4
Methadone Diversion Control

The concern for methadone diversion preceded the issuance of FDA methadone regulations in 1972, influenced the views of policymakers writing the regulations, and continues to shape the regulations today as thoroughly as does a concern for the medical use of methadone to treat opiate addiction.

The legitimate public interest in the control of methadone diversion stems from methadone's status as a schedule II controlled substance and the fact that it is a long-acting opiate, itself addictive, having a potential for abuse both by opiate addicts and by nonaddicts. Under certain circumstances, methadone, like any other opiate, can be dangerous and life-threatening. An examination of relevant data, however, indicates that the actual level of abuse and harm from illicit methadone falls short of its hypothetical potential for abuse.

The purpose of this chapter is to examine the degree to which methadone diversion is a public safety and public health problem within the context of federal methadone regulations. The discussion addresses the following topics:the early concern over diversion and its impact on the development of methadone regulations and legislation, official views on methadone diversion, the available data on diversion, the methods of methadone diversion, the characteristics and motivations of users of street methadone, the public safety and health consequences of diversion, and conclusions and recommendations.

Early Concern over Diversion

The concept of opiate substitution therapy using methadone in the treatment of opiate dependence was a radical break with the established approach to narcotics control in the United States, an approach that had been enforced by the Federal Bureau of Narcotics (FBN) since the 1920s (Courtwright, 1992; Musto, 1987). A prior attempt at treating opiate addiction by morphine had been established by some cities around 1920. This had been



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--> 4 Methadone Diversion Control The concern for methadone diversion preceded the issuance of FDA methadone regulations in 1972, influenced the views of policymakers writing the regulations, and continues to shape the regulations today as thoroughly as does a concern for the medical use of methadone to treat opiate addiction. The legitimate public interest in the control of methadone diversion stems from methadone's status as a schedule II controlled substance and the fact that it is a long-acting opiate, itself addictive, having a potential for abuse both by opiate addicts and by nonaddicts. Under certain circumstances, methadone, like any other opiate, can be dangerous and life-threatening. An examination of relevant data, however, indicates that the actual level of abuse and harm from illicit methadone falls short of its hypothetical potential for abuse. The purpose of this chapter is to examine the degree to which methadone diversion is a public safety and public health problem within the context of federal methadone regulations. The discussion addresses the following topics:the early concern over diversion and its impact on the development of methadone regulations and legislation, official views on methadone diversion, the available data on diversion, the methods of methadone diversion, the characteristics and motivations of users of street methadone, the public safety and health consequences of diversion, and conclusions and recommendations. Early Concern over Diversion The concept of opiate substitution therapy using methadone in the treatment of opiate dependence was a radical break with the established approach to narcotics control in the United States, an approach that had been enforced by the Federal Bureau of Narcotics (FBN) since the 1920s (Courtwright, 1992; Musto, 1987). A prior attempt at treating opiate addiction by morphine had been established by some cities around 1920. This had been

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--> vigorously resisted by law enforcement agencies, resulting in the closure of these clinics. The FBN upheld this antimaintenance position for the next 40 years. The use of methadone to treat opiate addiction thus violated the FBN's long-standing policy against maintenance treatment of addiction. The experimental work of Drs. Vincent Dole and Marie Nyswander on methadone maintenance at the Rockefeller Institute in New York City in the early 1960s led to an initial report on methadone treatment in the Journal of the American Medical Association (Dole and Nyswander, 1965). Following the success of the studies on methadone by Dole and his colleagues, the number of methadone treatment programs began to increase in all major U.S. cities. In 1968, fewer than 400 patients were enrolled in methadone maintenance programs nationwide. By January 1973, the number of patients enrolled in federal and nonfederal maintenance programs had increased to 73,000 (U.S. Congress, 1973c, p. 4). Administration of some of these programs was lax, resulting in the diversion of methadone to the street market by various means. In addition, in the early 1970s, a number of cities, particularly those on the East Coast, experienced a decline in heroin supplies, owing to a combination of enforcement efforts and dock strikes; the relative scarcity of heroin stimulated the market demand for illicit methadone as a substitute for heroin. The Bureau of Narcotics and Dangerous Drugs (BNDD, successor to the FBN, FDA, and the Special Action Office for Drug Abuse Prevention developed regulations for the operation of methadone programs primarily in order to control the problem of diversion.1 The concerns over methadone diversion of the early 1970s shaped many of the provisions of FDA methadone regulations issued in December 1972. Although it is not always clear whether a specific provision was designed to prevent diversion or to serve some other purpose or both, the following provisions are among the main ones that seem to have been included primarily to limit the likelihood that methadone would reach the street: Requiring that methadone in the treatment of opiate addiction be dispensed only by programs licensed by the federal government; Placing limits on the dispensing of methadone for treatment of narcotic addiction in hospitals; 1   A number of newspaper articles published at the time contributed to the view that methadone diversion was a problem. The tone of the articles is suggested by some of their titles: "Study finds black market developing in methadone" (New York Times, January 2, 1972, by J.W. Markham); "Curse or cure? Controversy balloons over use of methadone as a heroin substitute" (Wall Street Journal, July 27, 1972, by I. Walters); "Methadone: Will it spread addiction?" (National Observer, May 29, 1972, by A. Gribbon).

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--> Requiring that patients be enrolled in only one program; Requiring physician justification in patient records for daily dosages greater than 100 mg; Specifying strict timetables and criteria for granting (and rescinding take-home doses to patients; Denying take-home privileges to patients receiving a daily dose greater than 100 mg. The requirement for providing counseling and rehabilitative services to patients, while mainly concerned with treatment goals, could also be construed in terms of diversion prevention on the grounds that rehabilitated methadone patients would be less likely to use their medication irresponsibly, nor would they have reason to do so if, as a result of counseling and other treatment, they had quit using other illicit drugs and had become involved in school or work. In a series of Senate and House hearings held in 1972 and 1973 on the various bills that later become the Narcotic Addict Treatment Act of 1974, BNDD presented its views on methadone diversion. In their testimony, BNDD officials relied on a number of sources to document their position that diversion was a serious problem (see U.S. Congress, 1973a, pp. 657–663; U.S. Congress, 1973b, pp. 18–36, 53–57). BNDD officials cited research studies that had been conducted on diversion. One of the main studies referred to was by Chambers and Inciardi (1972), an interview study of 95 active heroin addicts in New York City in 1971. Eighty-seven percent of these addicts reported that they had been offered the opportunity to purchase illicit methadone at least once in the past six months; 55 percent had actually purchased diverted methadone during this period. Thirteen percent had sold methadone illegally at some time, 8 percent in the prior six months.2 BNDD also presented the results of a number of undercover operations in various cities that involved illegal and excessive dispensing by physicians in private practice or associated with treatment programs.3 A further indication of the extent of methadone diversion, according to BNDD, was an increase in arrests in various cities involving the sale or possession of illegal methadone. 2   Other research studies on methadone diversion and related subjects (e.g., primary methadone addiction) conducted in the early 1970s include Chambers and Bergen (1973), Sapira et al. (1973), Stephens and Weppner (1973a, 1973b), Walter et al (1973), Weppner and Stephens (1973), and Weppner et al (1972). 3   The most famous of these was that of Dr. Thomas W. Moore, Jr., of Washington, D.C., who dispensed methadone to several hundred patients who paid from $15 for 50 tablets to $75 for 200 tablets each week. He was eventually convicted on 22 counts of illegally dispensing or prescribing under the Controlled Substances Act of 1970 in a case that went to the Supreme Court (U.S. v. Moore, 423 U.S. 122 (1975)).

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--> Another source of data on methadone diversion offered by BNDD was deaths attributed to methadone. From 1970 through the first six months of 1972, the percentage of drug-related deaths attributed to methadone by medical examiners increased from 6 percent to 25 percent in New York City and from 20 percent to 40 percent in Washington, D.C.4 (This increase parallels the rapid increase in the number of methadone programs and patients during this period, as well as the shortage of heroin supplies that resulted in a decline in heroin-related deaths.) In June 1972, BNDD established a more systematic program for documenting the relative frequency of abuse of controlled substances. The Drug Abuse Warning Network (DAWN) collected data on drug ''mentions'' from a variety of sources, including hospital emergency rooms and inpatient facilities, student health centers, county medical examiners and coroners, and community drug crisis centers; later, DAWN reports were limited to hospital emergency rooms and medical examiners. (Briefly, "mentions" refer to medical examiner report that a descendent tested positive for a particular substance. A detailed discussion of drug mentions, "methadone-related death," and of the problems in interpreting DAWN data is presented below.) As shown in Table 4-1, results from the early months of the operation of DAWN indicated that as heroin reports were declining, methadone reports were increasing. BNDD interpreted this as an increase in the availability of diverted methadone. BNDD identified four main sources of methadone diversion: (1) the activities of "unscrupulous practitioners" who "wrote script" (i.e., prescriptions) for methadone; (2) the negligent operation of legitimate programs that resulted in unaccounted-for shortages of methadone stocks; (3) the diversion by patients enrolled in methadone programs; and (4) robberies from methadone clinics and pharmacies and hijackings from trucks transporting methadone. Of these four, the most important were the script-writing practitioners and sale by methadone patients. 4   References in this chapter to medical examiner data pertain to data about drug-related deaths.

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--> TABLE 4-1 DAWN Reports of Heroin and Methadone September 1972–January 1973   Heroin Methadone   No. of reports % No. of reports % September 643 85.5 93 14.5 October 683 76.7 159 23.3 November 667 64.6 236 35.4 December 552 62.1 209 37.9 January 680 65 235 35 NOTE: DAWN = Drug Abuse Warning Network. Data are based on 64 reporting facilities in 38 Standard Metropolitan Statistical Areas. Figures from the initial DAWN system did not differentiate between reports of drug-related deaths and reports of other drug-related incidents. The Narcotic Addict Treatment Act of 1974 The Narcotic Addict Treatment Act (NATA) addressed the two main sources of methadone diversion, namely, practitioners and patients. First, the act required that practitioners who wished to dispense narcotics drugs for maintenance treatment or detoxification needed to obtain a separate registration from the Attorney General; it also specified that such registration could be suspended for failure to comply with the treatment standards established by the Secretary of Health, Education, and Welfare (now Health and Human Services) and the security standards established by the Attorney General. Practitioners who continued to dispense narcotic drugs for maintenance or detoxification without a registration could be prosecuted under provisions of the Controlled Substances Act. Second, the potential for diversion by patients was addressed in the section that required the Secretary to establish standards (after consultation with the Attorney General) for the amount of methadone that could be provided to patients for unsupervised use (i.e., take-homes). The NATA created a closed distribution system, in which only approved programs could purchase methadone for treatment. This new system effectively put out of business the doctors who had been prescribing methadone indiscriminately, without regard for treatment. The impact of the NATA, combined with that of the FDA regulations of December 1972, which became

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--> effective in March 1973, on the availability of street methadone is less clear. According to DEA officials, the passage of the NATA in 1974 and the inspection activities of DEA to ensure compliance by methadone programs resulted in a decline in methadone diversion, as indicated by reductions in methadone mentions in emergency room episodes and by medical examiners (U.S. Congress, 1989, pp. 138–139). Methadone mentions by medical examiners reporting to DAWN declined from a three-month moving average of 88 mentions in August 1974 to 47 in July 1976. Over this same period, methadone mentions declined from 11.1 percent to 6.6 percent of all drug mentions (National Institute on Drug Abuse, 1977). The U.S. General Accounting Office (1976) also reported that, based on data from DEA and local police departments, illicit sales of methadone were declining and that what sales did occur consisted of small quantities of take-home doses. By contrast, two NIDA-funded studies on methadone diversion conducted by Fordham University in 1972–1973 and 1974–1975 indicated that the short-term impact of the NATA and FDA's restrictive take-home policy on the availability of diverted methadone was minimal (Martin et al.,; Martin et al., 1975, summarized in Inciardi, 1977). The Fordham studies found that illicit methadone was readily available on the streets of all cities investigated both before and after enactment of NATA. In fact, data from New York and Philadelphia suggested that the use of illicit methadone had become more widespread in the latter period. Despite its availability, only 4 percent of the street addicts interviewed the second study said that methadone was the main drug they used. The primary reason for the use of illicit methadone was for self-treatment of addiction ("to keep from getting sick"). Only a minority of respondents reported that they used the drug "to get high." (See chapter 2 for a discussion of the methadone ''high.") The studies did find that law enforcement officials, at both federal and local levels, placed a low priority on diverted methadone relative to their enforcement efforts against other illicit drugs. More Recent Official Views on Diversion House Select Committee Hearings Methadone diversion has continued to occupy the attention of DEA (successor to BNDD and members of Congress, particularly the House Select Committee on Narcotics Abuse and Control. At committee hearings, testimony focused on the seriousness of the diversion problem, with only isolated voices of dissent (U.S. Congress, 1978, 1989, 1990). A report of the Select Committee in 1978 concluded:

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--> From a public health perspective, methadone diversion and illicit use represent a significant threat. This committee documented numerous cases of primary methadone addiction, of drug death due to illicit methadone and of emergency episodes involving methadone. Illicit methadone must be minimized; that is why the committee has concluded that take-home dosage units represent a major threat. The benefits of methadone treatment are great but the social and public health costs of its widespread use are also great [U.S. Congress, 1978, p. 29]. At a hearing on August 2, 1989, the Select Committee heard from DEA officials regarding a month-long DEA undercover investigation of methadone diversion in the vicinity of methadone treatment programs in the five boroughs of New York City in August 1988, during which agents were able to purchase 98 containers totaling 5.45 grams of methadone, with an average price of about $35 per 80 mg (U.S. Congress, 1989, pp. 150–152; A.L. Carter, DEA, personal communication, April 15, 1994). Agents observed as many as 20 to 25 people selling their methadone at a given location. As a result of this investigation, DEA, in cooperation with FDA and the New York State Bureau of Controlled Substances, inspected five programs near which illegal methadone sales had been observed. The violations found at two of these programs led to the initiation of proceedings to have their DEA registration revoked (the cited problems were later corrected). The results of this action appeared on a nationwide news broadcast and were reported at a hearing of the Select Committee in March 1990 (U.S. Congress, 1990). Thus, methadone diversion remained before members of Congress and the public. Perspective of the Drug Enforcement Administration The Drug Enforcement Administration has responsibility, under the Controlled Substances Act of 1970 and the Narcotic Addict Treatment Act of 1974, for preventing the diversion and abuse of methadone by establishing and monitoring security and record-keeping procedures for licensed methadone programs. DEA continues to maintain BNDD's earlier concern over the potential for methadone diversion. In DEA's view, "Methadone is an addictive, euphoria-producing drug with a high street value, and we believe it obvious that the dispensing of such a drug to an addict population, which by definition has shown itself to be more likely to abuse drugs than the general population, should be done only within a tightly regulated framework" (U.S. Congress, 1989, p. 134). In addition to the fact that the sale of methadone is illegal, DEA regards diverted methadone as the source of other public health and safety problems, mainly as a cause or contributor to drug-related deaths, as a way for heroin addicts to manage their habit without entering treatment, as a source of income

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--> to support the use of other illicit drugs, and as a means of primary methadone addiction. In DEA's view, record-keeping and security procedures have effectively limited methadone diversion at the manufacturing, distribution, and program levels. Most of the diversion now seen, DEA asserts, occurs as a result of poor adherence to treatment standards, which allows patients to sell methadone on the streets. From DEA's perspective, lax program administration is evidenced by a variety of factors, including a trend toward increasing the number of patients at the expense of comprehensive services, a reluctance by programs to rescind take-home privileges following drug tests that are positive for drugs or negative for methadone, a movement toward higher daily methadone doses, indefinite maintenance program policies, and poor control over enrollment in multiple programs. DEA is also concerned about trends toward nonmedical administration, the increasing appearance of privately run "for-profit" programs, the emergence of programs in areas with low historic problems with heroin use (e.g., rural southeastern states), and budget cutbacks that have negatively affected publicly funded programs. All of these factors, in DEA's judgment, potentially increase the opportunity for patients to sell methadone on the street. DEA testimony before congressional committees and interviews of DEA officials by IOM committee members indicate that DEA appears to favor policies that would provide for comprehensive services, further tighten up treatment regulations (especially as regards take-home practices), and improve program monitoring to ensure compliance with regulations (again, especially as regards take-home doses). DEA officials often note that many methadone patients are polydrug users and that they continue to use drugs as evidenced by urine tests. At first sight, this observation may seem beside the point since methadone is specific only to opiate addiction. But the observation becomes relevant to DEA's perspective on diversion in regard to two points. First, DEA (like its predecessor, BNDD) has strongly argued that methadone treatment, in addition to dispensing the medication, must include comprehensive medical and social services, which should include addressing other drug use. Second, and more pertinent to diversion, methadone patients who continue to use other illicit drugs have an incentive to sell their methadone to purchase other drugs; thus, in DEA's view, methadone programs that fail to address other drug use may, in effect, be subsidizing drug abuse. According to Eugene Haislip, Deputy Assistant Administrator for Diversion Control of DEA, the failure by programs to address other drug use creates "little incentive for an individual to become drug free because their steady supply of methadone provides them with a constant source of illicit income with which to purchase other drugs, primarily cocaine. Any broadening of

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--> present standards regarding take-home dosages of methadone can only be expected to exacerbate the problem" (see U.S. Congress, 1989, p. 136). The Data on Diversion All of the problems cited by DEA that are associated with methadone diversion have occurred and will continue to occur to some extent so long as methadone programs exist. However, in assessing the degree of seriousness of methadone diversion as a public safety and public health problem (and therefore as a problem in need of a certain level of intervention), it is not enough to document instances of harm. What is needed is to determine (within the constraints of available data and methodology) how often methadone diversion and related consequences occur, how harmful they are, and how methadone diversion compares with the diversion of other drugs. This section offers information from a variety of data sources as a preliminary answer to that question. Drug Abuse Warning Network Data One of the main sources relied upon by DEA to document the extent of diversion is the methadone "mentions" in the Drug Abuse Warning Network (DAWN). Specifically, DAWN data consist of reports of "methadone-related deaths" from medical examiners. In addition to "mentions" however, DAWN data also include other emergency room data. A discussion of methadone toxicity and toxicology will help place the following discussion of DAWN and methadone-related deaths in context (see Barrett et al., 1993; Gottschalk et al., 1977; Karch, 1993). With typical maintenance dosing, methadone has a half-life of about 24 hours. As with all opiates, toxicity is thought to be the result of respiratory depression due to decreased sensitivity of the brain's respiratory center to the stimulatory effect of carbon dioxide. There is, however, no clear definition of what constitutes a toxic or fatal blood methadone level. One reason for the difficulty of determining a toxic blood methadone level is drug interaction. A given blood methadone level may or may not be toxic depending on the presence of other drugs, which may augment or counteract any toxic effects of methadone. Another factor that complicates establishing a toxic methadone level is individual variability in susceptibility to methadone's effects. Opiate tolerance is a major determinant of this variability. As opiate users develop tolerance, they need progressively higher doses to achieve the desired effect. The rate at

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--> which tolerance develops depends in part on the pattern of use. Some patients who are highly tolerant to methadone suffer no toxic effects at blood methadone levels that would be toxic to a person lacking tolerance. Therefore, because of the phenomena of drug interactions and tolerance, considerable overlap exists between therapeutic and toxic blood methadone levels. One cannot rely solely on blood methadone levels to determine if methadone toxicity is the cause of death. The main implication of this discussion is that existing medical examiner data, as reflected in DAWN, most likely overcount the number of drug-related deaths in DAWN reporting cities that can be attributed solely to methadone or to which methadone would be contributing. The difficulty in accurately interpreting DAWN medical examiner data is highlighted by two surveys conducted by Gottschalk and his colleagues (Gottschalk et al., 1979; Gottschalk and Cravey, 1980) of psychoactive drug-involved deaths in medical examiner and coroner offices in nine large cities. The first survey reviewed 2,000 deaths that occurred between 1972 and 1974; the second examined 1,004 deaths that occurred during the first eight months of 1975. Both surveys showed clearly defined differences in toxicological findings between different cities. In the second survey, for instance, methadone was detected in 52 percent of the cases reported in New York—more than three times the percentage of the next highest city. Wide intercity differences were also found in the rank order of drugs as to the cause of death. In New York, methadone was ranked as the primary cause of death in 47 percent of all cases. In other reporting centers, the percentage ranged from 0 percent to 11 percent. In attempting to account for these disparities, Gottschalk and his colleagues found significant differences in the toxicological examinations performed by laboratories at different regional offices. Moreover, they found that even when the toxicological results were the same in different offices, the interpretation of those results often differed. The investigators concluded that intercity differences in methadone-detected deaths were "largely artifactual and not true differences representative of epidemiological characteristics. Rather, these differences are representative of instrumental or methodological sophistication and/or personal or departmental emphasis. Until these interlaboratory differences can be further delineated and corrected, the epidemiological characteristics of psychoactive drug-involved deaths must be cautiously interpreted" (Gottschalk and Cravey, 1980, p. 56). A final point regarding methadone-involved deaths. The number of decedents who have methadone in their body is a direct function of the number of people who are enrolled in methadone treatment. As the number of methadone patients increases, so will the number of deaths in which methadone is detected. If all heroin addicts were enrolled in methadone and other

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--> types of treatment programs and if these treatment programs were successful in greatly reducing, if not eliminating, heroin use, then long-acting methadone would be detected in virtually all deaths involving opiates (Wright, 1992). This is why any sophisticated analysis of methadone's involvement in drug-related deaths (or in emergency room mentions) should include the treatment status of the decedent. Unfortunately, such information is not usually available. Harris County, Texas An opportunity to look behind the meaning of the oft-used term "methadone-related death" was afforded by a series of drug-related deaths in Harris County, Texas, in 1991. These deaths were widely publicized in the Houston Chronicle at the time and, on February 21, 1993, received nation-wide television attention on the CBS News program "60 Minutes." The Centers for Disease Control (CDC) was asked to investigate (for the background to the CDC investigation, see the chapter appendix). The CDC investigators restricted themselves to examining the Harris County medical examiner cases on decedents who tested positive for methadone on postmortem drug testing (methadone-detected deaths) from January 1, 1987, through December 31, 1992. They analyzed data from four sources: Harris County medical examiner data, methadone maintenance treatment data, review by three independent pathologists, and DAWN medical examiner data. Harris County Medical Examiner Data The investigators examined autopsy data on the 91 methadone-detected cases seen by the Harris County medical examiner from 1987 through 1992, of which 27 occurred in 1991. Cases were grouped by cause of death: toxicity, natural, and trauma. Of the 91 decedents, the CDC investigators found polydrug toxicity to be the most frequent primary cause of death, accounting for 37 percent of the deaths. The second most frequently cited cause was methadone toxicity, accounting for 12 percent. (In all, toxicity accounted for 59 percent of deaths; natural causes, 22 percent; and trauma, 19 percent). In addition, they found that the increase in methadone-detected deaths in 1990 and 1991 in Harris County reflected an increase in deaths due to polydrug use, rather than an increase in the frequency of methadone use alone.

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--> (also discussed in chapter 3).11 The following discussion summarizes the results for injection drug users with respect to questions asked about ''nonprescription methadone" (see Table 4-3). In an attempt to reflect possible differences in policy at the program or state level, results are also reported by U.S. census region. Overall, 27.3 percent of injection drug users said that they had used nonprescription methadone at some time in their life, and 3.6 percent had injected it.12 In the prior 6 months, 11.6 percent had used it, but only 2.0 percent used it regularly, twice a week or more. As can be seen from Table 4-3, use of street methadone was about twice as high in the Northeast as in other regions of the country. The "ever used" figures in Table 4-3 are considerably higher than those shown for the DUF results in Table 4-2. The difference is largely accounted for by the differences in the sample characteristics:The NADR subjects included in the above analysis were all injection drug users; by contrast, the DUF subjects were arrestees. The NADR sample includes a much higher percentage of hard-core, long-term drug users, who are more likely to have had experience with street methadone than the diverse subjects interviewed in DUF. However, even in this high drug use population, about 2 percent used street methadone twice a week or more. 11   Eligibility criteria for respondents were as follows: (1) 18 years or older for programs funded in 1987, and 13 years or older for programs funded in 1988; (2) injection of drugs in the past six months; and/or (3) sexual relations with an injection drug user within the past six months; and (4) not enrolled in treatment within the past 30 days. Using these criteria, respondents were classified as an injection drug user or as the sex partner of an injection drug user. (Since the former took precedence in client classification, none of the sex partners had injected drugs within the past six months). Participants were recruited mainly through community outreach in 5p sites. Most (80 percent) of the interviews were conducted in 1989 or 1990. Initial interviews were conducted with 43,443 injection drug users and with 9,791 sex partners. (The NADR public use data tape and documentation were provided by Richard Needle, Ph.D., M.P.H., Community Research Branch, National Institute on Drug Abuse. Thanks are due to Mel Widawski, Senior Statistician, UCLA Drug Abuse Research Center, for data analysis, and to Helen Cesare, Community Research Branch, National Institute on Drug Abuse, for reviewing the results of the analysis.) 12   Of these, 95 percent reported having ever used nonprescription methadone by noninjection and 13 percent by injection (the wording of the questionnaire accounts for the overlap in responses).

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--> TABLE 4-3 Percentage of Injection Drug Users Reporting Nonprescription Methadone Use in NADR Program Initial Interview, 1989–1990, by Region and in Total   Ever Used Used in Past 6 Months (Noninjection Only) U.S. Census Region Non-injection Injection Both Any <4 a Month Once a Week 2+ a Week Northeast 39.9 3.6 40.8 22.2 13.7 4.8 3.8 North Central 18.8 4.2 20.6 6.1 4.0 1.0 1.0 South 18.7 3.7 20.1 6.9 4.8 1.0 1.2 West 22.7 5.1 24.4 8.5 6.0 1.0 1.5 Puerto Rico 18.7 0.5 18.9 5.0 2.8 1.1 1.2 Total 26.0 3.6 27.3 11.6 7.5 2.1 2.0 NOTE: NADR = National AIDS Demonstration Research program. N = 43,443. How is Methadone Diverted? Potentially, methadone gets into the illicit market in various ways, including importation from other countries, clandestine domestic manufacture, thefts at various points in the manufacture and distribution system, excess physician dispensing, thefts by clinic staff, clinic patients' sales of their dosages, and theft of patients' take-home doses. The following discussion attempts to provide some indication of the importance of each of these. Estimates of the amount of methadone that is diverted per year are not available. Since most of the methadone diverted comes from patients, largely in the form of take-home doses, and since DEA does not prosecute street-level dealers, the agency makes no effort to determine the quantities of methadone diverted (A.L. Carter, DEA, personal communication, April 15, 1994). Such estimates would be useful in assessing the degree of harm that diverted methadone might be causing.

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--> Production and Distribution System DEA security and record-keeping requirements for schedule II drugs keep leakage of methadone from the production, distribution, and storage points to a minimum. In 1977, 18,000 methadone dosage units were reported stolen from in-transit vehicles, programs, or other sources; this represents sources less than 0.06 percent of the 31,000,000 dosage units dispensed in treatment programs (based on a standard dosage unit of 40 mg) (U.S. Congress, 1978). The rarity of thefts of substantial amounts of methadone has led federal drug enforcement officials to conclude that the traditional sources of illicit drugs—smuggling from other countries, domestic illicit manufacture, and distribution by organized crime—play little or no role in the marketing of street methadone. Sale by Patients: Who Sells and Why? Since 1974, when the Narcotic Addict Treatment Act of 1974 effectively ended indiscriminate script writing by physicians, the sale of methadone by program patients has been regarded as the main avenue by which methadone reaches the street market. To collect ethnographic data on street sale and use of methadone, in 1981–1982, Spunt et al. (1986) conducted a study of methadone diversion through interviews with 247 subjects drawn from three groups located in three northeastern states:patients in methadone treatment programs, current narcotic users not in treatment, and patients recently withdrawn from methadone. Additional data came from observations by research staff and informal interviews conducted at the programs and in the surrounding areas. The study provided information on two main questions:Who sells diverted methadone? Who buys diverted methadone? Spunt and his colleagues found that program staff accounted for a very small amount of the diverted methadone, partly because DEA security and record-keeping requirements made such diversion very difficult. Procedures for delivering methadone from wholesalers to individual programs also made it unlikely that in-transit methadone was diverted to the street market in any significant quantity. Patients, according to Spunt, were found to be the main source of diverted methadone, through sales of either take-home medication or "spitbacks" (medication held in the mouth rather than swallowed and spit into a container after leaving the clinic). At the time the study was conducted, a take-home bottle of 50 mg cost between $15 and $25 on the street, with the price varying with the amount of methadone in the area, the day of the week, and program

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--> policy.13 The less desirable "spitbacks" cost less than take-home doses. Spitting back was more likely to occur at programs where take-home privileges were kept to a minimum, and where there were no other methadone programs nearby. While one-third of patients interviewed had sold their medication at least once, only 10 percent (23) did so regularly. The two most common reasons given by these regular diverters were to make money (often to buy other drugs) and to provide methadone to a spouse or a friend who needed it. Spunt and his colleagues concluded that regular diversion of methadone can be attributed to three main interrelated factors: (1) continued drug use (of heroin or other drugs) by patients, (2) the need to supplement income, and (3) the desire to share with or sell the diverted methadone to an addicted friend or spouse.14 Although there are a number of motives or reasons for selling or sharing methadone, and these may differ at different times for the same individual, the small number of people in this study who regularly sold methadone makes it difficult to determine the relative importance of the various motives among methadone diverters generally. Who Uses Diverted Methadone and Why? The study by Spunt and his colleagues (1986) also collected data on the characteristics of buyers of diverted methadone and why they used it. Most buyers of street methadone were heroin addicts who were either unwilling or unable to enter treatment. Over half of the sample of heroin users not currently in treatment reported that they used illicit methadone in the week before the interview, 60 percent of these to eliminate withdrawal symptoms, and the remainder to get "high." The researchers identified a number of reasons for using street methadone: To substitute for heroin when heroin supplies are low, when prices are high, or when it is inconvenient or difficult to contact a dealer; To avoid formal treatment when wishing to withdraw from heroin or to create an unsupervised program; 13   As an example of the effect of program policy, in one city illicit supplies of methadone increased when a program dismissed many of its maintenance patients for nonpayment of fees. Presumably, this group increased demand for illegal methadone. 14   To the reasons identified by the Spunt study, may be added another: In any area where patients must pay for treatment, they may sell methadone to help pay for treatment (Rosenbaum, Murphy, & Beck, 1987).

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--> To experience the euphoric effects of methadone;15 To supplement the methadone prescribed by the program, either to eliminate withdrawal symptoms resulting from an inadequate dose of methadone or to experience euphoria from "double dosing." There is some reason to believe that those who supplement their prescribed doses of methadone do so because the low doses provided by some programs as a matter of policy do not "hold" them for 24 hours. Thus, such programs may encourage a street market for methadone among their patients. While the current movement toward more adequate dosing practices may help to reduce this factor in diversion, it may also enable patients who find the low doses sufficient to divert part of their prescribed doses. From the results of this study, as well as earlier studies, it appears that street methadone is more often used by heroin addicts and methadone-maintained patients as a form of self-medication than to produce euphoria (to get high). Consequences of Methadone Diversion The consequences of methadone diversion fall into two broad areas:public safety and public health. Public Safety Issues The sale or distribution of methadone outside of the closed system of registered manufacturers, wholesalers, hospitals, pharmacies, and programs is illegal. The public has a right to expect that federal agencies will enforce the provisions of the Controlled Substances Act and its implementing regulations. There is no information on the degree to which methadone is implicated in drug-related crime or how much police effort is devoted to the prevention of its diversion. The lack of such information suggests that diverted methadone plays a small part in the overall drug-crime problem and receives a low priority in law enforcement efforts. 15   For 13 percent of the narcotic addicts in the Spunt study not in treatment (n = 142), methadone was the main drug taken for its euphoric effect.

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--> Public Health Issues Is Diverted Methadone Dangerous? To what extent, and under what circumstances, does methadone cause or contribute to death and morbidity? In assessing the meaning of "methadone-related death," as noted above, it is important to determine whether methadone detected in the decedent was taken during treatment or obtained on the street. It is also important to know the cause of death. Is death due to an overdose of methadone or to some other cause having little or nothing to do with methadone? And do drug overdose deaths in which methadone is present generally involve simultaneous toxic levels of other drugs? If drugs other than methadone are detected in a overdose case, how is the contribution, if any, of methadone determined? We noted earlier that there is no strong evidence that methadone plays an important role in drug-related deaths or emergency hospital care. Because methadone is taken orally in the vast majority of cases (96 percent), it does not expose users to the hazards consequent on injection with nonsterile needles, which play such an important role in heroin's contribution to disease and death. However, diverted methadone would be expected to have the same adverse side effects as does clinic-dispensed methadone (see chapter 2). DEA argues that the income from street methadone is used to purchase other illicit drugs. If these other drugs are then injected, the risk to the public health is increased. Data to support this argument are not available. Indeed, in the absence of reliable data, it is impossible to arrive at a clear assessment of any potential public effects of diverted methadone. At the very least, the extent and consequences of methadone diversion need to be considered carefully in any assessment of the public health benefits and risks of diversion. Is Diverted Methadone a Major Drug of Abuse? The data presented above from DAWN, DUF, and other sources indicate that while methadone has some potential for abuse when diverted from normal channels, the extent of the abuse associated with diverted methadone is small relative to heroin and cocaine. While methadone has a high addiction liability, instances of primary methadone addiction are few. Thus, while some street methadone is abused, it constitutes a relatively small part of the drug abuse problem generally.

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--> Summary DEA and FDA regulations and their implementation reduced the methadone diversion that existed in the early 1970s. In addition, clinical practices and procedures have contributed to keeping methadone diversion at a low level. Although practices vary from clinic to clinic, the following are in common use:(1) Upon entry of patients to treatment, counselors discuss, among other things, dosing procedures, take-home polices, and procedures for dealing with diverting methadone; (2) regular clinic patients present an identification card that indicates program enrollment; (3) the methadone dose is diluted with water and patients are required to drink all of it, which makes it difficult to retain in the mouth; (4) patients take their methadone dose under observation and the nurse asks the patient to speak afterwards, which discourages "spitbacks"; (5) cups or other containers are not allowed in the dosing area; (6) waiting and dispensing areas are separated, which helps the monitoring of medication ingestion; (7) patients receiving take-home doses are required to return with empty bottles, and clinics may make random calls to ask that all issued bottles (empty and filled) be brought in for inspection; (8) urine samples are tested for the presence of the methadone metabolite, which discourages diversion by those with take-home doses; and (9) any patient observed, or otherwise known to be, selling methadone is subject to clinic disciplinary action, including a fair hearing, but which may involve discharge from the program. However, as long as patients are allowed to take weekend doses home, and as long as programs reward long-term compliance with program rules with greater take-home privileges, there is a potential for patient-initiated diversion. Even without "take-homes," some patients would continue to pretend to swallow a dose in the clinic but manage to save it and expel it for sale after they leave the premises. Other potential sources of diverted methadone are thefts, hijackings, and robberies at the various distribution points. The evidence reviewed above, however, indicates that the amount of methadone diverted to the street, through whatever means, is relatively small. What happens to diverted methadone? Methadone has rarely been the preferred drug of abuse by users of illegal drugs. Its action is too slow, and the level of euphoria it provides, particularly when taken orally, is too mild for most drug users to select it over other opiates. Rather, it has mainly served as a way to avoid or end withdrawal symptoms, as a form of self-treatment for heroin addiction, or as a substitute for heroin or other opiates when they are in short supply. How much medical harm does diverted methadone do? Although methadone has the potential to cause death in individuals who lack tolerance to it or opiates in general, its use primarily by individuals who are dependent

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--> on, and tolerant to, opiates results in minimal medical harm. Although the risk of medical harm of street methadone is greatest for nontolerant persons, the number of cases in which methadone has been documented as the sole direct cause of death is very small. Chapter one reviewed the evidence on the effectiveness of methadone maintenance treatment. Briefly, research conducted over the past 30 years has indicated positive outcomes from methadone maintenance, including reductions in illicit opiate use, in criminal activity, and in risk of disease, death, and HIV transmission, and increases in socially productive activities. These beneficial outcomes have been obtained despite the highly restrictive regulatory environment, primarily to control methadone diversion. In the main, the committee concludes, on the basis of the available data and the experience of its clinician and researcher members, that should FDA regulations be changed in the ways recommended in chapter 7, the potential increase in methadone diversion would be small because of its intrinsic lack of attractiveness compared with other drugs of abuse. This belief rests on limited data and thus the committee recommends careful monitoring of effects of the suggested changes with a plan to act quickly to reinstate restrictions if diversion becomes a major health problem. Further, the committee concludes that the risks to the public safety and the public health of diverted methadone do not outweigh the benefits of making methadone treatment more readily available. Finally, the approval, in 1993, of LAAM for the treatment of opiate addiction by the FDA is related to the issue of diversion. Owing to its long duration of action, patients only need to take LAAM three times a week rather than every day. In addition, LAAM's slow onset of action virtually eliminates the possibility of getting ''high," thus greatly reducing its demand on the street as a drug of abuse. FDA regulations for LAAM, which now form a section of the original methadone regulations (as described in chapter 5), do not allow for any take-homes doses. As the use of LAAM becomes more common in the treatment of opiate addiction, there may be a reduction in the number of patients receiving methadone (assuming no significant increase in funding for opiate agonist pharmacotherapy), with a corresponding decrease in methadone diversion. At the same time, concern for methadone diversion may have influenced FDA's decision to prohibit LAAM take-homes, even though LAAM has advantages as a take-home medication in terms of its lower diversion risk and abuse potential.

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--> Appendix Harris County, Texas A Centers for Disease Control (CDC) investigation was prompted by events in Harris County, Texas. In 1991, a reported rise in the number of methadone-related deaths in Harris County led to increased scrutiny by authorities over local methadone treatment programs. Most methadone treatment programs in Houston and the surrounding areas are private, and for-profit, having been developed to fill the void left when local government abandoned the service delivery of methadone treatment. Federal regulators began investigating the claim that methadone-related deaths were occurring from illicit methadone originating from poorly monitored methadone treatment programs. Liberal methadone take-home policies were blamed for creating a situation where addicts could sell their surplus methadone on the black market. These problems prompted a six-month joint investigation by DEA, FDA, and the Texas Department of Health. In March 1992, acting on the basis of an undercover purchase of illicit methadone, DEA ordered a privately owned, for-profit methadone clinic in Houston to show cause why its license to dispense methadone should not be suspended. The clinic was closed and this closure was soon followed by similar orders to close two more clinics—all three owned by the same person. DEA orders to close these three clinics were described in a series of articles by the Houston Chronicle (e.g., "Methadone Clinic Shut in Raid Here," March 19, 1992, and "2d Methadone Facility Shuts Down," April 10, 1992), which were distributed over the national wire services and publicized widely. The articles also reported, quite inaccurately, that methadone was killing nearly twice as many people in the Houston area as was heroin, which was attributed to poorly run methadone clinics. In November 1992, prompted by reports of an increase in the number of methadone-related deaths in Harris County in 1991, the Texas Department of Health and the Interagency Methadone Policy Review Board, a committee composed of representatives from all federal agencies involved in oversight of methadone treatment, invited the CDC to investigate the deaths in Harris County. The CDC investigation was the most careful and comprehensive of recent investigations into methadone-related deaths. The incidents in Texas (but not including the CDC investigation, which was then in progress) received nationwide television attention on February 21, 1993, when CBS News, on "60 Minutes," broadcast a segment entitled "Just Say Yes." In this segment, "60 Minutes" focused on DEA-enforced closures of the three Houston methadone maintenance clinics and stressed the public and political opposition to methadone maintenance treatment. The ''60 Minute''

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--> report focused on the Houston controversy, arguing that when methadone treatment of Heroin addicts became a for-profit, money-making business, the emphasis shifted from detoxification to maintenance. References Barrett, DH, Luk, AJ, Parrish, G, and Jones, TS. 1993. Medical examiner cases in which methadone was detected, Harris County, Texas, 1987–1992 . Unpublished report. Atlanta, Centers for Disease Control and Prevention. Chambers, CD, and Bergen, JJ. 1973. Self-administered methadone supplementation. In: C. D. Chambers and L. Brill (eds.), Methadone: Experiences and Issues. New York: Behavioral Publications. Pp. 131–142. Chambers, CD, and Inciardi, JA. 1972. An empirical assessment of the availability of illicit methadone. In: Proceedings, Fourth National Conference on Methadone Treatment, San Francisco, January 8–10. Pp. 149–151. Courtwright, DT. 1992. A century of American narcotic policy. In: D. R. Gerstein and H. J. Harwood (eds.), Treating Drug Problems. Vol. 2. Washington, D.C.: National Academy Press. Pp. 1–62). Dole, VP, and Nyswander, M. 1965. A medical treatment for diacetylmorphine (heroin) addiction. Journal of the American Medical Association 193:80–84 General Accounting Office. 1976. More Effective Action Needed to Control Abuse and Diversion in Methadone Treatment Programs: Food and Drug Administration, Department of Health, Education and Welfare, Drug Enforcement Administration, Department of Justice. GGD-76–51. Washington, D.C.: Government Printing Office. General Accounting Office. 1990. Methadone Maintenance: Some Treatment Programs Are Not Effective. HRD-90–104. Washington, D.C.: U.S. Government Printing Office. Gottschalk, LA, McGuire, FL, Dinovo, EC, Birch, H, and Heiser, JF. 1977. Guide to the Investigation and Reporting of Drug-Abuse Deaths . DHEW Publication No. (ADM) 77–386. Rockville, Md.: National Institute on Drug Abuse. Gottschalk, LA, McGuire, FL, Heiser, JF, Dinovo, EC, and Birch, H. 1979. Drug Abuse Deaths in Nine Cities: A Survey Report. NIDA Research Monograph 29, Rockville, Md. Gottschalk, LA, and Cravey, RH. 1980. Toxicological and Pathological Studies on Psychoactive Drug-Involved Deaths. Davis, Calif.: Biomedical Publications. Inciardi, JA. 1977. Methadone Diversion: Experiences and Issues. Rockville, Md.: National Institute on Drug Abuse. Karch, S. 1993. The Pathology of Drug Abuse. Boca Raton, Fla.: CRC Press. Martin, JM, Quinn, TM, and Bonacum, WT. 1975. Methadone diversion II: A second study in five cities. Unpublished manuscript. Bronx, N.Y.: Fordham University, Institute for Social Research. Martin, JM, Quinn, TM, and McCahey, JP. 1973. Methadone Diversion: A Study in Five Cities. Rockville: National Institute on Drug Abuse. Musto, DF. 1987. The American Disease: Origins of Narcotic Control . (Expanded edition.) New York: Oxford University Press.

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--> National Institute on Drug Abuse. 1977. Drug Watch: July 1977. DHEW Publication No. (ADM) 77–503. Rockville, Md.: NIDA. National Institute on Drug Abuse. 1989. NIDA's methadone diversion field investigation, October 3–4, 1989. Unpublished report (October 6). Project DAWN III. 1976. Washington, D.C.: Drug Enforcement Administration and National Institute of Drug Abuse. Rosenbaum, M, Murphy, S, and Beck, J. 1987. Money for methadone: Preliminary findings from a study of Alameda County's new maintenance policy. Journal of Psychoactive Drugs 19(1):13–19. Sapira, JD, Ball, JC, and Cottrell, ES. 1973. Methadone as a primary drug of addiction. In: C. D. Chambers and L. Brill (eds.), Methadone: Experiences and Issues. New York: Behavioral Publications. Pp. 87–93. Spunt, B, Hunt, D, Lipton, DS, and Goldsmith, DS. 1986. Methadone diversion: A new look. Journal of Drug Issues 18(4):569–583. Stephens, RC, and Weppner, RS. 1973a. Legal and illegal use of methadone: One year later. American Journal of Psychiatry 130(12):1391–1394. Stephens, RC, and Weppner, RS. 1973b. Patterns of "cheating" among methadone maintenance patients. Drug Forum, 2(4):357–366. U.S. House of Representative. 1973. Committee on Interstate and Foreign Commerce. Subcommittee on Public Health and Environment (1973). Regulation of Methadone and Other Narcotic Drugs in Treatment Programs. Hearings, June 18 and 27, 1973. 93rd Cong., 1st sess. (Serial No. 93-29) U.S. Senate. 1973c. Committee on the Judiciary. Subcommittee to Investigate Juvenile Delinquency. Methadone Use and Abuse: 1972–1973. Hearings, November 14 and 16, 1972; February 8, 13, and 14, and April 5, 1973. 92nd Cong., 2nd sess., and 93rd Cong., 1st sess. U.S. Senate. 1973b. Committee on the Judiciary. Methadone Diversion Control Act of 1973. 93rd Cong., 1st sess. June 4, 1973. (Report 93-192) U.S. House of Representatives. 1978. Select Committee on Narcotics Abuse and Control. Methadone Diversion:A Report. 95th Cong., 2nd sess. (SCNAC-95-2-17) U.S. House of Representatives. 1989. Select Committee on Narcotics Abuse and Control. Efficacy of Drug Abuse Treatment Programs. Hearings, July 25, August 2, 1989. 101st Cong., 1st sess. U.S. House of Representatives. 1990. Select Committee on Narcotics Abuse and Control. 1990. Hearing on Methadone Treatment and Drug Addiction . March 23, 1990. 101st Cong., 2nd sess. (SCNAC-101-2-7) Walter, PV, Sheridan, BK, and Chambers, CD. 1973. Methadone diversion: A study in illicit availability. In C. D. Chambers and L. Brill (eds.), Methadone: Experiences and Issues. New York: Behavioral Publications. Pp. 171–176. Weppner, RS, and Stephens, RC. 1973. The illicit use and diversion of methadone on the street as related by hospitalized addicts. Journal of Drug Issues 3:42–47. Weppner, RS, Stephens, RC, and Conrad, HT. 1972. Methadone: Some aspects of its legal and illegal use. American Journal of Psychiatry 129:111–115. Wright, C. 1992. Medical Officer Briefing Package: The Houston Methadone Outbreak. Rockville, Md.: Food and Drug Administration.