News & Updates – April 25, 2014; Issue 199

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

Surge in Narcotic Prescriptions for Pregnant Women

“Doctors are prescribing opioid painkillers to pregnant women in astonishing numbers, new research shows, even though risks to the developing fetus are largely unknown.

Of 1.1 million pregnant women enrolled in Medicaid nationally, nearly 23 percent filled an opioid prescription in 2007, up from 18.5 percent in 2000, according to a study published last week in the journal Obstetrics & Gynecology. That percentage is the largest to date of opioid prescriptions among pregnant women. Medicaid covers the medical expenses for 45 percent of births in the United States.”

The lead author, Rishi J. Desai, a research fellow at Brigham and Women’s Hospital, said he had expected to “see some increase in trend, but not this magnitude.”

http://www.nytimes.com/2014/04/15/science/surge-in-prescriptions-for-opioid-painkillers-for-pregnant-women.html

Source: NewYorkTimes.com – April 15, 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

Naloxone ‘Stigma’ a Barrier to Prescribing?

“Although giving out naloxone to patients at high risk of overdose sounds like a good idea, researchers who work with the drug say the stigma surrounding its use may be a barrier to wider uptake among both patients and doctors.

Patients may feel they’re being treated like addicts and that their opioid prescriptions will be tempered, while doctors worry that just talking about naloxone may scare patients away, said Caleb Banta-Green, PhD, MPH, of the University of Washington in Seattle. “Both doctors and patients feel like they’re under the microscope,” Banta-Green told MedPage Today. “It’s a very sensitive time.”

Banta-Green and his colleagues are enrolling patients at high risk for opioid overdose — both heroin users and patients on prescription opioids — in a randomized trial to test whether providing naloxone, along with education and counseling, can reduce overdose.”

http://www.medpagetoday.com/Psychiatry/Addictions/45164

Source: MedPageToday.com – April 9, 2014

FDA Commissioner Margaret A. Hamburg Statement on Prescription Opioid Abuse

FDA“For more than a decade, the U.S. Food and Drug Administration has been working to address the important public health problems associated with the misuse, abuse, addiction and overdose of opioid analgesics, while at the same time working to ensure continued access to effective and appropriate medications for millions of Americans currently suffering from pain. I firmly believe that these goals are compatible, and that actions to address one should not be at the expense of the other.

Tragically, the most recent data shows that more than 16,000 lives are lost each year due to opioid-related overdoses. In fact, drug overdose deaths, driven largely by prescription drug overdose deaths, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. We know that the illegal diversion, misuse, and abuse of prescription opioids are often fueled by inappropriate prescribing, improper disposal of unused medications, and the illegal activity of a small number of health care providers. This highlights the important role that education of prescribers and patients can play in addressing this epidemic. The FDA has taken steps to address this but more work remains to be done.

Combatting the serious public health problem of misuse, abuse, addiction and overdose from opioid analgesics is a high priority. Since 2001 the FDA has taken a number of actions designed to help address prescription opioid abuse and to encourage the development of new drug treatments for pain. These actions include:

  • Revising the labeling for opioid medications to foster their safe and appropriate use, including recent changes to the indications and safety warnings of extended-release and long-acting opioids.
  • Requiring that manufacturers conduct studies of the safety of long-term use of prescription opioids.
  • Improving appropriate prescribing by physicians and use by patients through educational materials required as a part of a risk mitigation strategy for extended-release and long-acting opioids.
  • Using the agency’s expedited review programs to advance development of new non-opioid medications to treat pain with the goal of bringing new non- or less-abusable products to market.
  • Working with other federal agencies and scientists to advance our understanding of the mechanisms for pain and how to treat it, including the search for new non-opioid medications for pain.
  • Recommending that hydrocodone-containing combination products have additional restrictions on their use by rescheduling them from Schedule III to Schedule II.
  • Strengthening surveillance efforts to actively monitor the changing nature of prescription opioid abuse and to identify emerging issues.
  • And, importantly, encouraging the development of medications to treat opioid abuse, such as buprenorphine for use in medication-assisted treatment, and to reverse opioid overdoses, such as naloxone.

Today’s FDA approval of Evzio (naloxone autoinjector) provides an important new tool in our arsenal to more effectively combat the devastating effects of opioid overdose, which is one part of our comprehensive work to support opioid safety. Reflecting the FDA’s commitment to encouraging important new therapies, the FDA’s review of Evzio was granted priority status, and the application was reviewed by the FDA in just 15 weeks.

This product is the first auto-injector designed to rapidly reverse the overdose of either prescription or illicit opioids. While the larger goal is to reduce the need for products like these by preventing opioid addiction and abuse, they are extremely important innovations that will help to save lives.

The FDA will continue to work to reduce the risks of abuse and misuse of prescription opioids, but we cannot solve this complex problem alone. A comprehensive and coordinated approach is needed; one that includes the White House Office of National Drug Control Policy, the Drug Enforcement Administration and many of our sister agencies within the Department of Health and Human Services, as well as state and local governments, public health experts, health care professionals, addiction experts, researchers, industry, and patient organizations.

I am confident that this can be accomplished, but we will all need to work together to invest in strategies and responsible approaches that deter or mitigate the effects of abuse while preserving access to pain medicines for the patients that need them the most.”

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391590.htm

See related press release on EVZIO available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391465.htm

Source: Federal Drug Administration – April 3, 2014

States That Don’t Expand Medicaid Leave Millions of Mentally Ill Uninsured: Report

“About 3.7 million Americans, who live in states that have not expanded their Medicaid programs under the Affordable Care Act, suffer from mental illness, psychological distress or a substance use disorder and don’t have health insurance, according to a recent report.

Twenty-four states have not expanded their Medicaid programs, according to USA Today. In the states that did expand Medicaid, about 3 million people with a mental health or substance use disorder, who were formerly uninsured, now are eligible for coverage. The findings come from the American Mental Health Counselors Association (AMHCA).”

http://www.drugfree.org/join-together/community-related/states-that-dont-expand-medicaid-leave-millions-of-mentally-ill-uninsured

Source: JoinTogether.org – April 9, 2014

World Health Organization (WHO) Releases Guidelines: Substance Use and Pregnancy

These recently released guidelines contain recommendations on the identification and management of substance use and substance use disorders for health care services which assist women who are pregnant, or have recently had a child, and who use alcohol or drugs or who have a substance use disorder. They have been developed in response to requests from organizations, institutions and individuals for technical guidance on the identification and management of alcohol and other substance use and substance use disorders in pregnant women, with the target of healthy outcomes for both pregnant and their fetus or infant.

http://www.who.int/substance_abuse/publications/pregnancy_guidelines/en/

Source: World Health Organization – March 2014

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