Requests that the FDA recategorize Naloxone 4mg Nasal Spray from Legend (prescription only) to over-the-counter status.
Citizen Petition CDER recategorize Naloxone 4mg Nasal Spray from Legend (prescription only) to over-the-counter status Oregon Pain Guidance
2018-11-28 2018-11-28 2018-11-05 2018-11-28 2018-11-28 2018-09-27 2018-11-28 2018-11-28 2018-12-13 2018-11-20
FDA-2018-P-3355-0012 FDA-2018-P-3355-0015 FDA-2018-P-3355-0007 FDA-2018-P-3355-0009 FDA-2018-P-3355-0010 FDA-2018-P-3355-0006 FDA-2018-P-3355-0011 FDA-2018-P-3355-0014 FDA-2018-P-3355-0016 FDA-2018-P-3355-0008
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https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0012 https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0015 https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0007 https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0009 https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0010 https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0006 https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0011 https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0014 https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0016 https://api.regulations.gov/v4/comments/FDA-2018-P-3355-0008
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As an infectious diseases specialist who was a pioneer in HIV/AIDS research, I have seen first-hand  the impact of an epidemic has on affected individuals, their families and loved ones, and on the public health of a community.  I am now working at the intersection of infectious diseases and the injection opioid epidemic and on developing harm reduction services in rural West Virginia. West Virginia leads the country in opioid overdose fatalities, with the highest rate per 100,000 by a wide margin. Widespread access to naloxone is key to curbing the overdose fatality rate.Not only does naloxone meet the medical criteria for OTC designation, but  the continued difficulties that both people who inject drugs (as well as their families and friends) encounter in obtaining this life-saving medication-- despite state laws meant to facilitate access-- has been well-documented in published studies, including here in West Virginia which is at the epicenter of this devastating epidemic.OTC access-- as long as the naloxone is affordable-- will go a long way to solving the problem of getting naloxone into the hands of the people who actually need it, especially in rural areas where 911 help can be a 20-minute ride away. This loss of primarily young lives is a public health emergency, and there is no more important mission in healthcare than saving lives. Readily accessible naloxone is essential to that mission. Increasing the accessibility and availability of Naloxone will save lives.  I was a pharmacy technician at the time condoms were moved from behind the pharmacy counter out to the shelves in the Health and Beauty section of a local Target store, and since I stocked those shelves I saw at first hand the increase in sales of these products.  There was no prescription requirement on these products, it was simply removing one step (asking the pharmacist or technician for the product).  Eliminating the need to ask for a prescription, present the prescription to the pharmacist, and then be offered counselling on the product will reduce stigma and possible embarrassment; this will lead to more instances of Naloxone in the possession of those that could benefit.  The only downsides I can see are whether insurances will continue to pay for this product once it is OTC, and what the cost of the product would be (i.e., above the copay amounts the patient would have paid had the product been filled as a prescription). There are too many people dying from lack of availability.  Also the cost remains too high but should be reduced as an over the counter item. An effective health intervention is one which is sound in and of itself and which is well-timed.  Making naloxone widely available is sound in itself and it would be desperately well timed.In the past 3 years Ive trained about 200 people to use naloxone.  They include frightened parents, stressed counselors, and nurses, lab techs, patients and prescribers.  Laypeople readily understand how to use nasal naloxone.  Ive seen the light go on in someones eyes because they have one more thing now that could save their child or a client they are meeting in the home. The range of health literacy among these has been great.  No one has been mystified by the training. What upsets people is the idea of meeting an overdose without it. Fentanyl is like a runaway train in the switch yard of the opioid epidemic. Its the steepest graph among the 3 describing opioid overdose death.  Because the onset of overdose is so quick our best chance to save lives is to have naloxone widely available in our communities.  Making naloxone over the counter is a strong step in that direction.  While it does not in itself bring the price down, over the counter status is likely to help by expanding the number of people who would access it.  If the projected number of deaths, let alone total number of overdose events, for the next decade is approximately 500,000 (AJPH Oct 2018 Humphreys et al) that is a market, unfortunately.The risk profile for naloxone is nearly zero. Its benefit immense.  It is actually a deterrent to abuse:  in order to breath the victim must also suffer withdrawal. As one of the 70 signers of this petition to FDA to make naloxone over the counter I hope FDA will find that it is sound, compassionate and timely to agree with our request. I submitted a comment about 10 days ago but have not either seen it posted or gotten a rejection.  Is there a better way to submit?  Others have asked about how to comment.  Thanks! Why should an addict who purchases illegal drugs on the street in order to get high  (not for legitimate pain relief) be able to get over the counter help, while mllions of americans with painful medical conditions are forced to suffer because medication that helps them has been forcibly reduced to a level where it does not work, or worse, completely removed? US taxpayers and honest Americans should not be paying the price in pain or tax dollars to fix someone elses medical problem. If people in pain cannot get their medication over the counter (and we do not me nsaids which destroy kidneys, liver, cause blood condition problems), OR by prescription, than there is absolutley no reason why someone with an addiction disorder should be able to get their meds OTC. Figures Lie and Liars Figure  Why the Demographics of the So-Called Prescription Opioid Crisis Dont Work, Richard A, Lawhern, NPR 11/16/17http://nationalpainreport.com/figures-lie-and-liars-figure-why-the-demographics-of-the-so-called-prescription-opioid-crisis-dont-work-8834839.htmlThe Opioid Epidemic In 6 Charts Designed To Deceive You, ACSH, Josh Bloom, 10/12/17https://www.acsh.org/news/2017/10/12/opioid-epidemic-6-charts-designed-deceive-you-11935The truth about the US opioid crisis  prescriptions arent the problemMarc Lewis is a neuroscientist and author on addiction, The Guardianhttps://www.theguardian.com/commentisfree/2017/nov/07/truth-us-opioid-crisis-too-easy-blame-doctors-not-prescriptionsCDC Researchers State Overdose Death Rates From Prescription Opioids Are Inaccurately High, CATO INSTITUTE, J Singer, 3/22/18https://www.cato.org/blog/cdc-researchers-state-overdose-death-rates-prescription-opioids-are-inaccurately-highAre Prescription Opioids Driving the Opioid Crisis? Assumptions vs Facts. Rose ME1.Pain Med. 2018 Apr 1;19(4):793-807. doi: 10.1093/pm/pnx048.https://www.ncbi.nlm.nih.gov/pubmed/28402482Message to CDC: Tear Down Your Walls of Silence!, 8/20/18,Richard Lawhern, PhDhttps://www.painnewsnetwork.org/stories/2018/8/19/message-to-cdc-tear-down-your-walls-of-silenceCDC: Most Overdoses Involve Illicit Opioids, 8/31/18 Pat Ansonhttps://www.painnewsnetwork.org/stories/2018/8/31/cdc-most-overdoses-involve-illicit-opioidsOne in 10 Suicides Linked to Chronic Pain, 9/12/18, Pat Ansonhttps://www.painnewsnetwork.org/stories/2018/9/12/one-in-10-suicides-linked-to-chronic-painChronic Pain Among Suicide Decedents, 2003 to 2014: Findings From the National Violent Death Reporting System, Annals of Internal Medicine 9/11/18http://annals.org/aim/fullarticle/2702061/chronic-pain-among-suicide-decedents-2003-2014-findings-from-nationalCDC: 50 Million Americans Have Chronic Pain, 9/13/18, Pat Ansonhttps://www.painnewsnetwork.org/stories/2018/9/13/cdc-50-million-americans-have-chronic-painCDC Prevalence of Chronic Pain and High-Impact Chronic Pain Among AdultsUS, 2016, Weekly / 9/14/18 / 67(36);10011006, MORBIDITY  MORTALITYhttps://www.cdc.gov/mmwr/volumes/67/wr/mm6736a2.htmStop Calling it an Opioid CrisisIts a Heroin and Fentanyl Crisis, JEFFREY SINGER, 1/9/18https://www.cato.org/blog/stop-calling-it-opioid-crisis-its-heroin-fentanyl-crisisDiversion of Blame and the Opioid Crisis, 9/4/18, Richard Dobson, MDhttps://www.painnewsnetwork.org/stories/2018/9/4/diversion-of-blame-and-the-opioid-crisisB.C. doctors cant limit opioids or discriminate against pain patients: collegeCAMILLE BAINS, VANCOUVER THE CANADIAN PRESS, 6/6/18https://www.theglobeandmail.com/canada/article-bc-doctors-cant-limit-opioids-or-discriminate-against-pain-patients-2/Fentanyl  Heroin Deaths Lead Soaring Overdose Rate, 12/21/17https://www.painnewsnetwork.org/stories/2017/12/21/fentanyl-heroin-deaths-exceed-overdoses-from-pain-medsWhy Untreated Chronic Pain is a Medical Emergency 1/28/18http://www.pharmaciststeve.com/?p=23988Untreated Chronic Pain can Kill!  6/20/17 Suzanne Stewarthttp://nationalpainreport.com/untreated-chronic-pain-can-kill-8833859.htmlJ Geurin, Staff sgt US Air Force (Honorably Medically Discharged)Served 1997-2008 https://www.regulations.gov/document?D=FDA-2018-N-1621-1264Why Living In Pain Will Eventually Kill You, By Kristin Hayes, RN, 7/27/17https://www.verywell.com/why-living-in-pain-will-eventually-kill-you-3972227Response Opioid Policy Steering Committee Stefan G. Kertesz, MD, MSc and Ajay Manhapra, MDUniversity of Alabama at Birmingham School of Medicine  Yale School of Medicine https://www.regulations.gov/contentStreamer?documentId=FDA-2017-N-5608-0938attachmentNumber=1contentType=pdfTime: Report: Chronic, Undertreated Pain Affects 116 Million Americans, Maia Szalavitz 6/29/11http://healthland.time.com/2011/06/29/report-chronic-undertreated-pain-affects-116-million-americans/War On Opioids Punishes Desperate Pain Patients, The Peoples Pharmacyhttps://www.peoplespharmacy.com/2017/03/13/war-on-opioids-punishes-desperate-pain-patients/comment-page-3/#comments Thank you for receiving our petition.  This is a much needed step in the right direction to keeping our community and families safe from accidental overdose. I am writing to support making naloxone available as an OTC medication. As a practicing physician it is clear that this increased availability will save many lives and produce minimal harm or risk.  To FDA Advisory Committee:This letter is in support of reclassifying naloxone nasal spray to over-the-counter (OTC). I ask the committee to reflect on the positive access changes that OTC has had on other drugs. Specifically, in 1996 the FDA approved nicotine as an OTC. An article published only one year later found use of the medications has increased by 152% compared with prior prescription use. Additionally, the study reported, with increased use of an efficacious treatment; OTC nicotine medications are estimated to yield from 114,000-304,000 new former smokers annually in the United States.Its important to remember that an OTC would NOT prohibit us from still prescribing naloxone if deemed necessary. OTC naloxone status removes barriers for those who wish to buy it without the worry/stigma from having to ask a pharmacist for it or schedule an appointment with a doctor.Access to the study can be found at:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1759603/pdf/v006p00306.pdf Two articles have recently been published in the Journal of American Medical Association which highlight barriers to opioid antidotes despite state and local actions to improve the ease of access for those who are themselves, caring for, on around at risk individuals.The Journal of American Medical Association (JAMA) Articles published 11/13/2018:    Naloxone Accessibility Without a Prescriber Encounter Under Standing Orders at Community Pharmacy Chains in Texas    Provision of Naloxone Without a Prescription by California Pharmacists 2 Years After Legislation ImplementationAs a pharmacist, I know first-hand that barriers outlined the articles and news reports below are real. Classifying naloxone as an over-the-counter (OTC) measure needs to be a priority for the FDA for the following reasons: .    OTC will help remove the stigma (real or perceived) that has been shown to impact whether a person will likely come into a pharmacy and buy naloxone or not. Simple example: more condoms sold if they are accessible on a shelf rather than behind the counter. Product placement and the removal of required interactions with pharmacy staff has been showed to improve access as this removes buyer stigma.I have spoken to many patients that do not want the naloxone claim processed via their insurance for fear of how this could impact them later. Fear of information breach or how insurance carriers could view a naloxone purchase has yet to be looked or regulated.    OTC will allow for full pricing transparency. Manufactures often raise the cost of their products however since this rarely leads to changes in co-pay their actions go unnoticed/unchecked by the end user. A low tier placement or low co-pay by insurance carriers should never be misconstrued as access as the real costs are found in the claims which many never seen publicly.     Additionally, it is well documented that OTC equates to price stability and often even an overall price drop. OTC also decreases the cost to the healthcare system who are now covering (paying) naloxone.    This WILL increase access, just look at Canada who has made it OTC.  https://jamanetwork.com/journals/jama/article-abstract/2714519https://jamanetwork.com/journals/jama/article-abstract/2714520https://www.statnews.com/2018/11/13/some-pharmacies-limit-access-to-naloxone-studies-show/https://www.huffingtonpost.com/entry/naloxone-narcan-pharmacy-research_us_5bec7165e4b0a2569fd1320c