Researchers call for Federal and State policy changes to make naloxone widely available

BOSTON – Following a 30 percent increase in fatal overdoses from 2019 to 2020 in the United States, addiction medicine experts at the Grayken Center for Addiction at Boston Medical Center are advocating for increased distribution of naloxone, a life-saving drug that can reverse an overdose. Published in the American Journal of Public Health, researchers suggest a four-step process to expand availability of naloxone to save lives:

1. Making naloxone widely available over-the-counter, including at community locations like convenience stores and gas stations as well as pharmacies
2. Increasing funding for community-based programs focusing on harm reduction
3. Permanently eliminating insurance co-payments and prior-authorization requirements
4. Mandating co-prescribed and co-dispensed naloxone with all higher risk opioid prescriptions and medications for opioid use disorder

Since March 2020, there have been remarkable public health efforts by the federal government to respond to the COVID-19 pandemic. However, restrictions put in place to protect communities from COVID-19 have exasperated the existing opioid epidemic. The reduced access to addiction treatment and services, combined with fentanyl infiltrating the drug supplies, have resulted in an estimated, but likely record-breaking 100,000 fatal overdoses in 2020 alone.

“While federal regulators have taken remarkable strides in expediting authorization, approval, and access to vaccines and novel therapeutics for COVID-19, similar regulatory steps must be taken to improve the availability of naloxone products where barriers to access remain,” says Raagini Jawa MD, MPH, an infectious diseases and addiction medicine physician at Boston Medical Center. “Naloxone access remains inadequate and given the pervasiveness of this national crisis, it is critical to have naloxone saturated throughout our communities now”.

Only one naloxone prescription is dispensed for every 70 high-dose opioid prescriptions nationwide. In communities which experience disproportionate rates of overdose from illicit opioids, a recent study suggests found non-urban areas have lower naloxone distribution relative to overdose deaths compared to urban areas.

Researchers suggest that traditional naloxone access points such as local pharmacies and syringe service programs are not universally available in all communities and often lack round-the-clock availability. Recommended solutions in this review include that naloxone be available at a subsidized cost at low-barrier access points such as gas stations and convenience stores, where people at risk of overdose could have 24-hour, anonymous access.

“Every overdose death is preventable,” says Jawa, also a clinical instructor of medicine at Boston University School of Medicine. “The ongoing surge in overdose deaths during the COVID-19 pandemic is a warning that immediate and comprehensive steps must be taken to reduce deaths”. 

Researchers are advocating for federal intervention to reduce the costs associated with access to naloxone, similar to what was done to reduce the fee for COVID-19 vaccinations by leveraging the Affordable Care Act.

The U.S. Food and Drug Administration will host a virtual public workshop on Mar. 29, to discuss critical questions around access to naloxone, a drug used to reverse opioid overdoses. The workshop is a collaboration with the Reagan-Udall Foundation for the FDA, and features co-author Jeffrey Bratberg, PharmD, FAPhA, from the University of Rhode Island College of Pharmacy on the panel.

Funding for this study was given by the Research in Addiction Medicine Scholars (RAMS) Program, NIDA grant R25DA033211 and Boston University Clinical HIV/AIDS Research Training (BU-CHART) Program Funded by NIAID grant T32AI052074.

-###-

About Boston Medical Center

Boston Medical Center (BMC) is a private, not-for-profit, 514-bed, academic medical center that is the primary teaching affiliate of Boston University School of Medicine. It is the largest and busiest provider of trauma and emergency services in New England. BMC offers specialized care for complex health problems and is a leading research institution, receiving more than $166 million in sponsored research funding in fiscal year 2019. It is the 13th largest funding recipient in the U.S. from the National Institutes of Health among independent hospitals. In 1997, BMC founded Boston Medical Center Health Plan, Inc., now one of the top ranked Medicaid MCOs in the country, as a non-profit managed care organization. Boston Medical Center and Boston University School of Medicine are partners in Boston HealthNet – 12 community health centers focused on providing exceptional health care to residents of Boston. For more information, please visit http://www.bmc.org .