Overdose Education and Naloxone Rescue in Massachusetts

Alexander Y. Walley, MD, MScAssistant Professor of Medicine

Boston University School of Medicine

Medical Director, Opioid Overdose Prevention Pilot, Massachusetts Department of Public Health

Cross-System Response to the Opioid EpidemicMonday, November 12, 2012

Disclosures – A Walley

• The following personal financial relationships with commercial interests relevant to this presentation existed during the past 12 months:– None to disclose

• 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 1R21CE001602-01

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All Poisoning Deaths Motor Vehicle-Related Injury Deaths

The source of the data is: Registry of Vital Records and Statistics, MA Department of Public Health

Poisoning Deaths vs. Motor Vehicle-Related Injury Deaths, MA Residents (1997-2008)

More Opioid Overdose Deaths than MVA Deaths in Massachusetts

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All Poisoning Deaths Opioid-related Poisoning Deaths Motor Vehicle-Related Injury Deaths

The source of the data is: Registry of Vital Records and Statistics, MA Department of Public Health

Poisoning Deaths vs. Motor Vehicle-Related Injury Deaths, MA Residents (1997-2008)

More Opioid Overdose Deaths than MVA Deaths in Massachusetts

Rate of opioid-related fatal overdoses in MA in 2006 was 9.9 per 100K

Strategies to address overdose

• Prescription monitoring programs– Paulozzi et al. Pain Medicine 2011

• Prescription drug take back events

• Safe opioid prescribing education– Albert et al. Pain Medicine 2011; 12: S77-S85

• Expansion of opioid agonist treatment– Clausen et al. Addiction 2009:104;1356-62

• Safe injection facilities– Marshall et al. Lancet 2011:377;1429-37

Rationale for bystander overdose education and naloxone distribution• Most opioid users do not use alone• Known risk factors:

– polydrug, abstinence, using alone, unknown source

• Opportunity window: – opioid OD takes minutes to hours and is reversible

with naloxone

• Bystanders are trainable to recognize OD• Fear of public safety

The Massachusetts OEND model

Standing order

Intranasal naloxone

Massachusetts OEND pilot: Standing order model

• Pilot program conducted under state Drug Control Program regulations (M.G.L. c.94C & 105 CMR 700.000)

• Medical Director issues standing order for distribution to potential bystanders

– Traditional prescription not needed

• Naloxone distributed by public health workers who are trained, but nonmedical staff

– >> access to populations at highest risk

OEND Program Components - Massachusetts

• Community program staff enroll, train and distribute naloxone

• Kit includes 2 doses and instructions• Curriculum delivers education on OD prevention,

recognition, and response • Referral to treatment available• Reports on overdose rescues are collected

when enrollees return for refills• Each overdose report reviewed by data

committee

Staff Training and Support

Staff complete:• 4 hour didactic training• knowledge test• At least 2 supervised bystander training

sessions

Sites participate in:• Quarterly all-site meetings• Monthly adverse event phone conferences

Intranasal Administration

Pro• 1st line for some local EMS• RCTs: slower onset of action

but milder withdrawal• Acceptable to non-users• No needle stick risk• No disposal concerns

Con• Not FDA approved• No large RCT• Assembly required, subject to

breakage • High cost:

– $40+ per kit

• Insurance does not typically cover the atomizer

• Subject to shortage

Scope of OEND in Massachusetts

Enrollments and Rescues: 2006-2012

• Enrollments– >15K individuals – 300 per month

• Rescues– >1500 reported – 30 per month

• AIDS Project Worcester • AIDS Support Group of Cape Cod• Brockton Area Multi-Services Inc.  (BAMSI) • Bay State Community Services• Boston Public Health Commission• CAB Health and Recovery• Cambridge Cares About AIDS• Greater Lawrence Family Health Center• Holyoke Health Center• Learn to Cope• Lowell Community Health Center• Seven Hills Behavioral Health• Tapestry Health• SPHERE

0 500 1,000 1,500 2,000 2,500 3,000 3,500

Home Visit/ Shelter/ Street Outreach

Inpatient/ ED/ Outpatient

Methadone Clinic

Other SA Treatment

Community Meeting

Drop-In Center

Syringe Access

Detox

Number enrolled

Using, In Treatment, or In Recovery Non Users (family, friends, staff)

Enrollment locations: 2008-2012

Data from people with location reported: Users: 7,220 Non-Users: 3,522Program data

Other venues

• First responder OEND– Quincy, Revere, Gloucester– Boston Police Academy e-training module

• Emergency Department (ED) SBIRT

• Post-incarceration

• Prescription naloxone– Prescribetoprevent.org

OEND program rescues: 2006-2012

Active use, In treatment, In

recovery N=1004

Non-User (Family, friend,

staff) N=108

911 called or public safety present

29% 64%

Rescue breathing performed 33% 33%

Stayed until alert or help arrived 90% 91%

Program data

Adverse Events: Sept 2006- Jan 2012

OD Reports N=1346

Deaths 7 / 1346 0.5%

OD requiring 3 or more doses 52 / 1226 4%

Recurrent overdose 1/1346 0.1%

Precipitated withdrawal 4/1346 0.3%

Difficulty with device 7/1346 0.7%

Negative interactions with public safety 82 / 332 25%

Confiscations 158 / 3594 4%

Program data

Impact of OEND on overdose rates in Massachusetts

Opioid Overdose Related Deaths: Massachusetts 2004 - 2006

No Deaths

1 - 5

6 - 15

16 - 30

30+

Number of Deaths

OEND programs2006-072007-08

2009Towns without

INPEDE OD (Intranasal Naloxone and Prevention

EDucation’s Effect on OverDose)

Study

Objective: Determine the impact of opioid overdose education with intranasal naloxone distribution (OEND) programs on fatal and non-fatal opioid overdose rates in Massachusetts

Supported: Center for Disease Control and Prevention 1R21CE001602

Design, population and setting

• Design: – Quasi-experimental interrupted time series

• Population: – 19 Massachusetts cities and towns with 5 or more

opioid-related unintentional or undetermined poison deaths in each year from 2004-2006

• Setting: – MA OEND programs were implemented by 8

community-based programs starting in 2006

Fatal opioid OD rates by OEND implementation: 2002-09

Under review

• Compared to towns in years when there was no OEND enrollment, the rate of overdose deaths was

• 27% lower in towns in years when 1-100 people per 100K were enrolled• 50% lower in towns in years when >100 people per 100K were enrolled

• Rates were adjusted for age, gender, race/ethnicity, poverty level, detox treatment slots, methadone slots, state-funded buprenorphine slots, prescriptions to doctor-shoppers, and year

• Total OEND enrollments through 2006-09 in 19 selected towns: 2912

Under review

• Compared to towns in years when there was no OEND enrollment, the rate of overdose ED visits and hospitalizations was

• Not significantly different for towns in years with OEND enrollment

• Rates were adjusted for age, gender, race/ethnicity, poverty level, detox treatment slots, methadone slots, state-funded buprenorphine slots, prescriptions to doctor-shoppers, and year

• Total OEND enrollments through 2006-09 in 19 selected towns: 2912

Opioid-related ED visits and hospitalization rates by OEND

implementation: 2002-09

INPEDE OD Study Summary

1. Fatal OD rates were decreased in MA cities-towns where OEND was implemented and the more enrollment the lower the reduction

2. No clear impact on acute care utilization

Implication

• Naloxone should be made more widely available to trained laypersons in an effort to reduce deaths due to opioid overdose

Considerations

• Intranasal works and is popular– It could be improved with a one-step, affordable

FDA-approved intranasal delivery device

• Nonmedical community health workers provide effective OEND– Broad dissemination to high risk groups and their

families– Facilitated by state-supported standing order

• Prescription status is a barrier

• Fear of police is a barrier to help seeking– Good Samaritan laws would address in part

Next steps for policy

• Expand number of sites and venues

• Good Samaritan law for bystanders

– Passed in August of 2012

• Liability protection for prescribers

– Passed in August of 2012

• Target incarcerated and ED patients

• Facilitate co-prescription of naloxone with chronic pain medication

Passed in August 2012:An Act Relative to Sentencing and Improving Law

Enforcement Tools

Good Samaritan provision: •Protects people who overdose or seek help for someone overdosing from being charged or prosecuted for drug possession

– Protection does not extend to trafficking or distribution charges

Patient protection: •A person acting in good faith may receive a naloxone prescription, possess naloxone and administer naloxone to an individual appearing to experience an opiate-related overdose.

Prescriber protection:•Naloxone or other opioid antagonist may lawfully be prescribed and dispensed to a person at risk of experiencing an opiate-related overdose or a family member, friend or other person in a position to assist a person at risk of experiencing an opiate-related overdose. For purposes of this chapter and chapter 112, any such prescription shall be regarded as being issued for a legitimate medical purpose in the usual course of professional practice.

Incorporating overdose education and naloxone rescue kits into medical and addiciton practice

1. Prescribe naloxone rescue kits• PrescribeToPrevent.org

2. Work with your OEND program

Challenges for community programs

• Naloxone cost is increasing, funding for is minimal

• Missing people who don’t identify as drug users, but have high risk

• Missing people who may periodically misuse opioids=no tolerance

Opportunities for prescription naloxone

• Co-prescribe naloxone with opioids for pain

• Co-prescribe with methadone/ buprenorphine for addiction

• Insurance should fund this• Increase patient, provider

& pharmacist awareness• Universalize overdose risk

Overdose Education in Medical Settings

• Where is the patient at as far as overdose?– Ask your patients whether they have overdosed, witnessed an overdose or

received training to prevent, recognize, or respond to an overdose• Overdose history:

1. Have you ever overdosed?1. What were you taking?

2. How did you survive?

2. What strategies do you use to protect yourself from overdose?

3. How many overdoses have you witnessed an overdose? 1. Were any fatal?

2. What did you do?

4. What is your plan if you witness an overdose in the future?1. Have you received a narcan rescue kit?

2. Do you feel comfortable using it?

Overdose Education in Medical Settings

What they need to know:1.Prevention - the risks:

– Mixing substances– Abstinence- low tolerance – Using alone– Unknown source– Chronic medical disease– Long acting opioids last longer

2.Recognition– Unresponsive to sternal rub with slowed breathing– Blue lips, pinpoint pupils

3.Response - What to do• Call for help• Rescue breathe• Deliver naloxone and wait 3-5 minutes • Stay until help arrives

Practical Barriers to Prescribing Naloxone

1. Prescriber knowledge and comfort2. How to write the prescription?3. Does the pharmacy stock rescue kits?

• Rescue IN kit with MAD? • Rescue IM kit with needle?

4. Who pays for it?• Insurance in Massachusetts covers naloxone, but not the

atomizer• The MAD costs $2.50 each• Work with your pharmacy to see if they will cover it

Thank you! awalley@bu.eduMA DPH• John Auerbach• Andy Epstein• Holly Hackman• Michael Botticelli• Kevin Cranston• Dawn Fakuda• Sarah Ruiz• Barry Callis• Grant Carrow• Len Young• Kyle Marshall• Office of HIV/AIDS• Bureau of Substance Abuse

ServicesRTI – Alex Kral

BU/BMC• Maya Doe-Simkins• Amy Alawad• Ziming Xuan• Al Ozonoff• Emily Quinn• Gregory Patts• Chris Chaisson• Jeffrey Samet• Peter Moyer• Ed Bernstein

BPHC

• Adam Butler

Program sites, staff and participants

NOPE group

Prescription Directions

• Dispense: One naloxone rescue kit – 2 prefilled syringes with 2mg/2ml naloxone– 2 mucosal atomizer devices– Risk factor info and assembly directions

• Directions: For suspected opioid overdose, spray 1ml in each nostril. Repeat after 3 minutes if no or minimal response- include infosheet

• Refills: None

Enrollee characteristics: 2006-2012

Active use, In treatment, In

recovery N=8476

Non-User (Family, friend,

staff) n=4079

Witnessed overdose ever 75% 43%

Lifetime history of overdose 50%

Received naloxone ever 44%

Inpatient detox, past year 65%

Incarcerated, past year 28%

Reported OD reversal 7.5% 2.1%

Program data

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Data only from people with current use or in treatment N= 8476

Enrollee past 30 day use: 2006-2012

Learn2cope.org Meeting Schedule

• Every Monday evening 7 - 9 PM– Good Samaritan Medical Center, 235 North Pearl Street, Brockton, MA. 02301

• Every Tuesday at 7:00 pm– Gloucester Family Health Center, 302 Washington Street, Gloucester, MA.

• Every Tuesday at 7:00 - 8:30 pm– Eastern Nazarene College, 180 Old Colony Avenue Quincy Mass.

• Every Wednesday evening 7 - 9pm– Saints Medical Center, One Hospital Drive, Lowell.

• Every Thursday evening 7 PM– Salem Massachusetts at North Shore Childrens Hospital, 57 Highland Ave. – UMASS Community Healthlink Campus, 26 Queen Street, 5th Floor, Room 515, Worcester, MA 01610

• Email for Dates– Mass General Hospital Boston in the Thier Research building first floor conference room.

This meeting is new and room is subject to change, email learntocope2001@yahoo.com for dates.

Outcomes

Variable Element Source

Outcome Fatal opioid OD per

town population per year

Registry of Vital Records and Statistics

*Defined as unintentional or undetermined intent opioid poisoning (X40-X44, Y10-Y14) in the underlying COD field and a T code of T40.0 – T40.4 and/or T40.6 in any of the multiple COD fields

Outcome Opioid-related ED or hospital discharges per

town population per year

MA Div. of Health Care Finance and Policy Discharge Database

*Defined as hospital and emergency department discharges with codes for opioid intoxication and poisoning ICD-9-CM 965 (.00, .01, .02, .09) or E code E850 (.0, .1, .2)

Analyses

Poisson regression to compare annual opioid-related overdose rates among cities/towns by OEND implementation– Natural interpretations as rate ratios (RRs)– Models adjusted for the city/town population rates of:

• age under 18

• Male

• race/ ethnicity

• below poverty level

• inpatient detox treatment• methadone treatment• DPH-funded bup treatment• prescriptions to doctor shoppers• year

INPEDE OD Limitations

• True population at risk for overdose is not known – Adjusted for demographics, treatment, PMP, and year

• Cause of death subject to misclassification– One medical examiner for all of MA

• Non-fatal overdose measure >> Diagnostic codes are subject to misclassification– No reason bias should be in one direction

• Overdoses may occur in clusters– Study conducted over wide area and several years

• Measures of OEND implementation have not been validated