Overdose Education and Naloxone
Rescue in Massachusetts
Alexander Y. Walley, MD, MSc
Assistant Professor of Medicine
Boston University School of Medicine
Medical Director, Opioid Overdose Prevention Pilot, Massachusetts
Department of Public Health
Cross-System Response to the Opioid Epidemic
Monday, November 12, 2012
Disclosures – A Walley
•
The following personal financial relationships with
commercial interests relevant to this presentation
existed during the past 12 months:
– None to disclose
•
My presentation will include discussion of “off-label” use
of the following:
– Naloxone is FDA approved as an opioid antagonist
– Naloxone delivered as an intranasal spray with a mucosal
atomizer device has not been FDA approved and is off label
use
•
Funding: CDC National Center for Injury Prevention and
Control 1R21CE001602-01
More Opioid Overdose Deaths than MVA
Deaths in Massachusetts
1200
Deaths per year
1000
Poisoning Deaths vs. Motor Vehicle-Related Injury Deaths,
MA Residents (1997-2008)
800
600
400
200
0
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
All Poisoning Deaths
Motor Vehicle-Related Injury Deaths
The source of the data is: Registry of Vital Records and Statistics, MA Department of Public Health
More Opioid Overdose Deaths than MVA
Deaths in Massachusetts
1200
Deaths per year
1000
Poisoning Deaths vs. Motor Vehicle-Related Injury Deaths,
MA Residents (1997-2008)
800
600
400
200
0
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
All Poisoning Deaths
Opioid-related Poisoning Deaths
Motor Vehicle-Related Injury Deaths
Rate of opioid-related fatal overdoses in MA in 2006 was 9.9 per 100K
The source of the data is: Registry of Vital Records and Statistics, MA Department of Public Health
Strategies to address overdose
• Prescription monitoring programs
– Paulozzi et al. Pain Medicine 2011
• Prescription drug take back events
• Safe opioid prescribing education
– Albert et al. Pain Medicine 2011; 12: S77-S85
• Expansion of opioid agonist treatment
– Clausen et al. Addiction 2009:104;1356-62
• Safe injection facilities
– Marshall et al. Lancet 2011:377;1429-37
Rationale for bystander overdose
education and naloxone distribution
• Most opioid users do not use alone
• Known risk factors:
– polydrug, abstinence, using alone, unknown source
• Opportunity window:
– opioid OD takes minutes to hours and is reversible
with naloxone
• Bystanders are trainable to recognize OD
• Fear of public safety
The Massachusetts OEND
model
Standing order
Intranasal naloxone
Massachusetts OEND pilot:
Standing order model
•
•
Pilot program conducted under state Drug
Control Program regulations (M.G.L. c.94C &
105 CMR 700.000)
Medical Director issues standing order for
distribution to potential bystanders
–
•
Traditional prescription not needed
Naloxone distributed by public health workers
who are trained, but nonmedical staff
–
>> access to populations at highest risk
OEND Program Components Massachusetts
• Community program staff enroll, train and
distribute naloxone
• Kit includes 2 doses and instructions
• Curriculum delivers education on OD prevention,
recognition, and response
• Referral to treatment available
• Reports on overdose rescues are collected
when enrollees return for refills
• Each overdose report reviewed by data
committee
Staff Training and Support
Staff complete:
• 4 hour didactic training
• knowledge test
• At least 2 supervised bystander training
sessions
Sites participate in:
• Quarterly all-site meetings
• Monthly adverse event phone conferences
Intranasal Administration
Pro
• 1st line for some local EMS
• RCTs: slower onset of action
but milder withdrawal
• Acceptable to non-users
• No needle stick risk
• No disposal concerns
Con
• Not FDA approved
• No large RCT
• Assembly required, subject to
breakage
• High cost:
– $40+ per kit
• Insurance does not typically
cover the atomizer
• Subject to shortage
Scope of OEND in
Massachusetts
Enrollments and Rescues:
2006-2012
• Enrollments
– >15K individuals
– 300 per month
•
•
•
•
•
•
•
•
•
•
•
•
•
•
AIDS Project Worcester
AIDS Support Group of Cape Cod
Brockton Area Multi-Services Inc. (BAMSI)
Bay State Community Services
Boston Public Health Commission
CAB Health and Recovery
Cambridge Cares About AIDS
Greater Lawrence Family Health Center
Holyoke Health Center
Learn to Cope
Lowell Community Health Center
Seven Hills Behavioral Health
Tapestry Health
SPHERE
• Rescues
– >1500 reported
– 30 per month
Enrollment locations: 2008-2012
Using, In Treatment, or In Recovery
Non Users (family, friends, staff)
Detox
Syringe Access
Drop-In Center
Community Meeting
Other SA Treatment
Methadone Clinic
Inpatient/ ED/ Outpatient
Home Visit/ Shelter/ Street Outreach
0
500
1,000
1,500
2,000
2,500
3,000
3,500
Number enrolled
Program data
Data from people with location reported: Users: 7,220 Non-Users: 3,522
Other venues
• First responder OEND
– Quincy, Revere, Gloucester
– Boston Police Academy e-training module
• Emergency Department (ED) SBIRT
• Post-incarceration
• Prescription naloxone
– Prescribetoprevent.org
OEND program rescues: 2006-2012
911 called or public safety
present
Rescue breathing performed
Stayed until alert or help arrived
Active use, In
treatment, In
recovery
N=1004
Non-User
(Family, friend,
staff)
N=108
29%
64%
33%
90%
33%
91%
Program data
Adverse Events:
Sept 2006- Jan 2012
OD Reports
N=1346
Deaths
7 / 1346
0.5%
OD requiring 3 or more doses
52 / 1226
4%
Recurrent overdose
1/1346
0.1%
Precipitated withdrawal
4/1346
0.3%
Difficulty with device
7/1346
0.7%
Negative interactions with public safety
82 / 332
25%
158 / 3594
4%
Confiscations
Program data
Impact of OEND on overdose
rates in Massachusetts
Opioid Overdose Related Deaths: Massachusetts
2004 - 2006
OEND programs
2006-07
2007-08
2009
Towns without
Number of Deaths
No Deaths
1-5
6 - 15
16 - 30
30+
INPEDE OD
(Intranasal Naloxone and Prevention
EDucation’s Effect on OverDose)
Study
Objective:
Determine the impact of opioid overdose education with
intranasal naloxone distribution (OEND) programs on
fatal and non-fatal opioid overdose rates in
Massachusetts
Supported: Center for Disease Control and Prevention 1R21CE001602
Design, population and setting
• Design:
– Quasi-experimental interrupted time series
• Population:
– 19 Massachusetts cities and towns with 5 or more
opioid-related unintentional or undetermined poison
deaths in each year from 2004-2006
• Setting:
– MA OEND programs were implemented by 8
community-based programs starting in 2006
Fatal opioid OD rates by OEND
implementation: 2002-09
•
Compared to towns in years when there was no OEND enrollment, the rate of
overdose deaths was
•
•
27% lower in towns in years when 1-100 people per 100K were enrolled
50% lower in towns in years when >100 people per 100K were enrolled
•
Rates were adjusted for age, gender, race/ethnicity, poverty level, detox
treatment slots, methadone slots, state-funded buprenorphine slots,
prescriptions to doctor-shoppers, and year
•
Total OEND enrollments through 2006-09 in 19 selected towns: 2912
Under review
Opioid-related ED visits and
hospitalization rates by OEND
implementation: 2002-09
•
Compared to towns in years when there was no OEND enrollment, the rate of
overdose ED visits and hospitalizations was
•
Not significantly different for towns in years with OEND enrollment
•
Rates were adjusted for age, gender, race/ethnicity, poverty level, detox
treatment slots, methadone slots, state-funded buprenorphine slots,
prescriptions to doctor-shoppers, and year
•
Total OEND enrollments through 2006-09 in 19 selected towns: 2912
Under review
INPEDE OD Study Summary
1. Fatal OD rates were decreased in MA citiestowns where OEND was implemented and the
more enrollment the lower the reduction
2. No clear impact on acute care utilization
Implication
• Naloxone should be made more widely
available to trained laypersons in an effort
to reduce deaths due to opioid overdose
Considerations
• Intranasal works and is popular
– It could be improved with a one-step, affordable
FDA-approved intranasal delivery device
• Nonmedical community health workers provide
effective OEND
– Broad dissemination to high risk groups and their
families
– Facilitated by state-supported standing order
• Prescription status is a barrier
• Fear of police is a barrier to help seeking
– Good Samaritan laws would address in part
Next steps for policy
• Expand number of sites and venues
• Good Samaritan law for bystanders
– Passed in August of 2012
• Liability protection for prescribers
– Passed in August of 2012
• Target incarcerated and ED patients
• Facilitate co-prescription of naloxone with
chronic pain medication
Passed in August 2012:
An Act Relative to Sentencing and Improving Law
Enforcement Tools
Good Samaritan provision:
•Protects people who overdose or seek help for someone overdosing from being charged
or prosecuted for drug possession
–
Protection does not extend to trafficking or distribution charges
Patient protection:
•A person acting in good faith may receive a naloxone prescription, possess naloxone
and administer naloxone to an individual appearing to experience an opiate-related
overdose.
Prescriber protection:
•Naloxone or other opioid antagonist may lawfully be prescribed and dispensed to a
person at risk of experiencing an opiate-related overdose or a family member, friend or
other person in a position to assist a person at risk of experiencing an opiate-related
overdose. For purposes of this chapter and chapter 112, any such prescription shall be
regarded as being issued for a legitimate medical purpose in the usual course of
professional practice.
Incorporating overdose education
and naloxone rescue kits into
medical and addiciton practice
1. Prescribe naloxone rescue kits
•
PrescribeToPrevent.org
2. Work with your OEND program
Challenges for
Opportunities for
community programs prescription naloxone
• Naloxone cost is
increasing, funding for is
minimal
• Co-prescribe naloxone
with opioids for pain
• Co-prescribe with
methadone/
• Missing people who don’t
buprenorphine for
identify as drug users, but
addiction
have high risk
• Missing people who may • Insurance should fund this
• Increase patient, provider
periodically misuse
& pharmacist awareness
opioids=no tolerance
• Universalize overdose risk
Overdose Education in Medical
Settings
• Where is the patient at as far as overdose?
– Ask your patients whether they have overdosed, witnessed an overdose or
received training to prevent, recognize, or respond to an overdose
• Overdose history:
1. Have you ever overdosed?
1.
2.
What were you taking?
How did you survive?
2. What strategies do you use to protect yourself from overdose?
3. How many overdoses have you witnessed an overdose?
1.
2.
Were any fatal?
What did you do?
4. What is your plan if you witness an overdose in the future?
1.
2.
Have you received a narcan rescue kit?
Do you feel comfortable using it?
Overdose Education in Medical
Settings
What they need to know:
1.Prevention - the risks:
–
–
–
–
–
–
Mixing substances
Abstinence- low tolerance
Using alone
Unknown source
Chronic medical disease
Long acting opioids last longer
2.Recognition
– Unresponsive to sternal rub with slowed breathing
– Blue lips, pinpoint pupils
3.Response - What to do
•
•
•
•
Call for help
Rescue breathe
Deliver naloxone and wait 3-5 minutes
Stay until help arrives
Practical Barriers to Prescribing
Naloxone
1.
2.
3.
Prescriber knowledge and comfort
How to write the prescription?
Does the pharmacy stock rescue kits?
•
•
4.
Rescue IN kit with MAD?
Rescue IM kit with needle?
Who pays for it?
•
•
•
Insurance in Massachusetts covers naloxone, but not the
atomizer
The MAD costs $2.50 each
Work with your pharmacy to see if they will cover it
Thank you! awalley@bu.edu
MA DPH
• John Auerbach
• Andy Epstein
• Holly Hackman
• Michael Botticelli
• Kevin Cranston
• Dawn Fakuda
• Sarah Ruiz
• Barry Callis
• Grant Carrow
• Len Young
• Kyle Marshall
• Office of HIV/AIDS
• Bureau of Substance Abuse
Services
RTI – Alex Kral
BU/BMC
• Maya Doe-Simkins
• Amy Alawad
• Ziming Xuan
• Al Ozonoff
• Emily Quinn
• Gregory Patts
• Chris Chaisson
• Jeffrey Samet
• Peter Moyer
• Ed Bernstein
BPHC
• Adam Butler
Program sites, staff and participants
NOPE group
Prescription Directions
• Dispense: One naloxone rescue kit
– 2 prefilled syringes with 2mg/2ml naloxone
– 2 mucosal atomizer devices
– Risk factor info and assembly directions
• Directions: For suspected opioid overdose,
spray 1ml in each nostril. Repeat after 3
minutes if no or minimal response- include
infosheet
• Refills: None
Enrollee characteristics: 2006-2012
Active use, In
treatment, In
recovery
N=8476
Non-User
(Family, friend,
staff)
n=4079
Witnessed overdose ever
75%
43%
Lifetime history of overdose
Received naloxone ever
50%
44%
Inpatient detox, past year
Incarcerated, past year
65%
28%
Reported OD reversal
7.5%
2.1%
Program data
Enrollee past 30 day use: 2006-2012
Daily
Intermittent
Percent using
100
80
60
40
20
Su
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on
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Al
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ar
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Be
Po
ly
su
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Data only from people with current use or in treatment N= 8476
Learn2cope.org
Meeting Schedule
•
Every Monday evening 7 - 9 PM
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Good Samaritan Medical Center, 235 North Pearl Street, Brockton, MA. 02301
• Every Tuesday at 7:00 pm
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Gloucester Family Health Center, 302 Washington Street, Gloucester, MA.
Every Tuesday at 7:00 - 8:30 pm
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Eastern Nazarene College, 180 Old Colony Avenue Quincy Mass.
• Every Wednesday evening 7 - 9pm
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•
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Saints Medical Center, One Hospital Drive, Lowell.
Every Thursday evening 7 PM
–
Salem Massachusetts at North Shore Childrens Hospital, 57 Highland Ave.
–
UMASS Community Healthlink Campus, 26 Queen Street, 5th Floor, Room 515, Worcester, MA 01610
Email for Dates
–
Mass General Hospital Boston in the Thier Research building first floor conference room.
This meeting is new and room is subject to change, email learntocope2001@yahoo.com for
dates.
Outcomes
Variable
Outcome
Element
Fatal opioid OD per
town population per year
Source
Registry of Vital
Records and Statistics
*Defined as unintentional or undetermined intent opioid poisoning
(X40-X44, Y10-Y14) in the underlying COD field and a T code of
T40.0 – T40.4 and/or T40.6 in any of the multiple COD fields
Outcome
Opioid-related ED or
hospital discharges per
town population per year
MA Div. of Health Care
Finance and Policy
Discharge Database
*Defined as hospital and emergency department discharges with
codes for opioid intoxication and poisoning ICD-9-CM 965 (.00, .01,
.02, .09) or E code E850 (.0, .1, .2)
Analyses
Poisson regression to compare annual
opioid-related overdose rates among
cities/towns by OEND implementation
– Natural interpretations as rate ratios (RRs)
– Models adjusted for the city/town population rates of:
•
•
•
•
age under 18
Male
race/ ethnicity
below poverty level
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inpatient detox treatment
methadone treatment
DPH-funded bup treatment
prescriptions to doctor shoppers
year
INPEDE OD Limitations
• True population at risk for overdose is not known
– Adjusted for demographics, treatment, PMP, and year
• Cause of death subject to misclassification
– One medical examiner for all of MA
• Non-fatal overdose measure >> Diagnostic codes are
subject to misclassification
– No reason bias should be in one direction
• Overdoses may occur in clusters
– Study conducted over wide area and several years
• Measures of OEND implementation have not been
validated