1. Narcan? You can!: A Legislative & Clinical Update on naloxone
Stephanie Nichols, PharmD, BCPS, BCPP
Associate Professor, Husson University

2. “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
aimed-at-increasing-access-to-heroin-anti-overdose-drug/

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

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

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

6. What if the treatment of other diseases mimicked that of addiction?
Diabetes
COPD and lung CA
Skin CA

7. 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 ) - Harm reduction: An approach to reducing risky health behaviours in adolescents. Paediatr Child Health 2008;13(1):53-56.

8. What are examples of harm reduction strategies?
Clean needles & needle exchange programs
Overdose education
Education about available treatment
Naloxone distribution

9. Harm Reduction Works…

10. “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 through All 11 HIV-infected persons reported having injected the extended- release formulation of the prescription opioid oxymorphone.”
N Engl J Med 2016;375:

11. The Indiana Case Study

12. Describe the mechanism of naloxone and its place in therapy

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

14. Naloxone - Narcan Pure opioid antagonist
Usually administered SQ, IM, or IV
Not bioavailable PO/SL
Can now be given via Intranasal route

15. SAMHS 2005

16. 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

17. 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

18. Scotland was the 1st country (in 2011) with a national program to provide naloxone

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

21. 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.

22. List the key components of LD 1547

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

25. 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 opioid- related drug overdose.

26. 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.

27. 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.

28. 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.

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

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

31. 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

32. Intranasal Naloxone Kits

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

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

38. At least 2mg (1mg each nostril)
Pharmacokinetics
Route
Onset
Duration
Bio-availability
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
<1%
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:

39. Clinical Advantages of Intranasal Naloxone
NO NEEDLE
Rapid onset of action – similar to (but may be slightly slower than) IM
Minimal training/education required

40. 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

41. Narcan NS

46. 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

47. Evzio Autoinjector

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

50. 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

57. 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

59. To Dispense Naloxone

60. Stephanie Nichols Nicholss@Husson.edu
Thank you!
Stephanie Nichols