1. Opioid Overdose Education and Naloxone Distribution for Clinicians
Nicholas Piotrowski, MD

2. I have no conflicts of interest to report.

3. Overview Background How to Use Naloxone VHA’s OEND Program
VHA – Veterans Health Administration
OEND – Opioid Education Naloxone Distribution
Aaron’s Law
Conclusions
Clinical Scenarios

4. Background

5. Background
2.1 million people in US age 12 and older (0.8 %) with opioid use disorder (NSDUH 2016)
11.8 million people misused opioids in 2016, mostly prescription pain relievers (NSDUH 2016)
33,091 opioid overdose deaths in 2015, up from 8,048 in 1999 (CDC Wonder)

6. Background

7. Background Opioid prescribing in the US peaked in 2010
However, opioid prescribing varies considerably between counties
And amount of opioids prescribed in 2015 was 3 times amount in 1999 (CDC)
Characteristics of high opioid prescribing counties: (CDC)
Small cities or large towns
Higher percent of white residents
More dentists and primary care physicians
More people who are uninsured or unemployed
More people who have diabetes, arthritis, or disability
Guy et al., 2017

8. Background
CDC Vital Signs, July 2017

9. How to Use Naloxone

10. How to Use Naloxone Is OEND effective?
Yes, efficacy of reversal of opioid overdose by bystanders is considered high, %, and effective in reducing opioid-related mortality (Rzasa, 2018).
Naloxone administered by bystanders may reduce opioid overdose mortality from 2-4% to 1% (Carlat, CATR Jan/ Feb 2015).
What are available routes of administration of Naloxone?
Given IM or IN in pre-hospital settings. Often given IV or IM in hospital settings. Can also be given SQ.
What is appropriate dosing?
Lowest effective dose is used in hospital settings, generally 0.04mg to 0.4mg IV or IM initial dose, to minimize risk of precipitated opioid withdrawal. Remember Naloxone has short half life (1-1.5 hours).
In pre-hospital settings, initial naloxone dose traditionally 0.4mg IM or 2mg IN (off label use). Current naloxone auto-injector dose FDA approved in 2014 is 2mg IM, and naloxone nasal spray (NARCAN) FDA approved in 2015 is 4mg, due to growing number of overdoses from highly potent opioids like fentanyl.
Doses less than 1mg/kg IV/IM generally do not produce side effects in non-opioid dependent patients.

11. How to Use Naloxone
Image by Harm Reduction Coalition
Harmreduction.org
IN naloxone as shown above is an off-label use. Naloxone frequently assembled into “kits” that include a syringe and nasal mucosal atomizer. There are also kits for IM naloxone administration.
Two branded products are FDA approved and designed for ease of use.
Naloxone auto-injector (Kaleo) and naloxone nasal spray (ADAPT Pharma, Inc.)

12. How to Use Naloxone
How can I implement OEND in my practice? (Suggestions by Carlat, CATR, Jan/ Feb 2015)
Need to include patients at high risk of overdose (e.g. illicit opioid use, combination regimens of opioid and benzodiazepine/ gabapentin/ other sedatives, recently abstinent patients, high dose prescribed opioids)
Need to include family/ friends/ “bystanders.”
Train bystanders in recognizing symptoms of opioid overdose. Can you use
I would add, refer to substance use treatment, as clinically indicated.
The actual prescription (though you can advise patients to go to any Indiana registered pharmacy with a standing order…we will get to this)
Follow local laws.

13. How to Use Naloxone
Sample prescription from Carlat, CATR, Jan/ Feb This is an off-label use.
Branded (FDA approved) products such naloxone auto- injector or naloxone nasal spray can also be used, but maybe more expensive for some patients.

14. How to Use Naloxone Examples of patient overdose education

15. How to Use Naloxone SAMHSA opioid overdose toolkit
4742

16. VHA OEND Program

17. VHA OEND Program
VHA was the first large health care system in the US to implement OEND nationwide (Oliva, et al. 2017)
VHA translated a community-based public health approach to OEND into a national health care system- based approach
Began with pilot program at Cleveland VHA facility, then regional program, then national program (< 2 years)
National website with implementation plans and resources
Mental health and pharmacy led, though program included all clinical settings (e.g. pain management, primary care, nursing)
Pharmacy developed standard naloxone rescue kits, available on-site

18. VHA OEND Program
Oliva, et al. 2017

19. VHA OEND Program
Steps for Implementing VHA Facility OEND Program (Oliva, et al. 2017)
Identify a clinical champion(s) for OEND implementation
Identify target patient populations
Garner support and prepare materials, resources, proposals, protocols
Obtain any necessary approvals to implement OEND
Train staff on OEND
Implement OEND
Evaluate OEND

20. VHA OEND Program
Total of 5,693 providers wrote 45,178 naloxone prescriptions for 39,328 patients as of September (Oliva, et al. 2017)
Of patients, 56% prescribed opioids, 23% had an opioid use disorder, and 17% were both prescribed opioids and had an opioid use disorder
62% of patients were 55 years of age or older, and 79% white
As of February 2016, there were 172 reported naloxone reversal events, though VHA is working to improve surveillance systems

21. Aaron’s Law

22. Aaron’s Law
SEA 406 (2015) is named after Aaron Sims, who died from an opioid overdose in 2013 at the age of 20.
From his obituary, I learned Aaron was talented at sports, particularly football. He also enjoyed skateboarding and art. He was well-liked by everyone, evidenced by all the messages of love and support on his webpage.
Aaron’s Law provides civil (not criminal) immunity to provide an overdose intervention drug by a bystander
Also allows naloxone to be prescribed under standing order by an eligible pharmacy
Aaron’s mother, Justin Phillips, founded Overdose Lifeline, Inc., which provides naloxone to the public and law enforcement, as well as support groups, training, and education.
Photo courtesy of Feeney-Hornak Keystone Mortuary

23. Aaron’s Law
Indiana State Department of Health website can help locate pharmacies that are registered to provide Naloxone by standing order, as well as Naloxone training/ education.

24. Conclusions

25. Conclusions
Fatal opioid overdoses continue to occur at record numbers despite steady reductions in opioid prescribing since 2010.
Pre-hospital administration of naloxone for opioid overdose is both safe and effective.
Clinicians should consider prescribing naloxone for any patient at risk of opioid overdose, including some patients on chronic opioid therapies for pain.
Overdose education and naloxone distribution programs can quickly be adapted to use in large healthcare systems. The VHA OEND Program is a good example to replicate.
Aaron’s Law (SEA 406/ 2015) allows pharmacies to provide naloxone under standing order, and provides civil immunity to bystanders who administer naloxone to a patient experiencing an opioid overdose.

26. Clinical Scenarios

27. Clinical Scenario 1
You are treating a patient who takes 100 OME daily for chronic pain (long acting + breakthrough opioid). He also is being treated with 1,200mg total daily of Gabapentin for a combination of anxiety and insomnia. He has 1-2 drinks at night.
Do you prescribe naloxone?

28. Clinical Scenario 2
You patient recently completed a 30 day inpatient detox and residential treatment program for opioid use disorder. She lives in transitional housing, attends 12-step meetings on site everyday, and recently started a new job. She no longer has contact with any of her drug using friends.
Do you prescribe naloxone?

29. References
Carlat, Daniel. CATR, January / February 2015, Vol 3, Issue 1, Detoxification Protocols
Guy GP Jr., Zhang K, Bohm MK, et al. Vital Signs: Changes in Opioid Prescribing in the United States, 2006– MMWR Morb Mortal Wkly Rep 2017;66:697–704.
Oliva, EM, et al. Opioid overdose education and naloxone distribution: Development of the Veterans Health Administration's national program. J Am Pharm Assoc (2003) Mar - Apr;57(2S)
Rzasa, Lynn and Galinkin JL. Naloxone dosage for opioid reversal: current evidence and clinical implications. Ther Adv Drug Saf Jan;9(1): Epub 2017 Dec 13
Substance Abuse and Mental Health Services Administration. (2017). Key substance use and mental health indicators in the United States: Results from the 2016 National Survey on Drug Use and Health (HHS Publication No. SMA , NSDUH Series H-52). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Retrieved from samhsa.gov/data/