Pediatric blinatumomab preparation : Risk assessment on SmPC for software compliance
INTRODUCTION: Blinatumomab is an anticancer drug used in the treatment of Acute Lymphoblastic Leukaemia (ALL) in both adults and children. ALL is the most common form of cancer in children and patients who are refractory to standard treatments have poor prognosis. The preparation of blinatumomab is unique and extremely complex. It's important to carry out any information to identify all the critical issues related to the preparation of blinatumomab: sharing procedure between prescribers, staff of the Centralized Chemotherapy Preparation Unit [Unità Farmaci Antiblastici (UFA)] and administering nurses aimed at reducing the clinical risk related to the management of the drug blinatumomab and to obtain correct prescriptions on the real dose to be prepared, safe worksheets with computer processing of all variables (volumes to be added and corresponding dose of drug) and complete labels containing all the information necessary for the control of the preparation and its correct infusion.
METHODS: A computerized process involves the use of specific software to which precise instructions must be given. This study is divided into two phases, the first one focused on the analysis of Summary of Product Characteristics (SmPC) and the extrapolation of any unclear part of SmPC. The second phase involved the manufacturer to answer a questionnaire.
RESULTS: This comparison with the company allowed to perfect the blinatumomab preparation process leading to: 1. allow the patient to be discharged and return a few times for infusions and consequently reduce the number of medical prescriptions; 2. set up the drug for each patient every 4 days; 3. reduce costs related to devices, staff employed.
CONCLUSION: Computerizing the preparation of anti-blastic drugs is a necessary path for the safety of the patient and all the operators involved, however it may be necessary to make changes in the preparation process to allow the software to work correctly. The comparison between pharmacist, clinician and, where necessary, the manufacturer of the drug, was effective in the preparation of this drug.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:27 |
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| Enthalten in: |
Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners - 27(2021), 7 vom: 27. Okt., Seite 1674-1683 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Cirino, Mario [VerfasserIn] |
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| Links: |
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| Themen: |
4FR53SIF3A |
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| Anmerkungen: |
Date Completed 24.11.2021 Date Revised 24.11.2021 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1177/1078155220966394 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM316748560 |
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| 100 | 1 | |a Cirino, Mario |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Pediatric blinatumomab preparation |b Risk assessment on SmPC for software compliance |
| 264 | 1 | |c 2021 | |
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| 500 | |a Date Completed 24.11.2021 | ||
| 500 | |a Date Revised 24.11.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a INTRODUCTION: Blinatumomab is an anticancer drug used in the treatment of Acute Lymphoblastic Leukaemia (ALL) in both adults and children. ALL is the most common form of cancer in children and patients who are refractory to standard treatments have poor prognosis. The preparation of blinatumomab is unique and extremely complex. It's important to carry out any information to identify all the critical issues related to the preparation of blinatumomab: sharing procedure between prescribers, staff of the Centralized Chemotherapy Preparation Unit [Unità Farmaci Antiblastici (UFA)] and administering nurses aimed at reducing the clinical risk related to the management of the drug blinatumomab and to obtain correct prescriptions on the real dose to be prepared, safe worksheets with computer processing of all variables (volumes to be added and corresponding dose of drug) and complete labels containing all the information necessary for the control of the preparation and its correct infusion | ||
| 520 | |a METHODS: A computerized process involves the use of specific software to which precise instructions must be given. This study is divided into two phases, the first one focused on the analysis of Summary of Product Characteristics (SmPC) and the extrapolation of any unclear part of SmPC. The second phase involved the manufacturer to answer a questionnaire | ||
| 520 | |a RESULTS: This comparison with the company allowed to perfect the blinatumomab preparation process leading to: 1. allow the patient to be discharged and return a few times for infusions and consequently reduce the number of medical prescriptions; 2. set up the drug for each patient every 4 days; 3. reduce costs related to devices, staff employed | ||
| 520 | |a CONCLUSION: Computerizing the preparation of anti-blastic drugs is a necessary path for the safety of the patient and all the operators involved, however it may be necessary to make changes in the preparation process to allow the software to work correctly. The comparison between pharmacist, clinician and, where necessary, the manufacturer of the drug, was effective in the preparation of this drug | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Cost savings | |
| 650 | 4 | |a compounding unit | |
| 650 | 4 | |a patient care team | |
| 650 | 4 | |a pharmacists | |
| 650 | 4 | |a software | |
| 650 | 7 | |a Antibodies, Bispecific |2 NLM | |
| 650 | 7 | |a Antineoplastic Agents |2 NLM | |
| 650 | 7 | |a blinatumomab |2 NLM | |
| 650 | 7 | |a 4FR53SIF3A |2 NLM | |
| 700 | 1 | |a Provasi, Riccardo |e verfasserin |4 aut | |
| 700 | 1 | |a Cebulec, Irina |e verfasserin |4 aut | |
| 700 | 1 | |a Palmieri, Clara |e verfasserin |4 aut | |
| 700 | 1 | |a Schincariol, Paolo |e verfasserin |4 aut | |
| 700 | 1 | |a Zanon, Davide |e verfasserin |4 aut | |
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