FDA Advances Mail-Back Disposal Envelopes for Opioid Analgesics Dispensed in Outpatient Setting and Continues Assessment of At-Home Technologies; CEPOP Issues Statement Calling for Combined Action

On April 3, 2023, the Food and Drug Administration (FDA) announced they would require manufacturers to provide pre-paid mail-back envelopes to pharmacies dispensing opioid analgesics in outpatient settings. Each manufacturer will be required to submit a proposed modification to the Opioid Risk Evaluation and Mitigation Strategy (REMS) within 180 days of the date included in their notification letters. Once modifications are approved, outpatient pharmacies and dispensers will be able to order the mail-back envelopes to co-dispense to patients. Additionally, manufacturers will need to develop educational materials on the proper disposal of opioid analgesics in an outpatient setting. The agency is also currently assessing whether manufacturers should be required to make in-home disposal products available to patients prescribed opioids and has issued a request-for-information to support the agency’s assessment. The agency will also participate in a public workshop on defining and evaluating in-home disposal systems hosted by the National Academies of Sciences, Engineering and Medicine’s (NASEM) Forum on Drug Discovery. Following FDA’s April 3rd announcement, CEPOP leaders issued a statement encouraging the agency to complete their ongoing work with the NASEM and include an in-home disposal option when launching the opioid REMS disposal requirement. FDA is expected to approve the modified REMS in 2024.

Articles & Resources

FDA – FDA Moves Forward with Mail-back Envelopes for Opioid Analgesics Dispenses in Outpatient Settings

Introduction of the OPIOIDS Act to the Senate

On March 29, 2023, Senators Peter Welch (VT) and Rick Scott (FL) introduced the Overcoming Prevalent Inadequacies in Overdose Information Data Sets (OPIOIDS) Act. The legislation will educate and assist law enforcement in identifying, understanding, and addressing opioid overdose. The legislation supports data collection at the state and local level, thus empowering public health groups, law enforcement, and the government to prevent and respond to overdoses appropriately. The act provides additional training for law enforcement, grants for updating systems to trace drugs, forensic labs, training to track darknet criminals and support COPS Grants for collaboration and the Fentanyl Profiling Program. On the issue, Senator Welsh said, “Ending this crisis will take hard work from all corners of our communities—from medical professionals and law enforcement to families, friends, and neighbors. But we cannot end overdoses without understanding their cause. That’s why I am proud to join Sen. Scott to introduce this bipartisan legislation. The OPIOIDS Act will help law enforcement gather essential data to make informed decisions on prevention, treatment, and recovery…”

Articles & Resources

Bill Text

Senator Welch—Welch Introduces Bipartisan OPIOIDS Act to Combat Fentanyl Crisis

NIH-Funded Study Suggests Buprenorphine can be Safely Started in Emergency Departments without Triggering Withdrawal

A recent study supported by the National Institutes of Health (NIH) found that buprenorphine can be safely introduced and well-tolerated in an emergency department. The study analyzed data from an ongoing clinical trial and reviewed precipitated withdrawal symptoms of individuals seeking medication-assisted treatment, including those using stronger opioids such as fentanyl. The multi-site clinical trial recruited adult patients with untreated moderate to severe opioid use disorder that tested positive for opioids, negative for methadone, and had a Clinical Opiate Withdrawal Scale score – which is used determine severity of withdrawal and assess the level of dependence on opioids – greater than or equal to four. Researchers found that, of the 1200 participants, 70% used fentanyl and only 9 out of the 1200 experienced precipitated withdrawal symptoms (.76%). Of those experiencing withdrawal symptoms, only 1% used fentanyl. Researchers noted that these results suggest that buprenorphine treatment for patients with OUD who also use fentanyl can be initiated in the emergency department with a low risk of triggering withdrawal symptoms. Director of the NIH HEAL Initiative, Dr. Rebecca Baker, stated, “The emergency department is an important touchpoint for providing life-saving medication and resources for people at risk for overdose. We need to meet people where they are amid an increasingly deadly overdose crisis.”

Articles & Resources

NIH – Buprenorphine initiation in the ER found safe and effective for individuals with opioid use disorder who use fentanyl

JAMA – Incidence of Precipitated Withdrawal During Multisite Emergency Department-Initiated Buprenorphine Clinical Trial in Era of Fentanyl

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.

Axios – DOJ, Tech Companies to Discuss Illegal Fentanyl Sales

Axios – Worsening Opioid Crisis Drives More Addiction Treatment in ER

Bloomberg Law – Opioid Victims Wait as Second Circuit Mulls Purdue Pharma Deal

British Journal of General Practice – The Association of Strong Opioids and Antibiotics Prescribing with General Practitioner Burnout

Cancer Therapy Advisor – US Medical Oncologists Are Prescribing Fewer Opioids

CBS News – The U.S. Could Designate Mexican Drug Cartels as Terrorist Organizations—What Would That Mean?

The Hill – Drug Overdose Death Have Quadrupled Among Seniors in the Last 20 Years. Why?

The Hill—How Schools can Help Combat the Rise in Teen Overdose Deaths

Reuters – Mexico asks China for Help to Control Fentanyl

The Washington Post – D.C. Vending Machines to Dispense Narcan, Fentanyl Test Strips

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