AT Forum Volume 23, #2 Spring 2013 Newsletter

Addiction Treatment Forum is made possible by an unrestricted educational grant from Mallinckrodt Inc., a Covidien company, St. Louis, MO, a manufacturer of opiate- and alcohol-addiction products.

Bob Newman is Retiring, But You Haven’t Heard the Last From Him

BobNewmanphotoLegendary methadone treatment advocate Robert G. Newman, MD, is retiring. But, he hastens to add, he is not leaving the field. “What I’m leaving,” he told AT Forum in February, “is the office.”

Dr. Newman announced via a January 26 e-mail that he would be giving up his “formal role” as director of Beth Israel’s Baron Edmond de Rothschild Chemical Dependency Institute. He will continue to work through June, but Hindy Bernstein, his assistant of the past 25 years, will be leaving in April. “Hindy is leaving me for Florida,” he said. Although he will no longer have the financial support of Beth Israel, he will continue advocacy efforts.

An Advocate

“The challenges are at least as great today as they were 40 years ago when I started my advocacy work,” Dr. Newman said. He will continue to be a fly in the ointment, but he does want to see more “noise” from the rest of the opioid treatment program (OTP) community.

His days will continue to begin and end the way they have for years, he told AT Forum. “I go to the Internet, I get the Google alerts, which very often have some particularly horrendous feature that I’m obliged to respond to.”

There is a lot of “bad news” for Dr. Newman to blog, write letters to the editor, and send e-mails about. And he does so very articulately. For example, some states are cutting off methadone treatment arbitrarily, trying to limit it to one or two years. Regulators are confounding addiction and dependence, not recognizing that maintenance medication is treatment, not a “substitute” for heroin. Unbelievable as it is that this non-science is going on today, some 50 years after medication-assisted treatment (MAT) has been proven effective, and in the face of federal officials, Dr. Newman sees it happening. And he isn’t going to be quiet about it.

NIMBY

NIMBY—the “not in my back yard” phenomenon in which even people who claim to support MAT don’t want programs in their neighborhoods—is illegal, violating the Americans with Disabilities Act (ADA). But despite the various ADA wins that OTPs have achieved, they are never “precedent-setting,” and therefore need to be fought over and over again. “This is terribly frustrating to me,” said Dr. Newman.

Dr. Newman said the opioid-treatment field can help with this fight. “There are many reasons for NIMBY, and some of those reasons have to do with the field, how we have allowed our treatment, our patients, our services to be viewed,” he said. “It isn’t just misperception on the part of communities and politicians. Some of the anti-methadone- patient bias reflects the way the field has chosen to isolate itself and adopt and embrace unique practices that make this treatment separate.”

 Office-based Methadone

 Dr. Newman is glad that buprenorphine has been made available to OTPs and to office-based opioid treatment (OBOT) providers, as a treatment tool for caring for opioid dependence. He notes that more than 40 years ago he proposed that private physicians be permitted to offer methadone maintenance, in addition to OTPs. And now that buprenorphine can be utilized in OBOT, why not methadone, he asks rhetorically. Dr. Newman also notes the extremely limited willingness of office-based physicians to become “waivered” to prescribe buprenorphine. “I think some of the practices of programs are so foreign to what is done in every other field of medicine that medical colleagues view this as something that is from Mars and refuse to get involved in any form of opioid-dependence treatment.”

In fact, the requirement that patients go to a clinic every day is a barrier to care. Dr. Newman is skeptical about the effect of the Affordable Care Act (ACA) on OTPs in particular. “I have seen repeated references to the notion that under the ACA, there’s going to be a sudden upsurge of demand for addiction treatment,” he said. “Increased demand, maybe,” he said. “But how is that demand going to be met? You can have all the insurance you want, but an awful lot of people who need treatment will avoid OTPs because of the requirements and the stigma, and there are not that many OBOT providers.”

Nevertheless, he noted that hundreds of thousands of patients do go to OTPs for MAT, which shows how motivated these patients are. “How many people would have the motivation to deal with obesity, smoking, hypertension, or a great many other medical problems if the treatment regimen required many months of daily attendance and a host of other demands? The fact that there are 300,000 people enrolled in MAT is amazing.”

 Methadone Safety and Dosing

With an appropriate dosage schedule, methadone is an extremely safe medication, said Dr. Newman. But he warned that some OTPs give induction increments that are too great. The federal regulations state that the dose on the starting day must not be more than 40 milligrams—the first dose has to be no more than 30, and an additional dose that day can be 10, said Dr. Newman. But after that, there are some programs that raise the dose too quickly. “Some programs have induction protocols of 30, 40, 50, 60, 70,” with the dose going up daily, he said. The rule of thumb—“start low, go slow, aim high”—needs more of an emphasis on “go slow.”

 Federal Exclusions

Finally, Dr. Newman would like to see more support for methadone treatment at the federal level. The insurance plans of the federal Department of Veterans Affairs and the Department of Defense have an exclusion against methadone and buprenorphine maintenance treatment, something Dr. Newman has long railed against. “Tom McLellan (then deputy director of the federal Office of National Drug Control Policy) and other very high-level officials have said the exclusion is bad, and that they were trying to change it,” said Dr. Newman. “But it persists, and that’s inexcusable and shameful. “

What Dr. Newman wants advocates to do is to speak up. “Silence equals death,” he said, citing an oft-used slogan of AIDS activists years ago. And he is not going to be silent. “There are a lot of windmills still out there.”

Two Kinds of Roles for OTP Peers under the Affordable Care Act

flag and stetPeers—patients in medication-assisted treatment (MAT) who are in recovery—are gradually being enlisted into the workforce, thanks to the Affordable Care Act (ACA). Two kinds of roles are surfacing: recovery coaches, and “navigators” who help enroll uninsured people in private insurance through health insurance exchanges. The recovery coaching idea is not new, but the navigator one is—especially at the level of actually enrolling patients.

Community-based organizations in New York City have already signed up to be navigators, and the National Alliance for Medication Assisted Recovery (NAMA) hopes to be a part of this, says Joycelyn Woods, executive director.

Ms. Woods, like many observers, thinks there are going to be many glitches in getting people enrolled, and doubts that everyone who isn’t insured will be by next January. NAMA received a grant from the Substance Abuse and Mental Health Services Administration (SAMHSA) for educating patients and training navigators. “What SAMHSA is trying to do is to educate people,” explains Ms. Woods.

Recovery coaches will be a great asset to opioid treatment programs (OTPs), because they will make the programs more like the early ones in which “half the staff were patients,” says Ms. Woods. “They would hire patients and social workers and pair them together. The social worker would teach the patient about the academic part, and the patient would teach the social worker about the other part.” The “other part” is the experience of being a patient, a person with addiction, a person in a program.

Training

Training is based on the Connecticut Community for Addiction Recovery (CCAR) protocol. As it is being used in the FOR-NY Recovery Coach Academy, the training consists of 30 hours. CCAR includes regular follow-up telephone calls—that probably won’t happen with Medicaid, which requires face-to-face contact, says Ms. Woods. But in New York City, which is not rural like Connecticut, it’s likely that face-to-face counseling can be done.

There are also issues with the payment structure for the peers doing coaching, and the state is still working on those.

Some methadone counselors have already participated in training, because they want the recovery coach credential, says Ms. Woods. Although recovery coaching spans all addiction, including alcohol, in New York State anyone doing recovery coaching in a methadone program must also have four hours of training in MAT. This is essential, says Ms. Woods. “Can you imagine people from abstinence-based programs doing recovery coaching in an OTP?”

The NYCB recovery coach credential which requires 60 total hours of training requires 4 hours of MAT training for all coaches wanting the credential, explains Mr. Ginter. The NYCB is the only certification board currently requiring this for their recovery coach credential.

Navigator vs Peercoaching

There’s a subtle difference between what a navigator does, and what the peer acting as a navigator does, says Tom Hill, director of programs at Faces and Voices of Recovery, which has been a major guiding light in the peer recovery coaching movement. “The peer assister or navigator does outreach and pulls people in to walk through the insurance enrollment process,” says Mr. Hill. “There’s one port of entry, and depending on the income, the person would be routed to Medicaid or the exchanges.”

The enrollment process for Medicaid has always been cumbersome, but the Center for Medicare and Medicaid Services (CMS) says it has simplified that process, notes Mr. Hill. “An organization that is able to conduct outreach and get someone to a computer can walk them through the process and get them enrolled.” The Centers for Medicare and Medicaid Services (CMS) is soon to issue a request for applications for navigator grants, says Mr. Hill.

The SAMHSA grants are small: only $25,000 for and there were only eight awarded, says Mr. Hill. “They’re not very detailed because there’s only so much you can do with that amount,” he says. “Some of the grants deal directly with developing enrollment strategies—but others are more generally focused on educating the community,” he says.

There’s a lot of pressure to enroll uninsured people by October 1, says Mr. Hill. “We’ve been pretty clear that the folks we have on the ground in addiction recovery communities are capable of doing the assisting and the navigating,” he says. “Now it’s just a matter of everything falling into place.”

New York City is a good litmus test for the navigator grants, says Mr. Hill, noting that the NAMA grant is good model.

The NAMA contract is to educate MAT patients about the ACA, says Walter Ginter, project director of the Medication Assisted Recovery Support (MARS) project at NAMA. “We’re going to contact all the doctors, and through focus groups and webinars, provide the education about the exchanges,” he says. But he is concerned that the education isn’t going to go far enough, and that actually enrolling people in insurance is a task that has not been well thought out.

“There’s a lot going on at breakneck speed right now,” he says. “It’s exciting and scary and terrifying.”

NASADAD Issues Consensus Statement Endorsing Medication-Assisted Treatment

health insurance approved1The top state officials in substance abuse treatment approved a consensus statement in December that states that medication-assisted treatment (MAT) should be paid for by public and private health insurance plans. This was the first time that the board of directors of the National Association of State Alcohol and Drug Abuse Directors (NASADAD) approved a statement that endorsed MAT as evidence-based treatment. The statement was released January 15. It focuses on MAT for opioid addiction, and is essentially an anti-stigma document, aimed at supporting single state agencies (SSAs)—the authorities over the Substance Abuse Prevention and Treatment block grant.

The consensus statement is footnoted and includes the following assertions:

  •  Dependence on alcohol and drugs is a complex but treatable disease that affects brain function and behavior.
  •  No one treatment protocol is appropriate for everyone.
  •  For some individuals, use of medication is recommended as a recovery tool.
  •  Where clinically appropriate, use of medication as a recovery resource should be utilized as an adjunct to other treatment services.

 Medications such as methadone, buprenorphine, and naltrexone (both oral and extended release injection) have been shown to reduce opioid use; and naltrexone, disulfiram, and acamprosate have been shown to be effective in the treatment of alcohol dependence. The appropriate use of these medications allows individuals to experience sustained recovery from opioid and alcohol dependence, including through long-term management using medication maintenance. The medications should be made available to individuals who could benefit from them.

 It is recommended that any medication-assisted treatment be combined with psychosocial and behavioral strategies that are clinically matched to the severity of the individual’s addiction.

 Longitudinal studies show that treatment initiated in the criminal justice system and continued in the community garners lasting reductions in criminal activity and drug abuse. This includes medication-assisted treatment (e.g., methadone, buprenorphine/naloxone, and injectable naltrexone) for some prisoners with opioid dependence.

 “There is still ambivalence around the use of addiction medications,” says Belinda Greenfield, PhD, the State Opioid Treatment Authority (SOTA) for New York. “That’s why NASADAD and the Opioid Treatment Network say MAT is important to be considered as a treatment option.” The SOTAs became part of NASADAD last year when the association formed the Opioid Treatment Network (OTN). Dr. Greenfield, president of the OTN, is also director of the Bureau of Treatment, Addiction Medicine & Self Sufficiency Services of the Office of Alcoholism and Substance Abuse Services (OASAS) in New York State.

 The problem—not accepting MAT—is particularly significant outside of the methadone field, but even in the substance abuse treatment world, a substantial number of providers espouse “drug-free” treatment, says Henrick Harwood, research director for NASADAD. “Many public-sector programs feel on principle that drug-free is the best approach,” he says. . However, he points out that over the last several years, many have been changing their point of view. “There’s been growing support for MAT.”

 Fight Stigma from Within

Dr. Greenfield says that opioid treatment programs (OTPs) themselves could be better advocates for MAT: they need to be vocal about the fact that patients in MAT are in recovery—they should be called “drug-free” because they’re taking a medication, not seeking a drug. “People in MAT are stable and drug-free, and are maintained on an addiction medication.”

Unfortunately, to some degree, Dr. Greenfield says, patients don’t consider themselves part of the recovery community, and that’s something that OTPs should be working to correct, partly by educating staff. “OTPs should be really actively involved in ROSC functions,” she says, referring to Recovery-Oriented Systems of Care.

 It also would help for OTPs to acknowledge that it is not only methadone that constitutes treatment, but buprenorphine, and behavioral therapies as well, says Dr. Greenfield. “We need to consider addiction medications as one of the options. We can’t say we use only methadone. Patients aren’t that cookie-cutter anymore.”

The Medical Mainstream

Stigma relates directly to the mainstreaming of OTPs, says Mr. Harwood. “It’s important to communicate that methadone treatment has moved in the direction of mainstream medication.” Accreditation by the Joint Commission and CARF are helping to promote the fact that OTPs are in the medical mainstream, he says.

Dr. Greenfield also says part of making MAT better accepted means involving patients more—something that is being encouraged in the rest of medicine, as well. “The language around patient-centered care needs to be better integrated in an OTP setting,” she says, noting that patient advisory committees can be helpful in implementing patient-centered care.

Finally, OTP staff need support as well, because they feel stigmatized, says Dr. Greenfield. They should be proud to tell their family and friends that they are working in an OTP, with patients on MAT. “As long as working in an OTP setting doesn’t seem desirable, this is a problem,” she says. “How do we elevate the cachet of working in an OTP and having staff feel proud of the work we do?”

Challenges for SOTAs

In some states, SOTAs themselves have challenges promoting MAT with their own governors and legislature.

“SOTAs are doing everything they can to advocate within their own states,” says Dr. Greenfield. The problem is that despite the scientific literature, methadone isn’t well understood—the fact that it prevents relapse. “Why can’t this rest with the clinicians and physicians?” she asks. Unfortunately, there are places where the legislature and state administrations oppose methadone and OTPs. This hasn’t been a problem in New York. “But the SOTAs and the SSAs in many states have a huge undertaking and a huge task in trying to advocate for methadone.”

One argument that might help sway some MAT opponents is cost-effectiveness. Mr. Harwood notes that the literature documents the cost-effectiveness of methadone and OTPs. “This is something that advocates need to keep in mind,” he says. “It’s not just that MAT is effective. It’s a win-win for society and communities to provide MAT, especially for opioid addiction.”

For the consensus statement, go to http://nasadad.org/wp-content/uploads/2013/01/13-January-15-NASADAD-Statement-on-MAT.pdf

NASADAD Prescription Drug Inquiry Reveals SSAs Very Concerned About Prescription Drug Misuse and Abuse

doctor and prescription bottlePrescription drug abuse—something a whole industry of monitoring and law enforcement is growing up around—is a public health problem first, according to the state substance abuse officials responsible for treatment and prevention. That said, these same directors—the single state agencies (SSAs) with authority over the Substance Abuse Prevention and Treatment block grant—also want to participate in the prescription drug abuse conversation, explains Rob Morrison, executive director of the National Association of State Alcohol and Drug Abuse Directors (NASADAD).

Based on an inquiry of its entire membership, NASADAD staff found that single state agencies consider prescription drug misuse and abuse very important—for some, the most important—issue they face. The inquiry took place last year and was released in fall of 2012.

Forty-seven states responded to the inquiry, which yielded the following results:

  • Prescription drugs are the most important issue affecting states (23%), very important (58%), or important/moderately important (19%)
  • Of the states surveyed,
    • 62% currently have a task force addressing prescription drugs
    • 15% had a task force on prescription drugs that completed its work
    • 68% passed legislation in the past 5 years addressing prescription drug misuse and abuse
    • 83% have undertaken education efforts about prescription drug abuse for the general public
  • Among states with prescription drug monitoring programs (PDMPs),
    • 54% have some single state agency (SSA) involvement with the PDMP
    • 43% have no SSA involvement with the PDMP
    • 64% find PDMP data very useful or useful
    • 13% describe the data as somewhat useful in addressing prescription drug abuse issues

There are continued challenges to SSAs trying to address prescription drug misuse and abuse “related to data, funding constraints, collaboration, workforce development, public education, and ease of access to pills,” according to the report. It found that “although PDMPs and the data they provide are useful to SSAs, the level of oversight, access, and involvement of SSAs continues to be limited.”

Great emphasis has been placed on addressing the utility of PDMPs, but it’s important for the SSAs, as the public health and treatment experts, to be involved. SSAs would like to have more oversight, access, and involvement with PDMPs, according to the report.

In only three states—Vermont, Maine, and Maryland—is the PDMP operated under the purview of the SSA, and the agency could use the information to help get people who are misusing or abusing medications into appropriate treatment. “We have a steep growth curve here,” says Henrick Harwood, research director of NASADAD. “We need to increase the education so prescribers can help people get into treatment.”

The Office of National Drug Control Policy (ONDCP) has been very helpful in issuing a strategy and structure around which to build a public health approach to prescription drug abuse, says NASADAD’s Mr. Morrison.

 Connection to MAT

There is a clear connection between prescription opioid abuse and medication-assisted treatment (MAT). Many patients newly admitted to treatment are dependent on opioids—either because they started taking them for pain, then began misusing them, or abused them from the beginning. When they try to stop, they go into withdrawal. So some states have increased training for treatment staff, in particular on prescription drug abuse and on MAT.

And there are particular challenges for states in addressing prescription drug abuse. For example, PDMP data aren’t always of good quality or easy to utilize, according to the report. And substance use disorder treatment providers don’t always have a way to access it. There is also a dearth of financial resources, with lack of adequate funding for MAT and lack of funding for naloxone overdose kits, a promising public health response to overdoses, according to the report. And there are problems with states’ proposing to restrict MAT funding.

The NASADAD report is available at: http://nasadad.org/wp-content/uploads/2012/10/NASADAD-Report-SSAs-and-Prescription-Drug-Misuse-and-Abuse-09.20121.pdf

Seeking and Getting Substance Abuse Treatment: Barriers Women Face

BarrierOur first article in this series, “Becoming Addicted: It’s Different—and Riskier—for Women,” delved into the vulnerabilities that challenge women who have an opioid use disorder (OUD).

Now we examine the potentially daunting barriers women face in seeking and getting substance abuse treatment. Some barriers are largely internal, based on the woman’s attitudes; others are generated by society; still others exist within treatment programs.

As noted in the first article, few women misuse a single substance, so many studies we cite yield data for substance use disorders (SUDs) rather than for OUDs alone.

Finding Treatment

Barriers to treatment confront women from the outset, and it’s no surprise that most women with an SUD are never treated for it. Compared to men with OUDs, women are likely to be at a socioeconomic and educational disadvantage, to be underemployed or unemployed, and to have primary child-care responsibilities. Their OUD comes on more quickly, and they progress more rapidly to serious consequences. Yet women tend to see their substance abuse as stress-related, a temporary crutch that will go away without treatment.

Women are less likely than men to know how and where to get treatment. Typically they refer themselves, sometimes prompted by family or friends, or are referred by the criminal justice system or social service agencies. Men usually are referred by employers, doctors, or the legal system—sources generally considered more knowledgeable about treatment options.

Women may consider private residential clinics too time-consuming, expensive, and tightly regulated to be an option. Television and print media lead many to think that treatment means substance withdrawal, and that methadone is a drug to avoid (see Hearing Bad Things About Methadone Treatment? Thank “Dr. Drew”—Summer 2012 issue).  So it’s no surprise that women account for less than half of treatment admissions for opioid abuse.

Internal (Patient-Related) Barriers

According to Susan M. Gordon, PhD, in addition to misperceptions about programs, internal barriers include low motivation for treatment, denial of problems, psychological problems, internalization of negative social attitudes toward women with SUDs, self-definition, and independent attitudes about help-seeking and self-reliance. Dr. Gordon is director of research at the Caron Foundation Treatment Center in Wernersville, Pennsylvania.

In particular, depression and anxiety may lead women to delay or do without treatment. Studies suggest that high levels of estrogen can enhance the stress response in subcortical regions of the brain, contributing to the higher prevalence of depression and anxiety in women.

Many women with an SUD have a history of sexual, emotional, or physical abuse, as well as suicidal thoughts and attempts. Post-traumatic stress disorder is common, resulting from trauma or abuse. If a woman with an SUD has a history of emotional, physical, or sexual abuse perpetrated by men—and most do—the very idea of a treatment environment that includes men can be distressing.

Women are more likely than their male counterparts to have a drug-using partner supporting her drug use. These women generally receive little encouragement to enter treatment, and may instead encounter resistance.

Health professionals are less likely to identify substance abuse in women than in men; often they refer women to mental health care providers instead of treatment programs. Women themselves are partly responsible; they often choose psychological or psychiatric help rather than substance abuse treatment. Shame and guilt, or lack of awareness of the significance or severity of their addiction, may keep them from sharing their substance history with the mental health provider. So their true problem may go undiagnosed, and they lose the opportunity for treatment for their SUD.

Social Barriers

Society stigmatizes women who abuse substances—especially women who have children or are pregnant. Communities and families often fail to provide the support women need, including child care and encouragement to enter treatment.

“Once a woman has developed an addiction, she deviates more from the female norm, compared with a man with an addiction,” according to Drs. Dorte Hecksher and Morten Hesse, writing in Women’s Issues. She’s viewed by some—and often by the woman herself—as a “fallen woman.” She worries about the disapproval of friends, family, co-workers, and employers, if she enters substance abuse treatment, especially if she is pregnant, or a mother. Her concerns about providing child care and the possibility of losing custody are a heavy burden.

Treatment Program Barriers

Denial. “Breaking the denial is a necessary first step to assisting substance-dependent women to get into treatment,” according to Ozietta D. Taylor, PhD, MEd, LCPC, assistant professor at Coppin State University, Baltimore, Maryland. The Taylor reference below discusses ways of using methods of intervention to help get a woman into treatment.

Socioeconomic barriers. Substance-abusing women are less likely than men to have insurance or full-time jobs, and public funding often means a long wait. Getting to a program is another issue; many don’t have a car or driver’s license, or even money for public transportation.

Therapies and relationships. Men tend to enter treatment with an aggrandized sense of self, according to addictions and trauma expert Claudia Black, PhD, while women are more likely to have a diminished view of themselves, because of their primary role as caregiver. Dr. Black is a senior fellow at The Meadows, a trauma and addiction treatment facility in Wickenburg, Arizona.

Women entering treatment have different needs than men. According to Mary Jeanne Kreek, MD, of The Rockefeller University, “a strong positive correlation exists between troubled relationships, family violence, sexual abuse and poor self-esteem as integral factors in substance abuse among women.” These factors don’t apply to men, and lack of gender-specific services in treatment programs is a definite barrier for women.

Women with SUDs benefit most from supportive therapies and a relationship of mutual respect, empathy, and compassion, according to TIP 51, but “the type of confrontation used in traditional programs tends to be ineffective for women, unless a trusting, therapeutic relationship has been developed.”

The Meadows in Arizona uses a multidisciplinary approach “to address women who present with more complex trauma and addiction issues, and more dual diagnoses,” according to Nancy Bailey, PhD, clinical director, who has commented that many programs still focus on one primary issue.

Overcoming Barriers

Programs can do little to overcome barriers generated by the patient and by society, but the opportunities are many once women reach treatment. TIP 51 and the Taylor reference below offer many excellent suggestions.

In particular, women need substance abuse treatment that is multimodal and addresses social services such as vocational rehabilitation.  Comprehensive services can mean the difference between treatment failure and success.

Factors encouraging treatment retention include supportive therapy, a collaborative therapeutic alliance, and onsite child care and children’s services. For women who have lost child custody, comprehensive services can be a powerful motivational tool to stay in therapy. Pregnant women especially need comprehensive services. It’s estimated that as few as four percent of women are pregnant when entering treatment, and the services they sorely need are difficult to come by.

Successful treatment often means walking a fine line. Some women believe they are expected to maintain relationships, even abusive ones, and dependency or economic factors may motivate them to do so. If a woman’s drug use has involved a relationship with a spouse or significant other, OUD treatment may threaten that relationship—and the woman’s physical well-being.

Caregivers need to keep this in mind, and avoid focusing on maintaining relationships while excluding women’s other important needs. Dr. Black has stressed the importance of a woman’s building support and relationships with female peers. The insight of other women in treatment can help her work through a troublesome relationship, and, if necessary, break it off.

According to Dr. Gordon of the Caron Foundation, programs that increase the chances women will complete treatment comprise mixed-gender programs, services for women, and integrated treatment for co-occurring psychological and physical conditions.

Dr. Gordon believes that “internal and social barriers present more daunting obstacles” than treatment program barriers, and she calls for a change in public attitudes, “if women are to reduce their own feelings of shame and sense of denial.”

She maintains that these are not impossible goals. “Public education campaigns have eliminated the stigma from cancer, and have increased dramatically the numbers of people who are screened, diagnosed and successfully treated for this disease. We can achieve the same results for addiction in women.”

*     *     *

Sources

Back SE, Payne RL, Wahlquist MS, et al. Comparative profiles of men and women with opioid dependence: Results from a national multisite effectiveness trial. Am J Drug Alcohol Abuse. 2011;37(5):313-323. doi: 10.3109/00952990.2011.596982.

Center for Substance Abuse Treatment. Substance Abuse Treatment: Addressing the Specific Needs of Women. Treatment Improvement Protocol (TIP) Series 51. HHS Publication No. (SMA) 09-4426. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2009. http://kap.samhsa.gov/products/manuals/tips/pdf/TIP51.pdf

Goldstein JM, Jerram M, Abbs B, Whitfield-Gabrieli S, Makris N. Sex differences in stress response circuitry activation dependent on female hormonal cycle. J Neurosci. 2010;30(2)431-438.  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2827936/

Gordon SM. Barriers to treatment for women. Counselor. 2007; 8(3):22-29.

Hecksher D, Hesse M. Women and substance use disorders. Women’s Issues. 2009;7(1):50-62. doi: 10.4103/0973-1229.42585. PMID:21836779.  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3151455/

Jamison RN, Butler SF, Budman SH, Edwards RR, Wasan AD. Gender differences in risk factors for aberrant prescription opioid use. J Pain. 2010;11(4):312-320. doi:10.1016/j.pain.2009.07.016.

Kreek MJ, Borg L, Ducat E, Ray B. Pharmacotherapy in the treatment of addiction: Methadone. J Addict Dis. 2010;29(2):200-216. doi:10.1080/10550881003684798. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2885886/

National Abandoned Infants Assistance Resource Center, UC Berkeley. Prenatal Substance Exposure. Fact Sheet. http://aia.berkeley.edu/media/pdf/AIAFactSheet_PrenatalSubExposure_2012.pdf

Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality. Treatment Episode Data Set (TEDS): 2000-2010. National Admissions to Substance Abuse Treatment Services. DASIS Series S-61, HHS Publication No. (SMA) 12-4701. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2012. http://www.samhsa.gov/data/2k12/TEDS2010N/TEDS2010NWeb.pdf

Why MMT Patients Exchange Prescription Drugs

Patients in methadone maintenance treatment (MMT) exchange a variety of prescription drugs—but little is known about why this happens, and how common it is.

pills and moneyGiven the risks of this practice—drug interactions, side effects, addiction, antibiotic resistance, birth defects, and possible interruption of MMT—a group affiliated with Butler Hospital and Brown University, Providence, RI, decided to find out. They published their findings in the January 1, 2013 issue of Drug and Alcohol Dependence. From December 2008 through January 2012, the team screened 767 individuals who enrolled in a smoking cessation trial in nine MMT sites in Southern New England. Characteristics of the 315 participants recruited were:

  • Average age 40 years
  • 49% male
  • 79% non-Hispanic white, 12% Hispanic, 2.5% black
  • Health insurance: public, 56%; private, 14%
  • 42% received disability payments
  • Average length of methadone treatment, 154 weeks
  • Past-30-day use of heroin, 7%; cocaine, 8%

Study Results

About 79 percent of participants had been prescribed at least one medication during the previous year. The drugs include allergy medications, antibiotics, blood pressure medications, erectile dysfunction drugs, antidepressants, tranquilizers, and drugs of abuse: sedatives, medications for ADHD, sleep medications, pain medications, and Suboxone (buprenorphine and naloxone).

About 20 percent of participants reported sharing their medication, and almost 40 percent said they had used medication not prescribed to them. While these rates may not be significantly higher than those in the general population, they represent a substantial risk to MMT patients. According to the Centers for Disease Control and Prevention (CDC), people with substance abuse histories are particularly vulnerable to overdose and adverse events related to illicit prescription drug use. Moreover, the authors note that MMT confers significant health benefits, and continued use of non-prescribed prescription medications may interrupt treatment.

Medications most often shared (given or sold) and received (borrowed or bought) were those with abuse potential—pain medications, sleep medications, and sedatives.

Sources of Drugs of Abuse

Sources, by Patients’ Responses

Drug

No. of Patients

No. of Responses

Given by Friend or Family Member,

No. (%)

Bought From Someone Patient Knew, No. (%)

Bought on The Street, No. (%)

ADHDa medications

8

9

6
(66.7)
0
(0.0)
3
(33.3)
Pain medications

61

71

39
(54.9)
2
(2.8)
30
(42.3)
Sedatives

61

78

45
(57.7)
10
(12.8)
23
(29.5)
Sleep medications

43

41

40
(97.6)
1
(2.4)
0
(0.0)
Suboxoneb

34

40

16
(40.0)
0
(0.0)
24
(60.0)

aAttention deficit hyperactivity disorder.

bBuprenorphine and naloxone.

As the table shows, patients generally received medications of abuse from friends or family, rather than buying them. Of interest, the only exception was Suboxone; 40 percent of patients (n=16) received the buprenorphine and naloxone medication from friends or family, and 60 percent (n=24) bought it on the street. In contrast, 66.7 percent of patients received their ADHD drug from friends or family, and 33.3 percent bought on the street; the corresponding percentages for pain medications were 54.9 from friends or family, 42.3 from street purchases, and 2.8 from acquaintance purchases.

The authors commented that the frequent receipt of buprenorphine from nonmedical sources “is consistent with an earlier study of opioid users, where 76% reported that they had used illicit buprenorphine.”

The authors did not list the specific prescription sedatives and pain medications bought on the street, but the former group includes benzodiazepines and barbiturates, and the latter group, opioids and nonsteroidal anti-inflammatory drug (NSAID) combinations.

Reasons for Exchanging Medications of Abuse

The only factor significantly associated with sharing drugs of abuse was younger age.

Four factors were significantly associated with receiving medications of abuse: younger age, being male, recent use of heroin or cocaine, and financial hardship.

The authors noted the important impact of financial hardship and low socioeconomic status on sharing and receiving. In the previous 6 months, 21 percent of the study population had at times gone without food, clothing, or housing to pay for medicine, and 8 percent had gone without needed medical care to pay for those necessities.

Moreover, the MMT population “has high rates of being uninsured or underinsured”—thus is more likely to share and receive various medications, not just illicit opioids. Many participants had public rather than private insurance, so “medication access, continuity, and affordability may still be a concern,” the authors said.

Value of the Study

This early study sheds light on the high rate of medication exchanges among MMT patients, and on some characteristics that lead to sharing and receiving—in particular, vulnerability, financial hardship, “and the need to self-medicate a physical health problem.”

These reasons underscore the need for better approaches to help this at-risk population. The authors note that while many resources for studying, defining, and understanding prescription drug exchange focus on trafficking, “doctor shopping,” and internet purchase of illegal prescriptions, prescription medication sharing also contributes to illegal use.

Reasons for sharing and receiving need further examination both to prevent the exchange of prescription drugs and to “maximize care to a vulnerable and underserved population,” the authors said.

    *     *     *

Caviness CM, Anderson BJ, de Dios MA, et al. Prescription medication exchange patterns among methadone maintenance patients. Drug Alcohol Depend. 2013; 127(1-3):232-238. doi: 10.1016/j.drugalcdep.2012.07.007.

 

From the Editor – Maine Continuing to Push for Caps on Medication-Assisted Treatment

hour glass1First, Maine imposed two-year caps on methadone and buprenorphine treatment, if paid for by MaineCare, the state’s Medicaid program. The caps were due to take effect January 1, but treatment advocates were able to work out a medical-necessity exemption, which said that as long as patients were doing well, they could stay past the two-year limit.

Never mind that this made no sense—patients who are not doing well should be kicked off treatment—to go where, the streets? In any event, it was better than nothing. But in March, a new bill was introduced that would have eliminated even the medical necessity exemption. Two years on treatment, and that’s it.

Mark Publicker, MD, president of the Northern New England Society of Addiction Medicine, who helped lead the advocates’ battle for the medical necessity exemption, is “back in the saddle”—pressing the state legislature and the regulators for a reasonable approach.

Under the proposed bill, as of January 1, 2015 no patient would be allowed to be on methadone or buprenorphine for more than two years, if paid for by Medicaid.

“It’s outrageous,” he told AT Forum.

Events

events1Global Addiction and EUROPAD Conference
May 7-10, 2013
Pisa, Italy
Contact: http://www.globaladdiction.org/

National Association of Addiction Treatment Providers (NAATP) 2013 Annual Conference
May 18-21, 2013
San Antonio, Texas
Contact: https://www.naatp.org

Society for Clinical Trials (SCT) 34th Annual Meeting
May 19-22, 2013
Boston, Massachusetts
Contact: http://www.sctweb.org/

American Psychiatric Association (APA) 166th Annual Meeting
May 18-22, 2013
San Francisco, California
Contact: www.psych.org/

26th Annual Northwest Conference on Behavioral Health & Addictive Disorders
May 29-31, 2013
Hyatt Regency Bellevue, Seattle, Washington
Contact: http://www.usjt.com

Annual West Coast Symposium on Addictive Disorders
May 30-June 2, 2013
LaQuinta, California
Contact: http://www.wcsad.com

AT Forum Volume 23, #1 Winter 2013 Newsletter

Addiction Treatment Forum is made possible by an unrestricted educational grant from Mallinckrodt Inc., a Covidien company, St. Louis, MO, a manufacturer of opiate- and alcohol-addiction products.

OTPs Can Now Dispense Buprenorphine Take-Homes with No Waiting Periods

As of January 7, 2013, opioid treatment programs (OTPs) can now dispense buprenorphine take-homes, with no predetermined waiting period for stable patients. The Substance Abuse and Mental Health Services Administration (SAMHSA) at last issued its final rule giving OTPs the welcome flexibility this past November, and the rule was published in the Federal Register December 6, 2012. Fears of diversion were probably the driving force behind the delay in the final rule; the proposed rule was issued in June 2009.

Because Schedule III substances—like buprenorphine—have a lower potential for abuse compared to Schedule II substances—like methadone—there is justification for the less-restrictive rules on dispensing buprenorphine, according to SAMHSA.

Of course, states can have stricter rules. Some require OTPs to be open 7 days a week, and the idea of buprenorphine take-homes isn’t even on their radar screens. Still, the final rule is a very important first step for OTPs and their patients.

Most OTP physicians (80 percent) have already completed the DATA training and obtained the required waivers, according to SAMHSA. OTPs will not have a cap on how many patients they can treat with either buprenorphine or methadone. However, for take-homes, OTPs will still be “required to assess and document each patient’s responsibility and stability to handle opioid drug products, including buprenorphine products,” SAMHSA said in the final rule.

At this important juncture in the history of OTPs, accompanying articles in this issue take a look back at the development of buprenorphine and methadone for treating patients with opioid use disorders, and the differences between the two medications. We also report thoughts from leaders in the field as to what the new rule is likely to mean to OTPs and their patients.

Buprenorphine vs. Methadone

Buprenorphine and methadone, both being opioids, activate the opioid (mu) receptors on nerve cells. And both drugs have long half-lifes, meaning that they’re long-acting medications. The half-life can vary from 24 to 60 hours for buprenorphine, and from 8 to 59 hours for methadone. (The half-life is the amount of time a drug stays in the body before its concentration in the plasma drops by half. A drug’s half-life can vary from patient to patient.)

The long half-lifes of buprenorphine and methadone account for their usefulness in treating opioid dependence. Simply put, these drugs lack the peaks and troughs that are associated with short-term opioids, like heroin—swings in drug plasma levels that can cause overdose and withdrawal symptoms.

But there are key differences between buprenorphine and methadone.

Full Agonist vs. Partial Agonist

Buprenorphine is a partial agonist; methadone, like heroin, is a full agonist. It is by their actions on opioid receptors that opioids achieve their analgesic (pain-killing) as well as their addictive effects.

Methadone, as a full mu opioid agonist, continues to produce effects on the receptors until either all receptors are fully activated, or the maximum effect is reached.

Buprenorphine, as a partial agonist, does not activate mu receptors to the same extent as methadone. Its effects increase until they reach a plateau. At that level, opioid-addicted patients can discontinue opioid use without experiencing withdrawal. Buprenorphine reaches its ceiling effect at a moderate dose, which means that its effects do not increase after that point, even with increases in dosage.

Like all opioids, buprenorphine can cause respiratory depression and euphoria, but its maximal effects are less than those of full agonists. The benefits of this from an overdose perspective constitute the safety profile of buprenorphine—a lower risk of abuse, addiction, and side effects than with full agonists.

For people who are not addicted to or dependent on opioids, the effects of partial (buprenorphine) and full (methadone) agonists are indistinguishable. However, at a certain point, the increasing effects of partial agonists reach maximum levels. For this reason, people who are dependent on high doses of opioids are better suited to treatment with a full agonist, such as methadone.

Buprenorphine, like methadone, has a serious potential for drug-drug interactions. It must be used cautiously with other medications, in particular benzodiazepines, other sedatives, opioid antagonists like naltrexone, and opioid agonists.

Buprenorphine

Methadone

Heroin

Partial agonist Full agonist Full agonist
Long half-life (24 to 60 hours) Long half-life (8 to 59 hours) Short half-life
Ceiling effect; good safety profile No ceiling effect (useful in patients dependent on high doses of opioids) No ceiling effect

Formulations of Buprenorphine

In October 2002, the Food and Drug Administration (FDA) approved the buprenorphine monotherapy product, Subutex, and a buprenorphine/naloxone combination product, Suboxone, for treating opioid addiction.

Subutex is no longer sold in this country. It has been replaced by generic buprenorphine. Suboxone, a sublingual tablet (designed to dissolve under the tongue), comes in two dosage forms. Suboxone film was approved by the FDA in 2010. The sublingual film dissolves faster than the tablet, and is individually wrapped in unit-dose, child-resistant pouches. According to the manufacturer, Reckitt Benckiser, Suboxone film is clinically interchangeable with the tablet.

Last fall, Reckitt Benckiser voluntarily removed its Suboxone tablets from the market, citing a few pediatric overdoses. But it protected its hold on the Suboxone market by retaining the film formulation. The patent on the tablets had long expired; the patent on the film runs until 2023. Patients, of course, had to be switched to the film, unless their physicians wanted to switch them to generic buprenorphine. At the same time that Reckitt pulled the tablets, it filed a Citizen’s Petition with the FDA, calling on all buprenorphine products to be sold in childproof packaging.

The effect of these moves by Reckitt on the buprenorphine marketplace are not clear, said Nicholas Reuter, MPH, who was senior public health analyst with SAMHSA’s Center for Substance Abuse Treatment (CSAT) when this story was written (he retired on January 31, 2013). “Submitting a Citizen’s Petition doesn’t mean the FDA has to accept it,” he said. In addition, in November 2012 the FDA accepted Orexo’s New Drug Application for Zubsolv, a buprenorphine-naloxone combination. Zubsolv could well be the first generic competition to Suboxone. And on December 17, 2012, Titan licensed Probuphine, its buprenorphine implant, to Braeburn Pharmaceutical for exclusive commercialization in the U.S. and Canada. “The buprenorphine marketplace is looking at different formulations,” noted Mr. Reuter. “There could be a generic competitor [for Suboxone] tomorrow.”

Making the Decision: Methadone vs. Buprenorphine

Aside from the dosage issue, there is no “cookie-cutter” approach for deciding what patient gets buprenorphine and what patient gets methadone. Philip L. Herschman, PhD, chief clinical officer of CRC Health Group, pointed out that different patients react differently to different medications. “Some feel better on buprenorphine, some feel better on methadone,” he said. CRC has been using generic buprenorphine in its OTPs on the same basis as methadone. The extent to which CRC will be able to give buprenorphine take-homes will depend in large part on state regulations—just because the federal government has approved the plan doesn’t mean states will.

“Buprenorphine is great, but it’s not for everybody,” said Walter Ginter, CMA, project director of the Medication Assisted Recovery Support (MARS) project. He doesn’t think the final rule is going to make a big difference for most patients. He noted that few patients go to methadone maintenance as their first course of treatment.

In fact, Mr. Ginter can speak as an expert on subjective effects in a personal way: he has been maintained on both medications—buprenorphine during its development in the 1990s, when he was a study subject, and then methadone. He has been on a high dose of methadone for years, and says “I don’t think I’m clouded out.” Indeed, he is one of the most energetic and articulate advocates in the field. It comes down to a matter of personal preference, he said. “With methadone, you’re never sick and you’re never high, but you do get the serum peaking four hours after the dose,” he said. “I think Suboxone is too much the same, with no ups or downs.”

Still, there are OTPs that do switch patients from methadone to buprenorphine, titrating very carefully downward for patients on doses of 80 milligrams or more of methadone before switching to buprenorphine, said Mark Parrino. MPA, president of the American Association for the Treatment of Opioid Dependence (AATOD). In general, if a patient has been using opioids for a longer period, or has a higher tolerance, methadone would be more appropriate. The reason is that buprenorphine’s ceiling limits those higher-dose equivalents.

Publishers Note: Nicholas Reuter, MPH joined Reckitt Benckiser in February 2013 as a Treatment Manager.

History of Buprenorphine

 Buprenorphine has been in active use for 10 years as a treatment medication for opioid addiction.

As explained by Nicholas Reuter, MPH, senior public health analyst with SAMHSA’s Center for Substance Abuse Treatment (CSAT), the development of buprenorphine was preceded by the development and approval by the Food and Drug Administration (FDA) of levo-alpha-acetyl-methadol (LAAM). The government supported the development of LAAM, but the medication “couldn’t generate enough income from patient use to be sustainable,” he said.

“At the time, there was a lot of discussion about the treatment gap,” he told AT Forum. There were at least 2 to 3 million people who needed treatment for opioid addiction, and only 150,000 or fewer could get into Opioid Treatment Programs (OTPs). “The thinking was that we needed to develop an office-based model,” said Mr. Reuter.

Buprenorphine had been approved for addiction treatment in other countries, Mr. Reuter said, and the molecule is interesting because it is a partial agonist, which gives it a ceiling effect. This means that the risk of overdose is attenuated. “Taken in increasing amounts, it causes dysphoria [anxiety, depression, unease],” noted Mr. Reuter.

People on Capitol Hill were working to see how buprenorphine could be developed as an office-based treatment for opioid addiction, and this led to the development of DATA 2000, said Mr. Reuter. “It was set up as an experiment.” Safeguards were built into the law, so that if treating patients in the physician’s office with narcotic drugs did not turn out to be a good idea, the law could be rescinded. “We were required to do a formal analysis.”

The “experiment” worked, and in 2002 the FDA approved buprenorphine for the treatment of opioid addiction.

Why Not More OTPs?

Why didn’t SAMHSA just increase methadone slots in OTPs, if there was a need for more treatment? First of all, it’s not that easy to increase the number of OTPs, said Mr. Reuter, noting that almost everyplace a program tries to open up, there is a NIMBY battle from the local community. But perhaps more important, there were concerns about methadone overdoses. It turned out that the overdoses were mainly related to pain prescribing, but that was not known at the time. That’s because the increase in pain prescribing coincided with the rule allowing more flexible methadone take-home doses.

But SAMHSA was in a difficult position, nevertheless. “Here you have people saying methadone is a dangerous drug, too many people are dying from it, and we have to look at how it’s used,” said Mr. Reuter. “Methadone mortality was such a significant concern. We would hear it every day.”

While there has been an increase in the number of OTPs in the past decade, there is still a treatment gap, said Mr. Reuter. There were 900 OTPs ten years ago, and now there are 1,260. The number of patients treated in OTPs has gone from 170,000 In 1998 to about 300,000.

Instead of expanding some office-based models for methadone, the government decided to look at buprenorphine—in large part because of problems with methadone mortality, which peaked in 2001, said Mr. Reuter.

Buprenorphine in Practice

Something similar has happened with buprenorphine’s early years—in spite of all of the agency collaboration. “What’s interesting is that as physicians got more experience in treating opioid addiction, they realized that there is a high relapse rate, and maintaining the patient is better than withdrawing the patient,” said Mr. Parrino. This doesn’t mean that every patient will need to be on medication for life.

But by increasing access to buprenorphine, DATA 2000 did not necessarily provide access to counseling and other comprehensive treatment services, said Mr. Parrino. “As far as we know, many patients did not receive counseling in addition to the medication prescribed, did not receive routine toxicology tests to guide clinical decision making, and appeared to divert buprenorphine take-home medication,” he told AT Forum. “Without question, treatment access was increased significantly because patients who never would have sought treatment in the OTP, or simply felt more comfortable receiving such care in a physician office setting, did get access to treatment. But what kind of treatment did they receive?”

Buprenorphine Prescribing Trends

It’s easy to find the number of physicians who are certified through the DATA waiver process to prescribe buprenorphine, but much more difficult to find out how many of them are actually prescribing, or how many patients they have, or whether they are providing counseling or drug testing.

According to the Drug Enforcement Administration’s ARCOS data, over 190 million dosage units of buprenorphine were distributed to pharmacies in 2010, said Mr. Reuter. That’s almost five times the 40 million distributed in 2006. Only 1.1 million dosage units were distributed to OTPs during 2010. Almost 800,000 individuals got prescriptions for buprenorphine from office-based physicians in 2010—five times the 140,000 estimated in 2006.

SAMHSA measures the number of prescribing physicians by how many submit applications to get certified to prescribe buprenorphine. Currently, that’s about 23,000, according to Mr. Reuter. But that doesn’t mean that they are all prescribing—far from it. In fact, the number of physicians prescribing buprenorphine has gone down; fewer physicians are prescribing to more patients, and there is a clear need for more access to buprenorphine.

In 2005, there were 22,000 physicians certified to prescribe buprenorphine under DATA 2000. Of these, almost 5,200 requested to treat up to 100 patients, according to the final rule. In 2009, when the DEA stepped up its investigations of buprenorphine-prescribing physicians, to make sure they were adhering to 100-patient caps, some physicians objected, and surrendered their certificates. Mr. Reuter noted that some of these doctors (about 2,000) had obtained the certification but not gotten any patients, and didn’t want to be bothered with the inspections.

As of September 2012, about 3.9 million patients had been treated with Suboxone, said Tim Baxter, MD, global clinical director of Reckitt Benckiser, which makes the Suboxone brand of buprenorphine.  Of the 23,000 physicians who are waivered to prescribe buprenorphine, 12,000 have actually prescribed it—“many have written only one prescription,” said Dr. Baxter. In fact, there aren’t enough physicians prescribing it. “Initially the number of prescribers went up, and then it flattened out,” he said. Many active prescribers are now fully booked. “With the 100-patient limit, it’s harder for patients to find a prescriber.”

Buprenorphine Diversion

Abuse and diversion of buprenorphine are a concern to us and the FDA, said Mr. Reuter. The 2010 DAWN national data showed an increase in buprenorphine reports in the emergency department.

There are concerns about increases in buprenorphine abuse and diversion, which has paralleled the prescribing increase in the buprenorphine mono formulation, the one without naloxone. The naloxone is what prevents people from being able to get high from melting down and injecting the medication.

One problem is that the mono formulation has been available in generic versions for three years. Generic versions are less expensive than Suboxone, and prescribing of mono buprenorphine has increased steadily.

According to the final rule, HHS “is not aware of compelling evidence to support the assertion that more OTPs than office-based physicians will dispense mono buprenorphine.” But controls already in place regarding OTPs—much more intense controls than those regarding office-based physicians—“will mitigate diversion issues in OTPs with either buprenorphine formulation,” the final rule states. In addition, “the risk for buprenorphine diversion from buprenorphine dispensed by OTPs in accordance with this final rule will be less than the risk of diversion associated with office-based settings.”

If an OTP patient gets a 30-day supply of methadone, or, under the new rule, buprenorphine, that patient is “still subject to drug-testing requirements, still subject to counseling, and still has a treatment plan,” said Mr. Reuter. “On the other end of the spectrum are the buprenorphine prescribers who could prescribe a 30-day supply of Suboxone or buprenorphine, with no requirements for drug testing or counseling,” he said. “That may explain why there is an escalating abuse and diversion of buprenorphine.”

Buprenorphine Not a Miracle Cure

Treatment with buprenorphine is effective, said Mr. Reuter. Medication-assisted treatment has expanded, even in parts of the country where it wasn’t available, such  as Wyoming and North Dakota. Those states don’t permit OTPs. “But the success has to be looked at in terms of the real world, in which people relapse,” he said. “It’s not a miracle cure, and I never thought it would be. To my mind, it’s expanded treatment capacity, but it’s not a cure. And now we see increasing abuse and diversion.”

Mr. Parrino thinks the reason buprenorphine has been successful is that it is not “stigmatized,” the way methadone is. Interestingly, the earliest prescribers of buprenorphine were using it primarily as a withdrawal agent, rather than a maintenance agent, he said. Many of these patients undoubtedly relapsed; as a huge NIDA clinical trial showed, more than 9 out of 10 patients who were tapered off buprenorphine, relapsed.

See comment from Robert Newman, MD in comment section. 

Reference

Center for Substance Abuse Treatment. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series 40. DHHS Publication No. (SMA) 04-3939. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2004.

Promise of Health Care Reform for Opioid Treatment Programs Dimmed by State Discrimination

Health care reform will bring increased access to opioid treatment programs (OTPs), but not as great an increase as the federal government keeps saying it will be. The impediment is the states—specifically, the anti-methadone states, which many are in one way or another. Either they won’t let Medicaid pay for methadone maintenance, or they won’t force private insurers to cover it, or both.

Medicaid expansion, a cornerstone of the Affordable Care Act (ACA), won’t mean anything if the state involved doesn’t allow Medicaid to pay for treatment in an OTP, Mark Parrino, MPA, president of the American Association for the Treatment of Opioid Dependence (AATOD) told AT Forum. “For example, Georgia is a large state with many OTPs, but the state does not reimburse methadone treatment,” he said.

The other cornerstone of the ACA—exchanges, where individuals and small businesses can purchase affordable insurance—is also a state-by-state matter. California chose as its “benchmark” plan—the one that defines what benefits will be included in the exchange—a plan that doesn’t reimburse for methadone maintenance at all.

Of course, the federal Center for Medicare and Medicaid Services (CMS) has to approve the plans, for both Medicaid and exchanges. AATOD encourages CMS and the Substance Abuse and Mental Health Services Administration (SAMHSA) to include methadone, buprenorphine, and naltrexone for the treatment of opioid dependence as covered, Mr. Parrino said. “That is a critical issue of health care reform.” Since there are only three medications approved to treat opioid addiction, these medications should be part of the essential health benefits package, he said.

John O’Brien, the architect of the substance abuse treatment provisions of the ACA, is at the federal Department of Health and Human Services. He met with the AATOD board December 7, 2012. Mr. O’Brien also met with the AATOD board in Chicago in October 2010, and at that time recommended that states move to have Medicaid reimbursement for methadone maintenance, in order to be prepared for health care reform.

But in states that embrace methadone maintenance, and have a generous plan for Medicaid expansion and a generous benchmark package, there will be increases in patients—although not a “massive influx,” said Philip L. Herschman, PhD, chief clinical officer of CRC Health Group. He said that unlike residential programs, which have fixed numbers of beds, OTPs always have the capacity to expand. “It’s a matter of hiring the right number of counselors and nurses and other staff when you add patients,” Dr. Herschman told AT Forum. “You have to have enough capacity at the window to maintain decent wait times,” he said. “I don’t think there’s unlimited capacity, but there is some capacity in the system.”

But in some states, there are caps on the number of patients a clinic can have, regardless of the staffing, said Dr. Herschman, citing Washington State.

“There is no mandate for Medicaid to cover methadone maintenance,” agreed Dr. Herschman. “I don’t expect any immediate change in which states cover methadone maintenance.  But in those states that already have methadone maintenance, we will see an increase in the number of patients.”

And it’s still not clear whether the exchanges, in which people will choose between different private insurance plans, will cover methadone maintenance. “That’s where the rubber meets the road,” said Dr. Herschman. “Methadone maintenance is not covered now in the vast majority of private plans. That leads one to believe that it won’t automatically be covered.”

 The irony is that one year of treatment in an OTP with methadone is less expensive  than one year of Vivitrol alone or one year of Suboxone film alone— and the treatment in the OTP includes a lot more than giving methadone. “OTPs provide a tremendous service,” said Dr. Herschman. Counseling, not just medication, is included, and treatment is comprehensive.

 Another facet of the ACA—the health home, in which patients receive all medical care in one place—is something that a few OTPs are interested in—mainly ones that are affiliated with hospitals. But in general, it will be “very difficult for an OTP to be a health home,” said Dr. Herschman. Health homes will primarily be multi-specialty physician practices, and some will be mental health homes. “We’ve tried over the years to expand an OTP into a true outpatient substance abuse treatment program, offering all kinds of treatment, including drug-free,” said Dr. Herschman. “If you can expand, you have a chance of being that kind of mental health home,” he said, although CRC had only “limited success.” But making an OTP into a full medical home with primary care and other health services—that is not likely to happen except in rare cases, said Dr.Herschman.

 HHS, CMS, and SAMHSA did not respond to repeated requests for interviews on the topic of health care reform and OTPs.

Chronic Pain in Opioid Treatment Program Patients Typically Untreated

Many patients in opioid treatment programs (OTPs) are likely to have chronic pain, but in many, that pain will not be adequately treated, in part because there are so many problems balancing the methadone they are given for opioid dependence with the types of medications needed to treat pain.

“Most physicians in an OTP have experience treating addiction and pain, I can guarantee that,” said Nicholas Reuter, MPH, senior public health analyst with the Center for Substance Abuse Treatment (CSAT) at the federal Substance Abuse and Mental Health Services Administration (SAMHSA). “I go in and inspect the programs, and I can see patients who obviously have some chronic pain issues. They’re not hard to identify—they have canes, walkers, and scars.”

But OTPs cannot be pain management clinics because of regulations, said Randy Seewald, MD, medical director of the methadone maintenance treatment program at Beth Israel Medical Center in New York City.  “If a patient comes to us and says, ‘I just want methadone once a day for pain,’ we can’t admit them,” said Dr. Seewald, who has a fellowship in pain management. Sometimes patients may say this because they don’t want to admit that they are addicted.

Methadone needs to be given multiple times each day for pain relief. And the federal regulations allow OTPs to dose only once a day, which is adequate to prevent withdrawal.

At Beth Israel, the first OTP in the country, many patients are older, noted Dr. Seewald. “In general as people age, they are more likely to develop chronic pain,” she said, adding that many Beth Israel patients have had significant illnesses, including HIV and hepatitis C. She defines chronic pain as pain lasting 6 months or more.

Study: Epidemiology of Pain in MMT Programs

“We know this is a vulnerable population of chronic pain patients,” said Lara K. Dhingra, PhD, Co-chief of the Research Division in the Department of Pain Medicine and Palliative Care at Beth Israel. “Patients who are on methadone for treatment of their addictive disorder may still require treatment for their chronic pain, and at present there aren’t any guidelines for protocols we should be following with respect to the medication regimen,” said Dr. Dhingra, who works with Dr. Seewald. “The majority of patients are likely to not have their pain treated.”

Dr. Dhingra is the lead author of “Epidemiology of pain among outpatients in methadone maintenance treatment programs,” part of a larger study funded by the National Institute on Drug Abuse (R01DA020781, R01DA020841), published in the August 27 issue of Drug and Alcohol Dependence. Her study (Dr. Seewald and Russell K. Portenoy, MD, chairman of the Department of Pain Medicine and Palliative Care, are among the co-authors) was based on sites in New York and San Francisco in which all patients had hepatitis C. Of the 489 patients in the study, 237 (48.5 percent) had clinically significant pain.

The patients treated their pain with prescribed opioids (38.8 percent of patients), non-opioids (48.9 percent) and self-management approaches, including prayer (33.8 percent), vitamins (29.5 percent), and distraction (12.7 percent). (Some patients used more than one approach.)

The same steps that are followed for people who are not opioid dependent should be followed for OTP patients with chronic pain, said Dr. Seewald. This means diagnosing and trying to treat the cause if possible, starting with non-drug therapies and nonopioid drugs, and considering opioids only if an assessment indicates that these drugs are likely to be safe and effective, and taken in a responsible way over time. In this population, opioids often are viewed as the last resort, but for many OTP patients who have hepatitis C, acetaminophen, with its liver effects, would not be appropriate, and NSAIDs have a high risk of gastrointestinal bleeding, she said.

The primary care provider (PCP) is generally in charge of pain management, said Dr. Seewald. But she noted that the OTP sees the patients much more frequently than either the pain specialist or the PCP, and the OTP is required by the Joint Commission to assess pain at every visit.

Methadone for Pain

Interestingly, methadone can be a great medication for pain in general, because it does not produce the euphoria or rush of other opioids in patients who may be predisposed to this effect, said Dr. Seewald. “Methadone is challenging to use for pain, however, and doctors who do not have experience in using it this way should obtain help before doing so.” 

Although Dr. Seewald did a fellowship in pain management—precisely because so many OTP patients have pain—she does not treat patients for pain alone, even in her private practice. “I’m also a pain specialist, but if I have someone with pain and addiction, I will work with another pain specialist,” she said. “You don’t want to be the only one involved.”

 Need for Training on Opioids and Pain

“The federal regulations don’t say anything about pain treatment,” said Mr. Reuter. “They’re really tailored toward treating dependence.” But OTPs are ideal, in many ways, for dealing with patients who need opioids. With all of the training given to OTP physicians about the pharmacology of methadone treatment, said Mr. Reuter, these physicians would be likely to have more knowledge about opioids and their risks than average physicians. “Methadone is one of the most complicated opioids there are,” he said.

Primary care physicians need to know more about medication-assisted treatment of addiction, but it works both ways—OTPs need to know more about pain, said Dr. Seewald. “I worked in drug treatment with methadone patients for 20 years before I took my pain fellowship. We were never trained to treat pain.”

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