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January 22, 2019

'An unprecedented step': FDA developed its own product labeling for OTC naloxone

Daily Briefing

    Read Advisory Board's take on this story.

    FDA on Thursday set the stage for making the opioid overdose treatment naloxone available for purchase over the counter (OTC) without a prescription.

    FDA develops labeling models for OTC versions of naloxone

    Unlike prescription drugs, OTC medications are required to have a Drug Facts label explaining how to use the drug in easy-to-understand language.

    Since naloxone is not available OTC, it does not currently have a Drug Facts label—so FDA took the "unprecedented" step of making one itself, FDA Commissioner Scott Gottlieb said in a release. The agency also conducted the comprehensive testing drug companies typically must complete to demonstrate consumers can understand the label.

    FDA for the first time "proactively designed, tested, and validated the key labeling [required] to approve an OTC version of naloxone," Gottlieb said. The agency designed labels that could be used for both a nasal spray and an auto-injector.  

    Gottlieb said, "Naloxone is a critical drug to help reduce opioid overdose deaths... Increased availability of naloxone for emergency treatment of overdoses is an important step—one potential way to improve access to naloxone is to make it available for over-the-counter sale."

    Gottlieb said the move means "one of the key components for OTC availability is now in place." He said, "These efforts should jumpstart the development of OTC naloxone products to promote wider access to this medicine"(George, MedPage Today, 1/17; Ross Johnson, Modern Healthcare, 1/17; Baker, "Vitals," Axios, 1/18; FDA statement, 1/17).

    Advisory Board's take

    Rebecca Tyrell, Senior Consultant, Pharmacy Executive Forum and Colleen Keenan, Senior Analyst, Pharmacy Executive Forum

    Many states have policies that allow pharmacies to sell naloxone without a prescription—but currently there are not any over-the-counter (OTC) options. It is encouraging that the FDA is pushing for an OTC version of naloxone given the continued effects of the opioid crisis in the US. On average, 130 Americans die each day from an opioid overdose, and research has shown that increased naloxone distribution is related to increased opioid overdose reversals. According to one study, opioid overdose death rates were 27-46% lower in communities where overdose education and naloxone distribution was implemented.

    With the spotlight on the opioid crisis, naloxone use has increased among police officers, firefighters, EMS, and other emergency providers—which is a good start. However, community members also play a critical role in this fight, but have had inadequate access to naloxone to date. An OTC naloxone option would be another key lever to combat the opioid epidemic. But, that OTC option will need to be accessible, affordable, and include clear administration instructions to make an impact.

    Make sure you join us on Thursday, January 24th at 1 pm ET to learn more about what you can do to address the opioid epidemic. We'll be speaking with VP and Centura Health's Chief Pharmacy Officer Clint Hinman about the system's systematic approach to rightsizing opioid prescribing and managing drug diversion.

    Webconference Thursday: How to tackle the opioid crisis and drug diversion

    Learn how Centura Health addresses both unnecessary opioid prescribing and health care worker drug diversion to stem the tide of the growing opioid epidemic.

    Register Now


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