Institutional Usage of Ferric Pyrophosphate Citrate (FPC) Delivered Via Dialysate in Reducing Erythropoiesis Stimulating Agents (ESAs) and IV Iron Cost

Dialysis patients are often iron deficient due to a multiple factors. Ferric pyrophosphate citrate is a complex iron salt that can be given via dialysate allowing maintenance of hemoglobin (Hgb) concentration and iron balance while reducing the need for IV iron. The purpose of this study is to perform a cost evaluation of FPC and the effect it has on lowering the dose/use of ESAs and IV iron therapy. This study reviewed the same 100 hemodialysis patient’s charts before and after the use of FPC. The data points that were collected and analyzed are as follows: hemoglobin, ferritin levels, average weekly ESA dosing, and IV iron replacement therapy dose. Out of 100 patients, there was no statistical difference in the average hemoglobin, ferritin, and iron saturation levels observed in the patients before and after FPC use. The average weekly dose of darbepoetin alfa per patient was 52.74 μg before the FPC group compared to 39.27 μg in the post FPC group ( P < .0001). The total dose of ferric gluconate per patient was 3290.01 mg in the before FPC group and 585.60 mg in the post FPC group ( P < .0001). The average total iron sucrose dose per patient in the before FPC group was 3097.92 mg versus 1216.67 mg in the post FPC group ( P < .1563). When comparing FPC’s cost and implementation into both of our outpatient dialysis centers, this yielded a net savings of $296 751.49.

Analytical Methods for Ionic Profile of Dialysate Iron Therapy Drug Ferric Pyrophosphate Citrate By Ion Chromatography using Suppressed and Non-Suppressed Conductivity Detection

In present study, ionic profile of pharmaceutical drug molecule ferric pyrophosphate citrate by ion exchange chromatography using conductivity detection was carried out. Ferric pyrophosphate citrate is an iron organic complex used for hemodialysis for the chronic kidney disease patients. The drug is used as iron supplementation to balance the iron loss during the dialysis for the kidney affected patients. Anions, cation and metal ion were analyzed by ion chromatographic method. Relevant anions sulphate, phosphate, citrate and pyrophosphate were analyzed by suppressed conductivity detection. Both isocratic and gradient separation methods were developed for the anions analysis. Cation sodium was analyzed by non-suppressed conductivity detection. Metal iron was determined by direct conductivity detection. All the analyses were done covering selectivity, precision, linearity and accuracy aspects of analysis. Calibration outcome of RSD 0.4 to 3.0% and correlation coefficient values greater than 0.999 were observed during the studies. Spiking studies were done to check the accuracy of the analysis and the recovery values ranging from 93 to 110% were observed. Around 90% ionic content of the drug molecule can be characterized using the developed ion chromatographic methods. These methods can be directly applied for the routine analysis of drug in the pharmaceutical industries.