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Off-Label Prescribing of Erythropoiesis-Stimulating Proteins in US Hospitals

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Abstract

This study quantifies and describes off-label prescribing of currently marketed erythropoiesis-stimulating proteins (ESP): epoetin alfa and darbepoetin alfa. Methods: A retrospective database study examined on-label, off-label supported, and off-label unsupported ESP treatment of anemia in 464,834 in-patients. Findings: Epoetin was used in 97% of the patients studied from January 2002 to June 2004. ESPs were prescribed on-label in 48% of patients primarily for chronic kidney disease and nonmyeloid cancers. Off-label supported use was seen in 38% of patients mainly for unlabeled chronic kidney disease indications and anemia associated with critical illness. Off-label unsupported use occurred in 14% of prescriptions for cardiovascular, pulmonary, pediatrics, and other conditions. Differences in prescribing were associated with hospital, physician, patient, clinical, and drug variables. Conclusions: Off-label ESP drug use appears to be widespread and associated with many factors. It may be evidence based, since most is associated with conditions supported by the medical literature.

Learning Objectives

Upon completion of this article, participants should be able to

  • Describe the prescribing of erythropoiesis-stimulating proteins in on-label, off label, and off-label unsupported treatment settings

  • Discuss the impact of these uses on the patient population

Target Audience

This article is designed for physicians, pharmacists, nurses, other health care professionals, journalists, researchers, health care insurers, and policy makers.

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Author information

Authors and Affiliations

  1. Analyst, Applied Health Outcomes, Palm Harbor, Florida, USA

    Anuprita Patkar MS Pharm, PhD

  2. School of Pharmacy, Department of Pharmacy, Virginia Commonwealth University (MCV Campus), P.O. Box 980533, 23298-0533, Richmond, Virginia, USA

    David Holdford MS Pharm, PhD (Associate Professor), Donald F. Brophy PharmD, MSc, FCCP, BCPS (Associate Professor) & Michael Pyles PhD (Associate Professor)

Authors
  1. Anuprita Patkar MS Pharm, PhD
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  2. David Holdford MS Pharm, PhD
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  3. Donald F. Brophy PharmD, MSc, FCCP, BCPS
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  4. Michael Pyles PhD
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Additional information

At the time of this study, Dr. Patkar was a PhD candidate at Virginia Commonwealth University.

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Patkar, A., Holdford, D., Brophy, D.F. et al. Off-Label Prescribing of Erythropoiesis-Stimulating Proteins in US Hospitals. Ther Innov Regul Sci 41, 431–440 (2007). https://doi.org/10.1177/009286150704100401

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