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两种鼻腔纳洛酮给药装置的人体因素比较评估:NARCAN鼻腔喷雾剂和带鼻腔雾化器的纳洛酮预充式注射器

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

作者信息

Tippey Kathryn G, Yovanoff Mary, McGrath Larry S, Sneeringer Peter

机构信息

Design Science Consulting, Philadelphia, PA, USA.

出版信息

Pain Ther. 2019 Jun;8(1):89-98. doi: 10.1007/s40122-019-0118-0. Epub 2019 Mar 15.

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.

摘要

引言

阿片类药物过量急救情况时间紧迫、压力巨大,常常需要非医疗急救人员或旁观者进行干预并注射纳洛酮,以避免阿片类药物导致的死亡。培训非医疗人员在这种精神紧张的情况下做出反应,带来了如何设计一个安全有效的非专业给药系统这一人因工程学挑战。本文比较评估了两种鼻腔用纳洛酮给药产品的易用性:NARCAN鼻喷雾剂和配有鼻腔雾化器的纳洛酮预充式注射器(PFS-NA)。

方法

我们采用面向系统的方法评估了NARCAN鼻喷雾剂与纳洛酮PFS-NA的使用要求和可用性。首先,我们确定了不同用户群体的使用要求。接下来,我们着重构建了这两种产品的人因工程学任务分析。最后,我们对两种产品之间不同的任务进行了比较风险评估。

结果

经验不足的用户,如非医疗急救人员和旁观者,在错误注射纳洛酮方面风险最高,尤其是在高压力的阿片类药物过量紧急急救情况下。设备准备和药物给药任务最能区分NARCAN鼻喷雾剂和PFS-NA的使用。PFS-NA的任务复杂程度和这些任务中的步骤数量比NARCAN鼻喷雾剂要大得多。

结论

与纳洛酮PFS-NA相比,NARCAN鼻喷雾剂所需步骤更少,给药更容易。因此,在时间紧迫、压力巨大的阿片类药物过量急救情况下,使用NARCAN鼻喷雾剂应能增加非医疗人员正确及时注射纳洛酮的可能性。

资金来源

ADAPT制药公司

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5d70/6513948/3fe766686b7f/40122_2019_118_Fig1_HTML.jpg

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