Use of failure mode and effect analysis to improve the monoclonal antibody drugs management process in pharmacy intravenous admixture services
Abstract Monoclonal antibodies (mAbs) constitute a new form of immunotherapy that has shown great success in long-term tumour control. These injectable drugs are managed and compounded by the Pharmacy Intravenous Admixture Services (PIVAS) staff in a specified sterile environment. This study utilize...
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| Format: | Article |
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Nature Portfolio
2025-02-01
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| Series: | Scientific Reports |
| Online Access: | https://doi.org/10.1038/s41598-025-89145-3 |
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| author | Jian Cai Min-Xian Li Shuai Lu Dan Shen Wei Xie Jian-Jun Zhu Guo-Jun Jiang Chun-Xiao Lu |
| author_facet | Jian Cai Min-Xian Li Shuai Lu Dan Shen Wei Xie Jian-Jun Zhu Guo-Jun Jiang Chun-Xiao Lu |
| author_sort | Jian Cai |
| collection | DOAJ |
| description | Abstract Monoclonal antibodies (mAbs) constitute a new form of immunotherapy that has shown great success in long-term tumour control. These injectable drugs are managed and compounded by the Pharmacy Intravenous Admixture Services (PIVAS) staff in a specified sterile environment. This study utilized failure mode and effect analysis (FMEA) as a risk management tool to manage mAb drugs within the PIVAS. The nine-member multidisciplinary team mapped the processes; evaluated the severity, occurrence, and detection of each subprocess; and calculated the risk priority number (RPN). Further corrective actions were taken for high-risk steps, followed by re-evaluation and scoring to achieve a low-risk process. We identified seven major processes and twenty-eight subprocesses involved in the management of mAb drugs in PIVAS. A total of thirteen high-risk failure modes with an assigned RPN 1 were selected. This selection represents the first calculated RPN values, resulting in a total score of 3375. After a first round of evaluation and implementation of corrective actions, the RPN 2 score decreased to 464. Following a second round of the FMEA process, the RPN 3 score was further reduced to 51. Through refinement, we successfully mitigated the occurrence of high-risk failure modes of mAb drugs in PIVAS. These efforts are aimed at enhancing the safety and efficacy of mAb drugs, ultimately ensuring patient safety. |
| format | Article |
| id | doaj-art-a1060bc1d8f54331a31b8e404dae2854 |
| institution | Kabale University |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj-art-a1060bc1d8f54331a31b8e404dae28542025-02-09T12:33:34ZengNature PortfolioScientific Reports2045-23222025-02-0115111310.1038/s41598-025-89145-3Use of failure mode and effect analysis to improve the monoclonal antibody drugs management process in pharmacy intravenous admixture servicesJian Cai0Min-Xian Li1Shuai Lu2Dan Shen3Wei Xie4Jian-Jun Zhu5Guo-Jun Jiang6Chun-Xiao Lu7Department of Pharmacy, Zhejiang Xiaoshan HospitalDepartment of Pharmacy, Zhejiang Xiaoshan HospitalDepartment of Pharmacy, Zhejiang Xiaoshan HospitalDepartment of Pharmacy, Zhejiang Xiaoshan HospitalDepartment of Pharmacy, Zhejiang Xiaoshan HospitalDepartment of Pharmacy, Zhejiang Xiaoshan HospitalDepartment of Pharmacy, Zhejiang Xiaoshan HospitalDepartment of Pharmacy, Zhejiang Xiaoshan HospitalAbstract Monoclonal antibodies (mAbs) constitute a new form of immunotherapy that has shown great success in long-term tumour control. These injectable drugs are managed and compounded by the Pharmacy Intravenous Admixture Services (PIVAS) staff in a specified sterile environment. This study utilized failure mode and effect analysis (FMEA) as a risk management tool to manage mAb drugs within the PIVAS. The nine-member multidisciplinary team mapped the processes; evaluated the severity, occurrence, and detection of each subprocess; and calculated the risk priority number (RPN). Further corrective actions were taken for high-risk steps, followed by re-evaluation and scoring to achieve a low-risk process. We identified seven major processes and twenty-eight subprocesses involved in the management of mAb drugs in PIVAS. A total of thirteen high-risk failure modes with an assigned RPN 1 were selected. This selection represents the first calculated RPN values, resulting in a total score of 3375. After a first round of evaluation and implementation of corrective actions, the RPN 2 score decreased to 464. Following a second round of the FMEA process, the RPN 3 score was further reduced to 51. Through refinement, we successfully mitigated the occurrence of high-risk failure modes of mAb drugs in PIVAS. These efforts are aimed at enhancing the safety and efficacy of mAb drugs, ultimately ensuring patient safety.https://doi.org/10.1038/s41598-025-89145-3 |
| spellingShingle | Jian Cai Min-Xian Li Shuai Lu Dan Shen Wei Xie Jian-Jun Zhu Guo-Jun Jiang Chun-Xiao Lu Use of failure mode and effect analysis to improve the monoclonal antibody drugs management process in pharmacy intravenous admixture services Scientific Reports |
| title | Use of failure mode and effect analysis to improve the monoclonal antibody drugs management process in pharmacy intravenous admixture services |
| title_full | Use of failure mode and effect analysis to improve the monoclonal antibody drugs management process in pharmacy intravenous admixture services |
| title_fullStr | Use of failure mode and effect analysis to improve the monoclonal antibody drugs management process in pharmacy intravenous admixture services |
| title_full_unstemmed | Use of failure mode and effect analysis to improve the monoclonal antibody drugs management process in pharmacy intravenous admixture services |
| title_short | Use of failure mode and effect analysis to improve the monoclonal antibody drugs management process in pharmacy intravenous admixture services |
| title_sort | use of failure mode and effect analysis to improve the monoclonal antibody drugs management process in pharmacy intravenous admixture services |
| url | https://doi.org/10.1038/s41598-025-89145-3 |
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