An international panel of pharmacy professionals, researchers, and technology leaders with experience in i.v. robotics developed a set of 35 recommendations toward a better understanding of the role of automated i.v. compounding in hospital and health-system pharmacies worldwide.
Objectives To design and execute a comprehensive microbiological validation protocol to assess a brandnew sterile compounding robot in a hospital pharmacy environment, according to ISO and EU GMP standards.
Background
Paclitaxel albumin is indicated for the treatment of metastatic carcinoma of breast after failure of anthracycline therapy. It is notoriously a delicate drug to handle because it is a suspension with high tendency to foam. According to the information sheet, the drug reconstitution requires particularly attention during solvent injection. Furthermore, the vial needs to stand for 5 and 15 min, respectively before and after shaking, to reduce the foam. As a consequence, the therapy compounding appears laborious and demanding for technicians.
Purpose
To automate the compounding of Abraxane with APOTECAchemo and analyse the related performances.
Materials and methods
The manual procedure was deeply analysed to evaluate the feasibility to robotize the compounding of Abraxane. 10 preparations are compounded manually, according to the data sheet. Afterwards, 10 preparations of Abraxane were carried out with APOTECAchemo, following the standard procedure of the system. However, the vials were left to rest for 10 min after reconstitution, before going on with the compounding.
The preparations are analysed in terms of dosage accuracy and compounding time.
Results
The preparations compounded manually showed an average dosage error of 1.5% and a compounding time of 30 min. The dosage accuracy of preparations done automatically was -0.5%. The total compounding time resulted in 22 min for preparation: 7 min for reconstitution of 2 vials, 10 min for vial standing and 5 min for compounding. The 10-minute rest time resulted enough to significantly reduce the foam.
Dosage accuracy of the automatic procedure resulted similar or better than the manual compounding. In contrast, the use of APOTECAchemo implied a notable reduction of compounding time of 26%.
Conclusions
The automation of Abraxane preparation resulted feasible and sustainable. Because the dosage accuracy of APOTECAchemo is comparable with manual activity and compounding time is even shorter, the automatic compounding represents an easy and convenient alternative to the traditional practice.
No conflict of interest.
Background
The collaboration established in 2007 between the Oncology Pharmacy of the University Hospital of Ancona and the Loccioni Group was aimed at implementing, validating and integrating the robotised system for the chemotherapic drugs compounding in the day-to-day pharmacy activity. Currently the Oncology Pharmacy is almost totally automated (95%) and Loccioni has its clinical site for the continuous engineering. During this 4-year period, the constant implementation gave rise to three generations of robot with the final version ApotecaChemo released late in 2009. The authors had the chance to experience all three generations and to validate the tough work done to increase efficiency, ergonomics and user-friendliness.
Purpose
The objective of this work is to analyse the performance of the third generation robot and to compare it with the previous ones.
Materials and methods
Data were obtained from the robot database. An other advantage of automation is related to the data mining. Every step is measured and traced, providing a huge amount of information helpful for both performance statistics and process re-organisation. In this case, The authors compared production rate and the preparation time of specific drugs in standard protocols along the years.
Results
The average preparation time of a fluorouracil bag of a CMF protocol halved from 303 to 156 s with the 3rd generation robot. Similar trend is recorded for a methotrexate bag (CMF) and an epirubicin bag (FEC), whose preparation time passed from 276 to 127 s and from 565 to 253 s respectively. The improvement is even more significant for other drugs like gemcitabine, which is about 80%.
Conclusions
This technology has developed rapidly reaching high production rate. Nowadays, ApotecaChemo performances are comparable to those of the manual activity, with the added values of a quali-quantitative certification of each preparation compounded.
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