National Institutes of Health Press Release: HHS Leaders Call For Expanded Use of Medications to Combat Opioid Overdose Epidemic

New England Journal of Medicine commentary describes that vital medications are currently underutilized in addiction treatment services and discusses ongoing efforts by major public health agencies to encourage their use

A national response to the epidemic of prescription opioid overdose deaths was outlined in the New England Journal of Medicine by leaders of agencies in the U.S. Department of Health and Human Services (HHS). The commentary calls upon health care providers to expand their use of medications to treat opioid addiction and reduce overdose deaths, and describes a number of misperceptions that have limited access to these potentially life-saving medications. The commentary also discusses how medications can be used in combination with behavior therapies to help drug users recover and remain drug-free, and use of data-driven tracking to monitor program progress.

The commentary was authored by leaders of the National Institute on Drug Abuse (NIDA) within the National Institutes of Health, the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration (SAMHSA), and the Centers for Medicare and Medicaid Services (CMS).

“When prescribed and monitored properly, medications such as methadone, buprenorphine, or naltrexone are safe and cost-effective components of opioid addiction treatment,” said lead author and NIDA Director Nora D. Volkow, M.D. “These medications can improve lives and reduce the risk of overdose, yet medication-assisted therapies are markedly underutilized.”

Research has led to several medications that can be used to help treat opioid addiction, including methadone, usually administered in clinics; buprenorphine, which can be given by qualifying doctors; and naltrexone, now available in a once-a-month injectable, long-acting form. The authors stress the value of these medications and describe reasons why treatment services have been slow to utilize them. The reasons include inadequate provider education and misunderstandings about addiction medications by the public, health care providers, insurers, and patients. For example, one common, long-held misperception is that medication-assisted therapies merely replace one addiction for another – an attitude that is not backed by the science. The authors also discuss the importance of naloxone, a potentially life-saving medication that blocks the effects of opioids as a person first shows symptoms of an overdose.

The article describes how HHS agencies are collaborating with public and private stakeholders to expand access to and improve utilization of medication-assisted therapies, in tandem with other targeted approaches to reducing opioid overdoses.  For example, NIDA is funding research to improve access to medication-assisted therapies, develop new medications for opioid addiction, and expand access to naloxone by exploring more user-friendly delivery systems (for example, nasal sprays). CDC is working with states to implement comprehensive strategies for overdose prevention that include medication-assisted therapies, as well as enhanced surveillance of prescriptions and clinical practices. CDC is also establishing statewide norms to provide better tools for the medical community in making prescription decisions.

Charged with providing access to treatment programs, SAMHSA is encouraging medication-assisted therapy through the Substance Abuse Prevention and Treatment Block Grant as well as regulatory oversight of medications used to treat opioid addiction. SAMHSA has also developed an Opioid Overdose Toolkit  to educate first responders in the use of naloxone to prevent overdose deaths. The toolkit includes easy-to-understand information about recognizing and responding appropriately to overdose, specific drug-use behaviors to avoid, and the role of naloxone in preventing fatal overdose.

“SAMHSA’s Opioid Overdose Toolkit is the first federal resource to provide safety and prevention information for those at risk for overdose and for their loved ones,” said co-author and SAMHSA Administrator Pamela S. Hyde, J.D. “It also gives local governments the information they need to develop policies and practices to help prevent and respond appropriately to opioid-related overdose.”

CMS is working to enhance access to medication-assisted therapies through a more comprehensive benefit design, as well as a more robust application of the Mental Health Parity and Addiction Equity Act.

“Appropriate access to medication-assisted therapies under Medicaid is a key piece of the strategy to address the rising rate of death from overdoses of prescription opioids,” said co-author Stephen Cha, M.D., M.H.S., chief medical officer for the Center for Medicaid and CHIP [Children’s Health Insurance Program] Services at CMS. “CMS is collaborating closely with partners across the country, inside and outside government, to improve care to address this widespread problem.”

However, the authors point out that success of these strategies requires engagement and participation of the medical community.

The growing availability of prescription opioids has increased risks for people undergoing treatment for pain and created an environment and marketplace of diversion, where people who are not seeking these medications for medical reasons abuse and sell the drugs because they can produce a high.

The press release can be accessed at: http://www.nih.gov/news/health/apr2014/nida-24.htm

The New England Journal of Medicine article can be accessed at: http://www.nejm.org/doi/full/10.1056/NEJMp1402780?query=featured_home

Source: National Institutes of Health – April 24, 2014

Study Addresses Treatments for Waited-Listed Opioid-Dependent Individuals

waiting line“Addiction to heroin and prescription painkillers – has reached epidemic levels across the country, with treatment waitlists also at an all-time high. However, ensuring timely access to effective treatment – particularly in rural states like Vermont – has become a substantial problem. University of Vermont (UVM) Associate Professor of Psychiatry Stacey Sigmon, Ph.D., has taken a stand to address this issue and has a new grant to support her campaign.

Sigmon’s latest project, funded by a National Institute on Drug Abuse (NIDA) award, will develop a novel Interim Buprenorphine Treatment (IBT) to help opioid-dependent Vermonters bridge challenging waitlist delays. She’s proposed a treatment “package” of five key components designed to maximize patient access to evidence-based medication for opioid dependence while minimizing common barriers to treatment success, including risks of medication non-adherence, abuse and diversion.”

The five components include:

  • Three months of maintenance therapy using buprenorphine.
  • A, computerized portable device manufactured in Finland called a Med-O-Wheel, which dispenses each day’s dose at a predetermined time, after which all medication is locked away and inaccessible.
  • Clinical support will come from a mobile health platform that uses technology to deliver patient monitoring and support beyond the confines of the medical office.
  • The fourth component involves an automated call-back procedure during which participants are contacted at randomly-determined intervals and directed to visit the clinic for a pill count and urinalysis.
  • Development and provision of an HIV and hepatitis educational intervention delivered via a portable iPad platform.

“These technologies are particularly compatible with rural settings, says Sigmon, where there are multiple burdens – including long distances and transportation barriers – that can make it hard for a patient to come to a treatment center on a daily basis.

Once developed, these treatment components also don’t need to be limited to people on wait lists. In fact, they can also be used to support the physicians with patients already enrolled in a methadone, office-based buprenorphine or pain management clinics,” says Sigmon.”

http://medicalxpress.com/news/2014-04-treatments-waited-listed-opioid-dependent-individuals.html

Source: MedicalXpress.com – April 10, 2014

Infographic: Benzodiazepine Use and Medication-Assisted Treatment

benzo2The Institute for Research, Education and Training in Addictions (IRETA) has prepared an infographic that addresses immediate consequences, long-term effects, and the relationship between benzodiazepine use and medication-assisted recovery.

The infographic is available for free download at: http://iretablog.org/2014/04/10/infographic-benzodiazepine-use-and-medication-assisted-treatment/

Source: The Institute for Research, Education and Training in Addictions – April 10, 2014

Dr. Jana Burson Blog: Drug Interactions with Methadone

“Recently, medical directors of opioid treatment programs in my state pondered how to handle the risk of medication interactions with methadone. In my area of the country, chart reviews of patients who died while taking methadone revealed many decedents were taking other medications with known interactions with methadone. Obviously, we want to prevent these deaths, and need to protect against drug interactions.

To predict a possible drug interaction, the OTP doctor must know all of the other medications that the patient is taking, both prescription and non-prescription. I assume all doctors at opioid treatment programs ask the patients what medications they are prescribed on the first day, along with what they take over the counter. That’s a good start, but often it’s not sufficient.”

http://janaburson.wordpress.com/2014/03/25/drug-interactions-with-methadone/

Source: Dr. Jana Burson – March 25, 2014

Dr. Jana Burson Blog: Insomnia Medications for Patients in Medication-Assisted Treatment

“In one of my recent blog entries, I talked about some simple measures that can help patients with insomnia, called sleep hygiene. Many times these methods can fix the problem, but other times, patients still can’t sleep well, which interferes with life. In these cases, medications may be of some help.”

The “Z” Medications

“The “Z” group of medications includes zolpidem (Ambien), zaleplon (Sonata), and eszopiclone (Lunesta). These medications, which are not benzodiazepines, have been touted as being safer and less addictive than older benzodiazepines, like temazepam (Restoril), triazolam (Halcion) or clonazepam (Klonopin). However, the “Z” medications stimulate the same brain receptors as benzodiazepines, and are all Schedule IV controlled substances, just like benzodiazepines.

I don’t prescribe the “Z” medications for patients on medication-assisted treatment with methadone or buprenorphine because they can cause overdose deaths in these patients. Also, these medications can give many patients with the disease of addiction the same impulse to misuse their medication. I’ve had patients develop problems with misuse and overuse of these medicines.”

Other Medications

Dr. Burson also discusses clonidine, gabapentin and muscle relaxers.

http://janaburson.wordpress.com/2014/04/12/insomnia-medications-for-patients-in-medication-assisted-treatment/

Source: Dr. Jana Burson – April 12, 2014

New Resources and Events Available on ATForum.com

Have you visited ATForum.com lately? Over 30 new meetings, conferences, and webinars have been added to the site in addition to key new resources including the following on medication-assisted treatment.

Neonatal Abstinence Syndrome: How States Can Help Advance the Knowledge Base for Primary Prevention and Best Practices of Care
Association of State and Territorial Health Officials – March 2014.

Confronting the Stigma of Opioid Use Disorder—and Its Treatment
Journal of the American Medical Association – February 26, 2014.

Medication-Assisted Treatment With Methadone: Assessing the Evidence
Psychiatric Services – February 1, 2014.

Medication-Assisted Treatment With Buprenorphine: Assessing the Evidence
Psychiatric Services – February 1, 2014.

Medscape Ask the Pharmacist: Methadone or Buprenorphine for Maintenance Therapy of Opioid Addiction: What’s the Right Duration
Medscape – February 3, 2014. Note: A Medscape account is required to view this article. If you do not have a Medscape account you can create one for free.

Advancing Service Integration in Opioid Treatment Programs for the Care and Treatment of Hepatitis C Infection
International Journal of Clinical Medicine – January 2014.

Advancing Access to Addiction Medications Report
American Society of Addiction Medicine (ASAM) – December 2013.

Medication Assisted Treatment: A Standard of Care. An interview with Elinore McCance-Katz, MD, PhD, Chief Medical Officer, SAMHSA

Edit-Dr.M-KNote: This interview was issued by SAMHSA’s HRSA Center for Integrated Health Solutions in their February 2014 eSolutions newsletter.

“We have a huge need in our country to treat mental health and substance use concerns, and we have a chronic shortage of specialty care programs with enough capacity to treat everyone with a substance use concern. It is our responsibility to expand access to this care in a way that allows greater choice of where individuals can receive treatment.

With the Affordable Care Act, the treatment of substance use disorders is now an essential benefit. Individuals with multiple complex healthcare needs, including mental health and substance use concerns, can be seen in integrated care settings and health homes.

We are going to see more and more integrated care. All healthcare providers, whether in primary care, mental health, or substance use treatment, will need to learn how to provide treatment for disorders they may not have historically treated. Providers who are not used to treating patients with certain types of problems may not feel confident about providing care. When that happens, the individual is less likely to get the care they need. Primary care providers especially will need to be ready to assess and provide treatment for clients who present with mental health and substance use concerns.

The Need for Medication Assisted Treatment

Medication assisted treatment (MAT) is a standard of care. There are a variety of medications that have been shown to be effective in treating substance use disorders and that can be used safely. Specifically, there are a number of FDA-approved medications for tobacco, alcohol and opioid abuse treatments.

MAT is an effective form of care, when medication is taken as prescribed, used properly, and the individual is engaged with other supports and services. With opioid use disorders, studies show that clients who get medical detoxification only have a greater than 90% relapse rate.

We have to think about how effective the treatment is, what the alternative is if not treated, and where an individual is in their recovery. Individuals with chronic relapsing diseases should have access to MAT. It’s just the standard of care. We cannot diminish the importance of that.

Substance use disorders are not simply treated by taking a medication. In fact, taking medications can be part of the problem. Just giving someone medication is not enough. Psychosocial interventions, counseling, and other services are absolutely necessary and will always be very important.

Integrated care providers are going to have to learn about how to use these medications. Many medications can be used within primary care. We’re going to see a spectrum of severity with clients in primary care. Some may need referral to specialty care and others can be treated at the primary care organization.”

The interview can be accessed at: http://www.atforum.com/addiction-resources/documents/SAMHSA-MAT-A-Standard-of-Care-Feb-2014.pdf

Source: The Substance Abuse Mental Health Services Administration – February 2014

Viewpoint: Confronting the Stigma of Opioid Use Disorder—and Its Treatment Published Online in Journal of the American Medical Association

jama-logoIncreasing numbers of overdoses from prescription opioids and a more recent increase in heroin-associated fatalities have caused heartbreak in communities across the country.

Given the severity of this national epidemic, it is time to confront the stigma associated with opioid use disorder and its treatment with medications. By limiting the availability of care and by discouraging people who use opioids from seeking effective services, this stigma is impeding progress in reducing the toll of overdose.

Health care practitioners can counter stigma by adopting accurate, nonjudgmental language to describe this disorder, those it affects, and its therapy with medications. States can promote the provision of comprehensive health services in opioid treatment programs and expand access to effective therapies in the criminal justice system. The public can fight back against the rising threat of overdose by supporting broad access to effective treatment with medications.”

Viewpoint by Yngvild Olsen, MD, MPH; Joshua M. Sharfstein, MD

http://jama.jamanetwork.com/article.aspx?articleID=1838170

Source: The Journal of the American Medical Association – Online February 26, 2014

From NIDA Notes: Medications That Treat Opioid Addiction Do Not Impair Liver Health

A trial that compared buprenorphine/naloxone (Bup/Nx) to methadone produced no evidence that either medication damages the liver. Researchers concluded that Bup/Nx and methadone are equally safe for the liver, and Bup/Nx may be considered a first line alternative to the more established medication for treating opioid addiction.

Dr. Andrew Saxon at the Veterans Affairs Puget Sound Health Care System in Seattle, and Dr. Walter Ling at the University of California, Los Angeles Integrated Substance Abuse Program, conducted the trial with colleagues in the NIDA Clinical Trials Network. Dr. Saxon’s team randomly assigned 1,269 new patients in 8 U.S. opioid treatment programs to therapy with either Bup/Nx or methadone. The study findings reflect the experiences of 731 patients who provided blood samples for liver function tests at baseline, completed the 24 weeks of active treatment, and submitted blood for at least 4 of 8 scheduled tests of liver function during treatment. These tests include measuring the levels of two enzymes (alanine aminotransferase and aspartate aminotransferase) that the liver releases when it is injured.

Most trial participants maintained enzyme levels that indicate healthy liver function throughout the study. In 15.5 percent, enzyme levels increased to higher than twice the upper end of the normal range, indicating some ongoing liver injury. A few patients developed extreme elevations to 10 times the upper limit of normal or had other laboratory signs of severe liver injury.

The percentages of Bup/Nx and methadone patients who experienced each outcome were so close as to be statistically equivalent, warranting the conclusion that both medications were similarly safe. Although the researchers could not definitively rule out the possibility that the medications contributed to some of the observed worsening of liver function, their analysis produced no evidence to this effect. Instead, they say the changes most likely resulted from hepatitis, the toxicity of illicit drugs, and impurities in those drugs. Infection with hepatitis B or C doubled a patient’s odds of a significant change in enzyme levels and was the only predictor of worsening liver function. Most extreme increases in enzyme levels occurred when a patient seroconverted to hepatitis B or C, or used illicit drugs during the study.

The researchers note that about 44 percent of those screened for the study did not meet its enrollment criteria, suggesting that the participant group was healthier than many who visit clinics for addiction treatment. The ineligible population was also older, had a higher rate of stimulant use, and was less likely to be white than patients in the enrolled group, suggesting that the evaluable patient group might not be representative of all opioid-dependent patient groups.

Graphs available at: http://www.drugabuse.gov/news-events/nida-notes/2013/12/medications-treat-opioid-addiction-do-not-impair-liver-health

Source: National Institute on Drug Abuse (NIDA) Notes – December 2013

Q & A – Methadone or Buprenorphine for Maintenance Therapy of Opioid Addiction: What’s the Right Duration?

question boxQuestion: How long should patients with opioid addiction be treated with methadone or buprenorphine?

Response from Michael G. O’Neil, PharmD Professor, Department of Pharmacy Practice; Consultant, Drug Diversion and Substance Abuse, South College School of Pharmacy, Knoxville, Tennessee

“Data supporting positive long-term outcomes after definitive discontinuation of methadone or buprenorphine in a predetermined time frame for all patients are lacking. Prudent clinical practice dictates that duration of therapy should be individualized by well-trained addiction specialists, taking into account a disease treatment history that includes such factors as relapse, individual patient characteristics, evidence-based literature, patient adherence, socioeconomic characteristics, and environmental considerations until long-term evidence-based studies prove otherwise.

In summary, the complexities of the disease of opioid addiction have created a frustrating situation for practitioners and patients alike. Basic practice principles for chronic diseases, such as hypertension or schizophrenia, should be applied to patients who are unable to stay in recovery using abstinence programs alone. Strict discontinuance of opioid maintenance therapy solely on the basis of duration of treatment is not clinically justifiable at this time. Individualization of treatment for opioid addiction with methadone or buprenorphine by qualified specialists is necessary for many suffering patients, in conjunction with counseling, community support, or behavioral interventions. Treatment cultures for opioid addiction need to continue to evolve, as does education of the general public.”

The article can be accessed at: http://www.medscape.com/viewarticle/819875

Source: www.Medscape.com - February 3, 2014

Crime Does Not Increase Around Methadone Clinics in Baltimore

crime purchased shutterstock_78337543“Citizens’ concerns that methadone treatment centers (MTCs) might be focal points for serious crime are unwarranted, a recent NIDA-supported study suggests. Dr. Susan Boyd and colleagues at the University of Maryland School of Medicine in Baltimore found that crime rates in the immediate vicinities of that city’s MTCs were level with the rates in the surrounding neighborhoods.

The researchers used Baltimore City Police Department records from 1999‒2001 and global positioning data to plot the distribution of FBI Part I crimes (homicide, forcible rape, robbery, aggravated assault, burglary, larceny theft, motor vehicle theft, and arson) within a 100-meter (328-foot) radius of 15 MTCs. A statistical analysis of the plots showed that the crimes were no more frequent within 25 meters of the MTCs than they were 75 to 100 meters away.

In contrast to the case with MTCs, the likelihood of Part I crimes rose with closer proximity to convenience stores. The researchers suggest that the high volume of foot traffic around these stores provides opportunities for criminals to find victims. Consistent with this surmise, the frequency of crime declined near mid-block residences, where foot traffic is relatively sparse.

The study MTCs included all but one of the 16 centers located in Baltimore. They were situated in diverse communities, including inner-city, working-class, and middle-class neighborhoods, according to Dr. Boyd. The convenience stores and residences were located in neighborhoods that closely resembled those of the MTCs in demographic and social features that influence crime rates.

“There’s no evidence from our study of increased reports of crime around the methadone clinics,” says Dr. Boyd. She and colleagues are now analyzing data on actual arrests around the study sites to see whether drug sales and possession increase with proximity to methadone treatment centers. The researchers hope that demonstrating that MTCs are not hot spots for crime will reduce public resistance to the building of new centers, and thus remove an impediment to making methadone treatment more widely available.”

See graphs available at: http://www.drugabuse.gov/news-events/nida-notes/2012/12/crime-does-not-increase-around-methadone-clinics-in-baltimore

See related blog available from the Institute on Research, Education and Training in Addictions (IRETA) available at: http://iretablog.org/

Source: National Institute on Drug Abuse (NIDA) Notes – January 2014, IRETA – February 13, 2014

Jana Burson Blog: More about IRETA’s Guidelines for Benzodiazepines in OTPs

blog1“This is a continuation of my last blog post about the IRETA (Institute for Research, Education & Training in Addictions) guidelines for management of benzodiazepine use in medication-assisted treatment of opioid addiction. You can read all of the guidelines at: http://ireta.org/sites/ireta.org/files/Best%20Practice%20Guidelines%20for%20BZDs%20in%20MAT%202013_0.pdf

Under the section of recommendations regarding addressing benzodiazepine use is found the following statement:

“Many people presenting to services have an extensive history of multiple substance dependence and all substance abuse, including benzodiazepines, should be actively addressed in treatment. People who have a history of benzodiazepine abuse should not be disallowed from receiving previously prescribed benzodiazepines, provided they are monitored carefully and have stopped the earlier abuse.”

The experts, after reviewing the best data, are saying that if a patient has abused benzos in the past, but isn’t abusing prescribed benzos now, it may be OK to continue benzos, with careful monitoring.

I don’t like this statement. It doesn’t conform to my present thoughts on the topic. I fear that the majority of patients with a history of benzodiazepine abuse or addiction will, sooner or later, revert back to problem use of the medication. That’s my anecdotal experience. Anecdotal experience is worth something, but data from clinical trials trumps anecdotal experience, and IRETA’s guidelines are based on both clinical trials and expert opinion.

So now I need to challenge my previously held views about benzos in the OTP. It’s unpleasant and uncomfortable to change a long-held view. But isn’t that what I ask of my patients? In the interest of science, I will re-consider my present opinion, but I won’t ignore the last part of the statement, which says careful monitoring needs to be done.”

 http://janaburson.wordpress.com/2014/02/02/more-about-iretas-guidelines-for-benzodiazepines-in-otps/

Source: Jana Burson - February 2, 2014

SAMHSA’s New Report Tracks the Behavioral Health of America

 

samhsa“A new report from the Substance Abuse and Mental Health Services Administration (SAMHSA) illuminates important trends – many positive — in Americans’ behavioral health, both nationally and on a state-by-state basis.

SAMHSA’s new report, the “National Behavioral Health Barometer” (Barometer), provides data about key indicators of behavioral health problems including rates of serious mental illness, suicidal thoughts, substance abuse, underage drinking, and the percentages of those who seek treatment for these disorders. The Barometer shows this data at the national level, and for each of the 50 states and the District of Columbia.

The Barometer indicates that the behavioral health of our nation is improving in some areas. For example, the rate of prescription pain reliever abuse has fallen for both children ages 12-17 and adults ages 18-25 from 2007 to 2011 (9.2 percent to 8.7 percent and 12.0 percent to 9.8 percent respectively).

In the United States, only 14.8% of persons aged 12 or older with illicit drug dependence or abuse (an estimated 1.1 million individuals) in 2012 received treatment for their illicit drug use within the year prior to being surveyed.

The Barometer also shows more people are getting the help they need in some crucial areas. A case in point is that the number of people getting buprenorphine treatment for a heroin addiction has jumped 400 percent from 2006 to 2010. In 2012 the number of people who received buprenorphine as part of their substance abuse treatment was 39, 223. The number of people who received methadone as part of their substance abuse treatment was 311,718 in 2012.

The data in the Barometer is drawn from various federal surveys and provides both a snapshot of the current status of behavioral health nationally and by state, and trend data on some of these key behavioral health issues over time. The findings will be enormously helpful to decision makers at all levels who are seeking to reduce the impact of substance abuse and mental illness on America’s communities.

“The Barometer is a dynamic new tool providing important insight into the “real world’ implications of behavioral health issues in communities across our nation,” said SAMHSA’s Administrator, Pamela S. Hyde.”Unlike many behavioral health reports, its focus is not only on what is going wrong in terms of behavioral health, but what is improving and how communities might build on that progress.”

The Barometer also provides analyses by gender, age group and race/ethnicity, where possible, to further help public health authorities more effectively identify and address behavioral health issues occurring within their communities, and to serve as a basis for tracking and addressing behavioral health disparities.”

To view and download copies of the national or any state Behavioral Health Barometer, please visit the SAMHSA web site at http://store.samhsa.gov/product/SMA13-4796?from=carousel&position=1&date=0130214

http://www.samhsa.gov/newsroom/advisories/1401301041.aspx

Source: – Substance Abuse and Mental Health Services Administration – 1/31/14

From the Publisher—Special Issue on Recovery From Opioid Addiction

people-sunlight

For six decades methadone maintenance has been an approved treatment for opioid addiction. People who are taking methadone are no different from those who manage their diabetes by taking insulin: they are in recovery. Yet some policymakers—and even some medical, and yes, some addiction authorities—don’t believe it. Although that may change as more and more professionals buy into the scientific fact that addiction is a brain disease, and therefore it can be treated, and people can recover from it.

The federal government, from the Substance Abuse and Mental Health Services Administration (SAMHSA) to the Office of National Drug Control Policy (ONDCP), states that medication-assisted treatment (MAT) is recovery. In this issue, we write about a comprehensive literature review funded by SAMHSA demonstrating the efficacy of MAT. And we cover an article by William L. White describing the stigma and other obstacles methadone patients face when joining 12-step groups—and the important role these groups could play in helping patients in recovery. We also interview Walter Ginter, peer, patient, and advocate, who spoke before the ONDCP in December on the topic of recovery and MAT. Mr. Ginter, a methadone patient in long-term recovery, is an articulate spokesman for methadone and for patients, helping to guide peer services across the country from his position at MARS, in New York City. We also interview Zac Talbott, based in the less-welcoming South, about his work as an advocate.

Not all of the news is good: In New Jersey, a state that strongly endorses methadone as a treatment for opioid-dependent pregnant women, a woman is facing child abuse and neglect charges simply for being in a methadone program while pregnant. The Supreme Court is due to hear the case, and legal and medical authorities are hopeful that the court will not in effect ban MAT for pregnant women. The woman was in recovery, doing the right thing for herself and her baby, yet was reported, and was held by a lower court to have committed child abuse and neglect by being on methadone while pregnant. On the bright side, the best legal and medical minds who know about MAT have filed a friend of the court brief on the mother’s behalf.

In Philadelphia, where AT Forum attended the AATOD conference last fall, recovery transformation is happening in a solid way, moving from treating addiction as an acute episode to a continuum instead, in which someone enters recovery as a person, not a patient. Roland Lamb discusses efforts to help opioid treatment programs (OTPs) provide what is needed for recovery, with more of a focus on the person than on the dosage and the monitoring. Methadone is a way to recovery—that’s why it was created—but the person taking it is the point of recovery.

Finally, a new evidence-based document from ASAM provides guidance for safe methadone induction and stabilization in OTP patients. This is the first time this vital information has been brought together in one place. Our article by Stewart Leavitt is recommended reading for everyone interested in methadone maintenance treatment.

I hope you enjoy this issue, and we look forward to your comments and feedback.

Sue Emerson
Publisher

MAT With Methadone or Buprenorphine: Assessing the Evidence for Effectiveness

evidenceIt’s not surprising that a thorough review of the efficacy of medication-assisted treatment (MAT) with methadone or buprenorphine reveals  a high level of evidence for the positive impact of MAT in keeping patients in treatment and reducing or eliminating illicit opioid use.

What is surprising is that the stigma against MAT persists—even though evidence suggests that methadone maintenance treatment (MMT) has a positive impact on drug-related HIV risk behaviors and criminal activity—and thus could make clinic neighborhoods safer, rather than less desirable.

The research findings on MMT and buprenorphine or buprenorphine-naloxone maintenance treatment (BMT) were published in November 2013 in two peer-reviewed articles (see References) as part of the Assessing the Evidence Base (AEB) Series sponsored by the Substance Abuse and Mental Health Services Administration (SAMHSA).

The Assessing the Evidence Base Series

SAMHSA sponsored the AEB Series to help guide providers’ decisions about which behavioral health services public and commercially funded plans should cover. The Affordable Care Act (ACA) greatly expands health care coverage and provides the opportunity “for federal and state agencies to work with private and nonprofit sectors to transform the American health care system” by developing a comprehensive set of community-based, recovery-oriented, and evidence-based services for people with mental and substance use disorders. The ACA doesn’t specify specific treatments, leaving the decision to federal, state, and local agencies, managed care organizations, and commercial and private insurers.

Deciding which services have verified effectiveness isn’t an easy task. To help in the decision-making process, the AEB Series provides a literature evaluation for 14 behavioral health services. For people with substance use disorders, they include, in addition to MMT and BMT, residential treatment, peer-recovery support, and intensive outpatient programs. The goal of the AEB Series is “to provide a framework for decision makers to build a modern addictions and mental health service system for the people who use these services and the people who provide them.”

The Studies

Authors of the MMT and BMT studies searched major databases and other sources to review meta-analyses, reviews, and individual studies from 1995 through 2012.

In brief, the studies found that with adequate dosing, MMT (> 60 mg) and BMT (16 mg-32 mg) caused a similar reduction in illicit opioid use, but MMT was associated with better treatment retention and BMT with a lower risk of adverse events. In pregnancy, MMT and BMT (without naltrexone) showed similar efficacy, but MMT was better than BMT in retaining pregnant women in treatment, and BMT was associated with improved maternal and fetal outcomes, compared to no MAT.

MMT and BMT showed similar occurrence rates of neonatal abstinence syndrome, “but symptoms were less severe for infants whose mothers were treated with BMT.” BMT is associated with a lower risk of adverse events, and has the advantage of greater availability (office facilities improve access and provide earlier care). MMT may be needed for patients who require high doses of opioid agonist treatment, and has the advantage of a possible positive effect on mortality, drug-related HIV risk behaviors, and criminal activity.

The authors advise that MMT “should be a covered service available to all individuals,” and that BMT “should be considered for inclusion as a covered benefit.”

Sprinkled within the two articles are qualifiers such as “possible,” “associated with,” and “suggestive.” That’s because the statistical significance shown in some large, well-designed studies tends to disappear when data from individual studies are merged. Merging changes drug dosages, length of treatment, patient characteristics of the group, and other data; these changes may make reaching statistical significance impossible.

Areas for Future Research

The authors identified several areas where additional data would be helpful. For methadone, these include the impact of MMT on secondary outcomes, the efficacy and safety tradeoffs of doses > 100 mg, and confirmation of results of interim treatment for improved outcome. (In interim treatment, patients receive methadone daily under supervision for up to 120 days, and emergency counseling, while awaiting placement in a program.)  Another research area: the use of MMT in subpopulations—racial and ethnic minority groups, and people who misuse prescription drugs.

For buprenorphine, suggested research areas include the impact of BMT on secondary outcomes, appropriate dosing to enhance outcomes, and confirmation of stepped-care results. (Stepped-care involves gradually increasing buprenorphine doses to 32 mg—higher doses “do not provide additional efficacy;” patients requiring more medication are switched—“stepped-up”—to high-dose methadone.) Other research areas: the use of BMT in subpopulations (described above), and improved induction protocols to minimize retention problems.

A box in each publication summarizes the authors’ findings for each treatment. We reproduce them below, as they appeared in print.

 

Evidence for the effectiveness of MMT: high

Evidence clearly shows that MMT has a positive impacta on:

  • Retention in treatment
  • Illicit opioid use

Evidence is less clear but suggestive that MMT has a positive impact on:

  • Mortality
  • Illicit drug use (non-opioid)
  • Drug-related HIV risk behaviorsb
  • Criminal activity

Evidence suggests that MMT has little impact on:

  • Sex-related HIV risk behaviorsc

 

a Compared with placebo, detoxification, drug-free rehabilitation, or wait-listing
b Sharing injection equipment.
c Having unprotected sexual relations.

 

Evidence for the effectiveness of BMT: high

Evidence clearly shows that BMT has a positive impact compared with placebo on:

  • Retention in treatment
  • Illicit opioid use

Evidence is mixed for its impact on:

  • Non-opioid illicit drug use

 

Regarding retention in treatment and illicit opioid use, BMT had a positive effect compared to placebo, while MMT had a positive effect compared to placebo, detoxification, drug-free protocols, or wait-listing protocols.

Closing Statements

The authors note the importance of MAT, especially considering the poor success rates of abstinence-based treatments, and recognize both MMT and BMT as important treatment options. Below are summaries of their closing statements.

Methadone: The authors point out the need for educating providers, consumers, and family members about the benefits of MMT and ways to avoid the significant adverse events that can occur (referring to respiratory depression and cardiac arrhythmias). They also note the need for education about “appropriate doses to improve efficacy” and “appropriate initiation to minimize adverse events.”

They close with: Because of MMT’s relative efficacy, efforts should be made to increase access to MMT for all individuals who struggle with opioid use disorders. Directors of state mental health and substance abuse agencies and community health organizations should look for methods to increase access to MMT, and purchasers of health care services should cover appropriately monitored MMT.”

Buprenorphine: Noting the key advantage of buprenorphine—its availability—and the “limited access to and more restrictive safety profile of MMT,” the authors consider BMT an important treatment for opioid dependence. “Policy makers have reason to promote access to BMT for patients in substance use treatment who may wish to choose BMT as a potentially safer alternative to MMT.

They close with: “Administrators of substance use treatment programs, community health centers, and managed care organizations and other purchasers of health care services, such as Medicare, Medicaid, and commercial insurance carriers, should give careful consideration to BMT as a covered benefit.”

#     #     #

References

Fullerton CA, Kim M, Thomas CP, et al. Medication-assisted treatment with methadone: assessing the evidence. Psychiatric Services in Advance. November 18, 2013; doi: 10.1176/appi.ps.201300235.

Thomas CP, Fullerton CA, Kim M, et al. Medication-assisted treatment with buprenorphine: Assessing the Evidence. Psychiatric Services in Advance. November 18, 2013; doi: 10.1176/appi.ps.201300256.

Dougherty RH, Lyman DR, George P, Ghose SS, Daniels AS, Delphin-Rittmon ME.

Assessing the Evidence Base for Behavioral Health Services: Introduction to the Series.

Psychiatric Services. 2014; doi: 10.1176/appi.ps.201300214

http://ps.psychiatryonline.org/article.aspx?articleID=1759202

Walter Ginter on the Importance of Peers in Recovery With Medication-Assisted Treatment

walterStigma is a common theme among people seeking recovery from the disease of opioid addiction, but it’s particularly poignant for people in medication-assisted treatment (MAT), because stigma can itself prevent recovery from taking place. People who don’t understand MAT—and that’s a big group, including many employers, politicians, and even friends and family members—don’t believe methadone or buprenorphine treatment means being in recovery. But it does. And that’s the message that Walter Ginter, CMA, project director of Medication- Assisted Recovery Services (MARS), and the country’s foremost patient advocate, brings to patients. On December 9, he brought this message to the first White House drug policy conference.

Sponsored by the Office of National Drug Control Policy (ONDCP), the conference included a panel that focused on stigma and drug addiction. Michael Botticelli, deputy director of the ONDCP, and himself in recovery, invited Mr. Ginter to participate. “He called me himself to ask me to be on that panel, and afterwards I got a nice handwritten note from him thanking me for participating,” said Mr. Ginter.  Mr. Botticelli, formerly the official in charge of substance use disorder services for Massachusetts, is a strong supporter of MAT. “This direction and focus that we are seeing from the Obama Administration is encouraging,” continued Mr. Ginter “It would strengthen that effort to see Mr. Botticelli promoted and the recovery community is hopeful that he will fill the opening as director of the ONDCP.”

 Stigma Impedes Recovery

The main stigma patients face in terms of methadone comes from believing what people who know nothing about MAT tell them. They learn to believe the myth that methadone is a substitute drug, and that they aren’t really in recovery. What peer recovery support services can do for patients is to help them eliminate feelings of stigma by helping them understand that they are in treatment with a medication, just like someone with any other disease. “If people come into treatment with the idea that methadone is just substituting one addiction for another,” said Mr. Ginter, “that attitude makes them feel as if recovery isn’t an option, for them. This discouraging prospect sets the stage for a less than optimal outcome. They ask themselves what difference does it make if they use a little benzodiazepines or smoke a little pot, if recovery isn’t an option anyway? That is how stigma stops patients from achieving recovery.”

 Peers Believe Peers

Peers—other people who are in MAT—can help support patients’ recovery in a way that nobody else—not a physician and not other people who are not taking methadone—can. “In the recovery community, you always hear people say they ‘support all pathways to recovery,’” said Mr. Ginter, “but often this is just lip service and not really an endorsement, with too many anti-MAT people weighing in and adding to the stigma. A lot of people support it and understand it’s evidence based practice, but still they don’t accept it as a legitimate pathway.”

At the MARS project, patients learn from peers that methadone and buprenorphine are “not substitute drugs, they’re medications,” said Mr. Ginter. “And suddenly, that person is a candidate for recovery. Before that, they never had a choice.”

When people are given the option of being in recovery, they choose it. Once they realize that taking methadone or buprenorphine is not the same as using, they stop using other drugs and alcohol. Yes, they were in treatment, but neither the opioid treatment program nor the physician could convince them that they were in recovery—it took another person in MAT to do that. “Peers believe things from other peers that they would not believe from anyone else,” said Mr. Ginter.

 Feeling Good

One of the magical things about erasing stigma is this: Once people start to feel good about themselves, the community starts to look at them differently. That’s why one exercise patients can use is to write down three nice things that happen each day.“ At the end of a few weeks, people start to feel better,” said Mr. Ginter. “For us to do well in recovery, we have to feel good about ourselves.”

Calling addiction a brain disease—which it is—takes away a lot of guilt, said Mr. Ginter. That internal feeling of guilt is magnified by stigma coming from the outside world.

In some ways, stigma from the outside world isn’t getting any better. “There are these nice dissertations out there about your rights, but if you’re in jail because you got picked up outside your methadone clinic, you can’t tell the cop he’s wrong,” said Mr. Ginter. It would help if drug courts and parole officers saw more patients for whom treatment is working, and not just those for whom it isn’t, he added.

Finally, fear of stigma keeps people from even saying that they are on buprenorphine or methadone. Thousands of people are doing well in treatment—not just the few, like Mr. Ginter, who publicly identify themselves.

As an anecdote illustrating this, Mr. Ginter related that visitors from overseas at the MARS booth at the AATOD conference last fall were amazed that two of the people working at their display booth were patients. “They couldn’t believe that peer recovery support services were provided by ‘real’ methadone patients,” he said.

 Other Participants

The ONDCP half-day meeting also featured panels on public health approaches to drug policy, being “smart on crime” instead of “tough on crime,” with an emphasis on drug courts using MAT, and a screening of The Anonymous People. Mr. Ginter related that the drug court speaker, magistrate Alby Zweig from Denver, was shocked to hear that many of his colleagues require participants to stop using methadone or buprenorphine before they can be admitted.

Note: MARS is a project of the National Alliance of Medication-Assisted (NAMA) Recovery. NAMA chapters are small groups of individuals who organize around advocacy to teach patients about their rights and to support them in their rights. Patient advocates are not the same as peer recovery support.

For more information, go to www.marsproject.org.

Recovery Transformation in Philadelphia OTPs: Person-centered, not Patient-centered

RecoveryOver a decade ago, Philadelphia’s public health system moved toward recovery for mental health and addiction services. On the mental health side, there had been a belief that recovery wasn’t possible, especially for people with serious mental illness. On the addiction side, recovery was already in wide parlance, but the system was set up to treat the disorder as if it was acute, with no long-term or continuous follow-up care, resulting in relapses. Now, Philadelphia has taken great steps to bring along its providers in adopting a recovery-based framework. We caught up with Roland Lamb, director of addiction services for the Philadelphia Department of Behavioral Health and Intellectual disAbility Services (DBHIdS) to get an update on the recovery transformation as it affects patients in medication-assisted treatment (MAT).

“The good news is that we have moved towards more of a person-centered perspective in MAT,” Mr. Lamb said. In other words, providers are learning to look at people as people, not patients.

“We have the richest environment for MAT, with all levels of care,” he told AT Forum. He added that not only is there outpatient methadone, but there is medication-assisted treatment in all levels of care, and there are efforts to reach out to the 144 physicians in the system who are certified to dispense buprenorphine, and to provide access to those they are seeing to all of the treatment resources in Philadelphia.

The Medication ‘Culture’

But, because of the oversight and stigma, it has been a struggle to get providers to focus on the fact that people are people first, and not patients to be “dosed and monitored,” Mr. Lamb said. “The bad news is that we still have to work to overcome the stigma-driven culture of managing the medication, instead of treating addiction and focusing on recovery.”

This medication “culture” isn’t completely the fault of the opioid treatment programs (OTPs), Mr. Lamb noted. “It’s the most regulated form of treatment—in health care—that there is,” he conceded. The preoccupation with regulations, one drug after another, and the diagnosis, is at the cost of focusing on treating the addiction and supporting recovery and other needs. “People lose sight of managing the addiction.” Yes, methadone maintenance is part of recovery, but the medication isn’t the only part of it. “This treatment was created to help people get into recovery, but recovery is more than the medication alone.”

Buprenorphine—the medication—is not on the DBHIDS formulary, said Mr. Lamb. “But we do pay for all the services that surround it—the physical exams, counseling, and the drug screens.”

But whether those in care are taking methadone or buprenorphine, the focus has to be on the individual, said Mr. Lamb. “We are making sure that our providers have what they need—good assessment instruments, evidence-based practices, and psychiatric supports.”

There is a high prevalence of co-occurring mental illness in the MAT population, said Mr. Lamb. “We know a lot of what has happened with those co-occurring illnesses to those in care, who in many cases are self-medicating the very illnesses that they need help with.”

The DHBIdS meets with MAT providers every two months. These include inpatient and outpatient MAT providers, and the state licensing authority and the Drug Enforcement Administration are present as well.

No Involuntary Discharges

One of the key patient-centered initiatives in Philadelphia is this: “We say we don’t want involuntary discharging going on,” said Mr. Lamb, noting that “noncompliance” in addiction treatment is no worse than it is in treatment for high blood pressure or type II diabetes, and that terminating treatment is no solution. The reason for discharge may be violence, or threats of violence, for example, but many times this behavior is a result of untreated mental illness, said Mr. Lamb. Other reasons for discharge are drug dealing on the premises, or, of course, noncompliance with the treatment plan, but aren’t they some of the very reasons treatment is needed?

“We see ourselves as being in a partnership in terms of trying to overcome these issues,” said Mr. Lamb. The person in recovery, the providers, the regulators, and the payers all need to be at the recovery table to make this work.

Another point about person-centered care: OTPs should treat people based upon their need. For example, Pennsylvania requires two and a half hours a month of counseling—but patients should get more if they need it, said Mr. Lamb. “The issue for us is that we want to see counseling based upon the needs of the person.” That’s why the DBHIdS pays based on how much counseling is given. “We track the counseling separately.”

Training in CBT, Other Modalities

“The real challenge for us is to get staff to rethink what they’re doing,” said Mr. Lamb. “We’ve been doing it one staffer at a time.” Staffers are getting training in cognitive behavioral therapy (CBT), dialectal behavioral therapy (DBT), trauma, and the sanctuary model, he said. “All of these are evidence-based practices that we’ve been paying our providers to get trained in.”

There are 11 providers operating 13 OTPs in Philadelphia, treating a total of 5,000 patients a day. “When you think about it, that’s approximately 400 people coming in every day,” said Mr. Lamb. “It would be better if we could have smaller numbers of people in each facility, and more facilities.” He noted that community complaints about traffic would then go down. Of course, for that to happen, there would have to be community cooperation in siting clinics. “There is still so much stigma,” said Mr. Lamb, noting that this comes from the “outside” community and from the drug-addiction treatment community itself.

“Through a recovery focus we have a chance to change the usual ‘down with methadone’ discussion to a discussion about solutions for long-term opioid dependence and long-term recovery,” Mr. Lamb said. This is especially important now, with the burgeoning cohort of people becoming addicted via the non-medical use of prescription opioids, and their conversion to heroin. We need to do a better job of reaching out to, engaging, and retraining this population if we are going to impact the growing number of overdose deaths we are seeing, said Mr. Lamb. “We also need to evolve the recovery focus to one of wellness, and the need for those who are actively recovering to take better care of their health.”

Is Maternal Methadone Treatment Child Abuse and Neglect? New Jersey Supreme Court to Weigh In

pregnant woman jpegOne year after the New Jersey Supreme Court ruled that a pregnant woman did not commit child abuse just because she tested positive for cocaine, the state has brought a similar case to the court: that of a pregnant woman who was in methadone treatment in an opioid treatment program (OTP).

This January, experts in addiction treatment and maternal and fetal health filed a friend of the court brief before the New Jersey Supreme Court, urging it to overturn a lower court ruling in which a pregnant woman in a methadone treatment program was charged with child abuse and found guilty.

In the cocaine case, on February 6, 2013, the New Jersey Supreme Court unanimously held that the state’s child protection laws don’t give child welfare authorities control over pregnant women, and that positive drug test results alone on pregnant women and newborns do not establish neglect. That case involved positive test results for cocaine. The Supreme Court held that those positive test results did not by themselves show maternal neglect.

Here’s the situation now: The state wants to call it child abuse if a woman takes prescribed methadone while pregnant. This is despite the fact that the state has a robust system in which methadone is recommended for pregnant women.

The case involves a woman—YN—who was dependent on opioid pain relievers when she learned she was pregnant. Her medical providers recommended that she obtain methadone treatment and other care, which she did, and she subsequently gave birth to a healthy baby. The baby was successfully treated for neonatal abstinence syndrome (NAS), a predictable treatable and transitory, possible side effect of maternal methadone treatment.

But because of the NAS, YN was reported to the Division of Child Protection and Permanency (DCPP, formerly the Division of Youth and Family Services), and was judged by the lower court to have abused or neglected her child. In effect, the lower court is rewriting the law by applying child abuse statutes to pregnant women and their fetuses, according to the friend of the court brief.

Advocates hope that the Supreme Court will rule, as it did last year, in favor of the mother. Lawrence S. Lustberg, of Gibbons P.C., co-counsel for the amici, said that “the New Jersey Supreme Court has been a national leader in recognizing that when cases raise scientific, medical, or other technical issues, the evaluation of these issues must be informed by existing scientific knowledge, including expert testimony.” He added, “This case should not be an exception, yet, the decision in the lower court was reached without the input of a single medical expert and without considering the established science addressing the value of methadone treatment to maternal, fetal, and child health, and other key health and social welfare issues in the case.”

“As a matter of medicine and health care, it is simply nonsensical to regard methadone treatment as a form of child abuse,” said Robert Newman, MD, one of the experts represented in the brief. “Decades of research unequivocally demonstrate the benefits of treating a pregnant woman’s addiction to opioids with methadone, an extraordinarily well-studied medication whose benefits to the mother as well as the baby unquestionably outweigh the treatable and transitory side effects that are sometimes seen in the newborns.” He noted that “It is not recommended that women simply stop using opiates during pregnancy” and that “methadone and other related treatments are acknowledged by national and international governmental, academic, and clinic authorities to be the best choice for maternal, fetal, and child health, reducing risks of miscarriage, stillbirth, and premature birth.”

The bottom line: YN was in recovery. But unless the lower court’s ruling is reversed, New Jersey will effectively be the first state in the country to ban pregnant women from receiving methadone treatment, said Lynn Paltrow, Executive Director of National Advocates for Pregnant Women (NAPW) and co-counsel representing the experts. Not only do the DCPP’s actions “fly in the face of the recommendations of the World Health Organization and the U.S. government, but New Jersey itself, which, through collaborations between the New Jersey Department of Mental Health and Addiction Services and DCPP, provides methadone treatment to pregnant women and families in the child welfare system.”

The Legal Action Center signed on to the amicus brief and strongly supports the NAPW.  “It is wrong, counterproductive, and dangerous to charge a pregnant woman with child abuse simply because she is in a methadone maintenance program,” Sally Friedman, legal director for the Legal Action Center, told AT Forum. “Singling out pregnant women receiving methadone maintenance treatment also can violate anti-discrimination laws.” Ms. Friedman added that child welfare authorities “need to act on the basis of medical evidence, not myths.” The best way for OTPs to make sure that their patients aren’t reported is to educate, added Ms. Friedman.

The mother, YN, is represented by Clara S. Licata and T. Gary Mitchell.

For the friend of the court brief filed January 9, go to http://advocatesforpregnantwomen.org/briefs/DYFS%20v.%20YN%20-%20Amended%20Supplemental%20Brief%20and%20Appendices.pdf

Guidance Provided for Safe Methadone Induction and Stabilization in OTP Patients By Guest Author Stewart B. Leavitt

doctor and patient jpeg winter 2014Expert opinion from ASAM stresses safety during MMT start-up   

For roughly half a century, methadone dispensed in federally certified opioid treatment programs (OTPs) in the United States has been a well-studied, effective, and relatively safe addiction therapy. Yet, there have been ongoing incidents of methadone-associated overdoses and deaths, largely due to its widespread prescription and frequent misuse as a pain reliever, but also to a lesser extent in patients attending OTPs.

When properly prescribed and used in OTPs, methadone has a favorable safety profile; however, there can be special risks of overdose and death from methadone during start up and early phases of treatment. To address these concerns, the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) invited the American Society of Addiction Medicine (ASAM) to convene an expert panel to develop a consensus statement on methadone induction and stabilization, which provides recommendations for reducing risks of overdose or death related to the methadone maintenance treatment (MMT) of addiction.

Methadone Start-Up Takes Time and Caution

A distinguished panel of 10 experts in the MMT field—the “Methadone Action Group,” including Drs. Louis Baxter, Anthony Campbell, Michael DeShields, Petros Levounis, Judith Martin, Laura McNicholas, Tom Payte, Ed Salsitz, and Trusandra Taylor, along with Bonnie Wilford, MS—conducted a comprehensive literature search spanning 1979-2011. The group evaluated the resulting information and collaborated in formulating a best practices consensus document, which was subsequently reviewed and commented on by more than 100 experts in the addiction treatment field.

The final document, published in the November/December edition of ASAM’s Journal of Addiction Medicine [Baxter et al. 2013; PDF here], extensively focuses on safety during the 3 most critical phases of starting MMT: A. methadone induction (weeks 1-2); B. early stabilization (weeks 3-4); C. late stabilization (weeks 5+).

According to the medical literature examined by the expert panel, overdoses and deaths during methadone induction most commonly may occur either because 1) the initial dose is too high, 2) the dose is increased too rapidly, or 3) the prescribed methadone interacts with another drug. Therefore, the panel developed recommendations that help methadone providers avoid or minimize these risks.

When it comes to the initial methadone dosing at MMT start-up, the panel stresses the traditional advice to “start low, go slow.” Acknowledging the difficulties of accurately assessing a new patient’s opioid tolerance—and, therefore, a definitely “safe” methadone dose—the initial dose of methadone should typically range between 10 mg to 30 mg per day. An additional 5-10 mg/day is allowed if necessary to help relieve persistent withdrawal symptoms; however, the standard in the U.S. is that the total daily dose should not exceed 40 mg.

There are a number of high-risk situations to consider that may prompt low initial dosing. These include patient age >60 years, recent use of sedating drugs (e.g., benzodiazepines), alcohol abuse or dependence, concurrent physical disorders (e.g., respiratory or cardiac disease, sleep apnea, central nervous system depression, and others), or taking medications that either increase or decrease methadone metabolism.

It is essential to medically assess patients at intake and closely monitor their response to therapy. It may take several weeks before an optimal methadone dose can be safely achieved, during which time symptoms of withdrawal may persist to some degree, especially late in the day or during the night.

The ASAM panel states that the first day’s methadone dose may be increased “every five or more days in increments of 5 mg or less” [note that this dose increase is at the low end of what previous guidance has recommended]. Because methadone levels accumulate gradually before reaching a steady state, whereby opioid withdrawal is prevented throughout a 24-hour period, patients should be carefully assessed and they often need more time for full effects to be realized rather than more daily methadone during the induction period.

The first 2 weeks of MMT are a critical period from a safety standpoint, and the ASAM expert panel discusses the many subtle factors that may influence a patient’s therapeutic response to methadone and also affect clinical impressions of overmedication. For example, individual patient differences in metabolism may alter the duration of methadone effects; furthermore, in some cases, overmedication may be marked by unexpected feelings of excess energy, with or without euphoria.

Beyond the first 2 weeks—during early and late stabilization—the objective is to achieve a methadone maintenance dose allowing the patient to live a better life free of withdrawal symptoms, drug intoxication or excessive sedation, or troublesome drug craving. Various factors may upset this process—e.g., changes in physical health, psychological distress, continued substance abuse, etc.—so ongoing patient assessments and methadone dose adjustments may be necessary in some cases for an extended period of time. The ASAM expert panel does not comment on what optimal methadone dosing eventually might be, other than to note that “some patients require doses larger than 120 mg/day” for blocking euphoric effects of self-administered (e.g., illicit) opioids.

This new evidence-based document from ASAM is the first time all of this vital information has been so extensively brought together in one place; so, it is recommended and important reading for all persons involved or interested in MMT. At the same time, the principles and best practices described are not entirely new; indeed, this topic was previously discussed, although more briefly, in past AT Forum articles [see Special Report 2003 and ATF fall 2006]. Additionally, in 2007, a methadone induction instruction handout for patients and significant others was made available to AT Forum readers by Tom Payte, MD (who also is one of the Methadone Action Group panel members) [PDF here].

Education and Preparedness Are Essential

Methadone overdose can have a deceptive and slow onset, and the ASAM panel stresses the importance of patient and family education beginning with intake into MMT. Involvement of family [or significant others, and presumably with patient consent] can be a critical safety measure by helping to ensure that they understand the lengthy process of methadone induction and stabilization, as well as the signs/symptoms of overmedication and overdose to watch for along the way. Being able to recognize therapeutic risks and potential problems, and knowing appropriate actions to take if problems do occur, are essential for OTP staff, patients, and patients’ families.

Unfortunately, in the ASAM document there is only a single mention of naloxone, which is an effective and safe antidote for methadone overdose. It states, “Opioid treatment programs should establish protocols for emergency response to and management of patient overdoses, including onsite availability of naloxone and any necessary support and education for families.”

Indeed, there appears to be growing interest in the U.S. (and in other countries) in making naloxone more widely available to patients, their families, and others for helping to reverse opioid overdose in an emergency—whether involving prescribed or illicit opioid agents. For example, Washington State has an aggressive program of naloxone distribution [see StopOverdose.org] and the ASAM expert panel references an “Opioid Overdose Prevention Toolkit” from SAMHSA [PDF here]  that discusses how to identify overdose and the use of lifesaving naloxone. Methadone overdose in MMT—what to know; how to prevent it; what to do if it happens (including naloxone) —was the theme of a past edition of AT Forum [Summer 2007 PDF].

In sum, careful management of methadone induction and stabilization, coupled with patient/family education and increased clinical vigilance by staff, can be lifesaving measures during MMT. According to Louis Baxter, MD—ASAM immediate Past-President and chair of the expert panel—in a press release [PDF here], “The use of methadone to treat addiction has saved countless lives in the last 50 years, but it also has an increased risk of toxicity and adverse events for the patient during the medication’s induction and stabilization phases. The protocols designed by the ASAM expert panel could dramatically decrease these negative outcomes if all clinicians prescribing methadone would follow them.”

References

Baxter LE, Campbell A, DeShields M, Levounis P, Martin JA, McNicholas L, Payte JT, Salsitz EA, Taylor T, Wilford BB. Safe Methadone Induction and Stabilization: Report of an Expert Panel. J Addiction Med. 2013(Nov/Dec);7(6):377-386. PDF available at: http://www.asam.org/advocacy/find-a-policy-statement/view-policy-statement/public-policy-statements/2013/11/26/safe-methadone-induction-and-stabilization. Access checked 1/29/2014.

Leavitt SB. Methadone Dosing & Safety. AT Forum [special report]. 2003 (September). PDF available at: http://www.atforum.com/SiteRoot/pages/addiction_resources/DosingandSafetyWP.pdf. Accessed 1/27/2014.

Methadone Overdose in MMT. AT Forum. 2007(Summer);16(3). PDF available at: http://atforum.com/pdf/Summer07_news.pdf. Access checked 1/29/2014.

Payte JT. Methadone induction instructions to patients and significant others. CMG Induction Handout v7; 2007. PDF available at: http://atforum.com/pdf/PayteSafetyInstructions.pdf. Accessed 1/29/2014.

Safely starting methadone in MMT. AT Forum. 2006(Fall);15(4). PDF available at: http://atforum.com/SiteRoot/pages/current_pastissues/2006Fall.pdf Accessed 1/27/2014.

SAMHSA (Substance Abuse and Mental Health Services Administration). Opioid Overdose Prevention Toolkit. Rockville, MD: HHS Publication No. (SMA) 13-4742; 2013. PDF available at: http://store.samhsa.gov/shin/content//SMA13-4742/Overdose_Toolkit_2014_Jan.pdf. Access checked 1/29/2014.

StopOverdose.org. University of Washington Alcohol & Drug Abuse Institute. 2013. Website at: http://www.stopoverdose.org/pharmacy.htm. Access checked 1/29/2014.

————————————————————————————
Stewart B. Leavitt, MA, PhD, is a former editor of Addiction Treatment Forum and most recently was director/editor of Pain Treatment Topics.

The Joint Commission: Revised Requirements for Opioid Treatment Programs (OTPs)

Joint CommissionOn January 15 the Joint Commission issued for prepublication revised requirements for opioid treatment programs that will become effective March 23. The requirements address four areas:

  • Care, Treatment, and Services
  • Information Management
  • Medication Management
  • Rights and Responsibilities of the Individual

The prepublication requirements can be accessed at:

http://www.jointcommission.org/assets/1/18/Opioid_BHC.pdf

Source: The Joint Commission – January 15, 2014

Site last updated July 17, 2014 @ 5:55 pm