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Promoting the safety and accuracy of sterile compounding by creating quality control methods: design of gravimetric method for antineoplastic preparations
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Resumo(s)
Cytotoxic drugs require strict quality control due to their narrow therapeutic range. To identify methods for evaluating sterile preparations and to develop a method for quality controlo f chemotherapy preparations. A systematic review of studies on quality control methodologies for intravenous aseptic preparations published between 2014 and 2023 was carried out. In addition, a cross-sectional observational study was carried out in which, after analyzing the chemotherapy preparations, a semi-automatic gravimetric model was developed for quality controlo of 15 drugs. As proof of applicability, the model was tested in the evaluation of 47 preparations in a public hospital. Of the 17 studies included, 59% used gravimetric control (GC) methods. With regard to the GC method developed, no significant diferences were observed in the variability of density determinations in different containers, wich suggests the method’s applicability fo intermediate or finished producto control. All the preparations evaluated using the model developed were within the acceptance range in terms of predicted mass. Of the different methodologies described for quality control of antineoplastic preparations, GC is on of the most likely to be adopted by hospital units. The model developed in this study confirmasthe efficiency and applicability of the GC method, wich, after application, found 47 preparations to be correct.
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Palavras-chave
Antineoplastic drugs Quality control Gravimetric method