Both the automated and manual procedures for preparing antineoplastic preparations proved to be accurate and precise. The automated procedure resulted in substantial advantages in terms of quality maintenance standards and risk lowering.
BackgroundThe accuracy, safety and feasibility of, the compounding robot APOTECAchemo were evaluated in the clinical practice of Japan.MethodsAccuracy and precision of robotic preparations by APOTECAchemo was evaluated in 20 preparations of fluorouracil (FU) and cyclophosphamide (CPA) infusions by four pharmacists. Environmental and product contaminations with FU and CPA were evaluated by wipe testing. Robotic performance was compared with manual preparation in a biological safety cabinet. The number of robotic products, total compounding time and total pre-reconstitution time of lyophilized drugs between January 1, 2014 to December 31, 2015 were investigated.ResultsRobotic preparation resulted more accurate and precise (mean absolute dose error and coefficient of variation were 0.83 and 1.04% for FU and 0.52 and 0.59% for CPA) than those of manual preparation (respective values were 1.20 and 1.46% for FU and 1.70 and 2.20% for CPA). Drug residue was not detected from any of the prepared infusion bags with the robotic preparation, whereas FU was detected in two of four analyzed infusion bags with manual preparation. Average total time to make single anticancer drug preparation (compounding plus reconstitution of lyophilized drugs) was 6.11 min in the second half of 2015. During the study period, the highest percentage of production covered by APOTECAchemo was 70.4% of the total inpatient pharmacy activity.ConclusionRobotic preparation using APOTECAchemo should give substantial advantages in drug compounding for accuracy and safety and was able to be successfully worked in Mie university hospital.
ACTH and beta-endorphin have been evaluated by means of a specific and sensitive radioimmunoassay in athletes reaching a status of physical stress. A concomitant marked increase of these 2 peptides has been recorded. The implications of this finding lead to the conclusion that stress stimulates the synthesis of the common precursor (31 K) in the pituitary.
Compared to outcomes of other studies, our results underline good manufacturing procedures in this pharmacy with low contamination for both techniques (BSC and APOTECAchemo). Comparison of both preparation procedures validated that contamination of infusion bags was much lower by using the robotic system.
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.
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