Purpose: The quality and economic implications of manual versus automated preparation of antineoplastic drugs were compared.
Methods: This four-week study evaluated 10 routinely used antineoplastic drugs (fluorouracil, cyclophosphamide, gemcitabine, trastuzumab, bevacizumab, oxaliplatin, cisplatin, paclitaxel, irinotecan, and etoposide) prepared by manual and automated procedures. The accuracy of the dose of the active ingredient was calculated in terms of percent relative error for the difference between the nominal value indicated on the prescription and the actual value of the drug in the finished product. A comparative economic analysis of the manual and automated preparation procedures was performed by calculating the mean unit cost for each preparation at different production levels. Participating pharmacists and technicians completed a survey rating each preparation method in terms of performance, operator satisfaction, technology, and safety.
Results: Of the 2500 i.v. antineoplastic preparations made in the pharmacy during the four-week study period, 681 were analyzed (348 using the automated procedure and 333 manually). Of these, 17 varied by more than 5% of the prescribed dose, and 1 varied by over 10%. Accuracy, calculated in terms of average percent relative error, was the highest and lowest during manual preparation. The preparation time for individual drugs was always higher when prepared using the automated procedure. A lower mean variable unit cost was observed for preparations made using the automated procedure. Questionnaire results revealed that operators preferred the automated procedure over the manual procedure.
Conclusion: 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.