The burden of at-home preparation of lyophilized parenteral medications: an analysis of contributing factors and implications for chronic disease patients and caregivers

Background: In the acute care setting, parenteral medication errors are well-studied. However, there is comparatively little research on how these issues translate to patient- or caregiver-prepared medications in the home, particularly with reconstituted medications.

Methods: This was an ethnographic study designed to identify issues associated with four reconstitution use scenarios. Preparation burden was determined by measuring the time and manipulations required to prepare reconstituted medications across three preparation phases (assembly, reconstitution, and transfer). Deviations from product instructions for use, sterility breaches, self-reported preparation complications, and supply storage conditions were also analyzed.

Results: A total of 14 participants completed the study. Overall, preparation burden was markedly higher when purpose-built reconstitution devices were not available. The majority of participants reported experiencing at least one complication associated with their medication preparation process; the reconstitution phase was the most significant source of both instructions for use deviations and breaches in sterility. Participants reported that the volume and variety of medication preparation supplies were a significant source of burden.

Conclusions: At-home preparation of reconstituted medications poses several challenges for patients and caregivers. As parenteral medications continue to shift towards self-administration, manufacturers should carefully consider the usability of such products and employ purpose-built reconstitution devices whenever possible.