FDA Approves First DNA Test for Opioid Use Disorder

On December 19th, the Food and Drug Administration (FDA) approved AvertD test, a DNA test that assesses if an individual has a combination of genetic variants that is associated with an elevated risk of developing Opioid Use Disorder. The test is intended to be used before first oral opioid pain medication exposure in patients 18 years and older with a 4-30 day prescription for the acute pain treatment following planned procedures (e.g., wisdom tooth removal or other surgical procedures). The test is not intended for patients dealing with chronic pain. The manufacturer will provide training on appropriate uses and conduct a post-market study on the test’s performance. FDA notes that there are some concerns regarding false positives and negatives that may result in a false sense of security or inadequate pain treatment; therefore, they emphasize that, given these concerns, it is especially important that providers understand the results to use them as part of a broader treatment plan and not as the deciding factor.

Articles & Resources

FDA—FDA Approves First Test to Help Identify Elevated Risk of Developing Opioid Use Disorder

Biden-Harris Administration Guidance on Safety Stations

At the end of December, the Biden-Harris Administration released Guidelines for Safety Station Programs in Federal Facilities, which recommends the inclusion of opioid reversal medications in all federal facilities. Safety stations would build upon existing automated external defibrillator (AED) sites and expand to include the necessary tools needed to respond to emergencies. Guidance language recommends that safety stations include opioid reversal agents and hemorrhagic control components. White House Office of National Drug Control Policy (ONDCP) Director, Dr. Rahul Gupta, commented on the guidance saying, “Today, we are taking a historic step to recommend that every federal facility across the nation has lifesaving overdose reversal medications like naloxone on site…The lifesaving medications should be as readily available as fire extinguishers or defibrillators in all public spaces, from schools, to housing communities, to restaurants, retail, and other businesses…”

Articles & Resources

SAMHSA—Biden-Harris Administration Announces New Action to Increase Naloxone Access in Federal Facilities Across the Nation

Federal Register—Guidelines for Safety Station Programs in Federal Facilities

What We Read Last Week

Several articles were published last week pertaining to the opioid epidemic, covering a variety of different components of the topic. Links to relevant articles are provided below.

Forbes—Matthew Perry’s Death Underscores the Significance of Buprenorphine

National Academy of Medicine—Integrating Telehealth and Traditional Care in Chronic Pain Management and Substance Use Disorder Treatment: An Action Agenda for Building the Future State of Hybrid Care

National Institute on Drug Abuse—Monitoring the Future: National Survey Results on Drug Use, 1975-2023: Secondary School Students

National Public Radio—Americans on Medicare now get better access to mental health care. Here’s how

Politico—Mental hospitals warehoused the sick. Congress wants to let them try again.

STAT—How opioid overdoses in public restrooms led an electrician to invent ‘safe bathrooms’

Wall Street Journal—One State Wanted to Understand Youth Opioid Use. So It Tested High-School Wastewater

Wall Street Journal—Flesh-Rotting ‘Tranq’ Ushers In a Darker Era In the Opioid Crisis

Wall Street Journal—Addiction Treatment Can Work Even When It’s Not Voluntary

This Week’s Calendar

In the week ahead, there are no relevant events or hearings noticed at this time. In the event that there are any changes to the schedule for this week, we will make additional information available.

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