Off-Label Prescribing of Erythropoiesis-Stimulating Proteins in US Hospitals
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Off-Label Prescribing of ErythropoiesisStimulating Proteins in US Hospitals
Anuprita Patkar, MS Pharm, PhD* Analyst, Applied Health Outcomes, Palm Harbor, Florida David Holdford, MS Pharm, PhD Associate Professor Donald F. Brophy, PharmD, MSc, FCCP, BCPS Associate Professor Michael Pyles, PhD Associate Professor Virginia Commonwealth University (MCV Campus), School of Pharmacy, Department of Pharmacy, Richmond, Virginia Key Words Off-label; Prescribing; Evidencebased medicine; Erythropoietin; Darbepoetin Correspondence Address David Holdford, Virginia Commonwealth University (MCV Campus), School of Pharmacy, Department of Pharmacy. P.O. Box 980533, Richmond, Virginia 23298–0533.
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 inpatients. 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.
*At the time of this study, Dr. Patkar was a PhD candidate at Virginia Commonwealth University. “Understanding Off-Label Utilization Patterns of Two Biotechnology Drugs, Recombinant Human Erythropoietin and Darbepoetin Across Hospitals in United States” by A. D. Patkar and D. A. Holdford was presented at the Drug Information Association Annual Meeting, June 27, 2005, Washington, DC, Convention Center. The Drug Information Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The Drug Information Association designates this educational activity for a maximum of 1 AMA PRA Category 1 Credit(s)™ . Physicians should only claim credit commensurate with the extent of their participation in the activity. The Drug Information As
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