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Institutional response to FDA warning on aprotinin and impact on outcomes.

Publication ,  Journal Article
Swaminathan, M; Stuart, M; Hughes, GC; Jaggers, J; Hill, SE; Milano, CA; Bennett-Guerrero, E; Stafford-Smith, M
Published in: HSR proceedings in intensive care & cardiovascular anesthesia
January 2009

New evidence of potential risks of aprotinin in 2006 generated public concern about a previously approved drug that was routinely used. In response, we assembled a team of experts within the institution to form guidelines for the appropriate use of aprotinin in cardiac surgery. We report the basis for the guidelines, their implementation, follow-up and resulting patterns of change in aprotinin use.We proposed a three-tier system for aprotinin use, according to risk of bleeding and transfusion, and evidence of benefit of aprotinin. Specific recommendations were made with regard to discussion with the patient and documentation regarding aprotinin use and options for patients who refuse the drug. Guidelines were disseminated and accessible on all anesthesia workstations. Aprotinin use was compared before and after institution of guidelines in equivalent categories. Aprotinin was used in 58.5% (469/802) of cases from March 2005 to January 2006. Following institution of guidelines from March 2006 to January 2007, aprotinin was used in 19.7% (151/767) cases representing a 67.8% reduction in usage. In the subset of groups with large reductions in aprotinin use (pre- 82%, n=239; post-guidelines 17%, n=241) there was a significant decrease in acute kidney injury (%?Cr 43.8 vs. 31.7%, p=0.05).In response to new data and regulatory guidelines, we formulated guidelines based on expert review of data. We reduced aprotinin use, but more importantly, introduced an evidence-based approach to the use of aprotinin, consistent with regulatory guidelines. This model of guideline implementation can be useful in similar scenarios.

Duke Scholars

Published In

HSR proceedings in intensive care & cardiovascular anesthesia

EISSN

2037-0512

ISSN

2037-0504

Publication Date

January 2009

Volume

1

Issue

1

Start / End Page

30 / 36
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Swaminathan, M., Stuart, M., Hughes, G. C., Jaggers, J., Hill, S. E., Milano, C. A., … Stafford-Smith, M. (2009). Institutional response to FDA warning on aprotinin and impact on outcomes. HSR Proceedings in Intensive Care & Cardiovascular Anesthesia, 1(1), 30–36.
Swaminathan, M., M. Stuart, G. C. Hughes, J. Jaggers, S. E. Hill, C. A. Milano, E. Bennett-Guerrero, and M. Stafford-Smith. “Institutional response to FDA warning on aprotinin and impact on outcomes.HSR Proceedings in Intensive Care & Cardiovascular Anesthesia 1, no. 1 (January 2009): 30–36.
Swaminathan M, Stuart M, Hughes GC, Jaggers J, Hill SE, Milano CA, et al. Institutional response to FDA warning on aprotinin and impact on outcomes. HSR proceedings in intensive care & cardiovascular anesthesia. 2009 Jan;1(1):30–6.
Swaminathan, M., et al. “Institutional response to FDA warning on aprotinin and impact on outcomes.HSR Proceedings in Intensive Care & Cardiovascular Anesthesia, vol. 1, no. 1, Jan. 2009, pp. 30–36.
Swaminathan M, Stuart M, Hughes GC, Jaggers J, Hill SE, Milano CA, Bennett-Guerrero E, Stafford-Smith M. Institutional response to FDA warning on aprotinin and impact on outcomes. HSR proceedings in intensive care & cardiovascular anesthesia. 2009 Jan;1(1):30–36.

Published In

HSR proceedings in intensive care & cardiovascular anesthesia

EISSN

2037-0512

ISSN

2037-0504

Publication Date

January 2009

Volume

1

Issue

1

Start / End Page

30 / 36