Results 1 to 11 of 11

Thread: OTC Narcan

  1. #1
    Join Date
    Jan 2008
    Location
    landlocked in Mt. Solon, VA
    Posts
    1,639

    Default OTC Narcan

    The Road to Over-the-Counter Naloxone: FDA Releases Federal Register Notice


    To encourage sponsor application for over-the counter naloxone, the US Food and Drug Administration (FDA) today issued a Federal Register notice, “Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use,” that could help facilitate the development and potential approval of nonprescription naloxone drugs.1


    “Today’s action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone,” said FDA Commissioner Robert M. Califf, MD. “The agency will keep overdose prevention and reduction in substance use disorders as a key priority and area of intense strategic focus for action as rapidly as possible.”

    The notice states that naloxone drug products up to 4 mg nasal spray and up to 2 mg autoinjector for intramuscular or subcutaneous use may be safe and effective for nonprescription use. Although this notice does not mean nonprescription/over-the-counter naloxone is immediately available, it does make application holders aware of the willingness of the FDA to consider nonprescription naloxone drug products. First, the FDA needs additional data, including product-specific data on the user interface design, such as packaging and labeling.


    This is not the first step the FDA has taken to improve access to naloxone. In September, the FDA issued guidance to clarify that certain Drug Supply Chain Security Act requirements do not apply to naloxone distribution to harm reduction programs during the Opioid Public Health Emergency.


    “The agency remains focused on responding to all facets of substance use, misuse, substance use disorders, overdose, and death in the US through the four priorities of the framework, including: supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks,” the FDA shared in a new release.

    https://www.psychiatrictimes.com/vie...ZWxvcy5uZXQ%3D
    "George Washington as a boy
    was ignorant of the commonest
    accomplishments of youth.
    He could not even lie."

    -- Mark Twain

  2. #2
    Join Date
    Sep 2010
    Location
    Bainbridge Island WA
    Posts
    5,328

    Default Re: OTC Narcan

    it will be interesting to see how this plays out.

    I've administered narcan multiple times, there are things to be aware of. One is that the overdosed person you just woke up is likely to be upset because you just took away their buzz so don't stand too close. Also, narcan only lasts so long, potentially less time than whatever substance your patient ingested, it may require multiple doses.

    I'm not saying we shouldn't make narcan more available, just pointing out there are aftercare issues that don't get much coverage.
    Steve

    If you would have a good boat, be a good guy when you build her - honest, careful, patient, strong.
    H.A. Calahan

  3. #3
    Join Date
    Mar 2002
    Location
    Duncan, Vancouver Island
    Posts
    29,317

    Default Re: OTC Narcan

    Users could wear bracelets that say 'In case of overdose, please resuscitate', or conversely, 'In case of overdose, DNR'. That way a good samaritan or professional EMT wouldn't have to guess. And the users who were resuscitated would have time to get to a hospital before the naloxone wore off.
    There is no rational, logical, or physical description of how free will could exist. It therefore makes no sense to praise or condemn anyone on the grounds they are a free willed self that made one choice but could have chosen something else. There is no evidence that such a situation is possible in our Universe. Demonstrate otherwise and I will be thrilled.

  4. #4
    Join Date
    Nov 2008
    Location
    New Hampshire
    Posts
    40,160

    Default Re: OTC Narcan

    I heard the strangest thing and maybe someone can explain it.

    I know a school district where the police in the schools carry Narcan, but the school nurse does not.

    The two are under the direction of different people (police chief vs school district superintendent). That explains how it happens, but not why.
    "Where you live in the world should not determine whether you live in the world." - Bono

    "Live in such a way that you would not be ashamed to sell your parrot to the town gossip." - Will Rogers

    "Those are my principles, and if you don't like them... well, I have others." - Groucho Marx

  5. #5
    Join Date
    Mar 2002
    Location
    Duncan, Vancouver Island
    Posts
    29,317

    Default Re: OTC Narcan

    Quote Originally Posted by CWSmith View Post
    I heard the strangest thing and maybe someone can explain it.

    I know a school district where the police in the schools carry Narcan, but the school nurse does not.

    The two are under the direction of different people (police chief vs school district superintendent). That explains how it happens, but not why.
    What's strangest to me is police in the schools. I lead such a sheltered life.
    There is no rational, logical, or physical description of how free will could exist. It therefore makes no sense to praise or condemn anyone on the grounds they are a free willed self that made one choice but could have chosen something else. There is no evidence that such a situation is possible in our Universe. Demonstrate otherwise and I will be thrilled.

  6. #6
    Join Date
    Nov 2008
    Location
    New Hampshire
    Posts
    40,160

    Default Re: OTC Narcan

    Quote Originally Posted by JimD View Post
    What's strangest to me is police in the schools. I lead such a sheltered life.
    Yeah. Times have changed and not for the better.
    "Where you live in the world should not determine whether you live in the world." - Bono

    "Live in such a way that you would not be ashamed to sell your parrot to the town gossip." - Will Rogers

    "Those are my principles, and if you don't like them... well, I have others." - Groucho Marx

  7. #7
    Join Date
    Sep 2003
    Location
    Somewhere in South Central PA
    Posts
    3,784

    Default Re: OTC Narcan

    Here in Pennsylvania, the Physician General issued a standing order so Narcan is available without a doctors prescription, but you still have to ask a pharmacist for it or get it from a community based organization.

    Having lost my son Simon to a fentanyl overdose, I think this is a good thing.

  8. #8
    Join Date
    Mar 2006
    Location
    o
    Posts
    10,578

    Default Re: OTC Narcan

    So sorry to hear that, Brian. What a tragic loss.


  9. #9
    Join Date
    Nov 2008
    Location
    New Hampshire
    Posts
    40,160

    Default Re: OTC Narcan

    Quote Originally Posted by Brian Palmer View Post
    Having lost my son Simon to a fentanyl overdose, I think this is a good thing.
    I'm very sorry to hear that. That's dangerous stuff and I'm sorry your son got into it. We should have a world where people can make mistakes, but that stuff doesn't tolerate mistakes.
    "Where you live in the world should not determine whether you live in the world." - Bono

    "Live in such a way that you would not be ashamed to sell your parrot to the town gossip." - Will Rogers

    "Those are my principles, and if you don't like them... well, I have others." - Groucho Marx

  10. #10
    Join Date
    Jan 2008
    Location
    landlocked in Mt. Solon, VA
    Posts
    1,639

    Default Re: OTC Narcan

    Brian, I am so sorry for your loss. Young folks often think they are invulnerable and the exception to the sad statistics. In addition to increasing the availability of last minute interventions, we also need better evidence-based prevention efforts.
    "George Washington as a boy
    was ignorant of the commonest
    accomplishments of youth.
    He could not even lie."

    -- Mark Twain

  11. #11
    Join Date
    Mar 2002
    Location
    Duncan, Vancouver Island
    Posts
    29,317

    Default Re: OTC Narcan

    When I was 15 a friend offered me a syringe full of something. I said cool! Didn't give it a thought. He might as well have been offering me an ice cream cone. There was no fentanyl back then.
    There is no rational, logical, or physical description of how free will could exist. It therefore makes no sense to praise or condemn anyone on the grounds they are a free willed self that made one choice but could have chosen something else. There is no evidence that such a situation is possible in our Universe. Demonstrate otherwise and I will be thrilled.

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •