naloxone kit: what, for whom, and how? · • naloxone kits and auto-injector added to national...

Elizabeth M. Oliva, PhD VA National Opioid Overdose Education and

Naloxone Distribution (OEND) Coordinator

Francine Goodman, PharmD, BCPS National PBM Clinical Pharmacy Program Manager—Formulary Management

Robert Sproul, PharmD Program Director, Orlando VAMC Pain Management

Co-Chair, VA National Pain Management Strategic Coordinating Committee

October 21, 2014

Naloxone Kit: What, For Whom, and How?

This program is starting

VETERANS HEALTH ADMINISTRATION

Objectives

For ALL Disciplines Except

Pharmacy Technicians

• cite at least 3 key patient situations in which the health professional should consider offering a naloxone kit;

• describe one way to initiate a conversation with a patient about the need for a naloxone kit; and

• describe at least one model or strategy to implement the Naloxone Kit Training Program Initiative at your facility.

For Pharmacy Technicians:

• describe one situation in which a pharmacy technician should consider discussing a naloxone kit with a patient; and

• describe how a pharmacy technician might start a conversation with a patient about the need for a naloxone.

At the conclusion of the program, learners will be able to:


Faculty

• Robert Sproul, PharmD Program Director, Orlando VAMC Pain Management Co-Chair, VA National Pain Management Strategic Coordinating Committee

• Francine Goodman, PharmD, BCPS National PBM Clinical Pharmacy Program Manager—Formulary Management

• Elizabeth M. Oliva, PhD VA National Opioid Overdose Education and Naloxone Distribution (OEND) Coordinator All presenters have no conflicts of interest to disclose. Today’s Program has been acknowledged by the Office of Mental Health Operations

9


Acknowledgments • National

– VA Opioid Overdose Education and Naloxone Distribution (OEND) National Support & Development Workgroup

– Dan Kivlahan (MHS), Mike Valentino and Tom Emmendorfer (PBM), Mario Franchi (CMOP)

– Peggy Knotts (EES) and Matt McCaa (OEND SharePoint)

• VISN/Facility – Jesse Burgard (VISN 10)

– Initial OEND pilot programs (VISN 10, Atlanta, Brockton, Palo Alto, Salt Lake City, San Francisco, Providence)

• Community – Eliza Wheeler and Sharon Stancliff (Harm Reduction Coalition)

– Alexander Walley (Boston University; MA Dept of Public Health)

– Phillip Coffin (UCSF; SF Dept of Public Health)

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Naloxone Kit: Why? • Opioid Overdose Crisis

• Opioid Overdose Education and Naloxone Distribution (OEND)

– Part of broad approach to opioid overdose prevention and opioid safety

• “Why not?”

– Not overly complicated

• In fall 2013 the Cleveland VA was the first to implement OEND ; inspired VISN 10 to implement OEND in every facility in FY14 as part of a phased roll-out

– Response has been overwhelmingly positive (patients, significant others, staff)

– IT SAVES LIVES! • 9 opioid overdose reversals reported among VA OEND programs (8 of 9 in VISN 10)

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Naloxone Kit: WHAT?

October 2014

TOPICS • Overview of naloxone and naloxone kit as part of Opioid

Overdose Education and Naloxone Distribution (OEND) • Evidence-base for OEND • VA Need and Support for OEND • Review of VA Naloxone Kits • Take-Home Points


• Naloxone, on formulary, is a highly effective treatment for reversing opioid overdose if administered at time of overdose

• It takes 1 – 3 hours to die from an opioid overdose

• Naloxone acts quickly, usually within 5 minutes

• Naloxone’s effects start to wear off after ~30 minutes and are gone by ~90 minutes


Naloxone Kit : One Component of OEND

• Opioid Overdose Education (OE)

– Provide patient education on how to prevent, recognize, and respond to an opioid overdose

• Naloxone Distribution (ND)

– Provide patient with a naloxone kit

• Train patient on how to use naloxone kit (e.g., how to assemble components)

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Evidence-base for OEND 3 models

1. Initial Public Health model • Distribution to high-risk patients in the community (primarily injection heroin users)

• Evidence for effectiveness and cost-effectiveness

2. Expanded Public Health model • Distribution to high-risk populations and self-identified potential bystanders

• Evidence for reduced mortality

3. Health Care model • Distribution to patients by health care systems and providers

• Scotland—evidence from urban and rural pilot programs

Gaps in evidence-base

– Limited evidence for OEND to patients prescribed opioids

– Intranasal device not FDA-approved for naloxone delivery

– Newly released auto-injector (EVZIO®)

– No evidence for OEND among Veterans

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VA Need and Support for OEND

• Over 55,000 VA patients with an Opioid Use Disorder

• Over 625,000 VA patients prescribed opioids (decreased over 50,000 from July 2012)

• Naloxone kits and auto-injector added to National Drug File

• “Free-to-Facilities” Naloxone Kit Initiative – Potential to provide up to 28,000 kits—paid

for by PBM—to be dispensed to VA patients without the medical center incurring the cost of the kits (standard Veteran co-payment rules apply to the kits)

• VA OEND SharePoint – https://vaww.portal2.va.gov/sites/mentalh

ealth/OEND/default.aspx

https://vaww.portal2.va.gov/sites/mentalhealth/OEND/default.aspx



VA Naloxone Kit Components Intranasal Naloxone Kit – 2 mucosal atomizer devices – 2 naloxone 1 mg/ml (2ml) – 1 Laerdal face shield – 1 pair nitrile gloves – 1 opioid safety brochure – 1 intranasal naloxone kit brochure – 1 blue zippered pouch

Intramuscular Naloxone Kit – Two 3 ml, 25g, 1-inch syringes – Two .4 mg/ml vials of naloxone – 1 Laerdal face shield – 1 pair nitrile gloves – 2 alcohol pads – 1 opioid safety brochure – 1 intramuscular naloxone kit brochure – 1 black zippered pouch

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Naloxone Kit: What? Take-Home Points

• Increasing data supporting effectiveness of OEND to reverse overdose and reduce overdose deaths – Most evaluated implementation has used a public health approach.

Models of implementation in health care systems are emerging.

– Data suggest effectiveness and cost-effectiveness when targeting persons with opioid use disorders. Data is limited on programs targeting higher risk patients prescribed opioid medication.

• OEND provides a promising risk mitigation strategy for reducing opioid overdose deaths in Veterans and VA facilities are encouraged to initiate programs – Under Secretary for Health’s Information Letter supports implementation

– Naloxone kits are on national formulary and currently “Free-to-Facilities”

– VA OEND SharePoint

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Overview

• Naloxone Kit: What?

• Naloxone Kit: For Whom? – PBM Recommendations for Use

• Naloxone Kit: How? – National Tools

– Clinical Presentations

• Q & A

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Naloxone Kit: FOR WHOM?

National PBM Recommendations for Use

October 2014

TOPICS • Recommendations for Use (RFU) in detail • Who seems to benefit from OEND? • Who may potentially benefit from OEND? • Magnitude of risk and risk factors • Take-home points


Naloxone Kit RFU

• Naloxone Kits, Recommendations for Use (Rev Sep 2014) https://vaww.cmopnational.va.gov/cmop/PBM/Clinical%20Guidance/Forms/AllItems.aspx

• Offer naloxone kits to Veterans prescribed or using opioids who are at increased risk for opioid overdose or whose provider deems, based on their clinical judgment, that the Veteran has an indication for a naloxone kit.

• Individuals in hospice / palliative care are likely NOT appropriate candidates for naloxone kits. OEND should be considered on a case by case basis and not routinely in hospice / palliative care patients.

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https://vaww.cmopnational.va.gov/cmop/PBM/Clinical Guidance/Clinical Recommendations/Naloxone Kits, Recommendations for Use (Rev Sep 2014).docx

https://vaww.cmopnational.va.gov/cmop/PBM/Clinical Guidance/Clinical Recommendations/Naloxone Kits, Recommendations for Use (Rev Sep 2014).docx

https://vaww.cmopnational.va.gov/cmop/PBM/Clinical Guidance/Forms/AllItems.aspx

https://vaww.cmopnational.va.gov/cmop/PBM/Clinical Guidance/Forms/AllItems.aspx


• Are not Criteria for Use

• Do not require local adjudication

• Intend to identify rather than prioritize Veterans

• Intend to be inclusive rather than exclusive

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Naloxone Kit RFU: Key Points


Naloxone Kit RFU: In Detail

“Offer naloxone kits”

• Have a patient-provider discussion

• Ensure access; “Naloxone kits are available”

• Not a requirement to prescribe

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“Veterans prescribed or using opioids who are at increased risk for opioid overdose ”

• Include those likely to restart opioids; for example:

– In abstinence treatment for Opioid Use Disorder (OUD)

– After an abstinent period / stopping naltrexone for OUD

– Abstinent but cued by heroin addicts

– Stopped opioids temporarily; restarting previous dose

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Adherent

Abusing

Addicted Misusing

• Any Veteran on opioids has an increased risk for opioid overdose

• Even patients adherent to dosing instructions can ‘overdose’

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“who are at increased risk for opioid overdose”


“or whose provider deems, based on their clinical judgment, that

the Veteran has an indication for a naloxone

kit”

Other factors can matter

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Provider discretion

Patient request

Patient preference

Regional OD patterns



Risk and Risk Factors for Opioid Overdose Deaths

RISK FACTORS • Risk increased by ~ 0.07 to 0.45

percentage points *

• Absolute risk increment may have a large impact

• E.g., For >=100 vs. 50-<100 mg/d max MEDD in CNCP:

o +0.58 deaths per 1000 person-months

o +7 deaths per 1000 persons in 12 months

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How do we determine “who are at increased risk for opioid overdose”

Patient Factors

Prescription Factors

Situational Factors Other Factors

*Bohnert, et al. 2011 JAMA. 2011 Apr 6;305(13):1315-21. Excluded buprenorphine and methadone, hospice/palliative care. FY2004-FY2008.


Who Seems to Benefit from OEND?

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Direct Association

with Benefit

Risk criteria used in

community health OEND

programs associated with

reduction in opioid

overdose deaths

Heroin or other injection drug use

Substance use

Opioid or drug use disorder

diagnosis

High likelihood of opioid overdose

or witnessing an opioid overdose

VETERANS HEALTH ADMINISTRATION 33

Who May Potentially Benefit from OEND?

Indirect Association

with Potential Benefit

Factors associated with an

increased risk for fatal or nonfatal

opioid overdose or any drug

overdose death in U.S. Veterans.

Some of these criteria have been

used by an established OEND

program without outcome data.

Identified Patient Risk Factors

SUD diagnosis

PTSD or other MH diagnosis

Suspected or confirmed history of heroin or nonmedical

opioid use

Male Veterans 30–59 years old

Any opioid prescription and known or suspected smoking,

COPD, emphysema, asthma, sleep apnea, other

respiratory system disease; renal or hepatic disease;

alcohol use

Identified Prescription Risk Factors

High-dose opioid prescription (50 to 100 mg or more

MEDD)

Long-acting non-tramadol opioid

Methadone initiation in opioid-naïve patients

Opioid prescription with concomitant benzodiazepine use

or concurrent antidepressant prescription

Situational Risk Factors or Criteria

Loss of opioid tolerance and likely to restart opioids (e.g.,

recent release from jail or prison / post-incarceration re-

entry programs)

Remoteness from or difficulty accessing [emergency]

medical care

Voluntary patient request


Who May Potentially Benefit from OEND?

Clinical Judgment

of Potential Benefit

Common factors found in drug

overdose deaths in nonveterans;

factors associated with increased

risk for nonfatal overdose or for

respiratory depression from opioid

therapy, and other clinical factors

suggested by experts

Identified Patient Risk Factors

Previous suicide attempt or on high-risk suicide list

Outpatient opioid prescription with the following:

oUnstable renal or hepatic disease

oCardiac illness

oHIV/AIDS

oAge 65 years or older, cognitive impairment or

debilitated condition

oVoluntary caregiver request

Identified Prescription Risk Factors

Home-based continuous intraspinal opioid infusion

Home-based patient-controlled opioid infusion

Opioid rotation to methadone

Opioid induction, upward titration or rotation (for SUD

or pain)

Situational Risk Factors

Fear of police arrest (reluctance to call 911)

Aberrant opioid use / misuse (e.g., early fills; extra

doses; overlapping, multi-site fills).

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Naloxone Kit RFU: Take-Home Points

Many factors can influence risks of fatal

opioid overdose

We can’t predict who will overdose and when a

Veteran will need a naloxone kit

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Taking or using opioids (or likely to)?

THINK / OFFER NALOXONE!

Naloxone Kit: HOW?

National Tools

Clinical Presentations

October 2014

TOPICS • Overview of National Tools • VA OEND SharePoint Resources and Quick Guide • Naloxone Kits for Patients Prescribed Opioids • Clinical Presentations

• Focus on patients prescribed opioids; clear evidence to support distribution to patients with opioid use disorder

• Implementation Considerations


Overview of National Tools • VA OEND SharePoint (https://vaww.portal2.va.gov/sites/mentalhealth/OEND/default.aspx)

– Step-by-step instructions, program models, quick guide, patient education brochures

• Opioid Safety Initiative (OSI) Dashboard – When reviewing cases, in addition to considering wide array of recommended opioid

safety practices (OSI Toolkit; http://vaww.va.gov/PAINMANAGEMENT/index.asp), may also want to consider OEND

– Recommend consideration for patients in OSI dashboard who are: • Prescribed > 200 MEDD • Co-prescribed opioids and benzodiazepine

• Forthcoming – EES TMS training for providers and videos to place on patient-facing websites – OEND Patient Identification Tool

• Every patient with an encounter for an opioid use disorder diagnosis or an opioid prescription (including tramadol)

• Include risk factors (e.g., diagnoses, opioid poisoning, suicide attempt) and patient contact information

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http://vaww.va.gov/PAINMANAGEMENT/index.asp




VA OEND Quick Guide

40


Patient Education Brochure: Patients with Opioid Use Disorder

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Patient Education Brochure: Patients Prescribed Opioids

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Implementation Considerations • Encourage leadership to work across services to develop a local

implementation strategy to ensure that high-risk patients receive OEND – SUD programs and MH RRTPs are current early adopters with some

facilities developing phased facility-wide implementation plans starting with these programs

– High-risk patients may be seen across services (e.g., PACT, ED) – Training strategies should take into consideration that effective use of

naloxone requires that bystanders/family are trained in overdose response

• Implementation approaches that encourage referral to a regular OEND group might help maximize resources – Individual training should still be available within each clinic/program

45


\

Naloxone Kits for Patients Prescribed Opioids: Where Do They Fit?

• OSI / OSI Toolkit / OSI Dashboard / Signature Informed Consent For Long-Term Opioid Therapy / Taking Opioids Responsibly

– Integration of education / training

– Identification of patient’s at risk

– Appropriate implementation risk mitigations strategies to improve patient safety and pain care in the VA

• Identification: Daily *Variety of Clinical Presentations for a provider’s consideration

• Today’s Examples/Considerations

• Opioids Continued but Risk Apparent (Continued Opioid Therapy)

• Outpatient Opioid Taper Initiated (Opioid Tapering Process)

• Post Opioid Taper/Medically Supervised Withdrawal (Post Opioid/Discontinuance)

46


N-KIT Clinical Presentations Setting the Stage

• Purpose of this section and the following case scenarios to:

– Provide a few *examples for which the N-Kit may benefit an at-risk patient

• Variety of presentations may present in the clinical settings

– Some most obvious, some most *subtle

» Risks may be stealthy

– Provoke a provider’s interest in exploring the RFU’s

• To assist the provider clinical decision process for identifying a patient at risk

– Not all inclusive; use best clinical judgment in the best interest of your patient

– Note that the N-KIT would be *one component of a comprehensive plan of care

• As with each component, education at the core

• Ultimately each provider will have a unique perspective for a given patient and

the associated risk: If you feel the patient is at risk, and may benefit from the N-KIT, then *ask

47


N-KIT Clinical Presentations Metastatic CA Patient “Obvious”

• 58 YO Male Cancer Patient / Boney Metastases (Non-Hospice AMB Care Presentation)

– Opioids Dose: 400mg/day Morphine Equivalents

– Current UDS: Positive for Cocaine

• Patient Interview with the Interdisciplinary Pain Service (patient’s report)

– Crack Cocaine (intermittent use: frequent last 2 months)

– Ineffective Pain Control—Requesting an increase in opioids

• Recent history of doubling his opioid dose

• Agreed Plan of Care

– Pt Visit *QD x2 Weeks

– UDS Daily – Opioids Dispensed Daily-Dose Reduction Strategy Implemented

– Slow graduation to less visits overtime (not less than once per wk. long-term)

• Collaborative Division of Labor/Care: MH-PCP-Pain Service

– Mandatory Participation with MH/Substance Abuse Services

– Naloxone Kit: Discussed/Agreed-Education/Training for Both Mother and Veteran

48 Take Home: N-KIT RMS for Continued Opioid Therapy


N-KIT Clinical Considerations “Opioid Taper”

• 35 YO Male: PTSD, Severe Depression with SI

– Past Hx of Substance Abuse

– Current issue with multiple request for early refills

– Non-Compliant with MH Treatment Parameters

– Opioids Total Daily Dose: 180mgs/day MEs

• *Outpatient Tapering Scheme

– Agreed conditionally upon by the PCP and Patient with MH/SA Concurrence

– Opioid Stride: Approximately 10-25% of previous dose every 2-4 weeks

• Contingent on patient’s compliance with the tapering parameters

– UDS to continue during and *after the taper

– Naloxone Kit discussed with the patient and wife:

• Agreed: Education and Training to Follow

• Patient informed of risk following detox or discontinuation

Take Home: N-KIT RMS *during the Opioid Tapering Process

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N-KIT Clinical Presentations

• 28 YO Female : Panic Disorder, MST, GAD, Past Hx of SI (no attempts) – Past history of using non-prescribed opioids for pain and mood

– Recipient of an Outpatient Opioid Taper/Discontinuance: SP 3 weeks

– Long-Term BZD Use: Alprazolam 1mg QID • MH and PCP concur that taper is warranted • Rotation To Long-Acting Diazepam • SSRI initiated • Anticipated duration of taper: Approximately 4-5months-Flexible (may be longer) • 5-15% reduction from the previous week’s dose-Flexible

– Patient appropriately engaged with *MH services: Treatment Complaint

– N-KIT discussed • Emphasis on recent cessation of opioids and *very high risk for re-implementing opioids

on her own or should another provider prescribe • Patient to avoid but in no way should patient attempt to resume the dose previously on

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Take Home: N-KIT RMS Post Opioid/Discontinuance

Q&A

October 2014

Thank You for Your Interest in Getting this Life-Saving Intervention to Our Veterans!

Please Send Questions/Concerns/Feedback about VA OEND

Implementation to [email protected]

Faculty: Elizabeth M. Oliva, PhD Robert Sproul, PharmD Francine Goodman, PharmD, BCPS

mailto:[email protected]

Pharmacy Education and Training Webinars Every 3rd Tuesday of the month at 3 PM EST

Live Meeting with VANTS 1-800-767-1750 Access Code: 49792#

Upcoming Pharmacy Education Webinars • November 18, 2014: Concomitant Use of BZDs with

Opioids (Repeated Dec. 16th, 2014)


Addendum

Additional Slides Describing Rationale and

Resources for OEND Implementation

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Death Rate from Unintentional Overdose, United States

Data from National Vital Statistic System, CDC


Deaths from Unintentional Overdose by Type of Drug, United States

Data from National Vital Statistic System, CDC


Rationale for OEND

• Overdose usually witnessed

• Death takes a while

• EMS not routinely accessed

• Naloxone very safe and very effective

• More rapid reversal with naloxone improves outcomes

• Community-level mortality reduced

• Training is feasible and relatively short

56

Davidson et al., J Urban Health, 2003; Gonzva, Am J Emerg Med, 2013;

McGregor, Addiction 1998; Piper et al., Harm Reduction J, 2007; Sporer,

Ann Intern Med 1999; Strang et al., BMJ, 1996; Walley et al., BMJ, 2013


Initial Public Health Model Community-Based OEND Training

• 5-10 minutes

• Includes: • Opioid overdose risk factors and prevention

strategies

• Recognizing an overdose

• Responding to an overdose, including stimulation (sternal rub), calling 911, performing rescue breathing and administering naloxone

• Complete paperwork, issue kit to participant


Effectiveness Among Community-Based Opioid Overdose Prevention Programs

Providing Naloxone

58

Number of local opioid overdose programs, naloxone vials provided, program

participants, and overdose reversals — United States, 1996–2010

Program size (by no. of vials of naloxone provided

annually)

No. of local programs

No. of naloxone vials provided to

participants annually

No. of program participants from

beginning of program through

June 2010

Reported opioid overdose reversals from beginning of program through

June2010

N N N

Small <100 24 754 1,646 371

Medium 101–1,000 18 5,294 13,214 3,241

Large 1,001–10,000 74 9,792 26,213 5,648

Very large >10,000 72 23,020 11,959 1,091

Total 188 38,860 53,032 10,171


Expanded Public Health Model

• Massachusetts public health program (Walley et al., BMJ, 2013)

– Implemented OEND among 19 communities

– 2,912 potential bystanders trained; 327 rescues

– Communities that implemented OEND had significantly reduced deaths related to opioid overdose compared to those that did not implement OEND

• San Francisco County Jail – Offer OEND to individuals in re-entry pod

60


Scotland established national program in 2010

• Implementation strongly supported by successful pilot programs in both urban and rural areas of Scotland

– McAuley et al., Drugs: education, prevention, and policy, 2012

• Patient Group Direction allows qualified nurses or pharmacists to supply naloxone to anyone they identify as at-risk of opioid overdose; may also be given to family/friends of at-risk person (with consent) and staff who work with at-risk populations

• Primarily distributed via harm reduction (needle exchange and outreach) and SUD treatment program

• Developing a general practice model

– Matheson et al., BMC Family Practice, 2014

Health Care Model


• Increasing interest yet limited experience with naloxone distribution to patients prescribed opioids

– Fort Bragg OpioidSAFE (intranasal)

• Modeled on Project Lazarus—community-based, multi-faceted

• Use risk stratification to identify appropriate patients

– San Francisco Department of Public Health (intranasal)

• Prescribe naloxone to all patients on chronic opioid therapy (>3 months of enough opioids to take at least 1 pill daily) in 6 clinics

– Limited data

• Project Lazarus—Preliminary unadjusted data: Overdose death rate (per 100,000) in Wilkes County dropped from 46.6 in 2009 to 29.0 in 2010

– Albert et al., Pain Medicine, 2011

• Interest for suicide prevention and previous overdose patients

– No data

• Intranasal device not FDA-approved for naloxone delivery

• Newly released EVZIO auto-injector

Gaps in Evidence Base


• Mortality Statistics

• Overdose Education and Naloxone Distribution (OEND)

• Status of OEND within VA

Overview


• Inconsistent overdose education in at-risk patients

• A few locally-initiated VA pilots – VISN 10—Implementation VISN-wide part of FY14 strategic plan (intranasal)

• Cleveland – RRTP (Aug 2013); individual and group training

• Dayton – Opioid agonist program (Feb 2014); group training for pts and family members

• Cincinnati – Individual overdose education in 4 clinics (May 2014): buprenorphine screening, methadone screening, residential rehab screening, and OP detox

• Chillicothe–Pts discharged from suboxone clinic for non-compliance (May 2014)

• Columbus – Awaiting kits; late planning stage

– Palo Alto – Domiciliary (Jan 2014; intramuscular); group training

– Salt Lake City—Developing facility-wide implementation plan (Nov 2013; intranasal)

– Atlanta – initially in OAT program (April 2014; intranasal); plan to target high-risk patients within facility using 2 nurses in OAT program as POCs for entire hospital

– Providence – OAT program (May 2014; intramuscular); individual & gp trng by RN

– San Francisco – OAT program (April 2014; intramuscular)

Initial VA OEND Implementation


• Models of delivery within health care systems have not been standardized

• High risk patients may engage with the health care system in wide range of clinical settings

– (e.g., SUD programs, ED, primary care, mental health, pain clinics, residential programs, inpatient units)

• Effective use of naloxone requires that bystanders/ family are trained in overdose response

• Providers that identify high-risk patients may or may not be the best people to provide overdose education and naloxone training

Challenges


Original Patient Brochure (MH RRTP)


National Resources

• VA OEND SharePoint

• https://vaww.portal2.va.gov/sites/mentalhealth/OEND/default.aspx

• VA OEND Quick Start Guide

• VA Naloxone Kit Brochures

• VA Patient Education Brochures

• VA Posters



naloxone kit: what, for whom, and how? · • naloxone kits and auto-injector added to national...

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