Table of Contents Author Guidelines Submit a Manuscript
Journal of Healthcare Engineering
Volume 3 (2012), Issue 3, Pages 391-414
http://dx.doi.org/10.1260/2040-2295.3.3.391
Research Article

Applying System Engineering to Pharmaceutical Safety

Nancy Leveson,1 Matthieu Couturier,1 John Thomas,1 Meghan Dierks,2 David Wierz,5 Bruce M. Psaty,3 and Stan Finkelstein1,4

1Engineering Systems Division, Massachusetts Institute of Technology, Cambridge, MA, USA
2Beth Israel Deaconness Medical Center, Boston, MA, USA
3Cardiovascular Health Research Unit, Departments of Medicine, Epidemiology, and Health Services, University of Washington, Seattle, WA, USA
4Harvard University Medical School, Boston, MA, USA
5Independent Consultant, Philadelphia, PA, USA

Received 1 December 2011; Accepted 1 March 2012

Copyright © 2012 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. Agency for Healthcare Research and Quality (AHRQ), TeamSTEPPS Home, http://teamstepps.ahrq.gov/, Accessed Feb 20, 2012.
  2. B. D. Edwards and F. Giovanni, “How to apply the human factor to periodic safety update reports,” Drug Safety, vol. 33, no. 10, pp. 811–820, 2010. View at Google Scholar
  3. L. T. Kohn, J. Corrigan, and M. S. Donaldson, To Err is Human: Building a Safer Health System, National Academy Press, Washington D.C., 2000.
  4. J. Pecquet, Senators call for joint government task force on adverse drug reactions, The Hill, Feb 2012, http://thehill.com/blogs/healthwatch/medical-devices-and-prescription-drug-policy-/201715-senators-call-for-joint-government-task-force-on-adverse-drug-reactions, Accessed Feb 15, 2012.
  5. U. S. FDA Task Force on Risk Management, Managing the risks from medical product use: creating a risk management framework: Report to the FDA Commissioner from the Task Force on Risk Management, U. S. Dept. of Health and Human Services, Food and Drug Administration, Washington D.C., 1999.
  6. N. G. Leveson, Engineering a Safer World: Applying Systems Thinking to Safety, MIT Press, Cambridge, MA, 2012.
  7. M. Couturier, A Case Study of Vioxx using STAMP [SM thesis], MIT.
  8. J. D. Sterman, Business Dynamics: Systems Thinking and Modeling for a Complex World, McGraw-Hill, New York, 2000.
  9. S. N. Finkelstein and P. Temin, Reasonable Rx: Solving the Drug Price Crisis, FT Press/Pearson Education, New York, 2008.
  10. A. Baciu, K. R. Stratton, and S. Burke, The Future of Drug Safety: Promoting and Protecting the Health of the Public, Institute Of Medicine, Washington D.C., 2007.
  11. S. Barlas, “New REMS guidelines raise fears in hospitals and pharmacies,” Pharmacy and Therapeutics (P&T), vol. 35, no. 3, pp. 128–178, 2010. View at Google Scholar
  12. D. J. Graham, D. Campen, R. Hui et al., “Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study,” Lancet, vol. 365, no. 9458, pp. 475–481, 2005. View at Google Scholar
  13. Food and Drug Administration, FDA's Sentinel Initiative, April 26, 2010, http://www.fda.gov/Safety/FDAsSentinelInitiative/default.htm, Accessed April 17, 2011.
  14. M. M. D. Angell, Your Dangerous Drugstore, The New York Review of Books, June 8, 2006.
  15. J. Avorn, “Paying for drug approval—who's using whom?” N Engl J Med., vol. 356, no. 17, pp. 1697–1700, 2007. View at Google Scholar
  16. S. Okie, “What ails the FDA?” N Engl J Med., vol. 352, no. 11, pp. 1063–1066, 2005. View at Google Scholar