Evaluating the usability and safety of the semaglutide single‐dose pen‐injectors through summative (human factors) usability testing

AIMS/INTRODUCTION: A single‐dose, shield‐activated pen‐injector for each of the three approved dose variants (0.25, 0.5 and 1 mg) of once‐weekly subcutaneous semaglutide has been developed to improve usability. This analysis presents findings from the summative usability testing process for the single‐dose semaglutide pen‐injectors, including the pen‐injector four‐pack cartons and instructions for use. MATERIALS AND METHODS: A total of 60 adults representing four user groups were included: patients with/without pen‐injector experience, non‐pharmacist healthcare professionals and pharmacists (each n = 15). Participants carried out four tasks: (i) pen‐injector carton retrieval; (ii) first simulated injection; (iii) pen‐injector retrieval; and (iv) second simulated injection. All participants carried out task 1, and patients and non‐pharmacist healthcare professionals took part in tasks 2–4 (n = 45). The number and types of use errors, close calls and operational difficulties were evaluated, and participants subjectively rated the ease of each task on a scale of 1 (difficult) to 7 (easy). RESULTS: No potentially serious use errors and only one non‐serious use error were reported. Eight participants committed use errors with no potential for harm, one participant committed an unclassified use error, one participant encountered a close call with no potential for harm and one participant experienced an operational difficulty. Mean ease‐of‐use ratings were 6.7 (task 1), 5.9 (task 2), 6.6 (task 3) and 6.9 (task 4). CONCLUSIONS: All three dose variants of the semaglutide single‐dose pen‐injector were considered easy to use (subjective feedback scores near 7) and not associated with any serious use errors, even when participants received no training before study participation.