Intravenous iron supplementation has been found to increase the efficacy of Erythropoietin Stimulating Agent (ESA) by improving anaemia in Chronic Kidney Disease (CKD) patients and allowing a reduction in dose of up to 70%. Studies have shown that haemodialysis patients need approximately 1000mg of iron yearly to replenish iron stores for haemoglobin maintenance. Iron therapy alone has been associated with improving haemoglobin (Hb) for patients not yet receiving ESA. Iron Polymaltose has been administered as the preferred iron therapy in Australia since 1999. Currently Ferrosig® (Sigma Pharmaceuticals) is the brand widely used.

Iron Polymaltose is generally well tolerated and the incidence of adverse reactions is small. However between April and May 2008 we experienced an increased number of patients having adverse reactions to this medication. In total 27 adverse reactions were reported to the Therapeutics Goods Administration (TGA) leading to a product recall.
This presentation discusses the types of reaction our patients experienced and what was reported to the Adverse Drug Reactions Advisory Committee (ADRAC/TGA). We will explore the different options for reporting an adverse reaction to medications and medical devices.

It would seem Nurses are reluctant to report adverse reactions, we see it as the Pharmacists or some one else’s job. As we have all the information at the time of the event, empowerment to report is ours.