Naxolone: What You Need to Know

Heather Taylor, PharmD, Consultant Pharmacist

Drug-related overdoses were the cause of 91,799 deaths in the Unites States in 2020. Of those, 68,630 were caused by opioids.1 Over 16,000 deaths were caused specifically by prescription opioids.2 In 2018, two million people were reported to have Opioid Use Disorder (OUD).3 The CDC defines OUD as “a problematic pattern of opioid use that causes significant impairment or distress. OUD is a treatable, chronic disease that can affect anyone – regardless of race, gender, income level, or social class. A diagnosis of OUD is based on specific criteria such as unsuccessful efforts to cut down or control use or use resulting in a failure to fulfill obligations at work, school, or home, among other criteria. It can even lead to overdose and death. In 2020, an estimated 2.7 million people ages 12 or older reported having an OUD”.4 Opioid use disorder is known to increase hospitalizations, and those with OUD who were hospitalized were more likely to die in the hospital or more likely to be readmitted within 30 days.5,6

In Florida, over 7,000 deaths reported were caused by a drug-related overdose in 2020.7 This was a 28% increase from years past.

Prescription drugs were more often the cause instead of illicit drugs. Fentanyl and benzodiazepines were the most found drugs, with fentanyl causing the most deaths.8 The increasing number of drug-related overdoses has prompted Florida leaders to take measures to ensure public safety. In 2016, House Bill 1241 was signed. It gave permission to pharmacists to dispense an emergency opioid antagonist with a non-patient specific standing order.9 Section 381.887 of the Florida Statutes allows pharmacists with a current active license who work in a pharmacy located in Florida to dispense Naloxone (IM, Sub Q and Nasal Spray) to emergency personnel without a prescription to be administered to persons exhibiting signs of opioid overdose.10 Senate Bill 544 amends 381.887 to allow Florida Pharmacists to dispense an emergency opioid antagonist without a prescription to patients and their caregivers who could use the treatment in a suspected overdose, and it was signed into law by Governor DeSantis in April 2022.11

Naloxone is an opioid antagonist. It works by attaching to opioid receptors and blocking and reversing the effects of opioids. Evidence suggests it works by competing with mu, kappa and sigma opiate receptor cites.12 Once administered, Naloxone works in the body for only 30-90 minutes. Because opioids remain in the body longer, multiple doses of Naloxone may need to be given. Withdrawal can occur after reversal in persons who are physically dependent on opioids, therefore 911 should be contacted immediately if an overdose is suspected and patients should be monitored after receiving Naloxone. Symptoms of withdrawal can include sweating, headache, nausea, vomiting, increased heart rate and changes in blood pressure. Naloxone will have no effect if administered to a patient without opioids in their system. Naloxone formulations include a Nasal Spray (Narcan®, Kloxxado®) and an Intramuscular, Intravenous and Subcutaneous injection. Intramuscular administration has a longer duration of action than Intravenous, however the onset of action is faster with intravenous administration when compared to intramuscular and subcutaneous formulations.13 The recommended dose for Naloxone injection is 0.4-2mg initially in adults. Doses may be repeated in intervals of 2-3 minutes up to 10mg. The recommended dose of Naloxone Nasal Spray is 1 spray which can also be repeated every 2-3 minutes in alternating nostrils until EMS arrives.14

The availability of Narcan may become more accessible in 2023. Emergent BioSolutions, the manufacturer for Narcan is seeking FDA approval to sell Narcan over the counter. Currently the application is reported to be fast tracked and a response is expected at the end of March.15

Death rate maps and graphs. CDC.gov, 2, June 2022, https://www.cdc.gov/drugoverdose/deaths/index.html

Overdose Death Rates. NIH.com, 20, January 2022, https://nida.nih.gov/research-topics/trends-statistics/overdose-death-rates

Substance Abuse and Mental Health Services Administration. 2018. https://www.samhsa.gov/sites/default/files/aatod_2018_final.pdf. Atlanta, GA: CDC; https://www.cdc.gov/drugoverdose/data/index.html. Accessed March 2019. [Google Scholar]

Opioid Use Disorder. CDC.gov, 30 August 2022, https://www.cdc.gov/dotw/opioid-use-disorder/index.html

, Ghertner R, Groves L. The Opioid Crisis and Economic Opportunity: Geographic and Economic Trends, Assistant Secretary of Policy and Analysis. Washington, DC: ASPE; 2018. [Google Scholar] Weiss A, Heslin KL, Barrett ML, Izar R, Bierman AS. Opioid-Related Inpatient Stays and Emergency Department Visits Among Patients 65 Years and Older, 2010 and 2015. Statistical Brief #244 HCUP Rockville, MD: AHRQ; 2018. [Google Scholar]

McCarthy D., Johnson M, Audet AM. Recasting readmissions by placing the hospital role in community context. JAMA. 2013;309(4):351–352. [PubMed] [Google Scholar] Ahmad FB, Cisewski JA, Rossen LM, Sutton P. Provisional drug overdose death counts. National Center for Health Statistics. 2023, https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm

Florida Medical Examiners.(2020) Drugs Identified in Deceased Persons by Florida Medical Examiners. Florida Department of Law Enforcement. https://www.fdle.state.fl.us/MEC/Publications-and-Forms/Documents/Drugs-inDeceased-Persons/2020-Annual-Drug-Report-FINAL.aspx

HB 1241: Ordering of Medication. Flsenate.gov, 1 July 2016, https://www.flsenate.gov/Session/Bill/2016/1241

10 Statewide Standing Order for Naloxone. Fla Statute 381.887 (2022) https://www.floridahealth.gov/licensing-and-regulation/ems-system/_documents/ standing-order-naloxone.pdf

11 CS/SB 544-Drug-related Overdose Prevention. 2022. https://www.flsenate.gov/Committees/BillSummaries/2022/html/2727

12 Naloxone. Drugs.com, 1 May 2022, https://www.drugs.com/pro/naloxone.html