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  • November 16, 2017 11:29 AM | Deleted user
    by Alexandria Bachert MPH, Staff Writer, MedPage Today November 15, 2017

    WASHINGTON -- A first-in-class neurostimulation device to relieve symptoms of opioid withdrawal is approved for marketing, the FDA announced Wednesday.

    The NSS-2 Bridge device is a small, battery-powered electrical nerve stimulator that is placed behind a patient's ear and emits electrical pulses to stimulate branches of certain cranial nerves. Patients can use the device for up to 5 days during the acute physical withdrawal phase.

    The device, made by Innovative Health Solutions, was previously cleared by the FDA in 2014 for use in acupuncture.

    "Given the scope of the epidemic of opioid addiction, we need to find innovative new ways to help those currently addicted live lives of sobriety with the assistance of medically assisted treatment," said FDA Commissioner Scott Gottlieb, MD, in an agency press release. "While we continue to pursue better medicines for the treatment of opioid use disorder, we also need to look to devices that can assist in this therapy."

    Device approval was based on a study that evaluated the clinical opiate withdrawal scale (COWS) score -- measuring symptoms on a scale of 0 to more than 36 (0 being the least severe) -- in 73 patients undergoing opioid physical withdrawal. Study results showed that all patients had a reduction in COWS of at least 31% within 30 minutes of using the device and that 88% of patients transitioned to medication-assisted therapy after 5 days.

    The device is available only by prescription and is contraindicated for patients with hemophilia, cardiac pacemakers, and psoriasis vulgaris.

    Learn more

  • November 06, 2017 2:38 PM | Deleted user

    Lagisetty P, et al. PLOS One. 2017;doi:10.1371/journal.pone.0186315.

    November 3, 2017

    Multidisciplinary and coordinated care delivery models effectively provide opioid use disorder treatment and increase access to medication-assisted treatment in primary care, according to data published in PLOS One.

    “It’s hard to convince primary care physicians to do this work when they’re already busy and they don’t have additional addiction-related training or experience,” Pooja Lagisetty, MD, from the division of general internal medicine and the Institute for Health Policy and Innovation at the University of Michigan, Ann Arbor, and VA Ann Arbor Healthcare System, said in a press release. “But, if we can learn from others and find a way to offer physicians logistical support, then maybe it’s possible. There is a major need to do this.”

    SEE ALSO

    People who need addiction care outnumber the physicians willing to provide medication-assisted treatments (MATs) like buprenorphine and methadone in primary care, despite prior research showing that MAT can reduce mortality for patients with opioid use disorder. Researchers compiled data on evidence-based, primary care MAT interventions and program structures and processes that were associated with improved patient outcomes using clinical databases. They reviewed randomized controlled trials and observational studies that assessed MAT for adult patients with opioid use disorder to determine what kinds of primary care-based models may help guide future policy and implementation in primary care settings.

    Lagisetty and colleagues included 35 interventions that tested MAT in primary care settings across eight countries in their systematic review. Analysis showed that patients were more likely to have successful opioid addiction treatment when their PCP worked with teams of nurses, medical assistants, social workers and pharmacists to deliver MAT. The successful interventions featured joint multidisciplinary and coordinated care by physician and nonphysician provider delivery models to offer MAT. Seven studies showed that 60% or more of patients continued their MAT regimen for 3 months or longer. Not all successful programs were the same in reported patient outcomes, processes and tools used, but they used similar key design factors, such as:

    • integrated clinical teams with support staff — usually advanced practice nurses and pharmacists — as clinical care managers;
    • patient agreements with providers that outlined consequences for continued drug misuse; and
    • home inductions of buprenorphine to make treatment more convenient.

    Lagisetty noted that it makes sense to provide MAT in primary care because the results are similar to providing it in specialty care. In addition, patients may be more likely to seek help from their PCP because of the lack of stigma and their ability to address other health concerns as well, according to the release.

    “I don’t think that many primary care physicians went into medicine with a desire to focus on treating addiction. However, opioid addiction is increasingly becoming common in our practices and our patients are struggling to find help,” Lagisetty said. “Primary care doctors don’t need to all be treating 100 patients. It can just be five. We should just have the medication in our tool box and be able to screen and potentially treat patients in our own setting.” – by Savannah Demko

    Disclosures: The authors report no relevant financial disclosures.


  • November 02, 2017 10:31 AM | Deleted user

    Please note that ASAM physician members may apply for the Distinguished Fellow, American Society of Addiction Medicine (DFASAM) title until November 15, 2017. ASAM and the Board of Directors recognize these elite professionals as "Distinguished Fellows" because of their significant contributions to the field of addiction medicine and their work as outstanding, prominent, and distinguished professionals in the medical community. Authorized members may employ the DFASAM designation after their names as a mark of distinction and to provide a description of their unique position.

    We encourage you to apply (If you haven’t already) and remind physician members in your chapter that the DFASAM application period is open for only 2 more weeks.  Click here to access the DFASAM page.


  • October 30, 2017 3:31 PM | Deleted user

    Department of Health Services Names Paul Krupski as Director of Opioid Initiatives

    New position aimed at coordinating efforts to fight the state's opioid crisis

     The Wisconsin Department of Health Services (DHS) announced today Paul Krupski has been selected to serve as the new Director of Opiate Initiatives to coordinate the department’s efforts to end the state’s opioid crisis, effective today. 

    “Opioid overdoses and the misuse of opioids affects every corner of the state, and Paul’s experience and skills support our efforts to ensure that our response is as aggressive and effective as possible,” said DHS Secretary Linda Seemeyer. “Opioid use disorder, including heroin and prescription drugs, is destroying families, and we must do whatever we can to end the heartbreak affecting so many.” 

    View the entire news release.


  • October 30, 2017 10:26 AM | Deleted user

    by Ilene MacDonald | 

    Oct 27, 2017 9:17am

    President Donald Trump on Thursday declared a war on drug addiction and opioid abuse, saying he would mobilize his entire administration to address the crisis now that he has officially determined it is a national public health emergency.

    “We will defeat this opioid epidemic,” Trump said. “We will free our nation from the terrible affliction of drug abuse. And, yes, we will overcome addiction in America … We have fought and won many battles and many wars before, and we will win again.”

    Although he didn’t offer specific actions the administration would take during his remarks or how they will be funded, Trump said federal agencies are working with doctors and medical professionals to implement best practices for safe opioid prescribing, and requiring that federally employed prescribers undergo special training.

    The public health emergency directive allows the government to waive some restrictions, Trump said, such as a 1970s-era rule that prevents states from providing care at certain treatment facilities with more than 16 beds for those who suffer from drug addiction. But it doesn’t come with a substantial amount of funding that would have been available had Trump declared a national emergency under the Stafford Act, which would have allowed access to funding under the Federal Emergency Management Agency.

    Later in the day the administration released a statement that provided some of the actions the government would take as a result of the declaration:

    • Expand access to telemedicine services, including services involving remote prescribing of medicine commonly used for substance abuse or mental health treatment.
    • Allow the Department of Health and Human Services to quickly make temporary appointments of specialists who can help the agency respond to the crisis.
    • Allow the Department of Labor to issue dislocated worker grants to help those who have been displaced from the workforce because of the opioid crisis (subject to available funding).
    • Shift resources within HIV/AIDS programs to help people eligible for those programs to receive substance abuse treatment, an action that the administration noted is vital given the connection between HIV transmission and substance abuse.

    Trump said during his remarks that he is awaiting a final report from the President’s Commission on Combating Drug Addiction and the Opioid Crisis and the administration will act quickly to evaluate and implement its recommendations.

    The administration later said in a statement that since Trump took office the government has allocated or spent more than $1 billion to address drug addiction and the opioid crisis. That funding includes $800 million for prevention, treatment, first responders, prescription drug monitoring programs, recovery and other care in communities, inpatient settings, and correctional systems. It also includes $254 million in funding for high-risk communities, law enforcement, and first responder coordination and work.



  • October 25, 2017 12:49 PM | Deleted user

    The Hill
    BY RACHEL ROUBEIN - 10/24/17 12:44 PM EDT

    As America grapples with an opioid epidemic, senior citizens are often overlooked.

    Yet, older adults are highly susceptible to chronic pain and the prescription painkiller addiction is hitting this population.

    “We really are looking at the opioid epidemic, we know how destructive it is, but we think of its younger victims,” Rep. Katherine Clark (D-Mass.) said at an event on aging and addiction, hosted by The Hill and sponsored by Surescripts. “This is more of a quiet, more silent, but equally deadly part of the opioid epidemic,” she said.

    Roughly one in three beneficiaries in Medicare’s prescription drug program received a prescription for opioids in 2016. About half a million received high amounts of opioids. And nearly 90,000 are at “serious risk” of opioid misuse or overdose, according to a July report by the inspector general of the Department of Health and Human Services (HHS).

    “What the data really revealed — the final takeaway — is that Medicare may be paying for opioids that are not medically necessary and in fact Medicare may be paying for opioids that are doing harm to seniors and perhaps even others as the drugs are diverted into the street for resale,” said Ann Maxwell, assistant inspector general for evaluations at the HHS Office of Inspector General.

    At the event, Clark and Rep. Markwayne Mullin (R-Okla.) touted their bill requiring e-prescriptions for controlled substances under Medicare.

    Of potential opposition to the measure, Clark said, “the burden is really going to come to doctors, to hospitals, to upgrade their technology to be able to do the e-prescribing.” She added the legislation includes built in ways to give them time to meet this criteria.

    But, she said, “this is worth it,” calling it a “critical tool going forward.” Mullin added that the bill doesn’t go into effect until 2020.

    A panel of experts discussed their views on how Congress and the administration can help combat the rates of opioid addiction among older adults. These recommendations included an infusion of federal funds, regulations from the Centers for Medicare and Medicaid Services on pharmacy and prescriber lock-in programs under Medicare, cautious prescribing of opioids and more.


  • October 24, 2017 11:01 AM | Deleted user

    Under the leadership of Governor Walker, the Department of Health Services (DHS) Division of Medicaid Services (DMS) is pleased to announce that effective January 1, 2018, we will increase reimbursement for outpatient mental health (MH) and substance use disorder (SUD) treatment.

    We have heard the feedback from our partners in the MH and SUD provider community regarding the barriers they face in meeting the demand for these important services. Generally, financial mechanisms alone will not resolve many of the health care challenges of our state.  However, by increasing Medicaid rates and removing the administrative burden of prior authorization for outpatient mental health providers, we expect that our members will have improved access to treatment services by encouraging licensed providers to enroll with Wisconsin Medicaid. To enroll in the Medicaid program, go to the ForwardHealth Portal.

    DMS will invest $7 million GPR annually to increase rates for MH and SUD. This substantial investment will make Wisconsin Medicaid a rate leader in the Great Lakes region in terms of provider reimbursement for MH and SUD treatment.

    This announcement will be followed soon by a ForwardHealth Update with additional details of the rate increase and billing guidance for fee-for-service providers. DMS will provide guidance to HMOs on the rate/billing guidance changes and will adjust our HMO capitation rates (and encounter data submission process) effective January 1, 2018, to assure alignment.

    I hope this investment by Governor Walker will spur you to enhance and expand mental health and substance abuse services to our residents in need.  We look forward to our continued partnership and collaboration on behalf of our members.

    Michael Heifetz

    Medicaid Director


  • October 23, 2017 10:54 AM | Deleted user
    • by Kristina Fiore, Deputy Managing Editor, MedPage TodayOctober 20, 2017

    Monthly naltrexone shots (Vivitrol) worked as well as daily buprenorphine/naloxone (Suboxone) for treating opioid use disorder, according to the first head-to-head trial between the two.

    In an open-label randomized controlled trial, retention in the extended-release naltrexone group was non-inferior to buprenorphine/naloxone at 12 weeks (mean time 69.3 and 63.7 days, respectively), according to Lars Tanum, MD, PhD, of the University of Oslo in Norway, and colleagues.

    Naltrexone was also non-inferior for other primary outcomes including the number of opioid-negative urine drug tests, use of heroin, and use of other illicit opioids, the team reported online in JAMA Psychiatry.

    "The main clinical implication of these findings is that extended-release naltrexone seems to be as safe and effective as buprenorphine/naloxone treatment for maintaining short-term abstinence from heroin, opioids, and other illicit substances in opioid-dependent individuals newly detoxified and/or discharged from inpatient treatment or prison."

    The study wasn't funded outright by Alkermes, the maker of Vivitrol, but the company was "allowed to comment on the manuscript before submission for publication," according to the study's disclosure section.

    Earlier this year, investigative reports found that Alkermes was using lobbyists to get Vivitrol written into state laws about opioid abuse treatment, and has persuaded drug courts to mandate Vivitrol over other drugs.

    For the study, the researchers enrolled 159 patients with opioid dependence (mean age 36; 28% were women) who went through detoxification and were then randomized to buprenorphine/naloxone 4 to 24 mg/day (with a target dose of 16 mg/day) or to monthly naltrexone injections (380 mg).

    After 12 weeks, 105 (66%) participants had attended all scheduled follow-up appointments and had taken their medication as prescribed. A total of 53 participants dropped out: 24 in the naltrexone group and 29 in the buprenorphine/naloxone group.

    In addition to non-inferiority for retention, naltrexone was also non-inferior for:

    • Number of opioid-negative urine drug tests (mean 0.9 and 0.8, respectively; P<0.001)
    • Use of heroin (mean difference −3.2, P<0.001)
    • Use of other illicit opioids (mean difference −2.7, P<0.001)

    Extended-release naltrexone was superior for lower use of heroin and other illicit opioids, but not superior for the proportion of negative urine drug tests.

    In terms of secondary outcomes, there were no significant differences between groups for the use of amphetamines, cocaine, alcohol, cannabis, or injecting drugs, but those on naltrexone had a significant reduction in benzodiazepine use, while the buprenorphine/naloxone group remained stable.

    There were more adverse events among those on naltrexone (69% versus 34.7%, P<0.001), but only 10 participants discontinued treatment owing to adverse events: four in the naltrexone group and six in the buprenorphine/naloxone group. A number of events were related to withdrawal symptoms and were more frequent among the naltrexone group (28 patients, 39.4%, versus 10 patients, 13.9%).

    There were no deaths, but more naltrexone patients reported having serious adverse events including pneumonia and withdrawal (8.5% versus 4.2%).

    Tanum and colleagues noted that naltrexone induction required full detoxification to a greater extent than buprenorphine/naloxone treatment. In fact, the detoxification protocol was changed a year into the trial, which reduced the number of new adverse events related to naltrexone induction.

    The researchers noted that the study was limited by a lack of blinding, as the use of placebo among newly detoxified opioid users was considered unethical. Also, participants likely recognized their treatment easily, given their long experience with opioid use.

    Still, the researchers concluded that extended-release naltrexone was as effective and safe as buprenorphine/naloxone and should be considered a treatment for opioid-dependent patients.

    Drugmaker Alkermes was allowed to comment on the manuscript before submission for publication.

    The authors disclosed no financial relationships with industry.

    • Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner

    LAST UPDATED 10.20.2017


  • October 23, 2017 10:53 AM | Deleted user

    FRIDAY, Oct. 20, 2017 (HealthDay News) -- Drug overdose death rates in rural areas of the United States are now higher than in cities, a trend that worries federal health officials.

    In 2015, drug overdose was the leading cause of injury-related death in the United States -- with 52,000 fatalities attributed to opioid painkillers, heroin and other potentially deadly drugs, researchers said in a new report.

    U.S. Centers for Disease Control and Prevention Director Dr. Brenda Fitzgerald said rising overdose death rates outside metropolitan areas warrant attention.

    "We need to understand why this is happening so that our work with states and communities can help stop illicit drug use and overdose deaths in America," Fitzgerald said in an agency news release.

    In 1999, drug overdose death rates were 6.4 per 100,000 in urban regions and 4 per 100,000 in rural areas. But the gap gradually disappeared. By 2015, the rate was 17 per 100,000 in rural areas and 16.2 per 100,000 in cities, the study findings showed.

    The researchers assessed illicit drug use and disorders from 2003 to 2014, and drug overdose deaths from 1999 to 2015 in urban and rural areas. The investigators were led by Karin Mack of the CDC's National Center for Injury Prevention and Control.

    Although the percentage of people reporting illegal drug use is actually lower in rural areas, the effects appear to be greater, the researchers noted.

    Overall, "most overdose deaths occurred in homes, where rescue efforts may fall to relatives who have limited knowledge of or access to life-saving treatment and overdose follow-up care," the authors explained in the news release.

    Looking at where drug users live and where they die from overdoses might lead to better preventive measures, the team pointed out.

    Some other findings in the report:

    • Rising rates of drug overdose deaths nationwide between 1999 and 2015 were consistent across gender, race and intent (unintentional, suicide, homicide or undetermined).
    • The actual number of drug overdose deaths remains much higher in cities. In 2015, about six times as many drug overdose deaths occurred in urban areas (45,059) as in rural areas (7,345).
    • The percentage of people reporting use of illicit drugs in the past month fell among those aged 12 to 17 over a 10-year period, but rose sharply in other age groups.
    • On a positive note, past-year illicit drug use disorders declined during 2003-2014.

    "On the one hand, the decline in illicit drug use by youth and the lower prevalence of illicit drug use disorders are encouraging signs," Mack's team wrote. "On the other hand, the increasing rate of drug overdose deaths in rural areas, which surpassed rates in urban areas, is cause for concern."

    Since rural residents are less likely to have access to substance abuse treatment services, the findings point to a need to beef up such services outside cities, the authors of the report said.

    Moreover, doctors should be updated on guidelines for prescribing opioids for chronic pain. And communities with high opioid-use disorder rates might benefit from greater access to addiction/overdose treatments such as methadone, buprenorphine or naltrexone, Mack and colleagues concluded.

    The findings were published in the Oct. 20 issue of the CDC's Morbidity and Mortality Weekly Report.

    More information

    The U.S. National Institute on Drug Abuse has more about drug addiction.

    SOURCES: U.S. Centers for Disease Control and Prevention, news release, Oct. 19, 2017; Oct. 20, 2017, Morbidity and Mortality Weekly Report


  • October 16, 2017 11:05 AM | Deleted user

    Shionogi and Purdue announced the launch of Symproic (naldemedine) tablets for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (eg, weekly) opioid dosage escalation. 

    Symproic, initially approved as a CII controlled substance in March 2017, was officially descheduled by the Drug Enforcement Agency (DEA) in September 2017. It is an oral peripherally-acting mu-opioid receptor antagonist (PAMORA) that acts in tissues such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids. Its ability to cross the blood-brain barrier is reduced due to a side chain that has been added, which increases the molecular weight and polar surface area.

    In clinical trials (COMPOSE 1, COMPOSE 2), the proportion of responders (patient who had at least 3 spontaneous bowl movements [SBM] per week and a change from baseline of at least 1 SBM/week for at least 9 out of the 12 weeks including 3 out of the last 4 weeks) was found to be significantly higher with Symproic versus placebo: COMPOSE 1 (48% vs. 35%); COMPOSE 2 (53% vs. 34%).

    Symproic is available as 0.2mg strength tablets in 90-count bottles.  

    For more information call (800) 849-9707 or visit Symproic.com.


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