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COLLEEN M. CULLEY, PHARMD., BCPS, is Clinical Specialist, Drug Use and Disease State Management (DUDSM) Program, Department of Pharmacy and Therapeutics, University of Pittsburgh Medical Center (UPMC), Pittsburgh, PA, and Associate Professor, Department of Pharmacy and Therapeutics, School of Pharmacy, University of Pittsburgh (UP), Pittsburgh. SUSAN GUTTENDORF, PHARM.D., is Clinical Pharmacist, DUDSM Program, Department of Pharmacy and Therapeutics, UPMC—Presbyterian, Pittsburgh. MEGAN COLDREN, PHARM.D., is Pharmacist, Department of Pharmacy and Therapeutics, UPMC—Shadyside, Pittsburgh; at the time of writing she was Intern, DUDSM Program, Department of Pharmacy and Therapeutics, UPMC—Presbyterian. SUSAN J. SKLEDAR, B.S.PHARM., M.P.H., FASHP, is Director, DUDSM Program, Department of Pharmacy and Therapeutics, UPMC, and Associate Professor, Department of Pharmacy and Therapeutics, School of Pharmacy, UP. PAIGE R. GROSS, B.S.PHARM, is Clinical Pharmacist, DUDSM Program, Department of Pharmacy and Therapeutics, UPMC—Presbyterian. RICHARD M. SPIRO, M.D., is Assistant Professor of Neurological Surgery and Director, Adult Spine Services, Department of Neurological Surgery, UP and UPMC—Presbyterian. DARRELL J. TRIULZI, M.D., is Vice President and Medical Director, Institute for Transfusion Medicine, Pittsburgh, and Professor, Department of Pathology, School of Medicine, UP. MARGARET V. RAGNI, M.D., M.P.H., is Director, Hemophilia Center of Western Pennsylvania, Pittsburgh, and Professor of Medicine, Division of Hematology/Oncology, School of Medicine, UP.

Address correspondence to Dr. Culley at the Department of Pharmacy and Therapeutics, University of Pittsburgh Medical Center, 302 Scaife Hall, 200 Lothrop Street, Pittsburgh, PA 15213 (culleycm{at}upmc.edu).

Purpose. The clinical outcomes, safety, and use of resources associated with the administration of factor VIIa (recombinant) to nonhemophilic patients requiring neurosurgery were evaluated. Methods. An interdisciplinary group created guidelines for the pharmacy and therapeutics committee for the unlabeled use of factor VIIa (recombinant). Nonhemophilic patients were eligible to receive the agent without approval from the hematology–coagulation service if they had an intracranial hemorrhage (ICH), were undergoing an emergency neurosurgical procedure, and had coagulopathy. A standard single dose of 40 µg/kg was recommended for these patients. Data were prospectively collected between March 2004 and March 2006 for all neurological surgery patients receiving factor VIIa (recombinant). Results. A total of 92 nonhemophilic patients received single doses of factor VIIa (recombinant) under the guidelines during the two-year study period. The majority of patients had a baseline International Normalized Ratio (INR) of >2, underwent emergency neurosurgical procedures, and had an intracranial hemorrhage. All guideline criteria for indication and approval were followed for 48 patients. Eighty-seven patients received concomitant treatment for reversal of anticoagulation. A significant correction in the baseline INR after administration of factor VIIa (recombinant) was noted (p < 0.0001). Five patients experienced adverse events. Implementation of the guidelines decreased the annual cost of factor VIIa (recombinant) by 46%. Conclusion. A protocol calling for administration of factor VIIa (recombinant) 40 µg/kg in nonhemophilic patients with coagulopathy and ICH led to a rapid and significant decrease in the INR, allowing for emergency surgical intervention. Few adverse events were detected in these patients, and none were deemed to be directly related to factor VIIa (recombinant). Index terms: Costs; Drugs; Factor VIIa; Hemorrhage; Hemostatics; International normalized ratio; Protocols; Surgery; Thrombosis; Toxicity