New AATOD Policy Statement: Increasing Access to Medication to Treat Opioid Addiction

AATODEarlier this month AATOD issued a policy paper “Increasing Access to Medication to Treat Opioid Addiction – Increasing Access for the Treatment of Opioid Addiction with Medications.” AATOD noted that “this paper raises a number of questions in order to stimulate a thoughtful policy discussion given the urgency of the public health crisis of untreated opioid addiction”.

The statement provides a discussion of: the value of providing comprehensive treatment services to treat a complicated illness, current policy debates on OTPs, DATA 2000 practices, reports of medication diversion, and future policy considerations

http://www.aatod.org/wp-content/uploads/2014/07/MAT-Policy-Paper-FINAL-070214-2.pdf

Source: The American Association of the Treatment of Opioid Dependence – July 2, 2014

 

Overdose Deaths from Opioids, Heroin on the Rise

News Update 7-18-14“Overdose deaths from both prescription opioids and heroin increased in 2011, the most recent year available, according to new data from the U.S. Centers for Disease Control and Prevention.

While prescription opioid deaths followed a more than decade long trend and increased by about 2% from 2010 to 2011, to 16,917; heroin deaths jumped by about 44% in the same span of time to 4,397.

Officials with the CDC said the increase in heroin deaths may be partly due to users having less access to prescription opioids and switching to the illicit drug.

Leonard Paulozzi, a physician and researcher with the CDC, said about 75% of heroin users say they started out by using prescription opioids.

Paulozzi said doctors need to do a better of job of screening for opioid abusers by checking prescription drug monitoring programs in their states for patients who are doctor shopping and using urine screens to detect if they are using illicit drugs.”

http://www.jsonline.com/watchdog/watchdogreports/overdose-deaths-from-opioids-heroin-on-the-rise-b99302962z1-265452991.html

Source: Milwaukee Journal Sentinel – July 2, 2014

How Heroin Baggies are Marketed Like iPhones

“Nine years ago, when Graham MacIndoe was living in New York City and addicted to heroin, he started collecting the small glassine bags that held the drugs he bought. MacIndoe was a commercial photographer, and even in the grip of a years-long addiction that would ultimately leave him broke, imprisoned on Riker’s Island, and facing deportation, he became interested in the baggies on a visual level.

“There was just something about the design, the typography, the branding,” MacIndoe tells Quartz. “And just being around the drug trade myself, the promises that were in the bags—of good times and money, and this elusive lifestyle that you thought drugs would bring you.

MacIndoe found that marketing in the underground economy mirrored the corporate one in other ways. Special offers often accompanied a new drug’s introduction. Popular brands quickly attracted imitators, who adopted the visual look of the packaging but filled it with a lower-quality product. A kind of built-in obsolescence was common too, with suppliers “cutting” (i.e., adulterating) initially potent brands to maximize profits—a pressure to upgrade that MacIndoe compares to Apple’s strategy with the iPhone. “They’re giving you a product that seems really great at the time,” he says, “and then after a little while you realize you’ve got to move on, because they’re telling you something else is better—and they’re making it better intentionally so you’ll move on to a different brand.”

http://qz.com/229470/how-heroin-baggies-are-marketed-like-iphones/

Source: Quartz – July 7, 2014

FDA Designates Opioid Overdose Treatment for Fast Track Development Program

FDA“A Kentucky company headed by a recognized expert in nasal delivery of medication says its intranasal naloxone spray, a drug designed to treat opioid overdoses, has received Fast Track designation from the Food and Drug Administration (FDA).

The Fast Track program of the FDA is designed to expedite the development and review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track-designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process. AntiOp and the FDA may also be able to employ additional tools to expedite the FDA review process such as “rolling submission,” whereby AntiOp may submit portions of the new drug application (NDA) in a staged NDA submission process.”

http://www.marketwatch.com/story/fda-designates-opioid-overdose-treatment-for-fast-track-development-program-2014-07-15 

Source: MarketWatch.com – July 15, 2014

 

 

Across The US, An Explosion of Addiction

heroin and injection“Over the last 18 months, The Cincinnati Enquirer has used a team of reporters to cover the heroin problem locally. We joined with Gannett papers in Arizona, Delaware and Vermont for this series on heroin nationally.”

Part IThe Resurgence Of The Deadly Drug Has Sparked A Flurry Of Action From Governors’ Mansions And Statehouses Across New England And The Midwest To Small-Town Police Stations From Northern Kentucky To Wisconsin

Part II – Heroin’s Hidden Journey – Nearly All Heroin Fueling A U.S. Resurgence Enters Over the 1,933-Mile Mexico Border

Part III – Heroin addicts left trapped; families, heartbroken

Part IV – Scanning the battlefield in war on heroin

Part V – In Vermont, on the front lines of war on heroin

Source: USAToday.com – June 12, 2014

Heroin Users Are 90 Percent White, Living Outside Urban Areas

“The image of the heroin user is changing, according to researchers who say the great majority are now white men and women who mostly live outside the cities.

Their study published in JAMA Psychiatry, tracked data from almost 2,800 heroin users and found that first-time users are now generally older than those who began taking the drug in the 1960s. About 90 percent are white, according to the study, and 75 percent now live in non-urban areas.

The research also confirmed a link between the rise of opioid abuse and the growing use of heroin that had been noted in earlier studies. Heroin use has jumped 80 percent to 669,000 users from 2007 to 2012, according to the National Survey on Drug Use and Health, after being relatively stable since 2000.”

http://washpost.bloomberg.com/Story?docId=1376-N6AV3H6S972C01-71HUL1EQ4U5J4QKSAPSPOBBT5I

See related article  - Opioids leading to new class of heroin abusers, study finds at: http://www.jsonline.com/news/health/opioids-leading-to-new-class-of-heroin-abusers-study-finds-b99278535z1-260996001.html

Source: WashingtonPost.com – May 29, 2014

Drugs for Treating Heroin Users: A New Abuse Problem in the Making?

“Evidence is mounting that certain drugs used to treat heroin users are themselves being sold on the streets – and may even be a ‘gateway’ to heroin or opioid use. As some experts herald their value for treating addiction, others ask if the ‘cure’ is making things worse.

More than a decade ago, the FDA partnered with a British company to develop Suboxone, a new treatment for addiction to opioids. But that effort has had highs and lows, experts say. Lifesaving to some opioid abusers, Suboxone and generic drugs like it have not helped others to whom they have been prescribed – in part, these experts say, because of poor oversight of how the opioids are dispensed and used.

Those drugs have also ended up where the U.S .government hoped they wouldn’t: on the street, where they are sold in the same illicit subculture in which heroin and prescription painkillers are peddled.”

http://www.csmonitor.com/USA/Society/2014/0530/Drugs-for-treating-heroin-users-a-new-abuse-problem-in-the-making

Source: Christian Science Monitor – May 30, 2014

To Beat Heroin Addiction, A Turn To Coaches

“Recommendations out this week from a task force on opiate abuse include more peer support and home-based counseling. Health insurers and state Medicaid leaders say they will look at funding for recovery coaches, but there is no plan to do so right now.

Across the country, there’s growing interest in using recovery coaches to help heroin users stop, says Robert Lubran, director of the division of pharmacologic therapies at the federal Substance Abuse and Mental Health Services Administration. At least one state, New York, is paying for coaches to help treat addiction through its Medicaid program.

“This is an evolving field,” Lubran says. “[We are] learning more and more about the best ways to treat addiction and certainly the use of peer counselors, or peer coaches, has become more and more widespread.”

http://commonhealth.wbur.org/2014/06/heroin-recovery-coaches

Source: WBUR’s CommonHealth Reform and Community – June 13, 2014

Blog by Jana Burson – Naloxone

“Naloxone is the opioid buzz-kill drug… and it’s also the opioid overdose life saver.

People die from opioid overdoses because the brain gets saturated with opioids. The part of the brain that tells us to breathe during sleep, the medulla, also gets saturated, and eventually shuts off. This usually occurs gradually. The respiratory rate slows over one to three hours, until all respirations stop. Then tissues of essential organs like the brain and heart die from lack of oxygen.

If naloxone can be given during this process, the opioids are tossed off brain receptors, and the medulla fires urgent orders for the body to resume breathing. The patient wakes up, so long as irreversible damage hasn’t yet been done to the brain and heart. In some cases, the patient goes into full precipitated opioid withdrawal, but usually the naloxone doesn’t reverse all of the opioids on board, just enough to save the patient’s life.”

http://janaburson.wordpress.com/2014/06/15/naloxone/

Source: Jana Burson – June 15, 2014

News From the States

E-mail Communication from AATOD President Mark Parrino on MAT for Opioid Addiction in the Criminal Justice System

AATOD“I am providing a link to an important letter to Attorney General Eric Holder, dated April 10, 2014, which was signed by sixteen US Senators. The Senators are urging the Attorney General to work with all of the branches in the Department of Justice to utilize the federally approved medications to treat opioid addiction “in combination with counseling”. “Specifically, the Department should initiate a multi-state program utilizing anti-addiction medications to support successful reentry into society of opioid addicted offenders from various correctional settings.” I know that you will join me in supporting this approach and clearly the sixteen Senators understand the benefit of providing access to Medication Assisted Treatment for opioid addiction in the Criminal Justice setting.”

The AATOD letter can be accessed at: http://www.aatod.org/wp-content/uploads/2014/04/Letter-to-AG-Holder-on-Prescription-opioid-and-heroin-addiction.pdf

Source: American Association for the Treatment of Opioid Dependence – April 28, 2014

Belgium Study Suggests Heroin-Assisted Treatment Superior to Methadone for Heroin Addiction (Free registration required to view article)

“Patients severely addicted to heroin may respond to a treatment practice that incorporates pharmaceutical heroin, a new feasibility study suggests.

An open-label, randomized controlled trial (RCT) of 74 patients showed that significantly more of those who received diacetylmorphine under strict nurse supervision in a specialized center responded at 3, 6, and 9 months after starting treatment than those who received methadone.

http://www.medscape.com/viewarticle/825108

Source:  Medscape.com -May 13, 2014

Other National News of Interest

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

Heroin a Growing Threat Across USA, Police Say

heroin and injection“Between 2009 and 2013, according to the assessment produced by the government’s National Drug Intelligence Center, heroin seizures increased 87%. The average size of those seizures increased 81% during the same time.”

“The consciousness of the nation has not really focused on the problem,” Attorney General Eric Holder told the conference of more than 200 officials organized by the Police Executive Research Forum, a D.C.-based think tank. “People saw this more as a state and local problem. …This is truly a national problem. Standing by itself, the heroin problem is worthy of our national attention.”

http://www.usatoday.com/story/news/nation/2014/04/16/heroin-overdose-addiction-threat/7785549/

Source: USAToday.com – April 17, 2014

U.S. Attorney General Holder Urges Use of Drug to Help In Heroin ODs

Attorney General Eric Holder declaring heroin addiction is an “urgent and growing public health crisis,” urged first responders to carry the drug naloxone that helps resuscitate victims from an overdose.

“Addiction to heroin and other opiates — including certain prescription pain-killers — is impacting the lives of Americans in every state, in every region, and from every background and walk of life — and all too often, with deadly results,” Holder said in a video message posted Monday on the Justice Department website.”

http://www.usatoday.com/story/news/politics/2014/03/10/holder-heroin-overdose-help/6247281/

Source: USAToday.com – March 10, 2014

National Institute on Drug Abuse (NIDA) Updated Research Report on Heroin

Message from AATOD Regarding the Death of Philip Seymour Hoffman

AATOD“Philip Seymour Hoffman’s death has attracted national media attention as most celebrity deaths do, especially when they relate to a drug overdose. We have seen this phenomenon shortly after the deaths of Anna Nicole Smith and Michael Jackson. There was an immediate flurry of media attention, and then other stories took center stage.

For many addiction treatment professionals and patient advocates, the issues surrounding celebrity deaths represent the daily struggles that must be confronted by a wary public. A number of issues naturally come to surface during such times about opioid addiction and treatment.”

The AATOD message addresses:

  • Changing Social Attitudes
  • Changing Federal and State Oversight
  • The Opportunity to Educate

“The tragedy of Mr. Hoffman’s death will inevitably be revisited by another celebrity death in the future. We will engage once again in the flurry of media stories which typically have a limited lifespan. Ultimately, we need to work effectively to change America’s perceptions about the safety and danger of prescription opioids, the danger of heroin (which is obviously not an FDA approved drug), and the value of prevention and early intervention in providing access to care. Mr. Hoffman’s death is a stark reminder of the dangers of using heroin. It is not, nor has ever been, a safe drug. The user simply does not know what the drug has been cut with or its potency.

Many people who have worked in the addiction treatment community for many years know that heroin has been adulterated with all sorts of dangerous chemicals which can lead to death. We need to continually educate the public about these issues and work with patient advocates and public policy officials to ensure that the message is consistent and sticks.”

http://www.aatod.org/news/message-from-aatod-regarding-the-death-of-philip-seymour-hoffman/

Source: The American Association for the Treatment of Opioid Dependence – February 11, 2014

Wider Use of Antidote Could Lower Overdose Deaths by Nearly 50%

“Distributing naloxone and training people to use it can cut the death rates from overdose nearly in half, according to a new study.

The new study, published in the BMJ, followed the expansion of Overdose Education and Naloxone Distribution (OEND) programs in Massachusetts.  The programs were offered at emergency rooms, primary care centers, rehabilitation centers, support groups for families of addicted people and other places that might attract those at risk.

The study involved 2912 people in 19 different Massachusetts communities — each of which had had at least 5 opioid overdose deaths between 2004 and 2006.  The participants were trained to recognize overdose, call 911 and administer naloxone using a nasal inhaler.  If the naloxone didn’t work, they were instructed to try another dose and perform rescue breathing until help arrived.

During that time, 153 naloxone-based rescues were reported for which there was data on outcomes, and in 98% of those cases, the drug revived the victim.

There are still practical barriers however, to widely distributing naloxone and implementing more OEND type programs. Advocates have argued that the medication should be made available over-the-counter since it has little potential for abuse and is nontoxic. The Centers for Disease Control (CDC), the director of the National Institute on Drug Abuse and even the drug czar’s office support making it more widely available, and unlike the case with needle exchange programs, there has been no organized opposition to OEND. But the Food and Drug Administration (FDA) has no precedent for allowing over-the-counter sales of such a drug: naloxone is a generic medication approved in an injectable form. Without a company to submit an application for its use in the intranasal version, the agency isn’t likely to OK over-the-counter sales.”

http://healthland.time.com/2013/02/05/wider-use-of-antidote-could-lower-overdose-deaths-from-by-nearly-50/

Source: HealthlandTime.com – February 5, 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

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