Fresenius Medical Care North America Research Articles

Suspected iron dextran-related adverse drug events in hemodialysis patients

Despite the use of recombinant erythropoietin, anemia remains a significant problem for patients with end-stage renal disease, in part related to chronic dialysis-related blood loss and resultant iron deficiency. Because oral iron preparations have been relatively ineffective and poorly tolerated in this population, intravenous (IV) iron dextran has been widely prescribed, despite a finite risk for adverse effects associated with its use. We analyzed data from Fresenius Medical Care North America (FMCNA) clinical variance reports to determine the incidence of suspected iron dextran-related adverse drug events (ADEs) and associated patient characteristics, dialysis practice patterns, and outcomes. We used a case-cohort study design, comparing individuals who experienced suspected ADEs with the overall FMCNA population. Among 841,252 IV iron dextran administrations from October 1998 through March 1999, there were 165 reported suspected ADEs, corresponding to an overall rate of 0.000196%, or approximately 20 per 10,000 doses. Forty-three patients (26%) required an independent emergency department evaluation, 18 patients (11%) required hospitalization, and 1 patient (0.6%) died. Dyspnea (43%), hypotension (23%), and neurological symptoms (23%) were the most common major ADEs; nausea (34%), vomiting (23%), flushing (27%), and pruritus (25%) were the most common other ADEs. ADEs were 8.1-fold more common among patients administered Dexferrum (American Regent Laboratories, Inc, Shirley, NY) compared with those administered InFed (Watson Pharmaceuticals, Phoenix, AZ). In summary, serious adverse reactions to IV iron dextran are rare in clinical practice. The risk appears to depend on the specific formulation of IV iron dextran-related ADEs are difficult to predict.

The Role of Providers in Implementation of the National Kidney Foundation-Dialysis Outcomes Quality Initiative: Fresenius Medical Care North America Perspective

This is a brief review of the history of utilization of quality indicators by a major dialysis provider and how those indicators have been modified in response to the National Kidney Foundation-Dialysis fOutcomes Quality Initiative (NKF-DOQI). Fresenius Medical Care North America (FMCNA) has monitored adequacy of dialysis, anemia management, and nutrition therapy for a number of years, using a self-directed continuous quality improvement program. FMCNA supports the NKF-DOQI Guidelines and has used the DOQI as it continues to enhance its patient quality care program. Specific goals and action thresholds of that program are delineated.