A.T.F. Volume IX #3 Summer 2000

Clinical Notes - MMT Accreditation: Hard Work Ahead
MMT & Beyond - Shifting Paradigms & Slippery Slopes
Events to Note

From the Editor: Patient? Client? Who are we talking about?
Brainstorm: Addiction and the Duress of Stress Part 5

Reader Survey Results - Addiction Treatment & Sexual Disorders

Clinical Concepts - MMT Accreditation: Hard Work Ahead

Revolutionary Changes

In July 1999, a document was entered into the Federal Register (Vol. 64, No. 140, pp 39810-39857) that could bring revolutionary changes to methadone maintenance treatment (MMT) programs in the US. With the ominously lengthy title, “Narcotic Drugs in Maintenance and Detoxification Treatment of Narcotic Dependence; Repeal of Current Regulations and Proposal to Adopt New Regulations,” the proposed rule includes the repeal of existing regulations enforced by the Food and Drug Administration (FDA), the creation of a new regulatory system based on an accreditation model, and a transfer of administration and regulatory oversight to the Substance Abuse and Mental Health Services Administration (SAMHSA).

Team Approach

The proposed rule reflected recommendations from a 1995 report by the Institute of Medicine, as well as from other entities, to improve MMT programs by allowing for increased clinical judgment in treatment, with a focus on patient care. Although that concept was warmly received by the methadone treatment community, there was some trepidation as to what the accreditation process would entail. Perhaps, rightly so.

According to the Federal Register, there are about 900 opioid treatment programs (OTPs) in the US (also referred to as NTPs or narcotic treatment programs, or MMT programs in this publication since methadone is still the primary medication employed). As part of an orderly transition from the current regulatory approach to the proposed accreditation/ regulatory approach, SAMHSA’s Center for Substance Abuse Treatment (CSAT) developed an ongoing pilot study of an initial cohort of randomly selected MMT programs.

This pilot study was expected to take several years, since it would involve assessing programs prior to the accreditation process, the accreditation survey itself, and follow-up examinations to see if treatment improved as a result. Some programs would serve as controls, providing baseline information but not undergoing the whole accreditation process.

Several organizations are involved in the pilot study. The Research Triangle Institute (RTI) in Raleigh/Durham, NC is conducting assessments from a research perspective. Johnson, Bassin & Shaw (JBS) of Silver Spring, MD has been contracted to provide technical assistance, helping MMT programs prepare for the accreditation survey.

One of two organizations will do the actual surveying and accreditation of MMTPs. CARF (Commission on Accreditation of Rehabilitation Facilities), Tucson, AZ, is a private, not-for-profit organization resulting from the melding of 2 rehabilitation associations in 1966. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO), Chicago, IL, also an independent, not-for-profit organization, was founded in 1951.

Eventually, each state will be able to chose which organization — CARF or JCAHO — they want to serve as the accrediting body. Or, those states with a large number of MMTPs can choose to serve as their own accrediting agency. Final details are yet to be elucidated.

Devil In Details

Three of the 9 MMT programs sponsored by the Division of Substance Abuse, Albert Einstein College of Medicine, Bronx, NY, are in the midst of the CARF accreditation process. According to Ira J. Marion, Executive Director and Program Sponsor, the 3 clinics were “mock surveyed” last spring. “In May, we started preparing in earnest for the actual site survey by CARF, which is scheduled for the end of this September. We created an oversight committee and have had the equivalent of 2 full-time staff working on this project,” he notes.

Marion likes the very strong patient-oriented focus of accreditation. “For example, you must meet with patients to determine their satisfaction levels and needs, and all policies must be communicated to them. You also must have organized activities that reduce stigma surrounding treatment.”

Accreditation is also good for the staff. “It forces clinic management to clearly communicate duties, responsibilities, and expectations via staff training and development programs,” he observes. “And, employees must receive ongoing feedback on their performance.”

However, Marion and his team discovered that the “devil is in the details.” Although the Albert Einstein program is among the largest in the world, serving 3400 patients, they still had to write numerous new policies and procedures. “Some didn’t exist and others needed special wording to comply with CARF criteria,” Marion recalls.

There have been concerns about the costs of accreditation and, as Marion learned, it can be an expensive process. “Some believe a full-time employee will be required just to track the quality assurance and improvement processes on an ongoing basis,” he says. And, some tasks may be daunting, such as the requirement to collect post-discharge information on at least 10% of persons who leave the program. Yet, this is a population that is very difficult to track over time once they are discharged.

Marion believes that once the final rule is promulgated, the accreditation process could cost an MMT program as much as $10,000 for the survey alone, including the CARF or JCAHO fees and survey preparation costs. Added to that are ongoing costs of maintaining accreditation, such as for a quality assurance manager.

Work In Progress

According to Marion, who also serves on government committees overseeing the accreditation project, there are several potential outcomes of the accreditation survey process. An MMT program may receive a 3-year accreditation, which is most desirable, or only 1-year accreditation and have to repeat the whole process within a fairly short period. Or, a program might be given a 3-month abeyance to correct deficiencies prior to a second survey, in lieu of failing accreditation completely.

Marion observes that writing all the policies and procedures is just the beginning, and it could prove to be a monumental effort for some clinics. He feels that the documentation process would have been much easier had there been already-prepared manuals — a compendium of written materials or “boilerplate” that meet CARF requirements — that could be adapted and customized to individual clinic situations. CARF has a series of guides available for $245 (see Web site listed below), but these do not provide such policies and procedures.

However, there is much more to accreditation. Surveyors also talk to staff and patients to make certain that what is in writing is communicated and put into practice. For example, staff might be asked if they know what the program’s mission statement is; patients might be asked if they are aware of their personalized treatment plans.

At Einstein, considerable effort also was devoted to presenting their program to site surveyors. They developed a slide program to communicate the most information in the shortest possible time. It highlights the history of their program, current organizational structure, service offerings, changes over recent years, demographics of employees and patients, and much more.

In sum, Marion believes the accreditation process is still a “work in progress” and some aspects may need change or refinement. It could be challenging for some clinics but, overall, it should benefit the opioid addiction treatment field and, especially, improve patient care.

Ready In Texas

In Texas, Bobby Glass agrees with Marion that the switch in oversight from the FDA to CSAT, and accreditation, will be good for MMT patients. He is president of Addiction Medicine Associates Inc. and program sponsor of the Brentwood Stair Clinic in Fort Worth, serving 427 patients. His clinic is part of the control group of MMTs being assessed by the RTI, but not undergoing the accreditation survey at this time.

He believes that, in Texas, clinics already have fairly well-developed written policies and procedures as mandated by state authorities. “I doubt that my clinics [he has a second clinic in Denton] will have to make many changes. We have good documentation, good counselors, and good patient care treating everyone with dignity and respect.”

Still, Glass expects that under an accreditation system he might have to hire an additional person, possibly just to audit charts. “That’s not necessarily a bad thing,” he says, “although accreditation will probably create more paperwork.”

However, Glass suspects that many clinics in other locales may not operate under the tight regulation found in Texas. “Some of the records I see of patients transferring to us from other states are not in very good shape,” he observes.

Worth The Effort

Glass feels some aspects of the proposed rule may need modification. For example, it will be good if patients can qualify for 6-day take-home doses after only the first year in treatment, but he feels that eventually giving up to 30 days of take-homes is concerning. “Patients might be tempted to abuse that privilege by self-medicating with extra doses if they are in pain or become ill,” he says.

He noted that Texas clinics will have the option of deciding whether CARF or JCAHO would be selected as their accrediting organization. He estimated it could cost up to $8,200 just for the accreditation process, not including added staff and administrative time or costs of improvements.

“If this accreditation process brings the deficient clinics — those that give MMT a bad name — up to higher standards, then I’m all for it,” he stresses. “Even if it does take a bit more money and effort.” Glass concedes, however, that the added costs of accreditation, improvements, and ongoing administration may need to be passed on to patients or their insurance providers.

For more information on the accreditation process, visit the following Web sites: CARF: www.carf.org/BehavioralHealth/ OpioidTreatment.htm JCAHO : www.jcaho.org/standard/ bhc_supp/bhc_frm.html.

MMT & Beyond - Shifting Paradigms & Slippery Slopes

Cautious Optimism

“Heroin’s New Fix,” hyped the headline of a story last May 31st in USA Today,[1] the highest daily circulation newspaper in the country. The lead paragraph proclaimed, “Scientists are ready to usher in a generation of anti-addiction drugs that could significantly improve the prognosis for the nation’s 1 million heroin addicts.” And, NIDA director Alan Leshner declared, “This could be the biggest advance in the last 10 years. We’re very optimistic.”

Although such articles promoting the benefits of addiction treatment make positive contributions to public perception, certain aspects of this story also might temper optimism with caution.

The USA Today article by Donna Leinwand accurately described three emerging paradigm shifts in the field of opioid-addiction treatment:

• Accreditation of methadone maintenance treatment (MMT) programs resulting in less regulation, more reliance on clinical judgment, and greater accountability for outcomes;

• A new focus on office-based opioid treatment (OBOT, or medical maintenance), which officials hope will better serve a new generation of addicts;

• New medications – buprenorphine, a combination buprenorphine/naloxone, and a long-lasting naltrexone formulation – are being advocated as “superior, less-addictive alternatives to methadone” and welcome additions to the clinician’s toolbox.

The new treatment approaches and new medications may prove effective. However, there is still the question: Will the stigma, biases, and deficiencies that have unjustly haunted MMT programs for years be perpetuated and passed on to the newer therapies and a new generation of treatment providers?

MMT Bashing?

The USA Today article may portend slippery slopes ahead for MMT. It stated that, although MMT programs have been around since the 1970s, “[these] have had only moderate success.” Furthermore, “Scientists and health officials say the new drugs could diminish methadone’s role as well as that of clinics.”

The author pointed to a study published in the Journal of the American Medical Association reporting that half of patients in a San Francisco MMT had used illicit opioid drugs at least monthly while in treatment. “Scientists called the finding ‘not encouraging,’” Leinwand wrote.

The study in question, by Sees et al published March 8, 2000 in JAMA,[2] was designed to compare the outcomes of opioid addicts in MMT versus a psychosocially enriched 180-day methadone-assisted detoxification program (M180). It should be noted that the researchers’ conclusions favored MMT as more useful than detox in reducing heroin use and HIV risk behaviors. However, this study appears to symbolize how many clinicians still see detoxification as the goal of treatment and seek to prove its benefits over long-term methadone.

Also, in many other ways, this study epitomizes the limitations of research investigating MMT over the years. Of particular concern, continued heroin abuse – 50% or greater monthly use rates in this study – is not an unusual finding in clinical research on methadone.

Why does this occur? Several aspects of the Sees et al. study seem noteworthy:

• A maximum 14 months of treatment was allowed; either continuous MMT or psychosocial aftercare following detox. Knowing treatment was time-limited, the patients’ commitments to opioid abstinence must be questioned, and the authors noted that only 50% of the sample reported having a goal of total abstinence in the first place.

• There was an arbitrary dose ceiling of 100 mg/day, and both groups averaged roughly 85 mg/d. Is it possible that such doses were inadequate for half or more of the subjects, resulting in continued opioid abuse? Would methadone dose increases above 100 mg/d for the recalcitrant heroin abusers have resulted in greater abstinence rates?

• Considerable numbers of subjects had psychiatric diagnoses – depression, posttraumatic disorder, dysthymia, antisocial personality disorder – for which they were likely receiving psychoactive medications, and there was a high prevalence of alcohol and cocaine abuse. Such medications and drugs can interact with methadone metabolism, but this was not considered or discussed in the study.

• The attrition rate in the detox group was nearly twice that of the MMT group. Plus, heroin use escalated quickly in the detox (M180) group just as soon as methadone dose decreases began at 120 days as part of the detoxification process. In contrast, illicit opioid use in the MMT group remained relatively constant and appeared to decline toward the end of the study (See graph). Such results reaffirm the benefits of continuous methadone administration for moderating opioid abuse and better retention in treatment.

From Sees et al. 2000

• Neither treatment modality was effective in reducing cocaine use. As most past research has demonstrated, methadone is not a treatment for stimulant abuse.

The results of this study are not surprising. Five years earlier, Bell and colleagues [3] had reported that a time-limited abstinence-oriented treatment philosophy resulted in lower, inadequate methadone doses and higher rates of heroin abuse. They concluded that “in investigating the effects of treatment factors, the powerful influence of methadone dose needs to be taken into account.”

Where are the Standards?

Sees et al. [2] claimed the methadone doses in their study were “adequate by current practice standards,” but they did not reveal the source of those standards. A sampling of commentary from recently reported research studies suggests that standards still do not exist and current MMT practices may be inadequate.

In a study comparing 2 levels of methadone dose, Strain et al. [4] noted: “Despite methadone treatment’s extensive history, controversy regarding optimal dosing persists.” They observed that “no contemporary studies [that they knew of] have examined doses greater than 80 mg/d.” And, although their study had average “high” doses of nearly 90 mg/d, 53% of patients in that high-dose group still exhibited opioid-positive urine tests. The authors conceded that, “It is possible that dosages in excess of 100 mg/d may be required for optimal benefits in some patients.” But they also believed that “current federal regulations in the United States discourage methadone dosages greater than 100 mg/d.”

A study by Preston et al. [5] sought to improve MMT outcomes by providing vouchers for desired behavior, “since dose increases alone may not always be adequate or acceptable to clinic staff” [italics added]. A baseline methadone dose of 50 mg/d was chosen in this study because “it had been reported to be customary in more than half of the programs surveyed in 1988.” (However, it actually was noted in that survey by D’Aunno and Vaughn [6] that such doses were totally inadequate.) In one of the groups, a dose increase to 70 mg/d was allowed, but Preston et al. conceded that, “the methadone doses were modest and were not individualized… [which] may have contributed to high overall rates of opiate use….” Part of the rationale behind this study, the authors noted, was that there may be situations in which dose increases are “…impossible for regulatory or philosophical reasons” [italics added].

In a large prospective study of more than 1000 MMT patients by Magura et al.[7] high levels of heroin abuse persisted. And, despite limited methadone dose increases, the entire sample population averaged 52 mg/d (± 20 mg/d SD) and only 3% received 90 mg/d or more. The authors acknowledged that “it may be that such upward dosage adjustments [were] simply not high enough to achieve their aim.” This same group of researchers later acknowledged that “there are as yet no recognized standards and validated program quality variables in methadone treatment.”[8]

The “Science of Under-Medication”

It appears that, even after 35 years, MMT patient care standards are unsettled, and burdened by the specter of regulatory control and misdirected treatment philosophies. Certain trends seem evident:

1. Although past research has persistently and consistently reported the value of higher versus lower methadone doses, practically all studies have had maximum dose limits of 100 mg/day and average doses, even in “high dose” groups, have been substantially below that ceiling threshold.

2. Continued opioid abuse in patients – sometimes significantly high percentages – is a common finding in all studies, whether patients are on “high” or “low” doses. Because these studies set an upward limit on dose adjustment, optimum dose for possibly completely alleviating such recidivism is unknown.

3. Although most studies report high attrition rates, patients receiving higher methadone doses exhibit greater retention in treatment. Again, due to the upward limits on dose, it is impossible to know how retention might be maximized further via methadone dose.

4. Patient populations and the drug culture have changed over the years. Large numbers of patients in MMT today have comorbid physiologic and psychiatric disorders for which they are prescribed medications that may affect methadone metabolism. Heroin is purer and cheaper, leading to more dynamic drug dependency. Research studies typically do not account for such variables.

In all fairness, researchers have noted the deficiencies in their studies, as discussed above, but little has been done to remedy the situation. Consequently, much of the research to date might be characterized as defining the “science of methadone under-medication.”

Implications Beyond MMT

In the USA Today article,[1] buprenorphine was portrayed as “cutting-edge because it’s different from methadone,” according to Charles O’Brien, chief of psychiatry at the Philadelphia VA Medical Center. “You almost can’t overdose on heroin when you’re on buprenorphine,” he said. “It’s really been a huge success. People can function totally normally and be very alert if it’s properly dosed.”

“Properly dosed” is an important caveat in O’Brien’s statement, for therein may lie a tripwire at the slippery slope. The dosing question may eventually confound newer medications like buprenorphine – or methadone applied in private medical practice – just as it has MMT clinics to this day. And, reductions in federal control over methadone and the newer medications may have little impact if current stigma and biases cannot be overcome.

Upcoming articles in this “MMT & Beyond” series will examine critical questions more closely from evidence-based perspectives. Where did the 100 mg/d methadone dose ceiling come from? What can be learned from the very few studies that have exceeded that threshold? How might desirable addiction treatment outcomes be defined and maximized?

1. Leinwand D. Heroin’s new fix. USA Today. May 31, 2000

2. Sees KL, Delucchi KL, Masson C, et al. Methadone maintenance vs 180-day psychosocially enriched detoxification for treatment of opioid dependence. A randomized controlled trial. JAMA. 2000;283(10):1303-1310.

3. Bell J, Chan J, Kuk A. Investigating the influence of treatment philosophy on outcome of methadone maintenance. Addiction. 1995;90(6):823-830.

4. Strain EC, Bigelow GE, Liebson IA, Stitzer ML. Moderate- vs high-dose methadone in the treatment of opioid dependence. A randomized trial. JAMA. 1999;281(11):1000-1005.

5. Preseton KL, Umbricht A, Epstein DH. Methadone dose increase and abstinence reinforcement for treatment of continued heroin use during methadone maintenance. Arch Gen Psychiatry. 2000;57:395-404.

6. D’Aunno T, Vaughn TE. Variations in methadone treatment practices: results from a national study. JAMA. 1992;267:253-258.

7. Magura S, Kang S-Y, Nwakeze PC, Demsky S. Temporal patterns of heroin and cocaine use among methadone patients. Substance Use & Misuse. 1998;33(12):2441-2467.

8. Magura S, Nwakeze PC, Kang S-Y, Demsky S. Program quality effects on patient outcomes during methadone maintenance: a study of 17 clinics. Substance Use & Misuse. 1999;34(9):1299-1324. [Disclosure: This article was sponsored by an educational grant from Mallinckrodt Inc., a manufacturer of methadone.]

Events to Note

For additional postings & information, see: www.atforum.com

October 2000

National Alliance of Methadone Advocates Consumer Group; 3rd National Harm Reduction Conf.

October 21-25, 2000

Miami, FL

Contact Suzie Ko: 212-213-6376 x31

suzie@harmreduction.org

ASAM Review Course in Addn. Med.

October 26-28, 2000

Chicago, IL

Contact: 301-656-3920

email@asam.org

November 2000

Social Work 2000 Natl. Conf.

November 1-4, 2000

Baltimore, MD

Contact Jessica Berry: 703-739-4480

jberry@teamprecision.com