1. Community Approaches to the Opioid Overdose Epidemic Association for Medical Education and Research in Substance Abuse 36th Annual National Conference Bethesda, MD
Traci C. Green, PhD, MSc Assistant Professor of Emergency Medicine & Epidemiology The Warren Alpert School of Medicine at Brown University, Rhode Island Hospital

2. Disclosures-Traci C. Green
The following personal financial relationships with commercial interests relevant to this presentation existed during the past 12 months:
Employment at Inflexxion, Inc.
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, 5R21CE and 1R21CE ; National Institute on Drug Abuse, 1R21DA A1

3. Roadmap
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

4. Poisoning: Leading cause of injury death
In 2008, poisoning became the leading cause of injury death in the United States and nearly 9 out of 10 poisoning deaths are caused by drugs.
During the past three decades, the number of drug poisoning deaths increased sixfold from about 6,100 in 1980 to 36,500 in 2008.
During the most recent decade, the number of drug poisoning deaths involving opioid analgesics more than tripled from about 4,000 in 1999 to 14,800 in 2008.
Opioid analgesics were involved in more than 40% of all drug poisoning deaths in 2008, up from about 25% in 1999.
In 2008, the drug poisoning death rate was higher for males, people aged 45–54 years, and non-Hispanic white and American Indian or Alaska Native persons than for females and those in other age and racial and ethnic groups.
30 states—leading cause is poisoning
NVSS—Warner--Dec 2011

5. Prescription opioids driving death trends
More poisoning deaths involve prescription opioids than heroin, other illicit drugs
CDC has declared this an epidemic
Source:

6. Impacts on Life Expectancy?
The life expectancy of whites without a high school degree has fallen in recent years. Among the least educated Americans, white women have lost 5 years of life expectancy since 1990, and white men have lost 3 years.
The five-year decline for white women rivals the catastrophic seven-year drop for Russian men in the years after the collapse of the Soviet Union, said Michael Marmot, director of the Institute of Health Equity in London.
The decline among the least educated non-Hispanic whites, who make up a shrinking share of the population, widened an already troubling gap. The latest estimate shows life expectancy for white women without a high school diploma was 73.5 years, compared with 83.9 years for white women with a college degree or more. For white men, the gap was even bigger: 67.5 years for the least educated white men compared with 80.4 for those with a college degree or better.
Olshansky et al., Health Affairs 2012

7. Opioid/opiate substances: all can be prescribed legally except for heroin
Morphine
Codeine
Methadone
Fentanyl
Oxycodone
OxyContin
Percodan
Percocet
Hydrocodone
Vicodin
Hydromorphone
Dilaudid
Availability, access, & potency of prescription opioids is unprecedented

8. Endemicity of Opioid Problem: DEA Drug Threat Assessment, 2011

9. Who is using prescription opioids non-medically?
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)
Street drug users (Davis & Johnson, 2008)
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

10. ASI-MV Prescription opioid use latent class analysis (n=26,384)
Use as prescribed
N=4,973
Class 2
Prescribed misusers
N=7,079
Class 3
Medically healthy abusers
N=9,420
Class 4
Illicit users
N=4,842
Class Prevalence
18.9%
26.9%
35.8%
18.4%
Indicators: ‘YES response to the following
Nonmedical use of Short acting prescription opioid
0.0761
0.7545
0.7512
0.8161
Nonmedical use of Long acting prescription opioid
0.0031
0.4682
0.5091
0.9236
Use by non-indicated route of administration
0.0111
0.2430
0.3374
0.9089
Illicit source (i.e., not one’s own, single physician)
0.0005
0.4773
0.8816
0.9994
Has a current chronic medical health problem/ pain problem
1.00
0.9706
0.5138
0.4346
Takes prescribed medication for a medical problem/ Receives help for a medical problem, past 30 days
0.9485
0.8863
0.6068
0.4859

11. Opioid overdose| Opioid poisoning
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

12. Where are overdoses highest?
Drug overdose death rates by state per 100,000 people (2008)

13. Painkillers sold by state per 10,000 people (2010)

14. 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
(Sporer 2007, Binswanger 2007, Green 2012)

15. Haddon Matrix Method for conceptualizing injury=
HOST +
TIME +
AGENT
ENVIRONMENT
Method for conceptualizing injury
Pre-event Event Post-event
Tackle problems identified with each factor during each phase

17. RARx Study: Unintentional poisoning deaths involving Rx opioids in RI & CT
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

18. RI statistics
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 non-medical 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
Ranks 4th as of 2010 for illicit drug use per capita for any illicit drug, 1st for illicit drugs other than marijuana
5th for yos for nonmedical use
Sources: National Survey on Drug Use and Health, SAMHSA 2010, 2011, 2012; CDC WISQARS 2012

19. Overdose Consequences: RI Emergency Department visits & Hospitalizations
Green TC & Donnelly E. Preventable Death: Accidental Drug Overdose in Rhode Island. RI Med Health, Nov 2011

20. Injury-related1 Deaths: Rhode Island 2005-2009, all ages
*Unintentional
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

21. Overdose deaths in CT over time
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: Drug and Alcohol Dependence (2011).

22. RARx: Rapid Assessment & Response
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
Review publicly available data, media, online
Existing local data sources (ambulance run data)
143 Key informant interviews
52 Brief surveys

25. Overdose deaths: Forensic Case review
Two-thirds involved a prescription opioid
Deaths occur among age range, primarily non-Hispanic Whites, increasingly female, die at home
Involve other pharmaceuticals: anti-depressants, sedatives/hypnotics

26. Overdose deaths: Forensic Case review themes
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 events-surgery, work injury
Typical patient/decedent?

27. Factors contributing to overdose epidemic in Rhode Island
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

28. Ambulance runs & Decedent locations Warwick, RI 2009
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

29. Recommendations CDC ONDCP FDA Key Concerns PRIMARY PREVENTION
Use PMPs, insurance to combat “dr. shopping”
Tracking, monitoring: operational PMPs, inter-state 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
Moral hazard, “message”?
MAT: suboxone, methadone
Cost, readiness
Patients, parents education
Target? Necessary but not sufficient
Medication ‘take-backs’ / drop boxes
Effectiveness?; stigma
ADFs
Unintended consequences: heroin, riskier use

32. PMP Survey Findings: prescribers
Green et al., How Does Use of a Prescription Monitoring Program Change Medical Practice?
Pain Medicine in press
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
Indirect not direct influence on overdose risk

33. MANY OPIOID OVERDOSES ARE
PREVENTABLE
Prevention: Alter demand, supply, & harm

34. Community-Based Prevention
Interventions
Recommendations
Demand
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
Supply
Medication Dropbox at Police Station
Harm
Naloxone Distribution
First Responder Prevention
Good Samaritan law
Structural
Coordinate cross-agency response
Sponsor multi-agency meeting
Local Task Force involvement

35. Community-Derived Responses
Activities
Demand
Supply
Harm
Structural
Developed safer prescribing materials for RI, CT on Poison control website, Dept of Health, PMP; mailings to local providers
Medication assisted therapy (MMT, Suboxone) expanded to two study sites
Created, printed, distributed English, Spanish overdose awareness posters for treatment centers, community organizations, clinics; wallet cards
Targeted continuing medical education on safer prescribing + overdose for study area health professionals
Medication drop boxes installed in one study site

36. Clinician Resources maripoisoncenter.com/prescription

38. Community-Derived Responses
Activities
Demand
Supply
Harm
Structural
Developed safer prescribing materials for RI, CT on Poison control website, Dept of Health, PMP; mailings to local providers
Medication assisted therapy (MMT, Suboxone) expanded to two study sites
Created, printed, distributed English, Spanish overdose awareness posters for treatment centers, community organizations, clinics; wallet cards
Targeted continuing medical education on safer prescribing + overdose for study area health professionals
Medication drop boxes installed in one study site
RI, CT Good Samaritan, Naloxone laws enacted, dissemination strategy

39. Law as problem & solution
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)
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)

40. Community-Derived Responses
Activities
Demand
Supply
Harm
Structural
Developed safer prescribing materials for RI, CT on Poison control website, Dept of Health, PMP; mailings to local providers
Created, printed, distributed English, Spanish overdose awareness posters for treatment centers, community organizations, clinics; wallet cards
Medication assisted therapy (MMT, Suboxone) expanded to two study sites
Targeted continuing medical education on safer prescribing + overdose for study area health professionals
Medication drop boxes installed in one study site
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

41. Naloxone: What is it? Reverses opioid effects, restores breathing
Not scheduled, not controlled, not abuseable
Must be prescribed
Works only on opioids (heroin, methadone, pain pills)
Has no effect unless opioids are present
Standard antidote used by EMS to diagnosis & treat respiratory depression that causes overdose
Can be administered by laypeople, with training
Should mentioned often confused with naltrexone…but not.

42. Existing Naloxone Programs
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)

43. Community-based overdose prevention: Naloxone distribution models
One-to-one
Provider-patient: Prescribe naloxone to patients at high risk of opioid overdose
One-to-many
Standing order (state, institution)
Designate prescriber proxy
Collaborative Pharmacy Practice Model (flu vaccine)

44. Project Lazarus, NC

45. Remarks from G. Kerlikowske, Head of ONDCP: August 22, 2012
 ”Drug prevention—especially overdose prevention—is a critical piece of our mission.”
“Naloxone is a tool of overdose intervention, and once used, can become a critical link to substance abuse treatment—a tool for long-term overdose prevention.”

47. Who might benefit most from Narcan training & prescription?
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

48. Community-Derived Responses
Activities
Demand
Supply
Harm
Structural
Developed safer prescribing materials for RI, CT on Poison control website, Dept of Health, PMP
Created, printed, distributed English, Spanish overdose awareness posters for treatment centers, community organizations, clinics; wallet cards
Medication assisted therapy (MMT, Suboxone) expanded to two study sites
Targeted continuing medical education on safer prescribing for study area health professionals
Medication drop boxes installed in one study site
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
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

49. Special Population: Prisoners
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

50. Project SOON: Overdose prevention & take-home naloxone at release
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
15.42

51. Community-Derived Responses
Activities
Demand
Supply
Harm
Structural
Developed safer prescribing materials for RI, CT on Poison control website, Dept of Health, PMP
Medication assisted therapy (MMT, Suboxone) expanded to two study sites
Created, printed, distributed English, Spanish overdose awareness posters for treatment centers, community organizations, clinics; wallet cards
Targeted continuing medical education on safer prescribing for study area health professionals
Medication drop boxes installed in one study site
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
RI adopts Poisoning as one of 5 priority areas for CDC injury prevention planning grant; CT DMHAS adopts naloxone as “Good Clinical Practice”
RI Department of Correction adopts overdose prevention as standard pre-release health education topic
RI Collaborative Pharmacy Practice Agreement for naloxone adopted by Pharmacy Board
Naloxone Summit: Strategic Planning to improve naloxone access in RI

52. Tailored Preventive Interventions
C1 Use as
prescribed
C2 Prescribed
misusers
Overdose prevention counseling
BMI
PMP-based intervention
Psychosocial
web-based interventions, social support
Interdisciplinary pain management
Targeted overdose prevention counseling & response (detox, EDs, AA groups)
SBIRT ED,
primary care
Poison Control Center-based interventions
C3 Medically healthy
abusers
C4 Illicit users
Targeted overdose prevention counseling & response (SEPs, detox, prison)
SEP, POS syringe access
Police-based interventions
Law/policy reform
SBIRT pediatric
Safe prescribing
Package inserts
Provider education
Prescription monitoring
Availability & access to Medication-assisted
substance abuse treatment

53. Drug Poisoning = Injury
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,
Source: US Department of Health and Human Services

54. Thank you!
(401)

55. References
Staying Alive on the Outside video available at prisonerhealth.org &
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).
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 Meta-Analysis. AIDS 2012 Feb 20;26(4):
TC Green, EF Donnelly. Preventable death: Accidental drug overdose in Rhode Island. Medicine & Health Rhode Island. 2011; 24(11):
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):
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):
TC Green, LE Grau, HW Carver, M Kinzly, R Heimer. Epidemiologic and geographic trends in fatal opioid intoxications in Connecticut, USA: 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):
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
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.

56. Spicy Debate:

57. CHAPTER 28.8 THE GOOD SAMARITAN OVERDOSE PREVENTION ACT: Immunity from legal repercussions & liability for naloxone use
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.

58. CHAPTER 28.8 THE GOOD SAMARITAN OVERDOSE PREVENTION ACT: Immunity from legal repercussions & liability for naloxone use
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 or , 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 or , 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.  
Prescribing Narcan to opioid drug users is fully consistent with state and federal laws regulating medication prescribing.
Patients receiving a Narcan prescription should receive verbal and written instructions on how and when to use this drug. Prescribers/staff should not instruct patients to administer Narcan to persons who do not have a valid prescription for the drug; however, both prescribers and patients can educate a potential bystander how to administer the medication to the patient during an overdose emergency (like they would with an Epipen)
The risks of malpractice liability with prescribing Narcan are consistent with those generally associated with providing healthcare. Narcan is a relatively safe medication that is generally associated with fewer risks than other commonly used injectable rescue medications such as epinephrine for anaphylactic shock and glucagon for hypoglycemia.
While there is no precedent for prescriber or lay bystander liability following Narcan administration during an overdose, several states have taken steps to limit liability by enacting Overdose Good Samaritan legislation.