intranasal naloxone delivery – clinical implications
TRANSCRIPT
Intranasal Naloxone Delivery – Clinical Implications
Lecture outline 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 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)
60 -75% of deaths occur in the home (Darke, et al. 1999)
Heroin Overdose
Some numbers related to Heroin IDU’s 70-80% have no intervention before death
(Darke et al., 1999)
60% of fatal ODs - someone else is present(Darke & Zador, 1996; Loxley & Davidson, 1998; McGregor et al., 1998)
70% death occurs >1 hour after injection(Darke et al., 1999)
Opiate Overdose
Nasal Opiate reversal agent Naloxone
Opiate Overdose
Nasal Opiate reversal agent Naloxone
Opiate OverdoseWhy these numbers matter in relationship to
today’s discussion 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 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
Naloxone has a strongeraffinity to the opioidreceptors than the heroin, soit knocks the heroin off thereceptors for a short timeand lets the person breatheagain.
Heroin
Naloxone
Opiatereceptor
My interest and involvement in intranasal naloxone
1980’s 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 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 Anyone can be trained quickly to deliver nasal naloxone Injection phobia eliminated - witnesses will deliver a nasal drug
Speed of delivery OD witness delivered IN naloxone saves lives / brain
Gentler awakening OD patient awakens less acutely, less intense (but still not pleasant)
Safety No needle stick risk – No risk of HIV, Hepatitis transmission
Costs Costs less than EMS activation, IV starts, hospital visit, etc
Optimizing absorption of IN drugs
Minimize volume - Maximize concentration 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 Use BOTH nostrils (doubles your absorptive surface area)
Use a delivery system that maximizes mucosal coverage and minimizes run-off.
Atomized particles across broad surface area
Critical Concept
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:
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 LMA-MAD 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:
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 supportKey Articles – Australia EMS
Kerr, Addiction 2009 (LMA-
MAD): 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 supportKey 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 Naloxone
Opiate Overdose epidemic, naloxone programs in USA
Nasal Opiate reversal agent Naloxone
Naloxone programs USA
MMWR article 2012 (data as of 2010) 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 Naloxone
Naloxone programs - police
Nasal Opiate reversal agent Naloxone
Naloxone programs - AustraliaExpanding 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 - AustraliaANEX 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 whoadminister it.”
Opiate Overdose
Nasal Opiate reversal agent Naloxone
Naloxone options
Options Advantages
“Disadvantages”
Single dose‐pre loaded‐syringe
Pre measured‐No add’lequipment
Cost (~$15 USD /dose)Fragile apparatusSingle dose
Intranasalatomizer
No needlesPremeasured
Cost (~15 USD /dose)Slightly less efficacySingle dose
Multi dose‐multi use‐10cc vial
Cost (~$0.27 /dose)Multiple doses
Need add’l needlesContamination issuesNeed 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 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 - ResponseNasal Opiate reversal agent - naloxone
Opiate Overdose - Response
Airway / Rescue Breathing - continue
Opiate Overdose - AftercareRecovery position
IN naloxone for opiate overdose – my insightsWhy not? Is there a downside? 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 overdosesEvery ambulance system, police agency and many clinics and families
with high risk patients should be utilizing this approach.
Adelaide Advertiser Dec 2010