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Matching Treatment to Patient Needs in Opioid Substitution Therapy
Treatment Improvement Protocol (TIP) Series 20

Appendix B -- Massachusetts Methadone Treatment Criteria

Introduction

The Massachusetts Methadone Treatment Criteria were developed and written by the Massachusetts Methadone Treatment Providers Association. The American Society of Addiction Medicine (ASAM) has not, as yet, published admission, continuing care, and discharge criteria for methadone treatment. Therefore, although these criteria were modeled on the format and conceptualization of the ASAM criteria, the content is original work.

Several challenges were present in the development of methadone treatment criteria. First, methadone treatment, including admission into this service, is a heavily regulated substance abuse treatment modality on both the state and federal level. For example, methadone treatment is regulated for the type of substance being abused (opiates); the length and severity of addiction (1 year or more); a client's age (18 years or older); and several other issues. Therefore, the development of admission criteria needed to address and incorporate each applicable regulation.

Secondly, writing discharge criteria for methadone treatment is complex and variable on a number of levels. For example, methadone treatment can be either a short-term or a long-term treatment approach. In some instances it is a lifetime treatment modality. This variability, dependent on the goals and objectives of individualized treatment plans, made the development of uniform discharge criteria challenging. The Massachusetts Methadone Treatment Providers have successfully developed criteria that capture and address these complex issues.

A. Brief Description of Treatment Level

An organized, ambulatory addictions service for opiate addicted clients with designated addiction trained personnel and/or addiction credentialed clinicians that provide individualized treatment, case management, and health education including HIV, TB, and STD. The nature of the services (e.g., level of dose, length of stay, frequency of visits) is correlated with the client's clinical needs, but consists of regularly scheduled psychosocial treatment sessions and daily medication visits within a structured program. These services function under a defined set of policies and procedures; admission, discharge, and ongoing treatment criteria are also stipulated by state (DPH 105 CMR 750.720) and Federal regulations (FDA 21 C.F.R. Part 291 Vol.54 No.40 p.8962).

Methadone treatment is designed to address the client's individual needs to achieve changes in the individual's level of functioning, including elimination of illicit opiate and other drug abuse including alcohol. To accomplish this, the program addresses major lifestyle, attitudinal, and behavioral issues which can undermine the goals of treatment and inhibit the individual's ability to cope with major life tasks.

B. Programmatic Description

1. Setting

A professional setting that includes permanent Free-Standing Clinic sites, Community Mental Health Centers, Community Health Centers, Hospitals, Medication Units, Satellite Clinics, or Mobile Units attached to a permanent clinic site.

2. Support Systems

a. Linkage or access to psychological, medical and psychiatric consultation.

b. Linkage or access to emergency medical and psychiatric affiliations with more intensive levels of care as needed.

c. Linkage or access to evaluation and ongoing primary medical care.

d. Ability to conduct and/or arrange for appropriate laboratory and toxicology tests.

e. Physician availability to provide evaluation for, prescription of, and on-going monitoring of methadone; nursing and/or pharmacy availability for the dispensing and administering of methadone.

f. Provisions for the safe storage of methadone.

Note: The preference is that programs have direct access to or on-site services; however, linkage to these services may suffice if direct access is not available.

3. Staff

a. A multidisciplinary team of appropriately trained and/or credentialed addictions professionals, including a medical director, physicians, nurses, and counselors. May include licensed psychologists and registered pharmacists as needed. They must be knowledgeable in the assessment, interpretation, and treatment of the biopsychosocial dimensions of drug and alcohol dependence. Staff members shall receive supervision appropriate to their level of training and experience.

b. Licensed medical staff (nursing, medical, or pharmaceutical) is available to administer medications in accordance with the physician's prescription and/or orders. The intensity of nursing care is appropriate to the services provided by an outpatient methadone treatment program.

c. A physician is available during medication dispensing and clinic operating hours either in person or by telephone.

4. Therapies

a. Multidisciplinary individualized assessment and treatment are provided.

b. Medication: Assessment, prescribing and administering adequate doses of methadone are provided; overseeing and facilitating access to appropriate treatment including medication for other physical and mental health disorders are provided as needed.

c. Counseling: A range of cognitive, behavioral, and other addictions-focused therapies reflecting a variety of treatment approaches are provided to the client on an individual, group, and family basis.

d. Case Management: Case management including medical monitoring and/or coordination of off site treatment services are provided as needed.

e. Psychoeducation including AIDS and other health education services are provided.

f. Provisions for or referral to vocational counseling, treatment of psychiatric illness, primary health care, and other adjunctive services are provided as needed.

5. Assessment/Treatment Plan

a. A comprehensive medical history, physical examination and laboratory tests must be provided or obtained. For clients seeking admission, tests must include the following: [blood analysis (CBC and differential, liver function); routine and microscopic urinalysis; Tuberculin test; Australian antigen HB Ag; Hepatitis Core Antibody (HBc Ab); pregnancy test; Syphilis Serology; Urine toxicology; and EKG, when appropriate,] are obtained upon admission (and annually thereafter or more often if indicated). These tests must be done on admission and reviewed by the physician [within 14 days of prescribing and administering of methadone. (Federal Register, Department of Health and Human Services, Food and Drug Administration 21 CFR Part 291 Vol.54, No.40, March 1989, p.8962-8964, and in Massachusetts, Department of Public Health, 105 CMR 750.720, p.21-23).]

b. An appropriate methadone dose is established by the physician upon admission, and reviewed annually, or more frequently as indicated during the client's course of treatment.

c. In the presence of life-threatening biomedical problems, continuing evaluation and referral by the program physician as required. These conditions include but are not limited to:

  1. Recurrent or multiple seizures; or
  2. Excessive use of alcohol, cocaine, or other drugs that can result in stupor, seizures, etc.; or
  3. Mental status indicators that require inpatient management (e.g., depression with suicide ideation, attempts, psychosis, etc.); or
  4. Biomedical problems that require 24-hour observation and evaluation.

d. The nurse (physician or pharmacist) is responsible for overseeing the monitoring of client progress and medication administration at each medication visit.

e. Individual biopsychosocial assessments are made of all clients.

f. Treatment plan reviews are conducted at specific times as noted in the treatment plan (e.g., 90 days intervals).

6. Documentation

a. Progress notes in the client's record are recorded at each face-to-face contact and clearly reflect implementation of the treatment plan as well as the client's response to treatment.

b. Documentation is recorded for each dose of methadone administered.

C. Diagnostic Admission Criteria

The client is assessed as meeting the diagnostic criteria for psychoactive substance use disorder as defined by current Diagnostic and Statistical Manual of Mental Disorders (DSM) or other standardized and widely accepted criteria.

In instances whereby the presenting drug-alcohol history is inadequate to substantiate such a diagnosis, the material submitted by other medical and health care professionals and/or programs, collaterals (e.g., family members, legal guardians, significant others) indicates a high level of probability of such a diagnosis based upon further evaluation.

Clients admitted into methadone treatment must demonstrate specific objective and subjective signs of opiate dependence as defined in the Federal Register, Department of Health and Human Services Food and Drug Administration, 21 C.F.R. Part 291, Vol.54, No.40, 1989.

D. Dimensional Admission Criteria

Admission into this level of care requires meeting the specifications for dimensions 1, a., b., and c., or one of the exception admission criteria defined in d., e., and f., and at least one of each of the dimensions of 2-6.

1. Acute intoxication and/or Withdrawal:

a. The physician determines that the client is "physiologically dependent upon an opiate drug and became physiologically dependent at least 1 year before admission for methadone maintenance." This means the client was addicted "continuously or episodically for most of the year immediately before admission." (FDA 21 C.F.R. Part 291 Vol.54 No.40 p.8962-3); and

b. Criteria to determine the client's current physiological dependence and history of addiction include but are not limited to vital signs, early physical signs of narcotic withdrawal, a positive urine screen for opiates, presence of old or fresh needle marks, documented medical and/or treatment history, client and/or family report, etc. (DPH 105 CMR 750.720); and

c. Exceptions for penal or chronic care may be admitted into methadone treatment within 14 days of release or within 6 months after release without documented evidence of physiological dependence provided that the individual was eligible for admission prior to incarceration. (FDA 21 C.F.R. Part 291 Vol.54 No.40 p.8963); or

d. Pregnant clients who have a documented opiate dependency history may be placed on methadone treatment without documentation of physiological dependence if the program physician certifies the pregnancy and finds treatment to be "medically justified (FDA 21 C.F.R. Part 291 Vol.54 No.40 p.8963); or

e. Previously treated clients: Under certain circumstances a client who has had previous methadone treatment and later voluntarily detoxified from methadone, may be readmitted to methadone treatment without evidence of current physiological dependence, up to two years after discharge, if the program is able to document prior methadone treatment of six months or more and in the program physician's reasonable judgment readmission to methadone treatment is medically indicated. (Federal Register, Department of Health and Human Services, 21 C.F.R. Part, 291,505(c) p.130.)

2. Biomedical Conditions and Complications

Must meet a and may meet b-c.

a. Biomedical criteria for opiate dependence with or without the complications of opiate addiction requiring medical monitoring and skilled care; or

b. Concurrent biomedical illnesses or pregnancy that can be stabilized and maintained safely on an outpatient basis with minimal daily medical monitoring; or

c. Presence of non-acute biomedical problems that can be managed on an outpatient basis and do not require inpatient treatment, such as:

  1. Liver disease, or problems with potential hepatic decompensation;
  2. Pancreatitis;
  3. Gastrointestinal problems;
  4. Cardiovascular disorders;
  5. HIV, AIDS, and other sexually related conditions;
  6. Sexually transmitted diseases;
  7. Concurrent psychiatric illness requiring sychotropic medications;
  8. Concurrent psychiatric illness requiring psychotropic medications;
  9. Tuberculosis.

3. Emotional/Behavioral Conditions and Complications

Must meet one of the criteria defined in a-f.

a. Emotional/behavioral complications of addiction are present and are manageable in an outpatient structured environment; or

b. Addiction related abuse/neglect of spouse/children/significant others requiring intensive outpatient treatment to reduce the risk of further deterioration; or

c. Emotional/behavioral complications related to HIV infection, AIDS, and sexually transmitted diseases; or

d. Diagnosed and stable emotional/behavioral or thought disorder which requires monitoring, management, and/or psychotropic medication due to a history indicating its high potential of distracting the client from recovery and/or treatment (e.g., stable borderline personality, compulsive personality, etc.); or

e. Mild risk of behaviors endangering self or others with or without a history of severe depression, suicidal and/or homicidal behavior that can be managed safely in a structured outpatient environment.

f. Emotional/behavioral stability are present but continued pharmacotherapy is required to prevent relapse to illicit opiate use.

4. Treatment Acceptance/Resistance

Must meet one of the criteria defined in a or b.

a. The client requires structured therapy, methadone and programmatic milieu to promote treatment progress and recovery.

b. The client attributes problems to persons or external events and not to client's addiction. This inhibits client's ability to make behavioral changes without clinically directed and repeated structured motivating interventions. The client's resistance is not so high as to render the treatment ineffective.

5. Relapse Potential

Must meet one of the criteria defined in a-c.

a. The client requires structured therapy, methadone and programmatic milieu to promote treatment progress and recovery because the client attributes continued relapse to physiological cravings/need for opiates; or

b. Despite active participation at a less intensive level of care (e.g., outpatient counseling), and/or other treatment interventions without the provisions for methadone, the client is experiencing an intensification of addiction symptoms (e.g., difficulty postponing immediate gratification and related drug-seeking behavior), or continued high risk behaviors (e.g., shared needle use), and the individual has a deteriorating level of functioning despite revisions in the treatment plan; or

c. The client is at high risk for relapse to opiate use without methadone, close outpatient monitoring and structured support as indicated, for example, by lack of awareness of relapse triggers, difficulty postponing immediate gratification, and/or ambivalence/resistance to treatment.

6. Recovery Environment

Must meet one of the criteria defined in a-c.

a. A sufficiently supportive psychosocial environment makes outpatient methadone treatment feasible, (e.g., significant others are supportive of recovery efforts, supportive work or legal coercion, adequate transportation to program is available, support, etc.); or

b. Family/significant others are supportive, but require professional interventions to improve chances of treatment success and recovery of the client (e.g., assistance in limit setting, communications skills, decrease rescuing behaviors, education about methadone treatment, AIDS education, etc.); or

c. Even though the client does not have an ideal primary or social support system to assist with immediate recovery efforts, or may be homeless, the client has demonstrated motivation and willingness to obtain such a support system and/or pursue with assistance adequate shelter to create an environment conducive for outpatient methadone treatment; or

d. Emotional/behavioral complications of addiction are present that are manageable in an outpatient structured environment. These behaviors include:

  1. Illicit/criminal activity;
  2. Victim of abuse or domestic violence;
  3. Unable to maintain a stable household, including providing for food, consistent shelter, supervision of children, and health care;
  4. Unable to attain or keep a job.

E. Length of Stay

Length of stay will vary with the severity of the client's illness.

F. Continued Stay Criteria

Continued stay requires meeting specifications in I and II.

I. Diagnosis

The client is assessed as meeting the diagnostic criteria for psychoactive substance abuse disorder as defined by the current Diagnostic and Statistical Manual of Mental Disorders (DSM) (Opiate Dependence Continuous -- 304.00) or other standardized and widely accepted criteria.

II. Dimensional Continuing Stay Criteria

Continued stay requires meeting the specification for dimensions 1., a-c and at least one specification of each of the dimensions of 2-6.

1. Acute drug dependence and/or Potential Relapse:

Must meet one of the criteria defined in a-c.

a. Continued methadone maintenance is required to prevent potential relapse to opiate use;

b. Client continues to need ongoing medical monitoring and access to medical management;

c. Client continues to have the presence of adequate support services to ensure commitment to and entry into continued addictions treatment.

2. Biomedical Conditions and Complications

Must meet one of the criteria defined in a-c.

a. Continued presence of biomedical condition and opiate dependence problem requires medical monitoring and/or medical management and skilled care; or

b. Presence of or threat of increased rate of one or more of the following:

  1. Episodic use of drugs other than narcotics;
  2. Positive HIV status or AIDS
  3. Chronic health conditions that could be medically compromised with discontinuation of methadone maintenance treatment including but not limited to:
    • Liver disease, or problems with the potential hepatic decompensation;
    • Pancreatitis;
    • Gastrointestinal, cardiovascular, and other systems disorders;
    • HIV, AIDS, and other sexually related conditions;
    • Sexually transmitted diseases;
    • Concurrent psychiatric illness requiring psychotropic medications;
    • Tuberculosis; or

c. Client is a pregnant opiate dependent woman.

3. Emotional/Behavioral Conditions And Complications

Must meet one of the criteria defined in a-g.

a. The client has achieved stable emotional/behavioral functioning that may be jeopardized by discontinuation of methadone treatment.

b. The client demonstrates the potential for making use of methadone treatment but may not have made significant life changes. (Client participates in the program, attends counseling, has decreased illicit activity, etc.); or

c. The client is making progress towards resolution of an emotional/behavioral problem, but has not sufficiently resolved problems to allow transfer from methadone maintenance to a less intensive level of care; or

d. The client's emotional/behavioral disorder, which is being concurrently managed, continues to distract the client from focusing on treatment goals, but the client is responding to treatment, and it is anticipated that with further interventions, will be able to achieve treatment objectives; or

e. The client continues to manifest mild risk behaviors endangering self or others (e.g., periodic shared needle practices, unprotected sexual activities, some outside drug use), but the condition is improving; or

f. The client is being "held" pending transfer to a more intensive treatment service (inpatient or residential care); or

g. The client continues high risk behaviors for HIV exposure with or without the presence of HIV disease; or

h. Diagnosed and stable emotional/behavioral or thought disorder which requires monitoring, management, and/or psychotropic medication due to a history indicating its high potential of distracting the client from recovery and/or treatment (e.g., stable borderline personality, compulsive personality, etc.).

4. Treatment Acceptance/Resistance

Must meet one of the criteria defined in a-c.

a. The client recognizes the severity of the drug problem, but demonstrates minimal understanding of self-defeating use of drugs (or alcohol), yet the client is progressing in treatment; or

b. The client recognizes the severity of the drug problem and manifests understanding of his/her relationship with psychoactive substances, yet does not demonstrate behaviors that indicate client has assumed responsibility necessary to cope with the problem; or

c. The client is beginning to recognize responsibility for addressing the drug problem, but still requires this level of intensity of motivating strategies to sustain personal responsibility in treatment.

d. The client has accepted responsibility for drug problem and has determined that ongoing methadone treatment is the most effective means of preventing relapse to drug addiction.

5. Relapse Potential

Must meet one of the criteria defined in a-c.

a. The client requires structured therapy, methadone and the programmatic milieu to promote continued progress and recovery because attributes continued relapse to physiological cravings/need for opiates; or

b. The client recognizes relapse triggers, but has not developed sufficient coping skills to interrupt or postpone gratification, or to change inadequate impulse-control behaviors; or

c. Addiction symptoms, while stabilized, have not sufficiently been reduced to support functioning outside of a structured milieu.

d. Methadone has served as part of an effective treatment to alleviate addiction symptoms and prevent relapse, and the withdrawal of methadone is likely to lead to a recurrence of addiction symptoms.

6. Recovery Environment

Must meet one of the criteria defined in a-f.

a. The client has not integrated sufficient coping skills to withstand stressors in the work environment or has not developed vocational alternatives; or

b. The client has not yet developed sufficient coping skills to deal with the non-supportive family/social environment or has not developed alternative living support systems; or

c. The client has not yet integrated the socialization skills necessary to establish a supportive social network; or

d. Problem aspects of the client's social and interpersonal life are responding to treatment, but are not sufficiently supportive of recovery to allow transfer to a less intensive level of care; or

e. The social and interpersonal life of the client has not changed or has deteriorated, and the client needs additional treatment to learn to cope with the current situation or take steps to secure an alternative environment; or

f. Emotional/behavioral complications of addiction are still present, are manageable in an outpatient structured environment, but need more work. These behaviors include:

  1. Illicit criminal activity;
  2. Victim of abuse or domestic violence;
  3. Unable to maintain a stable household, including providing for food, consistent shelter, supervision of children, and health care;
  4. Unable to attain or keep a job.

g. The social and interpersonal life of the client has stabilized while in methadone treatment and is supportive of continuing methadone treatment.

G. Discharge Criteria

The client is considered eligible for discharge from this level of care when the conditions in I and II below are fulfilled.

I. Diagnosis

  1. The client is assessed as meeting the diagnostic criteria from opiate dependence in remission without the need for methadone; or
  2. The client is diagnosed with continuing opiate dependence requiring another level of care.

II. Dimensional

Discharge requires meeting the specifications for dimension 1 and at least one of each of the specifications for dimensions 2-6.

  1. The client does not meet any of the dimensional continuing stay criteria.
  2. Biomedical Conditions and Complications:

Must meet one of the criteria defined in a or b.

a. The client's biomedical condition and opiate dependence problem has stabilized and can be managed without continued use of methadone, and the client does not meet any of the continued stay criteria that indicate the need for further methadone treatment; or

b. Continued methadone treatment presents a serious medical risk as determined by the program's medical director. Continued treatment is required in another treatment setting.

1. Emotional/Behavioral Conditions and Complications

Must meet one of the criteria defined in a or b.

a. The client's emotional or behavioral problems have diminished or stabilized to the extent that they can be managed through outpatient counseling and/or self-help fellowship, and the client does not meet any of the continued stay criteria that indicate the need for further methadone treatment; or

b. A psychiatric/emotional/behavioral condition exists that is interfering with addiction treatment in an outpatient methadone treatment setting.

  1. Continued participation in a methadone treatment program presents a serious psychiatric risk as determined by the program's medical director.
  2. Continued treatment is required at a more intensive level of care.

2. Treatment Acceptance/Resistance

Must meet all of the criteria defined in a, 1-3 or b.

a. The client's awareness and acceptance of an addiction problem and commitment to recovery is sufficient to expect maintenance of recovery through outpatient counseling and/or a self-directed recovery plan as evidenced by:

  1. The client is able to recognize the severity of their drug problem; and,
  2. The client demonstrates an understanding of a self-defeating relationship with psychoactive substances; and,
  3. The client is applying the essential skills necessary to maintain a stable recovery program without methadone at this time in either methadone aftercare treatment, outpatient drug-free counseling services and/or self-help fellowship; or

b. The client has consistently failed to achieve essential treatment objectives despite revisions to the treatment plan to the degree that the client needs placement at a more intensive level of care.

3. Relapse Potential

Just meet one of the criteria defined in a or b.

a. The client recognizes relapse triggers and has developed sufficient coping skills to interrupt or postpone gratification and impulse control behaviors without methadone. The client may need the continued support of outpatient counseling to maintain recovery.

b. The client is experiencing a continuation or exacerbation in drug-seeking behaviors or craving that is not responding to outpatient methadone treatment and has been determined to require more intensive level of care.

4. Recovery Environment

Must meet one of the criteria defined in a, b, or c.

a. The client's social system and significant others are supportive of recovery to the extent that the client can adhere to a self-directed recovery plan without substantial risk of relapse, and the client does not meet any of the continued stay criteria for methadone treatment; or

b. The client is functioning adequately and does not meet any of the continued stay criteria that indicate the need for further methadone treatment; or

c. The client's social system remains non-supportive or has deteriorated. The client is having difficulty coping with this environment and is at substantial risk of relapse. The client is unable to achieve essential treatment objectives within their current social environment.

 



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