Narcan nasal spray FINAL
Published on: Mar 3, 2016
Transcripts - Narcan nasal spray FINAL
NARCAN NASAL SPRAY
FOR OPIOID OVERDOSE.
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
• 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.
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
• 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.
• Opioids are painkillers.
• Example: hydrocodone, oxycodone, morphine, codeine,
heroin, hydromorphone, methadone, fentanyl, etc.
• Bind to opioid receptors in brains, spinal cords, different
• 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.
Opioid side effects 4,5,6,7
Opioid dependence vs opioid addiction8
• Central adaptations in brain when opioids are taken chronically.
• 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
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?
Treatments for opioid dependence11
• Goal: relieve withdrawal symptoms and
• Treatment options:
• Maybe safe to take for even lifetime.
• Do not discontinue without consulting your doctor.
• If taken as instructed, opioids is safe and effective to
• 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:
• Drowsy antihistamines.
• 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
• Illegal opioid overdose (heroin, opium.)
• Recreational use:
• Example: Oxycontin extended releases.
Recognizing signs of opioid overdose can help
• 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.
• Respiratory depression.
• Low blood pressure and/or low heart rate.
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.
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
• People can now use an approved formulation of
Narcan rescue kit18
How does it apply to pharmacy
• Naloxone is one of the life-saving medications for
• 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.
• Narcan standing order.
• CVS is expanding the sale of Naloxone over-the-counter in
12 more state besides Massachusetts and Rhode Island.
Naloxone rescue kits
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
• 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
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.
• Physical or chemical barriers.
• Agonist + antagonist combination.
• Delivery system.
• Combination of methods listed above.
• 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.
• Monitoring for side-effects.
• Expand prescription drug monitoring programs to multi-
• 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.
1. FDA Moves Quickly to Approve Easy-to-use Nasal Spray to Treat Opioid
Overdose. U.S. Food and Drug Administration.
3505. Last updated 11/19/2015. Accessed 11/27/2015.
2. Narcan Approval History. http://www.drugs.com/history/narcan.html.
3. What Are Opioids? National Institute on Drug Abuse.
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):
5. DiPiro, JT, Talbert RL, Yee, GC, et al. Opioid. In: Pharmacotherapy: A
Pathaophysiology Approach. 9e. United States: McGraw-Hill Education;
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
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-
updated 8/6/2007. Accessed 11/27/2015.
11. Medication and Counseling Treatment. Substance Abuse and Mental Health Service
treatment/treatment#medications-used-in-mat. Last updated 9/28/2015. Accessed
12. CNS depressants. National Institute on Drug Abuse.
Last updated 11/2014. Accessed 11/27/2015.
13. Opioid Overdose. Substance Abuse and Mental Health Service Administration.
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
naloxone-one-step-closer-to-public-availability. Last updated 6/12/2015. Accessed
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
18. Overdose Prevention and Survival. The Drug Overdose Prevention and Education
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.
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
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
23. Opioid Overdose ToolKit. Substance Abuse and Mental Health Service Administration.
• Thank you!