Microbiological Risk Assessment in an Italian Oncology Pharmacy

Donati C, Massa I, Bernabini M, Farina M, Bandini S, De Paoli G and Masini C

IRCCS - Istituto Romagnolo per lo Studio dei Tumori “Dino Amadori” IRST, Meldola, Italy
Istituto Romagnolo per lo Studio dei Tumori “Dino Amadori” IRST, Meldola, Italy
Quality Unit, Istituto Romagnolo per lo Studio dei Tumori “Dino Amadori” IRST, Meldola, Italy
Studio EmmEffe S.r.l, Milano, Italy

^*Correspondance to: Ilaria Massa 

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Abstract:

Purpose: To perform a risk analysis of the microbiological features of cancer drug preparation and to propose control measures and corrective actions to improve these processes.
Summary: A multidisciplinary team was set up to assess cancer chemotherapy preparation. The team drew up a list of all the oncological preparations made in the Oncology Pharmacy Laboratory of our institute in 2017 and calculated their risk. The team then identified the risk-reducing factors that had been applied for the different preparations and finally reviewed the risk level of the
preparations based on this reduction. It emerged that 37,830 sterile injectable preparations were made in 2017 and 21,474 met environmental class requirements. The present analysis focused on the remaining 16,356 preparations.
Conclusion: Of the 37,830 oncological preparations made in our institute in 2017, only 12 (0.1%) did not fulfil SIFO technical standards with regard to their preparation. None of the 12 preparations involved an experimental drug.

Keywords:

Microbiological risk; Anti-cancer drugs; Risk analysis; Quality management

Cite the Article:

Donati C, Massa I, Bernabini M, Farina M, Bandini S, De Paoli G, et al. Microbiological Risk Assessment in an Italian Oncology Pharmacy. Clin Oncol. 2022;7:1970..