Comparative Usability Study of a Novel Auto-Injector and an Intranasal System for Naloxone Delivery

Abstract

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.

Availability of naloxone in Canadian pharmacies:a population-based survey

“…41,42 Moreover, a more userfriendly formulation (such as naloxone spray) could improve uptake and demand, reduce the need for intensive training and the risk of needlestick injury, and increase the efficiency with which the drug could be administered. 43,44 However, the cost of intranasal naloxone is much higher than that of injectable naloxone and is likely to be prohibitive for many opioid users. 45 Our study has several strengths that merit emphasis.…”

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

“…In phase III, 100 % of participants completed a successful injection using the naloxone auto-injector versus 50.6 % using the IN naloxone delivery system (p < 0.0001). The average time for successful naloxone administration in Phase I with the naloxone auto-injector was 56 s and an average time was not available for the IN naloxone delivery system as no participants successfully administered the IN naloxone [35]. After excluding Phase III completion times for study participants who were unsuccessful in administering naloxone for any reason, study participants were able to successfully administer naloxone 3 times faster with the naloxone auto-injector (35 s) as compared to the IN naloxone system (88 s).…”

Patient Simulation for Assessment of Layperson Management of Opioid Overdose With Intranasal Naloxone in a Recently Released Prisoner Cohort

“…Additionally, trepidation associated with accessing public safety services, i.e., calling 9-1-1, in the context of illicit drug-related activities was reported frequently by subjects and represents a prominent impediment to optimal resuscitative care – expansion of Good Samaritan overdose immunity laws may ameliorate this problem. 30 Next steps for community IN naloxone research efforts will need to address these unique operational challenges while ensuring correct device assembly (or alternative delivery mechanisms 31,32 ), appropriate naloxone dose, proper administration technique and the avoidance of non-indicated actions.…”