Naloxone Statewide Standing Order Cheryl A. Viracola, PharmD Pharmacy Programs Manager, Community Care of Wake and Johnston Counties
Objectives Review the US & NC trends on opioid overdose Understand key elements of NC s statewide standing order for naloxone Identify patients at high risk of overdose and candidates for naloxone
Overdose Deaths in the US From 2000-2014, 500,000 drug overdose (OD) deaths Surpassed motor vehicle accidents - in 2014, ~ 1.5X more drug OD deaths vs deaths from MV crashes In 2014, opioids (Rx & heroin) were involved in 28,647 deaths, or 61% of all OD Rate of opioid OD has tripled since 2000. The 2014 data US opioid OD epidemic 2 trends a 15-year increase in overdose deaths involving prescription opioid pain relievers recent surge in illicit opioid overdose deaths, driven largely by heroin. 44 people in the US die EVERY DAY from an Rx opioid overdose (CDC) 78 people in the US die EVERY DAY from an OPIOID overdose MMWR - Increases in Drug and Opioid Overdose Deaths United States, 2000 2014 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6450a3.htm?s_cid=mm6450a3_w
Deaths per 100,000 population Death Rates* for Three Selected Causes of Injury, North Carolina, 1968-2014 40.0 35.0 Motor Vehicle Traffic (Unintentional) Drug Poisoning (All Intents) Firearm (All Intents) 30.0 25.0 20.0 15.0 10.0 5.0 0.0 1968 1970 1972 1974 1976 1978 1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014 Year *Per 100,00, age-adjusted to the 2000 U.S. Standard Population National Vital Statistics System, http://wonder.cdc.gov, multiple cause dataset Source: Death files, 1968-2014, CDC WONDER Analysis by Injury Epidemiology and Surveillance Unit 4
Number of deaths 1,400 1,200 1,000 800 Medication or Drug Overdose Deaths by Intent North Carolina Residents, 1999-2014 All intents Unintentional Self-inflicted Undetermined Assault 1,306 1,064 600 400 200 0 203 38 Source: N.C. State Center for Health Statistics, Vital Statistics-Deaths, 1999-2014 Analysis by Injury Epidemiology and Surveillance Unit Medication or drug overdose: X40-X44, X60-X64, Y10-Y14, X85 5
900 800 700 Substances Contributing to Medication or Drug Overdose Deaths North Carolina Residents, 1999-2014 Prescrip on Opioid Cocaine Heroin 684 Number of deaths 600 500 400 300 200 100 246 202 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 Source: N.C. State Center for Health Statistics, Vital Statistics-Deaths, 1999-2014 Analysis by Injury Epidemiology and Surveillance Unit 6
NC Heroin Deaths: 2008-2015* 300 250 200 554% increase from 2010 to 2014 179 246 174 150 147 100 63 75 76 50 37 0 2008 2009 2010 2011 2012 2013 2014 2015* Source: N.C. State Center for Health Statistics, Vital Statistics-Deaths, 2008-2015* *2015 data are provisional and likely increase as cases are finalized Analysis by Injury Epidemiology and Surveillance Unit 7
Heroin Hosp. and ED Overdoses: 2008-2014 1200 1,127 1000 800 From 2010 to 2014 a 429% increase for ED visits 643 600 474 400 200 213 252 213 76 75 58 311 101 122 195 0 2008 2009 2010 2011 2012 2013 2014 Source: N.C. State Center for Health Statistics, Vital Statistics-Hospital Discharge 2008-2013 NC DETECT- Statewide ED Visit data, 2008-2014 Analysis by Injury Epidemiology and Surveillance Unit ED Hosp
NC Statewide Standing Order This standing order signed by the North Carolina (N.C.) State Health Director authorizes any pharmacist practicing in the state of N.C. and licensed by the N.C. Board of Pharmacy to dispense the following Naloxone products to persons as directed below 9
Elements of the NC Statewide Standing Order Eligible candidates Naloxone products that can be dispensed under standing order Directions for use Refills: PRN Contraindications: A history of known hypersensitivity to Naloxone or any of its components Patient Education Notification of Participation Executed/signed standing order can be found on www.naloxonesaves.org
Naloxone: Pharmacology Opioid Naloxone Opioid receptor on brain
Naloxone: Basics Approved by the FDA in 1971 (available for lay use since 1996) No psychoactive effects No street value (because it causes withdrawal NOT EUPHORIA) No abuse potential : not known to produce tolerance or physical/psychological dependence Naloxone rarely has any effect on someone not taking opioids Not a controlled substance Administration routes IM & Intranasal routes : onset 3-5 minutes (give 2 nd dose if no response) PO (NOT absorbed - use as abuse deterrent) ; IV hospital, SC 12-18 month shelf life
Naloxone: Safety Well-established body of evidence of its safety and efficacy Adverse reactions are rare, however, when they occur they are often secondary to narcotic withdrawal (pain, sweating, agitation, etc) Typically occurs within minutes Subsides within two hours Other rare side effects include: Increased blood pressure and heart rate Arrhythmia Nasal Spray: premarketing trials showed transient hypertension, musculoskeletal pain, HA, nasal dryness/congestion/edema/inflammation
Naloxone: Duration of Action Anywhere from 30 to 120 minutes (shorter than many opioids) May not outlast effects of long-acting or ER opioids NOT meant to substitute going to the ED; it just buys more time AND helps prevents complications
Which Patients Are Eligible as Defined By Standing Order? Persons who voluntarily request Naloxone and are at risk of experiencing an opiate-related overdose, including, but not limited to: 1. Current/history of heroin or nonmedical opioid use 2. History of emergency medical care involving opioid poisoning/intoxication/overdose 3. Persons with a high dose opioid prescription >50 morphine mg equivalents (MME) per day 4. Persons with an opioid prescription and known or suspected concurrent alcohol use 5. Recent discharge from opioid detox or abstinence-based program
Which Patients Are Eligible as Defined By Standing Order (continued)? 6. Patients entering methadone maintenance treatment (addiction or pain) 7. Persons with opioid prescription and smoking/copd or other respiratory illness or obstruction 8.Persons with an opioid prescription who also suffer from renal dysfunction, hepatic disease, cardiac disease, HIV/AIDS 9. Persons who may have difficulty accessing emergency medical services 10.Persons enrolled in prescription lock in programs
Which Patients Are Eligible as Defined By Standing Order? Persons who voluntarily request Naloxone and are the family member or friend of a person at risk of experiencing an opiaterelated overdose. Persons who voluntarily request Naloxone and are in the position to assist a person at risk of experiencing an opiate-related overdose.
Which Other Patients Could Be Considered for Naloxone? Concurrent benzodiazepine prescription with opioid prescription Also sleep aids, muscle relaxants Multiple physicians and pharmacies Methadone Has been associated with disproportionate numbers of overdose deaths relative to the frequency with which it is prescribed for pain Involved in twice as many single-drug deaths as any other prescription opioid CDC Guideline for Prescribing Opioids for Chronic Pain United States, 2016 http://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm?s_cid=rr6501e1_w
Naloxone Just in Case Fairfield, Connecticut: 5 year old stepped (barefoot) on a fentanyl patch left on the kitchen floor. By the time he got emergency medical attention, it was too late, and he died of respiratory depression Burlington, NC: High School football player was sore after a Friday night game. Took his Grandma s methadone and died Pain medications are the single most frequent cause of pediatric fatalities reported to Poison Control. National Capitol Poison Center: http://www.poison.org/poison-statistics-national http://sports.yahoo.com/highschool/blog/prep_rally/post/north-carolina-high-school-qb-died-from-takingmethadone?urn=highschool,wp5836
Intramuscular Naloxone IM kits contents: 2 naloxone 0.4 mg/ml (1 ml) vials 2 IM syringes with alcohol swabs step-by-step instructions for responding to an opioid overdose directions for naloxone administration Gloves, mask optional Advantages: Least expensive option; NCHRC distributes Covered by most insurances Disadvantages: Some people not comfortable with giving injections
Intramuscular Naloxone Evzio Approved 4/3/14 Pre-filled auto-injector (IM/SC) Each Evzio contains a single dose of naloxone; do not reuse Each carton contains 2 autoinjectors Electronic voice instructions Advantages: Easy to use, instructions given Disadvantages: MOST expensive product NC Medicaid non-preferred Cannot be used with statewide standing order
Intranasal Naloxone (Generic) 2 mg/2ml prefilled syringes Requires nasal atomizer device for IN use Project Lazarus Kits/Generic IN Kits 2 naloxone 2 mg/2 ml prefilled syringes (filled by pharmacy and placed into kit) 2 atomizers Step-by-step instructions for responding to an opioid overdose Directions for naloxone administration Advantages: Needleless Slight cost advantage over branded IN product Disadvantages: Complex assembly procedure
Narcan Nasal Spray FDA approved 11/18/15, Released 2/26/16 Ready to go no assembly required 4mg dose 2x higher dose than generic IN formulation Advantages: Easy to use and no assembly required NC Medicaid Preferred as of 4/1/16 and many private/medicare Part D plans covering AWP $150 for 2 sprays Non-profit pricing $75 per 2 devices Disadvantages: Still somewhat expensive for uninsured
Patient Education Requirements For Standing Order Risk Factors Signs of an overdose Overdose Response Steps Naloxone administration education
CPESN Naloxone Service Set Dispense naloxone in accordance with the statewide North Carolina standing order, and provide the additional enhanced services: The pharmacist will talk with the patient about the aspects of their prescription medication and other substance use that increase their risk for overdose Utilization of the Controlled Substance Reporting System (As needed based upon the judgment of the pharmacist) Provide enhanced education to the patient and others on administration of naloxone Educate patients about safe opioid and benzodiazepine storage in the home Communicate with prescriber(s) and/or primary care provider to make them aware of naloxone dispensing As needed, participate in CPESN naloxone service set education provided by CCNC
Wake County
Johnston County
Medications Disposal Sites Wake County Holly Park Pharmacy 3004 Wake Forest Rd Raleigh, NC 27609 (919)-865-9993 Johnston County Beddingfield Drugs 95 Springbrook Ave Ste 101 Clayton, NC 27520 (919)-553-6224
Resources NC Specific Site for statewide standing order www.naloxonesaves.org College of Psychiatric and Neurologic Pharmacists www.cpnp.org/guideline/naloxone NC Board of Pharmacy FAQs, Standing Orders, Protocols http://www.ncbop.org/faqs/faqnaloxonegoodsamaritannchrc.p df Videos, ordering information, prescription forms, etc: www.prescribetoprevent.org NC Harm Reduction Coalition http://www.nchrc.org/
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