FDA Going Digital to Fight Opioid Overdoses

FDA Going Digital to Fight Opioid Overdoses

By Ed Coghlan

The U.S. Food and Drug Administration (FDA) is launching 2016 Naloxone App Competition.

According to the Agency, the competition is a public contest focused on developing innovative technologies to combat the rising epidemic of opioid overdose.

The FDA is inviting computer programmers, public health advocates, clinical researchers, entrepreneurs and innovators from all disciplines to create a mobile phone application that can connect opioid users experiencing an overdose with nearby carriers of the prescription drug naloxone – the antidote for an opioid overdose – thereby increasing the likelihood of timely administration and overdose reversal.

“With a dramatic increase in the number of opioid overdose deaths in the U.S., there’s a vital need to harness the power of new technologies to quickly and effectively link individuals experiencing an overdose – or a bystander such as a friend or family member – with someone who carries and can administer the life-saving medication,” said FDA Commissioner Robert M. Califf, M.D. “Through this competition, we are tapping public health-focused innovators to help bring technological solutions to a real-world problem that is costing the U.S. thousands of lives each year.”

The FDA says nearly two million Americans abused or were dependent on prescription opioids in 2014. Additionally, overdose deaths involving prescription opioids such as oxycodone, hydrocodone and morphine and illicit opioids, such as heroin and illegally produced fentanyl, have more than tripled since 1999 – with about 28,000 people dying in 2014 alone.

The FDA says many of these deaths could have been avoided if people experiencing an overdose had immediately received naloxone to stop or reverse the effects of an opioid overdose.

Naloxone is currently only available in the U.S. by prescription, but many states have taken steps to make it more readily accessible to first responders, community-based organizations and laypersons, including friends and family of opioid users. In fact, the number of laypersons provided naloxone nearly tripled between 2010 and 2014, according to the U.S. Centers for Disease Control and Prevention. However, persons carrying naloxone may not be present when an overdose occurs.

“The goal of this competition is to develop a low-cost, scalable, crowd-sourced mobile application that addresses this issue of accessibility,” said Peter Lurie, M.D., M.P.H., associate commissioner for public health strategy and analysis at the FDA. “Mobile phone applications have been developed to educate laypersons on how to recognize an overdose and administer naloxone, and to connect bystanders with individuals in need of other medical services, such as CPR. To date, however, no application is available to connect carriers of naloxone with nearby opioid overdose victims.”

Teams and individuals wishing to participate in the competition will have until Oct. 7, 2016 to register. Registrants will have access to background resources, including information on the opioid epidemic, the approved formulations of naloxone, the public health recommendations for the safe and appropriate use of naloxone and FDA guidance on mobile medical applications. On Oct. 19-20, 2016, the FDA will host a two-day code-a-thon on the FDA campus and virtually for registered entrants to develop their concepts and initial prototypes. All code will be made open-source and publicly accessible, and collaboration will be encouraged. Competition participants will then independently refine their concept and submit a video of a functional prototype along with a brief summary of their concept for the development and use of the app by Nov. 7, 2016.

A panel of judges will evaluate submissions and the highest-scoring entrant will receive an award of $40,000. Following the competition, entrants also may apply for NIDA Small Business Innovation Research (SBIR) grants, subject to eligibility requirements set forth in the SBIR funding opportunity announcement, to further develop their concepts and to develop data to evaluate their real-world impact.

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Authored by: Ed Coghlan

There are 16 comments for this article
  1. Al Leibbrand at 8:01 am

    For Tim. EXACTLY. could not have said it better myself. Good job. People gotta wake the h up and start paying attention and participate.

  2. Tim Mason at 4:10 pm

    Naloxone should be made available in the Poor Man’s Pharmacy “The Liquor Store” and in Quickie shops next to the glass pipes used to smoke meth, freebased cocaine (crack) and opium.
    Patients from pain management clinics that receive narcotics LEGITIMATELY and are at a certain risk receive an Rx for Naloxone.
    EMT’s and Police around here all have it with 99% of it being used on Heroin addicts and prescription thieves.
    Parents with teenagers be responsible. Keep your medicine under lock and key.

  3. Tim Stewart at 3:33 pm

    See if this will pass and get posted:
    A) the reports of opiod overdose from prescribed opiods is over-inflated and is largely due to the media’s ‘If it bleeds, it leads’ approach to anything remotely news worthy.
    B) Why does it not dawn on the government to just legalize EVERYTHING and tax it? Do you really think that more laws are going to make an appreciable dent in the failed 30 plus year ‘war on drugs’? Just like with prohibition, if they legalize it and get involved in manufacturing all controlled substances they can ensure purity and apply standards like they did with alcohol in the post-prohibition era.
    C) WHY does the federal government feel like they have a moral obligation to save the recreational users from themselves? As I stated previously, they are going to do what they want regardless of laws / legislation so let them. Again, the FDA could ensure purity and the criminal element would be excised from anything to do with the trafficking of drugs — again, just like with post prohibition, the feds got involved and taxed it and what happened? All the Al Capone-like killings that occurred because of alcohol and rum running stopped. If you can get whatever you want or need legally (remember, we live in a republic and we are free, so this shouldn’t be an issue to begin with), there is no need to have to deal with drug traffickers and pushers. Make sense? Yes, it does.
    D) Moralists that obviously don’t have *real* pain need to understand that supporting the CDC guidelines is like cutting your own throat — it will only make your situation exponentially worse.
    E) Finally, every person reading this needs to consistently call and leave messages for your congressmen and senators. If you don’t sound off, you are telling them that they have your tacit approval to continue to hurt you as a chronic pain patient.

  4. Melinda Roy at 11:51 am

    I can hear your pain,outrage,and yes blaiming!But very few should still be,without FIRST,telling said agencies:CDC,HHS,FDA,DEA,and anyone else involved in our fight for needed opioid medication! I have gotten responses back already from some of these tax paid official’s and, just like I and YOU all possess the same right.Lets use our combined numbers,(millions),and start telling our local,state,and especially Obama,we have brains behind our pain! I have restricted use of right hand,but the adrenaline rush that comes with doing the right thing,makes my pain,somehow,more bearable. I pray and love you all.We,we,and more we’s must not lose our Constitutional rights,to have a government BY the people,FOR the people!Amen

  5. Anne Fuqua at 10:16 am

    Better than spend time and money on a “Heeeeeelp I [or my buddy who is too high to use his phone] got too high and now I don’t wanna die” app than wasting taxpayer dollars on paper and postage to send out “please don’t prescribe opioids” letters.

  6. Maureen at 7:35 am

    This is absolutely appalling to be coming from the FDA. But why should we be surprised…they’ve approved 8 new opioids since January during a historic legally prescribed drug epidemic killing more that the Vietnam War.
    How about upholding your mission of “protecting public health safety” by issuing an alert such that every opioid script must be co-prescribed with naloxone? Now that public health safety. It opens the “educational conversation” between the prescriber and the patient of the very real dangers of painkillers. Taken as prescribed can and does cause overdose, taken as prescribed can and does cause addiction. Abuse is not required to overdose. Abuse is not required to become addicted. Where are the required “adverse effect/event” reports from every painkiller manufacturer? Who is hiding that information?
    Where are the reports of the injury and death to our Medicare patients? Who is hiding that data? How much of our money is being used to injure and kill our fellow senior citizens, veterans, and workers comp patients?
    GET THE REAL INFORMATION!!! Why is the FDA hiding the reports?

    Yet here again, its very telling of the corrupt relationship of Pharma and the FDA.

  7. scott michaels at 9:04 pm

    they have a data base of legal chronic pain legitimate patients. our name is on every computer.
    They cdc dea and the other meatheads need to bunch us into the junkies to legitimize their actions.
    although we all know the problem isn’t the chronic pain patient. We don’t use our medicine to get loaded. We take is as directed. hi or low dose it doesn’t matter. We follow the rules.
    NOW IF THE MEAT HEAD TOLD THE PUBLIC THEY’RE RAKING ALL THE GOOD PUBLIC MONEY AND giving it to the junkies that are just looking to get loaded. People would revolt. they must put us in the equation so society will pity us.
    They are fooling the public by killing the patients that need the medicine. sending them to the streets to add to the numbers of good people that were forced to turn bad by a govt that doesn’t care.
    I hope you people know that this was all obama and will continue if hillary wins. Trump will make sure vets and people in chronic pain get their medicine.
    hillary will outlaw all opioid medications. She is the enemy of the chronic pain patient

  8. connie at 9:04 pm

    The alphabet soup of agencies know who butters their bread and how to have job security. Making more addicts will cement their jobs!

  9. Kathy C at 8:35 pm

    Sometime I think if I hear about another darn “App” i will lose it! “They got an App for that.” People seem to be so enthralled with the idea. It is certainly easier than identifying and fixing a problem, and it sounds trendy. It seems like it is all Smoke and Mirrors. The Technology doesn’t solve the underlying problem anyway. I doubt that certain people will even use it, since it will put them on a List or their Information will be shared with a Big Pharma Marketing Database. We all need to be careful with our Medical Information even if we follow the Law. This App will, like many others share this information, and there will be small print agreeing to it.

  10. cindy deim at 6:42 pm

    It would be nice if they put some money into chronic pain patients.

  11. MichaelL at 5:49 pm

    Anything will be an improvement over nothing! The entire opiate scene needs to be properly analyzed, since most (95%+) pain patients take their meds as prescribed. Taking access away for those in need because of the 5%, that want to abuse it, makes no sense. It is like throwing the baby out with the bathwater! Torturing patients, or forcing them onto the street scene is the wrong thing to do. People are dying now because synthetic Fentanyl is being substituted for the weaker acetyl-morphine! The war on some drugs is killing patients, not saving people! We need to start thinking outside the box, since everything, so far, is failing to help so many people! Insanity describes it best! This study could be the first in many needed baby steps!

  12. Michael wag at 3:12 pm

    your always have something to say to us about over dosing as if we were prescribed fentanyl and should have naloxone handy.
    how many of us long time opiate users that are prescribed have these death problem’s, and if we had naloxone on hand would be in shape to get it and use it. and is it available with out prescription?

  13. Doug at 2:44 pm

    While this may help those who are addicted maintain their addictions and continue to feed their addictions knowing that they can push the envelope without dying. It doesn’t help the millions of people who suffer from chronic pain every day of their lives and who are getting their medications taken away. It’s like the addicts are the favorite puppy in the pet store and get all the attention while the chronic pain community is the group of unwanted puppy’s who end up getting gassed.
    The FDA and the rest of the Alphabet Soup Group does not have a CLUE. Addicts need proper treatment for their addictions and the chronic pain community need proper treatments for their pain. If the DEA would do their JOB properly and stop the illicit and illegal drugs from coming into our country. Then if the CDC would write proper Guidelines and research what causes Addictive Personality Disorder to find sufficient treatment for it. Finally, better education in all schools about the dangers of deadly illegal drugs to better catch it before addiction starts.
    It’s time to do the right thing instead of causing more addiction by sending legitimate pain suffers to the streets to buy the illegal drugs that the DEA has failed to stop. Why has the war on drugs failed?
    Because no one in the government has done their jobs right!!!!!

  14. mary s at 2:13 pm

    Opioid chronic pain users dont overdose! Wew follow our prescriptions to the letter.

  15. Casey at 2:12 pm

    My pain dr writes and requires her patients on opiates prescriptions for Evzio which is narcan in a voice promoted auto injector. The kit comes with two doses and a trainer. It is similar to the epi pen. I have an intrathecal pain pump inside me with sufentil and Marcaine in it so I carry my Evzio in the event that my pump malfunctions. I think all Drs that prescribe opiates require this prescription accompany it. You never know you may need it.

  16. HOWARD H. HEROLD at 2:11 pm

    Why can’t you develop a data base of people who are receiving pain medication legally.

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