Download Narcan? You can! - Maine Pharmacy Association

NARCAN? YOU CAN!:
A LEGISLATIVE & CLINICAL UPDATE ON NALOXONE
Stephanie Nichols, PharmD, BCPS, BCPP
Associate Professor, Husson University
[email protected]
• 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?
Deaths
400
378
350
300
272
250
200
208
176
150
100
50
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.
B.
C.
D.
Harm reduction
Medication Assisted Therapy
Substitution Therapy
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):1332. 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.
• Naloxone’s role in the treatment of a
person with an opioid use disorder is an
example of which of the following
approaches?
A.
B.
C.
D.
Harm reduction
Medication Assisted Therapy
Substitution Therapy
Psychotherapy
Describe the mechanism of naloxone and its
place in therapy
• Which of the following best describes the
mechanism of naloxone?
A.
B.
C.
D.
Mu opioid agonist (activator)
Mu opioid partial agonist
Mu opioid antagonist (blocker)
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 1ST 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.
B.
C.
D.
Mu opioid agonist (activator)
Mu opioid partial agonist
Mu opioid antagonist (blocker)
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.
• 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
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
Oral/Sublingual
8 – 13 min
??
4%
At least 2mg
(1mg each
nostril)
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
NARCAN NASAL SPRAY
VIDEO
• Under “how to use”
• 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
• 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
To Dispense Naloxone
THANK YOU!
Stephanie Nichols, PharmD BCPS BCPP
[email protected]