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Comparative Human Factors Evaluation of Two Nasal Naloxone Administration Devices: NARCAN® Nasal Spray and Naloxone Prefilled Syringe with Nasal Atomizer

  • Kathryn G. TippeyEmail author
  • Mary Yovanoff
  • Larry S. McGrath
  • Peter Sneeringer
Open Access
Original Research

Abstract

Introduction

Opioid overdose rescue situations are time-critical, high-stress scenarios that frequently require nonmedical first responders or bystanders to intervene and administer naloxone to avoid opioid-induced fatalities. Training nonmedical personnel to respond during such mentally constraining situations presents the human factors challenge of how best to design a safe and effective lay delivery system. This paper comparatively evaluates the ease of use of two nasal naloxone administration products: NARCAN® Nasal Spray and a naloxone prefilled syringe with nasal atomizer (PFS-NA).

Methods

We evaluated the use requirements and usability of NARCAN® Nasal Spray versus a naloxone PFS-NA using a systems-oriented method. First, we determined the use requirements of different user groups. Next, we focused on constructing a human factors task analysis of both products. Finally, we conducted a comparative risk assessment of the tasks that were different between the two products.

Results

Inexperienced users, such as nonmedical first responders and bystanders, are at the highest risk of incorrectly administering naloxone, particularly in high-stress emergency opioid overdose situations. The device Preparation and Medication Delivery tasks most differentiate the use of NARCAN® Nasal Spray and a PFS-NA. The level of task complexity and number of steps within those tasks is substantially greater for a PFS-NA than for the NARCAN® Nasal Spray.

Conclusions

NARCAN® Nasal Spray requires fewer steps and is easier to administer than a naloxone PFS-NA. Thus, using NARCAN® Nasal Spray should increase the likelihood that nonmedical personnel correctly deliver naloxone in time-critical, high-stress opioid overdose rescue situations.

Funding

ADAPT Pharma, Inc.

Keywords

Naloxone NARCAN® Opioids Overdose 

Introduction

Opioid overdose fatalities in the United States have drastically risen over the past two decades, leading to the development of training initiatives for nonmedical first responders and bystanders on when and how to administer the opioid reversal agent naloxone [1]. This authorization and promotion of lay users to respond to opioid overdoses prior to the arrival of emergency medical services (EMS) has already resulted in a reduction in opioid fatalities in areas with increased public access to naloxone [2, 3]. The goal of human factors research is to design devices that address the challenges faced by different user groups in various use environments and thus reduce the risks associated with using such products. Naloxone use by nonmedical personnel poses human factors design challenges as the medication administration device needs to effectively guide the user to correctly administer naloxone during time-critical emergency overdose scenarios.

Naloxone was developed in the 1960s and was the first opioid overdose reversal agent largely free of adverse effects, resulting in it quickly becoming the standard rescue medication for overdose management [2, 3]. Naloxone is currently available as a prefilled syringe (PFS) that the user can build into an intramuscular (IM) or intranasal (IN) kit by separately purchasing and adding a standard needle or nasal atomizer, respectively. Compared with IM naloxone, use of IN naloxone reduces the risk of a needlestick, which is important given the high prevalence of blood-borne illnesses among those with opioid use disorders [3]. However, the IN PFS kit is an off-label use [4]. The Food and Drug Administration (FDA) recently approved administration of naloxone by bystanders via NARCAN® Nasal Spray (approved in 2015; ADAPT Pharma, Inc., Radnor, PA) [3]. NARCAN® Nasal Spray (Fig. 1) costs $125 for two doses [5], whereas a PFS and independently added nasal atomizer (PFS-NA) (Fig. 2) costs approximately $44 for a single dose [5, 6]. The average insurance co-pay for both products, either the two doses of NARCAN® Nasal Spray or the one dose of a PFS-NA, is approximately $17 [6, 7, 8].
Fig. 1

NARCAN® Nasal Spray Kit (left); named components NARCAN® Nasal Spray Kit (right). Reused with permission from ADAPT Pharma, Inc

Fig. 2

Naloxone prefilled syringe with nasal atomizer (left); named components of Prefilled Syringe with Nasal Atomizer Kit (right)

The need for nonmedical personnel to appropriately deliver naloxone during opioid overdoses is well known and increasing. However, the safety of lay prehospital naloxone administration has not been established [9], and standardized medication administration training programs are limited. Additionally, the naloxone PFS-NA was recalled by the FDA in 2016 because the nasal atomizer was not reliably converting the fluid medication into a spray [10]. Despite these uncertainties, studies suggest that the risks involved in lay naloxone administration outweigh the dangers posed by an opioid overdose, particularly when users are not trained in other respiratory support methods [3].

Prior usability research found that no untrained, and only 40% to 60% of trained, users were able to successfully administer a full dose of naloxone using a PFS-NA, whereas  > 70% of untrained users were able to successfully administer a full dose using NARCAN® Nasal Spray [11, 12]. These studies provide information about lay users’ ability to administer naloxone but do not provide insights on why users commit more errors when using a PFS-NA.

Human factors is a discipline that focuses on how people interact with products in specific use environments (cf. [13]). The goal of human factors research is to optimize the design of a product to match the capabilities and limitations of the users, thus making product use safer and more effective [14]. In this paper, we conducted a human factors evaluation of NARCAN® Nasal Spray versus a PFS-NA by assessing the ease of use of administering each IN naloxone product in time-critical emergency situations. We hypothesized that increased task complexity and coupling lead to greater risk of incorrectly administering naloxone when using a PFS-NA compared with the NARCAN® Nasal Spray.

Methods

For this study, we employed a systems-oriented human factors evaluation approach to determine the differences in task complexity and risk between NARCAN® Nasal Spray and a PFS-NA. This article does not contain any studies with human participants or animals performed by any of the authors.

We first conducted a literature review to create an independent list of use requirements for different user groups. We used Google Scholar with the search terms {“naloxone”}, {“Narcan”}, {“opioid crisis”}, and {“opioid overdose”} as well as similar variations to build a database of articles. We also searched resources from government and public awareness organizations, such as the Centers for Disease Control and Prevention (CDC) and the Association for Addiction Professionals, for information about opioid abuse and opioid overdose rescue procedures. This search was conducted in October 2018. No papers were excluded based on publication date, but additional weight was given to newer articles citing current opioid use and treatment regimens.

We then constructed a task analysis of NARCAN® Nasal Spray and a PFS-NA by performing a mock administration using each product’s respective Instructions for Use (IFU) (Figs. 3, 4). The intent of the task analysis was to determine the tasks, subtasks, and workflow involved in administering naloxone with each kit. We performed this analysis in accordance with the 2016 FDA guidance “Applying Human Factors and Usability Engineering to Medical Devices” [15].
Fig. 3

NARCAN® Nasal Spray administration instructions [30]. Adapted with permission from ADAPT Pharma, Inc

Fig. 4

Naloxone prefilled syringe with nasal atomizer instructions [31]. Reused with permission from Project Lazarus

Finally, we constructed a risk assessment of all administration tasks that were substantially different between NARCAN® Nasal Spray and a PFS-NA. The goal of the risk assessment was to determine which tasks posed the greatest risk of preventing successful naloxone administration. We performed the assessment in accordance with the 2007 International Organization for Standardization standard “ISO 14971: Medical devices—Application of risk management to medical devices” [16].

Results

The following sections describe the results for each stage of the human factors evaluation, which included exploring the use requirements for naloxone and conducting a task analysis and risk assessment of NARCAN® Nasal Spray and a PFS-NA.

Use Requirements

Naloxone is used by emergency medical personnel and nonmedical personnel in a wide range of circumstances. Nonmedical personnel may include nonmedical first responders, bystanders that are also using opioids, and non-using bystanders. Understanding the perspectives, needs, and training (or lack thereof) on naloxone administration for each user group provides a framework for the development of effective drug delivery products.

User Groups

Levels of user training with drug delivery devices impacts how quickly and accurately users can administer medication in rescue situations. EMS personnel often administer naloxone and assist with mechanical ventilation via a bag valve mask after arriving on the scene of an opioid overdose. EMS personnel are trained to handle chaotic, high-stress situations in uncontrolled environments and have the expertise to quickly and accurately react to overdose emergencies.

Increasing numbers of nonmedical first responders (e.g., police and firefighters) and bystanders (e.g., opioid users and non-users) are being trained on how to administer naloxone for opioid overdoses prior to the arrival of EMS [3]. Law enforcement response training typically includes information about three basic elements: (1) how to recognize the symptoms of an opioid overdose, (2) how to react to an opioid overdose, and (3) how to recognize and react to opioid-induced events [17]. Both opioid-using and non-using bystanders are often trained similarly to first responders through community courses [18], with recent co-prescribing and peer administration efforts already resulting in a decrease in opioid-related deaths [1, 3]. However, this limited training for nonmedical personnel may make recalling rescue procedures difficult given the added mental constraints posed by emergency opioid overdose situations.

User Needs

Determining the user’s needs involves ascertaining how they go about reaching their goals. The following sections discuss the goals, context, and obstacles lay users encounter during naloxone administration within the framework of the user-centered design process.

Goal: Prevent Overdose Fatality

The primary goal of pre-EMS naloxone administration is to prevent an opioid overdose fatality. Figure 5 shows an overview of the process of treating an overdose with naloxone. The challenges users face include determining when or if they should administer the medication, how they should administer it, and if they have administered the appropriate dose. The product-based difficulties users encounter center on how the medication is administered; this is further explored in the task analysis and risk assessment sections.
Fig. 5

Naloxone administration process [29]

Context: Emergency Situation

Naloxone administration during opioid overdoses has become even more time-critical with the use and increased abuse of synthetic opioids, such as illicitly manufactured fentanyl. Fentanyl is estimated to be 50–100 times more potent than morphine [19, 20] and may result in an overdose fatality seconds or minutes after use. This leaves no time for the arrival of EMS [21], thus placing the burden of emergency naloxone administration on bystanders.

Emergency situations are time-critical, high-pressure scenarios that can induce a stress response impacting the user’s cognitive ability to adapt to task demands. Nonmedical first responders and bystanders with either limited or no training on naloxone administration are particularly susceptible to these cognitive impairments. Stress may cause users to (cf. [22]):
  • Narrow their attention toward one central task.

  • Lose the ability to coordinate or integrate information, particularly across different mediums.

  • Have a lower level of accuracy when performing tasks.

  • Have difficulty making decisions.

Product design features that mitigate the impact of emergency stress minimize the working memory load required to use the device. This is accomplished by visually displaying information, reducing the number of tasks required to administer the medication, and closely grouping items or instructions intended to be used together [22]. As observed in Figs. 4 and 6, using a PFS-NA involves assembling more components that have a higher level of complexity than using NARCAN® Nasal Spray. This may cause lay users to have more difficulty administering a PFS-NA.

Obstacles: Access to Naloxone

Several obstacles exist to appropriately using nasal naloxone, including knowledge of and about the medication and its administration, awareness of bystander overdose intervention laws, and the reliability of medication administration kits. Each of these factors directly impacts a product’s ease of use.

Studies suggest that increased naloxone co-prescribing and peer utilization efforts have reduced opioid overdose fatalities [1, 3]. However, opioid users often lack sufficient knowledge of naloxone: what it is, how to obtain it, and how to use it. For example, in a study by Kirane et al. [23], researchers interviewed 100 opioid users and found that while 65% of patients correctly identified that naloxone could be used for opioid overdose reversal, only 33% knew where to obtain a rescue kit. In addition, 19% thought prosecuting bystanders who responded at the scene of an overdose was legal [23].

Task Analysis

The task analysis that we performed assigned each element of naloxone administration into one of five major tasks: (1) Preparation, (2) Positioning of the Patient, (3) Positioning of the Device, (4) Delivery, and (5) Post-Delivery (see Fig. 6). The highlighted boxes in Fig. 6 represent those tasks with steps that were substantially different between a PFS-NA and NARCAN® Nasal Spray. The dropdown boxes on the illustration detail the specific steps required to use each product. For the tasks of Preparation and Delivery of medication, a PFS-NA requires substantially more steps than the NARCAN® Nasal Spray, potentially requiring more time and a more highly skilled user. The risks involved in each step of the Preparation and Delivery process are compared in the risk assessment.
Fig. 6

High-level summary of tasks involved in IN naloxone administration

Risk Assessment

A product risk is the chance that someone may be harmed by use of the product. A comparison of the risks involved in using NARCAN® Nasal Spray versus a PFS-NA provides insight into adverse outcomes that might occur due to the inappropriate use of either kit. The two tasks that most differentiated the products were Preparation and Delivery of medication.

The preparation of a PFS-NA and NARCAN® Nasal Spray both start with removing the products from their respective packaging. The device workflows then diverge, with a PFS-NA requiring more steps than NARCAN® Nasal Spray. Each additional PFS-NA step (see Fig. 6) opens multiple avenues for failure modes that may result in incorrect assembly of the kit. During the Preparation task, most failure modes result in delayed therapy or no therapy, which may cause harm to the overdose victim, such as brain damage or death [3, 24]. This suggests that use of a PFS-NA is likely to result in more adverse events than use of NARCAN® Nasal Spray.

The Delivery of naloxone also differs between the two products. With a PFS-NA, the user administers half the dose of medication in each nostril. This means users must maintain an awareness of the amount of medication they are administering and must remember to administer half the syringe into each nostril. Contrastingly, NARCAN® Nasal Spray only requires the user to deliver a single dose into one nostril. A lay user’s emergency stress response may thus make it more difficult to correctly administer naloxone when using a PFS-NA.

Discussion

The opioid crisis is widespread, and naloxone temporarily mitigates the life-threatening respiratory depression that causes opioid overdose fatalities. Given the speed of illicit fentanyl, its rising use, and the risk of consuming opioids laced with fentanyl [25], saving opioid overdose victims’ lives increasingly depends on the ability of nonmedical first responders and lay bystanders to appropriately administer naloxone rescue treatments. This study evaluated the ease of use of administering IN naloxone in time-critical emergency situations with two different products: NARCAN® Nasal Spray and a PFS-NA.

Opioid overdoses caused over 140,000 nonfatal emergency department visits and over 42,000 fatalities in 2017 [26, 27]. The symptoms of opioid overdose are pinpoint pupils, unconsciousness, and respiratory depression [28]; respiratory depression may cause death [3]. The treatment for opioid overdoses is to combat this suppressed breathing physically though cardiopulmonary resuscitation (CPR) and pharmacologically through naloxone administration.

Naloxone use in emergency opioid overdose situations is common and promoted for nonmedical users, making it important to evaluate this user group’s needs. Lay administration keeps overdose victims alive until EMS arrive. Lay users, however, often have minimal training on naloxone administration and are more likely to experience mental limitations due to stress in emergency situations. The human factors task and risk assessments revealed that compared with NARCAN® Nasal Spray, a PFS-NA involved substantially more steps to complete the Preparation and Delivery tasks. The task simplicity of NARCAN® Nasal Spray should thus aid lay users in correct medication administration.

Real-world findings from the Association for Addiction Professionals support the results from this study. Data indicate that a PFS-NA is difficult to assemble and that users commonly break or misuse kit components [29]. Our risk analysis strengthens usability study results from Edwards et al. [11] and Krieter et al. [12], which suggest that untrained users are unlikely to successfully administer naloxone using a PFS-NA and are more likely to successfully administer the medication using NARCAN® Nasal Spray.

The primary limitation of this comparative human factors analysis was that the task analysis did not involve actual opioid users. Future research might include evaluating these products with opioid users or using an expanded set of human factors techniques, such as time-and-motion analysis. This would provide further insights into the safety of each IN naloxone administration method.

Conclusions

Training nonmedical personnel to use naloxone presents the human factors challenge of how best to design a safe and effective delivery system for lay users given the added mental constraints posed by emergency situations. From a human factors perspective, nonmedical emergency responders and bystanders are more likely to correctly and successfully administer NARCAN® Nasal Spray than a naloxone PFS-NA.

Notes

Acknowledgements

The authors thank the Design Science Design Department, particularly Margo Hurst, for creating many of the graphics in this paper.

Funding

ADAPT Pharma, Inc., funded the technical evaluation of the products and the journal article processing charges. Design Science Consulting was recruited and paid by ADAPT Pharma, Inc., to perform a third-party evaluation of NARCAN® Nasal Spray and a naloxone PFS-NA. This paper presents a discussion of their results. Design Science Consulting is a human factors medical device consulting company with over 25 years of experience evaluating the usability of medical devices. All named authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.

Editorial Assistance

The authors thank MedVal Scientific Information Services, LLC (Princeton, NJ), for providing editorial and submission support, paid for by ADAPT Pharma, Inc. (Radnor, PA).

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Disclosures

Kathryn G. Tippey, has a PhD in Industrial and Systems Engineering from Texas A&M University, and completed a Postdoctoral Research Fellowship at Vanderbilt University Medical Center. Kathryn G. Tippey has been conducting human factors research across the medical, driving, aviation, and nuclear domains for nearly a decade. Kathryn G. Tippey is a Human Factors Engineer at Design Science Consulting. Mary Yovanoff is an Associate Engineer II at Design Science Consulting. Larry McGrath is a Researcher at Design Science Consulting. Peter Sneeringer is the Director of Research and Strategy at Design Science Consulting.

Compliance with Ethics Guidelines

This article does not contain any studies with human participants or animals performed by any of the authors.

Data Availability

Data sharing is not applicable to this article because no associated datasets were generated during this study.

Open Access

This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

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Copyright information

© The Author(s) 2019

Authors and Affiliations

  • Kathryn G. Tippey
    • 1
    Email author
  • Mary Yovanoff
    • 1
  • Larry S. McGrath
    • 1
  • Peter Sneeringer
    • 1
  1. 1.Design Science ConsultingPhiladelphiaUSA

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