This nonprescription availability is an important milestone for states and territories, community organizations, harm reduction advocates, those working to prevent overdose, and people at risk for overdose. State policy has evolved since the initial FDA approval of naloxone in 1971 to reduce access barriers and allow distribution to laypersons for emergency response. More than 20 years ago, harm reduction organizations spearheaded efforts to distribute naloxone to laypersons, particularly people who use drugs and their friends and families. Significant research has demonstrated naloxone is safe and effective for layperson use even with brief training.
The U.S. Food and Drug Administration on Wednesday approved selling the leading version of naloxone without a prescription, setting the overdose-reversing drug on course to become the first opioid treatment drug to be sold over the counter. It’s a move that some advocates have long sought as a way to improve access to a life-saving drug, though the exact impact will not be clear immediately.
Turning Point is calling on the government to make naloxone routinely available to the police, paramedics and the general public, as only treatment and healthcare staff are currently able to distribute the drug.
“We are trying to reduce the number of deaths from opiate overdoses and, as custody suites continually engage with people who are at risk of such drug poisoning it’s a very positive move, in line with the Government’s national drug strategy.
It’s unclear what will classify a business as high risk, though sources told CityNews on Tuesday that most construction sites, bars and nightclubs will be included. If needles are found on site, or if an employee discloses a substance abuse issue, a business may also be deemed high risk, as will any industry with a perceived risk of an overdose.
Drug maker Emergent BioSolutions is seeking approval from the Food and Drug Administration to sell Narcan over the counter, without need for a prescription.