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Background: It is important to understand and address patient and caregiver perceptions about and attitudes toward generic substitution of drug–device combination products. Objective: The goal of this study was to explore how differences in design and usability features of epinephrine autoinjectors (EAIs) affect patients’ and caregivers’ views of product quality, efficacy, and device usability in an emergency setting and to better understand attitudes about and perceptions of EAI substitution. Methods: This qualitative, enhanced focus group study was conducted in the United States among adult and adolescent EAI users. A journey mapping exercise was used to explore patient and caregiver perceptions of and barriers to switching to a generic EAI. Discussion topics also focused on questions participants would ask, challenges they would face, and actions they would take if they were switched to a generic EAI. Results: While patients and caregivers were interested in the potential cost savings and increased access to treatment offered by generic EAIs, they wanted to be informed by their prescriber or pharmacist about generic substitution before or when it occurs. In terms of design differences, participant feedback most often related to differences in look and feel (eg, size, force to execute user tasks, hand grip) or functionality and design differences (eg, the generic version has a twist-off cap at the needle end, and the brand-name EpiPen does not). Conclusion: Outcomes from these focus groups suggest opportunities for the US Food and Drug Administration, health care professional organizations, and patient advocacy organizations to improve generic drug literacy among adults, adolescents, and health care providers.

During the 2014-2016 Ebola epidemic in West Africa, the US Centers for Disease Control and Prevention (CDC) developed the CARE+ program to help travelers arriving to the United States from countries with Ebola outbreaks to meet US government requirements of post-arrival monitoring. We assessed 2 outcomes: (1) factors associated with travelers’ intention to monitor themselves and report to local or state public health authority (PHA) and (2) factors associated with self-reported adherence to post-arrival monitoring and reporting requirements. We conducted 1195 intercept in-person interviews with travelers arriving from countries with Ebola outbreaks at 2 airports between April and June 2015. In addition, 654 (54.7%) of these travelers participated in a telephone interview 3 to 5 days after intercept, and 319 (26.7%) participated in a second telephone interview 2 days before the end of their post-arrival monitoring. We used regression modeling to examine variance in the 2 outcomes due to 4 types of factors: (1) programmatic, (2) perceptual, (3) demographic, and (4) travel-related factors. Factors associated with the intention to adhere to requirements included clarity of the purpose of screening ( B = 0.051, 95% confidence interval [CI], 0.011-0.092), perceived approval of others ( B = 0.103, 95% CI, 0.058-0.148), perceived seriousness of Ebola ( B = 0.054, 95% CI, 0.031-0.077), confidence in one’s ability to perform behaviors ( B = 0.250, 95% CI, 0.193-0.306), ease of following instructions ( B = 0.053, 95% CI, 0.010-0.097), and trust in CARE Ambassador ( B = 0.056, 95% CI, 0.009-0.103). Respondents’ perception of the seriousness of Ebola was the single factor associated with adherence to requirements (odds ratio [OR] = 0.81, 95% CI, 0.673-0.980, for non-adherent vs adherent participants and OR = 0.86, 95% CI, 0.745-0.997, for lost to follow-up vs adherent participants). Results from this assessment can guide public health officials in future outbreaks by identifying factors that may affect adherence to public health programs designed to prevent the spread of epidemics.