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

No Deaths

1 - 5

6 - 15

16 - 30

30+

Number of Deaths

OEND programs 2006-07 2007-08

2009

Towns without

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

No coverage

1-100 ppl

100+ ppl

27% reduction

Fatal opioid overdose rates reduced where OEND implemented

Naloxone coverage per 100K 250

200

150

100

50

0

Opioid overdose death rate

46% reduction

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 45/4177 1%

Overdose requiring 3 or more doses 244/3981 6%

Recurrent overdose 9/2655 0.3%

Difficulty with device 17/2655 0.6%

Withdrawal symptoms after naloxone 1022/2141 48%

Negative interactions with public safety 268/1385 19%

Confiscations 405/11462 4%

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

Program data – 2008-2014 Other = confused, disoriented, headache, 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

8 67111

160

318

0

50

100

150

200

250

300

350

2010 2011 2012 2013 2014

Signsoflife,butdied Deadonarrival Rescue

Rescues and deaths, 2010-2014

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

• 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

-

Evaluations of Overdose Education and Naloxone Distribution Programs

Feasibility

• Piper et al. Subst Use Misuse 2008: 43; 858-70. • Doe-Simkins et al. Am J Public Health 2009: 99: 788-791. • 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 knowledge and skills

• Green et al. Addiction 2008: 103;979-89. • Tobin et al. Int J Drug Policy 2009: 20; 131-6. • Wagner et al. Int J Drug Policy 2010: 21: 186-93.

No increase in use, increase in drug

treatment

• Seal et al. J Urban Health 2005:82:303-11. • Doe-Simkins et al. BMC Public Health 2014 14:297.

Reduction in overdose in

communities

• Maxwell et al. J Addict Dis 2006:25; 89-96. • Evans et al. Am J Epidemiol 2012; 174: 302-8. • Walley et al. BMJ 2013; 346: f174.

Cost-effective $438 (best)

$14,000 (worst ) per quality adjusted

life year gained

Coffin and Sullivan. Ann Intern Med. 2013 Jan 1;158(1):1-9.

16

Evaluation Questions Study Design and

Data Sources

What is the secondary gain from naloxone rescue kits? • Responder empowerment, social network

dissemination, mitigating law enforcement actions

Qualitative studies Social network cohort

studies

What happens after rescue? • Connection to treatment, harm reduction services,

re-overdose

Observational cohort studies

What should happen after rescue? • Connect to harm reduction and treatment services, community outreach, “incentivized” treatment

Qualitative studies Controlled trials

How best to match training to venues and populations? • Automated, online, in-person, hands on demo

Implementation trials Simulation lab trials

Monitoring for adverse events? Surveillance

Cohort studies

Is naloxone naloxone co-prescribing happening? • Primary care, addiction treatment, pharmacy

Surveillance Include in PMP?

Thank you – awalley@bu.edu