Design of an Evidence-Based Checklist to Help Prevent Use Errors with Auto-Injector Pens

Auto-injector pens (AIPs) can improve a patient’s quality of life. However, some human factors problems in AIP design can prompt the occurrence of use errors with sometimes dramatic consequences. AIP manufacturers are required to identify characteristics of the user interface that might lead to use errors. This identification can be time-consuming and fastidious. Here, we report on the initial steps in the design of a checklist for identifying AIP use errors (CAPU). The checklist is intended to help professionals in charge of the design and risk management of disposable AIPs to determine the likelihood of use errors more easily. A review of the literature (57 publications) enabled us to identify 341 semantic units that were representative of use errors. These errors were grouped into 50 categories and covered all the steps in AIP use (i.e. from storage to injection and disposal). Initial feedback on CAPU from human factors engineers enabled us to clarify the list’s content and the way in which the use errors were listed. CAPU is intended to simplify certain tasks for risk management professionals working on AIPs. It is not intended to replace the involvement of human factors experts in AIP design, evaluation and risk management. The next steps in the project consist in developing a software version of the checklist and extending the volume and type of data underpinning it. Lastly, the checklist’s usefulness and psychometric qualities should be evaluated with risk management professionals working on AIPs.