Raffa Robert B, Taylor Robert, Pergolizzi Joseph V, Nalamachu Srinivas, Edwards Eric S, Edwards Evan T
Temple University School of Pharmacy, Philadelphia, PA, USA.
NEMA Research, Bonita Springs, FL, USA.
Drug Deliv Transl Res. 2017 Feb;7(1):1-10. doi: 10.1007/s13346-016-0323-x.
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.
阿片类药物用于慢性疼痛治疗的使用增加以及由此引发的阿片类药物过量流行已构成一项重大的公共卫生挑战。自20世纪70年代以来，肠外纳洛酮一直用于治疗阿片类药物过量。最近，一种新型纳洛酮自动注射器装置（EVZIO，卡莱奥公司，弗吉尼亚州里士满）获得了美国食品药品监督管理局的批准。在本文中，我们回顾了用于开发和测试这种新型纳洛酮自动注射器的人因工程（HFE）过程，该装置目前用于非医疗环境中对已知或疑似阿片类药物过量进行急救。在纳洛酮自动注射器的整个产品开发过程中都采用了HFE方法，包括形成性研究和总结性研究，以优化自动注射器的用户界面，减轻与使用相关的危害，并在阿片类药物紧急使用场景中提高可靠性。HFE还用于优化产品的设计和用户界面，以减少或防止用户混淆和误用。纳洛酮自动注射器经历了严格的HFE过程，包括感知、认知和身体动作分析；形成性可用性评估；使用错误分析和总结性设计验证研究。应用HFE导致开发出一种产品，在阿片类药物过量紧急情况下能够安全、快速、轻松且可预测地可靠地提供可能挽救生命剂量的纳洛酮。纳洛酮自动注射器可被视为为开具阿片类药物的高危患者或阿片类药物过量紧急风险增加的患者的一种通用预防选择。
