7
Treatment Standards and Optimal Treatment

As discussed in chapter 1, the rationale for government policy in opiate addiction treatment, in the view of the committee, flows from concerns for the functioning of individual addicts, the minimization of public health risks, and the reduction of criminal behavior associated with drug abuse, as well as the minimization of methadone diversion consistent with these objectives.

Although the Secretary of Health and Human Services is obligated under the law to set standards for narcotic addiction treatment, and the federal methadone regulations have been the sole means for implementing this requirement historically. The committee views one major purpose of standards to be improving the quality of treatment. In this chapter, we consider how standards should be implemented to improve treatment.

We begin by discussing the definition of terms, we then consider the characteristics of good treatment with respect to patient evaluation and admission, maintenance pharmacotherapy, medically supervised withdrawal, inpatient treatment, and pain management. As the discussion of our topics unfolds, we have occasion to refer to the barriers to effective treatment and suggest specific changes that should be made in the current regulations to remove or minimize these barriers. Throughout, we distinguish between methadone as a medicine and methadone maintenance treatment as a program of comprehensive services that enhance the effectiveness of the pharmacological treatment.

The detailed discussion in this chapter of treatment in relation to the federal methadone regulations stems from the view of the committee that regulations have an appropriate place, but that they can be improved in a number of ways. Moreover, improvements lie in the direction of reducing governmental involvement in the regulation of treatment services and relying more on the judgment of clinicians, aided by the development of clinical practice guidelines.



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--> 7 Treatment Standards and Optimal Treatment As discussed in chapter 1, the rationale for government policy in opiate addiction treatment, in the view of the committee, flows from concerns for the functioning of individual addicts, the minimization of public health risks, and the reduction of criminal behavior associated with drug abuse, as well as the minimization of methadone diversion consistent with these objectives. Although the Secretary of Health and Human Services is obligated under the law to set standards for narcotic addiction treatment, and the federal methadone regulations have been the sole means for implementing this requirement historically. The committee views one major purpose of standards to be improving the quality of treatment. In this chapter, we consider how standards should be implemented to improve treatment. We begin by discussing the definition of terms, we then consider the characteristics of good treatment with respect to patient evaluation and admission, maintenance pharmacotherapy, medically supervised withdrawal, inpatient treatment, and pain management. As the discussion of our topics unfolds, we have occasion to refer to the barriers to effective treatment and suggest specific changes that should be made in the current regulations to remove or minimize these barriers. Throughout, we distinguish between methadone as a medicine and methadone maintenance treatment as a program of comprehensive services that enhance the effectiveness of the pharmacological treatment. The detailed discussion in this chapter of treatment in relation to the federal methadone regulations stems from the view of the committee that regulations have an appropriate place, but that they can be improved in a number of ways. Moreover, improvements lie in the direction of reducing governmental involvement in the regulation of treatment services and relying more on the judgment of clinicians, aided by the development of clinical practice guidelines.

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--> The implementation of standards by regulations is not, in fact, required by the statute. Nonetheless, the regulations have been relied on to prescribe standards which have discouraged the development of alternative or complementary approaches. Chapter 8, therefore, deals with the role of federal regulations in improving treatment, as well as other ways to implement standards, such as clinical practice guidelines and formal quality assurance systems, and with issues of federal government leadership. Definition of Terms The following definitions are put forward to clarify certain important concepts. Tolerance is the condition resulting from continued use of an opiate drug (or of any substance) that makes it necessary to use increasing amounts of the drug to produce the desired effect. Physical dependence is the condition resulting from repeated administration of a drug that necessitates its continued use to prevent the unpleasant withdrawal syndrome that occurs when the drug is abruptly discontinued. Although physical dependence is associated with tolerance, the latter can occur without causing physical dependence. Addiction is a condition characterized by lack of control and compulsion that lead to illicit or inappropriate drug-seeking behavior. It can occur with or without physical dependence. An opiate agonist is a drug that mimics the effects of endorphin, a naturally occurring compound, thus producing an opiate effect by interaction with the opioid receptor site. Examples are morphine, heroin, and methadone. An opiate antagonist is a drug that displaces any opiate agonists and binds with the opioid receptor, thereby inhibiting the opiate effect of the agonist drug. An example is naloxone or naltrexone (Trexan), which prevents or reverses the effects of heroin by competitive binding at the receptor site. Opiate agonist pharmacotherapy refers to therapy based on a drug action that mimics the effects of another opiate drug. An example is the therapeutic use of methadone, an opiate agonist used to treat opiate addiction. Opiate antagonist pharmacotherapy involves the use of a drug that inhibits or prevents the effects of opiate agonist drugs. An example is the therapeutic use of naltrexone to block the effects of heroin or other opiate agonist drugs. The two primary clinical applications of opiate agonist pharmacotherapy to treat opiate addiction are the limited-term withdrawal of an addict from opiate use with the objective of achieving abstinence from illicit opiates and other psychoactive substances (known as detoxification treatment) and chronic administration of medication for chronic opiate addiction (known as maintenance treatment). These terms—''detoxification treatment" and "methadone maintenance treatment"—raise several issues. "Detoxification" has posed the most difficulty.

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--> In the 1950s, at the Lexington Public Health Hospital, methadone was used as a way to ''detoxify" heroin addicts by substituting methadone for heroin, then tapering the dose to zero to minimize withdrawal symptoms. The term "detoxification" entered the regulations in 1972 and was incorporated into the Narcotic Addict Treatment Act (NATA) in 1974. The term has been used historically to mean the use of methadone to terminate opiate use through the reduction of the methadone dose, and then to terminate methadone use as well. Current regulations, based on the NATA, specify short-term (up to 30 days) and long-term (31 to 180 days) detoxification treatment. The original 1972 regulations limited detoxification to 21 days and made no distinction between short and long-term. Three problems exist with these arbitrarily defined treatment periods. First, they bear no documented relationship to scientific or clinical data. Rather, they are based on a philosophic commitment to a drug-free state that ignores such data. Second, they arbitrarily constrain treatment decisions by clinicians. Third, treatment based on these artificial time limits often results in the patient relapsing to illicit opiate use. "Such" limits defeat the ultimate purpose that detoxification treatment was designed to serve, namely, of using methadone to withdraw from both the use of illegal opiates, such as heroin, and from continued reliance on methadone itself. Clinical experience of more than two decades has thus shown repeatedly that linking treatment to these predetermined time periods for "detoxification" does not help chronically relapsing opiate-dependent patients to recover from their addiction. Rather, these arbitrary periods may actually hinder recovery by encouraging treatment decisions based on nonclinical, administrative grounds. For example, because patients admitted for "detoxification" represent a short-term obligation of treatment programs, by definition, they often receive fewer services than patients admitted for maintenance, without respect to clinical need. Not surprisingly, the results of detoxification treatment have been generally disappointing. High rates of relapse to drug use and abuse have been a frequent correlate of detoxification treatment (Lipton and Maranda, 1981; Resnik, 1983. The steady lengthening of the permissible treatment period over time and the differentiation of detoxification into short- and long-term treatment is tacit recognition by the government of these disappointing results. Therefore, the committee recommends that "medically supervised withdrawal (MSW)" be substituted for "detoxification" and be defined as follows: "Acute or short-term (several days, several weeks, or a few months) administration of an approved, long-acting opiate agonist drug to an individual patient, at a steadily reduced dose on a schedule and rate such that the individual is able to continue to function with a tolerable level of discomfort and the use of short-acting opiates by the individual is discouraged."

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--> With respect to the term "methadone maintenance treatment," the committee also proposes that the definition of the sustained use of methadone to treat opiate addiction in the regulations be modified to describe the treatment more accurately. Specifically, the committee recommends that "maintenance pharmacotherapy (MPT)" be substituted for "methadone maintenance" (at Sec. 291.505(a)(2)) of the regulations and be defined as follows: "Sustained administration of an approved opiate agonist drug, at relatively stable doses, for the treatment of opiate addiction." In addition, the committee proposes that the following language changes be made in the regulations and incorporated in any practice guidelines that are developed later: Replace all references to the treatment of "narcotic addicts" with references to the treatment of "opiate addiction"; replace all references to "narcotic dependence" with ''opiate addiction"; and replace all references to ''opiate addict" with the definition of "opiate addiction." "Opiate" defines the class of drug in question; "narcotic" refers to any stupor-inducing drug, and is a legal term that includes cocaine (see chapter 5). "Addiction" is to be distinguished from "dependence." Replace the term "continuous or sustained use of a narcotic drug" (at Sec. 291.505 (a)(1)), and wherever it is used which could refer to pain patients, with the term "addiction to opiates." Eliminate the definition of "narcotic dependent" (Sec. 291.505(a)(5)), which fails to define the class of drugs and could be confused with physical dependence on non-opiate drugs. Replace the term "narcotic treatment program" (Sec. 291.505(a)(6)), with the term "opiate addiction treatment program." Narcotic is an inappropriate adjective for "treatment program," and the greater specificity of the latter term is desirable. Replace all references to the treatment of "narcotic addicts with a narcotic drug" with references to the treatment of "opiate addiction with an opiate." The greater specificity of the latter terms is desirable. Replace all references to the term "physiological dependence" with the term "physical dependence" and eliminate any use of "dependence" as a synonym for "addiction." "Physical" has a clear meaning; "physiological" does not change the meaning but does not add clarity. "Dependence" and "addiction" are to be distinguished; the former can occur without the latter.

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--> Patient Evaluation and Admission Criteria The evaluation of patients for admission to treatment is relatively simple at the two ends of the spectrum defined by long-term methadone maintenance and detoxification. Opiate addicts whose addiction has persisted over many years and who have a history of multiple relapses should typically be admitted to maintenance treatment. Individuals with only a brief history of opiate use (of a few weeks or months) who have developed tolerance and physical dependence and cannot stop use on their own are likely candidates for detoxification. The cases that do not fall clearly in either category pose the greatest challenge to the clinician. When the assessment of a candidate patient is not immediately clear, evaluation and admission decisions should be made by well-trained clinicians in consultation with the patient. The current federal methadone regulations do not help the clinical assessment of patients. Rather, they specify formulas, such as minimum standards for admission, which have no clinical relevance for determining which patients are eligible for maintenance and which for detoxification. In general, the decision to admit a patient to methadone pharmacotherapy, either medically supervised withdrawal,(MSW) or maintenance pharmacotherapy (MPT), should be based on a comprehensive evaluation and a clear clinical diagnosis of physical opiate dependence and chronic opiate addiction, defined to include the psycho-social-behavioral characteristics described as "drug-seeking behavior." A comprehensive evaluation should establish patient eligibility for methadone pharmacotherapy on the basis of the following: current physical opiate dependence and addiction; objective findings and subjective reports of the patient that support the need for pharmacotherapy; a judgment that the patient is capable of understanding and participating in a treatment program; and an expressed willingness of the patient to enter treatment after the nature of that treatment has been carefully explained to him or her. Once a primary diagnosis of opiate addiction has been made, an assessment of its duration and severity should determine the most appropriate treatment for the patient. The decision to treat should consider all available treatments, including nonpharmacological interventions. The initial assessment must also address the other medical and psychosocial needs of prospective patients needs. These are likely to be considerable in the case of candidates for MPT, since most such patients have diverse and often severe medical and psychological needs that require attention independently of the addiction treatment decision. It is essential to obtain informed patient consent to treatment at the initiation of treatment and again when the patient is stabilized. Obtaining

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--> consent should include a thorough explanation of clinic rules and procedures and the patient's acknowledgment that these have been explained and understood. Patient consent should be periodically reviewed. Admission to Medically Supervised Withdrawal The determination of who should be placed on MSW is based on whether the individual has an acute or chronic addiction, is or is not eligible for MPT, and prefers MSW to MPT. The patients for whom MSW is appropriate are the following: An individual diagnosed as having acute opiate addiction and who is ineligible for MPT. Although ineligible for MPT, the patient prefers MSW to an arbitrarily defined detoxification schedule or to no treatment at all. A chronic opiate addict who wishes to terminate the illicit use of opiates but does not wish to begin a program of MPT, even though he or she may meet the eligibility criteria for MPT, even though he or she may meet the eligibility criteria for MPT. A chronic opiate addict who has experienced the adverse effects of too rapid a reduction of methadone dose under an arbitrarily defined detoxification schedule, and who may have relapsed to the use of illicit opiates, and who wishes to withdraw from methadone use at a slower, less disruptive pace. An MPT patient who wishes to withdraw from methadone use, whose dose may be tapered off on an individualized basis as he or she continues MPT. Patients living in areas where MPT is not available, and who may have to be put on MSW by default. Individual patient assessments should determine what elements of comprehensive treatment should be in the patient's treatment plan. Although the treatment plan will change to reflect changes in the patient's clinical situation, it should be recognized that the probably shorter-term MSW patient may require more, not less, intensive and comprehensive care than the longer-term MPT patient. Admission to Maintenance Pharmacotherapy Admission to methadone maintenance treatment was originally limited to the "hard-core heroin addict," defined as a person with a year or more of daily self-administration of heroin. Current regulations still draw the line at an

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--> addiction history of at least one year duration. The intensity, severity, and course of the addiction history, however, must also be considered in the diagnosis, and not only the literal "history" based on dates provided by an applicant, who is often suffering from withdrawal during the initial interview. In some cases, an individual with as little as six months of heavy heroin use may be diagnosed as chronically opiate-dependent, even though a period of addiction closer to twelve months is needed in most cases. MPT should be reserved for the chronic cases of opiate addiction, as determined by the full array of clinical diagnostic criteria discussed above (pp. 8–9). The basis for requiring that admission be limited to chronic opiate addiction is that long-term exposure to opiates, including medications such as methadone and LAAM, may result in the adaptation or alteration of some neurobiological function. The patient with chronic opiate addiction is likely to have experienced this process of adaptation or alteration already. Other factors that should be considered by clinicians in the decision to begin MPT, in addition to current physical dependence on opiates and length of opiate use, include currently approved exceptions in the regulations, such as patients with history of chronic opiate addiction (pregnant women, those recently released from correctional or chronic care facilities, and former MPT patients at risk of relapse). Proper Patient Placement Admission to MPT should generally be limited to patients with opiate addiction. Unfortunately, a single clear definition of opiate addiction does not exist. Clinicians working in the field of addiction medicine are clear that opiate physical dependence alone does not equal opiate addiction. In addition to opiate physical dependence, addiction requires loss of control resulting in continued use of opiates despite adverse consequences. Loss of control may be characterized as illicit or inappropriate drug-seeking behavior, even in the absence of pain or withdrawal. Some members of the committee are concerned that distinctions between opiate addiction and opiate physical dependence may not be adequate to prevent inappropriate admissions to long-term MPT. For example, chronic pain patients who become physically dependent on opiates and then experience withdrawal symptoms when opiates are reduced or discontinued are sometimes referred, inappropriately, to methadone treatment programs which treat opiate addiction. The pain patient, whose remission of pain allows discontinuance of opiates, often requires treatment for opiate withdrawal symptoms. However, these patients usually manifest no compulsion or drug-seeking behavior. The

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--> treatment of pain patients who do not have a diagnosis or history of opiate addiction in the setting of a program designed for the treatment of opiate addiction is rarely appropriate. Such pain patients are more appropriately managed in the pain clinic or in a physician's office. On the other hand, some methadone treatment programs may be well-equipped to deal with pain patients, especially those located in hospitals. Two Conclusions The committee draws two conclusions from the above discussion about patient evaluations. First, the assessment of opiate addiction should be based on clinical diagnostic criteria and should not be determined by formulas set forth in regulations. Second, the diagnostic criteria for MPT should be set forth in clinical practice guidelines, such as the CSAT State Methadone Treatment Guidelines (see, e.g., Center for Substance Abuse Treatment, 1992) or the American Society of Addiction Medicine criteria, (see ASAM, 1991). Such guidelines should indicate the level of training and competence that is desirable for clinicians in treatment programs authorized to make such a diagnosis. Therefore, the IOM committee recommends that the regulations acknowledge the importance of the clinical evaluation of patients and minimize the administrative criteria in the maintenance pharmacotherapy admission decision by (1) noting that opiate physical dependence alone is not sufficient grounds for recommending MPT; (2) substituting "medically supervised withdrawal (MSW)" for "detoxification" and substituting ''maintenance pharmacotherapy (MPT)" for "methadone maintenance"; and (3) removing all language that encourages or discourages either MSW or MPT on the basis of nonclinical criteria (e.g., admission criteria that include arbitrary time frames.) Maintenance Pharmacotherapy Effective maintenance treatment for individual patients involves two elements—the provision of an appropriate dose of medication and a range of comprehensive services. The level of each of these elements is expected to change as a function of time in treatment and the patient's needs. We deal first with dosing principles, then with comprehensive services. In addition, we discuss take-home medication and urine testing. Implications for regulation are

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--> then examined, followed by a concluding subsection on addiction in pregnant women. Dosing The goals for pharmacotherapy of addiction to opiates include the following: the prevention or reduction of withdrawal symptoms, the prevention or reduction of drug craving, the prevention of relapse to use of such drugs, and, when possible, the restoration or movement toward normality of any physiological functions disrupted by chronic drug abuse (Kreek, 1992). Effective opiate pharmacotherapy (methadone or LAAM) is achieved by a dosage level that establishes a "steady-state" occupation of adequate numbers of specific opioid receptors. Dosing can be divided into phases (Payte and Khuri, 1992), which are indicated on Table 7-1. The committee concludes that dosing practices should not be determined by regulations but instead should be based on current scientific and clinical knowledge and on published guidelines, where feasible. What that knowledge tells us is: Patients tend to vary in level of opioid tolerance and dependence as well as in the absorption, metabolism, and elimination of methadone. Hence it is essential to determine each dose individually, taking patient reports seriously and monitoring the patient's reaction to medication carefully. In the patient with established tolerance to opiates the initial dose of methadone is usually 20 to 40 mg. The purpose of the initial and first few doses is to relieve withdrawal signs and symptoms that are present. The dose required to accomplish this purpose varies according to the level of tolerance and dependence. A single dose of methadone reaches a blood level peak between 2 and 4 hours. It is prudent to wait at least 3–4 hours before additional doses of methadone are provided and important that patients be observed closely in the induction period at the initiation of treatment. Abstinence symptoms may appear before the end of this initial, 24-hour dosing interval, because there has been no accumulation of methadone in the liver and other tissues to sustain steady drug levels in the circulation. Therefore, additional small doses of methadone (5–20 mg) may be needed three to twelve hours after the initial dose, for up to one week, to prevent signs and symptoms of opiate withdrawal (Dole et al., 1966; Kreek, 1991c; Payte and Khuri, 1992). After initial dosing, the goal is to achieve full prevention of both signs and symptoms of withdrawal for 24 hours. The 24-hour period requires that a steady-state level be established, which may require 5–10 days. Assessment of the effectiveness of dose in the first few days is best determined by the res-

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--> TABLE 7-1 Principles of Methadone Pharmacotherapy Dosing Phase Purpose Dose (range, mg) Initial dose Relieve withdrawal symptoms 20–40 in tolerant patients Early induction Bring dose to established tolerance level 5–10 mg every 3-24 hours Late induction Assure adequacy of dose; "blockade" +/- 5–10 mg every 7 days Maintenance/Stabilization Achieve goals listed above 60–120 mg, could be more, or less Long-term maintenance or medical maintenance Maintain stability and physiologic normalcy 60–120 mg Medically supervised withdrawal Gradual reduction of tolerance to zero Variable, reductions of 10% of dose level every 7–10 days (as tolerated) ponse at 10–12 hours after the dose, rather than at 24 hours. Early in treatment, the patient may need more time on the same dose of methadone rather than a larger dose of methadone. After initial stabilization, daily doses of methadone are then gradually increased, by 5 or 10 mg each week, until a full treatment dose of 60 to 120 mg is reached by the end of an induction period of four to eight weeks. In addition to prevention of the withdrawal syndrome, the dose should reduce or eliminate drug hunger or craving. Given the substantial availability of opiates in the environment of many patients, those individuals who may be vulnerable to the opportunistic use of opiates should have their dose gradually raised to a "blockade" level. The resulting cross-tolerance will ensure that supplemental opiates will not produce the desired effect. For most patients the "blockade" level will be between 60 and 120 mg daily. Some patients do well on less than 60 mg and others may require more than 120 mg (Dole, 1989; Inturrisi and Verebey, 1972; Kreek, 1973; Loimer, Schmit, et al., 1991).

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--> Determining methadone blood levels is seldom necessary but may be helpful to ensure adequate patient dosing in those situations where patients experience problems on doses that are usually in the therapeutic range. Blood levels should remain at levels greater than 150 ng/ml. An optimum level of methadone will be based on a clinical judgment of the ability of the patient to abstain from heroin and other opiates, and the comfort level of the patient. Optimal individual doses are more likely in the 400 ng/ml range. It is recommended that blood be collected at 3–4 hours and again at 24 hours after an observed dose (Payte and Khuri, 1992). The rate of elimination is as important as the actual levels. The peak should be no more than twice that of the trough level. Rapid metabolizers may benefit from split doses. (See chapter 2.) Stable maintenance doses may require adjustments from time to time. The vast majority of dose determinations can be based purely on clinical signs and symptoms. Subjective reports of the patients must be heeded as it is not realistic to rely solely on objective evidence for dose adjustments, especially when a patient is experiencing drug hunger or cravings. At the same time, the clinician must be alert to the occasional patient who wants a higher dose than necessary in order to sell a portion of it "on the street." Pregnant patients are managed by the same principles but with some special considerations (see below). In light of the above, the committee recommends that the regulations retain the language that "the amount of the initial dose should not exceed 30 mg" in order to protect the safety of the newly admitted methadone patient. Other dosing restrictions should be removed from the regulations, including the language that "the administering physician shall ensure that a daily dose greater than 100 mg is justified in the patient record"; patient take-home medication and other clinic privileges should not be contingent on dose levels, and clinical practice guidelines should be developed to assist clinicians regarding adequate dosing and take-home practices. Comprehensive Treatment Services Methadone as a medication is but one element of a comprehensive treatment program offering a full range of services, which include methadone administration, counseling, and other medical care (Hubbard et al., 1989; McLellan et al., 1993; TOPS 1979–1981). The premise of this argument is that the overriding goal of MPT is to habilitate (to make capable, to qualify) and rehabilitate (to return to a former capacity, healthy condition, or useful function) patients with opiate problems

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--> such as drug craving may recur. Many experienced practitioners of methadone maintenance find that there is an individual methadone dosage in some patients, usually between 15 and 50 mg, at which the patient has considerable difficulty making further reductions. Patients whose initial treatment is MSW and who then resume opiate use during withdrawal should be encouraged to stabilize themselves on methadone before resuming withdrawal. If appropriate, they may wish to consider initiation or resumption of MPT, instead of proceeding with withdrawal. Individuals who have withdrawn from methadone under medical supervision should be carefully followed by a treatment program and encouraged to participate in an ongoing program of recovery. In the event of relapse or impending relapse, additional therapeutic measures should be used, including, when appropriate, the rapid resumption of agonist pharmacotherapy. Under certain circumstances, MSW is initiated against a patient's will (e.g., given the certainty of discharge, the patient may elect MSW rather than pursue transfer to another program or facility). When withdrawal from methadone pharmacotherapy is not medically indicated, it is referred to as involuntary administrative withdrawal. The circumstances that justify involuntary administrative termination from treatment usually involve inappropriate behavior that threatens the program's welfare or jeopardizes the safety or health of patients and staff. Involuntary administrative withdrawal should be the course of last resort when it has been determined that methadone MPT (at the particular program) is no longer appropriate and when no alternative placement for the patient is possible. Transfer to another facility should be aggressively pursued (and documented in the patient's record) and is the preferred course for those patients for whom involuntary administrative discharge is indicated. Only if transfer is not possible, and all alternatives have been exhausted, should involuntary withdrawal commence, and it should be medically supervised. The decision to terminate methadone maintenance treatment has profound implications for a patient and should not be implemented until the conclusion of a hearing and appeal. In cases of involuntary MSW, it is particularly important that the pace of the withdrawal be accomplished safely (according to standards set forth in this report) and as comfortably as possible in order to minimize the patient's chances for relapse to illicit substance abuse. In cases where a patient's immediate departure from the program is imminent, the patient should be transferred to another facility for involuntary MSW. MSW patients who experience difficulties with small reductions in dose over considerable intervals of time should be considered for inpatient treatment, alternative or additional pharmacotherapy (clonidine, etc.), or in some cases early admission to maintenance pharmacotherapy. These decisions should be weighed carefully to determine the most appropriate action. Given

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--> the risks of HIV, hepatitis, STDs, and TB, any decision that increases the likelihood that the patient will return to the use of street drugs must be taken seriously. The outcome of MSW is more likely to depend on such factors as personal motivation, patient resources, support systems (especially family), and appropriate comprehensive treatment than on the number of days in the withdrawal schedule. In light of the above, the committee recommends: (1) that the Narcotic Addict Treatment Act be amended, if necessary, and the regulations changed accordingly, to eliminate the term "detoxification treatment" and replace it with "medically supervised withdrawal (MSW)," [as defined in the "Definition of Terms'' section above]; (2) that no time limits be specified for MSW in the revised regulations; (3) that the revised regulations indicate clearly that MSW is not appropriate for all opiate addicts but is an essential treatment that should be available to all who wish such treatment or would benefit from it; and (4) that clinical practice guidelines, based on the above general principles, be developed to assist clinicians in the clinical management of MSW patients, including the determination of appropriate dose schedules for individual patients. Recent years have seen increased utilization of non-opiate withdrawal regimens involving clonidine, available to methadone programs only under an Investigational New Drug (IND) protocol, and in some cases accelerated withdrawal using opiate antagonists. It is beyond the scope of this report to cover this material. The reader is referred to references (Senft, 1991; Brewer et al., 1988; Gossop, 1988; Kleber, et al., 1988) for more information. Inpatient Treatment The foregoing discussion has dealt with opiate-addicted patients treated in the outpatient setting. The federal regulations governing methadone treatment also affect opiate-addicted individuals in the inpatient setting: methadone maintenance patients who are hospitalized for medical or surgical reasons; and opiate addicted individuals not in treatment programs who are admitted for similar reasons.

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--> Maintenance Pharmacotherapy in Hospital Inpatient Settings Methadone patients who are admitted to hospitals as inpatients, whether for addiction-related reasons or for unrelated medical and surgical reasons, often are mistreated and mismanaged by hospital staff (Payte and Khuri, 1992). Mistreatment may vary from negative attitudes toward the patients by hospital staff to punitive decisions to withhold methadone; mismanagement may involve failing to provide for the adequate treatment of pain (Zweben and Payte, 1990). Consequently, the committee concluded that some guidance to hospital staff is warranted. Current regulations do not address the issues of inpatient MPT patients beyond providing a means for continued pharmacotherapy. (Most hospitals have a DEA registration, so they are not prohibited from providing methadone from their pharmacy stock.) These issues are most appropriately addressed by guidelines for hospital staff dealing with such patients. Guidelines, in the judgment of the committee, should reflect the following general principles: On admission of a methadone maintenance patient as a hospital inpatient, the hospital staff should notify the patient's treatment program and confirm the individual's enrollment in the treatment program, methadone dose, and time and date of last dose. During a methadone maintenance patient's inpatient stay, the hospital staff should ensure the continuity of methadone pharmacotherapy through the hospital's pharmacy or by making arrangement for its supply through the treatment program in the event the hospital does not stock methadone. Hospital staff and physicians should be prohibited from reducing or denying the methadone dose. Any changes in methadone pharmacotherapy should be made only after consultation with the treatment program physician and with the informed consent of the patient. Before discharge, the hospital staff should notify the methadone treatment program of the time of discharge and the time and amount of last dose of methadone to ensure that outpatient pharmacotherapy can be resumed without interruption. If patients are discharged from acute care to continuing care facilities, arrangements for continued provision of methadone should be part of the discharge plan. Inpatients with Untreated Opiate Addiction Currently, the federal methadone regulations restrict the use of methadone for treating opiate addiction to the following four situations: (1) a licensed "narcotic treatment program"; (2) a licensed, hospital-based, inpatient addiction

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--> treatment unit for detoxification from opiate addiction; (3) a hospital, for temporary maintenance or detoxification, when the admission is for an illness other than opiate addiction; and (4) an outpatient setting (hospital, private practice, clinic, or nursing home with a medical director and 24-hour nursing care) in which methadone is administered daily for a maximum of 3 days while the patient awaits admission into a methadone treatment program. The only circumstance in which methadone can be routinely prescribed and administered on an outpatient basis outside of an officially registered "narcotic treatment program" is for the treatment of pain. The above restrictions may on occasion result in precipitous withdrawal of opiate-addicted patients. Opiate-addicted patients admitted to hospitals with medical illness related or unrelated to illicit injecting drug use who are in need of methadone treatment pose particular problems. Two unfortunate scenarios can occur: (1) admitted methadone patients are not administered methadone for the relief of opiate withdrawal because detoxification would not be completed before discharge; or (2) opiate-addicted inpatients do receive methadone treatment, but are precipitously withdrawn from methadone at discharge because no arrangement have been made for their transfer to an outpatient treatment program or there are insufficient programs to accept them. Although it has been difficult to document accurately the length of waiting lists for methadone treatment programs, it is well-known in the treatment community that waiting lists exist, especially for those patients who do not have financial or insurance resources. Therefore, it is reasonable to assume that a significant number of patients who seek methadone treatment are unable to obtain access to services. The committee recommends that the following change be made in the regulations to accommodate the needs of hospitalized opiate addicted patients: Patients who meet the criteria for opiate addiction during any inpatient hospital admission may be treated, when appropriate, with methadone to relieve opiate withdrawal. Patients may then be discharged to methadone treatment programs for their continued treatment. If no resources are available for the patient upon discharge, or if a patient is ready for discharge before his or her withdrawal protocol can be completed, a hospital may accommodate such patients by completing the withdrawal protocol on an outpatient basis. For a patient awaiting admission to a licensed "narcotic treatment program," the hospital may maintain the patient on a maintenance dose of methadone until the patient is admitted by the program. In either case, methadone must be administered daily at the facility by staff licensed to handle and administer opiates. Patients shall not be given prescriptions for methadone for this purpose.

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--> Pain Management Methadone was approved by the FDA for the treatment of pain on August 13, 1947. As noted in chapter 1, its use in the treatment of opiate addiction has been highly regulated since late 1972. In the course of this study, the committee received communications from representatives of the pain management community indicating that the methadone regulations had created a number of problems, and much confusion, regarding the use of the drug in pain management. The regulations, intended for one purpose, had generated unanticipated, unintended, and undesirable consequences elsewhere. Although not asked to deal specifically with issues of pain and its clinical management, the committee has concluded that the intersection of the two uses of methadone—for treating opiate addiction and for pain treatment—is of sufficient importance to warrant this discussion. We identify two issues: first, the problems of the non-opiate addicted pain patient; and second, those of the methadone maintenance patient and the "recovering" opiate-dependent patient who also needs pain treatment. Central to these issues is the need to distinguish the pain patient from the opiate-addicted patient. Non-Opiate-Addicted Pain Patients The pain patient with no evidence of addiction poses one set of challenges; the patient with opiate addiction and chronic pain, a different set. The important distinction to be made is that tolerance and physical dependence do not equal addiction (see chapter 2 and the section "Definition of Terms" above). As a disease, addiction is chronic, progressive, relapsing, and often fatal, and it is characterized by compulsion and continued use of the substance despite adverse consequences (loss of control). The patient with opiate addiction will seek drugs in the absence of any pain or withdrawal symptoms. The pain patient, on the other hand, will develop tolerance to a number of opioid effects and physical dependence on opiates but will not exhibit the illicit or inappropriate drug-seeking behavior. Nor will many pain patients, in the absence of progressive disease, develop tolerance to the analgesic effects of opioids. The typical pain patient who experiences a cure or remission of pain does not experience the compulsion to resume or continue drugs. Portnoy and Payne (1992) cite three studies: in one, of 11,882 inpatients with no prior history of addiction who were administered opiates, only four cases of psychological dependence could be documented; in the second, a survey of 10,000 burn patients, with no prior history of addiction, who were treated with

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--> opiates identified no cases of addiction; in the third, of 2,369 pain patients who regularly used opiates for relief of headache, only three were addicted. The treatment of pain and the treatment of opiate addiction may both involve the prescription of methadone. Beyond that, treatment should be totally distinct. For example, it may be appropriate to treat patients with both a chronic pain disorder and opiate addiction in clinics having well-trained staff, especially those that are an integral part of a hospital. However, it is not appropriate to treat a chronic pain patient as an opiate addict in a maintenance pharmacotherapy program, regardless of the degree of tolerance, physical dependence, or duration of the prescription of methadone. On the other hand, persons suffering from opiate addiction are unlikely to receive appropriate treatment in pain clinics and, as a general rule, should not be treated for addiction in such clinics. Those MPT patients who also have chronic pain conditions may require coordinated treatment in both clinical settings, which sometimes may exist within in a single organization. The intensity of chronic or intractable pain cannot be measured objectively and, thus, physicians cannot determine clearly its authenticity. On the other hand, there are clear objective criteria for physical dependence. Physicians treating pain may lack the confidence to continue prescribing schedule II opiate analgesics in the absence of a very clear organic or anatomic basis for pain. The uneasy physician may then make an inappropriate referral to methadone pharmacotherapy. Therefore, the IOM committee proposes that the regulations establish a clear distinction between opiate addiction and dependence and that any guidelines developed for methadone treatment incorporate this distinction. In addition, the committee recommends that the regulations prohibit the admission of a person being treated solely for chronic pain to an opiate addiction treatment program for treatment as an opiate addict. As David E. Joranson, of the University of Wisconsin Pain Clinic, wrote to the committee (letter, October 25, 1993): "A person who needs a morphine-like drug only for the medical treatment of intractable pain and to prevent withdrawal associated with the treatment of intractable pain is not a narcotic addict and is not eligible for admission to a narcotic treatment program. A practitioner may prescribe, administer, or dispense narcotic drugs including methadone in the course of professional practice to such a person for the treatment of intractable pain." It is appropriate that pain experienced by opiate-addicted individuals, along with other medical and psychiatric conditions, be treated in the context of a comprehensive methadone treatment program. Pain treatment centers, on the

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--> other hand, are prohibited from and should not attempt treatment of opiate addiction involving any form of MPT, unless licensed and approved to do so. This prohibition should not prevent daily use of methadone at adequate doses for pain treatment as well as prevention of withdrawal symptoms. Methadone Patients The opiate-addicted patient with a chronic pain condition can challenge the treating clinician. Effective pain management may require an adequate maintenance dose of methadone as a foundation for pain treatment, but may also involve adequate doses of opiates other than methadone. Both conditions require specialized care. Methadone-maintained patients who are being treated for conditions associated with acute moderate-to-severe pain are often denied treatment for pain. This denial is usually based on two misconceptions: first, that any patient taking a daily dose of methadone should derive adequate analgesia from the maintenance dose, and second, that prescribing an additional amount of an opiate agonist would lead to relapse and/or compromise the treatment of the addiction. Opiate addiction treatment program medical staff must provide guidance to physicians, dentists, and other practitioners to ensure humane treatment of methadone-maintained patients being treated for acute pain. Three principles are involved: Continue methadone pharmacotherapy without interruption. Provide adequate doses of appropriate short-acting opiate agonist drugs for pain. Owing to cross-tolerance, higher than normal doses of short-acting opiate agonists will be required for relief of pain. Also, for adequate relief of pain, doses may be needed at more frequent intervals (Payte and Khuri, 1992). Antagonist and mixed agonist-antagonist opiate drugs are not to be given because they may produce a serious withdrawal reaction in opiate-tolerant individuals. ''Recovering" Opiate and Other Substance Dependent Patients Recovering patients who experience acute pain and require opiate pain medication are perceived to be at some risk for relapse to substance abuse or addiction. Clinical experience suggests that such relapses occur more frequently when the patient fails to inform the attending physician(s) of an alcohol or other drug history. The risk is minimal in cases in which the

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--> clinician has some understanding of addictive disorders and the recovery process in relation to the treatment of pain. Honest communication between the patient and the physician is essential. The minimal principles of management are: Provide adequate doses of appropriate short-acting opiate agonist drugs. Relief of pain is essential to avoid distrust and manipulation. Medicate generously for the first 24–48 hours for patients hospitalized for injury or surgery. Be thoughtful about PRN medication by anticipating pain where possible, rather than waiting for pain to manifest itself and then preparing medication, thus losing valuable time. Patient-controlled analgesia may be appropriate and effective if opiate tolerance levels are taken into consideration. Prescriptions offered on a specific schedule can be useful for many patients; a schedule avoids requiring the patient to ask for or to decide whether or not he or she needs medication. Change to non-opiate medication as soon as practical. Avoid extensive prescribing for self-administration of any opiate analgesic medications. Concluding Comments The federal methadone regulations have been very extensive and highly prescriptive about basically all aspects of treatment of opiate addiction. From 1972 to the present, these regulations have been modified in useful ways as their limiting effects on treatment have become apparent. However, these modifications, adopted in 1980, 1989, and 1993, have not seriously questioned the underlying assumptions of the original regulations. The committee's recommendations in this chapter reflect the view that wholesale abandonment of the current regulations is neither feasible nor desirable. The regulations do serve some useful purposes, as indicated above. On the other hand, the recommendations propose to reducing the scope of administrative control by FDA and other DHHS agencies over methadone treatment programs. The corollary of reducing governmental discretion over treatment programs is to recommend that increased reliance be placed on clinical practice guidelines, as they are developed, for clinicians and treatment programs. This shift of responsibility from government officials to clinicians, is already under way in some measure and should be extended, as the committee has recommended.

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