Risk of dosing errors in ART treatment: user experience of single- vs multi-use follitropin alfa pens

Abstract

Background: This user experience study evaluated the suitability of single-use versus multi-dose follitropin alfa pen injectors for self-administration by women undergoing fertility treatment. Methods: Twenty-four fertility patients and 19 specialist nurses were recruited in four European countries to assess their use of Bemfola (a single-use pen), Gonal-f ® , and Ovaleap ® (multi-use pens). Participants completed usability tests in which their performance in assembling and administering doses of each pen was assessed against defined critical steps for ensuring safe and correct administration.Results: Critical error rates among nurses were 4%, 40%, and 49% for Bemfola ® , Ovaleap ® , and Gonalf ® , respectively; and among patients were 7%, 16%, and 38%. The most frequently reported critical errors occurred with the multi-use pens and were incorrect/lack of priming and failure to check the dose window prior to setting a new dose. The need to 'top up' doses from a new pen or cartridge when a pen contained insufficient dose also caused errors. The single-use pens did not cause these errors.Overall, 63% of nurses and 67% of patients had most confidence in Bemfola ® for correct dosing and self-administration. Conclusions: Single-use pens require fewer preparation and administration steps than multi-use pens and are associated with fewer critical handling errors.

Analysis of Nurse and Patient Preferences for Pre-Filled Pen Devices for Self-Injection of Highly Purified Human Menopausal Gonadotropin (HP-hMG, MENOPUR®)

“…[24][25][26] Reusable and multi-dose pens have also been perceived by patients to reduce waste and contribute to the protection of the environment. 20 However, there is evidence that patients may be more likely to make handling errors with multidose pens compared with single-dose pens, 27 for example, dialing a dose too high in error. Therefore, there is a preference for devices where it is possible to "dial-back" the dose to ensure correct dosing with each use.…”