Application of human factors engineering (HFE) to the design of a naloxone auto-injector for the treatment of opioid emergencies

Robert B Raffa,Srinivas Nalamachu,Robert Taylor,Eric S Edwards,Evan T Edwards,Joseph V Pergolizzi

doi:10.1007/s13346-016-0323-x

Abstract

The increased use of opioids for chronic treatment of pain and the resulting epidemic of opioid overdoses have created a major public health challenge. Parenteral naloxone has been used since the 1970’s to treat opioid overdose. Recently, a novel naloxone auto-injector device (EVZIO, kaleo, Inc., Richmond, VA) was approved by the Food and Drug Administration. In this article, we review the Human Factors Engineering (HFE) process used in the development and testing of this novel naloxone auto-injector currently used in nonmedical settings for the emergency treatment of known or suspected opioid overdose. HFE methods were employed throughout the product development process for the naloxone auto-injector including formative and summative studies in order to optimize the auto-injector’s user interface, mitigate use-related hazards and increase reliability during an opioid emergency use scenario. HFE was also used to optimize the product’s design and user interface in order to reduce or prevent user confusion and misuse. The naloxone auto-injector went through a rigorous HFE process that included perceptual, cognitive, and physical action analysis; formative usability evaluations; use error analysis and summative design validation studies. Applying HFE resulted in the development of a product that is safe, fast, easy and predictably reliable to deliver a potentially life-saving dose of naloxone during an opioid overdose emergency. The naloxone auto-injector may be considered as a universal precaution option for at-risk patients prescribed opioids or those who are at increased risk for an opioid overdose emergency.

Highlights

Increasing awareness of the mechanisms of pain in humans and an ethical obligation to provide greater pain control [1] have driven increased prescribing of opioids
In a study of unintentional overdoses in West Virginia from 1999 to 2004, opioid analgesics were taken by 93 % of decedents, but only 44 % had prescriptions for those drugs [7]
The majority of opioid overdose deaths occur at home and are witnessed, including deaths associated with prescribed opioids [10]

Summary

Introduction

Increasing awareness of the mechanisms of pain in humans and an ethical obligation to provide greater pain control [1] have driven increased prescribing of opioids. Drug poisoning deaths attributable to opioid analgesics quadrupled from about 4000 in 1999 to over 16,000 in 2010 [3]. In 2014, there were 18,893 fatalities from prescription opioid overdoses. In a study of unintentional overdoses in West Virginia from 1999 to 2004, opioid analgesics were taken by 93 % of decedents, but only 44 % had prescriptions for those drugs [7]. The majority of opioid-associated unintentional deaths (60 %) occur in patients prescribed opioids according to current prescribing guidelines [6], are prescribed opioids by a single practitioner [8], and do not have a substance-abuse disorder diagnosis [9]. The majority of opioid overdose deaths occur at home and are witnessed, including deaths associated with prescribed opioids [10].

Methods

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Discussion

Conclusion