IntroductionThe standard of care for reversal of opioid-induced respiratory depression associated with opioid overdose is injectable naloxone. This study compared the usability of two naloxone delivery devices, a naloxone auto-injector (NAI) and a naloxone intranasal delivery system (NXN), in the administration of naloxone during a simulated opioid overdose emergency. NAI (EVZIO®; kaleo, Inc., Richmond, VA, USA) is a Food and Drug Administration approved single-use pre-filled auto-injector containing 0.4 mg of naloxone.MethodsStudy participants were randomly assigned to administer naloxone using NAI and NXN, sequentially. The primary endpoint was successful administration of a simulated dose of naloxone into a mannequin during a simulated opioid emergency, both before and after receiving training. Secondary endpoints included using the NAI or NXN in accordance with the instructions-for-use and the comparative measurement of successful completion time of administration for both NAI and NXN.ResultsA total of 42 healthy participants aged 18–65 years were enrolled in the study. The proportion of participants able to successfully administer a simulated dose of naloxone was significantly greater for NAI compared to NXN both before (90.5% vs. 0.0%, respectively, P < 0.0001) and after (100% vs. 57.1%, respectively, P < 0.0001) participant training. The proportion of participants able to administer a simulated dose of naloxone in accordance with the instructions-for-use was also significantly greater for NAI compared to NXN before (85.7% vs. 0.0%, respectively, P < 0.0001) and after (100% vs. 0.0%, respectively, P < 0.0001) participant training. The average time to task completion for administration attempt before training was 0.9 ± 0.25 min for NAI versus 6.0 ± 4.76 min for NXN and after training was 0.5 ± 0.15 min for NAI versus 2.0 ± 2.15 min for NXN.ConclusionLaypersons experienced substantially greater success administering a simulated dose of naloxone, both before and after training, using NAI versus NXN during a simulated opioid overdose emergency. No participants correctly used NXN without training.Electronic supplementary materialThe online version of this article (doi:10.1007/s40122-015-0035-9) contains supplementary material, which is available to authorized users.
Background: Despite the importance of prompt epinephrine auto-injector (EAI) treatment during anaphylaxis, proper administration technique is often lacking among patients and caregivers. Objective: To compare usability and participant preference of Auvi-Q and EpiPen Jr EAIs in a simulated lifethreatening allergic emergency-use scenario. Methods: In this randomized, crossover, human-factors usability study, untrained adults (18-65 years) were tasked with using 0.15 mg Auvi-Q and EpiPen Jr trainers to simulate epinephrine administration to a childsized manikin. Only written instructions on the device label and/or device voice instructions were available to participants. Endpoints included completing injection tasks per device instructions (primary endpoint), completing key injection tasks, and participant preference/ratings of devices. Completion of injection tasks were evaluated using a McNemar test for paired dichotomous data. Results: Ninety-six adults were included in study analyses. Significantly more participants completed all injection tasks per device instructions with Auvi-Q (85.4%) vs EpiPen Jr (19.8%; P < .001). Significant differences were also observed for completion of key injection tasks (Auvi -Q, 94.8%; EpiPen Jr, 72.9%; P < .001). No digital/hand injection errors were seen with Auvi-Q, whereas 14 participants (14.6%) would have accidentally received a digital/hand injection with EpiPen Jr (P < .001). Overall, significantly more participants preferred Auvi-Q over EpiPen Jr (91.7% vs 6.3%; P < .001 [2.1% no preference]). Median scores for 8 EAI characteristics were also higher for Auvi-Q vs EpiPen Jr. Conclusion: In this study, untrained adults preferred and were more likely to use Auvi-Q correctly vs EpiPen Jr, highlighting the importance of device design for successful epinephrine administration during a lifethreatening allergic emergency.
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.
For drug-device combination products, device labeling and usability are critical and have the potential to impact clinical outcomes. Application of HFE principles to the development of drug-delivery devices has the potential to improve product quality and reliability, reduce risk and improve patient safety when applied early in the development process. Additional clinical and real-world studies will confirm whether the application of HFE has helped to develop an EAI that better meets the needs of patients at risk of anaphylaxis.
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