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Narcan nasal spray FINAL

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Narcan nasal spray FINAL

  1. 1. NARCAN NASAL SPRAY FOR OPIOID OVERDOSE. Dien Vu 12/2/2015 1
  2. 2. What was the news?1,2 • FDA approved Narcan nasal spray to treat opioid overdose on November 18th, 2015. • The first FDA-approved naloxone that can be administered as nose spray. • Fast-track approval and priority review for Narcan nasal spray. • Took only 4 months for FDA to approve. • Adapt Pharma Limited submitted new drug application to FDA for Narcan nasal spray on July 29th, 2015. 2
  3. 3. Why is Narcan nasal spray approved quickly?1 • Death due to drug overdose is now number 1 cause of injury death in the U.S. • Death resulted from respiratory arrest from opioid overdose. • Naloxone could reverse opioid overdose and was only available in injectable forms (syringe and auto-injector.) • Naloxone nasal spray formulation is much easier to use. • There has been widely unapproved use of injectable naloxone with an atomizer that delivers naloxone nasally. • High risk of contaminated needle stick is eliminated. 3
  4. 4. 4
  5. 5. Opioids3,4 • Opioids are painkillers. • Example: hydrocodone, oxycodone, morphine, codeine, heroin, hydromorphone, methadone, fentanyl, etc. • Mechanism: • Bind to opioid receptors in brains, spinal cords, different organs, etc. • Opioid effects on central nervous system: • Reduce pain. • Reduce cough reflex. • Reduce respiration. • Increase euphoria/mood enhancer. • Increase sedation. • Increase nausea/vomiting. • Increase pupil constriction. 5
  6. 6. Opioid side effects 4,5,6,7 6 Peripheral effects
  7. 7. Opioid dependence vs opioid addiction8 • Central adaptations in brain when opioids are taken chronically. • Tolerance. • Dependence. • Tapering opioid or detoxification cause worsening of pain. • Powerful driving force for opioid seeker. • Addiction is the unusual and uncontrollable behaviors of opioid- seeking to achieve the euphoria effect and satisfy cravings. • Opioid dosing is extremely important as well as monitoring for opioid-seeking behaviors. 7
  8. 8. How do you identify drug-seeking patients?9,10 • Recognizing suspicious behaviors: • Obsessive, pushy, angry, impatient, fabricating a story, etc. • Doctor shopping/Poly-pharmacies. • Taking at a higher dose. • Excessive flattery: “You are the best pharmacist ever!” • Comes in right before closing. • Recognizing a fake prescription: • What to do after identified a fake script? 8
  9. 9. Treatments for opioid dependence11 • Goal: relieve withdrawal symptoms and psychological craving. • Treatment options: • Methadone. • Buprenorphine. • Naltrexone. • Maybe safe to take for even lifetime. • Do not discontinue without consulting your doctor. 9
  10. 10. Opioids safety12 • If taken as instructed, opioids is safe and effective to manage pain. • Abusing opioids can lead to consequences: • Respiratory depression. • Deterioration of white matter in brain in heroin users. • Avoid other substances that further depress the central nervous system: • Alcohol. • Drowsy antihistamines. • Barbiturates. • Benzodiazepines. • Anesthetics. 10
  11. 11. Opioids overdose reasons13 • Accidentally or purposely takes extra doses. • Accidentally swallowed by a child or pet. • Give a prescribed opioid medications to someone else. • Mixed with other opioids, medications, alcohol, or OTC medications, etc. • Illegal opioid overdose (heroin, opium.) • Recreational use: • Example: Oxycontin extended releases. 11
  12. 12. Recognizing signs of opioid overdose can help saving lives.13 • Call 911 immediately if: • Extremely pale face, clammy to the touch. • Limp body. • Purple or blue fingernail or lips. • Vomiting or making gurgling noise. • Cant be awakened or unable to speak. • Slow or stop breathing. • Slow or stop heart beating. • Signs and symptoms of opioid toxicity: • Pin-point pupil. • Sedation. • Respiratory depression. • Low blood pressure and/or low heart rate. 12
  13. 13. Treatments for opioid overdose13,14 • Call 911 if suspecting an overdose. • Begin CPR rescue if breathing is very weak or has stopped while waiting for ambulance. • Treatment: Naloxone. • Via syringe. • Via auto-injector. • Via nasal spray. 13
  14. 14. Benefits of Narcan nasal spray15,16,17 • First line treatment for pre-hospital intervention. • Lay person use. • Expend availability and overcome shortage. • Eliminate risk of contaminated needle stick injury to healthcare workers. • People can now use an approved formulation of nasal spray. 14
  15. 15. Narcan rescue kit18 15
  16. 16. 16
  17. 17. How does it apply to pharmacy practice?1,19,20 • Naloxone is one of the life-saving medications for medical emergency. • Save health workers from needle stick injury. • Easier to use compared to injection formulations. • Can be used on adults and children. • Designed for lay person use. • Controversies: • Narcan standing order. • CVS is expanding the sale of Naloxone over-the-counter in 12 more state besides Massachusetts and Rhode Island. 17
  18. 18. Naloxone rescue kits 18
  19. 19. Opioid overdose prevention13 • Always follow instructions. • Do not take more medications than prescribed. • Talk to your doctor if the dose is not high enough to sustain pain. • Always consult with your doctor or pharmacist. • Use pill box or pill minder. • Never mix painkillers with alcohol and other medications without asking your doctors or pharmacist. 19
  20. 20. Opioid overdose prevention13 • Store in a high and locked cabinet or drawer. • Dispose unused medications properly: • Fentanyl: flush down toilet. • Grind tablets and mix with coffee grounds or cat litter, seal and toss in trash. • Police department drop-off boxes. • Pharmacy drug-take back program. 20
  21. 21. Abuse-deterrent opioids21,22 • Formulation: • Physical or chemical barriers. • Agonist + antagonist combination. • Aversion. • Delivery system. • Prodrug. • Combination of methods listed above. • Example: • Suboxone SL film = agonist + antagonist. • Exalgo (hydromorphone) = crush and extraction resistant. • Oxecta (IR oxycodone) = aversion. • Oxycontin (CR oxycodone) = crush and extraction resistance, aversion. • Opana ER (oxymorphone) = crush and extraction resistance, aversion. 21
  22. 22. Future directions23 • Monitoring for side-effects. • Expand prescription drug monitoring programs to multi- states. • Tighten up regulations on illegal substances or prescription drug redistribution among patients. • Provide interventions right away if patients start to experience withdrawal symptoms. • Encourage patients to enroll in rehab programs. • More patient education. 22
  23. 23. Reference 1. FDA Moves Quickly to Approve Easy-to-use Nasal Spray to Treat Opioid Overdose. U.S. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM47 3505. Last updated 11/19/2015. Accessed 11/27/2015. 2. Narcan Approval History. http://www.drugs.com/history/narcan.html. Accessed 11/27/2015. 3. What Are Opioids? National Institute on Drug Abuse. http://www.drugabuse.gov/publications/research-reports/prescription- drugs/opioids/what-are-opioids. Accessed on 11/27/2015. 4. Al-Hasani, R, Bruchas MR. Molecular Mechanisms of Opioid Receptor- Dependent Signaling and Behavior. Anesthesiology. 2011 Dec; 115(6): 1363-1381. 5. DiPiro, JT, Talbert RL, Yee, GC, et al. Opioid. In: Pharmacotherapy: A Pathaophysiology Approach. 9e. United States: McGraw-Hill Education; 2014. 6. Swegle JM, Logemann C. Management of Common Opioid-Induced Adverse Effects. Am Fam Physician. 2006 Oct 15;74(8):1347-1354. 7. Rahman A, Choudhary MI. Frontiers in CNS Drug Discovery. Bentham Science Publishers, Jan 1,2010. 8. Ballantyne JC, Sullivan MD, Kolodny A. Opioid Dependence vs Addiction. Arch Intern Med. 2012; 172(17):1342-1343 23
  24. 24. Reference 9. Pretorius RW, Zurick GM. A Systematic Approach to Identifying Drug-Seeking Patients. Fam Pract Manag. 2008 Apr; 15(4):A3-A5. 10. Spera B. How to Spot and Handle Fake Rxs. http://drugtopics.modernmedicine.com/drug- topics/news/clinical/community-pharmacy/how-spot-and-handle-fake-rxs?page=full. Last updated 8/6/2007. Accessed 11/27/2015. 11. Medication and Counseling Treatment. Substance Abuse and Mental Health Service Administration. http://www.samhsa.gov/medication-assisted- treatment/treatment#medications-used-in-mat. Last updated 9/28/2015. Accessed 11/27/2015. 12. CNS depressants. National Institute on Drug Abuse. http://www.drugabuse.gov/publications/research-reports/prescription-drugs/cns-depressants. Last updated 11/2014. Accessed 11/27/2015. 13. Opioid Overdose. Substance Abuse and Mental Health Service Administration. http://www.samhsa.gov/medication-assisted-treatment/treatment/opioid-overdose. Last updated 9/25/2015. Accessed 11/25/2015. 14. Federal Guidelines for Opioid Treatment Programs. Substance Abuse and Mental Health Service Administration. http://store.samhsa.gov/shin/content//PEP15- FEDGUIDEOTP/PEP15-FEDGUIDEOTP.pdf. Last updated 3/2015. Accessed 11/27/2015. 15. Furlano, E. Naloxone’s Basic Benefit. http://www.emsworld.com/article/11625142/naloxone- use-by-emts. EMSWorld. Last updated 10/15/2014. Accessed 11/27/2015. 16. Nasal Spray Naloxone One Step Closer to Public Availability, National Institue on Drug Abuse. https://www.drugabuse.gov/news-events/news-releases/2015/06/nasal-spray- naloxone-one-step-closer-to-public-availability. Last updated 6/12/2015. Accessed 24
  25. 25. Reference 17. Kim D, Irwin KS, Khoshnood K. Expanded Access to Naloxone: Options for Critical Response to The Epidemic of Opioid Overdose Mortality. AM J Public Health. 2009 March;99(3): 402-407. 18. Overdose Prevention and Survival. The Drug Overdose Prevention and Education Project. http://harmreduction.org/wp-content/uploads/2012/02/dope-brochure-sept- 2010.pdf. Accessed 11/27/2015. 19. CVS to Sell Over-the-counter Narcan in 12 New States. http://www.ems1.com/ems- news/9948048-CVS-to-sell-over-the-counter-Narcan-in-12-new-states/ Last updated 9/30/2015. Accessed 11/27/2015. 20. CVS Set to Expand Drug Reversing Effect of Heroin Overdoses. http://www.nbcnews.com/nightly-news/video/cvs-set-to-expand-drug-reversing-effect- of-heroin-overdoses-533323331609. Last updated 9/27/2015. Accessed 11/27/2015. 21. Abuse-Deterrent Opioids – Evaluation and Labeling- Draft. U.S. Food and Drug Administration. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm 334807.htm. Accessed 11/27/2015. 22. Opioids with Abuse Deterrent Properties. http://www.empr.com/clinical-charts/opioids- with-abuse-deterrent-properties/article/333126/. Last updated 2/7/2014. Accessed 11/27/2015. 23. Opioid Overdose ToolKit. Substance Abuse and Mental Health Service Administration. https://store.samhsa.gov/shin/content/SMA13-4742/Overdose_Toolkit_2014_Jan.pdf. 25
  26. 26. Question? • Thank you! 26

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