Naloxone for Opioid Safety

Phillip O Coffin MD MIASan Francisco Department of Public Health

University of California San Francisco

Disclosures

• No financial disclosures

Oxycontin

Dilaudid/ Duragesic

Kadian

Norco

Atiq

HMO enrollment >80 million

FDA lifts rules on Direct-to-Consumer advertising

Welfare reform

State law/boards liberalize opioids for chronic pain

JCAHO 5th Vital Sign

Fentora

Subsys

Abstral

Roxicodone

Embeda Exalgo

Acuroxgeneric morphinesPalladone

Avinza

generic hydrocodone

generic fentanyl lozenge

generic oxycodones

Opana

Opana ER

Dilaudid (lower dose)

Onsolis

Lazanda

Oxecta Zohydro

Hysingla

generic oxymorphone Targiniq

CDC reports rising Rx deaths

Policy and practice changes to reduce OA prescribing begin

19951990

Naloxone Timeline

Naloxone Programs and OD Rate, 2010

Naloxone Programs and OD Rate, 2014Number* and location of local drug overdose prevention programs providing naloxone to laypersons, as of

June 2014, and age-adjusted rates† of drug overdose deaths§ in 2013 — United States

* Total N = 644; numbers on map indicate the total number of programs within each state.† Per 100,000 population.

§ CDC, National Center for Health Statistics; Compressed Mortality File 1999–2013 on CDC WONDER Online Database, released January 2015.

Naloxone Effectiveness

(10) Walley et al., BMJ 2013(13) Davidson et al., Naloxone distribution to drug users in California, unpublished data

Needle Atomizer / as-sembly

Expensive High dose?

Hero

in O

verd

ose

Deat

hs: S

F 19

97-1

999

Naloxone Distribution & Heroin Deaths in San Francisco

2000 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 20140

200

400

600

800

1000

1200

0

20

40

60

80

100

120

140

160

New Enrollments

Reversals

Heroin deaths (no 2013/14 data)

Naloxone distribution begins, 2003

? ?

Census tracts near DOPE sites

Naloxone Sites and Reversals 2010-2012

• 9% involved heroin

• Primary care data accessible for 50% of decedents, 80%

of whom were prescribed opioids

Census tracts near DOPE sites

Opioid Overdose Deaths 2010-2012

• 6 safety net clinics

• Staff trained

• Atomizer/brochure in ziplock bag

• IM or IN naloxone prescribed (covered by all public insurance)

• Pharmacists trained as needed

Clinical Program

All Patients Using Opioids Chronically

Risk-Stratification

Simple to remember Less costlyClinicians are poor at predicting risk Potentially less work for clinician / clinic

Risks are based on retrospective data analyses

Patients do not perceive a risk of “overdose” from prescribed medications1

~40% of deaths result from diverted medications2; co-prescribed naloxone

may go with the opioids

1) Coffin PO, unpublished data; 2) Hirsch A, Proescholdbell SK, Bronson W, Dasgupta N. Prescrip-tion histories and dose strengths associated with overdose deaths. Pain Med. 2014;15(7):1187-95.

 Provider Themes Regarding Naloxone PrescribingStrengthen patient/provider relationship

• “The ability to prescribe naloxone has been the most positive change to our management of chronic pain.”

Leads to more open discussion about opioids

• “[Naloxone] has allowed me to … keep them engaged in care … and has opened up conversations about substance use treatment options.”

 Patient Themes Regarding Naloxone (N=60)Frustration:

• “It felt like they think I’m gonna overdose…I don’t think I’m gonna overdose on something that’s prescribed”

Appreciation:

• “I felt great. I felt like she really cared about me.”

Community benefits:

• “I wasn’t sure if I’d ever use it. But on the other hand, because I live in the tenderloin … it might be a good thing to have with me.”

More cautious with opioids:

• “I’ve probably been a little more cautious. Just being careful to take the right amount, count the hours, you know, just thinking more cautiously about dosing.”

Opioid Refugees

?

Opioid Safety Initiatives

Reduce morbidity

& mortality

Opioid Safety Initiatives

Reduce morbidity

& mortality

Modify prescribing

practice• Staged treatment

(FDA relabeling)• Med

reconciliation• Risk factor

screens• Dose limits

Reduce diversion

•PDMP•Pharmacy

reviews•Take-back programs

•Pain Agreements

•Abuse deterrents

Opioid Safety Initiatives

Reduce morbidity

& mortality

Modify prescribing

practice• Staged treatment

(FDA relabeling)• Med

reconciliation• Risk factor

screens• Dose limits

Reduce diversion

•PDMP•Pharmacy

reviews•Take-back programs

•Pain Agreements

•Abuse deterrents

Expand non-opioid pain

management• PT/OT

• Behavioral therapy

• Acupuncture• Massage

• Non-opioid medications

Opioid Safety Initiatives

Reduce morbidity

& mortality

Modify prescribing

practice• Staged treatment

(FDA relabeling)• Med

reconciliation• Risk factor

screens• Dose limits

Reduce diversion

•PDMP•Pharmacy

reviews•Take-back programs

•Pain Agreements

•Abuse deterrents

Manage substance use• Opioid agonist

treatments• Good Sam laws• Comorbid SUD

treatment• Other harm

reduction services

Expand non-opioid pain

management• PT/OT

• Behavioral therapy

• Acupuncture• Massage

• Non-opioid medications

Opioid Safety Initiatives

Reduce morbidity

& mortality- Naloxone

Modify prescribing

practice• Staged treatment

(FDA relabeling)• Med

reconciliation• Risk factor

screens• Dose limits

Reduce diversion

•PDMP•Pharmacy

reviews•Take-back programs

•Pain Agreements

•Abuse deterrents

Manage substance use• Opioid agonist

treatments• Good Sam laws• Comorbid SUD

treatment• Other harm

reduction services

Expand non-opioid pain

management• PT/OT

• Behavioral therapy

• Acupuncture• Massage

• Non-opioid medications

Opioid Stewardship and Naloxone

Prescribing restrictions

initiated

Naloxone distribution

initiated

Trends in opiate-related deaths in Multnomah County, 2014

Inevitable

Pre-ventable

phillip.coffin@ucsf.edu

prescribetoprevent.org

Acknowledgments• Funding from:

• NIDA R21DA036776• NIDA R03DA038084• California Healthcare Foundation

• The many people lost to overdose and those who have helped save a life