Impact of European medicines agency recommendations for hypersensitivity reactions on intravenous iron prescription in haemodialysis centres of the Lombardy region

Rodolfo F. Rivera, Davide Guido, Lucia Del Vecchio, Enzo Corghi, Marco D’Amico, Corrado Camerini, Donatella Spotti, Andrea Galassi, Claudio Pozzi, Giovanni Cancarini, Giuseppe Pontoriero, Francesco Locatelli

Research output: Contribution to journalArticle

Abstract

Background: The European Medicines Agency (EMA) has recommended measures to minimize the risk of hypersensitivity reactions (HSRs) to intravenous iron (IVFe). We analysed the effects of these recommendations on IVFe clinical management among haemodialysis centres (HDCs) in Lombardy, Italy. Materials and methods: A questionnaire was sent to all 117 HDCs to collect information on centre characteristics, e.g. HDC type [hospital centre (HC) vs. centre with limited assistance (CAL)], presence/absence of intensive care unit (ICU) and/or emergency trained staff, IVFe therapy regarding molecules, administration modalities, side effects, and percentage variations in iron prescription between 2014 and 2013 (outcome, Δ-IVFe%). A linear regression model was applied to evaluate the focus effect (β) of HDC type on the outcome, controlling for possible confounding effects of the other characteristics. Results: Response rate was 73.5 %. IVFe therapy was used in 69.1 % (HDC range 11–100) of patients. Following EMA recommendations, prescription was reduced by 12.6 %, with the largest reduction observed in CALs. No severe HSRs were reported. HCs had more frequently an ICU [97.2 vs. 20 %, odds ratio (OR) = 63.6 (95 % confidence interval 15.56; 537.47), p < 0.001], emergency trained staff [97.2 vs. 61.2 %, OR = 10.7 (2.68; 85.33), p < 0.001] and instrumental facilities (91.7 vs. 58 %, OR = 5.8 (2.03; 23.55), p < 0.001] than CALs. Linear regression demonstrated a significant raw effect of HDC type on Δ- IVFe% [β = 19.6 (9.82; 30.63), p < 0.001]. No association was found when HDC type was adjusted for ICU-presence [β = 6.7 (−2.32; 18.30), p = 0.199] or for all-confounding factors [β = 5.6 (−5.50; 17.08), p = 0.337]. Conclusions: This survey shows a disparity in IVFe therapy prescription following EMA recommendations, which is largely influenced by the presence/absence of ICUs in HD centres.

Original languageEnglish
Pages (from-to)673-681
Number of pages9
JournalJournal of Nephrology
Volume29
Issue number5
DOIs
Publication statusPublished - Oct 1 2016

Keywords

  • Anaemia
  • Haemodialysis
  • Hypersensitivity reactions
  • Intensive care unit
  • Intravenous iron
  • Survey

ASJC Scopus subject areas

  • Nephrology

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    Rivera, R. F., Guido, D., Del Vecchio, L., Corghi, E., D’Amico, M., Camerini, C., Spotti, D., Galassi, A., Pozzi, C., Cancarini, G., Pontoriero, G., & Locatelli, F. (2016). Impact of European medicines agency recommendations for hypersensitivity reactions on intravenous iron prescription in haemodialysis centres of the Lombardy region. Journal of Nephrology, 29(5), 673-681. https://doi.org/10.1007/s40620-015-0254-5