Traci C. Green, PhD, MSc Assistant Professor of Emergency Medicine & Epidemiology The Warren Alpert School of Medicine at Brown University, Rhode Island Hospital The following personal financial relationships with commercial interests relevant to this presentation existed during the past 12 months: My presentation will include discussion of “off-label” use of the following: 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 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 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 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 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 (Sporer 2007, Binswanger 2007, Green 2012) HOST TIME + AGENT + = ENVIRONMENT Method for conceptualizing injury Pre-event Event Post-event Tackle problems identified with each factor during each phase 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 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). 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 • Two-thirds involved a prescription opioid • 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 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 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 MANY OPIOID OVERDOSES ARE PREVENTABLE Prevention: Alter demand, supply, & harm Demand Interventions Recommendations • • 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 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) 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 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 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) 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) ”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 longterm overdose prevention.” 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 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 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 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 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 Traci.c.green@gmail.com (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.