Rodolfo F Rivera1, Davide Guido2,3, Lucia Del Vecchio4, Enzo Corghi5, Marco D'Amico6, Corrado Camerini7, Donatella Spotti8, Andrea Galassi9, Claudio Pozzi5, Giovanni Cancarini7, Giuseppe Pontoriero4, Francesco Locatelli4. 1. Division of Nephrology and Dialysis, San Gerardo Hospital, Pergolesi 33, 20090, Monza, Italy. rodolfofrivera@gmail.com. 2. Medical and Genomic Statistics Unit, Department of Brain and Behavioural Sciences, University of Pavia, Via Bassi 21, 27100, Pavia, Italy. 3. Biostatistics and Clinical Epidemiology Unit, Department of Public Health, Experimental and Forensic Medicine, University of Pavia, Pavia, Italy. 4. Division of Nephrology and Dialysis, A. Manzoni Hospital, Via dell'Eremo 9/11, 23900, Lecco, Italy. 5. Division of Nephrology and Dialysis, Bassini Hospital, via Gorki 50, 20092, Cinisello Balsamo (MI), Italy. 6. Division of Nephrology and Dialysis, Sant'Anna Hospital, via Ravona 20, 22020, San Fermo della Battaglia, Como, Italy. 7. Operative Unit of Nephrology, A.O. Spedali Civili and University of Brescia, Ple Spedali Civili 1, 25123, Brescia, Italy. 8. Operative Unit of Nephrology and Dialysis, San Raffaele, via Olgettina 60, 20132, Milan, Italy. 9. Division of Nephrology and Dialysis, Desio Hospital, Via Mazzini 1, 20832, Desio, Italy.
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.
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.
Authors: Michael Auerbach; John Adamson; Andreas Bircher; Christian Breymann; Steven Fishbane; Anat Gafter-Gvili; Christoph Gasche; Jeffrey Gilreath; Giuliano Grazzini; David Henry; Giancarlo Liumbruno; Francesco Locatelli; Iain Macdougall; Manuel Munoz; David Rampton; George Rodgers; Aryeh Shander Journal: Haematologica Date: 2015-05 Impact factor: 9.941
Authors: Michelle J Irving; Jonathan C Craig; Martin Gallagher; Stephen McDonald; Kevan R Polkinghorne; Rowan G Walker; Simon D Roger Journal: Med J Aust Date: 2006-09-18 Impact factor: 7.738
Authors: Marc A Pfeffer; Emmanuel A Burdmann; Chao-Yin Chen; Mark E Cooper; Dick de Zeeuw; Kai-Uwe Eckardt; Jan M Feyzi; Peter Ivanovich; Reshma Kewalramani; Andrew S Levey; Eldrin F Lewis; Janet B McGill; John J V McMurray; Patrick Parfrey; Hans-Henrik Parving; Giuseppe Remuzzi; Ajay K Singh; Scott D Solomon; Robert Toto Journal: N Engl J Med Date: 2009-10-30 Impact factor: 91.245
Authors: Roberto Minutolo; Patrizia Berto; Maria Elena Liberti; Nicola Peruzzu; Silvio Borrelli; Antonella Netti; Carlo Garofalo; Giuseppe Conte; Luca De Nicola; Lucia Del Vecchio; Francesco Locatelli Journal: J Clin Med Date: 2021-03-23 Impact factor: 4.241