One of the studies within work package GOLD was carried out by comparing two hospital settings – one in Sweden and one in Spain, by RealHOPE researchers Mattias Paulsson and Carmen Lopez.
By comparing the two hospital settings – the Hospital Clínic of Barcelona (Carmen López) and the Uppsala University, Akademiska sjukhuset (Mattias Paulsson), the researchers discovered that light exposure, temperature fluctuations, vibrations during transport, and handling practices are key stressors for protein drugs. These stressors can compromise the quality of sensitive medications, potentially affecting patient safety and treatment outcomes.
To reach these conclusions, they conducted real-world observational studies, analyzing workflows, storage conditions, and transport methods. They also compared this data to existing guidelines and controlled experiments to assess the stability of protein drugs under different stress conditions.
“The study uses the SEIPS (Systems Engineering Initiative for Patient Safety) model to define the stressors and facilitators of the correct handling of protein drugs in hospitals and defines a list of “good practices” that may be useful to other colleagues working with biopharmaceuticals in the hospital environment. On the other hand, the pharmaceutical industry may also find it interesting to know the main stressors to which these products may be exposed in real life”, says Carmen.
“To ensure the correct use of protein drugs in the clinical environment, we should fight against the information gap detected in professionals involved in the handling of protein drugs, avoid physical stressors during storing, transport or reconstitution procedures, and find out the compatibility of these molecules with new technologies, such as CSTD (closed system transfer device), pneumatic tube or compounding robots”.
She points out that future research efforts could focus on expanding the discussion to explore the potential implementation of the study results in different hospital settings. A more in-depth investigation of the scalability of the proposed best practices would be beneficial, addressing how these practices can be effectively adapted to accommodate the different resources and infrastructures found in different healthcare settings.
“On the other hand, it would be desirable to complement this qualitative research with other types of studies that can quantify the effect of stressors on protein drugs under real-world management,” she says.
“This research was made possible thanks to the RealHOPE project, which brought together researchers from academia, hospitals and the pharmaceutical industry to address critical knowledge gaps and ensure that protein-based therapies are used safely and effectively in clinical settings. This work underlines the importance of research funding and cross-sectoral collaboration to advance the practice of hospital pharmacy. We are pleased that through this project we have connected with others who have an interest in improving the safety and quality of these life-saving protein-based medicines!”, Mattias concludes.
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