Twelve States Pass “Right to Know” Laws

Utah and Washington are the latest states to pass a Patient Notification Law. The laws require all practitioners to have a conversation with their patients on the addictive nature of opioids before they are prescribed and discuss possible non-opioid alternatives that are available.

According to the advocacy campaign Prevent Opioid Abuse , versions of the legislation have passed in California, Connecticut, Maryland, Michigan, New Jersey, Nevada, Oklahoma, Ohio and Rhode Island and West Virginia. Efforts to adopt it are currently underway in six other states and Puerto Rico. In New Jersey the law takes it a step further and requires physicians, physician assistants, dentists and optometrists to complete one Continuing Medical Education credit on topics that include responsible prescribing practices, as well as risks and signs of opioid abuse, addiction and diversion.

Read more.

Dear Representative Kuster and Senator Markey,

The undersigned organizations in the Coalition to Stop Opioid Overdose (CSOO) are writing today to voice our support for your bill – the Community Re-entry through Addiction Treatment to Enhance (CREATE) Opportunities Act. CSOO is a coalition of diverse organizations united around common policy goals to reduce opioid overdose deaths. CSOO members aim to elevate the national conversation around opioid overdose and work to enact meaningful and comprehensive policy changes that support evidence-based prevention, treatment, harm reduction, and recovery support services.

The morbidity and mortality statistics related to addiction, and in particular addiction involving opioid use, are grim. In 2017, there were a record 70,237 drug overdose deaths in the United States, two-thirds of which have been linked to opioids.  i. Furthermore, those who report opioid use are significantly more likely to interact with the criminal justice system than those who do not report opioid use. ii. It is vital that those who are incarcerated while suffering from opioid use disorder (OUD) receive the treatment they need to improve their health outcomes and decrease recidivism. Fortunately, medication-assisted treatment (MAT) has proven to be successful in treating OUD. Those receiving MAT as part of their treatment are 75% less likely to experience a mortality related to addiction than those not receiving MAT, and are more likely to maintain gainful employment. iii. Additionally, MAT has been shown to reduce recidivism, illegal drug overdose deaths, and infectious disease transmission.iv Given the positive impact of MAT, we appreciate your leadership in the introduction of the CREATE Opportunities Act. Read more.

AOAAM supports the Opioid Workforce Act of 2019 (H.R. 3414).

Dear Chairman Neal and Ranking Member Brady:

On behalf of the organizations below, we write to express our support for the Opioid Workforce Act of 2019 (H.R. 3414). This thoughtful, bipartisan legislation would provide Medicare support for an additional 1,000 graduate medical education (GME) positions over five years in hospitals that have, or are in the process of establishing, accredited residency programs in addiction medicine, addiction psychiatry, or pain medicine. We greatly appreciate the Committee’s commitment to advancing policies that would strengthen the health care workforce serving on the front lines of the nation’s opioid epidemic.

According to the Substance Abuse and Mental Health Services Administration, in 2016 approximately 21 million people needed treatment for a substance abuse disorder, however only 11% of those received any treatment at all. Part of the reason for this disparity is a shortage of physicians trained in addiction medicine, addiction psychiatry, or pain management. The lack of physicians trained in these specialties reflects the nation’s larger physician shortages. Funding new, targeted residency positions will strengthen the health care workforce and help mitigate the effects of the overall physician shortage.

The Opioid Workforce Act of 2019 is a targeted and important step that Congress must take to help ensure a robust physician workforce that can deliver high-quality care to those suffering from substance abuse disorders.

We encourage all members of the Committee to support this bipartisan bill.

View the full letter.

A new National Health Service Corps Program, the Rural Community Loan Repayment Program, will expand and improve access to quality opioid and substance use disorder (SUD) treatment in our rural, underserved areas nationwide. Health care clinicians qualified to provide SUD treatment may be eligible for this loan repayment in return for service at an NHSC-approved SUD treatment facility. For more information and to apply, visit the Rural Community LRP website.

The application cycle closes Thursday, July 18, 2019 at 7:30 p.m. ET.

A group shot from the ORN Summit in Kansas City (May 15-17). During this summit Technology Transfer Specialists and Partners worked collaboratively on how to streamline and optimize our efforts. Summaries from select presentations are included in this issue of the ORN Impact Bulletin.

• Photos and copies of presentations from the ORN Summit are now available here.
• ORN now has a Spanish brochure! Email jane@aaap.org and nic@aaap.org for copies.

Read more.

With recent data from our evaluator, RTI International, the Opioid Response Network will be releasing our first year summary. See preliminary information below. 

More community trainings are scheduled. ORN community trainings are free two-day meetings  focusing on the opioid crisis. The purpose is to share ORN resources , provide opioid use disorder training and help participants develop technical assistance requests and action plans for their communities. Select upcoming trainings will be hosted in Indianapolis, IN; Montgomery, AL; Reno and Las Vegas, NV; and Juneau, AK.

Are you participating in an ORN event? We need your help! We want to see your smiling faces at ORN events across the country. Please take photos at your events and share with jane@aaap.org and nic@aaap.org so we can post in the Bulletin and on our website.

The 2019 Opioid Response Network Summit was held from May 15-17 in Kansas City. Technology Transfer Specialists and Partners worked collaboratively on how to streamline and optimize our efforts across the country and locally. Stay tuned for a recap.

Read more news including: Lessons Learned, Consulting Spotlight, CORE Team Snapshots, Filed Updates, Upcoming Webinars and In the News.

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.