Background Quality oncology preparation requires at least three important conditions: safety, quality and cost effectiveness.
Purpose To compare the quality of the oncology preparations made by two different methods: traditional manual preparation in a vertical laminar flow hood (Hv) and robotic compounding with APOTECAchemo (Ac).
Material and methods 21 different drugs were monitored from January 2013 to June 2014 in terms of dose accuracy (E%), for both procedures.
The dosage accuracy with Ac was extrapolated automatically from the system database.
Concerning the manual compounding, drugs vials were weighed before and after the liquid was withdrawn, by means of an analytical scale. Afterwards, E% was calculated using the density (d) of the solution.
Several technicians were involved in the manual compounding.
Results All the preparations showed dose errors within European Pharmacopoeia standard. E%. Big differences in accuracy among drugs were recorded in both procedures.
These values are related to the specific formulations of some drugs, such as: paclitaxel oleate solution (Ac%-0.28 vs Hv%1.10), foaming trastuzumab (Ac%-1.15 vs Hv%-2.50), eribulin with small withdrawn volumes (Ac%-2.33 vs Hv%5.00), docetaxel for the combination with all the above-mentioned factors (Ac%-3.30 vs Hv%-5.50). In the case of lyophilised drugs the error can also occur during reconstitution: cyclophosphamide (Ac%-0.62 vs Hv%2.30), pemetrexed (Ac%-0.44 vs. Hv%3.14) and paclitaxel albumin (Ac%-0.55 vs. Hv%3.20).
In addition, high variability was observed in Hv among different technicians and within the same technician.
Conclusion Both procedures result in oncology preparations that comply with the European Pharmacopoeia. However, the automatic production shows better results, with higher accuracy than the traditional compounding. The data highlight the high repeatability of the automatic production compared with the less predictable manual behaviour.
Allestimento di Preparato Oncologico di Qualita’-S. Corridoni et al. Giorn Ita Farm Clinica 2013;27:3–4
ReferenceNo conflict of interest.
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