NC’s Statewide Standing Order for Naloxone:Working with Partners to Lead Change

2017 NC State Health Director’s Conference

Chris Hoke, JD and Anna Stein, JD, MPH

The Problem: Opioid Overdose

3

*Per 100,00, age-adjusted to the 2000 U.S. Standard Populationα - Transition from ICD-8 to ICD-9β – Transition from ICD-9 to ICD-10

National Vital Statistics System, http://wonder.cdc.gov, multiple cause datasetSource: Death files, 1968-2014, CDC WONDERAnalysis by Injury Epidemiology and Surveillance Unit

Death Rates* for Three Selected Causes of Injury, North Carolina, 1968-2014

0.0

5.0

10.0

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25.0

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1968 1970 1972 1974 1976 1978 1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014

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4

Source: N.C. State Center for Health Statistics, Vital Statistics-Deaths, 1999-2015Analysis by Injury Epidemiology and Surveillance Unit

Substances Contributing to Medication or Drug Overdose DeathsNorth Carolina Residents, 1999-2015

738

291

363

0

100

200

300

400

500

600

700

800

900

Num

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Prescription Opioid

Cocaine

Heroin

884% increase in Heroin

deaths since 2010

Don’t forget

about cocaine

Prescription Opioid Analgesic Sales vs. DeathsNorth Carolina, 2000 - 2015

0.00

1.00

2.00

3.00

4.00

5.00

6.00

7.00

8.00

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2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Sales (kg per 10,000 population) Deaths (per 100,000)

Source: N.C. State Center for Health Statistics, Vital Statistics-Deaths, 2000-2015. DEA ARCOs

data, North Carolina, 2000-2015. Analysis by Injury Epidemiology and Surveillance Unit

http://www.cdc.gov/vitalsigns/opioid-prescribing/index.html

7

Unintentional/Undetermined Prescription Opioid Overdose Deaths Rates & Outpatient Prescriptions Dispensed for Opioids Rates

North Carolina Residents, 2011-2015

8

Heroin DeathsNorth Carolina Residents, 2008-2015

Source: N.C. State Center for Health Statistics, Vital Statistics-Deaths, 2008- 2015Analysis by Injury Epidemiology and Surveillance Unit

6172

37

76

147

179

246

364

0

50

100

150

200

250

300

350

400

2008 2009 2010 2011 2012 2013 2014 2015

Nu

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884% increase from

2010 to 2015

Source: Paulozzi, LSource: CDC, Len Paulozzi, July 2014Source: CDC, Len Paulozzi, July 2014

Source: N.C. State Center for Health Statistics, Vital Statistics-Deaths, 2015Analysis by Injury Epidemiology and Surveillance Unit

N=1,251

Demographics of Medication or Drug Overdose Deaths

North Carolina Residents, 2015

One Response: Naloxone Access

CDC Vital Signs, July 2015

http://www.cdc.gov/vitalsigns/heroin/index.html

• Naloxone (Narcan®, Evzio®)

– A prescription medication used to treat an opioid overdose

– Works by reversing the effects of opioids by temporarily binding

to the same brain receptors as opioids

– Safe medication; few side effects other than putting people into

immediate withdrawal from opioids

– Can be administered intra-nasally or intra-muscularly

13

Naloxone

14

Death

Respiratory depression

Diminishing cognition/ Motor control

Nodding, unresponsive

Euphoria; Relief from dope sickness

Pain relief

Pain, withdrawal, craving, dope sickness, boredom

• In 2013, legislature passed the Good Samaritan law

–Provided immunity for possession of small amount of drugs for

people seeking help for an overdose

–Provided civil and criminal immunity for persons who administer

naloxone to someone experiencing an overdose

–Allowed health care practitioners to prescribe naloxone by

standing order and allowed 3rd party prescribing (to friends and

relatives of people at risk of an overdose)

“A practitioner acting in good faith and exercising reasonable care

may directly or by standing order prescribe an opioid antagonist to (i) a

person at risk of experiencing an opiate-related overdose or (ii) a

family member, friend, or other person in a position to assist a person

at risk of experiencing an opiate-related overdose.”

15

2013 Good Samaritan Law

16

Number of Naloxone Kits Distributed by the

North Carolina Harm Reduction Coalition by County 8/1/2013 – 12/31/2016 (39,451 total kits distributed)

Source: North Carolina Harm Reduction Coalition, January 2017

Analysis: Injury Epidemiology and Surveillance Unit

2 kits distributed in an unknown location in North Carolina.

No kits distributed

1000-6877

100-999

10-99

1-9

17

Number of Opioid Overdose Reversals with Naloxone Reported to

the North Carolina Harm Reduction Coalition by Date8/1/2013 - 12/31/2016

Source: North Carolina Harm Reduction Coalition, January 2017

Analysis: Injury Epidemiology and Surveillance Unit

35 189 1,548 3,684

22 6 1 6 7 6 5 15 12 20 16 15 25 1340

1534

97

47 50

125

34

143

187

128

204197

302290

204

307275

343

251255

687

255241

316

260

0

100

200

300

400

500

600

700

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NC

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5,456 reported reversals

18

Number of Opioid Overdose Reversals with Naloxone Reported by

the North Carolina Harm Reduction Coalition by County 8/1/2013 - 12/31/2016 (5,456 total reversals reported)

17 reversals in an unknown location in North Carolina and 81 reversals using NCHRC kits in other states reported to NCHRC.

Source: North Carolina Harm Reduction Coalition, January 2017Analysis: Injury Epidemiology and Surveillance Unit

No reversals reported

10-99

100-499

500-1360

1-9

19

Source: North Carolina Harm Reduction Coalition, January 2017

Analysis: Injury Epidemiology and Surveillance Unit

Counties with Law Enforcement Carrying NaloxoneAs of December 31, 2016 (60 Counties, 136 Agencies)

20

Source: North Carolina Harm Reduction Coalition, January 2017Analysis: Injury Epidemiology and Surveillance Unit

1 1

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Number of Opioid Overdose Reversals with Naloxone Reported by

NC Law Enforcement by Date1/1/2015 - 12/31/2016

20 reported reversals with unknown date

36 317

21

Source: North Carolina Harm Reduction Coalition, January 2017

Analysis: Injury Epidemiology and Surveillance Unit

Number of Opioid Overdose Reversals with Naloxone Reported by

NC Law Enforcement by Date1/1/2015 - 12/31/2016 (373 total reversals reported)

No reversals reported

10-24

25-49

50-98

1-9

• Fall 2015: NC Injury and Violence Prevention

Branch(IVBP) received Prevention for States grant from

CDC

–A 4-year grant to work on prescription drug overdose prevention

• IVPB had been investigating possibility of statewide

standing order for naloxone by State Health Director

under the Good Samaritan law

• October 2015: Pennsylvania’s Physician General signed

statewide standing order

• December 2015: Maryland’s Deputy Secretary for state

health department signed statewide standing order

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Statewide Standing Order Initiative

• Injury and Violence Prevention Branch approached State

Health Director Dr. Randall Williams about creating a

Statewide Standing Order for Naloxone

• Dr. Williams indicated need to consult partners

–NC Medical Board

–NC Medical Society

–NC Pharmacy Board

• After talking with partners, decided to seek legislative

change to specifically allow State Health Director to issue

a statewide standing order

23

What about North Carolina?

• Working with DHHS legislative liaisons

• Trying to find way to introduce legislation in the short

session

• Dealing with concerns regarding cost neutrality from

Medicaid

–Decision to exclude Evzio (auto-injector version) from standing

order

• Committee hearings in House and Senate

–Dr. Williams served as effective champion of the bill

–Legislators very receptive to bill on a bi-partisan basis

24

Legislative Maneuvering

• Wrote draft standing order and shared with multiple

partners to get feedback

–NC Medical Board

–NC Medical Society

–NC Pharmacy Board

–NC Retail Merchants Association

•All major pharmacy chains

–Community pharmacies representatives

–NC Division of Medical Assistance

–Community Care of NC

• Pharmacies praised simplicity of standing order

compared to those in other states; greatly appreciated

ability to give input

25

Advanced Preparation for the Passage of the Bill

• Working on very tight deadline (one month); needed to

have website up and running as soon as law effective

• NC Injury Prevention Research Center helped design

website

• Created FAQs document

• Created searchable map with plan to populate with

pharmacies dispensing under the standing order

• Had a call organized by NC Retail Merchants Association

with pharmacy chains and community pharmacy

representatives to explain website and the process of

“signing up” to dispense under the standing order, and to

get feedback before website was “official”

26

Creation of NaloxoneSaves.org Website

27

www.NaloxoneSaves.Org

• Urgent messages to pharmacies and pharmacists to be

prepared for the statewide standing order

–Determine whether they intended to dispense under the standing

order

–Put in place any internal protocols they desired for standing order

–Order naloxone and have it in stock

• Worked NC Pharmacy Board and NC Retail Merchants

Association to get the word out quickly

• Gave DPH attorney email to all NC pharmacists for help

with questions

28

Spreading the Word to Pharmacies in Advance of the Law’s Passage

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Authorizes any pharmacist practicing in the state and licensed by the N.C. Board of

Pharmacy to dispense naloxone to:

• A person at risk of experiencing an opiate-related overdose

• A family member or friend of a person at risk of experiencing an opiate-related

overdose.

• A person in the position to assist a person at risk of experiencing an opiate-related

overdose.

June 20, 2016: Gov. McCrory signed legislation authorizing State Health Director

to issue statewide standing order for naloxone and standing order signed by Dr.

Randall Williams immediately afterward

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NaloxoneSaves.Org

1,300+ NC Pharmacies operating under standing

order listed on the website. More added each week.

31

Number of Pharmacies Selling Naloxone Under Standing Order by County, Sept 2016

1,330 Pharmacies in the state selling naloxone

About 60% of retail pharmacies in NC

Most of the large chains

• Multiple chains and independent pharmacies dispensing

by standing order

–CVS, Rite-Aid, Harris Teeter, Walgreen’s, Kroger, Ingles, others

• Have not run into implementation hurdles

• Standing order being used by law enforcement in some

locations to obtain naloxone

• Need for evaluation of law

–UNC Injury Prevention Research Center working with UNC School

of Pharmacy to conduct a survey of NC pharmacies about the

standing order

–Need to determine how much naloxone has been dispensed

under the standing order

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Post Script

NC Counties with Local Health Department Standing

Order/Protocol for Naloxone

• Alexander

• Cabarrus

• Davidson

• Duplin

• Durham

• Forsyth

• Hoke

• Johnston

• Lenoir

• Madison

• Orange

• Pender

• Pitt

• Union

• Wake

• Wilkes

• Others?

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• Bill passed July 11, 2016 to legalize syringe exchanges (Three weeks after standing order bill signed)

• Any governmental or nongovernmental organization can start a SEP

• Legal protections: No employee, volunteer or participant of the syringe exchange can be charged with possession of syringes or other injection supplies, or with residual amounts of controlled substances in them, obtained from or returned to a syringe exchange

• NC Safer Syringe Initiative of the Division of Public Health

https://www.ncdhhs.gov/north-carolina-safer-syringe-initiative

34

NC Syringe Exchange Programs (SEP)

35

Source: North Carolina Division of Public Health, January 2017Analysis: Injury Epidemiology and Surveillance Unit

Counties with Syringe Exchange ProgramsAs of December 31, 2016 (16 SEPs covering 20 counties)