Download Wolfe - Intranasal naloxone in safe injection setting

Intranasal Naloxone Delivery –
Clinical Implications
Lecture outline
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The epidemic of opiate overdoses
Nasal naloxone: What is it?
Optimizing nasal naloxone – general concepts
2 cases – Ambulance, Lay person delivered
Literature support for intranasal naloxone
Lay person delivered naloxone – life saving,
empowering
 How to effectively delivery nasal naloxone
Heroin Overdose
Some numbers related to Heroin IDU’s
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Approximately 50% have experienced an
overdose
Approximately 90% have witnessed an OD
In only 50-60% of ODs is an ambulance is called
(Burris et al., 2000; Darke, Ross & Hall et al., 1996)
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60 -75% of deaths occur in the home
(Darke, et al. 1999)
Heroin Overdose
Some numbers related to Heroin IDU’s
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70-80% have no intervention before death
(Darke et al., 1999)
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60% of fatal ODs - someone else is present
(Darke & Zador, 1996; Loxley & Davidson, 1998; McGregor et al., 1998)
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70% death occurs >1 hour after injection
(Darke et al., 1999)
Opiate Overdose
Nasal Opiate reversal agent
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Naloxone
Opiate Overdose
Nasal Opiate reversal agent
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Naloxone
Opiate Overdose
Why these numbers matter in relationship to
today’s discussion
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Most heroin overdoses are witnessed and
reversible but due to legal fears – little
intervention is instituted
There is also an epidemic (especially in my
country, but increasingly here as well) related to
accidental prescription opiate overdoses
There is time to intervene if an easy, effective
intervention is instituted in the public domain.
Opiate Overdose
Why these numbers matter in relationship to
today’s discussion
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An antidote DOES exist that is safe, has no
addiction potential, and can be administered by
lay persons
Antidote delivery saves lives, is more palatable
to witnesses than calling for help, and empowers
the users to help themselves (actually leading to
LESS use of heroin)
What is the antidote?
Naloxone
Naloxone – mechanism of action
 Displaces heroin (any opiate) off the receptor
Heroin
Naloxone
Opiate
receptor
Naloxone has a stronger
affinity to the opioid
receptors than the heroin, so
it knocks the heroin off the
receptors for a short time
and lets the person breathe
again.
My interest and involvement in
intranasal naloxone
1980’s
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Trained at an inner city medically under-served hospital.
Large heroin user population, frequent OD’s, difficult IV access, onset
of HIV epidemic with huge fear involved in the prehospital and ER
community.
I began sublingual and intralingual injections – worked well but still a
needle
1990’s
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Began experimenting with nasal drug delivery for patients
Designed first clinical trial on IN naloxone, recruited Dr. Erik Barton to
conduct the trial (published in 2002).
Began using IN naloxone in our prehospital system 1999
My interest and involvement in
intranasal naloxone
2000’s
 Introduced the concept and data to Harm Reduction group
in New Mexico who adapted immediately.
 Presented the concept at the U.S National Harm Reduction
conference – a seed was planted for lay person use.
 Convinced many other Ambulance agencies in US to adopt
the strategy
 Advised Project Lazarus, NYC, Boston, Melbourne, etc
regarding the concept.
Why do I think nasal naloxone
delivery is important to this audience?
Ease of delivery and empowerment of bystanders
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Anyone can be trained quickly to deliver nasal naloxone
Injection phobia eliminated - witnesses will deliver a nasal drug
Speed of delivery
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OD witness delivered IN naloxone saves lives / brain
Gentler awakening
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OD patient awakens less acutely, less intense (but still not pleasant)
Safety
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No needle stick risk – No risk of HIV, Hepatitis transmission
Costs
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Costs less than EMS activation, IV starts, hospital visit, etc
Optimizing absorption of IN
drugs
Critical
Minimize volume - Maximize concentration Concept
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0.2 to 0.3 ml per nostril ideal, 1 ml is maximum
Most potent (highly concentrated) drug should be used
Maximize total absorptive mucosal surface area
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Use BOTH nostrils (doubles your absorptive surface area)
Use a delivery system that maximizes mucosal
coverage and minimizes run-off.
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Atomized particles across broad surface area
Dropper vs Atomizer
Absorption
 Drops = runs down to
pharynx and swallowed
 Atomizer = sticks to broad
mucosal surface and absorbs
Usability / acceptance
 Drops = Minutes to give,
cooperative patient, head
position required
 Atomizer = seconds to
deliver, better accepted
Opiate Overdose Cases
Case: Heroin
Overdose
The ambulance responds to an unconscious, barely breathing
patient with obvious intravenous needle marks on both arms –
the case is consistent with heroin overdose
 An intramuscular dose of naloxone (Narcan) is administered
and the patient is successfully resuscitated.
 Unfortunately, the medic suffers a contaminated needle stick
after providing the intramuscular injection.
 The patient admits to being infected with both HIV and
hepatitis C. He remains alert for 2 hours with no further
therapy in the ED and is discharged.
Case: Heroin Overdose
 The medic now needs treatment - HIV prophylaxis
 The next few months will be difficult for him:
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Side effects that accompany HIV medications
Personal life is in turmoil due to issues of safe sex with
his spouse
Mental anguish of waiting to see if he develops HIV or
hepatitis C.
 He wonders why his system is not using the LMAMAD nasal to deliver naloxone on all these patients.
Case: Methadone
induced coma
A mother enters her daughters room to find her unconscious,
barely breathing, blue color. Since her daughter is on
methadone maintenance, the family was trained to deliver
rescue naloxone (see photo of kit above).
 The mother quickly delivers the naloxone intranasally.
 She provides 2-3 minutes of rescue breathing until her
daughter begins to arouse. She gradually awakens over 10
minutes.
 The patient is transferred to the emergency room for
observation due to the long half life of methadone, but makes
an uneventful recovery.
Opiate overdose –
Literature support
Intranasal naloxone literature
 Barton 02, 05; Kelly 05; Robertson 09; Kerr 09; Merlin 2010;
Doe Simkins 09; Walley 12:
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IN naloxone is at least 80-90% effective at reversing opiate
overdose
When compared directly it is equivalent in time of onset and in
efficacy to IV or IM therapy.
IN naloxone results in less agitation upon arousal
IN naloxone is lay person approved in many places. It is safe, has
saved many lives and reduces medical resource consumption
Nasal Naloxone Literature support
Key Articles – Australia EMS
 Kerr, Addiction 2009 (LMAMAD): IN naloxone is as effective
and as fast as IM naloxone at
waking patients up with opiate
overdose – but there is NO risk of
contaminated needle stick and
anyone can deliver the nasal drug
with minimal training.
Nasal Naloxone Literature support
Key Articles – Layperson
administered treatment
 Doe-Simpkins, Am J Public
Health 2009 (LMA-MAD): IN
naloxone is safe and effective
when delivered by laypersons
who are present when a patient
overdoses.
Lay person administered
naloxone programs
The data are compelling
Opiate Overdose
Nasal Opiate reversal agent
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Naloxone
Opiate Overdose epidemic,
naloxone programs in USA
Nasal Opiate reversal agent
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Naloxone
Naloxone programs USA
MMWR article 2012 (data as of 2010)
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53,000 individual trained to use naloxone
10,000 rescues reported
Most programs are combined with needle
exchange
As of 2010 87% distributed injectable
naloxone, 8.5% nasal, rest either
Opiate Overdose
Nasal Opiate reversal agent
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Naloxone
Naloxone programs - police
Nasal Opiate reversal agent
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Naloxone
Naloxone programs - Australia
Expanding Naloxone Availability in the ACT
“As a community we should be promoting interventions that
can save lives, regardless of people’s backgrounds. Naloxone
can reverse the potentially fatal effects of an overdose, but it
needs to be given within minutes of an overdose occurring,
which is why it makes sense to give it to people who may
witness an overdose.”
said Carrie Fowlie, Executive Officer of the peak body the Alcohol Tobaccoand Other Drug
Association ACT (ATODA).
Naloxone programs - Australia
ANEX Australia – Position statement
“Regulatory barriers in Australia need to be removed in order to
allow non-medical personnel, including families of opiate users,
access to Naloxone so that they may have access to this effective
intervention to better respond to an overdose immediately.”
“steps should immediately taken to have Naloxone rescheduled
to make it available across the counter in pharmacies. Legal
protection should be provided to non-medical personnel who
administer it.”
Opiate Overdose
Nasal Opiate reversal agent
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Naloxone
Naloxone options
Options
Advantages
“Disadvantages”
Single‐dose Pre‐measured
pre‐loaded No add’l
syringe
equipment
Cost (~$15 USD /dose)
Fragile apparatus
Single dose
Intranasal
atomizer
No needles
Premeasured
Cost (~15 USD /dose)
Slightly less efficacy
Single dose
Multi‐dose
multi‐use
10cc vial
Cost (~$0.27
Need add’l needles
/dose)
Contamination issues
Multiple doses Need to measure a dose in
stressful setting – error
potential
Sarz Maxwell
Nasal Naloxone – How to do it
Nasal Opiate
Naloxone training for lay public
Components of Training
1. What is an overdose?
2. What causes an overdose?
3. Prevention messages
4. Recognition
5. Response
6. Aftercare
7. Follow‐up and refills
Opiate Overdose - Recognition
Nasal Opiate reversal agent
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Naloxone
Opiate
Overdose Response
Opiate Overdose - Response
Stimulation - Sternal Rub
Opiate Overdose - Response
Call for help
Opiate Overdose - Response
Airway / Rescue Breathing
Opiate Overdose - Response
Nasal Opiate reversal agent - naloxone
Opiate Overdose - Response
Nasal Opiate reversal agent - naloxone
Opiate Overdose - Response
Airway / Rescue Breathing - continue
Opiate Overdose - Aftercare
Recovery position
IN naloxone for opiate
overdose – my insights
Why not? Is there a downside?
Adelaide Advertiser Dec 2010
 Elimination of needle eliminates needle stick risk to provider
 They awaken more gently than with injected naloxone
 New epidemiology shows prescription drugs (methadone, etc)
are causing many deaths that naloxone at home could reverse.
 Simple enough that lay public can administer and not even call
ambulance in many settings
 Empowers the users leading to LESS overdoses
Every ambulance system, police agency and many clinics and
families with high risk patients should be utilizing this
approach.
Questions?
Educational Web site:
 www.intranasal.net