Stakeholders Call for OTC Availability of Naloxone to Curb Opioid Overdoses

Public health advocates called on the FDA Wednesday to expand access to the opioid overdose reversal drug naloxone by converting it from prescription-only to over-the-counter status.

Naloxone needs to be readily available in any situation where someone could overdose on an opioid, as the current prescription-only status limits the situations in which naloxone can be used, said Corey Davis, deputy director of the Network for Public Health Law.

The problem with a prescription-only stance is that many people with opioid dependency, especially heroin, don’t have health insurance or visit traditional healthcare providers, and those who do may be afraid to talk to them about their addiction issues, he said.

The federal government needs to get on the same page as many states, Davis said. As of June 22, 38 states permit the prescribing and dispensing of naloxone to a person other than the person at risk of an overdose, and 28 states permit the drug to be dispensed to persons who meet specified criteria to redistribute. 34 states have also reduced liability for prescribers, dispensers and administrators.

These changes are welcome but inadequate, as most continue to require a prescriber, pharmacist or both — and many at-risk people don’t have access to the medical system. Changing naloxone’s status state-by-state is time-consuming, so it must be done at the federal level, he urged.

Changing naloxone to OTC can be initiated through a citizen petition, manufacturer request or by the FDA commissioner. Consumer behavior, safety and efficacy must be shown, but this shouldn’t be an issue since naloxone’s efficacy is beyond dispute, there are no known contradictions or negative effects and tens of thousands of overdose reversals have been performed by lay people, Davis said. The drug’s label would need to be consistent with lay administration, but that has already been created for an autoinjector system.  

“Federal inaction is literally costing lives,” Davis said.

John Strang, head of the Nation Addiction Centre at King’s College London echoed the call for OTC availability, saying naloxone needs to be as readily available for addicts as an EpiPen is for people with severe allergies. He said that 10 percent of his constituents calling for OTC availability are families, who want it on hand for loved ones struggling with addiction.

The meeting reconvenes today at the FDA’s White Oak Campus in Maryland (DID, May 19). — Kellen Owings