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`FOOD AND DRUG ADMINISTRATION
`
`EXPLORING NALOXONE UPTAKE AND USE
`
`Public Meeting
`
`Wednesday, July 1st, 2015
`8:03 a.m. to 4:59 p.m.
`
`White Oak Campus
`10903 New Hampshire Avenue
`Silver Spring, Maryland
`
`National Capitol Contracting, LLC
`200 N. Glebe Road, Suite 1016 | Arlington, VA 22203
`Tel: (703) 243-9696 | Fax: (703) 243-2844
`www.nccsite.com
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`C O N T E N T S
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` PAGE
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`AGENDA ITEM
`Welcoming Remarks
` Peter G. Lurie, MD, MPH
`Introductory Remarks
`Michael Botticelli
`Overview of the Public Health Burden of
`Prescription Drug and Heroin Overdoses
`Grant Baldwin, PhD, MPH
`Panel 1: Review of the Current Use of Naloxone
` Moderator Christine A. Cichetti
`The Clinical Use of Naloxone
`42
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`Joshua Lloyd, MD
`First on the Scene: People Who Use Drugs, their
`Families and their Friends
`
`Sharon Stancliff, MD
`Community Management of Opioid Overdose: the
`World Health Organization Guidelines
`
`Melinda Campopiano, MD
`Naloxone Schemes in the United Kingdom: From
`Local Initiatives to National Politics
`Professor John Strang
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`C O N T E N T S (continued)
`
` PAGE
`AGENDA ITEM
`N-ALIVE: Randomized Trial of Naloxone-On-Release
`to Prevent Heroin Overdose Deaths on Prison
`Release in England
`Professor John Strang
`Market Structure for Naloxone
`Matthew Rosenberg, MSPPM
`Panel 2: Clinical Aspects of Co-Prescribing
`Moderator Sharon Hertz, MD
`Addressing Legal and Regulatory Barriers to
`Naloxone Access
`Corey Davis, JD, MSPH, EMT-B
`Mainstream Medical Co-Prescribing
`Fred Wells Brason II
`Opioid Overdose Prevention: Online Campaigns
`156
`Mitra Ahadpour, MD
`Saving Veterans Lives through Implementation of
`Opioid Overdose Education and Naloxone
`Distribution
`Elizabeth M. Oliva, PhD
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` PAGE
`184
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`C O N T E N T S (continued)
`AGENDA ITEM
`Open Public Hearing
`Panel 3:
`Using Data to Identify Appropriate
`Patients for Co-Prescribing Naloxone
`C O N T E N T S (continued)
` Moderator Robert Lubran, MS, MPA 232
`What the Data Tell Us About Who Is at Risk
`232
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`CDR Christopher M. Jones
`
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`Naloxone Provision to Pain Patients in Primary
`Care Practice: Preliminary Results from the
`Naloxone for Opioid Safety Evaluation
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`Phillip Coffin, MD, MIA
`
`Data and Clinical Considerations for Determining
`to Whom Naloxone Should be Distributed
`Caleb Banta Green PhD, MPH, MSW
`Facilitators of and Barriers to Naloxone Co-
`Prescribing in Three Large Health Systems
`Ingrid A. Binswanger, MD, MPH, MS
`Panel 4:
`Training Issues for Communities and
`Families
` Moderator Wilson Compton, MD, MPE
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`National Capitol Contracting, LLC
`200 N. Glebe Road, Suite 1016 | Arlington, VA 22203
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`National Capitol Contracting, LLC
`200 N. Glebe Road, Suite 1016 | Arlington, VA 22203
`Tel: (703) 243-9696 | Fax: (703) 243-2844
`www.nccsite.com
`
`FDA: Exploring Naxolone Uptake and Use
`
`Day 1
`
`Nalox1211
`Nalox-1 Pharmaceuticals, LLC
`Page 1 of 97
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`

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`C O N T E N T S (continued)
`AGENDA ITEM PAGE
`Opioid Overdose Prevention: Knowledge and Skill
`Development
`
`
`Melinda Campopiano, MD
`Overdose Prevention and Response Training:
`Lessons from Rhode Island
`
`Traci C. Green, PhD, MSc
`Training Addiction Treatment Providers
`Sarah Ruiz, MSW
`
`
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`Closing Remarks
`Peter G. Lurie, MD, MPH
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`P R O C E E D I N G S
`(8:03 a.m.)
`DR. LURIE: All right. Could everybody take a
`
`seat, please? Good morning, everybody. I’m Peter
`Lurie. I’m an associate commissioner for public health
`strategy and analysis. And part of my job is to keep
`everybody on time during a very tightly-structured
`meeting. I can assure you, we’ll be done by 3:00
`tomorrow because my wife and children will be outside
`Building One, picking me up to go camping. So, we’re
`going to keep to a tight schedule here. So, good
`morning, and welcome to FDA. As I look out over here,
`I see a large number of familiar faces, including many
`who attended our first meeting on sure th on these very
`premises -- I think in this room -- in April 2012. As
`Dinah Washington might have said, “What a difference
`three years makes.”
`
`Just a couple of weeks ago, CDC published in
`its MMWR -- and some of the authors are here today -- a
`report on the growth of naloxone distribution programs
`between 2010 and 2014. And the growth really is
`remarkable -- a 243 percent increase in the number of
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`local sites providing naloxone, a 183 percent increase
`in the number of laypersons providing naloxone kits,
`and most importantly, a 160 percent increase in the
`number of overdose reversals reported. Those reversals
`now total over 26,000, going back to the beginning of
`these programs. And 8,000 of those are reported to
`have taken place in 2013 alone. These accomplishments
`are the results of the hard work and dedication of
`people in this very room, people who pioneered these
`programs, who were willing to advocate for them, to
`actually carry them out when they were more
`controversial than they are today, and when their
`future was less clear.
`
`You can see some of the differences between
`the 2012 meeting and today. And the differences, I
`think, are instructive. Like last time, this meeting
`is sponsored by a number of HHS agencies -- FDA,
`National Institute on Drug Abuse, CDC, Substance Abuse
`and Mental Health Services Administration, and -- new
`to the table this time -- the Health Resources and
`Services Administration, HRSA. And we also have a
`representative from CMS in the room, who’ve been
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`involved in planning our meeting. All of those
`agencies were involved, also, in drafting the HHS
`secretary’s opioid initiative, which has only three
`elements. And one of those is naloxone, a sign of how
`accepted this intervention has become. And of course,
`in a moment, ONDCP Director Botticelli will be making
`some introductory remarks, a further sign of the
`commitment of the administration on this issue. And
`I’d also like to welcome Dr. Stephen Ostroff, who’s
`sitting next to Dr. Botticelli, who’s acting
`commissioner and has been a big supporter of this
`meeting.
`When we last met over here at -- FDA was
`
`describing the regulatory path to approval for new
`products. And indeed, in April 2014, the auto-injector
`EVZIO was approved and now can be used by family
`members or caregivers to treat a person known or
`suspected to be suffering from an overdose. But at
`this meeting, you’ll hear about intranasal products
`currently under development, a further sign of
`progress. We will revisit some of the same topics that
`we looked at last time. But today’s agenda is much
`
`National Capitol Contracting, LLC
`200 N. Glebe Road, Suite 1016 | Arlington, VA 22203
`Tel: (703) 243-9696 | Fax: (703) 243-2844
`www.nccsite.com
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`National Capitol Contracting, LLC
`200 N. Glebe Road, Suite 1016 | Arlington, VA 22203
`Tel: (703) 243-9696 | Fax: (703) 243-2844
`www.nccsite.com
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`FDA: Exploring Naxolone Uptake and Use
`
`Day 1
`
`Nalox1211
`Nalox-1 Pharmaceuticals, LLC
`Page 2 of 97
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`more comprehensive. We have panels on naloxone use in
`clinical and nonclinical settings, questions of access,
`state law, over-the-counter status, training, and
`evaluation. We’ll have discussions on ways to include
`police and fire departments, to expand naloxone
`availability on ambulances, and to address issues of
`cost, logistics, and supply. And finally, we have a
`broader audience even than last time -- and, I think,
`by the time everybody makes it through FDA’s vaunted
`security system, a larger audience.
`
`[laughter]
`
`That audience is reflected in the makeup of
`the speakers in our open public hearing and sessions,
`which many of you have signed up, and in the audience
`more generally -- members of community-based
`organizations that first pioneered the administration
`of naloxone, medical professionals, policymakers,
`public health officials, first responders, product
`developers, researchers, and of course, patients and
`their families. All of us are united in a common goal
`-- to reduce the massive toll opioid overdoses are
`exacting on our country. In sum, the meeting builds on
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`the good work already done by those in this room to
`examine what I think we might call second-generation
`questions -- growth and sustainability of the programs.
`Their usefulness is no longer in question. But how we
`grow and sustain them is the subject of this meeting.
`What a difference three years makes.
`
`Let me just finish with a couple of, more than
`a couple of logistic issues, just to make sure
`everybody’s on the same page. As I hinted already,
`there is going to be a Q&A session after each and every
`panel, in which people can go to the mics and ask any
`questions they might have of the speakers. We also
`have two one-hour open public sessions, one today and
`one tomorrow, at which one can make any comment of
`their choosing. And people have signed up for those,
`and they’re quite packed, so we look forward to those.
`If you come to the microphone at any of those
`circumstances, please identify yourself and the
`organization you’re representing and any conflict of
`interest you might have. For the press, our press
`officer today is Eric Pahon. I can introduce you to
`him if you need to.
`
`National Capitol Contracting, LLC
`200 N. Glebe Road, Suite 1016 | Arlington, VA 22203
`Tel: (703) 243-9696 | Fax: (703) 243-2844
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`National Capitol Contracting, LLC
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`Tel: (703) 243-9696 | Fax: (703) 243-2844
`www.nccsite.com
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`There will be kiosks set up outside the
`
`meeting room where refreshments will be sold during the
`breaks and at lunch. And while you’re at it, after our
`first break, you should preorder your lunch to be more
`efficient when it comes to lunchtime. And lunch will
`include offerings such as salads, sandwiches, and other
`refreshments. Remember that only those who have FDA
`badges will be able to venture past our vaunted
`security folks, so stay within the general confines of
`this meeting area. You should know that the meeting is
`currently being webcast live and will be archived and
`available to view after the meeting. And a transcript
`of the meeting will be made available within 45 days of
`this meeting. The slides will be -- that are being
`presented today will be made available unless the
`speakers prefer not. But you should be able to get
`those on the web after the meeting. And we’ll post a
`meeting summary as well. Should you have any comments
`on this meeting, you can submit written or electronic
`comments at www.regulations.gov.
`
`Please turn off your cellphones because that
`can interfere with our transcriber, who’s recording the
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`meeting. You can find the bathrooms to the left. You
`can find the bathrooms to the right. And then, I just
`wanted to thank Mary Gross, who’s sitting over here to
`my right, and Georgiann Ienzi as well, who helped me
`pull this meeting together. We had a series, a large
`series of meetings with people from across the
`department who were involved in pulling this together.
`But I think, really, the heart and soul of all of it
`was Mary. So, thank you very much for everything you
`did.
`[applause]
`
`And finally, thanks to all of you for coming,
`
`especially on the cusp of a holiday weekend. And we
`look forward to a very informative two days. And with
`that, I’d like to introduce Director Botticelli. Thank
`you for coming.
`
`MR. BOTTICELLI: Good morning, everybody.
`Good morning, everybody. I know this crowd is a lot --
`makes a lot more noise than they just did. First of
`all, I really want to thank my colleagues at the FDA --
`Dr. Ostroff, Peter Lurie, Chris Jones -- who’ve been
`incredible partners, not just on the work with
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`National Capitol Contracting, LLC
`200 N. Glebe Road, Suite 1016 | Arlington, VA 22203
`Tel: (703) 243-9696 | Fax: (703) 243-2844
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`National Capitol Contracting, LLC
`200 N. Glebe Road, Suite 1016 | Arlington, VA 22203
`Tel: (703) 243-9696 | Fax: (703) 243-2844
`www.nccsite.com
`
`FDA: Exploring Naxolone Uptake and Use
`
`Day 1
`
`Nalox1211
`Nalox-1 Pharmaceuticals, LLC
`Page 3 of 97
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`naloxone, but in all of our work as it relates to the
`prescription drug and opioid epidemic that we have in
`the United States. They’ve been huge colleagues, as
`well as other federal colleagues that we have here
`today. And I know I’m going to miss folks -- Grant
`Baldwin, Wilson Compton from NIDA.
`
`You know, I’d like to give a particular shout-
`out to my colleagues from Massachusetts, Dr. Alex
`Walley and Sarah Ruiz. And, you know, I often get
`credit for what happened in Massachusetts, but all I
`did was listen to what they suggested that we needed to
`do. And we were able to do it. You know, I can’t help
`but think back of being in this room a number of years
`ago -- three years ago. And I was actually in the
`holding pattern for deputy director. And I had to sit
`in the back, and I couldn’t open my mouth at that point
`-- which, for people who know me, know it’s a really
`challenging feat --
`
`[laughter]
`
`-- particularly as it relates to issues around
`overdose prevention. So, I really want to thank you
`all for being here today and particularly thank our
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`federal colleagues. As director of the Office of
`National Drug Control Policy, our office establishes
`policies, priorities, and objectives for the nation’s
`drug control programs, and ensures that adequate
`resources are provided to implement them. We also
`develop, evaluate, coordinate, and oversee the
`international and domestic drug policy efforts of the
`executive branch agencies and ensure that such efforts
`sustain and complement state and local drug
`initiatives. I really appreciate being here today to
`address the public health consequences of non-medical
`use of opioid drugs, and the critically important role
`that naloxone plays in preventing overdose deaths. I
`am particularly appreciative of the individuals who
`have been working on this issue for many, many years.
`We at ONDCP are pleased to have worked with all of you
`over the years, with law enforcement communities who
`have responded in an extraordinary manner to the
`overdose crisis. Their work builds upon the tireless
`work of community organizations who have been at the
`forefront of this issue for many, many years.
`
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`I think you all know the data, but according
`
`to the CDC, every day in America 100 people -- 120
`people, on average, die every day from a drug overdose.
`That’s nearly 44,000 overdose deaths a year. And
`opioid pain relievers are involved in more than 16,000
`of them, and heroin in over 8,000. Overall, drug use -
`- overdose deaths now outnumber deaths from motor
`vehicle crashes in the United States. While we are
`heartened to see some of the numbers around overdosing
`on prescription drugs decrease in 2013, that number has
`been offset by the number of people dying of heroin
`overdoses. Heroin is striking a younger, more rural
`and suburban population, overwhelming already-strained
`criminal justice and treatment systems, and often in
`parts of the country with little or no health
`infrastructure. Besides putting people at risk for
`overdose, injection drug use is also contributing to
`the spread of HIV and hepatitis C. I think all of us
`have been particularly concerned with the HIV outbreak
`in Scott County, Indiana, something that can be
`prevented through the availability of syringe services
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`programs and better access to both substance use
`disorder treatment and infectious disease services.
`
`Many of us in this room today were also at the
`National Prescription Drug Meeting in Atlanta, Georgia,
`in April. The annual meeting, organized by Congressman
`Hal Rogers, brings together academics, law enforcement
`professionals, parents, and others interested in the
`opioid abuse epidemic to arrive at solutions to this
`national problem. At the conference, we stressed that
`we don’t have time to wait. The time for urgent action
`is now. And I say this not because I’m concerned about
`leaving a mark as the director of ONDCP. I say that
`because of the people who die every day from drug
`overdoses -- people who did not have to die, people
`whose lives we can save, and who can enter treatment
`and who can recover and who can go on to live full,
`healthy, and happy lives.
`
`After this meeting, I will participate in a
`phone call with over 200 parents who have lost their
`children to the disease of addiction. These are really
`tough meetings. But it’s important to meet with
`parents and people in recovery because it keeps me
`
`National Capitol Contracting, LLC
`200 N. Glebe Road, Suite 1016 | Arlington, VA 22203
`Tel: (703) 243-9696 | Fax: (703) 243-2844
`www.nccsite.com
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`National Capitol Contracting, LLC
`200 N. Glebe Road, Suite 1016 | Arlington, VA 22203
`Tel: (703) 243-9696 | Fax: (703) 243-2844
`www.nccsite.com
`
`FDA: Exploring Naxolone Uptake and Use
`
`Day 1
`
`Nalox1211
`Nalox-1 Pharmaceuticals, LLC
`Page 4 of 97
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`connected to the work that we do. If you ever wonder
`whether the work you do is important, I can tell you
`about the lunch I had with a father who lost his son to
`an overdose. This man clearly loved his son and had
`done everything he could do to help. He was wracked
`with guilt over what he could have done or should have
`known, not because he didn’t have resources, he did;
`not because he was not educated, he was. This
`concerned parent did not know about medication-assisted
`treatment because the program didn’t offer it, though
`his son had been in treatment for opioid use disorders.
`And he was sad to tell me that he also did not know
`about naloxone, a drug that could have saved his son’s
`life. And that is why we are here today. We are here
`today because we still have more to do, and that urgent
`action is needed.
`
`We have come a long way since the days when
`people in positions of authority would publicly state
`that naloxone would enable more use, and that we should
`not expand naloxone because it would send the wrong
`message. But we also know that there are too many
`barriers to naloxone, and there are opportunities that
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`exist. We know that price is a barrier. We know that
`prescribing practices continue to fuel this epidemic.
`We know that availability is a barrier, and knowledge
`is a barrier. What is not a barrier is the will of the
`public, and the people in this room to make a
`difference. And with this, we can and we will save
`lives. Naloxone is one piece of the puzzle. The other
`pieces remain prevention, treatment, recovery support
`services. But based on the most recent national survey
`on drug use and health, far too few people who need
`substance use disorder treatment actually receive it.
`
`To address this challenge in the final years
`of the Obama administration, we are promoting two
`complementary approaches. The first is overdose
`education and increasing access to naloxone for at-risk
`patients and all first responders. The second is
`better access to evidence-based treatment for
`prescription drug and heroin use disorders,
`particularly medication-assisted treatment. Prior to
`2012, just six states had laws that expanded access to
`naloxone or limited criminal liability. As of April,
`33 states had passed laws allowing naloxone
`
`National Capitol Contracting, LLC
`200 N. Glebe Road, Suite 1016 | Arlington, VA 22203
`Tel: (703) 243-9696 | Fax: (703) 243-2844
`www.nccsite.com
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`National Capitol Contracting, LLC
`200 N. Glebe Road, Suite 1016 | Arlington, VA 22203
`Tel: (703) 243-9696 | Fax: (703) 243-2844
`www.nccsite.com
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`distribution to third parties or first responders via
`direct prescription or standing order. Additionally,
`25 states and the District of Columbia passed laws
`offering protections from charge or prosecution for
`possession of a controlled substance and/or
`paraphernalia if the person was seeking assistance for
`someone experiencing an opiate overdose.
`
`The federal government has focused a great
`deal of time and effort on expanding access to
`naloxone. The Substance Abuse and Mental Health
`Services Administration updated its Opioid Overdose
`Prevention Toolkit. And the Department of Justice
`created a naloxone toolkit for law enforcement. The
`Veterans Health Administration added naloxone to its
`formulary and created a policy for naloxone co-
`prescribing. President Obama announced an executive
`action directing the Department of Defense law
`enforcement officers to carry naloxone. Additionally,
`SAMHSA permits the use of block grant funds for
`naloxone purchase. And the president’s FY 2016 budget
`request adds an additional $12 million in grants to be
`issued to first responders in high-risk communities
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`with this lifesaving medication. Our administration
`continues to support the co-prescribing of naloxone
`with opioid medication prescriptions, expansion and use
`of standing orders and collaborative practice
`agreements between health care practitioners and
`pharmacists that allow patients to purchase naloxone
`without a prescription, and efforts to make naloxone
`available over-the-counter.
`
`But it’s not enough to simply reverse an
`overdose. We must connect overdose victims and people
`struggling with opioid use disorders to treatment
`facilities and doctors that offer MAT. Today, thanks
`to the work of the FDA and NIDA, we have approved
`medications available for care for people with opioid
`abuse disorders -- methadone, injectable naltrexone,
`and medications containing buprenorphine. Medication-
`assisted treatment involves using one of these
`medicines, along with a full array of counseling,
`diversion prevention efforts, and recovery support
`services, so patients learn the skills they need to
`function in recovery. There is clear and convincing
`evidence that maintenance with MAT is more effective
`
`National Capitol Contracting, LLC
`200 N. Glebe Road, Suite 1016 | Arlington, VA 22203
`Tel: (703) 243-9696 | Fax: (703) 243-2844
`www.nccsite.com
`
`National Capitol Contracting, LLC
`200 N. Glebe Road, Suite 1016 | Arlington, VA 22203
`Tel: (703) 243-9696 | Fax: (703) 243-2844
`www.nccsite.com
`
`FDA: Exploring Naxolone Uptake and Use
`
`Day 1
`
`Nalox1211
`Nalox-1 Pharmaceuticals, LLC
`Page 5 of 97
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`than treatment without medication. Additionally,
`studies have shown that medication-assisted treatment
`can help save lives by preventing overdose deaths.
`Medication-assisted treatment should be the recognized
`standard of care for people with opioid use disorders.
`
`We are privileged to be in the room among so
`many thoughtful and dedicated decision makers and
`advocates. We will, we have, and we will continue to
`learn a great deal over the next two days. However,
`simply coming away with more knowledge is not enough.
`I implore you to use this knowledge and the contacts
`you will make to commit to additional action in your
`agencies and your organizations that will work to save
`and change lives. The clock is ticking. Thank you
`very much.
`
`[applause]
`Presentation - Grant Baldwin
`DR. BALDWIN: Oops. Good morning. It’s a
`
`pleasure to be here today. It’s always nice to follow
`someone like Director Botticelli. His results-driven
`and action-oriented leadership style is both pragmatic
`and inspiring to all of us. Let me also begin by
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`thanking Peter and his FDA colleagues, as well as all
`of you, for joining in this meeting. I think it’s
`going to be an important conversation. My role today
`is to help set the context. Specifically, I will share
`with you the latest data on the public health burden of
`prescription drug and heroin-related overdoses. This
`is unequivocal. We’re in the midst of an opioid
`epidemic, driven largely by the overprescribing of
`opioid painkillers in the treatment of chronic pain
`outside of end-of-life care. More recently, the sharp
`rise in heroin-related deaths is a new and not entirely
`unrelated development in an epidemic that is impacting
`every corner of this country. All told, I hope my
`remarks can serve as a frame of reference for our
`discussion over the next couple of days, and galvanize
`us to do everything possible to stop this epidemic,
`including the need for increased naloxone uptake and
`use.
`Not surprisingly, being from CDC, my remarks
`
`are filled with graphs highlighting data from our
`present reality. However, I want to start by calling
`attention to society’s complicated relationship with
`
`National Capitol Contracting, LLC
`200 N. Glebe Road, Suite 1016 | Arlington, VA 22203
`Tel: (703) 243-9696 | Fax: (703) 243-2844
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`National Capitol Contracting, LLC
`200 N. Glebe Road, Suite 1016 | Arlington, VA 22203
`Tel: (703) 243-9696 | Fax: (703) 243-2844
`www.nccsite.com
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`the morphine molecule, a history that dates back to
`4000 BC. These two books, “Drugged” by Richard Miller
`and “Dreamland” by Sam Quinones, do a masterful job of
`telling the story of how we got to now. “Drugged” is
`more technical and outlines the origin, development,
`and use of natural and manmade opiates, including its
`proliferate medicinal use in cough, cold, and pain
`remedies in the 18th and 19th centuries. It was also,
`by the way, used as a children’s sleep aid. Its
`medicinal use was so common during the U.S. Civil War
`that drug-addicted veterans referred to it as Soldier’s
`Disease. “Dreamland” is more contemporary and outlines
`the confluence of factors leading to the current
`epidemic, including pain being designated the fifth
`vital sign, an under-appreciation of the addictive
`potential of prescription opioids, aggressive marketing
`of these drugs to clinicians, rogue actions by
`clinicians who ran pill mills that profited from
`overprescribing, and the sophisticated actions of
`Mexican drug traffickers to open new black tar heroin
`markets that made it as easy to get heroin as it is to
`get a pizza.
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`More than 145,000 people have died from
`
`overdoses involving prescription opioid pain relievers
`in the last decade. And deaths have quadrupled since
`1999. While opioid pain relievers can and do play an
`important role in the management of some types of pain,
`the overprescribing of these powerful drugs created
`this epidemic. To unravel and better target our
`prevention efforts, we need to answer a few key
`questions. Among them -- how many opioids are being
`prescribed? What is the prevalence of prescribing
`across medical specialties? What conditions are
`opioids being used to treat? What is the relationship
`between dose, duration, and overdose? Are some opioids
`riskier than others? Who is at increased risk of
`abuse, overdose, and death? And what is the
`relationship between prescription opioids and heroin?
`
`Sometimes pictures tell the story better than
`words. And this is certainly true in this epidemic.
`This “Time” series map shows state-based drug overdose
`mortality rates shifting between ’99 and 2010.
`Prescription drug overdoses are among the few causes of
`death that are on the rise, and the trends, as
`
`National Capitol Contracting, LLC
`200 N. Glebe Road, Suite 1016 | Arlington, VA 22203
`Tel: (703) 243-9696 | Fax: (703) 243-2844
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`National Capitol Contracting, LLC
`200 N. Glebe Road, Suite 1016 | Arlington, VA 22203
`Tel: (703) 243-9696 | Fax: (703) 243-2844
`www.nccsite.com
`
`FDA: Exploring Naxolone Uptake and Use
`
`Day 1
`
`Nalox1211
`Nalox-1 Pharmaceuticals, LLC
`Page 6 of 97
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`evidenced here, are stark. Every state has seen
`dramatic increases in mortality rates, with some states
`in Appalachia and the Southwest being among the
`hardest-hit. Opioid pain relievers such as oxycodone,
`hydrocodone, and methadone are responsible for driving
`the dramatic increase in overdose deaths. The yellow
`line shows the fourfold increase in deaths since 1999.
`In 2013, over 16,000 people died from a prescription
`opioid overdose, or about one death every 33 minutes.
`Among all drug overdosed deaths that year,
`approximately 37 percent involved prescription opioids,
`and another 19 percent involved heroin.
`Benzodiazepines like Valium and Xanax were involved in
`30 percent of opioid pain reliever deaths in 2013. And
`this is up from 13 percent in 1999. Notice the slight
`plateauing of the yellow line in recent years.
`Beginning in 2012, deaths dropped for the first time
`since the ‘90s. Nearly 1,000 fewer people died from a
`prescription opioid in 2012 compared to the year
`before. That said, as Director Botticelli indicated,
`the data shows another troubling trend that I’ll
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`discuss in greater detail later -- the recent alarming
`increase in heroin overdose deaths.
`
`When we look at the total health impact of
`opioid use, a staggering number of Americans are
`impacted. In 2011, for every one overdose death
`involving opioids, there were 12 substance abuse
`treatment admissions, 25 emergency department visits
`for misuse or abuse, 105 people who met criteria for
`abuse or dependence on opioids, and 659 people, 12 and
`older, who reported using these drugs non-medically.
`Equally staggering, for every one overdose death,
`America incurs an estimated $4.3 million in health
`care-related costs across this cascade. One-quarter of
`a billion -- providers wrote more than a quarter of a
`billion opioid prescription