title: Risk evaluation mitigation strategy: impact of application of the Food and Drug Adminstration's strategy on use of erythropoiesis-stimulating agents and transfusion in patients with chemotherapy-induced anaemia.
abstract: OBJECTIVE
  The Food and Drug Administration (FDA) instituted a risk evaluation mitigation strategy (REMS) for erythropoiesis-stimulating agent (ESA) use in patients with cancer in February 2010. Implementation of REMS was considered likely to reduce ESA use and increase red blood cell transfusions. We aimed to quantify ESA and transfusion use pre- and post-REMS.
  
  
  METHODS
  A retrospective data analysis was conducted using the Medicare 5% Sample Database from 2008 through 2011. Patients were 66 years of age or older and had lung and/or breast cancers along with chemotherapy-induced anaemia. Patients initiated chemotherapy in pre-REMS and post-REMS periods (1Q2008 through 4Q2009 and 1Q2010 through 4Q2011, respectively). Logistic regression was used to evaluate differences in proportions of patients receiving ESAs and transfusions pre-REMS and post-REMS.
  
  
  CONCLUSIONS
  The pre-REMS group included 1526 patients and the post-REMS group included 1689 patients. ESA use in patients with lung cancer decreased 30·2% from pre- to post-REMS and 33·1% in patients with breast cancer. Both decreases were statistically significant. Transfusion rates increased 22·1% from the pre-REMS period to the pre-REMS period in patients with breast cancer (P < 0·0001), but there was no statistically significant change over time in patients with lung cancer.
  
  
  CONCLUSIONS
  Erythropoiesis-stimulating agent use decreased in patients with both lung and breast cancer (P < 0·0001), and transfusion rates increased significantly post-REMS in patients with breast cancer (P < 0·0001) but not in those with lung cancer.
authors.affiliation: Johnson & Johnson, Raritan, NJ, USA.
authors.forename: K
authors.initials: K
authors.lastname: Hollingsworth
authors.forename: M C
authors.initials: MC
authors.lastname: Romney
authors.forename: A
authors.initials: A
authors.lastname: Crawford
authors.forename: J
authors.initials: J
authors.lastname: McAna
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000139:chemically induced / Q000188:drug therapy*; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy; D017707:Erythrocyte Transfusion / Q000706:statistics & numerical data*; D005260:Female; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D016015:Logistic Models; D008175:Lung Neoplasms / Q000188:drug therapy; D008297:Male; D012189:Retrospective Studies; D018570:Risk Assessment / Q000379:methods; D012308:Risk Management / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000970:Antineoplastic Agents; D006397:Hematinics
keywords: chemotherapy-induced anaemia; erythropoiesis-stimulating agents; red blood cell transfusions; risk evaluation mitigation strategies