Transcript Plenary - T Green 2012

Traci C. Green, PhD, MSc
Assistant Professor of Emergency Medicine & Epidemiology
The Warren Alpert School of Medicine at Brown University,
Rhode Island Hospital
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The following personal financial relationships with
commercial interests relevant to this presentation existed
during the past 12 months:
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My presentation will include discussion of “off-label” use of
the following:
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Employment at Inflexxion, Inc.
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, 5R21CE001846-02 and 1R21CE002165-01; National
Institute on Drug Abuse, 1R21DA029201-02A1
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define the scope of national & state-level
epidemiologic trends in prescription opioid abuse
& overdose
identify factors influencing unintentional opioid
poisoning using the Haddon Matrix
conceptualize a community based participatory
research approach for understanding unintentional
opioid poisonings in the community
describe community-based interventions for
reduction of opioid overdose
More poisoning deaths involve prescription opioids than
heroin, other illicit drugs
CDC has declared this an epidemic
Source: http://www.cdc.gov/nchs/data/databriefs/db81.htm
Olshansky et al., Health Affairs 2012
 Heroin
 Morphine
 Codeine
 Methadone
 Fentanyl
 Oxycodone
 OxyContin
 Percodan
 Percocet
 Hydrocodone
 Vicodin
 Hydromorphone
 Dilaudid
Availability, access, & potency of prescription opioids is unprecedented
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Young people (Partnership for Drug-Free America, 2005)
College students (McCabe et al., 2005)
Elderly (SAMHSA, 2005)
Women (Manchikanti,2006; Green et al., 2008)
Chronic pain patients (Butler et al., 2004, 2008; Passik et
al.,2006)
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Street drug users (Davis & Johnson, 2008)
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Exhibits geographic patterns: greater in rural areas, also
seen among street-based users in large cities (Paulozzi et al., 2009;
Brownstein et al., 2009)
Difficult to summarize & contrast these disparate groups,
Let alone plan effective interventions
Class 1
Use as
prescribed
N=4,973
18.9%
Class Prevalence
Indicators: ‘YES response to the following
Class 2
Prescribed
misusers
N=7,079
26.9%
Class 3
Medically healthy
abusers
N=9,420
35.8%
Class 4
Illicit users
N=4,842
0.0761
0.7545
0.7512
0.8161
0.0031
0.4682
0.5091
0.9236
0.0111
0.2430
0.3374
0.9089
0.0005
0.4773
0.8816
0.9994
1.00
0.9706
0.5138
0.4346
0.9485
0.8863
0.6068
0.4859
18.4%
Nonmedical use of Short acting
prescription opioid
Nonmedical use of Long acting
prescription opioid
Use by non-indicated route of
administration
Illicit source (i.e., not one’s own,
single physician)
Has a current chronic medical
health problem/ pain problem
Takes prescribed medication for a
medical problem/ Receives help for
a medical problem, past 30 days
Pinpoint pupils
Respiratory depression (shallow/no breathing)
Blue or grayish lips/fingernails
No response to stimulus
Gurgling/ heavy wheezing or snoring sound
Occurs over 1-3 hours - the stereotype “needle in the arm”
death is rare (15%)
 Opioids repress the urge to breathe, decrease the
body’s/brain’s response to carbon dioxide, leading to
respiratory depression (decrease rate of breathing) and
death
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Drug overdose death rates by state per 100,000 people (2008)
Risk Factors for Unintentional
Opioid Poisoning
Change in TOLERANCE
 using ALONE, by oneself
 MIXING opioids with other central nervous
system depressing substances (alcohol,
benzodiazepines)
 ILLNESS
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(Sporer 2007, Binswanger 2007, Green 2012)
HOST
TIME +
AGENT
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+
=
ENVIRONMENT
Method for conceptualizing injury
Pre-event
Event
Post-event
Tackle problems identified with each factor during
each phase
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2-year CDC funded project
Collaborations with state medical examiners,
departments of health, consumer safety, mental
health & addiction services, corrections
4-part study: Forensic case review, inter-agency
data linkage (ME,PMP, DOC, SA/MH agencies),
provider & pharmacist surveys, & community
based rapid assessment field study in heavily
affected cities
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Rhode Island had the highest rate of past month
illicit drug use in the nation among people 12 or
older, according to national surveys conducted in
2008,2009, & 2010
5.93% of Rhode Islanders 12 or older report nonmedical use of opioids, ranking 7th in the nation
Nationally: 4.9%
Drug poisonings outrank motor vehicle
crashes as leading cause of injury death, since
2005
Sources: National Survey on Drug Use and Health, SAMHSA 2010, 2011, 2012; CDC WISQARS 2012
Green TC & Donnelly E. Preventable Death: Accidental Drug Overdose in Rhode Island. RI Med Health, Nov 2011
Age-adjusted Rate per 100,000
18
16
14
Poisoning*
12
Falls*
10
Motor Vehicle*
8
Suicide
6
Assault
4
2
*Unintentional
0
2005
2006
2007
2008
2009
Data Source: 2005 to 2009 Rhode Island Vital Record Death Data, Rhode Island Department of Health, Center for Health Data and
Analysis.
1Injury was listed as primary cause of death.
2Age-adjusted to the year 2000 U.S. standard population
300
Not opioid
involved
250
Polyopioid
Count
200
Methadone only
150
Single prescription
opioids other than
methadone
100
50
1997
Heroin only
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
Since 2005, leading cause of adult injury death, more than car crashes, fire, firearms deaths
TC Green, LE Grau, HW Carver, M Kinzly, R Heimer. Epidemiologic and geographic trends in fatal opioid
intoxications in Connecticut, USA: 1997-2007. Drug and Alcohol Dependence (2011).
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Ethnographic tool, used widely in public health:
HIV/AIDS
Investigate who, what, when, where, & why abuse/
deaths occurring
Suggest ways to intervene locally
Two, 10-person Community Advisory Boards
Data collection over 12-week period
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Review publicly available data, media, online
Existing local data sources (ambulance run data)
143 Key informant interviews
52 Brief surveys
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Two-thirds involved a prescription opioid
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Deaths occur among 35-54 age range, primarily
non-Hispanic Whites, increasingly female, die at
home
•
Involve other pharmaceuticals: anti-depressants,
sedatives/hypnotics
Drug &/or alcohol abuse/dependence, SA/MH
treatment, domestic violence, past suicide
attempts, previous overdose, incarceration, other
chronic diseases or conditions (diabetes, obesity,
back problems, chronic pain), recent acute eventssurgery, work injury
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Availability, accessibility of pain pills
Endemic opioid problem
Proliferation of pills in the home, community
Age distribution
“Complicated” patient
Constrained & isolated drug treatment resources
Poor awareness of overdose risk, recognition
Stigma of addiction, chronic pain care, pill use
Fear of police, calling 911
Calling 911:
•
Delay or don’t call 911
– Want to protect
script doctor, fear
of getting into
trouble, stigma of
drug use, they/
others have record
– Failure to
recognize overdose
symptoms
CDC
ONDCP
FDA
Key Concerns
PRIMARY PREVENTION
Use PMPs, insurance to
combat “dr. shopping”
Tracking, monitoring:
operational PMPs, interstate data sharing
Dr. shoppers: diverting or
seeking help? How used?
Access to pain care?
Effectiveness? Overdose risk?
Legislation/enforcement of
pill mill laws, Rx fraud
Target “unscrupulous”
health professionals, pill
mills, dr shopping
Swift opioid supply changes:
unintended consequences?
Effectiveness?
EBM, CMEs to improve safer
prescribing
*complex pain, pain-SA hx
Mandatory education for
controlled substance
prescribers
REMS,
voluntary
provider
education
Education necessary but not
sufficient
SECONDARY & TERTIARY PREVENTION
Distribution of naloxone to
laypersons, 1st responders
Distribution of naloxone to
laypersons
MAT: suboxone, methadone
Moral hazard, “message”?
Cost, readiness
Patients, parents
education
Target? Necessary but not
sufficient
Medication ‘take-backs’ /
drop boxes
Effectiveness?; stigma
Green et al., How Does Use of a Prescription Monitoring Program Change Medical Practice?
Pain Medicine in press
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Most use PMP reports to screen for abuse,
complement patient care
When concerned about “dr. shopping”/diversion,
PMP users significantly more likely than non-users
to:
 Screen for drug abuse, conduct urine screens, refer to
another provider, refer to substance abuse treatment
 Revisit pain treatment agreements
 Less likely to do nothing (ignore it)
 Fewer calls to law enforcement to intervene
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Indirect not direct influence on overdose risk
MANY OPIOID OVERDOSES ARE
PREVENTABLE
 Prevention: Alter demand, supply, &
harm
Demand
Interventions
Recommendations
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Prescriber Toolkit
Clinician Prescription Monitoring
Program Resources
Targeted Medical Education
Public Awareness Campaign
•Prescriber mandates
•Expanded treatment (especially
medication assisted treatment)
•Addiction medicine residency
•Local recovery center
Prescriber Toolkit
Clinician Prescription Monitoring
Program Resources
Targeted Medical Education
Medication Dropbox at Police
Station
•Prescriber mandates
•Addiction medicine residency
•
•
Supply
•
•
•
•
Harm
Structural
•Naloxone Distribution
•First Responder Prevention
•Good Samaritan law
•Coordinate cross-agency response
•Sponsor multi-agency meeting
•Local Task Force involvement
Activities
Demand
Developed safer prescribing materials for RI, CT on Poison control
website, Dept of Health, PMP; mailings to local providers
Created, printed,
Medication
assisted
distributed
therapy English,
(MMT, Suboxone)
Spanish overdose
expandedawareness
to two study
posters
sites
for treatment centers, community organizations, clinics; wallet cards
Supply
Targeted continuing medical education on safer prescribing + overdose for
study area health professionals
Medication drop boxes installed in one study site
Harm
Structural
Activities
Demand
Developed safer prescribing materials for RI, CT on Poison control
website, Dept of Health, PMP; mailings to local providers
Created, printed,
Medication
assisted
distributed
therapy English,
(MMT, Suboxone)
Spanish overdose
expandedawareness
to two study
posters
sites
for treatment centers, community organizations, clinics; wallet cards
Supply
Targeted continuing medical education on safer prescribing + overdose for
study area health professionals
Medication drop boxes installed in one study site
Harm
Structural
RI, CT Good Samaritan, Naloxone laws enacted, dissemination strategy
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Prescribing naloxone
 As of Aug 1, 2012, 8 states amended laws to make it
easier for health professionals to provide naloxone &
for lay administrators to use it without fear of legal
repercussions (NM, NY, IL, WA, CA, RI, CT and MA)
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Good Samaritan laws to encourage calling 9-1-1
 As of Oct 1, 2012, exist in 10 states (NM, WA, NY, RI,
CT, IL, CO, FL, MA and CA)
Activities
Demand
Developed safer prescribing materials for RI, CT on Poison control
website, Dept of Health, PMP; mailings to local providers
Created, printed,
Medication
assisted
distributed
therapy English,
(MMT, Suboxone)
Spanish overdose
expandedawareness
to two study
posters
sites
for treatment centers, community organizations, clinics; wallet cards
Supply
Targeted continuing medical education on safer prescribing + overdose for
study area health professionals
Medication drop boxes installed in one study site
Harm
RI, CT Good Samaritan, Naloxone laws enacted, dissemination strategy
Naloxone “train the trainer” pilots in CT and RI for 7 SA tx programs, MMT,
recovery centers
Structural
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Reverses opioid effects, restores breathing
Not scheduled, not controlled, not abuseable
Must be prescribed
Works only on opioids (heroin, methadone, pain pills)
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Has no effect unless opioids are present
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Standard antidote used by EMS to diagnosis &
treat respiratory depression that causes overdose
Can be administered by laypeople, with training
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Since 1996, community-based programs operating overdose
education and naloxone programs
In the last 15 years:
 188 local programs, 15 US states, DC
 10,171 drug overdose reversals w/naloxone
 53,032 people trained and given naloxone
RI: 177 trainings through community-based organization
pilot
 CT: 1 MMT, underground programs with limited distribution
 MA program trained >15,000 community lay people; >1,500
reversals. Protective effects seen with community saturation

(Walley et al., under review)
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One-to-one
 Provider-patient: Prescribe naloxone to patients
at high risk of opioid overdose
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One-to-many
 Standing order (state, institution)
 Designate prescriber proxy
 Collaborative Pharmacy Practice Model (flu vaccine)
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”Drug prevention—especially overdose
prevention—is a critical piece of our mission.”
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“Naloxone is a tool of overdose intervention,
and once used, can become a critical link to
substance abuse treatment—a tool for longterm overdose prevention.”
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Patients:
 with history or suspected history of substance abuse
 treated for opioid poisoning or intoxication at ED
 beginning Methadone or Buprenorphine therapy for
addiction
 with higher-dose opioid prescriptions (>50 mg morphine
equivalent/day)
 rotated from one prescription opioid to another
 with opioid prescriptions and:
▪
▪
▪
▪
▪
Benzodiazepine prescription
Anti-depressant prescription
Smoking, COPD, asthma, or other respiratory illness
Renal dysfunction, hepatic illness, cardiac disease, HIV/AIDS
Concurrent alcohol use
Activities
Demand
Developed safer prescribing materials for RI, CT on Poison control
website, Dept of Health, PMP
Created, printed,
Medication
assisted
distributed
therapy English,
(MMT, Suboxone)
Spanish overdose
expandedawareness
to two study
posters
sites
for treatment centers, community organizations, clinics; wallet cards
Supply
Targeted continuing medical education on safer prescribing for study area
health professionals
Medication drop boxes installed in one study site
Harm
RI, CT Good Samaritan, Naloxone laws enacted, dissemination strategy
Naloxone “train the trainer” pilots in CT and RI for 7 SA tx programs, MMT,
recovery centers
Structural
RI adopts Poisoning as 1 of 5 priority areas for CDC injury prevention
planning grant; CT DMHAS adopts naloxone as “Good Clinical Practice”
RI Collaborative Pharmacy Practice Agreement for naloxone adopted by
Pharmacy Board
Naloxone Summit: Strategic Planning to improve naloxone access in RI
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129 times more likely to die of drug overdose
during first 2 weeks following release
Tolerance altered by abstinence; physical isolation
(using alone)
Since 2005, RI pilot trained 1000’s prisoners, refer
to community program for naloxone upon release
<20 have ever presented for take-home naloxone
Similar outcomes in other locations, even with financial
incentives
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R21: NIDA grant (PI: Rich, Co-I: Green) started 4/11
19-minute overdose prevention & response DVD
 Conceptual model: Social learning theory, peer stories
 Prisoner-specific, highlighting unique risk & circumstances
 Rescue breathing, naloxone (IM, IN)
administration
 Literacy challenges
N=125 soon-to-be-released
prisoners: opioid users or likely to be
around opioid users post-release
 Naloxone mailed to known address or met at release
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Activities
Demand
Developed safer prescribing materials for RI, CT on Poison control
website, Dept of Health, PMP
Created, printed,
Medication
assisted
distributed
therapy English,
(MMT, Suboxone)
Spanish overdose
expandedawareness
to two study
posters
sites
for treatment centers, community organizations, clinics; wallet cards
Supply
Targeted continuing medical education on safer prescribing for study area
health professionals
Medication drop boxes installed in one study site
Harm
RI, CT Good Samaritan, Naloxone laws enacted, dissemination strategy
Naloxone “train the trainer” pilots in CT and RI for 7 SA tx programs, MMT,
recovery centers
Structural
RI adopts Poisoning as one of 5 priority areas for CDC injury prevention
planning
grant; of
CTCorrection
DMHAS adopts
“Good Clinical
Practice”
RI Department
adoptsnaloxone
overdoseas
prevention
as standard
preRI
Collaborative
Pharmacy
Practice Agreement for naloxone adopted by
release
health education
topic
Pharmacy Board
Naloxone Summit: Strategic Planning to improve naloxone access in RI
C1 Use as
prescribed
Safe
prescribing
Package
inserts
Provider
education
Prescription
monitoring
C2 Prescribed
misusers
Overdose
prevention
counseling
BMI
PMP-based
intervention
Psychosocial
web-based
interventions,
social support
Interdisciplinary
pain
management
C3 Medically healthy C4 Illicit users
abusers
Targeted
overdose
Targeted
prevention
overdose
counseling &
prevention
response (SEPs,
counseling &
detox, prison)
response (detox,
EDs, AA groups)
SBIRT ED,
primary care
Poison Control
Center-based
interventions
SEP, POS
syringe access
Police-based
interventions
Law/policy
reform
SBIRT pediatric
Availability & access to Medication-assisted
substance abuse treatment
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Motor vehicle safety: A 20th century public
health achievement
Motor-Vehicle–Related Deaths Per Million Vehicle Miles Traveled (VMT) and Annual VMT,
by Year—United States, 1925-1997
Source: US Department of Health and Human Services
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[email protected]
(401) 444 3845
Staying Alive on the Outside video available at prisonerhealth.org &
http://www.youtube.com/watch?v=_QwgxWO4q38&feature=player_embedded
TC Green, R Black, JM Grimes-Serrano, SH Budman, SF Butler. Typologies of Prescription Opioid Use in a Large Sample of
Adults Assessed for Substance Abuse Treatment. PLoS ONE (6(11): e27244).
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0027244
TC Green, MR Mann, SE Bowman, N Zaller, X Soto, J Gadea, C Cordy, P Kelly, PD Friedmann. How does use of a
prescription monitoring program change clinical practice? Pain Medicine (in press)
TC Green, S McGowan, M Yokell, ER Pouget, JD Rich. HIV Infection and Risk of Overdose: A Systematic Review and MetaAnalysis. AIDS 2012 Feb 20;26(4):403-17.
TC Green, EF Donnelly. Preventable death: Accidental drug overdose in Rhode Island. Medicine & Health Rhode Island.
2011; 24(11): 341-343.
TC Green, N Zaller, S Bowman, JD Rich, PD Friedmann. Revisiting Paulozzi et al.’s “Prescription Drug Monitoring
Programs and Death Rates from Drug Overdose”. Letter. Pain Medicine 2011; 12 (6): 982-985.
M Yokell, TC Green, S Bowman, M McKenzie, JD Rich. Opioid overdose prevention and naloxone distribution in Rhode
Island. Medicine & Health Rhode Island. 2011; 94 (8): 240-242.
TC Green, LE Grau, HW Carver, M Kinzly, R Heimer. Epidemiologic and geographic trends in fatal opioid intoxications in
Connecticut, USA: 1997-2007. Drug and Alcohol Dependence 2011 Jun 1;115(3):221-8.
JS Brownstein, TC Green, T Cassidy, SF Butler. Geographic Information Systems and Pharmacoepidemiology: Using
spatial cluster detection to monitor local patterns of prescription opioid abuse. Pharmacoepidemiology and Drug
Safety 2010; 19(6):627-37.
TC Green, J Grimes-Serrano, A Licari, SH Budman, SF Butler. Women who abuse prescription opioids: Findings from the
National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO™). Drug and Alcohol Dependence
2009.
TC Green, LE Grau, KN Blinnikova, M Torban, E Krupitsky, R Ilyuk, A Kozlov, R Heimer. Social and structural aspects of the
overdose risk environment in St. Petersburg, Russia. International Journal of Drug Policy, Special Issue: Drug Use and
Risk Environments 2009.
21-28.8-3. Authority to administer opioid antagonists –
Release from liability. – (a) A person may administer an
opioid antagonist to another person if:
(1) He or she, in good faith, believes the other person is
experiencing a drug overdose; and (2) He or she acts with
reasonable care in administering the drug to the other
person. (b) A person who administers an opioid antagonist to
another person pursuant to this section shall not be subject
to civil liability or criminal prosecution as a result of the
administration of the drug.
21-28.8-4. Emergency overdose care – Immunity from legal repercussions. 1
– (a) Any person who, in good faith, without malice and in the absence of
evidence of an intent to defraud, seeks medical assistance for someone
experiencing a drug overdose or other drug-related medical emergency shall not
be charged or prosecuted for any crime under RIGL 21-28 or 21-28.5, except for
a crime involving the manufacture or possession with the intent to manufacture a
controlled substance or possession with intent to deliver a controlled substance, if
the evidence for the charge was gained as a result of the seeking of medical
assistance.
(b) A person who experiences a drug overdose or other drug-related medical
emergency and is in need of medical assistance shall not be charged or
prosecuted for any crime under RIGL 21-28 or 21-28.5, except for a crime
involving the manufacture or possession with the intent to manufacture a
controlled substance or possession with intent to deliver a controlled substance, if
the evidence for the charge was gained as a result of the overdose and the need
for medical assistance.
(c) The act of providing first aid or other medical assistance to someone who is
experiencing a drug overdose or other drug-related medical emergency may be
used as a mitigating factor in a criminal prosecution pursuant to the controlled
substances act.