2/20/2017 NALOXONE PRESCRIPTIONS FOR OVERDOSE: OUTSIDE OF MISUSE AND ABUSE DISCLOSURES LEARNING OBJECTIVES

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1 NALOXONE PRESCRIPTIONS FOR OVERDOSE: OUTSIDE OF MISUSE AND ABUSE Brett Badgley Snodgrass FNP-C, CPE, FACPP, FAANP Consultant/Independent Contractor: McNeil Pharmaceuticals, Purdue Pharmaceuticals Speaker's Bureau: AstraZeneca, Depomed Pharmaceuticals, Iroko Pharmaceuticals DISCLOSURES LEARNING OBJECTIVES Explain the opioid crisis occurring in the United States List the patients at risk for potential opioid overdose Recognize the appropriate population to prescribe naloxone to, to prevent an opioid emergency 1

2 WHAT WE KNOW OPIOID MISUSE/ABUSE IS A MAJOR PUBLIC HEALTH PROBLEM Improper use of any opioid can result in serious AEs including overdose & death This risk can be greater w/ ER/LA opioids ER opioid dosage units contain more opioid than IR formulations Methadone is a potent opioid with a long, highly variable half-life In 2011, In 2010, 34.2 million Americans age 12 had used an opioid for nonmedical use some time in their life 425,247 ED visits involved nonmedical use of opioids Methadone involved in 30% of prescription opioid deaths SAMHSA. (2012). Results from the 2011 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-44, HHS Publication No. (SMA) Rockville, MD. SAMHSA. (2012). The DAWN Report: Highlights of the 2010 Drug Abuse Warning Network (DAWN) Findings on Drug-Related Emergency Department Visits. Rockville, MD. CDC. CDC Vital Signs. Prescription Painkiller Overdoses. Use and abuse of methadone as a painkiller FDA. Questions and Answers: FDA approves a Risk Evaluation and Mitigation Strategy for Extended-Release and Long-Acting Opioid Analgesics DEATH RATE BY ALL DRUG POISONING NOW GREATER THAN VEHICULAR COLLISIONS 6 Deaths per 100,000 People Motor Vehicle Collisions, Poisoning, Drug Poisoning, and Unintentional Drug Poisoning Death Rates: United States ( ) 1,2 Motor vehicle collisions All poisoning Drug poisoning Unintentional drug poisoning Leading Causes of Injury Deaths by Age Group Highlighting Unintentional Injury Deaths, United States MMWR.Vol. 62, No. 12, Quickstats. March 29,

3 U.S. PRESCRIPTION OPIOID-RELATED MORTALITY 7 Number of Deaths from Prescription Opioid Pain Relievers in the U.S., ,000 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 Source: CDC Wonder Total Female Male National Institute on Drug Abuse. Overdose Death Rates. Revised February PRESCRIPTION OPIOID MORTALITY 8 16,235 in ,893 in % increase ~ 52 people die from prescription opioids every day in the U.S. 2 deaths every hour Unintentional 83% 2 Intentional or Undetermined 17% 2 1 CDC. Number and age-adjusted rates of drug-poisoning deaths involivng opioid analgesics and heroin: United States, CDC Vital Signs. RATES OF RISK INCREASE CONCURRENTLY WITH DAILY DOSAGE OF OPIOIDS Dose and Risk of Overdose for Patients With Chronic Pain, by Study Hazard Ratio to <20 20 to <50 50 to < Daily Dose, Morphine-Equivalent mg Bohnert, et al Dunn, et al Studies show a dramatic increase in risk between 50 and 100 mg and a further increase with doses above 100 mg/day 1,2 This suggests many patients receiving opioids for chronic non-cancer pain at doses >50 mg/day are at increased risk for life-threatening OIRD and overdose OIRD=Opioid-Induced Respiratory Depression 1 Bohnert A, et al. JAMA. 2011;305: Dunn K, et al. Ann Intern Med. 2010;152:

4 HOW OPIOIDS WORK Most bind to mu-opioid receptors in the central and peripheral nervous system in an agonist manner to elicit analgesia 1 Have been used for thousands of years to treat acute and chronic pain 1 Are a mainstay of medical therapy used by millions of patients each year 2 OPIOIDS ARE EFFECTIVE ANALGESICS Neurotransmitter release Image adapted from Trescot A, et al. Pain Physician. 2008;11:S133-S153 1 Pathan H, Williams J. British Journal of Pain. 2012;6: Candiotti K. Use of opioid analgesics in pain management. Prescribe Responsibly website. Accessed 12/03/ Benefits Pain management 1 Acute Cancer Chronic Cough suppression 1 Treatment of dependence and abuse 2 BENEFITS AND RISKS OF OPIOIDS Adverse Effects 3 Constipation Nausea Vomiting Sedation Dizziness Physical dependence Tolerance Respiratory depression 1 Trescot A. Clinical uses of opioids. Pain Physician 2008: Opioid Special Issue: 11: S133-S153 2 Work Group on Substance Use Disorders. Practice guideline for the treatment of substance use disorders, 2 nd edition. Page 113. American Psychiatric Association Benyamin R, et al. Pain Physician. 2008;11(suppl 2):S105-S

5 OPIOID-INDUCED RESPIRATORY DEPRESSION Opioids binding to μ receptors in brainstem suppress chemoreceptor responses to hypercapnia. BLOCK CO 2 stimulates the respiratory drive. CO 2 levels signal the brainstem to increase the respiratory rate. Opioids block the CO 2 feedback loop. Breathing slows or stops. Self-potentiating cycle may result in life-threatening OIRD, associated hypoxemia, and/or respiratory arrest. OIRD=Opioid-Induced Respiratory Depression Adapted from Teater D. The Psychological and Physical Side Effects of Pain Medications. National Safety Council; Jungquist CR, et al. Pain Manag Nurs. 2011;12: OPIOID-INDUCED RESPIRATORY DEPRESSION (OIRD) Opioids depress a patient s respiratory drive 1 Characterized by a significantly reduced respiratory rate and tidal volume If prolonged, may result in hypoxemia Brain injury from apnea eventually leads to cardiac dysrhythmias, cardiac arrest, and death Opioid-induced sedation (CNS depression) generally precedes significant respiratory compromise 3 OIRD=Opioid-Induced Respiratory Depression; CNS=Central Nervous System 1. Pattinson KTS. Br J Anaesth. 2008;100: World Health Organization. Community Management of Opioid Overdose Geneva, Switzerland: WHO. 3. Trescot AM, Datta S, et al. Pain Physician. 2008;11(3):S133-S HOW NALOXONE WORKS 5

6 Naloxone ( N ) in the Brain opioid receptors activated by heroin and prescription opioids H opioids broken down and excreted O M H O M N N N Pain Relief Pleasure Reward Respiratory Depression Reversal of Respiratory Depression Opioid Withdrawal 16 WHO IS AT RISK BEYOND MISUSE AND ABUSE TAKING MEDICATIONS APPROPRIATELY BUT STILL AT INCREASE RISK Opioid Dependence Chronic Hepatitis or Cirrhosis 1 or more ER visits in past 6 mos Hospitalized 1 or more days in past 6 mos Use of ER/LA Opioid On Methadone Zedler et al (2015) Development of a Predictive Questionnaire for Prescription Opioid-Related Overdose or Respiratory/CNS Depression On Antidepressents, Bipolar or Schizophrenia Disorder Ever treated for Chronic Pulmonary Disease Chronic Kidney/Renal Disease 6

7 WHAT TO TEACH FAMILY AND FRIENDS RECOGNIZING AN OVERDOSE Unresponsiveness to yelling or stimulation, like rubbing your knuckles on breast bone Slow, shallow, or no breathing Turning pale, blue or gray (especially lips and fingernails) Choking sounds DO NOT put the individual in a bath They could drown. WHAT NOT TO DO DURING AN OVERDOSE DO NOT induce vomiting or give the individual something to eat or drink They could choke. DO NOT give over-the-counter drugs or vitamins (eg, No-Doz or niacin) They don t help and the patient could choke. 7

8 RESPONDING TO A SUSPECTED OPIOID OVERDOSE STEP 1 - RUB TO WAKE Rub your knuckles on the bony part of the chest (sternum) to try to get them to wake up and breathe. STEP 2 - GIVE NALOXONE Injectable: Give naloxone (discard any opened naloxone within 6 hours of using) Injectable naloxone: inject into the arm or upper outer top of thigh muscle 1cc at a time always start from a new vial Intranasal: Squirt half the vial into each nostril, pushing the applicator fast to make a fine mist. 8

9 STEP 3 - CALL 911 Tell them The address and where to find the person A person is not breathing When medics come tell them what drugs the person took if you know Tell them if you gave Naloxone AVAILABLE NALOXONE FORMULATIONS Naloxone for Medical Settings Vial and syringe for Injection Prefilled Glass Cartridges for Injection Take-Home Naloxone Naloxone Auto-injector Naloxone Nasal Spray Other Naloxone Option Intranasal (IN) Delivery Kit - Prefilled Cartridge for Injection adapted for IN Administration with Mucosal Atomizer 26 INJECTABLE NALOXONE PRODUCTS FOR MEDICAL SETTINGS Approved and Intended for Healthcare Professional Use Used for >40 years in hospital settings for the reversal of OIRD 1 1. Green TC. Addiction 2008;103(6):

10 TAKE-HOME NALOXONE Nasal Spray (naloxone HCl) Auto-injector (naloxone HCl injection) & Trainer for Practice 28 OTHER NALOXONE OPTION Not FDA approved as a combination product Not widely available in retail pharmacy settings Utilized mainly among harm reduction/needle exchange and select law-enforcement Requires assembly of multiple parts and substantial training (non-standardized kits and Intranasal (IN) Delivery Kit instructions for use) (glass cartridge, syringe and nasal atomizer) 1. Robinson, A Am J Health-Syst Pharm Vol 71 Dec 15, Barton ED, et al. J Emerg Med. 2005;29(3): COMPARISON OF ROUTES OF ADMINISTRATION BY PRE-HOSPITAL EMERGENCY CARE PROFESSIONALS Naloxone response (n=52) in Barton et al patients responded to IN kits No nasal abnormalities 9 did not respond to IN kits, but responded to IV rescue naloxone Nasal abnormalities present (n=5) Ŧ Ŧ Epistaxis, nasal mucus, nasal trauma, septal abnormality, intranasal damage (cocaine) No. Patients IM or IN >10 Respirations per minute % Requiring Additional Naloxone Kelly et 155 IM 82% 13% al. 2 IN 63% 26% Kerr et al IM 78% 4.5%* IN 72% 18%* *Statistically significant OR 4.8 (95% CI 1.4,16.3) after controlling for age, gender and suspected concomitant alcohol and/or drugs. IN=Intranasal; IM=Intramuscular 1. Barton et al. J Emerg Med (3): Kelly et al. Med J Aust (1): Kerr et al. Addiction (12):

11 IMPORTANCE OF AN OPIOID EMERGENCY PLAN Patients should be educated OIRD is a risk of opioid therapy Mistakes can happen during treatment Patients may witness an opioid emergency and could be in best position to help save their lives Family, friends or other caregivers should be prepared to respond Their role in adherence to opioid therapy How to recognize an opioid emergency How to respond and manage an opioid emergency, including the importance of seeking definitive emergency care and follow-up treatment Need for ongoing response preparation and practice Equip patients and caregivers with take-home naloxone 1 Evzio Trainer allows for ongoing practice and preparation with ability to expand network of those trained to respond to opioid emergencies OIRD=Opioid-Induced Respiratory Depression 1. AMA Task Force. Help Save Lives: Increase Access to Naloxone, Questions? Thank You! 11