Assessment of final product dosing accuracy when using volumetric technique in the preparation of chemotherapy

Abstract

While the mean value of volumetric measurements is within the generally understood acceptable range for dispensing chemotherapy, the range of measurements is highly variable. Future studies are warranted to better understand the reasons behind the variation and to evaluate the impact of workflow changes on improving final product accuracy.

Evaluation of real-time data obtained from gravimetric preparation of antineoplastic agents shows medication errors with possible critical therapeutic impact: Results of a large-scale, multicentre, multinational, retrospective study

“…In our study, we found that the volumetric preparation method is unable to sufficiently detect the compounding variability that causes preparation errors. A preparation error threshold of 10% was chosen for our evaluation, based on previously published studies and the Société Française de Pharmacie Oncologique (SFPO)/European Society of Oncology Pharmacy (ESOP) guidelines used in European countries. The German Pharmacopoeia DAB 10 already states in its monograph “V.5.2 Uniformity of single dose drugs” that for parenteral drugs, dosing deviation must stay within ±10% and ±15% for doses >40 and <40 mg, respectively .…”

“…In our study, we found that the volumetric preparation method is unable to sufficiently detect the compounding variability that causes preparation errors. A preparation error threshold of 10% was chosen for our evaluation, based on previously published studies 11,12 This monograph has been replaced by the European Pharmacopoeia general chapters on uniformity of mass of single-dose preparations (2.9.5), uniformity of content of single-dose preparations (2.9.6) and…”

A three-year study of a first-generation chemotherapy-compounding robot

“…This was one of the biggest challenges faced when switching to new products or adding new products to be compounded by the robot; other researchers have reported problems of this sort. 5,8 Drug shortages, especially in oncology, pose an ongoing challenge, and strategies available to manage potential drug shortages are often lacking. 15 In addition, the impact of shortages of injectable oncology drugs on patient care is well documented.…”

“…3,7 A study that assessed the accuracy of volumetric technique in the preparation of chemotherapy doses found that 71.7% of the doses prepared were within ±5% and 87.4% were within ±10% of the ordered dose. 8 The study authors suggested that "the process of volumetric technique alone is not sufficient to accurately prepare chemotherapy doses, and a focus of improving the process of preparing i.v. medications needs to be undertaken."…”

“…medications needs to be undertaken." 8 The robot ensures the sterility of antineoplastic preparations because it operates in an aseptic (i.e., International Organization for Standarization [ISO] class 5) environment and prevents drug cross-contamination by using sterile syringes for each transfer. In addition, the compounding process involves numerous safety verification checks.…”