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To Save Lives, Make Naloxone an Over-the-Counter Drug

The FDA should facilitate access to the the opioid-overdose antidote.

Richard B. Levine/NewscomRichard B. Levine/NewscomThis month Surgeon General Jerome Adams issued an advisory that touted the lifesaving potential of naloxone, an opioid antagonist that reverses potentially fatal overdoses. He called for wider distribution of naloxone to opioid users, their relatives, and their close associates.

While that move is commendable, the surgeon general pulled his punches. He can and should go further by pressing the Food and Drug Administration to reclassify naloxone as an over-the-counter drug.

Naloxone, approved for use since 1971, works by blocking opioid receptors. It is an effective remedy that can be safely administered by laymen wth minimal training, using either a nasal spray (sold under the brand name Narcan) or an intramuscular auto-injector (Evzio).

Adams cites research demonstrating that community-based overdose education and naloxone distribution reduce overdose deaths and notes that first responders in most states and cities are now equipped with the drug. According to the U.S. Centers for Disease Control and Prevention, at least 26,500 overdoses were reversed by individuals without medical training between 1996 and 2014.

Since naloxone is available only by prescription, most states have developed work-arounds that make obtaining it easier for opioid users and people close to them. That usually involves authorizing pharmacists to prescribe the drug or issuing a "standing order" that lets pharmacists distribute it without a patient-specific prescription. The press often reports that such maneuvers make naloxone available "over the counter," but that's inaccurate, since pharmacists still serve as middlemen.

Because of the stigma associated with opioids, many users are reluctant to request naloxone from pharmacists, who in any case may be reluctant to prescribe it, believing they are "enabling" drug abusers. In five states, naloxone cannot be prescribed to third parties who know an opioid user.

Recognizing these obstacles to naloxone distribution, Australia made it available over the counter in 2016, so it as easy to purchase as cold remedies or antacids. Medical and nonmedical opioid users can discreetly make a purchase and check out at the cash register without having to answer any questions or face scrutiny from a pharmacist. The drug has been sold over the counter in Italy for more than 20 years.

Some argue that wider distribution of naloxone creates a "moral hazard" by providing opioid abusers with a safety net, reducing their incentive to quit or seek treatment. They point to a recent working paper published by the National Bureau of Economic Research (NBER) that found "broadening naloxone access led to more opioid-related emergency room visits and more opioid-related theft, with no reduction in opioid-related mortality."

A 2017 NBER working paper, by contrast, found wider naloxone availability was associated with a reduction in opioid-related deaths of 9 to 11 percent. A study reported last year in the journal Addictive Behavior found that drug consumption generally declined among heroin users after they were trained to use naloxone.

In any case, it is unethical to endanger the lives of some opioid users by impeding access to naloxone in the hope of discouraging others. Public policy should focus on saving the lives of the individuals in distress, regardless of how that may affect other people's behavior.

Judging from an August 2016 blog post published by the FDA, at least some officials at the agency think it is reasonable to consider reclassifying naloxone as an OTC drug. FDA Deputy Director Karen Mahoney said the agency was ready to assist manufacturers in submitting applications for reclassification. For OTC status, manufacturers must first get approval of labeling and packaging information that can be understood by the general public. The FDA even created a draft label for OTC use to facilitate petitions for rescheduling.

New labeling is arguably unnecessary, since the Narcan nasal spray and the Evzio auto-injector were specifically designed for use by the general public and have been used in the field for some time. It is even harder to understand why the FDA is waiting for manufacturers to request reclassification. FDA regulations authorize the agency's commissioner, Scott Gottlieb, to order a rescheduling review. They also allow petitions from "any interested person," not just drug manufacturers.

If Gottlieb is unwilling to order a review, the secretary of health and human services—or, if necessary, Congress—can make it happen. Even state legislatures or governors can formally request an FDA review.

The surgeon general's naloxone advisory makes it obvious that he is an interested party as well. Because he thinks the antidote should be more widely deployed to reduce overdose deaths, Adams should formally ask Gottlieb to order an expedited review with the goal of making naloxone available over the counter as quickly as possible.

*CORRECTION: This piece originally stated that naloxone cannot be prescribed to third parties who know an opioid user in six states and the District of Columbia. That figure was based on data from 2016. As of January 2018, only five states prohibit naloxone prescriptions for third parties.

Photo Credit: Richard B. Levine/Newscom

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  • SQRLSY One||

    "...most states have developed work-arounds that make obtaining it easier for opioid users and people close to them."

    WHY can they do that for Narcan, but they don't do it for utterly stupid "medical devices" like the "lung flute"? I think there is SOME moral culpability going on when you get hooked to heroin... Yet "junkies" are more "politically correct", and deserving an FDA bypass, than I am, for accessing a simple, cheap plastic flute! I wrote to my state rep and asked her to "enable" a state-wide prescription for the "lung flute" and the "ear popper" as samples of this utterly stupid trashy micro-management from the nannies and ninnies at the FDA... No dice, not even a response! Junkies deserve more freedom than I do, it seems...

  • gaoxiaen||

    I enjoy snoring. Sorry but not sorry.

  • SQRLSY One||

    If you're implying that CPAP machines are another example of extreme FDA "prescription policy" over-reach, I heartily agree!

    I am one of those bat-shit crazy ultra-libertarians in the areas of drugs and "medical devices", so I think that they should ALL be totally freed up from the FDA, DEA, etc! With the exception of refined pure poisons that have no uses other than slipping into your enemy's coffee to kill him or her, I suppose...

    I can understand the perspective of those who want to keep "addictive" pain pills "by prescription only", but I do disagree with these folks. Till they elect me dictator, I am not gonna change that...

    In the meantime, the FDA is beyond utterly silly! And I can't even fix that!

  • Citizen X - #6||

    Making it easier to save the life of someone who's o.d.ing is exactly the same thing as approving of that person's choice to shoot up in the first place. Ask almost anyone. It's moral hazard theory for people who don't understand what "moral" or "hazard" means, or how theories work.

  • I am the 0.000000013%||

    I save people's lives every day by not hitting them with my car or shooting them. Does that have anything to do with moral hazard theories?

  • SQRLSY One||

    Shit,I tried to explain to my boss that I should get a promotion and a raise, because I have NEVER placed a big fat juicy turd on his desk, or in his chair! He wouldn't buy it!!!

    Moral hazard can sometimes be like, "No, Dude, I can NOT allow you to be a water-pig, rewarding you with willy-nilly blanket permission to just drink whatever water you want, whenever you please!!! Next thing you know, you'll be drinking all of our oceans dry, dammit!!!!"

    MeThinks it is "morally hazardous" for us to appoint ourselves as judges of the morality of others, when they are NOT clearly violating the rights of others!

  • ThomasD||

    Yes, restricting access to opioids does create it's own form of moral hazard - encouraging people to obtain questionable substances of substantially greater risk.

    Although, imagine if opioids were not restricted. Now imagine how the same manufacturer/seller would be viewed for offering an antidote to their own product.

    We'd need to change a lot more than just the drug laws for that situation to not be a major problem.

  • Echospinner||

    At the door to the Emergency Department any moral hazard theory can stay in the parking lot.

    There is a philosophy section somewhere. Over there next to the gas tanks for oxygen.

  • SQRLSY One||

    Amen!!!

  • Robert||

    Usu. a rx-to-OTC switch is considered seriously only if the maker of the drug sponsors such a switch.

    Meanwhile, how 'bout that Trump, huh? A formal end to the Korean War! More than was bargained for, huh? See if the neocons can spike that.

  • ThomasD||

    Absent an ipse dixit approach to it's own regulations the FDA would need to seriously revise what it considers to be appropriate criteria for OTC use of a particular drug in order to make even naloxone nasal spray (much less any injectable version) OTC.

    Not that I'm opposed to the idea. Just that any such action would swing the door wide open for many, many other agents to potentially go OTC.

    Which would be great for consumers, but horrible for many drug makers. So it will not happen.

  • Robert||

    True. Traditionally FDA would never consider "saving someone's life" an indication for an OTC drug or device! But the statute doesn't say anything about that directly. It's just an interpret'n of statute that a treatment may be dangerous if it keeps someone from seeing a doc for a serious condition. But that should probably be thought of differently in the context of acute lifesaving!

    When you think about it, what is it about a drug's prescription status that's good for drug makers? It's an inhibition on their marketing. It seems like a bonanza because of the high price of prescription drugs, but that's only if insurers cover them.

  • MichaelL||

    But, but...only doctors know how to properly administer injections! How can a laymen expect to be able to properly save someone's life?! I takes specialists to treat an accidental overdose. I would not be another turf protection thing, would it? Then CPR training has been encouraged FOR EVERYONE! That is not any harder to learn.

  • ThomasD||

    "a treatment may be dangerous if it keeps someone from seeing a doc for a serious condition."

    There is a whole lot more than that to existing FDA regulations for OTC status. The package directions being chief among them. The product must be safe and effective when used according to package labelling, and the general standard there is the material can be no higher than a sixth grade reading level. And don't forget that "FDA approved" product labelling is not merely a form of permission for the seller to tap the OTC market, it is also very much a liability shield from idiots who can't/won't follow directions. If you had the financial assets sufficient to go into the OTC product business would you really want to put it all out there on naloxone being used by lay people to treat what may or may not be an opiod overdose?

    A lot of people have really 'simple' solutions to the drug problem. I'm not opposed to them, I just do not think they will actually work.
    Mainly because too many of these proponents do not understand the associated realities that actually govern the situations.

  • Echospinner||

    Ok show me evidence that naloxone is not available to those who need it as a pharmacist based drug.

    I cannot buy sudafed without going to the pharmacy counter.

  • buybuydandavis||

    Libertarian Moment!

  • John B. Egan||

    Try to keep up guy: Narcan Is Now Available Over the Counter in 46 States. Walgreens announced this week that they are now dispensing naloxone, the drug that can reverse an opioid overdose, over the counter in 46 states. (If you have a prescription, you can buy it in any state.) CVS offers it over the counter in 43 states.Oct 27, 2017

  • ThomasD||

    Naloxone is not available over the counter in any state, much less 46 of them. The FDA classifies all naloxone containing drug products as 'Rx only.' Currently states have no authority to alter that.

    https://definitions.uslegal.com/l/legend-drug/

    What all states can do is determine who in their state qualifies as an "licensed provider" so that's what they've done to improve access to naloxone . One of the more common approaches is to issue a standing orders from the State medical director that can serve as blanket prescription for anyone requesting the drug, or granting limited provider authority to particular professions or job descriptions (e.g. cops and correctional officers.)

  • SIV||

    Just legalize the "opioids" and the only people who overdose will be suicides, the innumerate and the illiterate.

  • gah87||

    Then who will be left standing?!

  • ThomasD||

    Probably not. Neither Elvis nor Tom Petty got any of their drugs via anything other than legal means, yet both were killed by them. You only know about them because they were famous, there were and will continue to be many others you never hear about.

    Legal or illegal people will continue to die from opioids. It's in the nature of both beasts (man and drug.) Not that that should be any of our concern anyway. 'Saving people from themselves' should not be part of any law.

  • Mark22||

    Few people overdose on natural opioids. The danger comes from the super-potent synthetic opioids.

  • ohdelilah||

    If politicians wanted to save lives, they'd legalize drugs.

  • buybuydandavis||

    "Libertarian" magazine takes the bold stand that it shouldn't require a government permission slip to purchase Naltrexone.

    It never occurs to them that it shouldn't require a government permission slip to purchase any drug. From anyone you want to purchase it from.

    Controlled opposition. Where would corporate profits be if the peasants were free?

  • Kermudjin||

    If you really want to stem the tide of overdoses, you should urge our Clown-In-Chief and other lawmakers to make Naloxone an over the counter drug, as other countries have done. Sign the petition at:

    https://bit.ly/2renwO7

    The FDA has already stated that it should be made OTC.

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