NARCAN? YOU CAN!: A LEGISLATIVE & CLINICAL UPDATE ON NALOXONE

NARCAN? YOU CAN!: A LEGISLATIVE & CLINICAL UPDATE ON NALOXONE Stephanie Nichols, PharmD, BCPS, BCPP Associate Professor, Husson University Nicholss@husson.edu

Why did you become a pharmacy professional? To help people? To save lives?

What if you could provide a therapy that, when used, nearly always directly prevents a death? What if it helped against a disease that kills over one Mainer every single day?

400 350 Deaths 378 300 272 250 200 150 100 50 176 208 0 2013 2014 2015 2016 Deaths THIS IS AN EPIDEMIC. MAINE IS IN A CRISIS RIGHT NOW.

Narcan can be the difference between an early grave and an intervention that can put an addict on the path to recovery. - Sen. Cathy Breen Falmouth - http://www.pressherald.com/2016/04/20/lepage-vetoes-billaimed-at-increasing-access-to-heroin-anti-overdose-drug/

LEARNING OBJECTIVES 1. Compare addiction to other medical/psychiatric diseases and describe the harm reduction approach to Maine s opioid epidemic 2. Describe the mechanism of naloxone and its place in therapy 3. List the key components of LD 1547 4. Demonstrate appropriate and effective opioid overdose and naloxone use education to patients and caregivers

Compare addiction to other medical/psychiatric diseases and describe the harm reduction approach to Maine s opioid epidemic

Naloxone s role in the treatment of a person with an opioid use disorder is an example of which of the following approaches? A. Harm reduction B. Medication Assisted Therapy C. Substitution Therapy D. Psychotherapy

WHAT IF THE TREATMENT OF OTHER DISEASES MIMICKED THAT OF ADDICTION? Diabetes COPD and lung CA Skin CA

WHAT IS HARM REDUCTION? Strategy directed toward individuals or groups that aims to reduce the harms associated with certain behaviours accepts that a continuing level of drug use (both licit and illicit) in society is inevitable and defines objectives as reducing adverse consequences emphasizes the measurement of health, social and economic outcomes, as opposed to the measurement of drug consumption Canadian Pediatric Society - POSITION STATEMENT (AH 2008-01) - Harm reduction: An approach to reducing risky health behaviours in adolescents. Paediatr Child Health 2008;13(1):53-56.

WHAT ARE EXAMPLES OF HARM REDUCTION STRATEGIES? Clean needles & needle exchange programs Overdose education Education about available treatment Naloxone distribution

HARM REDUCTION WORKS

On January 23, 2015, the Indiana State Department of Health began investigating a cluster of 11 newly diagnosed HIV infections among residents of a small rural community in Scott County, where only 5 HIV infections had been diagnosed from 2004 through 2013. All 11 HIV-infected persons reported having injected the extendedrelease formulation of the prescription opioid oxymorphone. N Engl J Med 2016;375:229-39.

THE INDIANA CASE STUDY

Opioid overdose accounts for half of the mortality among heroin users. Naloxone distribution is endorsed by the American Medical Association, targeting those at high risk of witnessing or having an opioid overdose Coffin PO, Sullivan SD et al. Ann Int Med 2013;158:1-9.

Naloxone programs in the US (2010): 188 programs Trained 53,032 persons 10,171 overdose reversals When naloxone distribution is initiated, a substantial decrease in overdose deaths has been reported Coffin PO, Sullivan SD et al. Ann Int Med 2013;158:1-9.

OUD is a disease with a very high relapse rate 50% of users relapse over 5 years So is naloxone really effective then? Coffin PO, Sullivan SD et al. Ann Int Med 2013;158:1-9.

Naloxone distribution has been associated with empowerment and reduced HIV risk behaviors 20% of people who inject drugs enroll in treatment within 30 days of an overdose. 1. Lankenau SE, Wagner KD, Silva K, et al. J community Health 2013 Feb;38(1):133-2. Coffin PO, Sullivan SD. Ann Int Med 2013;158:1-9. 3. Pollini RA, McCAll L, Mehta SH, Vlahov D, Stathdee SA. Drug Alcohol Depend. 2006;83:104-10.

Naloxone distribution likely prevents 6.5% of all overdose deaths for every 20% of heroin users who are distributed naloxone and educated about opioid overdose response and care NNT 164 Coffin PO, Sullivan SD et al. Ann Int Med 2013;158:1-9.

Overdose mortality numbers have reportedly reduced by 37-90% with the introduction of naloxone distribution Coffin PO, Sullivan SD et al. Ann Int Med 2013;158:1-9.

IS THIS A COST EFFECTIVE INTERVENTION? Yes! Naloxone cost $438 per Quality Adjusted Life-Year Interventions that cost <$50,000 per QALY are generally considered cost effective Coffin PO, Sullivan SD et al. Ann Int Med 2013;158:1-9.

Describe the mechanism of naloxone and its place in therapy

Which of the following best describes the mechanism of naloxone? A. Mu opioid agonist (activator) B. Mu opioid partial agonist C. Mu opioid antagonist (blocker) D. Mu opioid transporter

NALOXONE - NARCAN Pure opioid antagonist Usually administered SQ, IM, or IV Not bioavailable PO/SL Can now be given via Intranasal route

SAMHS 2005

NALOXONE MOA Naloxone acts as a mu opioid antagonist Reverses opioid agonism both therapeutic and in excess (overdose) Somewhat dose dependent degree of reversal and dose necessary depends on specific opioid s mu affinity

NALOXONE PLACE IN THERAPY Naloxone will reverse many opioid overdoses when used promptly and correctly, and at an effective dose for the route administration Carfentanil Sufentanil Fentanyl Naloxone works best when a person has access to it at the time of overdose Patients at risk should receive a naloxone prescription ahead of time

SCOTLAND WAS THE 1 ST COUNTRY (IN 2011) WITH A NATIONAL PROGRAM TO PROVIDE NALOXONE

In 2015, 272 Mainers died of an opioid overdose 2016 is on track for 378 deaths more than one person every day

WHAT NALOXONE IS NOT Naloxone is not effective instead of medication assisted therapy Naloxone is not a cure for OUD Naloxone is not a get out of jail free card any more than an epi pen is.

Which of the following best describes the mechanism of naloxone? A. Mu opioid agonist (activator) B. Mu opioid partial agonist C. Mu opioid antagonist (blocker) D. Mu opioid transporter

List the key components of LD 1547

Which of the following entities must establish procedures and standards for authorizing pharmacists to dispense naloxone by July 1, 2017? A. Maine Board of Pharmacy B. Maine Pharmacy Association C. Maine Board of Substance Use Disorder Specialists D. Substance Abuse and Mental Health Services Department

H.P. 1054 - L.D. 1547 - AN ACT TO FACILITATE ACCESS TO NALOXONE A HCP may directly or by standing order prescribe naloxone and A pharmacist may dispense naloxone in accordance with protocols to an individual at risk of experiencing an opioidrelated drug overdose.

An individual may provide the naloxone to a family member to possess and administer to the individual if the family member believes in good faith that the individual is experiencing an opioid-related drug overdose. A HCP may directly or by standing order prescribe naloxone and A pharmacist may dispense naloxone in accordance with protocols to a member of an individual's immediate family or a friend of the individual or to another person in a position to assist the individual.

A HCP or a pharmacist, acting in good faith and with reasonable care, is immune from criminal and civil liability and is not subject to professional disciplinary action for storing, dispensing or prescribing naloxone in accordance with this section or for any outcome resulting from such actions.

The board shall establish procedures and standards for authorizing pharmacists to dispense naloxone. The Maine Board of Pharmacy shall adopt rules no later than July 1, 2017. The rules must establish adequate training requirements and protocols for dispensing naloxone by prescription drug order or standing order or pursuant to a collaborative practice agreement.

Demonstrate appropriate and effective opioid overdose and naloxone use education to patients and caregivers

During an educational session with your patient DG, regarding the use of naloxone, he asks about the need to call 911. What is the most appropriate instruction regarding 911 when a person is found not breathing and an opioid overdose is suspected? A. If the suspicion for an opioid overdose is high, and naloxone is administered, there is no need to call 911 B. Administer naloxone and call 911 immediately C. Call 911 after the person has responded to the naloxone therapy and is able t o speak D. Call 911 only if the person does not respond to naloxone therapy

SAFETY OF NALOXONE Adverse effects Opioid withdrawal signs/symptoms Tremor, headache, irritability, sweating That s it! Not an opioid overdose? Naloxone is safe to administer! No (non-opioid) drug interactions 911 must be called in addition to administration of naloxone Short half life Poly substances Other (cardiac, neurologic) causes for event

Intranasal Naloxone Kits

Kelly AM, Kerr D, Dietze P et al. Med J Aust. 2005; 182:24-7.

Kerr D, Kelly AM, Dietze P et al. Addiction. 2009; 104:2067-74

PHARMACOKINETICS Route Onset Duration Bioavailability Initial Dose Intravenous < 2 min 30 90 min 100% 0.4mg Intramuscular 5-8 min 60 120 min 35% 0.4 0.8mg Intranasal 8 13 min?? 4% At least 2mg (1mg each nostril) Oral/Sublingual n/a n/a <1% n/a 1. Kelly AM, Kerr D, Dietze P et al. Med J Aust. 2005; 182:24-7. 2. Kerr D, Kelly AM, Dietze P et al. Addiction. 2009; 104:2067-74

CLINICAL ADVANTAGES OF INTRANASAL NALOXONE NO NEEDLE Rapid onset of action similar to (but may be slightly slower than) IM Minimal training/education required

CLINICAL DISADVANTAGES OF INTRANASAL NALOXONE Caution with epistaxis, nasal anatomical abnormalities or inhaled drug use (ex. cocaine) A single dose may not be sufficient to reverse some overdoses Especially with heroin cut with fentanyl analogues Requires an adapter/atomizer (naloxone kit) ~$5 each Makeshift kit is not an FDA approved formulation IN is an approved route

Narcan NS

Under how to use NARCAN NASAL SPRAY VIDEO http://www.narcan.com/

DISTINCTIONS FROM THE NALOXONE KIT 4mg per dose rather than 2mg per dose FDA approved formulation Only one nostril required for administration No need to adapt from injectable form Reduces potential for error in a stressful situation

Evzio Autoinjector

Intramuscular naloxone Device includes a speaker that provides voice instructions to guide the user through the injection steps

Evzio video

PROPER USE Refer to patient leaflet for detailed information Each auto-injector contains one dose Inject into the muscle or skin of outer thigh (through clothing is ok if necessary) If child <1 yr, pinch the thigh muscle before administration Practice with the trainer provided in advance of an emergency The trainer has no needle and can be used as often as needed to assure success

http://www.evzio.com/pdfs/evzio-patient-information.pdf

STORAGE Store at room temperature in its outer case Occasionally check: The viewing window to assure the solution remains clear and particle free The expiration date Keep out of reach of children

To Dispense Naloxone

THANK YOU! Stephanie Nichols, PharmD BCPS BCPP Nicholss@Husson.edu