Sept. 18, MedPage Today

The FDA said Tuesday that it is broadening its Risk Evaluation and Mitigation Strategy (REMS) for opioids to include immediate-release agents prescribed for outpatients, and will cover all "providers who are involved in the management of patients with pain" -- not just those writing prescriptions.

But although the agency is requiring opioid manufacturers to create new training modules for nonprescribers, and that cover immediate-release products, the training will remain voluntary for professionals.

The broadened REMS will also apply to extended-release and long-acting (ER/LA) opioids for outpatient use, for which the FDA first imposed a REMS in 2012. The agency noted that Tuesday's action raises the number of individual products subject to the opioid REMS from 62 to 347.

"Our aim is to make sure the medical community can take advantage of the available education on pain management and safe use of opioid analgesic products," said FDA Commissioner Scott Gottlieb, MD, in announcing the changes.

"At the same time, we're also taking new steps to advance the development of evidence-based, indication-specific guidelines to help further guide appropriate prescribing of opioids. The goal is that these guidelines will provide evidence-based information on the proper number of opioid doses that should be dispensed for different medical conditions for which these drugs may be indicated. The aim is to reduce overall dispensing as a way to further reduce exposure to these drugs," Gottlieb added. He did not give a timeline for when these more specific guidelines would be released.

The FDA noted that the new training -- components of which were outlined in a "blueprint" document -- must be made available to nurses and pharmacists, for example, in addition to those authorized to prescribe opioids. "The new REMS also requires that the education cover broader information about appropriate pain management, including alternatives to opioids for the treatment of pain. The agency is also approving new product labeling containing information about the health care provider education available through the new REMS," the agency said.

That labeling about education will now appear as part of the boxed warnings and other sections on "warnings and precautions."

Previously, the opioid REMS ordered manufacturers of ER/LA opioids to develop training materials for prescribers, with the aim of minimizing risks of overuse and abuse. However, the FDA stopped short of requiring prescribers to undergo special training. REMS requirements for many other types of medications do include mandatory training, and the agency said opioids could eventually be added to that list.

"The FDA's Opioid Policy Steering Committee continues to consider whether there are circumstances when the FDA should require some form of mandatory education for health care providers and how the agency would pursue such a goal," according to the Tuesday announcement.

The American Society of Addiction Medicine is seeking nominations for:

• The 2019 John P. McGovern, ASAM Annual Award, and 
• The ASAM Media Award

Awards will be presented at the ASAM 50th Annual Conference in Orlando, FL in April 2019. Members are encouraged to nominate deserving individuals for these awards.

Nomination submissions are being accepted through the ASAM Online Portal on or before October 31st . To be eligible for consideration, all nominations must be submitted electronically.  A separate nomination form for each nominee and/or award is required.

August 27, Wisconsin Health News

Drug overdoses increased about 7 percent in Wisconsin from 2016 to 2017, according to new data from the Centers for Disease Control and Prevention. About 1,200 died in the state last year from overdoses. 

Nationally, nearly 72,000 died of drug overdoses in 2017, a more than 6 percent increase from the year before.

August 27, Wisconsin Health News

The Department of Health Services has awarded almost $600,000 to 70 community coalitions fighting the opioid epidemic.

The grants range from $500 to $22,300 and will support organizations that promote awareness about opioid misuse, hold community drug take-back events and provide an anti-overdose drug and training on its use, according to a statement from last week.

All of the recipients are members of the Alliance for Wisconsin Youth, which is made up of organizations focused on substance abuse prevention. They're expected to complete their projects by April.

The money comes from $7.6 million in federal grant money received by Wisconsin, the second round of funding provided by the federal government.

Healthcare is poised to play a central role in the 2018 state and federal elections, and the results could reverberate across Wisconsin.

Democrats are hoping a blue wave will put the brakes on President Trump’s attack on the Affordable Care Act, but if Republicans retain control of Congress, it may seal the law’s fate. Meanwhile, the races for Governor and the Legislature are certain to shape the future of healthcare for years to come.

A panel of the state’s top healthcare lobbyists will analyze what’s at stake for the Badger State and preview their priorities for the coming year. Panelists:

• Eric Borgerding, CEO, Wisconsin Hospital Association
• ​Dr. Bud Chumbley, CEO, Wisconsin Medical Society
• ​Stephanie Harrison, CEO, Wisconsin Primary Health Care Association
• ​John Sauer, CEO, LeadingAge Wisconsin
• ​Nancy Wenzel, CEO, Wisconsin Association of Health Plans

The event is Tuesday, September 11 at the Madison Club (11:30am – 1pm).  Register here.

UW Madison will host a day-long workshop on Suicide Bereavement Clinician Training, presented by national experts Drs. Jack Jordan and Nina Gutin, on Wednesday, September 19, 2018 at the Pyle Center in Madison.

This unique opportunity in the arena of suicide post-vention and prevention coincides closely with the conclusion of National Suicide Prevention Week. Few clinicians have been properly trained to understand and respond to the complicated features of grief associated with suicide loss. The workshop is designed to prepare clinicians for working with individuals who are grieving the loss of someone to suicide. 

August 8, Wisconsin Health News

Fourteen offenders have completed a Department of Corrections’ opioid addiction treatment program, bringing the total number of graduates from the program to 58, according to a Tuesday statement.

The program got its start with $1.6 million from Gov. Scott Walker’s 2015-17 biennial budget. It received an additional $1.6 million this biennium.

The program provides medication-assisted treatment over a yearlong period, providing naltrexone to treat inmates with opioid dependency.

It targets inmates with a history of opioid dependency being released into Brown, Calumet, Door, Kewaunee, Manitowoc, Outagamie, Waupaca and Winnebago counties.

“The treatment offered through this program and drug courts across Wisconsin can transform lives and loosen the opioid epidemic’s hold on Wisconsin,” Attorney General Brad Schimel said in a statement.

After finishing the program, participants receive additional AODA treatment through the Department of Corrections or a medical provider. 

August 2, Wisconsin Health News

The University of Wisconsin and UW Health are offering a new hotline allowing primary care doctors and other providers in the state to consult with addiction experts to treat patients.

The Department of Health Services awarded a $500,000 grant for the hotline, which can be renewed for an additional year. The service, which UW believes is the first of its kind in the nation, will provide counsel about a range of addictions during weekdays.

Seventy percent of Wisconsin’s rural counties lack a provider who is certified to provide medication-assisted treatment for opioid use disorders, according to Dr. Randall Brown, who oversees the program team for the services.

“The goal of this project is to offer real-time support and expertise from specialists in addiction medicine, addiction psychiatry, psychology and AODA counseling,” he said in a statement last week. “I am confident that we can reduce the enormous suffering substance abuse produces in this state.”

July 17, Wisconsin Health News

A nonprofit policy and research organization released more recommendations last week for improving Wisconsin's substance use disorder treatment services.

Pew Charitable Trusts has spent the last year studying the state’s treatment system. The Governor’s Task Force on Opioid Abuse adopted a series of recommendations from the organization in January, with lawmakers enacting some through executive order and others through new laws.

Andrew Whitacre, senior associate for the Substance Use Prevention and Treatment Initiative at the Pew Charitable Trusts, presented more recommendations at a task force meeting in Madison Friday. He said lawmakers could accomplish them by April.

Whitacre said the recommendations aim to ensure the state is getting its “biggest bang for the buck” and building a treatment infrastructure that can address future drug epidemics. Pew tried to strike a balance between innovation and evidence-based approaches.

“There’s a lot of opportunity for states to be innovative and push the envelope,” he said. “The bottom line is an effective treatment system gets people into treatment sooner, so that people can get back to work and lead productive lives.”

Pew’s recommendations were:

• Expand opioid treatment programs. Whitacre said that Wisconsin does not have enough providers offering methadone, a medication used to treat opioid use disorder. Pew suggested allowing sites that deliver medical services to operate as methadone treatment programs. That could improve access to physical and mental health services for people with opioid use disorder.
  
• Develop a legal definition for recovery housing that would bar discrimination against those using medication-assisted treatment. Whitacre said that Pew’s interviews and focus groups in the state have confirmed that substance use disorder patients on medication-assisted treatment have been barred from some recovery housing in Wisconsin. 
  
• Ensure patients receiving medication-assisted treatment are placed in the right setting through a standardized patient placement tool. Patients seeking treatment aren’t often referred to the right care setting, leading to administrative waste and burdens on those who want help and providers, according to Whitacre. The tool could reduce costs and standardize care.
  
• Fund an expansion of buprenorphine training for providers during training programs for doctors, nurse practitioners and physician assistants, as many patients have difficulty accessing medication for opioid dependence.
  
• Use the Behavioral Health Review Committee established under recent state law to ensure that Wisconsin’s substance abuse counselor certification and licensure process align with best practices and that the number of counselors meets the state’s needs. Whitacre suggested the committee could find ways to evaluate and meet the need for counselors across the state. That could include a look at training requirements, scope of practicing, continuing education requirements and regulatory barriers.
  
• Direct the Department of Health Services to develop a plan with the Department of Corrections to pilot the availability of medication-assisted treatment in at least one prison or one jail. Part of the plan should include a review of prisons and jails to document the current availability of treatment. Whitacre suggested Rhode Island as a model, which has a correctional medication-assisted treatment program that led to a 61 percent decrease in overdose deaths among recently incarcerated people and a 12 percent decrease in overdose deaths statewide.
  
• Direct DHS to promote best practices of care for pregnant women with substance use disorder by requiring programs receiving Medicaid reimbursement and other public funding to follow guidelines that call for screening of patients and medication-assisted treatment. About 12.5 percent of treatment facilities in the state offer programs tailored to pregnant women, compared to 20.7 percent nationally.
  
• Direct DHS to incentivize healthcare providers to either offer or partner on postpartum care programs for women with substance use disorder.
  
• Direct the Medical Examining Board to establish guidelines on neonatal abstinence syndrome, a group of problems that newborns face if they're exposed to drugs in the womb. The rate of babies diagnosed with neonatal abstinence syndrome in Wisconsin more than doubled between 2009 and 2014, and treatment isn’t uniform across the state, according to Pew.
  

Whitacre said Pew is planning to wind down its work in Wisconsin, but it will help support recommendations if the state moves forward.

They’re also planning to release a final report soon, with other recommendations that could take longer than nine months. They'll include proposals targeting medication-assisted treatment in emergency rooms

The Wisconsin Department of Health Services is sponsoring an online training program on how to help behavioral health patients quit smoking. The program offers 6 hours of complimentary CE credits, and is being held in partnership with the University of Wisconsin Center for Tobacco Research and Intervention, and the Wisconsin Nicotine Treatment Integration Project. Learn more.