التفاصيل البيبلوغرافية
| العنوان: |
Examination of the Protein Drug Supply Chain in a Swedish University Hospital: Focus on Handling Risks and Mitigation Measures. |
| المؤلفون: |
Martínez, Clàudia Sabaté1,2 (AUTHOR), Amery, Leanne3 (AUTHOR), De Paoli, Giorgia4 (AUTHOR), Elofsson, Ulla5 (AUTHOR), Fureby, Anna Millqvist5 (AUTHOR), Kwok, Stanley6 (AUTHOR), López-Cabezas, Carmen7 (AUTHOR), Rosenberger, Marika8 (AUTHOR), Schoenau, Christian8 (AUTHOR), Wahlgren, Marie9 (AUTHOR), Paulsson, Mattias1 (AUTHOR) mattias.paulsson@kbh.uu.se |
| المصدر: |
Journal of Pharmaceutical Sciences. Nov2023, Vol. 112 Issue 11, p2799-2810. 12p. |
| مصطلحات موضوعية: |
*PROTEIN drugs, *UNIVERSITY hospitals, *FAILURE mode & effects analysis, *SPECIALTY pharmacies, *MEDICAL personnel, *SUPPLY chains, *HOSPITAL wards |
| مستخلص: |
Protein drugs, such as monoclonal antibodies, have proved successful in treating cancer and immune system diseases. The structural complexity of these molecules requires careful handling to ensure integrity and stability of the drug. In this study, a failure mode and effects analysis was performed based on a Gemba Walk method in a Swedish University Hospital. The Gemba Walk is focused on pharmacists observing the actual supply process steps from distributor, pharmacy cleanroom to patient administration. Relevant protein drugs are chosen based on sales statistics within the hospital and the corresponding wards were observed. Further is the Double Diamond design method used to identify major risks and deliver mitigation strategies. The study identified potential stress factors such as temperature, shock by impact, shaking, vibration and light exposure. There were also risks associated with porters' and healthcare professionals' lack of awareness and access to information. These risk factors may cause loss of efficacy and quality of the protein drug, potentially leading to patient safety concerns. In this study, a simulation is also performed to list measures that theoretically should be in place to ensure the quality of the protein drug, for example validated and protocol-based compounding in cleanroom, training and validated transports. [Display omitted] • The risks and potential stress factors associated with real-life handling and management of protein drugs in a hospital setting are presented. • The study employs the Gemba Walk method and the double diamond design method to identify risks and deliver mitigation strategies in a comprehensive approach. • Proposed measures are for example protocol-based compounding in cleanrooms, training of nurses and validated transport solutions. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
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