Efficiency Outcomes Associated with Increased Ferumoxytol Use In An Infusion Clinic

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 5151-5151 ◽  
Author(s):  
Michael Meyers ◽  
Erik Erdal ◽  
Christpoher Khan ◽  
Amy McKee ◽  
Betsy Lahue

Abstract Abstract 5151 Patients with iron deficiency anemia (IDA) may require intravenous (IV) iron supplementation in an outpatient hematology setting. Such infusions require multiple visits and several hours of patient time. Ferumoxytol (Feraheme®) Injection is a novel IV iron approved for IDA in patients with reduced kidney function (CKD stages 1–5). Ferumoxytol requires fewer visits and fewer hours per treatment than other IV iron treatments. For instance, iron sucrose is generally given to nondialysis CKD patients in 200 mg doses given in five separate 1 hour infusions while ferumoxytol may be given in 510 mg doses given as a rapid injection in 2 visits. The objective of this analysis was to understand the impact of increased ferumoxytol utilization on patient, staff and financial efficiency metrics for an outpatient infusion clinic. Data on IV iron and other procedure mix, payer mix, length of clinic visit, medication and administration costs, and treatment revenue were collected from hospital financial data, staff interviews and pharmacy records for the 10-chair outpatient infusion clinic of a 325-bed academically-affiliated, non-profit hospital from January 1, 2008 through June 30, 2010. Cost of medication and administration used in each procedure came from the hospital's cost accounting system, revenue was captured as the amounts reimbursed by payers and margin was calculated as the difference between costs and revenue. Cost, revenue, margin and chair time required per IV iron treatment were analyzed for each year and estimated for 2011 utilization. Per hour efficiency metrics were calculated as the total revenue divided by total hours for each procedure. Revenue and margin per hour for the clinic's other administered therapies were also analyzed and modeled to quantify the projected financial impact of allocating freed IV iron chair time to these therapies. The clinic estimates that 80% of patients receiving IV iron treatment have reduced kidney function. Ferumoxytol treatment became available in 2009 and its share of the clinic's administered IV iron increased from 0% in 2008, to 25% in 2009, and to 42% in 2010. From 2008 to 2010, the clinic's use of iron sucrose dropped from 12% to 4%, sodium ferric gluconate decreased from 65% to 5% and iron dextran increased from 23% to 49%. The clinic forecasts that ferumoxytol will represent 60% (in 75% of ferumoxytol-eligible patients) of all IV iron administered in 2011. Because ferumoxytol requires 30 minutes per visit vs. 1.5 to 4.5 hours for other IV iron treatments, the average number of patient hours required to infuse a gram of IV iron in the clinic dropped 80% from 9.6 hours in 2008 to 1.9 hours in 2010. Furthermore, our study estimates that the clinic saved 282 hours of chair time in 2009 and the first half of 2010, and will save an additional 23 hours in 2011 by further increasing ferumoxytol utilization. Staff interviews suggested that ferumoxytol IV iron procedures were associated with improved clinic efficiencies such as reduced pharmacy preparation time (10-15 minutes less time) and improved availability of high demand equipment such as IV smart pumps. While total IV iron medication cost increased from 2008 to 2010, decreased chair time resulted in increased revenue per hour for IV iron medication (542%) and IV iron administration (153%). IV iron medication and administration margins per hour also increased (370% and 571%, respectively), moving the clinic's overall IV iron treatment margin per hour in line with their higher margin therapeutics, such as chemotherapy agents, erythropoietin, and monoclonal antibodies. By 2011, the clinic will have increased IV iron medication and administration revenue per hour by 858% and 195%, respectively over 2008 figures, and margins per hour by 588% and 753%, respectively, over 2008 figures. Given the clinic's average revenue and margin per hour for the current mix of other (non-IV iron) infusion therapies, reallocation of freed chair hours to other infusion therapies represents an additional clinic revenue and margin opportunity of $191,669 and $18,670, respectively. In conclusion, increasing use of ferumoxytol in an outpatient infusion clinic was associated with patient, staff and clinic efficiencies including fewer IV iron patient visits, decreased IV iron procedure time, the opportunity for increased clinic throughput and a substantial increase in overall IV iron revenue and margin per hour. Disclosures: Meyers: AMAG Pharmaceuticals, Inc.: Honoraria. Erdal:Boston Strategic Partners: Consultancy. Khan:Boston Strategic Partners: Consultancy. McKee:AMAG Pharmaceuticals, Inc.: Consultancy. Lahue:AMAG Pharmaceuticals, Inc.: Employment.

2021 ◽  
Vol 12 ◽  
pp. 204062072110060
Author(s):  
Harris Khan ◽  
Paige May ◽  
Elim Kuo ◽  
Preetika Pai ◽  
Katherine Boles ◽  
...  

Purpose: Iron deficiency anemia (IDA) is the most common type of anemia. A single dose infusion of intravenous (IV) iron is a convenient treatment option. Ferumoxytol is an IV formulation of iron that is typically given in two doses of 510 mg each. Utilizing a single dose of 1020 mg over 15 min has previously been described as safe and effective. In July 2018, we began to administer a single 1020 mg dose of ferumoxytol to patients needing IV iron replacement at the North Florida/South Georgia Veterans Health System. To evaluate the impact of this change, a utilization review was conducted. Methods: Outcomes of all patients who received ferumoxytol injections in the 6 months prior to and after the dosing strategy change were analyzed. A total of 140 patients, who received 270 separate IV ferumoxytol infusions, were included in the analysis. Results: No significant difference in safety was observed, with one infusion reaction occurring in each group ( p = 1.00). Efficacy also appeared equivalent with no significant difference between the change in hemoglobin for those who received a single 1020 mg dose versus those who received two 510 mg doses ( p = 0.764). As expected, those who received a single total dose infusion of 1020 mg had less clinic utilization ( p < 0.0001). Conclusion: In summary, ferumoxytol administered as a 1020 mg single dose infusion was more convenient and should be considered a safe and effective treatment option for IDA.


Author(s):  
Mohamed Saber ◽  
Mohamed Khalaf ◽  
Ahmed M. Abbas ◽  
Sayed A. Abdullah

Anemia is a condition in which either the number of circulating red blood cells or their hemoglobin concentration is decreased. As a result, there is decreased transport of oxygen from the lungs to peripheral tissues. The standard approach to treatment of postpartum iron deficiency anemia is oral iron supplementation, with blood transfusion reserved for more server or symptomatic cases. There are a number of hazards of allogenic blood transfusion including transfusion of the wrong blood, infection, anaphylaxis and lung injury, any of which will be devastating for a young mother. These hazards, together with the national shortage of blood products, mean that transfusion should be viewed as a last resort in otherwise young and healthy women. Currently, there are many iron preparations available containing different types of iron salts, including ferrous sulfate, ferrous fumarate, ferrous ascorbate but common adverse drug reactions found with these preparations are mainly gastrointestinal intolerance like nausea, vomiting, constipation, diarrhoea, abdominal pain, while ferrous bis-glycinate (fully reacted chelated amino acid form of iron) rarely make complication. Two types of intravenous (IV) preparations available are IV iron sucrose and IV ferric carboxymaltose. IV iron sucrose is safe, effective and economical. Reported incidence of adverse reactions with IV iron sucrose is less as compared to older iron preparations (Iron dextran, iron sorbitol), but it requires multiple doses and prolonged infusion time. Intramuscular iron sucrose complex is particularly contraindicated because of poor absorption. It was also stated that when iron dextran is given intravenously up to 30% of patients suffer from adverse effects which include arthritis, fever, urticaria and anaphylaxis.


2020 ◽  
Vol 31 (3) ◽  
pp. 456-468 ◽  
Author(s):  
Elizabeth Katherine Batchelor ◽  
Pinelopi Kapitsinou ◽  
Pablo E. Pergola ◽  
Csaba P. Kovesdy ◽  
Diana I. Jalal

Anemia is a complication that affects a majority of individuals with advanced CKD. Although relative deficiency of erythropoietin production is the major driver of anemia in CKD, iron deficiency stands out among the mechanisms contributing to the impaired erythropoiesis in the setting of reduced kidney function. Iron deficiency plays a significant role in anemia in CKD. This may be due to a true paucity of iron stores (absolute iron deficiency) or a relative (functional) deficiency which prevents the use of available iron stores. Several risk factors contribute to absolute and functional iron deficiency in CKD, including blood losses, impaired iron absorption, and chronic inflammation. The traditional biomarkers used for the diagnosis of iron-deficiency anemia (IDA) in patients with CKD have limitations, leading to persistent challenges in the detection and monitoring of IDA in these patients. Here, we review the pathophysiology and available diagnostic tests for IDA in CKD, we discuss the literature that has informed the current practice guidelines for the treatment of IDA in CKD, and we summarize the available oral and intravenous (IV) iron formulations for the treatment of IDA in CKD. Two important issues are addressed, including the potential risks of a more liberal approach to iron supplementation as well as the potential risks and benefits of IV versus oral iron supplementation in patients with CKD.


Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 5157-5157
Author(s):  
Allen Poma ◽  
Karen Diana ◽  
Justin McLaughlin ◽  
Annamaria Kausz

Abstract Abstract 5157 BACKGROUND: Iron replacement therapy is essential for increasing iron stores and raising hemoglobin levels in patients with iron deficiency anemia (IDA). Oral iron supplements have limited absorption and are commonly associated with gastrointestinal (GI) side effects that reduce compliance, resulting in limited increases in hemoglobin. In patients without chronic kidney disease (CKD), oral iron therapy is frequently used to treat IDA. However, when oral iron therapy is unsatisfactory or cannot be tolerated, intravenous (IV) iron therapy may be appropriate. In the US, iron dextrans are the only approved IV iron products indicated for the treatment of IDA in non-CKD patients, and have limitations around convenience because they require a test dose and as many as 10 administrations via a slow infusion; iron dextrans have also been associated with a relatively high rate of serious adverse reactions compared to other IV iron products. Other IV irons, such as iron sucrose and sodium ferric gluconate, are only approved in the US for the treatment of IDA in patients with CKD. Like the iron dextrans, both of these products are limited by administration, requiring 5 to 10 clinic visits for the administration of a full therapeutic dose (1 gram of iron). Feraheme® (ferumoxytol) Injection is an IV iron product approved in the US for the treatment of IDA in adult subjects with CKD. Its carbohydrate coating is designed to minimize immunological sensitivity, and it has less free iron than other IV iron preparations. Ferumoxytol is administered as two IV injections of 510 mg (17 mL) 3 to 8 days apart for a total cumulative dose of 1.02 g. METHODS: To date, there have been a limited number of studies that have examined the safety and efficacy of IV irons in a head-to-head manner for the treatment of IDA, and no study has done so in a large number of subjects or in a broad patient population. AMAG, therefore, has initiated a randomized, controlled trial (ClinicalTrials.gov NCT01114204) to compare ferumoxytol with iron sucrose. Iron sucrose is approved in many countries outside the US for the treatment of IDA in patients intolerant to oral iron therapy, and is considered a safer alternative to IV iron dextran. This open-label trial (n=600) will evaluate the efficacy and safety of a 1.02 g of IV ferumoxytol, administered as 2 doses of 510 mg each, compared with 1.0 g of IV iron sucrose, administered as 5 doses of 200 mg each. Enrolled subjects will have IDA associated with a variety of underlying conditions including abnormal uterine bleeding, GI disorders, cancer, postpartum anemia, and others (eg, nutritional deficiency). Endpoints include changes in hemoglobin and transferrin saturation at Week 5, as well as evaluation of the requirement for erythropoiesis stimulating agent therapy and blood transfusion. Patient reported outcomes instruments will be employed to assess the impact of IV iron therapy on anemia symptoms and health-related quality of life (fatigue, energy, etc). Additionally, detailed information on healthcare utilization will be collected. CONCLUSION In the US, non-CKD patients with IDA who have a history of unsatisfactory oral iron therapy have limited options for iron replacement therapy. Study NCT01114204 will provide novel information comparing the safety and efficacy of two IV iron therapies for the treatment of IDA in a broad patient population. Disclosures: Poma: AMAG Pharmaceuticals, Inc.: Employment. Diana:AMAG Pharmaceuticals, Inc.: Employment. McLaughlin:AMAG Pharmaceuticals, Inc.: Employment. Kausz:AMAG Pharmaceuticals, Inc.: Employment.


Author(s):  
Satish Kumar

Introduction: Anemia is the commonest major contributing factor in maternal mortality and morbidity in developing countries and according to World Health Organization (WHO) criteria, it contributes to 20% of maternal deaths. Anemia in pregnancy defined as hemoglobin level <11 gm/dl (7.45 mmol/L) and hematocrit less than 33% (WHO). Aim: To compare the efficacy of oral iron ferrous sulphate therapy with intravenous iron sucrose therapy in the treatment of iron deficiency anemia during postpartum period. Material & Methods: This was a prospective randomized comparative clinical trial single center study conducted on 200 postpartum women aged >18 years (after normal delivery or LSCS) within 10 days of delivery with Hb level more or equal to 6 gm/dl but less than 10 gm/dl were included in the study. This was a one year study conducted during 1st December 2018 to 30th November 2019. Results : There was a significant increase in the hemoglobin level in both the groups i.e. in IV iron group, from 8.26 ±1.03gm/dl on day 1 to 11.62±0.94gm/dl on day 45 as compared to oral iron group, from 8.24±1.09gm/dl on day 1 to 11.07±1.14gm/dl on day 45; and serum ferritin level from 41.69±40.45ng/ml on day 1 to 77.34±41.60ng/ml on day 45 in IV iron group as compared to the oral iron group from 22.20±8.82ng/ml on day 1 to 31.72±9.72 ng/ml on day 45. So, there was a rapid increase in both hemoglobin and serum ferritin levels in IV iron group as compared to the oral iron group. Conclusion: Intravenous iron sucrose administration increases the hemoglobin level and serum ferritin more rapidly in compare to the oral intake of ferrous sulphate in women with iron deficiency anemia in postpartum women in our study. Keywords: Iron deficiency anemia, Intravenous iron sucrose, Serum ferritin, Maternal mortality.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 1052-1052 ◽  
Author(s):  
Julia Ramos ◽  
Melissa Rosenstein ◽  
Andrew Leavitt

Abstract Introduction: Multiple studies in industrialized countries indicate that postpartum anemia affects 20-50% of patients immediately after delivery (Barroso F et al Eur J Obstet Gynecol Reprod Biol 2011; Bergmann RL et al Eur J Obstet Gynecol Reprod Biol 2010; Urquizu IBX et al Med Clin (Barc) 2016). A growing body of literature suggests that intravenous (IV) iron improves time to anemia recovery in postpartum patients (Breymann C et al. Int J Gynaecol Obstet. 2008; Seid MH et al, Am J Obstet Gynecol 2008). We therefore developed recommendations for the use of IV iron on our Labor and Delivery (L&D) service to treat postpartum anemia. Three months after initiation of the IV iron recommendations, we performed an audit to assess its use. Methods: The UCSF pharmacy identified medical record numbers for obstetrical patients given IV iron sucrose 5/1/17 - 10/31/17, which spans 3 months pre-release of the IV iron protocol through the first 3 months after protocol release. Seventy-one patients were identified and their charts were individually reviewed to determine the dose and number of IV iron infusions received, interval between infusions when more than one infusion was given, the IV location for each infusion, and whether phlebitis was reported. Phlebitis was considered to have occurred if a physician or nursing note indicated that the patient had pain, swelling or erythema in an arm correlating to documented site of IV iron infusion. This study was conducted under UCSF Institutional Review Board approval number 17-22831. Results: Patients received 100 mg, 200 mg, or 300 mg of iron sucrose per infusion. Each infusion was administered over 30-90 minutes and patients received 1, 2, or 3 IV iron infusions. Venofer® is the only IV iron sucrose product received by patients in this study. The overall incidence of phlebitis was 9.9% (7 of 71 patients), higher than expected based on the previously published safety data and the published experience using IV iron sucrose in the postpartum setting (Breymann C et al. Eur J Clin Invest. 2000; Westad S et al. Acta Obstet Gynecol Scand. 2008). In addition, we found an increase in phlebitis incidence with increasing number of IV infusions: phlebitis was seen in 2 of 18 (11%) patients who received 2 iron infusions on consecutive days via a single IV site, while patients who received 300 mg iron sucrose on 3 consecutive days (5 out of 16 patients; Table 1) had a 31% incidence of phlebitis. Importantly, the phlebitis incidence was 50% for the 10 patients who received 3 infusions of 300 mg iron sucrose at a single IV site. Interestingly, in 6 patients who received 3 infusions of 300 mg iron sucrose on 3 consecutive days but had their peripheral IV re-sited between infusions, none developed phlebitis. No phlebitis was reported in 37 patients who received a single infusion of iron sucrose (100 - 300 mg dose range). Of the 7 phlebitis cases, 3 patients were readmitted to the hospital for evaluation and treatment. Three patients returned to our OB clinic or to L&D Triage for evaluation. One patient communicated her symptoms by telephone encounter. Discussion. IV iron safety analyses have historically focused on dose limitations and the risk for infusion reaction and anaphylaxis. We identified an increasing incidence of post-infusion phlebitis with increasing number of infusions of daily iron sucrose in patients admitted to our L&D service, an adverse event not previously highlighted in published safety literature for iron sucrose. We found the phlebitis events to be clinically significant for the patient, and to result in increased healthcare utilization post-infusion. It is our opinion that this adverse effect deserves attention because of the patient discomfort, inconvenience, and increased healthcare resource utilization. Physicians treating patients for iron-deficiency anemia, including hospitalists, hematologist, and OB-Gyn providers, should be aware of post-infusion phlebitis as a possible complication of iron sucrose therapy. Based on our findings, we recommend against daily IV iron sucrose infusions through a single peripheral venous access site. In addition, other formulations that allow for complete iron replacement in a single infusion session offer a convenience advantage to doctor and patient and may minimize the risk of phlebitis we observed with serial daily iron infusions. Disclosures No relevant conflicts of interest to declare.


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4661-4661
Author(s):  
Michael F Driscoll ◽  
Derek Forster ◽  
Brandi Dyer ◽  
Damian A. Laber

Abstract Introduction: Iron deficiency anemia is one of the most commonly encountered hematologic medical conditions in general practice. Oral replacement of iron can be a slow and suboptimal process, limited by low absorption rates and disease-enhanced malabsorption. When clinicians are faced with patients with large iron deficits, intravenous (IV) iron is the best option. Currently there are four IV preparations available; iron sucrose, iron gluconate, low-molecular weight iron dextran and high-molecular weight iron dextran. Upon informal questioning, we found reluctancy by many physicians to use iron dextran due to fear of allergic reactions. We examine these four preparations for clinical utility, adverse drug events (ADEs), and cost-effectiveness. Methods: We performed a systematic review and retrospective meta-analysis of studies investigating various forms of intravenous iron preparations for toxicity, ADEs, and costs. Also, we obtained actual costs of infusing intravenous iron at four hospitals in metro Louisville, KY. Results: Fourteen studies met the criteria and were reviewed. One study compared all four iron preparations, two compared three preparations and the rest compared two. Eight had a small sample size. The number of ADEs were quite small. Data from FDAderived ADE reporting of the four IV iron preparations from 2001–2003 showed a total of 1141 per 30,063,800 doses administered, yielding an ADE rate of approximately 38 per million. Absolute rate of all ADEs for iron sucrose, iron gluconate, low molecular weight iron dextran and high molecular weight iron dextran were 19.2, 18.5, 36.9, and 117.8 per million, respectively. Absolute rates of life-threatening ADEs were significantly lower at 0.6, 0.9, 3.3, and 11.3 per million respectively for iron sucrose, iron gluconate, low molecular weight iron dextran, and high molecular weight iron dextran. Based on cost differences between iron sucrose and dextran preparations, the cost to prevent one lifethreatening ADE related to the use of lower molecular weigh iron dextran was estimated to be $5.0–7.8 million. Also the cost to prevent one low-molecular weight iron dextran related death was estimated to be $33 million. These calculations are based on cost of preparations only. Estimates based on hospital-related costs incurred due to multiple infusions vs total dose infusion (TDI) puts the estimate of cost to prevent one lower molecular weight related death over $150 million. Conclusions: The perceived rate of ADEs related to infusion of IV iron preparations in medical practice has been overstated. Smaller studies with lower patient and total infusion numbers, and anecdotal evidence, tended to overestimate the frequency of life-threatening reactions. The incidence of ADEs and serious life-threatening ADEs, is exceedingly low for all IV iron preparations. In light of costs associated with the use of iron sucrose and iron gluconate vs iron dextran, we recommend that all clinicians re-assess the clinical utility of low molecular weight iron dextran for iron deficiency anemia necessitating parenteral iron replacement. Moreover, large doses of iron dextran can be safely given, thereby reducing costs associated with multiple small infusions of iron sucrose.


Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 5152-5152
Author(s):  
Ralph Boccia ◽  
Betsy Lahue ◽  
Robert Hauser ◽  
Jessica Dioguardi

Abstract Abstract 5152 Anemia in oncology patients is common and may negatively impact cancer treatment outcomes. Iron deficiency is a major contributor to anemia, which can be exacerbated by both underlying conditions and chemotherapeutic agents. Additionally, many oncology patients may have concomitant renal insufficiency or chronic kidney disease (CKD), increasing their susceptibility to iron deficiency. Therefore, recognizing renal insufficiency as well as iron deficiency may improve anemia management in oncology patients. To determine the proportion of oncology patients with iron deficiency anemia (IDA), potential renal insufficiency and the current utilization of IV iron treatment in these populations, a large electronic medical records database was examined. All patients treated with chemotherapy in a physician services oncology network from January 1, 2008 to August 1, 2010 were selected in order to determine the prevalence of an iron deficiency anemia (IDA) diagnosis (expressed as an ICD-9-CM 280.1-.9), and a diagnosis of CKD (expressed as either from a diagnosis code of CKD (585.1-.6) or estimated GFR <60 mL/min). Overall, 83,219 patients receiving a chemotherapeutic agent were selected. Of these patients, 36% (30,298) were diagnosed with IDA, 34% of whom were receiving IV iron treatment (9,971/30,298). These patients represented approximately 85% (9971/11,776) of the total IV iron treated population in the dataset. While only 8% (2,482/30,298) of patients with a diagnosis of IDA also had a diagnosis of CKD. Of the patients that did present with a GFR level, 49% of patients had a GFR level <60 mL/min. However, the true prevalence of CKD in this population was difficult to determine because a significant percentage of patients did not present with a GFR level available in their records. In this oncology patient population IDA is relatively common, with greater than 30% of patients diagnosed. While only one third of these patients were receiving IV iron treatment in the IDA patient population, it is unknown whether patients are not being treated for their iron deficiency or are being managed on oral iron therapy alone. Given recent controversies around ESA use, guidelines suggest that iron indices should be checked, and IV iron supplementation should be considered in patients receiving ESA therapy. Additionally, only a fraction of patients diagnosed with IDA are also diagnosed with CKD, even though analysis of GFR values suggests that a significant number of patients may have renal insufficiency. These data suggest that identification of patients with renal insufficiency may be suboptimal and that further treatment of IDA in this patient population may be warranted in order to optimize anemia management. Disclosures: Boccia: AMAG: Consultancy, Honoraria, Speakers Bureau. Lahue:AMAG: Employment. Hauser:AMAG: Research Funding. Dioguardi:AMAG: Employment.


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