programs in   FDA officials told us that during the 5-month period, May to September
                            1989, FDA had planned to inspect 480 methadone treatment programs.
    Violation of Federal    However, the officials were unable to tell us how many inspections FDA
    Regulations             completed in fiscal year 1989. While the total number of inspections is
                            not known, FDA inspection records show that 62 programs failed to com-
                            ply with methadone treatment regulations. Letters of adverse findings
                            were sent to 57 of these programs. In addition, five programs received
                            regulatory letters. According to FDA officials, an adverse finding letter is
                            issued only when serious regulation violations exist, which, if not
                            promptly corrected. will result in further regulatory action. This action


                            Page29                                    GAO/HBD-90104MethadoneMaintenanee
                          Chapter 3
                          Improvements in Federal Overnight   of
                          Methadone Maintenance   Needed




                          New York State records indicated that, as of June 1989,900 persons
                          were on waiting lists for methadone maintenance treatment, 885 of
                          these were in New York City. The records further indicated that more
                          than one-half of the persons awaiting treatment were on the waiting
                          lists of one treatment provider. Two phone surveys conducted by a New
                          York City methadone provider addressed the availability of methadone
                          treatment in New York City. Of the programs that responded to the sur-
                          vey, performed in August 1989, over 600 methadone treatment slots
                          were identified throughout New York City for addicts who sought treat-
                          ment. The results of a November 1988 survey identified over 400 availa-
                          ble methadone treatment slots.

                          While the phone surveys indicated that treatment was available, treat-
                          ment slots may have been inaccessible to many addicts because of their
                          location. However, without a mechanism for informing addicts seeking
                          treatment of available slots in New York City as well as other locations,
                          many addicts may continue to wait for treatment while slots remain
                          unfilled.


Research and Treatment    In March 1989, FDA and NDA proposed revised methadone maintenance
Officials Indicate That   regulations to allow interim maintenance. The purpose is to get addicts
                          who are waiting for comprehensive treatment into treatment more
Interim Maintenance Is    quickly, thereby decreasing the incidence of IV drug abuse and risk of
Not Effective             AIDS.

                          The proposed regulation recognizes that comprehensive methadone
                          maintenance treatment programs are more effective than interim main-
                          tenance treatment. Therefore, at a minimum, interim maintenance is
                          only justified if it is significantly better than doing nothing to prevent IV
                          heroin use. We doubt. however, that even this minimum condition would
                          be met

                          Recent research has shown that interim maintenance is, at best, only
                          marginally better t,han doing nothing. A new study by the Department
                          of Veterans Affairs (v.4) and the University of Pennsylvania medical
                          school shows that methadone, without comprehensive services (essen-
                          tially similar to dispensing methadone under the proposed interim main-
                          tenance), is not effective in reducing IV drug use.’ Moreover, NIDA'S


                          ‘Childress,Anna Rose,Thom;isA. McClellan,GeorgeE. Woody,and CharlesI’. O’Rncn,“Are There
                          Minimum ConditionsNewssaq for MethadoneMaintenanceto ReduceIntravenousDrug Useand
                          AIDS-l&k Rehaviors“”



                          Page 3 1                                          GAO/HRD90-104Methadone Maintenance
Chapter 3
Improvements in Federal Oversight   of
Methadone Maintenance   Needed




Officials from substance abuse agencies in the eight states included in
our review varied on whether to implement interim maintenance. Offi-
cials for only one state indicated that they would approve the use of
interim maintenance as proposed. Officials in three states said that their
states would not allow interim maintenance. Officials in the remaining
four states indicated that they had not yet determined if they would
allow interim maintenance to be provided in their states.




Page 33                                  GAO/HRD90194   Methadone   Maintenance
Page 36   GAO/HBD9MO4   Methadone   Maintenance
Appendix I
Alternative Treatments   Developed   for
Heroin Addiction




not require daily administration. Further, research indicates that with-
drawal from buprenorphine is less difficult than from methadone. Early
evidence indicates that buprenorphine may also work as an antagonist
for cocaine. Although FDA has not yet approved buprenorphine for drug
treatment, independent researchers have been granted permission to use
it in clinical trials.




Page 37                                    GAO/HRLNO-104   Methadone   Maintenance
%qlwWi      for copit% of   GAO   reports   should be sent to:

U.S. General Accounting       Office
post office Box 6ofS
Gaithersburg,  Maryland       20877

Telephone    202-275-6241

The first five copies of each report        are free. Additional   copies are
$2.00 each.

There is a 26% discount      on orders for 100 or more copies mailed to         a
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Appendix II                                                                                  .-
Major Contributors to This Report


                        Janet L. Shikles, Director, Health Financing and Policy Issues
Human Resources         Mark V. Nadel, Associate Director, National and Public Health Issues,
Division, Washington,      (202) 2756195
D.C.                    Albert B. Jojokian, Assistant Director
                        Rose Marie Martinez, Assignment Manager


                        Ronald G. Viereck, Regional Management Representative
Los Angeles Regional    Walter L. Raheb, Evaluator-in-Charge
Office                  Jill F. Norwood, Site Senior
                        Denise R. Dias, Evaluator
                        Edward N. Nash, Computer Specialist
                        I,. Thomas Kinch, Computer Specialist


                        Kevin M. Kumanga, Regional Assignment Manager
New York Regional       Robert R. Poetta, Site Senior
Office                  Anthony P. Lofaro, Senior Evaluator
                        Leslie Black-Plumeau, Evaluator
                        Daniel Bertoni, Evaluator
                        Mary E. Taber, Evaluator




(108696)                Page 38                                 GAO/HBD90-104 Methadone Maintenance
Appendix I

Alternative Treahnents Developed for
Heroin Addiction

               The National Institute on Drug Abuse (NIDA) recognizes that additional
               methods are needed for treating heroin addiction. Some alternative drug
               therapies for the treatment of heroin and other drug addictions have
               been approved or are under investigation. One such alternative drug
               therapy, naltrexone, has received Food and Drug Administration (FDA)
               approval for treating opiate addiction. However, its use has been limited
               because of the reluctance among heroin addicts to take the medication.
               Two other drugs are undergoing clinical trials to determine their safety
               and effectiveness. To date, methadone treatment remains the primary
               treatment method for heroin addicts.

               Naltrexone, an opiate antagonist,’ is the only FDA-approved drug alterna-
               tive currently available. Yet, few heroin addicts seek this type of treat-
               ment. Naltrexone has been proven to effectively block the euphoric
               effects of heroin use. However, naltrexone has no agonist effect2 and
               should be used only after a patient has abstained from heroin use for at
               least 1 week. Naltrexone is not addictive, but must be taken regularly.
               Patients feel no effect when they stop taking the drug, and must be
               highly dedicated to continue this treatment.

               Levo-alpha-acetylemthadol (LAAM) treatment, a long-acting and a less
               addictive substitute for heroin, has received limited-use approval from
               FDA for drug treatment research. Unlike methadone, which must be
               taken daily, LAAM can be used less frequently, thus reducing the fre-
               quency of clinic visits. This quality makes LAAM an attractive alternative
               to methadone from a diversion-control standpoint. Intensive clinical tri-
               als to test the effectiveness of LAAMwere conducted during the 1970s by
               NIDA, but FDA has not yet approved it for commercial use. LAAM has
               caused some controversy because some research indicates that LAAM
               may cause cancer in humans.

               Buprenorphine, which FDA approved for use as a analgesic, has been
               found to have both opiate agonist and antagonist properties, and is
               being considered as another treatment for heroin abuse. Clinical trials
               are ongoing to determine its safety and effectiveness in treating heroin
               addicts. Recent studies have found that buprenorphine alleviated opiate
               cravings in heroin addicts (agonistic effect). Requiring lower dosages
               than methadone, buprenorphine remains in the system longer and does



               ‘Blocks narcotic effects.
               “Producesa narcotic effect.



               Page36
Conclusions and Recommendations


                      Research indicates that a well-managed methadone maintenance pro-
Conclusions           gram can provide effective treatment for heroin addiction. However for
                      the programs we visited, the continued use of heroin among patients
                      indicates that nearly one-half the programs we visited were not effec-
                      tive in achieving the benefits of methadone maintenance treatment.

                      More federal leadership is needed to better assure that methadone main-
                      tenance programs provide effective treatment. In this regard, we
                      believe:

                  l   Result-oriented performance standards should be developed to set
                      expectations for treatment programs and provide a basis to assess their
                      effectiveness as contemplated by the President’s National Drug Control
                      Strategy.
                  l   Standards should be based on results obtainable from proven treatment
                      approaches that combine appropriate doses of methadone and compre-
                      hensive rehabilitative services.
                  l   Greater program oversight is needed and should be based on perform-
                      ance standards.

                      Recent federally sponsored research found that interim maintenance
                      would not significantly reduce IV heroin use and the corresponding risk
                      of AIDS. We did not find clear evidence of an overall serious shortage of
                      methadone treatment slots that would justify interim maintenance.
                      Therefore, the justification for interim maintenance is questionable.


                      To better monitor and assess methadone maintenance treatment pro-
Recommendations       grams we recommend that the Secretary of Health and Human Services
                      direct the Food and Drug Administration or the National Institute on
                      Drug Abuse, as appropriate, to: (1) develop result-oriented performance
                      standards for methadone maintenance treatment programs, (2) provide
                      guidance to treatment programs regarding the type of data that must be
                      collected to permit assessment of programs’ performance, and (3) assure
                      increased program oversight oriented toward performance standards,

                      We also recommend that the Secretary withdraw the proposed interim
                      maintenance regulations until such time as (1) documented evidence
                      demonstrates that demand greatly exceeds treatment capacity for meth-
                      adone maintenance treatment programs and (2) research demonstrates
                      that interim maintenance is significantly better than no treatment at all
                      in preventing IV drug use and the corresponding risk of AIDS.



                      Page 34                                  GAO/HRLWl-104 Methadone Maintenance
Chapter3
Improvements in Federal Oversight of
Methadone Maintenance Needed




research findings (discussed in ch. 1) demonstrate that for programs to
be effective, comprehensive treatment services are needed. The NIDA
study further indicated that long-term rehabilitative services were
important for reducing IV drug use.

The report by researchers at VA and the University of Pennsylvania
found that over 90 percent of patients that received treatment that was
essentially the same as that proposed for interim maintenance, contin-
ued to use heroin. The report stated: “Clearly, administering methadone
does not by itself guarantee clinical improvements or reduced AIDS risk.”
The report concludes that merely increasing the availability of metha-
done in the absence of administrative, counseling, and rehabilitative ser-
vices may not adequately protect the majority of patients from
continued drug use and the risk of AIDS.

The proposed interim maintenance regulations are based, in large part,
on a pilot interim maintenance project known as the Innovative AIDS
Risk Reduction Project. The project was carried out by Beth Israel Medi-
cal Center of New York City. Beth Israel concluded that an interim main-
tenance program that provides minimal services could have a significant
impact on decreasing IV drug use and therefore reduce the risk for con-
tracting or spreading AIDS.

While the report on the pilot interim maintenance project at Beth Israel
provided a substantial basis for FDA’S proposed regulations, the pilot
study had a methodological problem in that it relied on patient self-
reporting for evidence concerning reductions in heroin and cocaine use.
Research indicates that patient self-reporting is a much less reliable
method of determining reductions in heroin use than through the use of
urinalysis testing. Therefore, we believe that the pilot study does not
provide an adequate basis of support for the proposed interim mainte-
nance regulations.

Many treatment program administrators also expressed their concern
over the interim maintenance proposal. One official stated that new
patients are the ones most in need of comprehensive care. He indicated
that while it is important to provide heroin addicts seeking treatment
with immediate access to methadone treatment, to do so without clinical
and supported services will ultimately lead to the end of methadone
treatment in the United States. An official of the New York State Divi-
sion of Substance Abuse Services expressed concern that unless addi-
tional funds were forthcoming, funds intended for comprehensive
treatment would be diverted to cover the cost of interim maintenance.


Page 32
                            Chapter 3
                            Improvements in Federal Oversight   of
                            Methadone Maintenance   Needed




                            may include FDA'S revocation of the program’s approval to operate. A
                            regulatory letter is sent for the most serious of violations and provides
                            for the closing of a treatment program if full regulatory compliance is
                            not achieved within specified time limits. Violations found among the 62
                            treatment programs included failure to (1) meet minimum urine testing
                            requirements, standards for admissions, and medical evaluation require-
                            ments; (2) comply with frequency of attendance and take-home require-
                            ments; or (3) maintain an adequate patient record system.


                            In March 1989, FDA and NIDA proposed revised methadone maintenance
Proposed Interim            regulations to allow the use of interim maintenance. The proposed regu-
Maintenance                 lation is based on the assumption that (1) demand greatly exceeds treat-
Regulations Should          ment capacity at methadone maintenance treatment programs and (2)
                            the immediate availability of methadone to addicts awaiting treatment
Be Withdrawn                would reduce IV heroin and other narcotic drug use and consequently
                            the attendant risk of AIDS.

                            While we found that some programs had waiting lists, there is no clear
                            evidence of a serious shortage of treatment slots. Moreover, research
                            studies indicate that interim maintenance would not significantly reduce
                            heroin use.


Availability of Treatment   A primary reason for the development of interim maintenance regula-
Varied by Program           tions was the perception that treatment slots were not available. We
                            found that 14 of the 24 methadone treatment programs we reviewed did
                            not have waiting lists and would accept addicts seeking treatment into
                            their program. The remaining 10 programs indicated that their treat-
                            ment capacity was full and they were placing people on waiting lists. Of
                            the 10 programs, 4 were located in California, and 2 each in New York,
                            Illinois, and New Jersey. One of the 10 programs (a California clinic) did
                            not have any publicly funded treatment slots available, however, it
                            would accept a person who had the ability to pay for treatment.

                            At the time of our review, the 10 programs had a waiting period ranging
                            from 1 week to 3 months. About 1,000 addicts were awaiting treatment
                            at these programs; however, most of these addicts were on the waiting
                            list at 1 of the 10 programs. Moreover, because 4 of the 10 programs did
                            not update their waiting lists to remove addicts that entered treatment
                            elsewhere or who were no longer interested in treatment, the actual
                            total number of patients awaiting treatment may be smaller.



                            Page 30                                  GAO/HRB90-104   Methadone   Maintenance
Improvements in Federal Oversight of
Methadone Maintenance Needed

                      Although the Food and Drug Administration and the National Institute
                      for Drug Abuse have responsibility for regulating methadone mainte-
                      nance treatment programs, these agencies have provided little oversight
                      for the programs. Federal methadone maintenance regulations, devel-
                      oped jointly by FDA and NIDA, do not establish performance standards,
                      such as the percent of patients no longer using heroin. Instead, the regu-
                      lations are process oriented in that they establish certain conditions for
                      providing methadone treatment, such as admissions requirements and
                      the security of methadone supplies. Neither agency routinely evaluated
                      the effectiveness of treatment programs. FDA’S recent compliance inspec-
                      tions of these programs have found serious problems.

                      In March 1989, FDA and NIDA proposed revised methadone maintenance
                      regulations to allow interim maintenance-the     provision of methadone
                      without any treatment-related counseling or rehabilitative services for
                      addicts who are on waiting lists for comprehensive methadone mainte-
                      nance treatment. The proposed regulations are baaed on the assump-
                      tions that many addicts are on waiting lists for treatment and that
                      interim maintenance would result in reduced IV heroin use and the
                      attendant risk of AIDS. However, we found no clear support for either
                      assumption.


                      Pursuant to the 1974 Narcotic Addiction Treatment Act, NIDA and FDA
Federal Regulations   developed methadone maintenance regulations that specify the condi-
Lack Standards for    tions of use for methadone in the treatment of narcotic addictions. How-
Treatment             ever, the regulations do not establish treatment performance standards
                      for use in determining whether programs are effectively treating their
Effectiveness         patients. Moreover. there are no requirements for federal agencies or
                      treatment programs to evaluate the effectiveness of individual treat-
                      ment programs. Without program evaluation, treatment programs and
                      federal oversight agencies do not know how useful and effective the
                      programs are in carrying out their treatment activities.

                      The President’s National Drug Control Strategy recognizes the need to
                      improve drug addiction treatment and calls for federal action to award
                      federal treatment funds to states on the condition that they develop and
                      implement treatment action plans. The President’s strategy seeks to (1)
                      ensure that treatment programs are accountable for their effectiveness
                      and (2) obtain information concerning the performance of individual
                      treatment programs to understand what treatment methods work for
                      different types of addicts.



                      Page 28
                                        Chapter 2
                                        Methadone Maintenance    Treatment
                                        Pregrama Vary in Approach
                                        and Effectiveness




Table 2.5: Average Patient Caseloads                                                                                                  I
and Number of Counseling Sessions for                                                      Average patients          Average monthly
the 24 Methadone Maintenance            Program                                               per counselor       counseling sessions
Treatment Programs                      California
                                          A                                                                40                              2




                                                                                                           34                              2
                                        New York
                                           N                                                               42                              2
                                           0                                                               49
                                           P                                                               67                              1
                                            Q                                                              55                              1
                                            Z                                                              65                              2
                                        Flonda
                                            D                                                              25                              2
                                            H                                                              35                              2
                                        llllnols
                                            R                                                              15                              4
                                            s                                                              21                              4
                                        &as
                                            C                                                              45                              2
                                            G                                                              32                              3
                                        Maryland
                                            V
                                             w
                                        hv Jersey
                                             T
                                             U                               -                             96                              2
                                        Washinaton
                                           B                                                               50                              2
                                           F                                                               48                              2
                                         nThe average monthly counsellrlg SESSIONS
                                                                                 for this cl~ntcvaried

                                         For programs with high counselor/patient ratios, the potential benefits
                                         of counseling may not have been realized. Many counselors and program
                                         directors told us that it was difficult to provide more than minimal coun-
                                         seling to patients when a counselor’s caseload exceeded 35 patients.
                                         They also stated that smaller counselor/patient ratios can lead to more



                                         Page 26                                                 GAO/HRB90-104   Methadone   Maintenance
                          Chapter 2
                          Methadone Maintenance   Treatment
                          Progmms Vary in Approach
                          and Effectiveness




                          did not offer services on site, program officials stated that they referred
                          patients to other agencies or private programs for these services. Most
                          programs with on-site vocational or educational training were able to
                          track patient progress. However, program officials at most of the pro-
                          grams that referred patients elsewhere for these services did not know
                          whether the patients used the service or how they were progressing.

                          Only three programs had information regarding the number of patients
                          utilizing the services they had been referred to. Little, if any, feedback
                          occurred between the program and the referral agency. Without feed-
                          back, treatment programs cannot determine whether the services were
                          utilized or beneficial to the patient.

                          Given the low employment rates at a number of the programs we vis-
                          ited, vocational and educational services would appear to be needed to
                          assist patients in treatment. However, patients were not required to use
                          these services. For example, at one program offering on-site vocational
                          services, 5 percent of all patients utilized vocational training while 74
                          percent of the patients were not employed. In the best-case example
                          among the four programs offering on-site vocational training, 19 percent
                          of the patients utilized vocational training while 55 percent of the
                          patients were not employed.


Limited Co1mselor Staff   The counselor’s primary role is to assist patients in the recovery pro-
May Affect Quality of     cess. Counselors help patients address their addiction as well as deter-
                          mine what additional treatment may be required.
Treatment
                          Research indicates that a good relationship between the counselor and
                          the patient improves treatment results. These relationships could be
                          expected to be developed over time. We found for the 19 programs that
                          provided us data, the average length of employment for counselors
                          ranged from 6 months to over 8 years. However, over one-half of the
                          counselors had been employed for 1 year or less. Salaries and work
                          loads could be factors for the low average employment tenure among
                          counselors at the programs. Counselor salaries ranged from $12,500 to
                          $30,200 annually. Over one-half the counselors made less than $20,000
                          annually. While some counselors had little or no college experience, most
                          (70 percent) had 4-year college or graduate degrees.

                          Until recently, federal regulations required that no more than 50
                          patients be assigned to each counselor. Regulations do not address the
                          amount of patient counseling or the length of a session for patients in


                          Page 24                                   GAO/lfRlS9l%1O4   Methadone   Maintenance
chapter 2
Methadone Mdntmmn~      hhnent
Pro@ama Vary in Approach
and Effectiveness




Treatment program officials told us that insufficient services, including
counseling, can contribute to a patient leaving treatment and returning
to drug use. We found the percentage of patients who remained in treat-
ment for more than 6 months at 21 programs we visited ranged from 83
to 42 percent.” At 9 of the 21 programs, more than 40 percent of patients
left treatment before 6 months. At two of the programs more than 40
percent of the patients left treatment before 3 months. Table 2.4 lists
retention rates by program for both the 3- and 6-month periods.




“Wecalculatedpatient retention rates at 21 of the 24 programs(3 programsdid not have the neces-
sary information). At the 21 programs,we determinedthe numberof patients who enteredtreatment
during the period January 1 through August 31,1988. Patientswho were dischargedfrom treatment
only to reenterat another time within this time period were countedas separateadmissions.We
matchedthe admissionsinformation with dischargedata collectedfor the period January 2,1983
through February 28,1989.



Page 22
Chapter2
Methadone Maintenance Treatment
Programs Vary in Approach
and Effectiveness




in treatment. Program directors stated that many patients have alcohol
problems at the time they are admitted into treatment. One official said
while patients reduce opiate use, which includes heroin, during treat-
ment, many increase their consumption of alcohol.

For the 24 programs we visited, the rate of patients who missed receiv-
ing their daily dose of methadone ranged from an average of 4 percent
at one program to 51 percent at another. At nine programs, 25 percent
or more of the patients missed their daily dose of methadone. Patients
must take the appropriately prescribed levels of methadone daily
because, as a long-acting opiate (usually 24 to 36 hours), it interrupts
and prevents the craving for heroin. Table 2.3 provides the attendance
data for the 24 programs.




Page 20                                 GAO/HRD&-104 Methadone Maintenance
Chapter 2
Methadone Maintenaner    Treatment
Programs Vary in Approach
and Effectiveness




Besides heroin, patients used other drugs-primarily     cocaine,* but also
amphetamines, benzodiazepineq3 or alcohol. At eight of the 24 treat-
ment programs, between 20 and 40 percent of patients used cocaine.
Cocaine use at the remaining programs ranged from none at one pro-
gram to 15 percent at three others. Table 2.2 shows the percentage of
heroin, cocaine, and overall drug use by patients in treatment longer
than 6 months.”




“Most treatment modalities (drug-free, therapeutic communities, etc.) have seen recent increases in
the number of patients seeking or receiving treatment for cocaine use.

“A class of drugs used for treatmg anxiety and sleep disorders

‘Total drug use includes herom and other opiates, cocaine, amphetamines, benzodiazepines, and
barbiturates.



Page 18                                                 GA0/HRLWO.104      Methadone    Maintenance
                                                                                                                                 -
                            Chapter 2
                            Methadone Maintenance    Treatment
                            Programs Vary in Approach
                            and Effectiveness




Wide Variation Found in     As with treatment goals, programs differed widely in their policies
Testing, Discharge, Take-   regarding urinalysis testing, patient discharge, and methadone take-
                            home privileges. Urinalysis results are the primary tool used by pro-
Home Policies, and Costs    grams to determine if patients are continuing to use heroin or other
                            drugs. Federal regulations require that, during the first year of treat-
                            ment, treatment programs test patients’ urine at least eight times a year
                            and thereafter at least quarterly. The number of times programs tested
                            patients varied from once a week to eight times a year. Officials from
                            the 15 programs that tested patients once a month or less, said that the
                            costs for the tests prohibited their programs from testing more often.
                            The costs of urinalysis tests ranged from $0.00 to $19.00 and averaged
                            $6.51 for the 24 programs.’

                            A NIDA researcher told us that to ensure accurate urinalysis test results,
                            programs must observe the collection of urine samples. Nine of the 24
                            programs we visited did not observe urine collection. Program officials
                            said that urine collections were not observed because it would increase
                            the work load for their staff.

                            A consequence of continued drug use could be discharging patients from
                            methadone maintenance treatment for any drug use, including cocaine.
                            Seventeen programs discharged patients for continued drug use while
                            six programs would not, even if a patient’s urinalysis tests were repeat-
                            edly positive for heroin or other drug use. The remaining program would
                            discharge patients in publicly funded slots but not patients that paid for
                            their own treatment. Programs in the state of Washington are required
                            by state regulations to discharge patients from a program if they test
                            positive for any illicit drug three times in a 6-month period. Officials
                            from programs that allowed patients who continued to use drugs to stay
                            in treatment said that the risk of contracting AIDS was the primary rea-
                            son for retaining these patients in treatment. However, four programs
                            that did not discharge patients from treatment for continued use of
                            drugs would discharge patients if they were delinquent in paying their
                            fees for treatment.

                            Federal regulations allow take-home methadone doses to be provided to
                            patients on days that a program is closed or for patients who have
                            demonstrated improvement and who can adhere to program rules. Take-
                            home methadone doses permit patients to reduce the number of days
                            they must come to the program to receive methadone. However, because

                            ‘In two cases, urinalysis testing was paid for by the state, and the programs were not charged for
                            these costs.



                            Page 16                                                 GAO/HRlMO-104       Methadone   Maintenance
                             Chapter 2
                             Methadone Maintenance   Treatment
                             Pmgranw Vary in Approach
                             and Effectiveness




                             state is preferable, but a patient should not be forced to stop taking
                             methadone.
                           s Eight programs sought to stop all drug use, including methadone. Some
                             program directors told us that patients should ultimately become com-
                             pletely free of all drugs. One program director told us that he only uses
                             methadone maintenance if patients are unwilling to undergo or unable
                             to successfully complete a 90- to MO-day detoxification period.


Methadone Dosages Varied     Programs had different philosophies and practices regarding the appro-
                             priate methadone dosage level. The National Institute on Drug Abuse
                             believes that an adequate dose of methadone is necessary to stop heroin
                             use. NIDA found that 60 milligrams (mp) to be the lowest effective dose
                             and that low-dose maintenance (20 to 40 I& is considered
                             “inappropriate.”

                             However, physicians at the various programs we visited differed con-
                             cerning the amount of methadone they believe should be prescribed to
                             patients. At 21 of the 24 programs the average milligram dosage of
                             methadone prescribed was below 60 mg-the lowest effective dose. The
                             average dose of methadone at the 24 programs ranged from 21 to 68
                             milligrams. One program physician told us that program rules prevented
                             him from prescribing methadone in doses greater than 50 milligrams to
                             any patient. This rule was based on internal administrative policy. The
                             mean dose of methadone among programs and the median and mode for
                             patient dosages are listed in table 2.1.




                              Page 14
Chapter1
Introduction




treatment goals and the types of rehabilitative services provided. To
determine the federal role in regulating and overseeing methadone main-
tenance treatment programs, we reviewed current and proposed federal
methadone maintenance regulations and interviewed officials from the
Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA), FDA,
NIDA, and DEA. We also reviewed records of the most recent FDA compli-
ance inspections for each of the 24 programs we visited to determine
when they took place and to review the findings of the inspections.

To examine the effectiveness of methadone maintenance and the status
of alternative strategies, we reviewed the relevant literature and inter-
viewed NIDA officials and other experts in the drug treatment field.

Our review was performed between March and October 1989 in accord-
ance with generally accepted government auditing standards. We did
not obtain official agency comments on this report; however, a copy of
the draft report was provided to FDA and NIDA officials and we incorpo-
rated their views where appropriate.




page12
                   Chapter 1
                   Introduction




                   There is no typical methadone maintenance treatment program. Pro-
Program Profiles   grams can be found in rural and suburban areas and inner cities. Pro-
                   grams may range in size from fewer than 100 to more than 700 patients.
                   Many programs are established by private not-for-profit organizations
                   and others are privat,e for-profit and public programs. These programs
                   can be linked with a hospital. Under federal regulations, admission to
                   methadone treatment is limited to persons who have been addicted to
                   heroin or other opiates for at least 1 year.

                   Funding for methadone maintenance treatment varies by state and
                   sometimes by county. Many private for-profit programs do not receive
                   public funding and charge their patients a fee for services. Depending on
                   the state and/or local governments involved, programs may receive pub-
                   lic funds in the form of Medicaid, block grant funds, or other state and
                   local government assistance.

                   Heroin addicts come from every race and may be from rich, poor, or
                   middle-class families. Many patients in treatment are employed, includ-
                   ing some in professional careers. Costs to the patients also vary by loca-
                   t,ion and often the patient’s ability to pay.

                   A new problem faced by heroin addicts and methadone maintenance
                   treatment programs is AIDS. Heroin is commonly administered intrave-
                   nously, and IV drug users are the second largest population at risk of
                   AIDS. Some experts have estimated that in New York City over 60 per-
                   cent of IV drug users are mv infected. Further, methadone maintenance
                   treatment programs have become involved with a host of problems asso-
                   ciated with heroin use, including homelessness and mental illness, tuber-
                   culosis, pneumonia, and numerous other debilitating diseases.


                   At the federal level, the Food and Drug Administration (FDA), ~IUA and
Federal Agency     the Drug Enforcement Administration (DEA) share responsibility for
Responsibilities   issuing methadone maintenance treatment regulations and for oversee-
                   ing methadone maintenance programs. FDA is responsible for approving
                   the operations of methadone maintenance treatment programs and has
                   primary responsibilit), for ensuring that programs comply with the
                   methadone maintenance regulations. NIDA works with FDA in developing
                   methadone maintenance regulations and is responsible for federal
                   research of drug treatment. DEA registers programs to procure and dis-
                   pense methadone. It also is responsible for ensuring that supplies of
                   methadone are safeguarded appropriately by methadone programs and
                   methadone manufacturers and distributors.


                    Page 10                                 GAO/HRD-90-104Methadone Maintenamr
Introduction


                      Heroin addiction is widespread in the United States. The National Insti-
                      tute on Drug Abuse (KIDA) estimates that there are approximately
                      500,000 heroin addicts in the United States. Treatment experts believe
                      that heroin addiction is a chronic and relapsing disease that addicts will
                      battle the rest of their lives. The most commonly used treatment for her-
                      oin addiction is methadone maintenance.

                      Methadone is an orally administered synthetic narcotic. Methadone
                      “blocks” the effect of heroin and prevents withdrawal symptoms. It is
                      not a “cure” for addiction. It is provided in clinics as a substitute for
                      heroin and other narcotic drugs.’ In 1988, approximately 100,000 heroin
                      addicts received methadone maintenance treatment at over 650 pro-
                      grams nationwide. These treatment programs attempt to help addicts
                      stop using street drugs and lead more stable and productive lives by
                      combining the use of methadone with counseling and other services.

                      The Chairman of the Select Committee on Narcotics Abuse and Control,
                      House of Representatives, requested that we review the treatment pro-
                      vided to patients in methadone maintenance treatment programs and
                      examine the federal government’s oversight of methadone maintenance
                      programs. In requesting our review, the Chairman expressed concern
                      about the kinds of treatment services made available to methadone
                      patients, and whether methadone programs pursue a goal of restoring
                      patients to a totally drug-free state where they no longer use
                      methadone.


                      The use of methadone as a method of drug treatment for heroin addic-
Concerns and          tion started in the early 1960s. As methadone programs expanded in the
Controversy Have      early 197Os, concern emerged over the diversion of methadone to illicit
Surrounded            use. In 1974, the Congress, recognizing both the potential benefits of
                      methadone maintenance and the risk of diversion, passed the Narcotic
Methadone Treatment   Addict Treatment Act of 1974 (P.L. 93-281). Legally sanctioning nar-
                      cotic maintenance treatment, the legislation required the then-Depart-
                      ment of Health, Education and Welfare (now the Department of Health
                      and Human Services) to establish regulations regarding who may enter
                      methadone maintenance treatment programs and the conditions under
                      which the drug could be administered.



                      ‘Narcotic drugs include heroin, morphine,and other morphine-likedrugs,but do not include drugs
                      such ascocaine,marijuana,and certain other drugs.



                      Page 8                                               GAO/HRD-90104Methadone Maintenance
Contents


Executive Summary                                                                                        2

Chapter 1                                                                                               8
Introduction           Concerns and Controversy Have Surrounded Methadone
                           Treatment
                                                                                                        8

                       Program Effectiveness Linked to Counseling and                                    9
                           Rehabilitative Services
                       Program Profiles                                                                 10
                       Federal Agency Responsibilities                                                  10
                       Objectives, Scope, and Methodology                                               11

Chapter 2                                                                                               13
Methadone              Treatment Goals and Policies Differed Among Programs
                       Substantial Variation Found in Program Results and
                                                                                                        13
                                                                                                        17
Maintenance                Services
Treatment Programs
Vary in Approach and
Effectiveness
Chapter 3                                                                                               28
Improvements in        Federal Regulations Lack Standards for Treatment
                           Effectiveness
                                                                                                        28
Federal Oversight of   FDA Inspections Have Been Infrequent and Do Not Assess                           29
Methadone                  Program Performance
Maintenance Needed     Proposed Interim Maintenance Regulations Should Be                               30
                           Withdrawn

Chapter 4                                                                                               34
Conclusions and        Conclusions
                       Recommendations
                                                                                                        34
                                                                                                        34
Recommendations
Appendixes             Appendix I: Alternative Treatments Developed for Heroin                          36
                           Addiction
                       Appendix II: Major Contributors to This Report                                   38

Tables                 Table 2.1: Methadone Dose Among Patients at the 24
                           Methadone Maintenance Treatment Programs



                       Page 6                                GAO/HltB90-164   Methadone   Maintinance
                           ExecutiveSummary




                           testing ranged from once a week to 8 times a year, 15 programs dis-
                           missed patients for repeated drug use while 9 programs did not, coun-
                           selor patient ratios ranged between 1 to 15 and 1 to 96, and average
                           methadone dosage levels ranged from 21 to 67 milligrams. (See pp. 13-17
                           and 25.)

                           There are no federal treatment standards for methadone maintenance
                           treatment programs. Further, none of the programs we visited evaluated
                           the effectiveness of their treatment. (See chapter 3 and p. 27.)


Federal Oversight of       FDA  and NIDA have responsibility for regulating methadone maintenance
Methadone Maintenance      treatment programs. These agencies provided little oversight of the pro-
                           grams between 1982 and early 1989. Neither agency routinely evaluated
Limited                    the effectiveness of treatment programs. FDA'S recent inspection of pro-
                           grams for compliance with the administrative requirements of federal
                           methadone maintenance regulations have found serious problems. FDA
                           inspections in fiscal year 1989 found 62 programs that failed to (1) meet
                           minimum urine testing requirements, standards for admissions, and
                           medical evaluation requirements; (2) comply with frequency of attend-
                           ance and take-home requirements; or (3) maintain an adequate patient
                           record system. (See pp. 28-30.)


Effectiveness of Interim   In March 1989, FDA and KIDA proposed revised methadone maintenance
Maintenance Questionable   regulations to allow interim maintenance-the    provision of methadone
                           without any counseling or rehabilitative services for addicts who are on
                           waiting lists for comprehensive methadone maintenance treatment. The
                           proposed regulation is based on the assumption that (1) demand greatly
                           exceeds treatment capacity at methadone maintenance treatment pro-
                           grams and (2) the immediate availability of methadone to these addicts
                           would reduce IV heroin use with its attendant risk of AIDS.

                           While we found that some programs had waiting lists, there is no clear
                           evidence of a serious shortage of treatment slots. Moreover, recent
                           research findings by the Department of Veterans Affairs (VA) and Uni-
                           versity of Pennsylvania researchers indicate that interim maintenance




                           page4
Executive Summ~


                   Methadone maintenance is the most commonly used treatment for her-
Purpose            oin addiction. The treatment combines the use of methadone, an orally
                   administered synthetic narcotic, with counseling and other rehabilita-
                   tive services. Methadone is not a “cure” for heroin addiction, rather,
                   treatment programs attempt to help addicts stop using illegal drugs and
                   lead more stable and productive lives. Treatment experts believe that
                   heroin addiction is a chronic and relapsing disease that addicts will bat-
                   tle their entire life.

                   The Chairman of the House Select Committee on Narcotics Abuse and
                   Control requested GAO to review the treatment provided to patients in
                   methadone maintenance treatment programs and to examine the federal
                   government’s oversight role for such programs. The Chairman
                   expressed concern about the extent of treatment services made availa-
                   ble to methadone patients and whether treatment programs have been
                   successful in reducing heroin and other drug use among their patients.
                   He also expressed concern over a recently proposed regulation, referred
                   to as interim maintenance, that would allow methadone to be dispensed
                   without supportive services.


                   The use of heroin remains a widespread problem in the United States.
Background         Government estimates place the number of heroin addicts nationwide at
                   about 500,000. In 1988, approximately 100,000 heroin addicts received
                   methadone maintenance treatment in over 650 programs. (See p. 8.)

                   There is no typical methadone maintenance treatment program. Pro-
                   grams can be found in rural and suburban areas and the inner cities.
                   They may range in size from fewer than 100 to over 700 patients. Many
                   programs are established by private not-for-profit organizations while
                   others are private for-profit and public programs. (See p. 10.)


Federal Agency     The Food and Drug Administration (FDA), National Institute on Drug
Responsibilities   Abuse (NDA), and Drug Enforcement Administration (DEA) share respon-
                   sibility for regulating methadone maintenance treatment programs. FDA
                   approves methadone maintenance treatment programs and has primary
                   responsibility for ensuring programs comply with federal methadone
                   maintenance regulations. NIDA is responsible for federal research of drug
                   treatment. DEA registers programs and is responsible for ensuring that
                   supplies of methadone are safeguarded against illegal diversion. (See p.
                    10.)



                   Page 2                                    GAO/HRLNO-104   Methadone   Maintenance