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Considering the Potential Benefits of Over-the-Counter Naloxone

Authors Evoy KE, Hill LG, Davis CS

Received 23 November 2020

Accepted for publication 27 January 2021

Published 15 February 2021 Volume 2021:10 Pages 13—21


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Professor Jonathan Ling

Kirk E Evoy,1 Lucas G Hill,2 Corey S Davis3

1University Health, Department of Pharmacy, The University of Texas at Austin College of Pharmacy, San Antonio, TX, USA; 2Pharmacy Practice, The University of Texas at Austin College of Pharmacy, Austin, TX, USA; 3Harm Reduction Legal Project, Los Angeles, CA, USA

Correspondence: Kirk E Evoy Email

Abstract: Since 1999, annual opioid-related overdose (ORO) mortality has increased more than six-fold. In response to this crisis, the US Department of Health and Human Services outlined a 5-point strategy to reduce ORO mortality which included the widespread distribution of naloxone, an opioid antagonist that can rapidly reverse an opioid overdose. Increased distribution has been facilitated by the implementation of naloxone access laws in each US state aimed at increasing community access to naloxone. While these laws differ from state-to-state, most contain mechanisms to enable pharmacists to dispense naloxone without a patient-specific prescription. These laws have enhanced community naloxone distribution, both from pharmacies and overdose education and naloxone distribution programs, and produced positive effects on ORO mortality. However, a growing body of evidence has revealed that significant barriers to naloxone access from pharmacies remain, and annual ORO deaths have continued to climb. Given these concerns, there has been a push among some clinicians and policymakers for the US Food and Drug Administration to re-classify naloxone as an over-the-counter (OTC) medication as a means to further increase its accessibility. If an OTC transition occurs, educational outreach and funding for clinical innovations will continue to be crucial given the important role of health professionals in recommending naloxone to people at risk for experiencing or witnessing an ORO. Recognizing the severity of the ORO public health crisis, we believe transitioning formulations of naloxone approved for layperson use to OTC status would result in a net benefit through increased access. However, such a change should be combined with measures to ensure affordability.

Keywords: opioid, opioid overdose, naloxone, naloxone access law, over-the-counter

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