A report in the October 21 issue of JAMA Internal Medicine offers another reason for the Food and Drug Administration to reclassify the opioid overdose antidote naloxone over‐the‐counter. The study finds that despite a growing number of community pharmacies in the U.S. between 2009 and 2015, the overall numbers don’t reflect the “churn” in the community pharmacy industry. The number of pharmacies increased from nearly 63,000 in 2009 to nearly 68,000 in 2015. But of the nearly 75,000 pharmacies in operation at any point during this time period, one in eight had closed by the end of 2015. It found a disproportionate rate of closure among independent pharmacies in low‐income urban areas.
I have argued here and at a recent Capitol Hill Briefing that the FDA should reclassify the opioid overdose antidote naloxone from prescription‐only to OTC. All 50 states and the District of Columbia have developed work‐arounds that allow patients to obtain naloxone directly from a pharmacist. A recent RAND study found greater reductions in overdose mortality rates in those states that had the most liberal work‐arounds.
But the stigma attached to opioid use has deterred many would‐be beneficiaries from walking up to the pharmacist’s counter and explaining why they need and want naloxone. In addition, many pharmacies still don’t stock the naloxone and some pharmacists won’t dispense it because they believe they are “enabling” opioid use.
For those reasons, naloxone was reclassified to over‐the‐counter in Australia in 2016, and the antidote has been OTC in Italy since the 1990s.
Not everyone is close to a pharmacy or has an easy way of getting there. Another advantage of making naloxone OTC is that this would make the drug available at hundreds of thousands of convenience stores and other retail outlets in addition to pharmacies. It could even be dispensed in vending machines.
This latest report from JAMA Internal Medicine provides another reason for reclassifying naloxone OTC: it should improve access to naloxone by people in low‐income urban neighborhoods where pharmacies are not as numerous, and where naloxone is sorely needed.
If the FDA won’t reclassify naloxone OTC then Congress should do so.