Assessment of the safety and ease of use of the naloxone auto-injector for the reversal of opioid overdose

Abstract

Over the last decade, opioid-related deaths in the United States have increased at an alarming rate. The use of naloxone by laypersons is a newer concept and its utilization can benefit patients by rapid administration due to it being readily available immediately after an opioid overdose. The US Food and Drug Administration approved a naloxone auto-injector on April 3, 2014 for adults and pediatrics, designed for use by anyone including patients, family members, bystanders, and medical professionals. This device (EZVIO™) is the first device of its kind available on the market. The auto-injector is a battery-operated disposable 0.4 mg/0.4 mL prefilled device for use in the lateral thigh by patients, bystanders, or health care professionals. It utilizes auditory and visual commands for ease of administration and instructs patients to seek further medical care after injection. EVZIO costs about $600 for two auto-injectors and a trainer. Additionally, in August 2013, the Substance Abuse and Mental Health Services Administration introduced the Opioid Overdose Toolkit, a federal resource promoting safety and prevention information. This extensive document provides information for medical professionals, first responders, patients, caregivers, and overdose survivors. It outlines many strategies for dealing with this health care crisis. Most importantly, it highlights the importance of rapid recognition and treatment of opioid overdoses as well as routine conversations with patients assessing the need for naloxone prescriptions. The auto-injector is a safe, portable device with limited instruction needed and should routinely be made available to anyone who has contact with an opioid user.

Current summary of the evidence in drone-based emergency medical services care

“…The rapid administration of naloxone can reverse a potentially fatal opioid overdose, which in its intranasal (IN) form, can be easily administered by a bystander. 58 Although the prescription of home IN naloxone to at-risk patients has increased over the past decade, 59 recent data suggest that less than five percent of overdose victims receive bystander-administered naloxone, 60 likely attributable to inadequate naloxone access. There remains a critical need to improve naloxone availability on the scene of otherwise often-fatal opioid overdoses, especially in rural settings.…”

Intranasal naloxone and related strategies for opioid overdose intervention by nonmedical personnel: a review

“…The Evzio naloxone autoinjector is a preassembled, lightweight, compact, battery-operated, disposable, prefilled device for use in the lateral thigh and is designed for immediate administration, with little to no training, by caregivers of opioid overdose victims outside of a medically supervised setting. 58 , 59 The device provides voice instructions that assist in guiding the user through administration of 2 mg naloxone and seeking further medical care after injection, which involves a retractable needle system that conceals the needle before, during, and after administration, eliminating the risk of caregiver needlestick injury. With strong advocacy by NIDA, Evzio was rapidly approved by the FDA in 2014, prior to the approval of Narcan Nasal Spray the following year.…”

“…Although the ability of untrained bystanders to successfully use off-label IN naloxone may be brought into question since connection of the atomizer to the naloxone syringe is required, it is difficult to then conclude that overdose victims would be better off if all bystander naloxone were simply unavailable. This objection is less relevant to FDA-approved, fully assembled IN naloxone devices 49 – 51 and IM autoinjectors, 58 , 59 since approval required, in part, experimental demonstration of usability by untrained laypersons.…”

Autoinjector – A smart device for emergency cum personal therapy

“…In emergency, it is the standard first line drug. In 2014, FDA has approved naloxone injector for adults and children ( Merlin et al, 2015 ). The autoinjector ezvioTM was considered as an extremely important innovation.…”

“…It has a 23 gauge retractable needle which can be used to inject the drug into the lateral thigh even through the dress ( Berteau et al, 2010 ). The rapid dissemination of naloxone is the only effective way to combat the crisis of opioid overdose around the world ( Merlin et al, 2015 ).…”