Over the counter naloxone needed to save lives in the United States.

Abstract

The United States continues to face a public health emergency of opioid-related harm, the effects of which could be dramatically reduced through increased access to the opioid antagonist naloxone. Unfortunately, naloxone is too often unavailable when and where it is most needed, partly due to its continued status as a prescription medication. Although states and the federal Food and Drug Administration (FDA) have acted to increase access to naloxone, these changes are insufficient to address this unprecedented crisis. In this Commentary, we argue that FDA can and should immediately reclassify naloxone from prescription-only to over-the-counter status, a legally permissible change that could save hundreds if not thousands of lives in the United States every year.