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How are we handling protein drugs in hospitals? A human factors and systems engineering approach to compare two hospitals and suggest a best practice

Sabaté-Martínez, Clàudia ; Paulsson, Mattias ; González-Suárez, Silvia ; Elofsson, Ulla ; Fureby, Anna Millqvist ; Wahlgren, Marie LU orcid and López-Cabezas, Carmen (2024) In International Journal for Quality in Health Care 36(1).
Abstract

Biopharmaceuticals are complex biological molecules that require careful storage and handling to ensure medication integrity. In this study, a work system analysis of real-world protein drug (PD) handling was performed with the following goals: identify main barriers and facilitators for successful adherence to accepted recommendations in PD handling, analyse differences in two organizations, and define a Best Current Practice in the real-life handling of PDs based on the results of the work system analysis. Observational study was held in two university hospitals in Spain and Sweden. Based on the Systems Engineering Initiative for Patient Safety (SEIPS) model, the tools chosen were: the PETT scan, in order to indicate the presence of... (More)

Biopharmaceuticals are complex biological molecules that require careful storage and handling to ensure medication integrity. In this study, a work system analysis of real-world protein drug (PD) handling was performed with the following goals: identify main barriers and facilitators for successful adherence to accepted recommendations in PD handling, analyse differences in two organizations, and define a Best Current Practice in the real-life handling of PDs based on the results of the work system analysis. Observational study was held in two university hospitals in Spain and Sweden. Based on the Systems Engineering Initiative for Patient Safety (SEIPS) model, the tools chosen were: the PETT scan, in order to indicate the presence of barriers or facilitators for the PETT components (People, Environment, Tools, Tasks); the Tasks and tools matrices to construct a checklist to record direct observations during the real-life handling of biopharmaceuticals, and the Journey map to depict the work process. Observations were performed between March and November 2022. Each episode of direct observation included a single protein drug in some point of the supply chain and considered all the elements in the work system. Based on the results of the work system analysis and the literature review, the authors propose a list of items which could be assumed as Best Current Practice for PDs handling in hospitals. There were a total of 34 observations involving 19 PDs. Regarding People involved in the work process, there was a diversity of professionals with different previous training and knowledge, leading to an information gap. With respect to Environment, some structural and organizational differences between hospitals lead to risks related to the time exposure of PDs to room temperature and mechanical stress. Some differences also existed in the Tools and Tasks involved in the process, being especially relevant to the lack of compatibility information of PDs with new technologies, such as pneumatic tube system, robotic reconstitution, or closed-system transfer devices. Finally, 15 suggestions for best current practice are proposed. Main barriers found for compliance with accepted recommendations were related to the information gap detected in professionals involved in the handling of protein drugs, unmonitored temperature, and the lack of compatibility information of protein drugs with some new technologies. By applying a Human Factors and Systems Engineering Approach, the comparison of two European hospitals has led to a suggested list of Best Current Practices in the handling of protein drugs in a hospital.

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author
; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
chemical stability, hospital pharmacy, human factor, monoclonal antibodies, protein aggregation, protein handling
in
International Journal for Quality in Health Care
volume
36
issue
1
article number
mzae020
publisher
Oxford University Press
external identifiers
  • scopus:85190154114
  • pmid:38462489
ISSN
1353-4505
DOI
10.1093/intqhc/mzae020
language
English
LU publication?
yes
id
7d7e1c4d-8354-4213-9932-89d8a570a216
date added to LUP
2024-04-24 15:11:15
date last changed
2024-06-19 20:18:50
@article{7d7e1c4d-8354-4213-9932-89d8a570a216,
  abstract     = {{<p>Biopharmaceuticals are complex biological molecules that require careful storage and handling to ensure medication integrity. In this study, a work system analysis of real-world protein drug (PD) handling was performed with the following goals: identify main barriers and facilitators for successful adherence to accepted recommendations in PD handling, analyse differences in two organizations, and define a Best Current Practice in the real-life handling of PDs based on the results of the work system analysis. Observational study was held in two university hospitals in Spain and Sweden. Based on the Systems Engineering Initiative for Patient Safety (SEIPS) model, the tools chosen were: the PETT scan, in order to indicate the presence of barriers or facilitators for the PETT components (People, Environment, Tools, Tasks); the Tasks and tools matrices to construct a checklist to record direct observations during the real-life handling of biopharmaceuticals, and the Journey map to depict the work process. Observations were performed between March and November 2022. Each episode of direct observation included a single protein drug in some point of the supply chain and considered all the elements in the work system. Based on the results of the work system analysis and the literature review, the authors propose a list of items which could be assumed as Best Current Practice for PDs handling in hospitals. There were a total of 34 observations involving 19 PDs. Regarding People involved in the work process, there was a diversity of professionals with different previous training and knowledge, leading to an information gap. With respect to Environment, some structural and organizational differences between hospitals lead to risks related to the time exposure of PDs to room temperature and mechanical stress. Some differences also existed in the Tools and Tasks involved in the process, being especially relevant to the lack of compatibility information of PDs with new technologies, such as pneumatic tube system, robotic reconstitution, or closed-system transfer devices. Finally, 15 suggestions for best current practice are proposed. Main barriers found for compliance with accepted recommendations were related to the information gap detected in professionals involved in the handling of protein drugs, unmonitored temperature, and the lack of compatibility information of protein drugs with some new technologies. By applying a Human Factors and Systems Engineering Approach, the comparison of two European hospitals has led to a suggested list of Best Current Practices in the handling of protein drugs in a hospital.</p>}},
  author       = {{Sabaté-Martínez, Clàudia and Paulsson, Mattias and González-Suárez, Silvia and Elofsson, Ulla and Fureby, Anna Millqvist and Wahlgren, Marie and López-Cabezas, Carmen}},
  issn         = {{1353-4505}},
  keywords     = {{chemical stability; hospital pharmacy; human factor; monoclonal antibodies; protein aggregation; protein handling}},
  language     = {{eng}},
  month        = {{01}},
  number       = {{1}},
  publisher    = {{Oxford University Press}},
  series       = {{International Journal for Quality in Health Care}},
  title        = {{How are we handling protein drugs in hospitals? A human factors and systems engineering approach to compare two hospitals and suggest a best practice}},
  url          = {{http://dx.doi.org/10.1093/intqhc/mzae020}},
  doi          = {{10.1093/intqhc/mzae020}},
  volume       = {{36}},
  year         = {{2024}},
}