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.
Keywords: Generic substitution; anaphylaxis; attitudes; autoinjector; caregivers; complex; drug–device combination product; emergency use; epinephrine; patients; perceptions.