Organizational Strategies for the Management of Intravenous Iron Therapy in Non-Hospitalized Settings: A Safe Opportunity to Implement Patient Blood Management in Italy
Abstract
:1. Introduction
2. Organizational Strategies for the Safe Management of Intravenous Iron Therapy in Patients in Non-Hospital Settings
3. Recommendations
3.1. Patient Safety Recommendations
3.2. Management Strategies
3.3. Communication Recommendations
3.4. Recommendations on Reporting Adverse Reactions and Events and Sentinel Events
4. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
- Vos, T.; Abajobir, A.A.; Abate, K.H.; Abbafati, C.; Abbas, K.M.; Abd-Allah, F.; Abdulkader, R.S.; Abdulle, A.M.; Abebo, T.A.; Abera, S.F.; et al. Global, Regional, and National Incidence, Prevalence, and Years Lived with Disability for 328 Diseases and Injuries for 195 Countries, 1990–2016: A Systematic Analysis for the Global Burden of Disease Study 2016. Lancet 2017, 390, 1211–1259. [Google Scholar] [CrossRef] [Green Version]
- Kassebaum, N.J.; Jasrasaria, R.; Naghavi, M.; Wulf, S.K.; Johns, N.; Lozano, R.; Regan, M.; Weatherall, D.; Chou, D.P.; Eisele, T.P.; et al. A Systematic Analysis of Global Anemia Burden from 1990 to 2010. Blood 2014, 123, 615–624. [Google Scholar] [CrossRef]
- Musallam, K.M.; Tamim, H.M.; Richards, T.; Spahn, D.R.; Rosendaal, F.R.; Habbal, A.; Khreiss, M.; Dahdaleh, F.S.; Khavandi, K.; Sfeir, P.M.; et al. Preoperative Anaemia and Postoperative Outcomes in Non-Cardiac Surgery: A Retrospective Cohort Study. Lancet 2011, 378, 1396–1407. [Google Scholar] [CrossRef]
- Fowler, A.J.; Ahmad, T.; Abbott, T.E.F.; Torrance, H.D.; Wouters, P.F.; De Hert, S.; Lobo, S.M.; Rasmussen, L.S.; Della Rocca, G.; Beattie, W.S.; et al. Association of Preoperative Anaemia with Postoperative Morbidity and Mortality: An Observational Cohort Study in Low-, Middle-, and High-Income Countries. Br. J. Anaesth. 2018, 121, 1227–1235. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Krishnasivam, D.; Trentino, K.M.; Burrows, S.; Farmer, S.L.; Picardo, S.; Leahy, M.F.; Halder, A.; Chamberlain, J.; Swain, S.; Muthucumarana, K.; et al. Anemia in Hospitalized Patients: An Overlooked Risk in Medical Care. Transfusion 2018, 58, 2522–2528. [Google Scholar] [CrossRef] [PubMed]
- Shander, A.; Javidroozi, M.; Ozawa, S.; Hare, G.M.T. What Is Really Dangerous: Anaemia or Transfusion? Br. J. Anaesth. 2011, 107 (Suppl. 1), i41–i59. [Google Scholar] [CrossRef] [Green Version]
- Murphy, M.F.; Palmer, A. Patient Blood Management as the Standard of Care. Hematology 2019, 2019, 583–589. [Google Scholar] [CrossRef]
- Spahn, D.R.; Shander, A.; Hofmann, A. The Chiasm: Transfusion Practice versus Patient Blood Management. Best Pract. Res. Clin. Anaesthesiol. 2013, 27, 37–42. [Google Scholar] [CrossRef]
- Meybohm, P.; Richards, T.; Isbister, J.; Hofmann, A.; Shander, A.; Goodnough, L.T.; Muñoz, M.; Gombotz, H.; Weber, C.F.; Choorapoikayil, S.; et al. Patient Blood Management Bundles to Facilitate Implementation. Transfus. Med. Rev. 2017, 31, 62–71. [Google Scholar] [CrossRef] [Green Version]
- Leahy, M.F.; Hofmann, A.; Towler, S.; Trentino, K.M.; Burrows, S.A.; Swain, S.G.; Hamdorf, J.; Gallagher, T.; Koay, A.; Geelhoed, G.C.; et al. Improved Outcomes and Reduced Costs Associated with a Health-System–Wide Patient Blood Management Program: A Retrospective Observational Study in Four Major Adult Tertiary-Care Hospitals. Transfusion 2017, 57, 1347–1358. [Google Scholar] [CrossRef]
- Meybohm, P.; Froessler, B.; Goodnough, L.T.; Klein, A.A.; Muñoz, M.; Murphy, M.F.; Richards, T.; Shander, A.; Spahn, D.R.; Zacharowski, K. “Simplified International Recommendations for the Implementation of Patient Blood Management” (SIR4PBM). Perioper. Med. 2017, 6, 5. [Google Scholar] [CrossRef] [Green Version]
- Althoff, F.C.; Neb, H.; Herrmann, E.; Trentino, K.M.; Vernich, L.; Füllenbach, C.; Freedman, J.; Waters, J.H.; Farmer, S.; Leahy, M.F.; et al. Multimodal Patient Blood Management Program Based on a Three-Pillar Strategy: A Systematic Review and Meta-Analysis. Ann. Surg. 2019, 269, 794–804. [Google Scholar] [CrossRef] [PubMed]
- Desai, N.; Schofield, N.; Richards, T. Perioperative Patient Blood Management to Improve Outcomes. Anesth. Analg. 2018, 127, 1211–1220. [Google Scholar] [CrossRef] [PubMed]
- Trentino, K.M.; Mace, H.S.; Leahy, M.F.; Sanfilippo, F.M.; Farmer, S.L.; Murray, K. Appropriate Red Cell Transfusions Are Often Avoidable through Patient Blood Management. Blood Transfus. 2021, 19, 177–178. [Google Scholar] [CrossRef] [PubMed]
- Bolcato, M.; Russo, M.; Trentino, K.; Isbister, J.; Rodriguez, D.; Aprile, A. Patient Blood Management: The Best Approach to Transfusion Medicine Risk Management. Transfus. Apher. Sci. 2020, 59, 102779. [Google Scholar] [CrossRef]
- Meybohm, P.; Straub, N.; Füllenbach, C.; Judd, L.; Kleinerüschkamp, A.; Taeuber, I.; Zacharowski, K.; Choorapoikayil, S. Health Economics of Patient Blood Management: A Cost-benefit Analysis Based on a Meta-analysis. Vox Sang. 2020, 115, 182–188. [Google Scholar] [CrossRef]
- Shander, A.; Van Aken, H.; Colomina, M.J.; Gombotz, H.; Hofmann, A.; Krauspe, R.; Lasocki, S.; Richards, T.; Slappendel, R.; Spahn, D.R. Patient Blood Management in Europe. Br. J. Anaesth. 2012, 109, 55–68. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Camaschella, C. Iron Deficiency. Blood 2019, 133, 30–39. [Google Scholar] [CrossRef] [Green Version]
- Rasmussen, K.M. Is There a Causal Relationship between Iron Deficiency or Iron-Deficiency Anemia and Weight at Birth, Length of Gestation and Perinatal Mortality? J. Nutr. 2001, 131, 590S–603S. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Sachdev, H.; Gera, T.; Nestel, P. Effect of Iron Supplementation on Mental and Motor Development in Children: Systematic Review of Randomised Controlled Trials. Public Health Nutr. 2005, 8, 117–132. [Google Scholar] [CrossRef] [Green Version]
- McCann, J.C.; Ames, B.N. An Overview of Evidence for a Causal Relation between Iron Deficiency during Development and Deficits in Cognitive or Behavioral Function. Am. J. Clin. Nutr. 2007, 85, 931–945. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Mantadakis, E. Advances in Pediatric Intravenous Iron Therapy. Pediatr. Blood Cancer 2016, 63, 11–16. [Google Scholar] [CrossRef]
- Milman, N.; Taylor, C.L.; Merkel, J.; Brannon, P.M. Iron Status in Pregnant Women and Women of Reproductive Age in Europe. Am. J. Clin. Nutr. 2017, 106, 1655S–1662S. [Google Scholar] [CrossRef] [PubMed]
- Lasocki, S.; Lefebvre, T.; Mayeur, C.; Puy, H.; Mebazaa, A.; Gayat, E. Iron Deficiency Diagnosed Using Hepcidin on Critical Care Discharge Is an Independent Risk Factor for Death and Poor Quality of Life at One Year: An Observational Prospective Study on 1161 Patients. Crit. Care 2018, 22, 314. [Google Scholar] [CrossRef] [PubMed]
- Pasricha, S.-R.; Drakesmith, H.; Black, J.; Hipgrave, D.; Biggs, B.-A. Control of Iron Deficiency Anemia in Low- and Middle-Income Countries. Blood 2013, 121, 2607–2617. [Google Scholar] [CrossRef] [Green Version]
- Cappellini, M.D.; Comin-Colet, J.; de Francisco, A.; Dignass, A.; Doehner, W.; Lam, C.S.; Macdougall, I.C.; Rogler, G.; Camaschella, C.; Kadir, R.; et al. Iron Deficiency across Chronic Inflammatory Conditions: International Expert Opinion on Definition, Diagnosis, and Management. Am. J. Hematol. 2017, 92, 1068–1078. [Google Scholar] [CrossRef] [Green Version]
- Peyrin-Biroulet, L.; Williet, N.; Cacoub, P. Guidelines on the Diagnosis and Treatment of Iron Deficiency across Indications: A Systematic Review. Am. J. Clin. Nutr. 2015, 102, 1585–1594. [Google Scholar] [CrossRef] [Green Version]
- United Nations. Revision of World Population Prospects 2019. Available online: https://population.un.org/wpp/Download/Probabilistic/Population/ (accessed on 2 August 2021).
- Farmer, S.L.; Towler, S.C.; Leahy, M.F.; Hofmann, A. Drivers for Change: Western Australia Patient Blood Management Program (WA PBMP), World Health Assembly (WHA) and Advisory Committee on Blood Safety and Availability (ACBSA). Best Pract. Res. Clin. Anaesthesiol. 2013, 27, 43–58. [Google Scholar] [CrossRef]
- Tolkien, Z.; Stecher, L.; Mander, A.P.; Pereira, D.I.A.; Powell, J.J. Ferrous Sulfate Supplementation Causes Significant Gastrointestinal Side-Effects in Adults: A Systematic Review and Meta-Analysis. PLoS ONE 2015, 10, e0117383. [Google Scholar] [CrossRef] [Green Version]
- Muñoz, M.; Gómez-Ramírez, S.; Besser, M.; Pavía, J.; Gomollón, F.; Liumbruno, G.M.; Bhandari, S.; Cladellas, M.; Shander, A.; Auerbach, M. Current Misconceptions in Diagnosis and Management of Iron Deficiency. Blood Transfus. 2017, 15, 422–437. [Google Scholar] [CrossRef]
- Muñoz, M.; Acheson, A.G.; Auerbach, M.; Besser, M.; Habler, O.; Kehlet, H.; Liumbruno, G.M.; Lasocki, S.; Meybohm, P.; Rao Baikady, R.; et al. International Consensus Statement on the Peri-Operative Management of Anaemia and Iron Deficiency. Anaesthesia 2017, 72, 233–247. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Organizational Strategies for the Safe Management of Intravenous Iron Therapy in Patients in Non-Hospitalized Settings. Available online: https://salute.regione.emilia-romagna.it/notizie/regione/2020/luglio/sicurezza-dei-farmaci (accessed on 2 August 2021).
- Bolcato, M.; Beverina, I. Organisational Strategies for the Safe Management of Intravenous Iron Therapy: A Revolutionary Tool for Implementing Patient Blood Management. Blood Transfus. 2021, in press. [Google Scholar]
- European Medicines Agency. New Recommendations to Manage Risk of Allergic Reactions with Intravenous Iron-Containing Medicines. EMA/579491/2013. London, European Medicines Agency. Available online: https://www.ema.europa.eu/en/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-new-recommendations-manage-risk_en.pdf (accessed on 2 August 2021).
- Bolcato, M.; Fassina, G.; Rodriguez, D.; Russo, M.; Aprile, A. The Contribution of Legal Medicine in Clinical Risk Management. BMC Health Serv. Res. 2019, 19, 85. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Bolcato, M.; De Salvia, A.; Rodriguez, D.; Aprile, A. Is the Italian Consent to Transfusion Really Informed? A Medico-Legal Analysis between Old Ghosts and New Evidence. Transfus. Apher. Sci. 2020, 59, 102823. [Google Scholar] [CrossRef] [PubMed]
- Dignass, A.U.; Gasche, C.; Bettenworth, D.; Birgegård, G.; Danese, S.; Gisbert, J.P.; Gomollon, F.; Iqbal, T.; Katsanos, K.; Koutroubakis, I.; et al. European Consensus on the Diagnosis and Management of Iron Deficiency and Anaemia in Inflammatory Bowel Diseases. J. Crohns Colitis 2015, 9, 211–222. [Google Scholar] [CrossRef] [PubMed]
- Bolcato, M.; Russo, M.; Rodriguez, D.; Aprile, A. Patient Blood Management Implementation in Light of New Italian Laws on Patient’s Safety. Transfus. Apher. Sci. 2020, 59, 102811. [Google Scholar] [CrossRef]
- Albolino, S.; Bellandi, T.; Cappelletti, S.; Di Paolo, M.; Fineschi, V.; Frati, P.; Offidani, C.; Tanzini, M.; Tartaglia, R.; Turillazzi, E. New Rules on Patient’s Safety and Professional Liability for the Italian Health Service. Curr. Pharm. Biotechnol. 2019, 20, 615–624. [Google Scholar] [CrossRef]
- Bellandi, T.; Tartaglia, R.; Sheikh, A.; Donaldson, L. Italy Recognises Patient Safety as a Fundamental Right. BMJ 2017, 357, j2277. [Google Scholar] [CrossRef]
- Spahn, D.R. Patient Blood Management: The new standard. Transfusion. 2017, 57, 1325–1327. [Google Scholar] [CrossRef] [Green Version]
- Rampton, D.; Folkersen, J.; Fishbane, S.; Hedenus, M.; Howaldt, S.; Locatelli, F.; Patni, S.; Szebeni, J.; Weiss, G. Hypersensitivity Reactions to Intravenous Iron: Guidance for Risk Minimization and Management. Haematologica 2014, 99, 1671–1676. [Google Scholar] [CrossRef] [Green Version]
- Gómez-Ramírez, S.; Bisbe, E.; Shander, A.; Spahn, D.R.; Muñoz, M. Management of Perioperative Iron Deficiency Anemia. Acta Haematol. 2019, 142, 21–29. [Google Scholar] [CrossRef] [PubMed]
- Jericó, C.; Beverina, I.; Quintana-Diaz, M.; Salvadori, U.; Melli, C.; Rondinelli, M.B.; Recasens, V.; Brando, B.; Garcia-Erce, J.A. Efficacy and Safety of High-Dose Intravenous Iron as the First-Choice Therapy in Outpatients with Severe Iron Deficiency Anemia. Transfusion 2020, 60, 1443–1449. [Google Scholar] [CrossRef] [PubMed]
- Beverina, I.; Scalvini, R.; Brando, B. “Camel Humps”—Shaped Red Blood Cell Histogram in a Woman with Extreme Anemia Treated with Intravenous Iron. Transfusion 2020, 61, 348–349. [Google Scholar] [CrossRef]
- Beverina, I.; Macellaro, P.; Parola, L.; Brando, B. Extreme Anemia (Hb 33 g/L) in a 13-Year-Old Girl: Is the Transfusion Always Mandatory? Transfus. Apher. Sci. 2018, 57, 512–514. [Google Scholar] [CrossRef] [PubMed]
- Beverina, I.; Razionale, G.; Ranzini, M.; Aloni, A.; Finazzi, S.; Brando, B. Early Intravenous Iron Administration in the Emergency Department Reduces Red Blood Cell Unit Transfusion, Hospitalisation, Re-Transfusion, Length of Stay and Costs. Blood Transfus. 2020, 18, 106–116. [Google Scholar] [CrossRef]
- Trentino, K.M.; Mace, H.S.; Symons, K.; Sanfilippo, F.M.; Leahy, M.F.; Farmer, S.L.; Hofmann, A.; Watts, R.D.; Wallace, M.H.; Murray, K. Screening and Treating Pre-Operative Anaemia and Suboptimal Iron Stores in Elective Colorectal Surgery: A Cost Effectiveness Analysis. Anaesthesia 2021, 76, 357–365. [Google Scholar] [CrossRef]
- Trentino, K.M.; Mace, H.; Symons, K.; Sanfilippo, F.M.; Leahy, M.F.; Farmer, S.L.; Watts, R.D.; Hamdorf, J.M.; Murray, K. Associations of a Preoperative Anemia and Suboptimal Iron Stores Screening and Management Clinic in Colorectal Surgery With Hospital Cost, Reimbursement, and Length of Stay: A Net Cost Analysis. Anesth. Analg. 2021, 132, 344–352. [Google Scholar] [CrossRef]
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Bolcato, M.; Beverina, I.; Rodriguez, D.; Aprile, A.; Trabucco Aurilio, M. Organizational Strategies for the Management of Intravenous Iron Therapy in Non-Hospitalized Settings: A Safe Opportunity to Implement Patient Blood Management in Italy. Healthcare 2021, 9, 1222. https://0-doi-org.brum.beds.ac.uk/10.3390/healthcare9091222
Bolcato M, Beverina I, Rodriguez D, Aprile A, Trabucco Aurilio M. Organizational Strategies for the Management of Intravenous Iron Therapy in Non-Hospitalized Settings: A Safe Opportunity to Implement Patient Blood Management in Italy. Healthcare. 2021; 9(9):1222. https://0-doi-org.brum.beds.ac.uk/10.3390/healthcare9091222
Chicago/Turabian StyleBolcato, Matteo, Ivo Beverina, Daniele Rodriguez, Anna Aprile, and Marco Trabucco Aurilio. 2021. "Organizational Strategies for the Management of Intravenous Iron Therapy in Non-Hospitalized Settings: A Safe Opportunity to Implement Patient Blood Management in Italy" Healthcare 9, no. 9: 1222. https://0-doi-org.brum.beds.ac.uk/10.3390/healthcare9091222