title: Impact of European medicines agency recommendations for hypersensitivity reactions on intravenous iron prescription in haemodialysis centres of the Lombardy region.
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.
  
  
  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.affiliation: Division of Nephrology and Dialysis, San Gerardo Hospital, Pergolesi 33, 20090, Monza, Italy. rodolfofrivera@gmail.com.
authors.forename: Rodolfo F
authors.identifier: http://orcid.org/0000-0002-5456-6785
authors.initials: RF
authors.lastname: Rivera
authors.affiliation: Medical and Genomic Statistics Unit, Department of Brain and Behavioural Sciences, University of Pavia, Via Bassi 21, 27100, Pavia, Italy.|Biostatistics and Clinical Epidemiology Unit, Department of Public Health, Experimental and Forensic Medicine, University of Pavia, Pavia, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Guido
authors.affiliation: Division of Nephrology and Dialysis, A. Manzoni Hospital, Via dell'Eremo 9/11, 23900, Lecco, Italy.
authors.forename: Lucia
authors.initials: L
authors.lastname: Del Vecchio
authors.affiliation: Division of Nephrology and Dialysis, Bassini Hospital, via Gorki 50, 20092, Cinisello Balsamo (MI), Italy.
authors.forename: Enzo
authors.initials: E
authors.lastname: Corghi
authors.affiliation: Division of Nephrology and Dialysis, Sant'Anna Hospital, via Ravona 20, 22020, San Fermo della Battaglia, Como, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: D'Amico
authors.affiliation: Operative Unit of Nephrology, A.O. Spedali Civili and University of Brescia, Ple Spedali Civili 1, 25123, Brescia, Italy.
authors.forename: Corrado
authors.initials: C
authors.lastname: Camerini
authors.affiliation: Operative Unit of Nephrology and Dialysis, San Raffaele, via Olgettina 60, 20132, Milan, Italy.
authors.forename: Donatella
authors.initials: D
authors.lastname: Spotti
authors.affiliation: Division of Nephrology and Dialysis, Desio Hospital, Via Mazzini 1, 20832, Desio, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Galassi
authors.affiliation: Division of Nephrology and Dialysis, Bassini Hospital, via Gorki 50, 20092, Cinisello Balsamo (MI), Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Pozzi
authors.affiliation: Operative Unit of Nephrology, A.O. Spedali Civili and University of Brescia, Ple Spedali Civili 1, 25123, Brescia, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Cancarini
authors.affiliation: Division of Nephrology and Dialysis, A. Manzoni Hospital, Via dell'Eremo 9/11, 23900, Lecco, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Pontoriero
authors.affiliation: Division of Nephrology and Dialysis, A. Manzoni Hospital, Via dell'Eremo 9/11, 23900, Lecco, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Locatelli
mesh_terms: D061605:Administration, Intravenous; D000554:Ambulatory Care Facilities / Q000458:organization & administration / Q000592:standards; D002983:Clinical Competence; D017277:Drug Approval; D004342:Drug Hypersensitivity / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D011307:Drug Prescriptions; D006077:Government Agencies / Q000592:standards; D019983:Guideline Adherence; D019538:Health Care Surveys; D054625:Healthcare Disparities; D006397:Hematinics / Q000008:administration & dosage / Q000009:adverse effects*; D006436:Hemodialysis Units, Hospital / Q000458:organization & administration / Q000592:standards; D006801:Humans; D007362:Intensive Care Units; D058085:Iron Compounds / Q000008:administration & dosage / Q000009:adverse effects*; D007558:Italy; D016014:Linear Models; D016017:Odds Ratio; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians' / Q000458:organization & administration / Q000592:standards; D006435:Renal Dialysis / Q000592:standards; D018570:Risk Assessment; D012307:Risk Factors
chemical_list: D006397:Hematinics; D058085:Iron Compounds
keywords: Anaemia; Haemodialysis; Hypersensitivity reactions; Intensive care unit; Intravenous iron; Survey