
For the first time, the (FDA) has approved a naloxone treatment – a drug called Narcan that rapidly reverses opioid overdoses – for use without a prescription. The decision is welcome news for a country in the midst of an ever-worsening opioid crisis. It will no doubt save lives, but it won’t turn the tide so long as treatment for opioid use disorder remains inaccessible.
For the past decade, the US has witnessed a catastrophic upswing in fatal drug overdoses, largely driven by synthetic opioids such as fentanyl. In 2021, overdose deaths in the country reached a record high, killing more than – a 16 per cent increase from the year prior.
Over-the-counter Narcan, at least on its own, falls short of the all-out effort the tragedy necessitates. For one, most people already have access to it. Laws in and Washington DC permit pharmacists to dispense Narcan to qualifying individuals who don’t have a prescription – typically people with opioid use disorder, and their friends and family.
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The issue was that people still had to request the drug instead of buying it off the shelves, which posed a significant barrier for many with opioid use disorder who feared judgement from pharmacists, says at Massachusetts General Hospital in Boston.
The FDA’s push to make the drug more widely available could boost sales by allowing people to buy Narcan online or through self-checkout without having to speak to anyone, she says. A 2019 study estimated that over-the-counter approval would increase naloxone sales between , though it is unclear how that translates to overdose deaths.
A 2018 study modelled the effect of handing out naloxone kits to people at risk of opioid overdose and found that distributing up to per person in settings like pharmacies would decrease fatal overdoses by just over 8 per cent. In a scenario where people passed kits on to others, the model showed overdose deaths falling by almost 43 per cent. That is a promising outcome that lends support to the FDA’s recent decision. “It’s hard to know exactly how big the impact of this will be, but I think we can safely say that making naloxone available over the counter will prevent deaths,” says at Northwell Health in New York.
One concern, though, is the price tag. “When drugs go over the counter, typically insurers stop paying for it,” says at the Brookings Institution, a public policy organisation in Washington DC. Without insurance, a two-dose pack of Narcan costs about .
Despite access to naloxone becoming more widespread in recent years, opioid deaths have continued to soar – which is ultimately why the FDA’s decision won’t do enough. “Naloxone is a rescue medication that does not work to reduce or prevent the use of opioids,” says Berman. “Making structured treatment for opioid use disorder more accessible is what is needed overall.”
In 2020, only about of people with opioid use disorder reported receiving medication-assisted treatment – the gold standard for opioid addiction – partially due to . people with opioid use disorder in the US don’t have insurance, and without it the average cost of medications for opioid dependence is $539 per month. With private insurance, the price falls to $25 a month, on average.
“Narcan is absolutely a necessary ingredient to the crisis – we can’t get people on medication if they die from overdose first,” says at Boston University.
But that is only the first step. We could prevent more overdoses if we helped people get the care and help they need, says Hoffman. If the FDA made support services and recovery programmes as widely available as Narcan now is, the US may finally be able to make a dent in the country’s worst drug crisis in history.