NDLI: 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.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Hollingsworth, K. Romney, M. C. Crawford, A. McAna, J.
Spatial Coverage	United States
Description	Country affiliation: United States Author Affiliation: Hollingsworth K ( Johnson & Johnson, Raritan, NJ, USA.)
Abstract	WHAT IS KNOWN AND 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. RESULTS AND DISCUSSION: 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. WHAT IS NEW AND CONCLUSION: 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.
File Format	HTM / HTML
ISSN	02694727
Issue Number	3
Volume Number	40
e-ISSN	13652710
Journal	Journal of Clinical Pharmacy and Therapeutics
Language	English
Publisher	Wiley-Blackwell
Publisher Date	2015-06-01
Publisher Place	Great Britain (UK)
Access Restriction	Subscribed
Subject Keyword	Discipline Therapeutics Discipline Pharmacology Anemia Drug Therapy Antineoplastic Agents Adverse Effects Erythrocyte Transfusion Statistics & Numerical Data Hematinics Administration & Dosage Aged Aged, 80 And Over Chemically Induced Therapeutic Use Breast Neoplasms Female Humans Logistic Models Lung Neoplasms Male Retrospective Studies Risk Assessment Methods Risk Management United States United States Food And Drug Administration Journal Article Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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