(cid:48)(cid:72)(cid:71)(cid:76)(cid:70)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:36)(cid:86)(cid:86)(cid:76)(cid:86)(cid:87)(cid:72)(cid:71)(cid:3)(cid:55)(cid:85)(cid:72)(cid:68)(cid:87)(cid:80)(cid:72)(cid:81)(cid:87)
`(cid:73)(cid:82)(cid:85)(cid:3)(cid:50)(cid:83)(cid:76)(cid:82)(cid:76)(cid:71)(cid:3)(cid:36)(cid:71)(cid:71)(cid:76)(cid:70)(cid:87)(cid:76)(cid:82)(cid:81)
`(cid:51)(cid:75)(cid:68)(cid:86)(cid:72)(cid:71)(cid:3)(cid:36)(cid:83)(cid:83)(cid:85)(cid:82)(cid:68)(cid:70)(cid:75)
`
`Page 1 of 60
`
`ALKERMES EXHIBIT 2040
`Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited
`IPR2018-00943
`
`

`

`In This
`Chapter…
`Rationale for a
`Phased-Treatment
`Approach and
`Duration
`
`Phases of MAT
`
`Transition Between
`Treatment Phases
`in MAT
`
`Readmission to the
`OTP
`
`7 Phases of Treatment
`
`The consensus panel recommends that medication-assisted treatment
`for opioid addiction (MAT) as provided in opioid treatment programs
`(OTPs) be conceptualized in terms of phases of treatment so that inter-
`ventions are matched to levels of patient progress and intended outcomes.
`The sequential treatment phases described in this chapter apply primari-
`ly to comprehensive maintenance treatment, rather than other treatment
`options such as detoxification or medically supervised withdrawal. When
`MAT is organized in phases, patients and staff better understand that it
`is an outcome-oriented treatment approach comprising successive, inte-
`grated interventions, with each phase built on another and directly related
`to patient progress. Such a model helps staff understand the complex
`dynamics of MAT and the potential sticking points and helps counselors
`organize interventions based on patient needs.
`
`The model described in this chapter comprises either five or six patient-
`centered phases for planning and providing MAT services and evaluating
`treatment outcomes in an OTP, including the (1) acute, (2) rehabilita-
`tive, (3) supportive-care, (4) medical maintenance, (5) tapering (option-
`al), and (6) continuing-care phases.
`
`Rationale for a Phased-Treatment
`Approach and Duration
`Research on the effectiveness of organizing MAT into phases is limited,
`partly because MAT is a relatively long-term process, often with no
`fixed endpoint and with a variety of possible approaches, and partly
`because patients often leave and then return to MAT, which makes
`systematic studies difficult. Although research is limited, the consensus
`panel believes that the notion of phased progression is implicit in treat-
`ment and underlies most of a patient’s time in MAT. Many OTPs operate
`according to an informal phased-treatment model, and others use phases
`at least to develop treatment plans.
`
`101
`
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`
`

`

`[T]reatment
`
`phases should not
`
`Hoffman and Moolchan (1994) recognized the
`value of treatment phases in OTPs and described
`a highly structured model. This chapter builds
`on, adapts, and
`extends their model
`as part of an overall
`strategy for matching
`patients with treat-
`ments. The phases
`described below
`are suggested as
`guidelines—a way
`of organizing treat-
`ment and looking at
`progress on a care
`continuum—and
`as an adjunct to
`the levels of care
`specified by the
`American Society of
`Addiction Medicine
`in its patient place-
`ment criteria (Mee-Lee et al. 2001a) and
`referred to by accreditation agencies.
`
`be viewed as fixed
`
`steps with specific
`
`timeframes and
`
`boundaries...
`
`individual circumstances. For many patients,
`MAT is the entry point for diagnosis and treat-
`ment of, or referral for, other health care and
`psychosocial needs. In general, most patients
`need more intensive treatment services at entry,
`more diversified services during stabilization,
`and fewer, less intensive services after bench-
`marks of recovery begin to be met (McLellan et
`al. 1993; Moolchan and Hoffman 1994).
`
`The consensus panel emphasizes that treatment
`phases should not be viewed as fixed steps with
`specific timeframes and boundaries but regard-
`ed as a dynamic continuum that allows patients
`to progress according to individual capacity.
`Some patients progress rapidly and some
`gradually. Some progress through only some
`phases, and some return to previous phases.
`Treatment outcomes should be evaluated not
`only on how many phases have been completed
`or whether a patient has had to return to an
`earlier phase but also on the degree to which
`the patient’s needs, goals, and expectations
`have been met. As described in chapter 4,
`assessment of patient readiness for a particu-
`lar phase and assessment of individual needs
`should be ongoing.
`
`Duration of Treatment Within and
`Across Phases
`Decisions concerning treatment duration (time
`spent in each phase of treatment) should be
`made jointly by OTP physicians, other members
`of the treatment team, and patients. Decisions
`should be based on accumulated data and
`medical experience, as well as patient partici-
`pation in treatment, rather than on regulatory
`or general administrative policy.
`
`Phases of MAT
`Acute Phase
`Patients admitted for
`detoxification
`Although the phases of treatment model is struc-
`tured for patients admitted for comprehensive
`
`The model is not one directional; at any point,
`patients can encounter setbacks that require a
`return to an earlier treatment phase. Therefore,
`the chapter includes strategies for addressing
`setbacks and recommendations for handling
`transitions between phases, discharge, and
`readmission. In terms of medication, the model
`includes two distinct tracks, one of continuing
`medication maintenance and the other of
`medication tapering (medically supervised
`withdrawal). The implications of both tracks
`are discussed. Although most patients would
`prefer to be medication free, this goal is dif-
`ficult for many people who are opioid addicted.
`Maintaining abstinence from illicit opioids and
`other substances of abuse, even if that requires
`ongoing MAT, should be the primary objective.
`
`Variations Within Treatment
`Phases
`The phase model assumes that, although many
`patients need long-term MAT, the types and
`intensity of services they need vary through-
`out treatment and should be determined by
`
`102
`
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`
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`
`

`

`maintenance treatment, some patients may be
`admitted specifically for detoxification from
`opioids (see 42 Code of Federal Regulations
`[CFR], Part 8 § 12(e)(4)). These patients usu-
`ally do not wish to be admitted for or do not
`meet Federal or State criteria for maintenance
`treatment. Patients admitted for detoxification
`may be treated for up to 180 days in an OTP.
`The goals of detoxification are consistent with
`those of the acute treatment phase as described
`below, except that detoxification has specific
`timeframes and MAT endpoints. Detoxification
`focuses primarily on stabilization with medi-
`cation (traditionally using methadone but
`buprenorphine-naloxone tablets are now
`available), tapering from this medication, and
`referral for continuing care, usually outside
`the OTP. During this process, patients’ basic
`living needs and their other substance use,
`co-occurring, and medical disorders are identi-
`fied and addressed. Patients also may be edu-
`cated about the high-risk health concerns and
`problems associated with continued substance
`use. They usually are referred to community
`resources for ongoing medical and mental
`health care.
`
`Patients admitted for detoxification should
`have access to maintenance treatment if their
`tapering from treatment medication is unsuc-
`cessful or they change their minds and wish to
`be admitted for comprehensive MAT. If these
`patients meet Federal and State admission cri-
`teria, their medically supervised withdrawal
`from treatment medication should end, their
`medication should be restabilized at a dosage
`that eliminates withdrawal and craving, and
`their treatment plans should be revised for
`long-term treatment.
`
`Patients admitted for
`comprehensive maintenance treat-
`ment
`The acute phase is the initial period, ranging
`from days to months, during which treatment
`focuses on eliminating use of illicit opioids and
`abuse of other psychoactive substances while
`lessening the intensity of the co-occurring
`
`disorders and medical, social, legal, family,
`and other problems associated with addiction.
`The consensus panel believes that front-loading
`highly intensive services during the acute
`phase, especially for patients with serious
`co-occurring disorders or social or medical
`problems, engages patients in treatment and
`conveys that the OTP is concerned about all
`the issues connected to patients’ addiction.
`Exhibit 7-1 summarizes the main treatment
`considerations, strategies, and indicators of
`progress during the acute phase.
`
`Goals of the acute phase
`A major goal during the acute phase is to
`eliminate use of illicit opioids for at least 24
`hours, as well as inappropriate use of other
`psychoactive substances. This process involves
`
`• Initially prescribing a medication dosage that
`minimizes sedation and other undesirable
`side effects
`• Assessing the safety and adequacy of each
`dose after administration
`• Rapidly but safely increasing dosage to
`suppress withdrawal symptoms and cravings
`and discourage patients from self-medicating
`with illicit drugs or alcohol or by abusing
`prescription medications
`• Providing or referring patients for services to
`lessen the intensity of co-occurring disorders
`and medical, social, legal, family, and other
`problems associated with opioid addiction
`• Helping patients identify high-risk situations
`for drug and alcohol use and develop alter-
`native strategies for coping with cravings or
`compulsions to abuse substances.
`
`Chapter 5 details the procedures for determin-
`ing medication dosage.
`
`Indications that patients have reached the goals
`of the acute phase can include
`
`• Elimination of symptoms of withdrawal,
`discomfort, or craving for opioids and
`stabilization
`
`Phases of Treatment
`
`103
`
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`
`

`

`Treatment Issue
`Alcohol and drug use
`
`Exhibit 7-1
`
`Acute Phase of MAT
`
`Indications for Transition
`to Rehabilitative Phase
`• Elimination of opioid-
`withdrawal symptoms,
`including craving
`• Sense of well-being
`• Ability to avoid situations
`that might trigger or
`perpetuate substance use
`• Acknowledgment of
`addiction as a problem and
`motivation to effect lifestyle
`changes
`
`Strategies To Address Issue
`• Schedule weekly drug and
`alcohol testing
`• Educate about effects of
`alcohol and drugs; discourage
`their consumption
`• Ensure ongoing patient dialog
`with staff
`• Intensify treatment when
`necessary
`• Meet with program physician
`to ensure adequate dosage of
`treatment medication
`
`Medical concerns
`• Infectious diseases (e.g.,
`HIV/AIDS, hepatitis,
`tuberculosis [TB])
`• Sickle cell disease
`• Surgical needs, such as
`skin or lung abscesses
`Co-occurring disorders
`• Psychotic, anxiety,
`mood, or personality
`disorders
`
`Basic living concerns
`• Legal and financial
`concerns
`• Threats to personal
`safety
`• Inadequate housing
`• Lack of transportation
`• Childcare needs
`• Pregnancy
`• Advocacy
`
`• Refer patients immediately to
`medical providers
`• Vaccinate as appropriate (e.g.,
`for hepatitis A and B)
`
`• Resolution of acute medical
`crises
`• Established, ongoing care
`for chronic medical
`conditions
`
`• Identify acute co-occurring
`disorders that may need
`immediate intervention
`• Identify chronic disorders that
`need ongoing therapy
`
`• Resolution of acute mental
`crises
`• Established, ongoing care
`for chronic disorders
`
`• Assess needs
`• Refer patient to appropriate
`services
`• Work cooperatively with
`criminal justice system
`• Explore transportation options
`• Link to legal advocate, case-
`worker, or social worker
`• Identify financial resources
`• Provide ongoing case
`management
`
`• Satisfaction of basic food,
`clothing, shelter, and safety
`needs
`• Stabilization of living
`situation
`• Stabilization of financial
`assistance
`• Resolution of transportation
`and childcare needs
`
`104
`
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`
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`
`

`

`Exhibit 7-1
`
`Acute Phase of MAT (continued)
`
`
`Strategies To Address Issue
`
`Indications for Transition
`to Rehabilitative Phase
`
`• Regular attendance at
`counseling sessions
`• Positive interaction with
`treatment providers
`• Focus on treatment goals
`
`• Advocate adequate dosage
`• Remain consistent, flexible,
`and available; minimize
`waiting times
`• Provide incentives and
`emphasize benefits of
`treatment
`• Dispel myths about MAT
`• Educate patient about
`goals of MAT
`• Build support system
`• Build trust
`
`• Ensure adequate dosage
`• Address ambivalence
`• Empower patient
`• Emphasize treatment
`benefits
`• Emphasize importance of
`making a fresh start
`
`• Commitment to treatment
`process
`• Acknowledgment of
`addiction as a problem
`• Lifestyle changes and
`addressing addiction-
`related issues
`
`Treatment Issue
`Therapeutic relationship
`• Establishing trust and
`feeling of support
`• Addressing myths about
`MAT
`
`Motivation and readiness for
`change
`• Ambivalent attitudes about
`substance use
`• Avoidance of counseling
`(noncompliance)
`• Negative relationships with
`staff
`• Inadequate dosage
`• Negative attitude about
`treatment
`• Involuntary discharge
`
`• Expressed feelings of comfort and wellness
`throughout the day
`• Abstinence from illicit opioids and from
`abuse of opioids normally obtained by
`prescription, as evidenced by drug tests
`
`• Engagement with treatment staff in
`assessment of medical, mental health, and
`psychosocial issues
`• Satisfaction of basic needs for food, shelter,
`and safety.
`
`Phases of Treatment
`
`105
`
`Page 6 of 60
`
`

`

`Alcohol, opioid, and other
`drug abuse
`During the acute phase, OTP staff members
`should pay attention both to patients’ continuing
`opioid abuse and to their use of other addictive
`and psychoactive substances. Patients should
`receive information about how other drugs, nic-
`otine, and alcohol interact with treatment medi-
`cations and why medication must be reduced
`or withheld when intoxication is evident.
`When substance abuse continues during the
`acute phase, the treatment team should review
`patients’ presenting problems and revise plans
`to address them, including changes in dosage,
`increased drug testing, or other intensified
`interventions. Chapter 11 discusses treatment
`options to address multiple substance use.
`
`In addition, the consensus panel believes that
`frequent contact with knowledgeable and car-
`ing staff members who can motivate patients to
`become engaged in program activities, especial-
`ly in the acute phase, facilitates the elimination
`of opioid abuse. Engaging the patient by sched-
`uling extra individual or group counseling ses-
`sions provides additional support and commu-
`nicates staff concern for the patient. Intensified
`treatment in the OTP is an effective response
`and provides improved outcomes when com-
`pared with more infrequent counseling sessions
`(Woody 2003).
`
`Co-occurring disorders
`Many people entering OTPs have mental disor-
`ders. Persistent, independent co-occurring
`disorders (i.e., mental disorders that arise from
`causes other than substance use and need
`ongoing therapy) and substance-induced co-
`occurring disorders (i.e., mental disorders
`directly related to substance use and addiction
`that probably will improve as the addiction is
`controlled) should be identified during initial
`assessment and the acute phase of treatment so
`that appropriate treatment or referral can be
`arranged. Patients should be monitored closely
`for symptoms that interfere with treatment
`because immediate intervention might prevent
`patient dropout. Such disorders can be
`
`disruptive at the start of MAT and require
`immediate treatment. The course of recovery
`from substance-induced co-occurring disorders
`usually follows that of the substance use dis-
`order itself, and these co-occurring disorders
`typically do not require ongoing treatment after
`the acute phase. Some patients may require
`focused, short-term pharmacotherapy, psycho-
`therapy, or both. However, many patients
`may have co-occurring disorders requiring a
`thorough psychiatric evaluation and long-term
`treatment to improve their quality of life. (See
`chapters 4 and 12 for more information on
`assessing these conditions and chapter 12 for
`more information on psychiatric diagnosis and
`treatment in MAT.)
`
`Medical and dental problems
`Patients often present with longstanding,
`neglected medical problems. These problems
`might require hospitalization or extensive
`treatment and could incur substantial costs
`for people often lacking financial resources. In
`addition, many patients in MAT have neglected
`their dental health (Titsas and Ferguson 2002).
`Once opioid abuse is stopped, these patients
`often experience pain because the analgesic
`effects of the opioids have been removed. Such
`conditions must be recognized, assessed, and
`treated, either within an OTP or via referral.
`(See chapter 10 for discussion of the diagnosis
`and treatment of medical problems for patients
`in MAT.)
`
`Legal problems
`Most correctional systems do not allow MAT.
`The consensus panel believes that sudden,
`severe opioid withdrawal caused by precipitous
`incarceration can endanger health, especially
`that of patients already experiencing comorbid
`medical illness, and can increase the risk of sui-
`cide in individuals with co-occurring disorders.
`Therefore, it is critical to address patients’
`legal problems and any ongoing criminal activ-
`ity as soon as possible, preferably in the acute
`phase. On behalf of those on probation or
`parole or referred by drug courts, program
`staff members should work cooperatively with
`
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`
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`
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`
`

`

`criminal justice agencies, educating them about
`MAT and, with patients’ informed consent (see
`CSAT 2004b), reporting patient progress and
`incorporating continuing addiction treatment
`into the probation or parole plan. OTPs should
`work with local prisons and jails to provide
`as much support and consultation as possible.
`When medical care is provided in jails or
`prisons by contracted health agencies, OTPs
`should establish contacts directly with these
`medical providers to improve the care of
`incarcerated patients in MAT. (See TIP 44,
`Substance Abuse Treatment for Adults in the
`Criminal Justice System [CSAT 2005a].)
`
`Basic needs
`The consensus panel recommends that patients’
`basic needs such as food, clothing, housing,
`and safety be determined during the acute
`phase, if possible, as discussed in chapter 4,
`and that referrals be made to appropriate
`agencies to address these needs.
`
`Patients’ living situations should be relatively
`stable and secure so that treatment can move
`beyond the acute phase. Before they transi-
`tion to the rehabilitative phase, patients should
`begin to develop the coping skills needed to
`remove themselves from situations of inevitable
`substance use. A patient’s inability to gain this
`control may necessitate revision of the treat-
`ment plan to assist the patient in moving past
`the acute phase. The process often includes
`meeting directly with the patient to assess moti-
`vation and adequacy of dosage and to define
`treatment goals clearly.
`
`Therapeutic relationships
`Positive reinforcement of a patient’s treat-
`ment engagement and compliance, especially
`in the acute phase, is important to elicit a com-
`mitment to therapy. Chapter 8 addresses the
`importance of the therapeutic bond between
`patients and treatment providers and reviews
`practical techniques to address common
`problems in counseling.
`
`Furthermore, participation in peer support
`services and mutual-help groups (provided that
`
`these groups support MAT) can be helpful to
`patients. OTPs can provide information about
`appropriate meetings and peer support.
`
`Patients...report
`
`that a strong
`
`therapeutic
`
`relationship is one
`
`of the most critical
`
`factors influencing
`
`The consensus panel recommends that patients
`be introduced to key OTP staff members as
`early as possible during the acute phase to
`foster an atmosphere of safety, trust, and
`familiarity. Patients consistently report that
`a strong therapeutic
`relationship is one
`of the most critical
`factors influencing
`treatment outcomes
`and that therapists’
`warmth, positive
`regard, and accep-
`tance are major
`elements in relation-
`ship development
`(Metcalf et al. 1996).
`Treatment provid-
`ers should minimize
`waiting times during
`scheduled appoint-
`ments to demon-
`strate that they value
`patients’ time. In
`addition, when pro-
`viders remain flexible
`and available dur-
`ing the acute phase,
`they contribute to patients’ sense of security.
`Knowing how to reach staff in an emergency can
`foster patients’ trust in treatment providers.
`
`treatment
`
`outcomes...
`
`Motivation and patient
`readiness
`As discussed in chapter 4, patient motivation
`to engage in treatment is a predictor of
`retention and should be reassessed continu-
`ally. Counselors should explore and address
`patients’ negative treatment experiences. It
`might help to acknowledge the weaknesses of
`past staff efforts and to focus on future actions
`to move treatment forward. Counseling and
`motivational enhancement are discussed in
`detail in chapter 8.
`
`Phases of Treatment
`
`107
`
`Page 8 of 60
`
`

`

`The level of patient engagement during the
`acute phase is critical. Research has shown
`that patient motivation, staff engagement, and
`the trust developed during orientation and the
`acute phase are linked more closely to treat-
`ment outcomes than patients’ initial reasons
`for entering an OTP (Kwiatkowski et al. 2000;
`Marlowe et al. 2001).
`
`Transition to the rehabilitative
`phase
`The panel recommends the following criteria for
`transition from the acute to the rehabilitative
`phase:
`
`• Amelioration of signs of opioid withdrawal
`• Reduction in physical drug craving
`• Elimination of illicit-opioid use and reduction
`in other substance use, including abuse of
`prescription drugs and alcohol
`• Completion of medical and mental health
`assessment
`• Development of a treatment plan to address
`psychosocial issues such as education, voca-
`tional goals, and involvement with criminal
`justice and child welfare or other social
`service agencies as needed
`• Satisfaction of basic needs for food, clothing,
`shelter, and safety.
`
`Rehabilitative Phase
`The primary goal of the rehabilitative phase
`of treatment is to empower patients to cope
`with their major life problems—drug or alco-
`hol abuse, medical problems, co-occurring
`disorders, vocational and educational needs,
`family problems, and legal issues—so that
`they can pursue longer term goals such as
`education, employment, and family recon-
`ciliation. Stabilization of dosage for opioid
`treatment medication should be complete,
`although adjustments might be needed later,
`and patients should be comfortable at the
`established dosage for at least 24 hours before
`the rehabilitative phase can proceed. Exhibit
`7-2 summarizes the treatment issues addressed
`
`during the rehabilitative phase, strategies for
`addressing them, and indicators for subsequent
`transition to the supportive-care phase.
`
`As stated for the acute phase, during the
`rehabilitation phase treatment, providers
`should continue to assist or provide referrals
`for patients who need help with legal, educa-
`tional, employment, medical, and financial
`problems that threaten treatment retention
`(Condelli 1993).
`
`Throughout this phase, efforts should increase
`to promote participation in constructive activi-
`ties such as full- or part-time employment,
`education, vocational training, child rearing,
`homemaking, and volunteer work. As patients
`attend to other life domains, requirements for
`frequent OTP attendance or group participa-
`tion should not become barriers to employment,
`education, or other constructive activities or
`medical regimens. Consequently, program poli-
`cies in areas such as take-home medications
`and dosing hours should be more flexible in the
`rehabilitative phase, especially when patients
`must travel long distances to their OTP or
`receive medication at restricted hours.
`
`The consensus panel recommends that informa-
`tion about outside support groups, including
`faith-based, community, and 12-Step groups,
`be reviewed with patients in the rehabilitative
`phase and that patients be urged to participate
`in such groups, assuming that these groups sup-
`port MAT. As discussed in chapter 14, OTPs
`also should cultivate direct relationships with
`organizations that might lend support for
`patient recovery. Faith-based organizations
`can provide spiritual assistance, a sense of
`belonging, and emotional support, as well as
`opportunities for patients to contribute to their
`communities, and in the process can educate
`community members about MAT.
`
`Relapse triggers or cues such as boredom,
`certain locations, specific individuals, family
`problems, pain, or symptoms of co-occurring
`disorders might recur during the rehabilita-
`tive phase and trigger the use of illicit drugs or
`abuse of prescription drugs or alcohol. Helping
`
`108
`
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`
`

`

`Treatment Issue
`Alcohol and drug use
`• Continued opioid use
`• Continued abuse of
`other substances (e.g.,
`alcohol, cocaine,
`nicotine)
`
`Medical concerns
`• Chronic diseases (e.g.,
`diabetes, hypertension,
`seizure disorders, car-
`diovascular disease)
`• Infectious diseases (e.g.,
`HIV/AIDS, TB, hepa-
`titis B and C, sexually
`transmitted diseases)
`• Susceptibility to
`vaccine-preventable
`diseases
`• Dental problems,
`nicotine dependence
`• Women’s health issues
`(e.g., pregnancy, family
`planning services)
`
`Exhibit 7-2
`
`Rehabilitative Phase of MAT
`
`Strategies To Address Issue
`
`Indications for Transition
`to Supportive-Care Phase
`
`• Ability to identify and
`manage relapse triggers
`• Repertoire of coping skills
`• Demonstrated changes
`in life circumstances to
`prevent relapse
`• Discontinuation of opioid
`and other drug use
`• Absence of problem
`alcohol use
`• Smoking cessation plan
`
`• Compliance with treat-
`ment for chronic diseases
`• Improved overall health
`status
`• Improved dental health
`and hygiene
`• Regular prenatal care
`• Stable medical and mental
`health status
`
`• Begin behavioral contracting
`• Start short-term inpatient
`treatment
`• Introduce disulfiram for
`alcohol abuse
`• Provide pharmacotherapy and
`cessation groups for tobacco
`use
`• Intensify treatment services
`• Introduce positive incentives:
`take-home medication, recogni-
`tion of progress
`• Adjust dosage as necessary to
`prevent continued opioid use
`• Encourage participation in
`support groups and family
`therapy
`
`• Ensure onsite primary care or
`link to other services
`• Provide integrated treatment
`approach
`• Provide routine TB testing as
`appropriate
`• Provide education on diet,
`exercise, smoking cessation
`• Provide vaccinations as
`indicated
`• Adjust other medications
`that interfere with treatment
`medication or adjust dosage of
`treatment medication
`• Assess need and refer patient
`for pain management
`
`(continued on following page)
`
`Phases of Treatment
`
`109
`
`Page 10 of 60
`
`

`

`Exhibit 7-2
`
`Rehabilitative Phase of MAT (continued)
`
`Strategies To Address Issue
`
`Indications for Transition
`to Supportive-Care Phase
`
` •
`
` Stable mental status
`and compliance with
`psychiatric care
`
` •
`
` Evaluate status
`• Teach coping skills
`• Ensure early identification and refer-
`ral for co-occurring disorders
`• Refer for psychotropic medication or
`psychotherapy as indicated
`
`• Identify education deficiencies
`• Provide onsite general equivalency
`diploma (GED) counseling or referral
`• Provide literacy and vocational train-
`ing with community involvement
`• Provide training on budgeting of
`personal finances
`• Provide employment opportunities or
`referral to a job developer
`
`• Stable source of income
`• Active employment
`search
`• Involvement in produc-
`tive activity: school,
`employment, volunteer
`work
`
`• Involve community or faith-based,
`fellowship, recreation, or other peer
`group
`• Increase involvement in family life
`(in absence of family dysfunction
`that impedes progress)
`• Provide for well-child care
`
`• Social support system
`in place
`• Absence of major
`conflict within support
`system
`• Increased responsibil-
`ity for dependents
`
`• Provide access to legal counsel
`• Encourage patient to take responsi-
`bility for legal problems
`• Identify obstacles to eliminating illegal
`activities and replace them with con-
`structive activities
`
`• Resolution of, or
`ongoing efforts to solve,
`legal problems
`• Absence of illegal
`activities
`
`Treatment Issue
`Co-occurring
`disorders
`• Psychotic, anxiety,
`mood, posttraumat-
`ic stress, or person-
`ality disorders
`
`Vocational and
`educational needs
`• Unemployment/
`underemployment
`• Low reading skills
`• Illiteracy
`• Learning disabilities
`
`Family issues
`• Absence of family
`support system
`• Emergence of fam-
`ily problems (e.g.,
`traumatic family
`history, divorce,
`other problem
`situations)
`
`Legal problems
`• Criminal charges
`• Custody battles
`• Ongoing illegal
`activities
`
`110
`
`Chapter 7
`
`Page 11 of 60
`
`

`

`patients develop skills to cope with triggers
`should be emphasized in this phase (Sandberg
`and Marlatt 1991) and might involve individu-
`al, group, or family counseling or participation
`in groups focused on relapse prevention. (For a
`discussion of relapse prevention, see chapter 8.)
`
`Many factors that receive emphasis in the acute
`phase should continue to be addressed in the
`rehabilitative phase:
`
`• Continued alcohol and prescription drug
`abuse and use of illicit drugs
`• Ongoing health concerns
`• Acute and chronic pain management
`• Employment, formal education, and other
`income-related areas
`• Family relationships and other social supports
`• Legal problems
`• Co-occurring disorders
`• Financial problems.
`
`Continued alcohol and
`prescription drug abuse and
`use of illicit drugs
`The consensus panel recommends that elimina-
`tion of alcohol abuse, illicit-drug use, and inap-
`propriate use of other substances be required
`to complete the rehabilitative phase. Evidence
`of heavy alcohol use might warrant that a
`patient return to the acute phase. If a patient is
`using medications, particularly drugs of poten-
`tial abuse prescribed by a nonprogram physi-
`cian, the patient should be counseled to advise
`his or her OTP physician of these prescriptions
`and should sign an informed consent statement
`permitting OTP staff and the outside physi-
`cian to discuss these prescriptions. If drug use
`is illicit or unapproved by the OTP physician,
`then group, family, and individual counseling
`should continue, and the patient should remain
`in the rehabilitative phase. Patients who con-
`tinue to use illicit drugs or demonstrate alcohol
`use problems are not eligible for take-home
`medication. Take-home medication should
`not be considered until these patients have
`
`demonstrated a period of abstinence. Patients
`also should receive information on the risks of
`smoking, both for their own recovery and for
`the health of those around them. (See chapter
`11 for techniques to treat continued substance
`use during MAT and chapter 8 for counseling
`and behavior modification strategies.)
`
`The frequency of drug testing during the
`rehabilitative phase and all subsequent phases
`should depend on a patient’s progress in treat-
`ment. The consensus panel recommends that,
`once a patient is progressing well and has con-
`sistently negative drug tests, the frequency of
`random testing be decreased to once or twice
`per month. The criteria for this should be part
`of the treatment plan. (See chapter 9 for a
`detailed discussion of drug testing.)
`
`Ongoing health concerns
`As patients advance in the rehabilitative phase,
`they should attend to other medical problems,
`and OTP staff should help them navigate the
`medical- and dental-care systems, while edu-
`cating practitioners about MAT. Onsite primary
`health care is optimal and has been instituted
`successfully in many OTPs and can result in
`better outcomes for patients (Weisner et al.
`2001), although it requires careful coordination
`of activities and staff (Herman and Gourevitch
`1997). When lack of resources precludes onsite
`medical services in an OTP, referral arrange-
`ments with other service providers should be
`in place.
`
`The consensus panel recommends a more
`integrated approach to patient health in the
`rehabilitative phase. A patient’s health needs
`should be diagnosed and treated immediately.
`Education about topics with longer term ben-
`efits, such as nutrition, exercise, personal
`hygiene, sleep, and smoki