In a Swedish University Hospital, the RealHOPE research group conducted a study to evaluate the potential risks and mitigation strategies for ensuring the integrity and stability of protein drugs, including monoclonal antibodies used in cancer and immune system treatments.
Through a comprehensive analysis using the Gemba Walk method and the Double Diamond design approach, various stress factors such as temperature, impact, shaking, vibration, and light exposure were identified. Lack of awareness and information among healthcare professionals also posed risks. The study emphasized the importance of validated protocols, training, and proper communication to maintain the quality of protein drugs throughout their supply chain, from compounding in cleanrooms to transportation and patient administration.
“I was surprised to see how often boxes were dropped in the logistic chain. This type of deviation will likely only be reported if broken glass containers or leaking solutions are seen by supply chain staff. In our case, the container is often a soft plastic infusion bag that will be intact after a drop, but the contents may be affected”, says PhD Mattias Paulsson, Deputy chief pharmacist at Uppsala University Hospital and Associate professor at Uppsala University.
This study benefits healthcare professionals, patients, and pharmaceutical companies. Healthcare professionals gain insights into risks associated with protein drugs, emphasizing the need for proper handling and communication. Patients benefit from improved drug quality and safety through adherence to protocols. Pharmaceutical companies understand how their products are handled and can develop more robust formulations and strategies for packaging and transportation. Overall, the study promotes best practices, mitigates risks, and improves patient care and treatment outcomes.
“Now that we understand and have captured the real-life handling of protein drugs in hospitals we are currently simulating and studying in more detail those steps that we anticipate would be the most the most harmful. Finally, we will try to find the best way to communicate the new knowledge to healthcare professionals, patients, and pharmaceutical companies”, says Mattias Paulsson.
Link to the publication: https://jpharmsci.org/article/S0022-3549%2823%2900191-0/fulltext