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Center for Alcohol and Addiction Studies

Effective Medical Treatment of Heroin Addiction in
Office-Based Practices with A Focus on
Methadone Maintenance

 November 6, 2000 at the New York Academy of Medicine, NY.

Present: Jeremiah Barondess, Craig Burridge, Holly Catania, Edmund Drew, Ernie Drucker, Michael Glet, Marc Gourevitch, Herman Joseph, David Fiellin, Spencer Foreman, David Lewis, Martin Livenstein, Robert Lubran, Ira Marion, Vince Marrone, John McCarthy, Laura McNicholas, Joseph Merrill, Robert Newman, June Osborn, Hermenia Palacio, Mark Parrino, Ed Salsitz, Robert Schwartz, Janet Stein, Ellen Tuchman, Peter Vanderkloot, David Vlahov, and staff: Avi Astor, Kathryn Cates-Wessel.

In hopes of capturing some of the historical perspective of office-based methadone maintenance practices, Dr. Lewis opened the meeting by asking Dr. Herman Joseph to summarize the work of New York OASAS programs as they have supported these models since 1983. Dr. Joseph provided an overview of their four models in operation in New YorkState: the hospital based physician model at Beth Israel, the Program Pharmacy Model at Albert Einstein College of Medicine, the Nurse Practitioner/Physician model in NassauCounty and recently the Suburban Medical Office Model located in the Buffalo area opened. In the very near future two additional models with new innovations of medical maintenance will be opened.

Dr. Joseph continued saying that the New York System also fosters the integration of methadone maintenance treatment in other treatment environments such as the alcohol treatment centers which have been renamed Addiction Treatment Centers (ATCs). These ATCs include on-site treatment of methadone patients with alcohol problems. Methadone is now dispensed within most of these facilities from the ATC pharmacies. This innovation was preceded by staff education since staff held strong anti-methadone attitudes.

Dr. Joseph discussed how methadone programs within the criminal justice system have remained resistant. In spite of the success of the well known Rikers Jail KEEP methadone program in New York City, they have not been able to expand statewide because of resistance by correctional staff. According to Dr. Joseph, the major resistances to expanding methadone are the misunderstandings, ignorance, and stigma associated with the treatment, the medication and the patients. He feels that education is an essential factor and that new innovations cannot be implemented without addressing community concerns, professional biases and ignorance. He also commented that with methadone patients, the stigma associated with methadone treatment is the major social problem they face.

Following Dr Joseph’s presentation, Dr Edwin Salsitz expanded on his experience at BethIsraelHospital’s ongoing 15-year program, which now has worked with about 300 patients.

The meeting then turned to the experience of a new generation of office-based practice programs to provide an overview of their work.

Presentation 1:  
D. Fiellin, Office-based Medical Maintenance in a Network of Primary Care Practitioners, Yale University

In this model 6 community practitioners are prescribing 46 patients using a medical maintenance model with monthly visits and weekly pickup from the practitioners’ offices.

Results: There was a very low percentage of patients that became clinically unstable during the six-month period of the program. Patient satisfaction with the medical maintenance was very high, and the majority expressed that, if given the option, they would prefer to receive methadone maintenance in their physicians’ offices. The benefits mentioned by patients expressing satisfaction with office-based treatment included: only having to come in three times a week, not having to be around “junkies,” increased privacy, enjoyment of relations with staff, convenience of location, and being treated in a more agreeable atmosphere. The dissatisfaction revolved around issues that all patients in the primary care clinic complain about (i.e. having to wait too long, having to come in too much, the parking situation, etc.). Most patients who showed concern during the program were concerned about returning to narcotic treatment centers rather than continuing with methadone maintenance. For a minority of patients, having to pick up medication in the doctor’s office would be problematic just as dispensing insulin in the office for many diabetics.  Overall, physicians and staff made a paradigm shift in their feelings/attitudes about dealing with and treating methadone patients.

In general, patients who experienced relapses felt comfortable speaking to clinicians about such episodes.These consultations provided opportunities for clinicians to strengthen their skills in dealing with relapse episodes.  In general, clinicians were extremely satisfied with the treatment model and did not feel as though methadone patients had more or less psychosocial issues than other patients.  Moreover, they did not take issue with on-site storage of methadone, except for the administrative requirement of having somebody from the DEA continually coming in to check records.   

Presentation 2: 
Joseph Merrill,  Methadone Treatment through an Outpatient Medial Clinic, Harborview Medical Center, University of Washington, Seattle

In this model, 31 stable methadone patients have been transferred to a unit of the Harborview Outpatient Medical Clinic, where they receive their methadone through a pharmacy unit located within the medical clinic that provides their primary medical care. This is a transitional Medical Maintenance model with weekly and bi-weekly pickup.

Results: In this medical model, methadone is distributed through a pharmacy unit, which keeps separate records for methadone patients.  Up to a one month supply of methadone is given to patients.  Patients also have the option of continuing with psychosocial services at narcotic treatment clinics. In this medical maintenance model, patients undergo transition gradually up to a one-month supply of take-home methadone.

Keeping two separate charts for purposes of confidentiality (i.e. separate methadone record because of extra privacy regulations), one for medical problems and another for methadone maintenance, has lead to complications as well.  If a patient comes in with a medical problem that might be related to methadone use, clinicians and patients are often confused as to where the information should be stored.  How should methadone information be segregated from medical information?  After all, one of the great strengths of the medical maintenance model is integrating medical, psychiatric, and substance abuse care.  However, separate charts split up these different forms of care, and thus defeat the purpose.  The solution might not lie in lowering the standards for confidentiality in methadone maintenance, but rather in raising the standards for all medical care.

One circumstance where the issue of confidentiality comes up is regarding insurance needs.  Patients may not want to release information about their use of methadone to insurance agencies, though they obviously need to release medical information.  In addition, you are forbidden to produce methadone records to respond to a subpoena in a methadone program, though you are required to respond in a medical setting.  However, clinicians in medical settings might not be forced to respond to a supine regarding records of methadone maintenance.  Nevertheless, they would be in an awkward situation as they might claim that federal regulations prohibit them from disclosing certain information, though they may not be able to claim why.  Clarifying these issues before the movement to private practice begins is of the utmost importance.

With regards to training, it is necessary for physicians to undergo a short program detailing the basics of methadone maintenance as well as what patients on methadone have gone through.  Physicians learned the most from talking to patients eligible for treatment.  Lastly, a source of mentorship or clinical support to which physicians may turn with patient-specific questions is key.  Such is the model for other clinical practices, so why not for methadone maintenance?

The goal of the program was to implement medical maintenance outside of the experimental context that prevented previous medical maintenance programs from being replicated widely. They were able to obtain regulatory approval from the FDA, DEA, Washington State and the Washington State Board of Pharmacy, and the FDA and CSAT have cited this program as a model for others wishing to use medical maintenance as a mechanism to improve quality and expand access to methadone treatment.

Overall, the patients feel that they lead a more productive life outside of treatment with some requesting decreases in their levels of methadone, but most patients requested increases (>100 mg) to require them coming in less often. Clinicians learned about treating this population with a noticeable decrease in stigma. Even with a one-year criterion of stability, there is a problem with only 10% qualifying – logistics from a policy and a treatment perspective have been very challenging. Medical Maintenance integrated with general medical care is challenging with overlapping and sometimes conflicting medical issues i.e. problem with insomnia.


• D. Lewis was interested in the training aspects for the clinicians – how much is needed and who should train?

• J. Merrill commented that training needed for physicians included one short session about methadone in addition to mentorship or clinical support to ensure patients get the right answers, highly recommending this as well. He felt overall it shouldn’t be very different from training for any other illness.

• J. Barondess asked if there were IRB issues? Any information about social support systems – effective or ineffective? Any data?

• J. Merrill – With regard to IRB we designed the program to be approved as a part of regular methadone treatment through Evergreen Treatment Services and Harborview Medical Center, not as an experimental trial. The program evaluation approved by the University of Washington IRB included only evaluation interviews with patients and physicians and not the treatment protocol themselves.

• M. Gourevitch suggested that he thought the model should be broadened integrating drug and other substance abuse charts with primary care treatment charts – keeping confidentiality of patient rights upheld.

There was quite a lot of discussion about the pros and cons of dual chart keeping –

• R. Newman – we don’t have dual charts in a hospital setting, as it is awkward to have different rules for methadone patients from all other patients.

• D. Fiellin – often patients request it since many of them pay for services out of their pockets to maintain their confidentiality.

• J. Barondess – under current rules – federal law prohibits the release of patient records without consent of the patients and there should be no difference related to methadone patients. What effect does the electronic format have on this?

• C. Burridge commented from the perspective of a practicing pharmacist that they’ve been maintaining electronic records for 5 years.

• S. Foreman mentioned their practice at Montefiore MedicalCenter was to have physicians log in to access patient records – it sets up barriers to penetrate this information. They audit these records periodically to determine if inappropriate log-ins have been made, etc.

• R. Lubran suggested that any guidance toward this issue related to confidentiality of patient rights would be extremely helpful for CSAT to be further informed.

• D. Fiellin – a major factor in this issue is stigma and this could be an important issue for the PLNDP to take on.

• I.Marion – PLNDP could also address insurance issues as patients pay for their own treatment, their employers should not have access to patient records.

• M. Parrino – FDA/CSAT allow every MTP access to medical maintenance treatment and every patient should be covered under patient confidentiality rights.

• D. Lewis commented that a working group should be developed from the meeting to discuss the need for broadening the expansion of treatment related to patient confidentiality rights.

Presentation 3:  
Ernest Drucker, Office-based Prescribing and Community Pharmacy Dispensing, Montefiore Medical Center / Albert Einstein College of Medicine (New York)

This is a randomized clinical trial comparing Office-based Practice to usual care in MMTPs. The subjects are 150 women stabilized in methadone treatment, and 15 primary care practitioners have been trained as new prescribers while the women continue to pick up methadone at their MMTP clinics. The first 3 years have demonstrated equivalence to MMTPs for treatment retention and rates of illicit drug use. The next 5 years of funding will incorporate dispensing through four community pharmacies in the Bronx and Manhattan.

Results: Most of their patients do not have primary care physicians of their own and it’s also one of the criteria for being in the program. They found that the key was not training as much as it was ongoing support for medical staff. He also commented that initially there was a little conflict or friction experienced between the prescribers and the MMTPs in the transition stage. He also found physicians willing to learn to deal with the addicted population and the issues around it in their daily practice. Over the next five years they hope to incorporate community pharmacies into the program. More recently he’s found that Pharmacists are becoming more a part of the medical profession once again, and are being integrated into care and treatment. E. Drucker also commented that he felt a need to establish Best Practice Standards and attempt to reverse the 75 years old problem of the medical profession not wanting to get involved in addiction treatment using maintenance drugs.

Stage One of this study involved recruiting physicians and patients to participate in the office-based treatment program.  In general, the doctors recruited were experienced in dealing with its population in their practices and open to learning more about methadone and to prescribing methadone. Patients were eager to find a way to manage their addictions outside of the methadone clinic. 

Stage Two involves laying out a framework to incorporate community pharmacies into treatment.  These pharmacists, unlike those in many large urban pharmacy chains, are a more constant figure who may get to know patients.  Integrating community pharmacies into care would also help to reestablish pharmacists as healthcare professionals and would provide a key partner in the effort to treat addiction at the local level. It is essential to facilitate communication between a patient’s doctor, pharmacist, and case manager if the new clinic model that we are proposing is to be effective.  We are working on a computerized system that would do just that.

Is there any rationale for including in a protocol that patients should return to the clinical setting if they show evidence of the disease for which they are being treated?  Sometimes it might be useful for a patient to return to a specialist if their clinicians feel that the private office is not providing adequate care.  This model of taking patients out of specialty treatment and placing them in primary care and possibly returning them to specialty treatment is a model with which doctors are already familiar – e.g. in psychiatric care. How do we determine patients’ needs in primary care settings, and how do we envision the connection between primary care and specialty care?  How will patients be moved back and forth between the two?  The challenge will be to match the level and intensity of services to the needs of the patient.

Recent legislation allows physicians to prescribe new drugs, like buprenorphine, without statutory or regulatory requirements for counseling. Methadone, has its own set of legal regulations that make it more difficult to prescribe.  It seems strange to base a patient’s need for counseling on the legal requirements surrounding the type of drug used rather than on the patient’s individual needs. However, this does not change the fact that buprenorphine would be easier to prescribe. There is a strong political desire to keep buprenorphine and methadone in separate legal camps, and this might have an impact on future addiction treatment.  Strong federal regulations on methadone and loose regulations on buprenorphine may lead physicians to prescribe the less satisfactory drugs. Buprenorphine does not reach high tolerance levels and might not be a satisfactory drug in many cases.  One role the PLNDP might play would be to look at the effect of legislation on the impact of methadone and buprenorphine distribution.

A broader and more pressing issue is that drug addiction continues to be treated separately from other diseases.  R. Newman: It is unheard of for Congress to control the number of patients seen with a given disease, the training that physicians might have, etc.  This recent Federal bill reinforces the stereotype that doctors cannot be trusted to treat addiction like other diseases.  With regard to the claim that drug addicts are too hard to handle, the same goes for patients with other diseases that suffer at the same time from psychosocial difficulties.  We cannot set a double standard for patients who are addicted to drugs and for those who suffer from other diseases.  Such action only reinforces the idea that addiction should not be treated in a similar manner to other chronic diseases.


• J. McCarthy inquired as to whether patients will go to hospitals for counseling?

• E. Drucker commented that there’s one MSW counselor/case manager for every 50 people (as NY state regulations require) and we propose to have the medical worker see patients at the pharmacy (which all have private consultation rooms) or at the site of the medical practice (networks of numerous clinics).

• C. Burridge added that in NY they are required to provide counseling and pharmacists are seen as an excellent resource for many referrals – 12 hours/day – 6 days/week.

• E. Drucker talked about the counseling requirement suggesting the need to go beyond the “watchdog” approach and serve as a case manager that coordinates care with the prescriber and pharmacy.

• R. Newman felt that it would be a concern for physicians to eliminate the counseling.

• I. Marion said that services are available that anyone in the program can access as they need guidance (anxious or depressed, etc.)

• L. McNicholas felt that we should move out of specialty treatment and more into primary care – invert the medical model. How much counseling is needed? Connect specialty care with primary care and determine what’s most appropriate for the patient.

• R. Schwartz added that the level of treatment services offered to patients should be based on their needs, much like with the treatment of depression. A newly admitted methadone patient might need more counseling services than a general primary care setting can offer. However, as patients progress, a physician’s office-based practice can manage more stable patients quite well. In addition, Dr. Van King of John Hopkins University is conducting a study in which patients from two methadone clinics in Baltimore, who have obtained at least one year of abstinence, are randomized to one of three conditions: treatment as usual, monthly physician visits and medication pick-up at a doctor's office, or monthly physician visits and medication pick-up at a methadone clinic. Preliminary results indicate that medical maintenance in either setting has high patient satisfaction, low urine positive rates and no detectable medication diversion. 

• R. Lubran mentioned pending approval of FDA for drug but deals with no standards – sponsoring of that bill viewed methadone different from other drugs – newer drugs seen as very safe in contrast to methadone.

• R. Newman commented that he felt it was irrational to have legislatures define a patient’s need for counseling or not.

• R. Lubran said that standards for methadone are different and are established by legislature.

• M. Parrino spoke about the recent Federal bill and they felt if methadone was mentioned it would stall approval of buprenorphrine. He also said that patients with co-morbidity (psychiatric plus addiction) do better with counseling but the issue is what level and degree of counseling is needed. On the subject of the length of patient stability in the hub MMTP, Parrino noted that, in general,  presenters indicated to him that the average length of pre-referral stability exceeded the 3-5 year range.

• D. Fiellin added that compared with diabetic patients their progress would improve with more counseling and that it’s an opportunity for primary care physicians and narcotics provided with buprenorphine and it’s office-based practice.

• J. Stein felt that it’s not always necessary to refer someone for specialty care but more as a resource for the healthcare professional vs. the patient

Presentation 4: 
Jack McCarthy, Director, Rural Network of Office-based Prescribers. BiValley MMTP and UC Davis, Sacramento Cal. (awaiting CSAT funding)

This program has recruited approximately 7 practitioners and 3 pharmacies in rural Shasta County in a network that will serve 130 patients.

Dr. McCarthy began by referencing SB1807 - OBOT Bill; the two main aspects of the bill are:  1) allows methadone programs to contract with physicians in rural agencies to provide for methadone patients in their clinic settings, and 2) mandates drug courts to accept methadone patients. 

Difficulty was encountered in rural counties where there was strong opposition to methadone programs, mainly resulting from the denial that a drug problem even exists. In some areas, the DEA opposed storage of methadone in patient offices, citing that such policy caused all sorts of trouble in the 1970’s.  However, they cooperated, and we received support from the National DEA, the California Bureau of Narcotics, and police and sheriff organizations, presumably because they were beginning to realize the importance of treatment. 

The program involves a dual record system.  The patient in the Narcotic Treatment Program will have to have a duplicate record of NTP services to prove that the methadone they are taking is legitimate.

The bill is geared to serve unstable patients, so intensive counseling services will be necessary.  Among physicians attending a course sponsored by the California Society of Addiction Medicine, there was a high interest in office-based treatment, so recruitment does not seem to pose a problem.  Buprenorphine may be a problem for patients that want methadone in that doctors will find it much easier to prescribe.   One difficulty will be distributing methadone on weekends, when offices are closed. Pharmacies may be able to make up for some of the problem, but the difficulty remains. 

Drug court judges opposed the proviso to make methadone accepted in drug courts, but the bill passed.  Criminal justice may interfere with treatment, and it is difficult in this new practice setting to counteract such interference.  In addition, the criminal justice system itself is a neglected place for opioid treatment. Methadone is not distributed in jails, mainly resulting from the fear that it will not be able to be controlled and from the lack of recognition of heroin addiction as a legitimate disease. The result is that detoxification is the "treatment" of choice.

Additional funding will be needed for research on outcomes.


• D. Lewis questioned if judges were against pharmacotherapy in general.

• J. McCarthy felt that judges, in general, promote a drug free model.

• R. Schwartz discussed issues related to criminal justice system. Incarceration of patients receiving opioid agonist therapy often interferes with treatment since methadone and LAAM are generally not available in jails in the United States.

• I.Marion – other medications are provided for those incarcerated but not for heroin addicts.

• M. Parrino suggested this would be something the PLNDP could help with in coordination with National Drug Court Association – help distinguish between buprenorphine and methadone treatment. State by state simultaneously with feds can help move policies to protect the incarcerated patients. Legal strategy is very expensive and difficult.

• H. Catania – when incarcerated they have a right to be treated but not to their treatment of choice.

• E. Drucker suggested that we build a medical constituency to move the criminal justice system along on methadone treatment.

• H. Joseph encouraged the PLNDP to get involved with this issue.

Presentation 5:

Herminia Palacio, PI, Treatment on Demand — Expanding Access to Methadone Treatment, City of San Francisco, Dept of Health.  Funded by CSAT, OSI, and SF/ DOH

This municipal program is recruiting practitioners and pharmacists to expand access to methadone treatment.

Results:  The primary goal of this program is to expand access to methadone treatment.  The project also aims to accommodate patient choice by finding out what patients think would be the most beneficial setting for treatment.  Patients have the option to present to old or new programs.  We encourage a team approach to treatment that includes the nurse practitioner, doctor, counselor, and pharmacist. 

The results of a study aimed at determining clinician interest indicated that pharmacists are excited at the prospect of professional development in this area, though a great deal of mythology still remains regarding who drug addicts are and how they are likely to behave.  The more pharmacists are educated, the more enthusiastic they become. Many providers are eager to integrate substance abuse issues with other medical problems.  This is especially the case with HIV and AIDS, since much overlap exists between patients who suffer from these diseases and those who suffer from heroine addiction. It is difficult for a clinician to manage anti-retroviral medication when unaware of a patient’s methadone dosage. There is also much overlap between the incidence of Hepatitis C and heroin addiction.  Integrated care would greatly facilitate treatment of patients who suffer from these diseases. The complex medical management issues in the care of Hepatitis C patients may not be able to be fully addressed in the narcotic treatment programs as presently structured and might be better cared for in a medical maintenance model.

Another point in need of emphasis is that engaging people in care is more than writing a prescription.  Sometimes methadone is not the best option, but this does not mean that patients for whom methadone does not work need be referred to a higher level of care.

General Discussion:

• M. Parrino – when will this program be put into motion?

• H. Palacio – summer 2001 pilot project will begin with a primary care model.

There was quite a bit of discussion about training healthcare professionals about addiction in general and specifically dealing with methadone.  A big issue seems to be certifications and who should be doing this if any. E.Salsitz felt that training should emphasize stigma and stigma related to methadone treatment specifically.  He commented that with methadone patients there’s even more stigma and 33% request increases in their dose because they are afraid.

•I.Marion – accreditation will help the mainstream deal with stigma.

• D. Fiellin – success breeds confidence and similar to primary care docs dealing with depression so will happen with buprenorphrine and methadone.

• L. McNicholas – specialty organizations (AAAP and ASAM) need to get involved. Many docs within the specialty organizations don’t want to deal with opiate dependence. She felt a need to put effective treatment and effective training before physicians.

• H. Palacio – PLNDP can help with Medical Education aspects – stress medical institutions focus on addiction in a substantial way. Have to trust physicians to come up to speed and to refer to specialist when they are over their heads.

• J. Merrill – effective treatment can truly change the way both physicians and patients view the way methadone treatment is perceived.

• E. Drucker felt that physicians need support from their institutions for working in addiction care and that the more physicians providing care the better.

• R. Lubran commented on CSAT’s priorities-

1.  training physicians – addiction and buprenorphrine – all specialty groups based on curriculum are being developed.

2. Anticipate new regulations to help programs meet accreditation and best practice guidelines.

3.  Expand access to treatment through innovative treatment models – virtual clinics

• R. Newman – Training is important – why is the government emphasizing newly trained physicians vs. majority of all physicians?

• R. Lubran – methadone treatment as well as buprehnorphrine – raising standards in treatment systems through training existing physicians or retraining existing treatment communities.

• M. Parrino – perceived quality is coming to surface – treatment experience in general is not just the physician’s problem. PLNDP can potentially move these issues along.


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