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Lucian L. Leape, MD; David W. Bates, MD, MSc; David J. Cullen, MD; Jeffrey Cooper, PhD; Harold J. Demonaco, MS, RPh; Theresa Gallivan, RN; Robert Hallisey, MS, RPh; Jeanette Ives, RN, MSN; Nan Laird, PhD; Glenn Laffel, MD, PhD; Roberta Nemeskal, RN; Laura A. Petersen, MD, MPH; Kathy Porter, RN, MSN; Deborah Servi, MS; Brian F. Shea, PharmD; Stephen D. Small, MD; Bobbie J. Sweitzer, MD; B. Taylor Thompson, MD; Martha Vander Vliet, RN; ADE Prevention Study Group; Lucian L. Leape, MD; Deborah Servi, MS; Nan Laird, PhD; David Bates, MD, MSc; Patricia Hojnowski-Diaz, RN; Laura A. Petersen, MD, MPH; Stephen Petrycki, RN; Martha Vander Vliet, RN; Michael Cotugno, PharmD; Heather Patterson, PharmD; Brian F. Shea, PharmD; Mairead Hickey, RN, PhD; Sharon Kleefield, PhD; Jeffrey Cooper, PhD; David J. Cullen, MD; Ellen Kinneally, RN; Roberta Nemeskal, RN; Bobbie J. Sweitzer, MD; Stephen D. Small, MD; Harold J. Demonaco, MS, RPh; Margaret Dempsey Clapp, MS, RPh; Robert Hallisey, MS, RPh; Theresa Gallivan, RN; Jeanette Ives, RN, MSN; Kathy Porter, RN, MSN; B. Taylor Thompson, MD; Glenn Laffel, MD, PhD; J. Richard Hackman, PhD; Amy Edmondson

JAMA. 1995;274(1):35-43.

Abstract
Objective.
—To identify and evaluate the systems failures that underlie errors causing adverse drug events (ADEs) and potential ADEs.

Design.
—Systems analysis of events from a prospective cohort study.

Participants.
—All admissions to 11 medical and surgical units in two tertiary care hospitals over a 6-month period.

Main Outcome Measures.
—Errors, proximal causes, and systems failures.

Methods.
—Errors were detected by interviews of those involved. Errors were classified according to proximal cause and underlying systems failure by multidisciplinary teams of physicians, nurses, pharmacists, and systems analysts.

Results.
—During this period, 334 errors were detected as the causes of 264 preventable ADEs and potential ADEs. Sixteen major systems failures were identified as the underlying causes of the errors. The most common systems failure was in the dissemination of drug knowledge, particularly to physicians, accounting for 29% of the 334 errors. Inadequate availability of patient information, such as the results of laboratory tests, was associated with 18% of errors. Seven systems failures accounted for 78% of the errors; all could be improved by better information systems.

Conclusions.
—Hospital personnel willingly participated in the detection and investigation of drug use errors and were able to identify underlying systems failures. The most common defects were in systems to disseminate knowledge about drugs and to make drug and patient information readily accessible at the time it is needed. Systems changes to improve dissemination and display of drug and patient data should make errors in the use of drugs less likely.

(JAMA. 1995;274:35-43)

Author Affiliations
Department of Health Policy and Management; Department of Biostatistics, Harvard School of Public Health, Boston, Mass; Department of Medicine; Department of Pharmacy; Department of Nursing; Department of Quality Management, Brigham and Women's Hospital, Boston, Mass; Department of Anesthesia; Pharmacy Department; Department of Nursing; Department of Medicine, Massachusetts General Hospital, Boston; APM Inc, New York, NY; Department of Psychology, Harvard University, Boston, Mass

From the Departments of Health Policy and Management (Dr Leape and Ms Servi) and Biostatistics (Dr Laird), Harvard School of Public Health; the Division of General Medicine and Primary Care, Department of Medicine (Drs Bates and Petersen and Ms Vander Vliet) and the Department of Pharmacy (Dr Shea), Brigham and Women's Hospital; the Departments of Anesthesia (Drs Cullen, Cooper, Small, and Sweitzer and Ms Nemeskal), Medicine (Dr Thompson), Nursing (Mss Ives, Gallivan, and Porter), and Pharmacy (Messrs Demonaco and Hallisey), Massachusetts General Hospital, and the Harvard Medical School, Boston, Mass; and APM, Inc (Dr Laffel), New York, NY.

Footnotes
A list of members of the ADE Prevention Study Group appears at the end of this article.

Reprint requests to the Department of Health Policy and Management, Harvard School of Public Health, 677 Huntington Ave, Boston, MA 02115 (Dr Leape).

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