Role of Naloxone in Opioid Overdose Fatality Prevention; Public Workshop; Request for Comments
cder2011177 CDER Naloxone Public Meeting Request for Comments 2015-376 open Exploring Uptake and Use
2012-04-12 2012-04-12 2012-06-13 2015-09-11 2012-06-14 2012-06-13 2012-06-14 2012-06-13 2012-02-28 2012-05-17
FDA-2011-N-0802-0006 FDA-2011-N-0802-0004 FDA-2011-N-0802-0016 FDA-2011-N-0802-0040 FDA-2011-N-0802-0034 FDA-2011-N-0802-0019 FDA-2011-N-0802-0032 FDA-2011-N-0802-0017 FDA-2011-N-0802-0002 FDA-2011-N-0802-0010
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https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0006 https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0004 https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0016 https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0040 https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0034 https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0019 https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0032 https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0017 https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0002 https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0010
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I stongly support the increase availability of Naloxone in the prevention of Opioid Overdose. Making naloxone availalble saves lives! I work as a nurse on a adult detox center at the University of Minnesota, Fairivew and we have noticed an alarming upward trend of 18 y o to 28 y o heroin addicts. Most started with abuse of narcotics then switched to heroin. Many are motivated to come to treatment because a friend overdosed and died. Recently I cared for a young male who came in because he himself nearly  died of an overdose but a friend did rescue breathing and got him to an ER. Unfortunetly this friend overdosed the next day and died. We just had a high school student overdose on heroin and alcohol and died. As a mother and a nurse I request you make naloxone and needles available to the public. One idea would be to have public health and/ or pharmacys distribute the medication/syringes after a person views an informational adminstartion/safety  video on an i-pad. As a community in the Twin Cities we organized a  multi -agencyOpioid coaltion to fight this horrific trend of young opioid abusers. Availability of Naxolone is one layer of a solution to this problem. Additonal prevention and public education measures are urgently needed for this nation wide epidemic. Thank you,Mary Kay Borgstrom RNOpioid Coalition  Prevention Leaderwww.opioidcoalition.org Working in Massachusetts on the opioid overdose prevention initiative has been one of the most fulfilling times of my professional life.  Teaching a parent or loved one of an opioid addict, who is consumed with the fear of losing their loved one to overdose, how to reverse an overdose with nasal naloxone is unparalleled.  Most people are amazed at how easy it is to save someones life with this medication.  There is so much misinformation around naloxone that it is crucial to educate the public on its use and importance in our society.  None of us can change the fact that presently we are literally fighting for peoples lives when we talk about opioid abuse, but we can save people from dying from an overdose.  An overdose often opens the door for people to reevaluate their situation and look at treatment as a viable option.  I did a focus group a few weeks ago and this came from a participant: I dont use drugs, but I have been here a lot, Im an alcoholic.  I have had alcohol poisoning and I was lucky to survive. So when I took your class I thought it was important to get Narcan, because you never know.  I left here and went to a sober house.  My first day in the house, a young kid overdosed on heroin.  I used that Narcan and saved his life. I called 911, they came, they took him to the hospital, no issues. I need to get more Narcan.  Its important that alcoholics know that it does apply to them, it applies to everyone if you can save someones life.  Hello,The United States is a leader in preventing overdose deaths with the use of naloxone.People from all over the world utilize the resources that have been produced in the US about naloxone. The US has the experience, research,  and expertise to respond to this preventable  epidemic; leading the way for so many other places. Having naloxone empowers all parties to engage in meaningful and educational dialogue about the risks associated with substances.  Naloxone use by VA Police in a first responder role outside the VA Hospital on VA grounds or City property requiresregulations to outline clear authority for use.The Minneapolis VA has extended the naloxone rescue kits to providers  to prescribe to patients, in addition, seek to enable our VA police officers to be trained and have clear authority to administer a potential life saving medication foropioid overdose.I have been unable to establish authority for VA Police to administer naloxone (prescription medicine)  under a standing order  because a standing order for naloxone  is for an unknown patient.  I have asked our VA Legal counsel but no information is available. The VA Police Chief here in Minneapolis wants naloxone rescue kits available in the medical kits used by the VA officers.Clinical staff want this as well.  VA Police officers are  first responders to off-site areas(not in the hospital) that include apartments on this campus and must call 911  for city ambulance response if needed. Naloxone could be useful.  Past history does include a drug overdose at VA run apartments, sadly naloxone would not have helped in that case.  The Chief anticipates need.  Pharmacy Service will commit to training the officers in opioid overdose avoidance, recognitionand response. Accidental drug overdose is the fourth leading cause of premature death among adults in NYC . Between 2005 and 2010, an average of 684 New Yorkers died annually of an accidental drug overdose, with 70% attributable to opioids.  Since 2006, when NYS passed legislation legalizing the administration of naloxone by trained laypersons, DOHMH and NYS Department of Health have distributed more than 20,000 naloxone kits to non-medically trained New Yorkers.  As a direct result of these programs, 523 overdose reversals have been reported in NYS by trained laypersons administering naloxone in the community, while many more reversals have occurred but not been reported. In NYS, naloxone can only be prescribed and dispensed by a medical doctor, nurse practitioner or physician assistant; however, the majority of certified programs dispensing naloxone have limited clinical staff on-site. An over the counter designation would diminish the need for on-site clinical staff and increase the accessibility of naloxone for those who would benefit.  DOHMH recognizes that such an important step must be accompanied by a significant increase in the availability of opioid overdose prevention education, including information on risk factors for overdose, recognizing overdose symptoms, administering naloxone and stressing the urgency of calling 911.Expanding access to naloxone beyond conventional medical settings is a safe and effective way to prevent unnecessary overdose deaths.  DOHMH strongly urges the FDA to build upon NYCs experience and expand access to naloxone by making it available over the counter and increasing the availability of intranasal naloxone by approving it as an on-label use. As a front line activist in the field of overdose prevention, I have recorded many firsthand accounts from bystanders responding to Opioid overdoses. The majority of these overdoses involved heroin and Oxycontin. Many of the bystanders responding were parents who had received  Narcan from our fixed pilot site in Cambridge Mass, which allows the distribution of nasal Narcan under standing order from a physician an d does not require a doctor or nurse practitioner to be present on site at time of training and distribution to the public. In all cases of Narcan being administered, not once was it reported to have negative effects on the person overdosing, nor was it considered hard to administer via the nasal. Every case recorded reported the successful reversal of a potentially fatal overdose. Had Narcan not been present at the time of many of the reported overdoses, the rate of death may have been notably higher due to the publics fear to call 911 for fear of negative consequence, such as loss of housing arrest etc. i believe Massachusetts has a model program for the safe and effective overdose prevention training and distribution of Narcan. It would beneficial for other states to base such programs on the groundwork laid down by such pilot programs in order to save lives. The idealism behind a standing order for Narcan is simple in itself, as it removes the cost of having a Doctor on site at all times to oversee the distribution of the medication. Not only is this costly, but also is not a reality for many underfunded programs. By allowing Narcan to be distributed in the manner that Massachusetts does, the medication is getting into the hands of a marginalized community that greatly needs it. In the end, the measure is saving so many lives. In collaboration with other medical and public health professionals throughout the U.S., I am currently developing NIH funded online curricula for overdose prevention with naloxone for peers, family members and trainers, and for police, firefighters and EMTs. As a researcher and curriculum developer, who has worked with injection and non-injection drug users for decades, I fully support the dissemination of overdose prevention education with naloxone to reduce fatal overdoses and encourage drug users to seek effective drug treatment. I support making the process as simple as possible with ready access to naloxone and with Good Samaritan laws to protect lay people from arrest or fear of arrest. I also believe overdose prevention education should be readily available through face to face classes and online for easy dissemination of this life-saving medication. In addition, prevention education should be tailored to meet the needs of various populations and be available in a wide array of venues (doctors offices, hospitals, harm reduction  drug treatment centers, detoxification units, schools). Research on best practices and the best ways to effectively disseminate this life-saving overdose prevention education and medication is also needed. The Baltimore City Health Department (BCHD) is pleased to comment on the potential value of making Naloxone more widely available outside of conventional medical settings to reduce the incidence of opioid overdose fatalities.BCHDs Staying Alive Overdose Prevention Program is currently the only overdose prevention program in Maryland.  BCHD launched Staying Alive in 2004 in response to a rising number of overdose deaths in the city, a number that surpassed the homicide rate.  In 2002, there were a record 343 overdose deaths involving alcohol or at least one drug of abuse, which included opioids, heroin or methadone.  In 2009, there were 229 overdose deaths.We believe that the Staying Alive program played a significant role in the drop in overdose deaths.  Among participants who have been dispensed Naloxone, there have been at least 240 reported overdose reversals. Additionally, through the Staying Alive program:4,000 vials of Naloxone have been dispensed1,200 providers have been trained at various facilitiesMore than 10,000 clients have been trained through the Staying Alive program.  Maryland, like many other states, is in the midst of an overdose epidemic.  While the Staying Alive program focuses its efforts on needle exchange clients and heroin drug users, there is a growing prescription drug abuse problem in Maryland such that 55% of all intoxication deaths involved a prescription opioid in 2010. This demonstrates an overwhelming need to expand the reach of overdose prevention programs and Naloxone distribution to populations beyond the traditional heroin user.  To address the overdose epidemic in Maryland, Naloxone needs to be easily accessible and made available to those who need it.  This includes making it available over-the-counter as well as including it in drug formularies for public and private health insurance programs. The ready availability of naloxone to reverse intended or unintended overdose of opioids is to be encouraged. It is likely to save many lives and isnt likely to present a risk to the public. I urge its acceptance by the FDA The availability of nalaxone makes the difference between life and death for many opioid users. Through increasing its availability the FDA will not only be saving lives but sending the message that all people, including those who use drugs are valuable and worth caring for. 