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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.

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