President's message: Food and Drug Administration approved naloxone and continued use of improvised nasal naloxone: What is a treatment advocate and educator to do?

References

• Centers for Disease Control and Prevention, National Center for Health Statistics. Multiple Cause of Death 1999–2014 on CDC WONDER Online Database, released 2015. Data are from the Multiple Cause of Death Files, 1999–2014, as compiled from data provided by the 57 vital statistics jurisdictions through the Vital Statistics Cooperative Program. Accessed at http://wonder.cdc.gov/mcd-icd10.html on Jan 19, 2016 7:47:47 AM CDC Wonder Database Multiple Cause of Death 2014 UCD - ICD-10 Codes: X40-44; X60-64; X85; Y10-Y14 and MCD – ICD-10 codesT40.1 (Heroin), T40.2 (Other opioids), T40.3 (Methadone), T40.4 (Other synthetic narcotics).
   Google Scholar
• CDC Health Advisory. Increases in fentanyl drug confiscations and fentanyl-related overdose fatalities, 2015. http://emergency.cdc.gov/han/han00384.asp#_edn11 (accessed September 9, 2016).
   Google Scholar
• U.S. Drug Enforcement Administration. 21 CFR part 1310. Control of a chemical precursor used in the illicit manufacture of fentanyl as a list 1 chemical. Fed Register 2007; 72:20039–47.
   Google Scholar
• U.S. National Library of Medicine. FDA DailyMed prescribing information fentanyl citrate intravenous, 2013. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5d40297-b769-48cc-9f84-f98b7a333507 (accessed September 9, 2016).
   Google Scholar
• 2014 Ohio drug overdose preliminary data: general findings, 2014. http://www.healthy.ohio.gov/vipp/data/rxdata.aspx (accessed September 9, 2016).
   Google Scholar
• Drug- and alcohol-related intoxication deaths in Maryland, 2014. http://dhmh.maryland.gov/data/Documents/Annual%20OD%20Report%202014_merged%20file%20v5.pdf (accessed September 9, 2016).
   Google Scholar
• Harvard TH. Chan school of public health summary of opioid overdose deaths: Massachusetts, January–June, 2014. http://s3.amazonaws.com/media.wbur.org/wordpress/15/files/2015/11/Brief-report-MA-opioid-OD-deaths-2014.pdf (accessed September 9, 2016).
   Google Scholar
• Rhode Island's strategic plan on addiction and overdose, 2015. http://www.health.ri.gov/news/temp/RhodeIslandsStrategicPlanOnAddictionAndOverdose.pdf (accessed September 9, 2016).
   Google Scholar
• Maine attorney general, 2015. http://www.maine.gov/ag/news/article.shtml?id=653671 (accessed August 20, 2015).
   Google Scholar
• This is an official NH DHHS health alert, 2015. http://www.dhhs.nh.gov/dphs/cdcs/alerts/documents/opioid.pdf (accessed September 9, 2016).
   Google Scholar
• Analysis of drug-related overdose deaths in Pennsylvania, 2014. http://www.dea.gov/divisions/phi/2015/phi111715_attach.pdf (accessed September 9, 2016).
   Google Scholar
• Connecticut office of chief medical examiner, 2016. http://www.ct.gov/ocme/lib/ocme/AccidentalDrugIntoxication2015.pdf (accessed September 9, 2016).
   Google Scholar
• Overdose deaths involving fentanyl up dramatically in Delaware, 2015. http://dhss.delaware.gov/dhss/pressreleases/2015/fentanyldeaths-122815.html (accessed September 9, 2016).
   Google Scholar
• Drug related fatalities Vermont Department of Health, 2015. http://healthvermont.gov/research/documents/databrief_drug_related_fatalities.pdf (accessed September 9, 2016).
   Google Scholar
• Fatal drug overdose quarterly report Virginia Department of Health, 2016. https://www.google.ie/url?sa=t&rct=j&q=&esrc=s&source=web&cd=4&cad=rja&uact=8&ved=0ahUKEwjxicLYiPzKAhUCPQ8KHTvHAMMQFgguMAM&url=https%3A%2F%2Fwww.vdh.virginia.gov%2FmedExam%2Fdocuments%2Fpdf%2FQuarterly%2520Drug%2520Death%2520Report.pdf&usg=AFQjCNGdcVORWdMwp2WhYoaXCZlEBSSopg&sig2=vOseqo73p9iTIPAXJNFNAA (accessed September 9, 2016).
   Google Scholar
• Gorner J, Nickeas P, Sobol RR. Chicago medics treat 74 narcotics overdoses in 72 hours. EMS1, 2015. http://www.ems1.com/naloxone/articles/11079048-Chicago-medics-treat-74-narcotics-overdoses-in-72-hours/ (accessed September 9, 2016).
   Google Scholar
• NJ news: shore program countering heroin overdoses is going state wide. Dirty Jersey recovery, 2014. http://dirtyjerseyrecovery.com/2014/06/nj-news-shore-program-countering-heroin-overdoses-going-state-wide/ (accessed September 9, 2016).
   Google Scholar
• The Buffalo News, 2016. http://mobile.buffalonews.com/?articleRedirect=1&url=http%3A%2F%2F-www.buffalonews.com%2Fcity-region%2F23-dead-in-erie-county-from-opiates-over-11-days-20160209.
   Google Scholar
• U.S. National Library of Medicine. FDA DailyMed prescribing information naloxone hydrochloride i.v., 2013. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=76f7eee1-d524-43a4-a868-ffa9f29638a6 (accessed September 9, 2016).
   Google Scholar
• Strang J, McDonald R, Tas B, Day E. Clinical provision of improvised nasal naloxone without experimental testing and without regulatory approval: imaginative shortcut or dangerous bypass of essential safety procedures? Addiction 2016; 111(4):574–82.
   PubMed Web of Science ®Google Scholar
• Dowling J, Isbister GK, Kirkpatrick CM, Naidoo D, Graudins A. Population pharmacokinetics of intravenous, intramuscular, and intranasal naloxone in human volunteers. Ther Drug Monit 2008; 30(4):490–6.
   PubMed Web of Science ®Google Scholar
• Edwards ET, Edwards ES, Davis E, Mulcare M, Wiklund M, Kelley G. Comparative usability study of a novel auto-injector and an intranasal system for naloxone delivery. Pain Ther 2015; 4(1):89–105.
   PubMed Web of Science ®Google Scholar
• Nordrum A. Addiction 2016: as heroin use escalates, a new drug to reverse overdoses hits US drugstores. International Business Times, 2016. http://www.ibtimes.com/addiction-2016-heroin-use-escalates-new-drug-reverse-overdoses-hits-us-drugstores-2271924 (accessed September 9, 2016).
   Google Scholar
• Hertz S. FDA comments on nasal naloxone dose concerns. MedPageToday, 2015. http://www.medpagetoday.com/EmergencyMedicine/EmergencyMedicine/55440 (accessed September 9, 2016).
   Google Scholar
• Summary Review for Regulatory Action. http://www.fda.gov/downloads/drugs/developmentapprovalprocess/developmentresources/ucm480092.pdf (accessed September 9, 2016).
   Google Scholar
• Therapeutic Intranasal Drug Delivery, n.d. http://intranasal.net/OpiateOverdose/Opiate_overdose_overview.htm (accessed September 9, 2016).
   Google Scholar
• U.S. Patent 9,192,570; WO 2015/095644 AntiOp, Inc.
   Google Scholar
• Indivior Receives Complete Response Letter From FDA Not Approving Naloxone Nasal Spray New Drug Application for Opioid Overdose. Indivior, 2015. http://indivior.com/wp-content/uploads/2015/11/Nasal-Naloxone-Final-Release_112415.pdf
   Google Scholar
• Rudd RA, Aleshire N, Zibbell, JE, Gladden RM. Increases in drug and opioid overdose deaths—United States, 2000–2014. MMWR 2016; 64(50):1378–82.
   PubMed Web of Science ®Google Scholar
• Recommendations for laboratory testing for acetyl fentanyl and patient evaluation and treatment for overdose with synthetic opioids. CDC health advisory, 2013. https://stacks.cdc.gov/view/cdc/25259 (accessed September 9, 2016).
   Google Scholar