Memorandum  Over the Counter (OTC) Naloxone

Date:	12/20/2023
Referenced Sources:	Bureau of Substance Addiction Services

Memorandum

TO: Massachusetts Retailers

FROM: Massachusetts Department of Public Health

RE: Over the Counter (OTC) Naloxone

This memo outlines information on the availability of the new over the counter (OTC) naloxone in Massachusetts. It also directs you to resources available for you and your customers to facilitate availability and access to naloxone.

What to know: The approval of OTC intranasal naloxone products is intended to increase the accessibility of naloxone as a key strategy to reducing fatal overdoses in communities. The addition of OTC naloxone access also aims to mitigate the stigma associated with seeking out this product.

On March 29th, 2023, the Food and Drug Administration (FDA) approved a 4-mg intranasal naloxone formulation (Narcan, Emergent Biosolutions) for over the counter (OTC) sale. A generic version of the 4-mg product (Padagis, Padagis) and a 3-mg intranasal branded formulation of naloxone (RiVive, Harm Reduction Therapeutics) were both approved in July 2023. The first formulation of OTC naloxone—the 4-mg intranasal by Emergent Biosolutions more commonly known as “Narcan”— officially became available for retailers to sell in September, 2023.

Access options–pharmacies and elsewhere:  In addition to these new OTC products, people can still access prescription naloxone via patient-specific prescriptions or by utilizing the current statewide standing order from retail pharmacies, or free naloxone through community-based organizations.  As always, an individual’s insurer determines the amount charged for prescription naloxone.  Naloxone that has been labeled for over the counter (OTC) sale will be available to purchase in more locations beyond pharmacy shelves, such as grocery stores, gas stations, convenience stores and other retail locations.

Cost and coverage: OTC naloxone access aims to reduce the stigma of acquiring and carrying naloxone. However, OTC access does not mean that the cost of naloxone will make it affordable for all people at risk of overdose and their networks. To reduce the financial burden of purchasing OTC naloxone, retailers should advertise and foster the use of healthcare savings or flexible spending accounts that can be used to cover the entire cost of OTC naloxone. Some insurance companies may cover the OTC naloxone products. MassHealth will cover most prescription and OTC naloxone with no prior authorization and at $0 copay.

Placement of OTC naloxone: Retailers should enable anonymous access to naloxone directly on a shelf, without locking it behind a cabinet nor in a container that necessitates contacting an employee to access it. Stocking OTC naloxone exclusively behind the counter limits access to the product to those willing to ask to purchase it from a clerk or pharmacy staff member. Businesses that can select where products will be shelved should consider placing OTC naloxone toward the front of stores or cash registers to maximize visibility.

Educational resources about OTC naloxone: The Department of Public Health has partnered with Brandeis University researchers who have conducted studies of pharmacy naloxone access as part of a study called Respond to Prevent.  Educational resources available include a pharmacist job-aid, informational videos, and an OTC infographic (tear-off and poster versions) for patients. Please utilize these resources.

Please direct any questions to: [e-mail]