Pediatric blinatumomab preparation: Risk assessment on SmPC for software compliance
Mario Cirino1, Riccardo Provasi1, Irina Cebulec1
1Presidio Ospedaliero Ospedale Maggiore, Azienda Sanitaria Universitaria Integrata Giuliano Isontina, Trieste, Italy.
Insights
Computerizing the preparation of blinatumomab, an anticancer drug for Acute Lymphoblastic Leukaemia (ALL), enhances patient safety and reduces costs. This process streamlines drug preparation and management for better clinical outcomes.
Area of Science:
- Oncology
- Pharmacology
- Health Informatics
Background:
- Blinatumomab is a critical anticancer drug for Acute Lymphoblastic Leukaemia (ALL), particularly in refractory cases with poor prognosis.
- The complex preparation of blinatumomab necessitates meticulous procedures to mitigate clinical risks.
- Effective communication among prescribers, Centralized Chemotherapy Preparation Units (UFA), and nurses is vital for safe blinatumomab management.
Purpose of the Study:
- To identify and address critical issues in blinatumomab preparation.
- To optimize the blinatumomab preparation process through computerization and collaboration.
- To ensure accurate dosing, safe preparation worksheets, and complete labeling for blinatumomab infusion.
Main Methods:
- Analysis of Summary of Product Characteristics (SmPC) to identify ambiguities.
- Development of a computerized preparation process using specialized software.
- Collaboration with the drug manufacturer through a questionnaire to refine procedures.
Main Results:
- Streamlined blinatumomab preparation, enabling outpatient infusions and reducing prescription frequency.
- Standardized drug preparation every 4 days per patient.
- Reduced costs associated with devices and personnel due to optimized processes.
Conclusions:
- Computerizing anti-blastic drug preparation is essential for patient and operator safety.
- Adaptations to preparation processes may be required for optimal software functionality.
- Multidisciplinary collaboration, including pharmacists, clinicians, and manufacturers, proved effective in optimizing blinatumomab preparation.
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.
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