Evaluating the Impact of Overdose Prevention Education and Naloxone Rescue Kits in Massachusetts Alexander Y. Walley, MD, MSc Boston University School of Medicine Exploring Naloxone Uptake and Use: Measuring Progress and Impact July 2, 2015 FDA White Oak Campus
Community level impact • Naloxone kits and overdose prevention education help save lives • The harms are few • Training should not be a barrier • Populations and venues 1. Active users • • Syringe access programs Emergency Department* • • Detox programs Criminal justice-involved* • • Methadone maintenance Pharmacy and primary care* 2. Caregivers and social networks • Community meetings and support groups • Primary care providers • Pharmacy – Behind the counter, over the counter 3. First responders • Public health-public safety partnership * Innovation and research needed
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+
Fatal opioid overdose rates reduced where OEND implemented Naloxone coverage per 100K Opioid overdose death rate 250 100% 90% 27% reduction 46% reduction 200 80% 70% 150 60% 50% No 100 40% coverage 30% 1-100 ppl 50 20% 100+ ppl 10% 0 0% Walley et al. BMJ 2013; 346: f174.
Fatal opioid OD rates by OEND implementation Cumulative enrollments per 100k RR ARR* 95% CI Absolute model: No enrollment Ref Ref Ref Low implementation: 1-100 0.93 0.73 0.57-0.91 High implementation: > 100 0.82 0.54 0.39-0.76 * Adjusted Rate Ratios (ARR) All rate ratios adjusted for the city/town population rates of age under 18, male, race/ ethnicity (hispanic, white, black, other), below poverty level, medically supervised inpatient withdrawal treatment, methadone treatment, BSAS-funded buprenorphine treatment, prescriptions to doctor shoppers, and year Walley et al. BMJ 2013; 346: f174.
Opioid-related ED visits and hospitalization rates by OEND implementation Cumulative enrollments per 100k RR ARR* 95% CI Absolute model: No enrollment Ref Ref Ref Low implementation: 1-100 1.00 0.93 0.80-1.08 High implementation: > 100 1.06 0.92 0.75-1.13 * Adjusted Rate Ratios (ARR) All rate ratios adjusted for the city/town population rates of age under 18, male, race/ ethnicity (hispanic, white, black, other), below poverty level, medically supervised inpatient withdrawal treatment, methadone treatment, BSAS-funded buprenorphine treatment, prescriptions to doctor shoppers, and year Walley et al. BMJ 2013; 346: f174.
INPEDE OD Study Summary 1. Fatal OD rates were decreased in MA cities-towns where OEND was implemented - The more enrollment the more benefit 2. No clear impact on acute care utilization
Adverse Events: 2006 - 2014 N=4,227 Deaths 1% 45/4177 Overdose requiring 3 or more doses 6% 244/3981 Recurrent overdose 0.3% 9/2655 Difficulty with device 0.6% 17/2655 Withdrawal symptoms after naloxone 48% 1022/2141 Negative interactions with public safety 19% 268/1385 Confiscations 4% 405/11462 Program data
Withdrawal symptoms after naloxone rescue 2010-2014 Community naloxone (n=2141) Police/fire naloxone (n=645) 52% 48% 26% 24% 23% 21% 11% 9% 7% 5% 5% 3% None Irritable/angry "Dope Sick" Vomiting Combative Other Other = confused, disoriented, headache, Program data – 2008-2014 aches and chills, cold, crying, diarrhea, happy, miserable
Do trained rescuers perform differently than untrained rescuers? Naloxone rescue after training (n=508) Naloxone rescue before training (n=91) 89% 89% 63% 62% 52% 48% 47% 39% 27% 23% Sternal rub >1 dose given 911 called or Rescue Breathing Stayed with the EMS present victim Doe-Simkins et al. BMC Public Health 2014
Help-seeking (calling 911 or EMS present) by people reporting rescues with MDPH naloxone 46% 42% 37% 37% 34% 32% 26% 2007/8 2009 2010 2011 2012 2013 2014 Program data
Training family members at support group meetings Bagley et al. Overdose Education and Naloxone Rescue Kits for Family Members of Individuals Who Use Opioids: Characteristics, Motivations, and Naloxone Use. Substance Abuse 2015.
Police and Fire naloxone rescues in MA 2010-2014 Massachusetts DPH First Responder Pilot 350 300 250 Rescues and deaths, 2010-2014 200 318 150 100 160 111 50 67 8 0 2010 2011 2012 2013 2014 Signs� of� life,� but� died Dead� on� arrival Rescue
Community level impact • Naloxone kits and overdose prevention education help save lives • The harms are few • Training should not be a barrier • Populations and venues 1. Active users • Emergency Department* • Syringe access programs • Criminal justice-involved* • Detox programs • • Pharmacy and primary care* Methadone maintenance 2. Caregivers and social networks • Community meetings and support groups • Primary care providers • Pharmacy – Behind the counter, over the counter 3. First responders • Public health-public safety partnership
Evaluations of Overdose Education and Naloxone Distribution Programs • Piper et al. Subst Use Misuse 2008: 43; 858-70. • Doe-Simkins et al. Am J Public Health 2009: 99: 788-791. Feasibility • Enteen et al. J Urban Health 2010:87: 931-41. • Bennett et al. J Urban Health. 2011: 88; 1020-30. • Walley et al. JSAT 2013; 44:241-7. (Methadone and detox programs) Increased • Green et al. Addiction 2008: 103;979-89. • Tobin et al. Int J Drug Policy 2009: 20; 131-6. knowledge • Wagner et al. Int J Drug Policy 2010: 21: 186-93. and skills No increase in use, • Seal et al. J Urban Health 2005:82:303-11. • Doe-Simkins et al. BMC Public Health 2014 14:297. increase in drug treatment Reduction in • Maxwell et al. J Addict Dis 2006:25; 89-96. • Evans et al. Am J Epidemiol 2012; 174: 302-8. overdose in • Walley et al. BMJ 2013; 346: f174. communities Cost-effective Coffin and Sullivan. Ann Intern $438 (best) Med. 2013 Jan 1;158(1):1-9. $14,000 (worst ) per quality adjusted - life year gained 16
Study Design and Evaluation Questions Data Sources What is the secondary gain from naloxone rescue kits? Qualitative studies • Responder empowerment, social network Social network cohort dissemination, mitigating law enforcement actions studies What happens after rescue? Observational cohort • Connection to treatment, harm reduction services, studies re-overdose What should happen after rescue? Qualitative studies • Connect to harm reduction and treatment services, Controlled trials community outreach, “incentivized” treatment How best to match training to venues and populations? Implementation trials • Automated, online, in-person, hands on demo Simulation lab trials Surveillance Monitoring for adverse events? Cohort studies Is naloxone naloxone co-prescribing happening? Surveillance • Primary care, addiction treatment, pharmacy Include in PMP?
Thank you – awalley@bu.edu
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