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Standard Operating Procedures for urgent chemotherapy mixture preparation by non-experienced staff

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European Statement

Production and Compounding

Author(s)

Ana Marín-Romero , Inés Monge-Escartín , Esther Carcelero-San Martín , Gisela Riu-Viladoms , Rubén González-García, Jaume Planas-López , Dolores Merino-Calderón , Rodolfo Juncos-Pereira , Carolina Lesta-Domene , Carmen López-Cabezas, Dolors Soy

Why was it done?

Cytostatics are hazardous drugs that must be prepared under safe and sterile conditions. In some life-threatening situations, there is an urgent need to initiate chemotherapy immediately. However, not all hospitals have experienced personnel in safe-handling cytotoxic drugs for 24 hours and 7 days per week.
The objective is to create a consensual protocol to be used when immediate start of chemotherapy is required, and preparation must be done out of working hours of specialized pharmacy staff. A secondary objective is to confirm that non-experienced staff can prepare cytostatics safely and to guarantee their quality by following this protocol.

What was done?

The oncohematology pharmacy team created a visual guide aimed to pharmacy personnel who do not routinely work with intravenous mixture preparations. This guide includes instructions about parenteral cytotoxic drug preparation for chemotherapy regimens that should be immediately initiated.

How was it done?

Urgent regimens were agreed with clinicians. They are: (i) fixed-dose intrapericardial cisplatin, (ii) intravenous carboplatin and etoposide, (iii) intravenous cisplatin and etoposide, (iv) intravenous cyclophoshamide and (v) fixed-dose intravenous daunorubicin. For schemes with different possible doses, fixed banding doses were agreed with clinicians.
A visual guide with images of all the material and preparation steps (including labelling, packaging and protection measures), for each scheme, was developed and attached to a prescription form to be completed by the physician and associated with a material kit that contained personal protective equipment, expendable material, cytostatic vials and serum bags.
The guide was distributed to pharmacy personnel external to preparation area, accompanied by a training session. Selected trained workers were supervised while preparing the mentioned cytostatic drugs in a simulated-base patient scenario.

What has been achieved?

All the cytostatic drugs were prepared correctly reaching a maximum preparation time of 45 minutes since physician’s prescription. The personnel involved maintained all the specified protection measures and reported feeling confident while cytostatic manipulation.
The guide proved to be useful to cover a possible urgent chemotherapy treatment outside the stipulated work schedule.

What next?

Re-training in safe-handling of cytotoxic drugs should be ongoing with regular updates to ensure a proper follow-up of this guide. This work methodology could be extrapolated to other pharmacy areas with similar needs.

NEW TECHNOLOGIES TO IMPROVE SAFETY IN PREPARATION AND ADMINISTRATION OF INTRAVENOUS ANTINEOPLASTIC DRUGS

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European Statement

Patient Safety and Quality Assurance

Author(s)

Carlos Aparicio Carreño, Arantxa Gándara Ande, Beatriz Fernández González, Andrea Forneas Sangil, Belén Rodríguez de Castro, Rubén Pampín Sánchez, Cristina Martínez-Múgica Barbosa, Paloma NIeves Terroba Alonso

Why was it done?

To improve safety during preparation and administration of IAD.

What was done?

A new computerized system was established to improve quality control and traceability in preparation and administration of intravenous antineoplastic drug (IAD).

How was it done?

The software currently in use was updated, checking densities of IAD, weights of diluents and consumables. Protocols in pharmacology were adapted and maximum permissible error rates during elaboration were established. The Aseptics Pharmacy Department was equipped with a barcode label printer (BLP), a barcode scanner (BS), a precision scale and an All In One computer for the biological safety cabinet (BSC). The Haematology and Oncology Day Treatment Unit (DTU) was equipped with a BLP (for hospital bracelets) and portable computers with BS.
Regarding elaboration, a qualitative control was performed in the BSC by scanning data matrix or barcodes, recording batches and expiration dates, both of the diluent and antineoplastic agents. A quantitative gravimetric test was also performed using weight measurement of the diluent and devices before and after adding the drug. When the mixture was correctly prepared a label was printed with an identifying barcode.
Administration of the right bag to the right patient was also ensured by scanning barcodes in DTU: A hospital bracelet with a barcode was printed to identify each patient at their arrival to DTU. Prior to administration, double scan confirmation was made, checking patient´s bracelet and treatment (label), by using BS, ensuring that each patient received the drug, at the right dose, on time and by the correct route of administration.

What has been achieved?

All intravenous cancer therapies have been administered with double scan confirmation in DTU since the new system was established (November 2019).
This new way of processing IAD has been completely installed, but not all the antineoplastic treatments have been prepared with quality control.
The whole process has also left a complete computer record of the staff, task performed, time, duration and potential incidents.

What next?

We will gradually implement quality control while processing all intravenous antineoplastic treatments.

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