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Safe and integrated onco-hematology workflow

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European Statement

Production and Compounding

IMPLEMENTING CHEMOTHERAPY DOSE-BANDING USING RETROSPECTIVE DATA ANALYSIS AND EXPONENTIAL CALCULUS

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European Statement

Production and Compounding

Why was it done?

Chemotherapies are generally prescribed and produced as a function of Body Surface Area (BSA). The most recent literature recommends that marketed drugs continue to use BSA-based dosing supported by clinical evidence. If not, it recommends DB with adjustments for other important parameters.

What was done?

Determine which of the drugs compounded in our centralised chemotherapy production unit were potential candidates for dose banding (DB) for adults, whilst guaranteeing patient safety and meeting the needs of physicians, pharmacists and nurses.

How was it done?

The database of chemotherapy doses produced between 2010 and 2013 was analysed to define a Top 10 chart of the most common protocols and compounds. Dosage patterns were analysed and new bands were modelled using exponential calculus in order to aid in DB decision-making. Discussions with interdisciplinary teams and senior physicians took place in order to promote acceptance of the project and its deployment.

What has been achieved?

Oncology professionals requested an integration of bands into the electronic prescription system, the possibility to prescribe doses above those suggested using BSA and a maximum 5% margin of difference to the usual prescribed dose. They highlighted the necessity of maintaining “ready for administration” doses. For example, in 2013, 613 infusion bags of gemcitabine were produced in 111 different doses, ranging from 266 to 2900 mg. Following the new specifications, just two bands (2000 mg and 1805 mg) already fulfil 50% of annual production needs; producing five band doses streamlines 90% of annual production needs.

What next?

Chemotherapeutic doses can now be prepared in bands and the pharmacy activity can be rationalised by producing doses in batches. The imminent introduction of automation should ensure accuracy of the doses delivered. Future studies should examine product stability so that chemotherapy production planning becomes highly efficient.

IMPROVING STAFF TRAINING IN A CYTOTOXICS PREPARATION UNIT

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European Statement

Production and Compounding

Author(s)

S. Sernache, H. Goncalves, A. Gouveia

Why was it done?

Improved processes were required due to new CPU facilities, PIC & acute requirements and workplace safety legislation. The training program started in 2013. Our aim was to change from an informal training to a program where minimal qualification standards were achieved despite heavy workload and budget constraints.

What was done?

Implementation of a training program for the Cytotoxics Preparation Unit (CPU) focusing on product and staff safety. Key steps were hand washing with fluorescent gel, media fill and simulated preparations with fluorescent dye. Wipe sampling of cytotoxic contamination and microbiological control were performed.

How was it done?

Absence of national experience required literature review and support from other hospital in Europe. Lack of commercial products and budget constraints led to adoption of more affordable solutions like in-place compounding of fluorescein vials, and use of standard sodium chloride IV bags for media fill. Other resources were procured externally and adapted.

We enhanced motivation with involvement of staff in the goals and open discussion of results.

What has been achieved?

All relevant staff went through the training and reached the qualification thresholds. All technicians successfully performed media fill test (no microbial growth), and fluorescein test (no dye spots counted). Hand wash results had median of 5 spots of inadequate washing. Results were discussed with staff and new session implemented afterwards. Only 9% of staff (n=33) did not improve, median of results was 1 spot . Regular microbiological monitoring results meet GMP criteria for the laminar flow cabinets, and cytotoxic contamination (8 drugs tested in 5 locations) is in line with reference values except for 5-FU storage shelf.

What next?

Training program is to be repeated yearly, as well as the monitoring processes. Despite budgetary and staff constraints, a sustainable training program can be implemented with adaptation of published sources, resulting in adhesion to good practice.