COMPREHENSIVE ADDICTION RESOURCES EMERGENCY

(CARE) ACT

Senator Elizabeth Warren, Representative Elijah E. Cummings and 94 of their colleagues in the Senate and House are reintroducing the Comprehensive Addiction Resources Emergency (CARE) Act, the most ambitious legislation ever introduced in Congress to confront the opioid epidemic. Senator Warren and Rep. Cummings' CARE Act would provide state and local governments with $100 billion in federal funding over ten years.

Bill Summary

Life expectancy in the United States has now dropped three years in a row—and drug overdoses are the single biggest reason why. In 2017, more than 70,000 Americans died from drug overdoses—the highest rate of drug overdose deaths ever in the United States. Opioids were a cause of 47,600 of these deaths—68% of all drug overdose deaths. But only about 10% of those in need of specialty treatment for substance use disorders are able to access it.

This is not the first time we have faced a public health crisis of this scale. During the 1980s and 1990s, deaths from HIV/AIDS grew rapidly, and the country’s medical system was ill-equipped to provide effective, evidence-based care. In 1990, Congress passed the bipartisan Ryan White Comprehensive AIDS Resources Emergency Act to provide funding to help state and local governments combat this epidemic.

The CARE Act is modeled directly on the Ryan White Act, supporting local decision-making and federal research and programs to prevent drug use while expanding access to evidence-based treatments and recovery support services. Funding allocated under the CARE Act would empower local leaders to tailor their approaches to their communities’ needs, and be targeted to places that have been hit the hardest by the opioid epidemic.

The updated CARE Act of 2019 includes provisions targeted to help workers who are at greater risk for, or are currently struggling with, addiction to get treatment, and to maintain or find employment while undergoing treatment.

The CARE Act would provide $100 billion over ten years to fight this crisis, including:

• $4 billion per year to states, territories, and tribal governments, including $2 billion to states with the highest levels of overdoses, $1.6 billion through competitive grants, and $400 million for tribal grants;
• $2.7 billion per year to the hardest hit counties and cities, including $1.43 billion to counties and cities with the highest levels of overdoses, $1 billion through competitive grants, and $270 million for tribal grants;
• $1.7 billion per year for public health surveillance, biomedical research, and improved training for health professionals, including $700 million for the National Institutes of Health, $500 million for the Centers for Disease Control and Prevention and regional tribal epidemiology centers, and $500 million to train and provide technical assistance to professionals treating substance use disorders;
• $1.1 billion per year to support expanded and innovative service delivery, including $500 million for public and nonprofit entities, $500 million for projects of national significance that provide treatment, recovery, and harm reduction services, $50 million to help workers with or at risk for substance use disorder maintain and gain employment by providing grants and supporting research, and $50 million to expand treatment provider capacity; and
• $500 million per year to expand access to overdose reversal drugs (Naloxone) and provide this life-saving medicine to states to distribute to first responders, public health departments, and the public

Click here for state-by-state information about funding that states and counties would receive under the CARE Act. (PDF)

Over 200 organizations have endorsed the CARE Act. Click here to view the full list. (PDF)

Click here for a letter signed by the American Osteopathic Academy of Addiction Medicine, as part of the Coalition to Stop Opioid Overdose, to Representatives Cummings and Warren in support of their bill.

Agency is also taking new steps to support development of over-the-counter and additional generics of naloxone to help reduce opioid overdose deaths, increase access to emergency treatment

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm636333.htm

FDA News Release:

The U.S. Food and Drug Administration today granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose. The agency is also planning new steps to prioritize the review of additional generic drug applications for products intended to treat opioid overdose, along with the previously announced action to help facilitate an over-the-counter naloxone product.

“In the wake of the opioid crisis, a number of efforts are underway to make this emergency overdose reversal treatment more readily available and more accessible. In addition to this approval of the first generic naloxone nasal spray, moving forward we will prioritize our review of generic drug applications for naloxone. The FDA has also taken the unprecedented step of helping to assist manufacturers to pursue approval of an over-the-counter naloxone product and is exploring other ways to increase the availability of naloxone products intended for use in the community, including whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death,” said Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “All together, these efforts have the potential to put a vital tool for combatting opioid overdose in the hands of those who need it most – friends and families of opioid users, as well as first responders and community-based organizations. We’re taking many steps to improve availability of naloxone products, and we’re committed to working with other federal, state and local officials as well as health care providers, patients and communities across the country to combat the staggering human and economic toll created by opioid abuse and addiction.”

Today’s approval is the first generic naloxone nasal spray for use in a community setting by individuals without medical training; however, generic injectable naloxone products have been available for years for use in a health care setting. The FDA also has previously approved a brand-name naloxone nasal spray and an auto-injector for use by those without medical training. While business and other considerations may impact how quickly this product becomes available, today’s approval is an important step for the agency as it works toward expanding access to this live-saving drug. The FDA also held a two-day advisory committee meeting in December to solicit input and advice on strategies to increase the availability of naloxone products intended for use in the community.

According to the Centers for Disease Control and Prevention, almost 400,000 people died from an opioid overdose from 1999 to 2017, and on average, more than 130 Americans die every day from overdoses involving opioids, a class of drugs that include prescription medications such as fentanyl, oxycodone, hydrocodone and morphine, as well as illegal drugs such as heroin or drugs sold as heroin. Drugs like heroin often contain fentanyl or derivatives of fentanyl. When someone overdoses on an opioid, it can be difficult to revive the person to full consciousness, and breathing may become shallow or stop completely – leading to death without medical intervention. If naloxone nasal spray is administered quickly, it can counter the overdose effects, usually within minutes. However, it is important to note that it is not a substitute for immediate medical care, and the person administering naloxone nasal spray should seek further immediate medical attention on the patient’s behalf.

As part of the U.S. Department of Health and Human Services’ ongoing efforts to combat the opioid crisis and expand the use of naloxone, in April 2017, the Department announced its 5-Point Strategy to Combat the Opioids Crisis. Those efforts include: better addiction prevention, treatment, and recovery services; better data; better pain management; better targeting of overdose reversing drugs; and better research. In April 2018, Surgeon General VADM Jerome Adams issued an advisory encouraging more individuals, including family, friends and those who are personally at risk for an opioid overdose to carry naloxone. In December 2018, ADM Brett P. Giroir, M.D., Assistant Secretary for Health and the Secretary’s Senior Advisor for Opioid Policy, released guidance for health care providers and patients detailing how naloxone can help save lives.

One of the ways the FDA is working to increase access to this life-saving treatment is through the approval of generic naloxone products. As part of HHS’ public health emergency to address the ongoing opioid crisis, the FDA will grant priority review to all abbreviated new drug applications for products indicated for the emergency treatment of known or suspected opioid overdose. As part of the priority review, sponsors will receive shorter goal dates or standard goal dates with earlier reviewer deadlines; enhanced agency communication with sponsors; and expanded agency engagement similar to Generic Drug User Fee Act enhancements for complex products, such as pre-submission and midcycle meetings. The FDA has determined that further expanding availability of and access to overdose reversal drugs could help address the public health emergency.

More generally, in an effort to promote competition to help reduce drug prices and improve access to safe and effective generic medicines for Americans, the agency is taking a number of new steps as part of its Drug Competition Action Plan. These steps include important work to improve the efficiency of the generic drug approval process and address barriers to generic drug development.

The FDA also remains focused on several additional priorities to address the opioid crisis, including: decreasing exposure to opioids and preventing new addiction; fostering the development of novel pain treatment therapies; supporting treatment of those with opioid use disorder; and improving enforcement and assessing benefit-risk.

Naloxone nasal spray does not require assembly and delivers a consistent, measured dose when used as directed. This product can be used for adults or children and is easily administered by anyone, even those without medical training. The drug is sprayed into one nostril while the patient is lying on his or her back and can be repeated if necessary.

The use of naloxone nasal spray in patients who are opioid-dependent may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps (piloerection), sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.

The FDA tentatively approved this generic drug product on June 8, 2018. Teva Pharmaceuticals USA Inc. has received final FDA approval to market generic naloxone nasal spray.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Osteopathic Certification in Addiction Medicine

American Board of Medical Specialties (ABMS) Recognizes Addiction Medicine as a Subspecialty

AOA Resolution

Download a copy of the addiction medicine certification fact sheet.

PCSS Discussion Forum: A Quick, Evidence-Based Resource from Clinical Experts

If you need an answer about treating opioid use disorder, the PCSS Discussion Forum is here to help. The forum is separated into major topics, such as office practices, pain management, burprenorphine, naltrexone, and methadone, and you may find the answers you need simply by browsing the posts or using the search bar. If not, write a post and an addiction specialist typically responds within 48 hours. For example, a recent post from a clinician requested help with patients having difficulty with buprenorphine induction. Within one hour..... Read more PCSS News.

(CNN) -- Deaths from the synthetic opioid fentanyl skyrocketed more than 1,000% from 2011 to 2016, according to a report released Thursday.

The number of fatalities related to the drug held fairly steady between 2011 and 2012, hovering around 1,600 deaths in both those years. In 2013, the number increased to just over 1,900 fatalities.

Beginning in 2014, though, fentanyl-related deaths began to double each year. In 2014, fentanyl was involved in 4,223 deaths. In 2015, it was 8,251 deaths. And in 2016, fentanyl-related deaths had jumped to 18,335.

The report from the US Centers for Disease Control and Prevention also analyzed who had been hardest hit by the fentanyl epidemic.

The researchers, who are part of the National Center for Health Statistics, found that while men and women had similar rates of fentanyl-related deaths from 2011 through 2013, that began to shift. By 2016, the rate of men dying from fentanyl overdoses was nearly three times that of women.

And while there were increases in fentanyl-related fatalities in all age groups, the largest rate increases were among younger adults between the ages of 15 and 34. The rate of 15- to 24-year-olds who died from fentanyl overdoses increased about 94% each year between 2011 and 2016, and about 100% each year for 25- to 34-year-olds.

Researchers also found that while whites had the highest overall rates of fentanyl fatalities, death rates among blacks and Hispanics were growing faster. Between 2011 and 2016, blacks had fentanyl death rates increase 140.6% annually and Hispanics had an increase of 118.3% annually.

A National Center for Health Statistics report released in December found fentanyl to be the drug mostly commonly involved in overdose deaths. In 2016, the drug was responsible for nearly 29% of all drug overdose deaths, making it the deadliest drug in America.

Researchers analyzed death certificate information that included mentions of fentanyl and fentanyl analogs. Previous analysis had not looked specifically only at fentanyl, but overall synthetic opioids.

Americans are now more likely to die from a drug overdose than a car accident. In 2017, drug overdoses killed more than 70,000 Americans, and opioids are the leading driver in US drug overdose deaths. Opioids are a class of drugs that includes illicit fentanyl and heroin, as well as commonly prescribed painkillers, such as oxycodone and morphine.

·        By Nadia Kounang, CNN

As federal lawmakers consider Fiscal Year 2020 Labor-HHS appropriations bills this Spring, we need them to prioritize funding for the following two new programs that would help address our nation’s substance use disorder (SUD) treatment workforce shortage:

(1) the Loan Repayment Program for the Substance Use Disorder Treatment Workforce, authorized in the SUPPORT for Patients and Communities Act; and

(2) the Mental and Substance Use Disorder Workforce Training Demonstration Program, authorized in the 21st Century CURES Act.

    
Funding these programs would allow more students and healthcare professionals to pursue and afford education and training in the prevention and treatment of addiction and would significantly increase the number of qualified experts available to help the more than 20 million Americans in need of treatment for SUD.

Members of Congress can publicly demonstrate their commitment to funding these programs by signing “Dear Colleague” letters of support before noon on March 25. It is essential that Members of Congress hear from the addiction treatment community about the importance of funding both of these programs.

Click the link below to log in and send your message:
https://www.votervoice.net/BroadcastLinks/NDMNLwyWKARPzz_Tb9tbwA 

The American Osteopathic Association (AOA) is investigating the restoration of a certification pathway which would provide an opportunity for osteopathic and allopathic physicians to obtain certification in the subspecialty of Addiction Medicine. Physicians who complete an AOA or ABPM approved fellowship in Addiction Medicine or demonstrate their qualifications via clinical pathway requirements, will be eligible to sit for the initial certification examination. 

The AOA and the American Osteopathic Academy of Addiction Medicine (AOAAM) respectfully request your participation in this short survey aimed at gauging interest in an Addiction Medicine certification. Your responses will inform the process of establishing a program that will afford certification opportunities in Addiction Medicine. The deadline to participate in the survey is April 7, 2019.

Please feel free to forward the link to the Addiction Medicine survey to your physician colleagues who practice in this field.

If you have any questions, contact the AOA at certification@osteopathic.org. Thank you in advance for your input.

PCSS has seen a huge increase in the number of MAT waiver courses in recent months, presenting numerous opportunities to address the opioid crisis. Only six months into the third year of the grant, already 416 waiver trainings have been conducted—slightly more than what was conducted for all of the second year of the grant. 

With the average training hosting 20 participants, PCSS potentially could train more than 14,000 clinicians this year alone—and this does not include those clinicians who take the course online. More than 12,800 clinicians have taken PCSS’s online course since May 2017, when PCSS began offering online courses. When the grant was first funded, the number of trainings per year was projected to be 94 .  [ Read more ]

Read More PCSS News

We present good news regarding the status of an osteopathic Addiction Medicine CAQ.                                                                          

As you recall, Dr. Margaret Kotz (AOAAM delegate), Dr. Stephen Wyatt (AOAAM alternate) and Nina Vidmer attended the AOA House of Delegates (HOD) meetings in Chicago July 16-22, 2018.  AOAAM submitted Resolution H215, which would allow for DOs who completed AOA-approved fellowships in Addiction Medicine to take the Addiction Medicine CAQ exam, and also to create a pathway for all qualified DOs to sit for the exam and become certified. Resolution H-215 was ultimately forwarded to the Finance Committee.

AOAAM leadership has been working with the AOA since the 2018 HOD July 2018 to move this matter forward.  This week Dr. Julie Kmiec, AOAAM president; Dr. Margaret Kotz, past president; and Nina Vidmer, executive director attended the AOA Mid-Year Meeting for a status update. Today the AOA Board of Trustees voted on the resolution that:

RESOLVED, that AOA allow DOs who have completed an AOA-approved fellowship in Addiction Medicine to take the CAQ exam in Addiction Medicine; and, be it further

RESOLVED, that AOA reopen a practice pathway for a period of time to be determined, and in discussion with AOAAM; and, be it further

RESOLVED, that AOA approach AOAAM for an investment towards shared financial responsibility for the reopening of the Addiction Medicine CAQ that could be paid back over a period of time assuming we have candidates that will take advantage of this exam; and, be it further

RESOLVED, that AOA set a price point that is comparable to ABPM, and determine the ROI.

The AOA Finance Committee will meet on April 24, 2019 to make their final recommendations, which will be based on the fiscal impact of creating this pathway and exam.

The AOA/AOAAM will be sending out a survey to determine the level of interest in taking the exam – watch for this and please participate!  Updates will follow as more news becomes available.

Best regards,

Julie Kmiec, DO
AOAAM President

Download a copy of the resolution.

Medical school loan repayment program (LRP) with a February 21 application deadline.  

If you have a primary care or psychiatry specialty and are working part-time or full-time in addiction medicine, you could qualify for up to $75,000 in medical school loan repayment. 

This program in being offered by HRSA through the National Health Service Corps (NHSC) in support of physicians who are or will be working to support patients with opioid use disorder, as well as other substance use disorders. Venues of service include not only clinics and other sites, yet also private practices. Due to the targeted scope of this program, applicants may qualify for LRP awards even if they are working at sites with Health Professional Shortage Area (HPSA) scores that would ordinarily be too low to qualify for NHSC LRP funding.  

If you are interested, additional information and an application can be found here:  

https://nhsc.hrsa.gov/loan-repayment/nhsc-sud-workforce-loan-repayment-program.html

(Please be advised that HRSA advises that applicants allow a few weeks to complete this application.  Thus, if you are interested, consider applying now.)