Automated chemotherapy compounding: Process optimization for the preparation of admixture containing high-dose of cyclophosphamide

Perego, Gianluca; Longobardo, Giorgia; Baldisserotto, Anna; Feliciani, Matteo; Fazio, Maria

doi:10.1177/10781552221130012

Cited by 2 publications

(2 citation statements)

References 10 publications

(13 reference statements)

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“…Cyclophosphamide was chosen as the worst case for sterility and endotoxin testing because it is the most complex drug to prepare, in addition to being a contaminant drug, as reported by many studies, often found on the surfaces of pharmaceutical compounding areas [20]. Furthermore, the last dispensed bag of each cycle was chosen as it represents the most stressed unit, i.e., the one most susceptible to possible contamination.…”

Section: Compounding and Formulation Systemmentioning

confidence: 99%

“…Currently, there are several automated drug dispensing systems on the market, in cluding some intelligent robotic systems (such as APOTECAchemo, ARCT, Cytocare) [17 In order to minimize operator exposure [18] and manual handling of toxic drugs [19 which are recognized as potent dangerous drugs due to their intrinsic carcinogenic, mu tagenic and nephrotoxic properties [20], while ensuring aseptic production conditions another important automated system called PHARMODUCT ® (Figure 1), built by Bioduc s.r.l. Firenze 50141, Italy part of the Dedalus group, was developed for the compoundin and preparation of personalized antineoplastic therapies performed in the hospital [21].…”

Section: Introductionmentioning

confidence: 99%

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Performance Qualification of Automatic System for Antineoplastic Preparation

Tesse,

Capasso,

Brattoli

et al. 2023

Applied Sciences

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The preparation of antiblastic and parental drugs should be carried out by ensuring an aseptic condition and minimizing exposure to toxic drugs. The aim of this study is to evaluate the quality and qualification of these features of an automated dispensing system, called PHARMODUCT®, built by Bioduct s.r.l, part of the Dedalus group. Three antiblastic drugs (cyclophosphamide (powder), 5-fluorouracil and paclitaxel) were used and three preparation and dispensing sessions were carried out for each drug, using PHARMODUCT®. Some of the infusion bags, prepared for each type of antiblastic, were sent to an external laboratory to perform the quantitative dosage analysis and compare it with the quantitative concentration, set on the automatic dispensing equipment, which was found to meet the acceptance criteria of 10%. In addition, to assess the safety of the process for operator exposure to toxic drugs, the differential pressure value between the main chamber and the clean room was measured to be ˂0 Pa, with an hourly leakage rate of ˂2.5 × 10−3 h−1. Media fill tests showed no microbiological growth after a 14-day incubation period. The PHARMODUCT® system meets the requirements of safety and repeatability for the dispensation of parenteral antiblastic drugs.

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Section: Compounding and Formulation Systemmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Performance Qualification of Automatic System for Antineoplastic Preparation

Tesse,

Capasso,

Brattoli

et al. 2023

Applied Sciences

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Manual versus automated chemotherapy preparation: A retrospective pharmaco-economic analysis

Chennaq,

El Baraka,

Cherif Chefchaouni

et al. 2024

J Oncol Pharm Pract

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Introduction The National Oncology Institute of Morocco's (NIO) shift to an automated cytotoxic drug preparation system (PHARMODUCT®) has prompted an evaluation of its economic and clinical impacts compared to traditional manual methods. Methods A retrospective cost-benefit analysis over six months, extrapolated to annual projections, assessed initial investments, labour, equipment, drugs and consumables. Four commonly used chemotherapy drugs were analyzed, with a focus on the cost implications of drug waste in manual preparation versus the efficiency of vial-sharing in automated methods. Results The automated system incurred a higher initial cost $2,934,098.74, but reduced annual drug consumption costs by 19.74% and drug-related expenses by $41,228.27. It also decreased personnel costs by $48,073.35. Despite the upfront investment, the system is projected to break even within two years, with no medication waste due to its vial-sharing capability. Conclusion The initial higher investment in pharmaceutical automation promises considerable long-term savings and efficiency gains. Despite the study's limited scope and duration, the findings endorse the adoption of automated systems in oncology pharmacy settings for sustainable financial management and improved clinical outcomes.

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Automated chemotherapy compounding: Process optimization for the preparation of admixture containing high-dose of cyclophosphamide

Cited by 2 publications

References 10 publications

Performance Qualification of Automatic System for Antineoplastic Preparation

Performance Qualification of Automatic System for Antineoplastic Preparation

Manual versus automated chemotherapy preparation: A retrospective pharmaco-economic analysis

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