NALOXONE KIT
Clinical Criteria Summary
Indications & Patient Populations
- All patients at risk of an opioid overdose
- Veterans prescribed or using opioids, including those unknowingly exposed to opioids (e.g., illicit drugs/pills containing fentanyl)
- Patients with increased risk for opioid overdose or where provider clinical judgment indicates indication for readily available naloxone
- Active substance use disorder (excluding tobacco)
- Diagnosis of opioid use disorder (OUD)
- Diagnosis of stimulant use disorder (e.g., amphetamines, cocaine)
- >50 MEDD
- Long-acting or extended-release formulations (e.g., morphine SA, fentanyl)
- Concomitant use of CNS depressants
- Identified as very-high risk per VHA’s Stratification Tool for Opioid Risk Mitigation (STORM)
- History of opioid or stimulant overdose in the past year
- Use of illicit or non-prescribed substances that could contain opioids
- Loss of tolerance and/or at risk of non-prescribed use (during/after recently completed opioid taper, after detoxification/withdrawal treatment/residential treatment/abstinence, recent incarceration/release)
- Higher risk for suicide/overdose based on predictive modeling tools (e.g., STORM, RIOSORD)
- Prescriber determines individual is at risk of a potential overdose
Exclusions & Special Populations
- Tramadol: Low-risk patients on single-agent tramadol generally do not warrant naloxone prescription due to low mu-opioid receptor affinity, non-opioid mechanism, lack of reversibility, and lack of significant withdrawal; high-risk patients remain candidates
- Hospice: Not routinely used for comfort-oriented goals receiving opioids toward end-of-life suffering due to overlapping signs/symptoms with the dying process; may be considered based on clinical conditions, prognosis, goals of care, home environment, opioid dose, and prior opioid history
Prescribing & Dispensing Parameters
- Requires a prescription but provided at zero copay to any Veteran enrolled in VHA care
- Each prescription order contains 2 dose units
- Prescriptions processed with a 1-day supply marked with at least one refill
- Standing orders may be utilized, but overdose education and Veteran agreement must occur prior to dispensation
- Reassessment of OEND need should occur at least annually
Product Selection & Administration
- Preferred products: Nasal preparations (4 mg nasal spray)
- Alternative routes: IM kit/injection available for patients with contraindications to nasal products
- Higher dose options: 8 mg naloxone nasal spray (KLOXXADO) for concerns requiring higher dose; nalmefene (OPVEE) for higher potency antagonist need or rare true naloxone allergy (accessed via routine non-formulary request)
- All products are FDA-approved and designed for layperson use without assembly
- Administration generally includes: place patient on back, administer dose, repeat after 2-3 minutes if no/minimal response, obtain emergency medical help (call 911), place in recovery position if breathing normally
Documentation & Monitoring Requirements
- Use “Overdose Education and Naloxone” CPRS note or “Naloxone Overdose Education” Oracle Powerform for education/order process
- Document whether Veteran accepts, declines, or reports having in-date product on hand (document “has current naloxone” if applicable)
- Report all overdoses within the past 12 months using national standardized documentation (e.g., Suicidal Behavior and Overdose Report template)
- If naloxone was used on someone other than the Veteran, use the Naloxone Use Note