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

ABSTRACT

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.

KEYWORDS:

• Medication preparation
• reconstitution system
• drug delivery device
• lyophilization
• parenteral drug
• ethnographic research

Acknowledgments

The authors would like to acknowledge Erika Bajars, Hayley Carabello, Allison Bellows, Iwayoshi Shun, and Takeuchi Katsuyuki for their contributions to this study and manuscript.

Author contributions

C Franzese: study design, study moderation, analysis, interpretation of the data, drafting and revising of the manuscript, and final approval of the version to be published. C Thomas: study design, study moderation, analysis, and interpretation of the data. A Rinaldi: study design, study moderation, analysis, and interpretation of the data. K Constable: study design and revising the manuscript critically for intellectual content. K Nakamura: study design and revising the manuscript critically for intellectual content. A Kalbermatten: study design and revising the manuscript critically for intellectual content. M Coyne: study design, analysis, interpretation of the data, drafting and revising of the manuscript, and final approval of the version to be published.

Declaration of interest

The authors have declared that this research may be used to inform the development of products that ultimately license Terumo products. K Constable, K Nakamura, and A Kalbermatten are employed by Terumo Pharmaceutical Solutions. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This research was sponsored by Terumo Pharmaceutical Solutions.