naloxone distribution in the emergency reduction strategy naloxone.pdf · synthesis of evidence •...
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Naloxone Distribution in the Emergency
Department: An Evidence Based Harm
Reduction Strategy
Stephanie C. Mullennix, MSN, RN, CEN, AGCNS-BC
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Continuing Education Activity Disclosure Statement
• No disclosures or conflict of interest
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Objectives
• Analyze the significance of the opiate epidemic
• Recognize patient populations that may benefit from take
home naloxone as a harm reduction strategy
• Demonstrate knowledge of an evidence-based naloxone
distribution program to reduce opioid overdose among at risk
patient populations
• Evaluate how a naloxone distribution program may be
implemented within the learners emergency practice
environment
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Problem1,2,4,6,7,8
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• The opioid epidemic has reached
national significance
• A large integrated hospital
system in the Midwest was
interested in exploring strategies
to impact the opioid epidemic
• Emergency Departments (ED)
within the system discharge over
500 patients per year following
an opioid overdose
• Over 170 of these overdoses
presented to regional EDs in a
rural setting
• In 2018, 78% of drug overdose
deaths within the surrounding
community were attributed to an
opiate
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The Epidemiology of the Opioid Epidemic1, 2
• The number of annual opioid prescriptions written in the US is roughly
equal to the number of adults in the country
• In 2015, 19,000 Americans died of an opioid overdose
• The death rate from all opioids (including heroin) now exceeds the
death rate from motor vehicle accidents
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Definitions
• Opiates/opioids/narcotics
• Derived from the opium
poppy or are synthetically
manufactured
• Differ in strength and half
life
• Long acting vs. short
acting preparations
• Naloxone
• Opiate antagonist
• Used for decades
• Good safety profile
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Guiding Principles: Opioid Crisis
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Project Purpose
Provide opiate overdose prevention education and equip at risk
individuals with a naloxone product prior to discharge with a vision to
reduce opiate overdose rates within the local community
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Interdisciplinary Team
• Executive Sponsor
• ED Medical Director
• ED Clinical Nurse Specialist
• Addiction Specialist
• Physician Champion
• Clinical Pharmacy Specialist
• Financial Analyst
• Data Analyst
• Quality Improvement Specialist
• Social Worker
• ED Manager
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Literature Review Process
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Figure 15: PRISMA Flow Diagram
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Synthesis of Evidence
• Naloxone distribution and education programs may decrease opiate-related
mortality rates1,6,7
• Community naloxone distribution programs are well established and now
should expand to hospital-based distribution and prescribing for at risk
patient populations2
• Patient characteristics are available to identify patients at risk for opiate
overdose that can be applied to hospital settings1
• Cost-effective intranasal routes of naloxone can be safely administered in
the event of a suspected opiate overdose by laypersons8
• Cost and reimbursement for in hospital naloxone distribution programs may
vary6
• Organizations may consider the use of grants or other funding to offset costs
incurred1,8
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Implications1,6,7,8
• Hospital systems may decreased opiate overdose mortality rates by
increasing the number of individuals educated on the risk of opiate
overdose, trained to respond to an opiate overdose, and equipped
with naloxone to reverse the respiratory depression incurred by opiate
overdose
• The Emergency Department is a prime setting to establish such
programs and equip at risk individuals with a potentially live saving
intervention
• For every 7 naloxone products dispensed, it is estimated that 1 will be
used within 30 days for an overdose event
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Intervention Implementation Plan
• Identify patient characteristics that increase the risk of opiate
overdose
• Select naloxone product
• Develop a kit for home distribution
• Develop a clinical guideline to direct best practice distribution
strategies
• Formulate an education plan (patient/clinicians)
• Implement at urban sites
• Evaluate metrics/review lessons learned
• Expand intervention throughout the system
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Work Breakdown Structure
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Characteristics that Increase the Risk of Opiate Overdose1,2,6,7,8
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Naloxone Product Selection1,2,8
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• Naloxone has a good safety profile
• Two FDA approved naloxone products for
distribution to laypersons
• Studies demonstrate greater
acceptance of intranasal (IN)
preparations
• Cost is a significant factor
• 575$ for the Evzio© auto-injector
• 100$ for the Narcan® Naloxone IN
Spray
• Intranasal Narcan® (Naloxone) was chosen
after completion of a cost benefit analysis
Photo Credit: Adaptapharma
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Development of a Naloxone Kit
• Intentional labeling and
packaging strategy
• Space for two naloxone
doses and the quick
reference pamphlet
• QR code for shared
education
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Patient & Clinician Education1,2,8
• Provide education to the patient, and any
representatives that the patient approves to participate
• The literature supported that brief education was
sufficient for IN naloxone products
• The more individuals who are trained in how to prevent,
recognize and respond to an opiate overdose in the
community the greater impact on opiate related mortality
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Naloxone Standing Order
• Family members or friends who request naloxone should be referred
to local pharmacies observing the State of Michigan standing order for
naloxone distribution (HB.5326 Sec. 17744e)
• Pharmacies authorized to dispense naloxone can be identified through
the Michigan Department of Health & Human Services Website
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Protection for Prescribers
• House Bill No. 5407, Sec. 17744b protects from civil
action for prescribing naloxone
• Michigan Legislature also allows for individuals to obtain
naloxone through a standing order at many participating
pharmacies throughout Michigan
• Encourage friends/family to go to the pharmacy to obtain
their own kit
• You can even pick up your own naloxone to carry!
• Traditional insurance co-pays will apply
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Project Deliverables
• Naloxone-take-home-kit for distribution to at risk ED patients utilizing
naloxone (Narcan®) Nasal Spray 4mg
• Comprehensive data reports for urban sites
• Comprehensive education for patients
• Custom video
• Education pamphlet in two languages
• System clinical guideline to for naloxone dispensing and prescribing
for ED, inpatient and outpatient
• Cost-analysis of the financial impact of the ED naloxone-take-home kit
• Securement of 20k in philanthropic funding for educational and kit
materials
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Naloxone Initiative Timeline
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Project Kick Off
November 2017
Implementation of Initial Pilot at Urban
Quaternary Care Site
May 2018
Implemented at Regional Sites and
Adolescent Populations
September 2018
Spread to ED Observation
Specialty Unit
October 2018
Inpatient Naloxone Prescribing
In Progress
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Outcomes
Metrics Pre-
Intervention
Goal Current State
(5 months
post)
Structure Number of ED within the system dispensing
naloxone
0 11/11 11/11
Process Percentage of ED patients discharged with
an opioid overdose and ordered a naloxone-
take-home kit (urban sites)
0 80% 73%
Outcome Total number of take home kits dispensed
throughout the system/number of naloxone
prescriptions written
0 500 101/24
Watch Metric Annual cost of naloxone distribution program 0 Less than 5k TBD
Watch Metric Opioid overdose mortality rates within the
local community
14.6 Reduction TBD
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Note: Mortality rates for 2018 are not inclusive of the entire calendar year.
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Lessons Learned
• Cost of naloxone products
• System
• Patients
• Resources for comprehensive data reports
• Clinical decision support needed to identify at risk patients
• Clinician bias
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Opioid Stigma Reflective Exercise
What does an overdose victim look like
to you…
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• 62 year old female. Chronic back pain, prescribed valium for
spasms and hydrocodone. History of chronic pulmonary
disease.
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Who is at Risk of Opioid Overdose1,2,6,7,8
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• 45 year old male. Occasionally drinks. Taking extended
release oxycodone for greater than 5 years. Recently
acquired a prescription for transdermal fentanyl for acute low
back injury.
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Who is at Risk of Opioid Related Overdose
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Who is at Risk of Opioid Related Overdose1,2,6,7,8
• Opiate-related overdose can occur for a variety of factors
• Deliberate misuse of illicit or prescription opioids
• Taking prescribed opiates as directed but have other factors that contribute
to an overdose (multiple medications, co-morbidities, depression, history of
depression)
• Dosing errors or patient misunderstanding the instructions for medication
use
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Opioid Stigma11,14
Stigma among healthcare workers can have significant
impact on patient outcomes
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Opioid Stigma11,14
Impacts include:
• Lowers the rate of patients who will seek help/treatment
• Patient’s feeling scared, depressed, angry and upset
• Inadequate pain management
• Lack of caring conversations and relationship building
• Premature discharge and neglect
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Reflection and recognition of your own bias is
the first step in eliminating stigma11,14
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Personal Impact Opioid Crisis
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Photo Credit: Bing.com
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Summary of Recommendations1,2,6,7,8
■ Patients at risk of opiate overdose should receive
interventions to decrease the risk of opiate overdose
mortality.
■ Prevent, recognize, respond, and administer
naloxone for a suspected opiate overdose
■ Increased access to naloxone within the community
decreases opioid overdose mortality rates
■ Emergency Departments can effectively distribute
naloxone to at risk patient populations
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Questions
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Photo Credit: Bing.com
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References
1. Substance Abuse and Mental Health Services Administration. (2016). Opioid overdose prevention toolkit. Retrieved from https://store.samhsa.gov/shin/content//SMA16-4742/SMA16-4742.pdf
2. Devries, J., Rafie, S., Polston, G. (2017). Implementing an overdose education and naloxone distribution program in a health system. Journal of American Pharmacists Association, 57(1), 154-160. doi:
10.1016/j.japh.2017.01.002
3. United States Department of Health and Human Services. (2013). Addressing prescription drug abuse in the United States: Current activities and future opportunities. Retrieved from
https://www.cdc.gov/drugoverdose/pdf/hhs_prescription_drug_abuse_report_09.2013.pdf
4. Kent County Health Department. (2018). Opiate Surveillance Report. Kent County: MI
5. Moher, D., Liberati, A., Tetzlaff, J., & Altman, D. G. (2009). Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. British Medical Journal, 339.
doi:10.1136/bmj.b2535
6. Clark, A. K., Wilder, C. M., & Winstanley, E. L. (2014). A Systematic review of community opioid overdose prevention and naloxone distribution programs. Journal of Addiction Medicine,8(3), 153-163.
doi:10.1097/ADM.0000000000000034
7. Walley, A. Y., Ziming, X., Hackman, H. H., Quinn, E., Doe-Simkins, M., Sorensen-Alawad, A., & ... Ozonoff, A. (2013). Opioid overdose rates and implementation of overdose education and nasal
naloxone distribution in Massachusetts: interrupted time series analysis. British Medical Journal, 346, (7894), 1-13. doi:10.1136/bmj.f174
8. Mitchell, K. D., & Higgins, L. J. (2016). Combating opioid overdose with public access to naloxone. Journal of Addictions Nursing,27(3), 160-179. doi:10.1097/JAN.0000000000000132
9. The Center For Disease Control and Prevention. (2017). Vital signs: Opiate Prescribing. Retrieved from https://www.cdc.gov/vitalsigns/opioids/infographic.html#graphic-a
10. Donabedian, A. (1988). The quality of care: How can it be assessed? Journal of American Medical Association, 260(12):1743–1748. doi:10.1001/jama.1988.03410120089033
11. Livingston, J. D., Milne, T., Fang, M. L., & Amari, E. (2012). The effectiveness of interventions for reducing stigma related to substance use disorders: a systematic review. Addiction, 107(1), 39-50.
doi:10.1111/j.1360-0443.2011.03601.x
12. Anesthetic and Analgesic Drug Product Advisory Committee and the Drug Safety and Risk Management Advisory Committee. (2016). FDA advisory on the most appropriate dose or doses of naloxone to
reverse the effects of a life-threatening opioid overdose in the community. Retrieved from
shttps://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM522688.pdf
13. McDonald, R., & Strang, J. (2016). Are take-home naloxone programs effective? Systematic review utilizing application of the Bradford Hill criteria. Addiction,111(7), 1177-1187. doi:10.1111/add.13326
14. Van Boekel, L. C., Brouwers, E. P., van Weeghel, J., & Garretsen, H. F. (2013). Stigma among health professionals towards patients with substance use disorders and its
consequences for healthcare delivery: Systematic review. Drug and Alcohol Dependence, 131, 23-35.
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