Analysis of 20% human albumin prescriptions from a teaching hospital and their respective expense description
DOI:
https://doi.org/10.33448/rsd-v12i1.36496Keywords:
Serum albumin human; Therapeutic indications; Rational drug utilization.Abstract
Albumin is the most important plasma expander in the bloodstream. In the form of medication, it must be prescribed after a thorough evaluation of the patients, basing its use according to the literature, as it has contraindications, such as bleeding in post-surgical patients, in addition to being a high-cost medication. Thus, the objective of this work was to carry out a survey of the therapeutic indications contained in the prescriptions of human albumin (HA) 20% of a Teaching Hospital in the city of Recife, Pernambuco, Brazil, in order to assess whether such indications have scientific basis, in addition to a survey of the costs related to the acquisition of this drug should be carried out. A cross-sectional, retrospective study was carried out, based on the analysis of prescriptions prescribed to patients, from May 2015 to May 2017. The therapeutic indications found were: relief paracentesis (29%), hepatorenal syndrome (HRS) (22,9%), hypovolemia (20.6%), septic shock (8.7%), spontaneous bacterial peritonitis (SBP) (6.4%), hypoalbuminemia (6.1%), ascites (4.1%), neoplasia (1.2%) and hepatic encephalopathy (HE) (0.6%). After a literature review, HA 20% has scientific support for the treatment of paracentesis, SHR and PBE, which corresponds to 63.1% of prescriptions and has no scientific support for the treatment of hypovolemia, septic shock, hypoalbuminemia, cancer and HE (36.9%), which can be replaced by other plasma expanders. Thus, the importance of basing the prescription of 20% HA according to the literature is highlighted, always aiming at the rational use of medicines.
References
Aday, A., & O’Leary, J. G. (2020). Acute on Chronic Liver Failure: Definition and Implications. Clinics in Liver Disease, 24(3), 521-534.
Annane, D., Siami, S., Jaber, S., Martin, C., Elatrous, S., Declère, A. D., Preiser, J.C., Outin, H., Troché, G., Charpentier, C., Trouillet, J. L., Kimmoun, A., Forceville, X., Darmon, M., Lesur, O., Reignier, J., Abroug, F., Berger, P., Clec’h, C., Cousson, J., Thibault, L., Chevret, S., & CRISTAL Investigators. (2013). Effects of fluid resuscitation with colloids vs crystalloids on mortality in critically ill patients presenting with hypovolemic shock: the CRISTAL randomized trial. Jama, 310(17), 1809-1817.
Artigas, A., Wernerman, J., Arroyo, V., Vincent, J. L., & Levy, M. (2016). Role of albumin in diseases associated with severe systemic inflammation: pathophysiologic and clinical evidence in sepsis and in decompensated cirrhosis. Journal of Critical Care, 33, 62-70.
Arvaniti, V., D'Amico, G., Fede, G., Manousou, P., Tsochatzis, E., Pleguezuelo, M., & Burroughs, A. K. (2010). Infections in patients with cirrhosis increase mortality four-fold and should be used in determining prognosis. Gastroenterology, 139(4), 1246-1256.
Bai, Z., Bernardi, M., Yoshida, E. M., Li, H., Guo, X., Méndez-Sánchez, N., Li, Y., Wang, R., Deng, J., & Qi, X. (2019). Albumin infusion may decrease the incidence and severity of overt hepatic encephalopathy in liver cirrhosis. Aging (Albany NY), 11(19), 8502.
Bernardi, M., Ricci, C. S., & Zaccherini, G. (2014). Role of human albumin in the management of complications of liver cirrhosis. Journal of clinical and experimental hepatology, 4(4), 302-311.
Borges, W. M., Almeida, S. M. D., Ferracini, F. T., & Fernandes, C. J. (2010). Pharmacy contribution to the prescription and rational use of human albumin at a large hospital. Einstein (São Paulo), 8, 215-220.
Brasil. (2001). Lei no 10.205, de 21 de março de 2001. Casa Civil. Regulamenta o § 4o do art. 199 da Constituição Federal, relativo à coleta, processamento, estocagem, distribuição e aplicação do sangue, seus componentes e derivados, estabelece o ordenamento institucional indispensável à execução adequada dessas atividades, e dá outras providências. Planalto. Brasília.
Brasil. (2012). Resolução nº 466, de 12 de dezembro de 2012. Conselho Nacional de Saúde. Comissão Nacional de Ética em Pesquisa. Normas regulamentadoras de pesquisa envolvendo seres humanos.
Caraceni, P., Tufoni, M., & Bonavita, M. E. (2013). Clinical use of albumin. Blood transfusion, 11(Suppl 4), s18.
Caraceni, P., Riggio, O., Angeli, P., Alessandria, C., Neri, S., Foschi, F. G., Levantesi, F., Airoldi, A., Boccia, S., Svegliati-Baroni, G., Fagiuoli, S., Romanelli, R.G., Cozzolongo, R., Di Marco, V., Sangiovanni, V., Morisco, F., Toniutto, P., Tortora, A., De Marco, R., Angelico, M., Cacciola, I., Elia, G., Federico, A., Massironi, S., Guarisco, R., Galioto, A., Ballardini, G., Rendina, M., Nardelli, S., Piano, S., Elia, C., Prestianni, L., Cappa, F.M., Cesarini, L., Simone, L., Pasquale, C., Cavallin, M., Andrealli, A., Fidone, F., Ruggeri, M., Roncadori, A., Baldassarre, M., Tufoni, M., Zaccherini, G., Bernardi, M., & ANSWER Study Investigators. (2018). Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial. The Lancet, 391(10138), 2417-2429.
Caraceni, P., Tufoni, M., Zaccherini, G., Riggio, O., Angeli, P., Alessandria, C.,Neri, S., Foschi, F. G., Levantesi, F., Airoldi, A., Simone, L., Svegliati-Baroni, G., Fagiuoli, S., Laffi, G., Cozzolongo, R., Di Marco, V., Sangiovanni, V., Morisco, F., Toniutto, P., Gasbarrini, A., De Marco, R., Piano, S., Nardelli, S., Elia, C., Roncadori, A., Baldassarre, M., & Andrealli, A. (2021). On-treatment serum albumin level can guide long-term treatment in patients with cirrhosis and uncomplicated ascites. Journal of Hepatology, 74(2), 340-349.
Carvalho, J. R., & Machado, M. V. (2018). New insights about albumin and liver disease. Annals of hepatology, 17(4), 547-560.
Casuccio, A., Nalbone, E., Immordino, P., La Seta, C., Sanfilippo, P., Tuttolomondo, A., & Vitale, F. (2015). Appropriateness of requests for human serum albumin at the University Hospital of Palermo, Italy: a prospective study. International Journal for Quality in Health Care, 27(2), 154-160.
Curfman, G. D., Morrissey, S., & Drazen, J. M. (2013). High-value health care—a sustainable proposition. The New England Journal of Medicine, 369(12), 1163-1164.
Dasarathy, S., Mookerjee, R. P., Rackayova, V., Thrane, V. R., Vairappan, B., Ott, P., & Rose, C. F. (2017). Ammonia toxicity: from head to toe?. Metabolic brain disease, 32(2), 529-538.
Duriseti, P., Mamtani, R., Madias, N. E., & Strom, J. A. (2020). Alkalemia and Hepatic Encephalopathy in a Chronic Dialysis Patient. The American Journal of the Medical Sciences.
Dutra, C. S. K., Silveira, L. M., Santos, A. O., Pereira, R., & Stabile, A. M. (2014). Prevalent nursing diagnosis in patients hospitalized with sepsis at the intensive care unit. Cogitare Enferm, 19(4), 688-94.
Estrela, C. (2018). Metodologia Científica: Ciência, Ensino, Pesquisa. Editora Artes Médicas.
European Association for The Study of the Liver. (2018). EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis. Journal of hepatology, 69(2), 406-460.
Facciorusso, A., Cosimo Nacchiero, M., Rosania, R., Laonigro, G., Longo, N., Panella, C., & Ierardi, E. (2011). The use of human albumin for the treatment of ascites in patients with liver cirrhosis: item of safety, facts, controversies and perspectives. Current drug safety, 6(4), 267-274.
Farasatinasab, M., Amouzegar, A., Safari, S., Ghanbari, B., Darkahian, M., Emami, S. Pakdaman, N., Salili, M. (2018). Albumin utilization evaluation in a major teaching hospital in Iran: Recommendations for guideline development. Journal of research in pharmacy practice, 7(3), 157.
Fernández, J., Monteagudo, J., Bargallo, X., Jiménez, W., Bosch, J., Arroyo, V., & Navasa, M. (2005). A randomized unblinded pilot study comparing albumin versus hydroxyethyl starch in spontaneous bacterial peritonitis. Hepatology, 42(3), 627-634.
Ferrer, R., Mateu, X., Maseda, E., Yébenes, J. C., Aldecoa, C., De Haro, C., Ruiz-Rodrigues, J.C., & Garnacho-Montero, J. (2018). Non-oncotic properties of albumin. A multidisciplinary vision about the implications for critically ill patients. Expert review of clinical pharmacology, 11(2), 125-137.
Fleck, A., Hawker, F., Wallace, P. I., Raines, G., Trotter, J., Ledingham, I. M., & Calman, K. C. (1985). Increased vascular permeability: a major cause of hypoalbuminaemia in disease and injury. The Lancet, 325(8432), 781-784.
Frazee, E. N., Leedahl, D. D., & Kashani, K. B. (2015). Key controversies in colloid and crystalloid fluid utilization. Hospital pharmacy, 50(6), 446-453.
Gildea, T. R., Cook, W. C., Nelson, D. R., Aggarwal, A., Carey, W., Younossi, Z. M., & Arroliga, A. C. (2004). Predictors of long-term mortality in patients with cirrhosis of the liver admitted to a medical ICU. Chest, 126(5), 1598-1603.
Guevara, M., Terra, C., Nazar, A., Solà, E., Fernández, J., Pavesi, M., Arroyo, V., & Ginès, P. (2012). Albumin for bacterial infections other than spontaneous bacterial peritonitis in cirrhosis. A randomized, controlled study. Journal of Hepatology, 57(4), 759-765.
Haskins, I. N., Baginsky, M., Amdur, R. L., & Agarwal, S. (2017). Preoperative hypoalbuminemia is associated with worse outcomes in colon cancer patients. Clinical Nutrition, 36(5), 1333-1338.
Ibidapo-Obe, O., Stengel, S., Köse-Vogel, N., Quickert, S., Reuken, P. A., Busch, M., Bauer, M., Stallmach, A., & Bruns, T. (2020). Mucosal-associated invariant T cells redistribute to the peritoneal cavity during spontaneous bacterial peritonitis and contribute to peritoneal inflammation. Cellular and molecular gastroenterology and hepatology, 9(4), 661-677.
Jahangard-Rafsanjani, Z., Javadi, M. R., Torkamandi, H., Alahyari, S., Talasaz, A. H., & Gholami, K. (2011). The evaluation of albumin utilization in a teaching university hospital in Iran. Iranian journal of pharmaceutical research: IJPR, 10(2), 385.
Kalkwarf, K. J., & Cotton, B. A. (2017). Resuscitation for hypovolemic shock. Surgical Clinics, 97(6), 1307-1321.
Kandiah, P. A., & Kumar, G. (2016). Hepatic encephalopathy—the old and the new. Critical care clinics, 32(3), 311-329.
Kazemi, Y., Hadavand, N., Hayatshahi, A., Torkamandi, H., Gholami, K., Hadjibabaie, M., Jahangard-Rafsanjani, Z., & Javadi, M. R. (2013). Albumin utilization in a teaching hospital in Tehran: time to revise the prescribing strategies. Journal of Pharmaceutical Care, 127-132.
Kim, J., Shim, S. H., Oh, I. K., Yoon, S. H., Lee, S. J., Kim, S. N., & Kang, S. B. (2015). Preoperative hypoalbuminemia is a risk factor for 30-day morbidity after gynecological malignancy surgery. Obstetrics & gynecology science, 58(5), 359-367.
Kragh-Hansen, U., Minchiotti, L., Galliano, M., & Peters Jr, T. (2013). Human serum albumin isoforms: genetic and molecular aspects and functional consequences. Biochimica et Biophysica Acta (BBA)-General Subjects, 1830(12), 5405-5417.
Kumar, A., Sevransky, J.E., Sprung, C.L., Nunnally,M.E., Rochwerg, B., Rubenfeld, G.D., Angus, D.C., Annane, D., Beale, R.J., Bellinghan, G.J., Bernard, G.R., Chiche, J.D., Coopersmith, C.,De Backer, D.P., French, C.J., Fujishima, S., Gerlach, H., Hidalgo, J.L., Hollenberg, S.H., Jones, A.E., Karnad, D.R., Kleinpell, R.M., Koh, Y., Lisboa, T.C., Machado, F.R., Marini, J.J., Marshall, J.C., Mazuski, J.E., McIntyre, L.A., McLean, A.S., Mehta, S., Moreno, R.P., Myburgh, J., Navalesi, P., Nishida, O., Osborn, T.M., Perner, A., Plunkett, C.M., Ranieri, M., Schorr, C.A., Seckel, M.A., Seymour, C.W., Shieh, L., Shukri, K.A., Simpson, S.Q., Singer, M., Thompson, B.T., Townsend, S.R., Van der Poll, T., Vincent, J.L., Wiersinga, W.J., Zimmerman, J.L., & Dellinger, R. P. (2017). Surviving sepsis campaign: international guidelines for management of sepsis and septic shock: 2016. Intensive care medicine, 43(3), 304-377.
Levitt, D. G., & Levitt, M. D. (2016). Human serum albumin homeostasis: a new look at the roles of synthesis, catabolism, renal and gastrointestinal excretion, and the clinical value of serum albumin measurements. International journal of general medicine, 9, 229.
Liumbruno, G., Bennardello, F., Lattanzio, A., Piccoli, P., & Rossettias, G. (2009). Recommendations for the use of albumin and immunoglobulins. Blood transfusion, 7(3), 216.
Lohsiriwat, V., Lohsiriwat, D., Boonnuch, W., Chinswangwatanakul, V., Akaraviputh, T., & Lert-Akayamanee, N. (2008). Pre-operative hypoalbuminemia is a major risk factor for postoperative complications following rectal cancer surgery. World journal of gastroenterology: WJG, 14(8), 1248.
Mishra, D., Satpathy, G., Wig, N., Fazal, F., Ahmed, N. H., & Panda, S. K. (2020). Evaluation of 16S rRNA broad range PCR assay for microbial detection in serum specimens in sepsis patients. Journal of infection and public health, 13(7), 998-1002.
Mori, F., Natali, L., Danesi, R., Nannizzi, S., & Farina, C. (2021). Post-translational modifications and antioxidant properties of different therapeutic human serum albumins. International Journal of Biological Macromolecules, 183, 927-935.
Naldi, M., Baldassarre, M., Domenicali, M., Bartolini, M., & Caraceni, P. (2017). Structural and functional integrity of human serum albumin: Analytical approaches and clinical relevance in patients with liver cirrhosis. Journal of pharmaceutical and biomedical analysis, 144, 138-153.
Nguyen, M. K., & Kurtz, I. (2004). Determinants of plasma water sodium concentration as reflected in the Edelman equation: role of osmotic and Gibbs-Donnan equilibrium. American Journal of Physiology-Renal Physiology, 286(5), F828-F837.
Oettl, K., Stadlbauer, V., Petter, F., Greilberger, J., Putz-Bankuti, C., Hallström, S., Lackner, C. & Stauber, R. E. (2008). Oxidative damage of albumin in advanced liver disease. Biochimica et Biophysica Acta (BBA)-Molecular Basis of Disease, 1782(7-8), 469-473.
Piano, S., Schmidt, H. H., Ariza, X., Amoros, A., Romano, A., Hüsing-Kabar, A., Solà, E., Gerbes, A., Bernardi, M., Alessandria, C., Scheiner, B., Tonon, M., Maschmeier, M., Solè, C., Trebicka, J., Gustot, T., Nevens, F., Arroyo, V., Gines, P., & Angeli, P. (2018). Association between grade of acute on chronic liver failure and response to terlipressin and albumin in patients with hepatorenal syndrome. Clinical Gastroenterology and Hepatology, 16(11), 1792-1800.
Rajora, N., De Gregorio, L., & Saxena, R. (2021). Peritoneal Dialysis Use in Patients With Ascites: A Review. American Journal of Kidney Diseases.
Razouk, F. H., & Reiche, E. (2004). Caracterização, produção e indicação clínica dos principais hemocomponentes. Revista Brasileira de Hematologia e Hemoterapia, 26, 126-134.
Rose, C. F., Amodio, P., Bajaj, J. S., Dhiman, R. K., Montagnese, S., Taylor-Robinson, S. D., Vilstrup, H, & Jalan, R. (2020). Hepatic encephalopathy: Novel insights into classification, pathophysiology and therapy. Journal of hepatology.
Rozga, J., Piątek, T., & Małkowski, P. (2013). Human albumin: old, new, and emerging applications. Annals of transplantation, 18, 205-217.
Safe Study Investigators (2004). A comparison of albumin and saline for fluid resuscitation in the intensive care unit. New England Journal of Medicine, 350(22), 2247-2256.
Salim, M. M., El Sharkasy, M. E., Belal, F., & Walash, M. (2021). Multi-spectroscopic and molecular docking studies for binding interaction between fluvoxamine and human serum albumin. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, 252, 119495.
Saló, J., Ginès, A., Ginès, P., Piera, C., Jiménez, W., Guevara, M., Fernández-Esparrach, G., Sort, P.,Bataller, R., Arroyo, V., & Rodés, J. (1997). Effect of therapeutic paracentesis on plasma volume and transvascular escape rate of albumin in patients with cirrhosis. Journal of hepatology, 27(4), 645-653.
Seymour, C. W., Liu, V. X., Iwashyna, T. J., Brunkhorst, F. M., Rea, T. D., Scherag, A.,Rubenfeld, G., Kahn, J. M., Shankar-Hari, M., Singer, M., FRCP; Deutschman, C. S., Escobar, G. J., & Angus, D. C. (2016). Assessment of clinical criteria for sepsis: for the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). Jama, 315(8), 762-774.
Shafiee, E., Rezaee, H., Entezari, M. T., & Hamishehkar, H. (2016). The evaluation of albumin use in an Iranian university hospital. Pharmaceutical Sciences, 22(3), 186-189.
Shankar-Hari, M., Phillips, G. S., Levy, M. L., Seymour, C. W., Liu, V. X., Deutschman, C. S., Angus, D.C., Rubenfeld, G.D., Singer, M., & Singer, M. (2016). Developing a new definition and assessing new clinical criteria for septic shock: for the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). Jama, 315(8), 775-787.
Simón-Talero, M., García-Martínez, R., Torrens, M., Augustin, S., Gómez, S., Pereira, G., Guevara, M., Ginés, P., Soriano, G., Román, Eva., Sánchez-Delgado, J., Ferrer, R., Nieto, J.C., Sunyé, P., Fuentes, I., Esteban, R., & Córdoba, J. (2013). Effects of intravenous albumin in patients with cirrhosis and episodic hepatic encephalopathy: a randomized double-blind study. Journal of Hepatology, 59(6), 1184-1192.
Sugio, S., Kashima, A., Mochizuki, S., Noda, M., & Kobayashi, K. (1999). Crystal structure of human serum albumin at 2.5 Å resolution. Protein engineering, 12(6), 439-446.
Sullivan, S. A., Van Le, L., Liberty, A. L., Soper, J. T., & Barber, E. L. (2016). Association between hypoalbuminemia and surgical site infection in vulvar cancers. Gynecologic oncology, 142(3), 435-439.
Tandon, P., & Garcia–Tsao, G. (2011). Renal dysfunction is the most important independent predictor of mortality in cirrhotic patients with spontaneous bacterial peritonitis. Clinical Gastroenterology and Hepatology, 9(3), 260-265.
Tapper, E. B., Bonder, A., & Cardenas, A. (2016). Preventing and treating acute kidney injury among hospitalized patients with cirrhosis and ascites: a narrative review. The American journal of medicine, 129(5), 461-467.
Taverna, M., Marie, A. L., Mira, J. P., & Guidet, B. (2013). Specific antioxidant properties of human serum albumin. Annals of intensive care, 3(1), 1-7.
Vincent, J. L., Russell, J. A., Jacob, M., Martin, G., Guidet, B., Wernerman, J., Roca, R.F., McCluskey, S.A., & Gattinoni, L. (2014). Albumin administration in the acutely ill: what is new and where next?. Critical Care, 18(4), 1-10.
Wang, J., Liang, T., Louis, L., Nicolaou, S., & McLaughlin, P. D. (2013). Hypovolemic shock complex in the trauma setting: a pictorial review. Canadian Association of Radiologists Journal, 64(2), 156-163.
Weissenborn, K., Bokemeyer, M., Krause, J., Ennen, J., & Ahl, B. (2005). Neurological and neuropsychiatric syndromes associated with liver disease. Aids, 19, S93-S98.
Wiedermann, C. J., & Eisendle, K. (2017). Comparison of hydroxyethyl starch regulatory summaries from the Food and Drug Administration and the European Medicines Agency. Journal of pharmaceutical policy and practice, 10(1), 1-6.
Wiggers, C. J. (1942). The present status of the shock problem. Physiological Reviews, 22(1), 74-123.
Wilkes, M. M., & Navickis, R. J. (2001). Patient survival after human albumin administration: a meta-analysis of randomized, controlled trials. Annals of internal medicine, 135(3), 149-164.
Wiltfang, J., Nolte, W., Weissenborn, K., Kornhuber, J., & Rüther, E. (1998). Psychiatric aspects of portal-systemic encephalopathy. Metabolic brain disease, 13(4), 379-389.
Winzer, R., Martin, R., Baldus, J. C., Heidrich, F. M., Hoberück, S., Hoffmann, R. T., & Fedders, D. (2020). Vascular changes of the superior mesenteric artery (SMA): A new component of the hypovolemic shock complex (HSC). European Journal of Radiology, 133, 109370.
Zsila, F. (2013). Subdomain IB is the third major drug binding region of human serum albumin: toward the three-sites model. Molecular pharmaceutics, 10(5), 1668-1682.
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