Systems Analysis of Adverse Drug Events
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)
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Patient safety activities place greater emphasis on the system in which practitioners work and less on individual performance.
“Conversely, patient safety activities place greater emphasis on the system in which practitioners work and less on individual performance.21”
From Work system design for patient safety: the SEIPS model (2006) · cites this paper as [21]
Errors in the medication administration stage are far less likely to be intercepted and far more likely to reach patients than in any previous stage.
“Errors in this latter stage of the medication process are far less likely to be intercepted and far more likely to reach patients than in any previous stage.”
From Workarounds to Barcode Medication Administration Systems: Their Occurrences, Causes, and Threats to Patient Safety (2008) · cites this paper as [5]
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- Authors
- Leape, L. L.
- Corresponding author
- Leape, Lucian L.
- Venue
- JAMA: The Journal of the American Medical Association
- Publisher
- American Medical Association (AMA)
- Published
- 1995-07-05
- Volume
- 274
- Issue
- 1
- Pages
- 35
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W4296300888
- Cited by
- 1,404
- References
- 0
- Citations by year
- 2026: 9 · 2025: 13 · 2024: 26 · 2023: 18 · 2022: 19 · 2021: 38 · 2020: 33 · 2019: 42 · 2018: 41 · 2017: 44 · 2016: 45 · 2015: 47 · 2014: 49 · 2013: 72 · 2012: 77
- FWCI
- 47.36
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA (publishedVersion)
- Funders
- Agency for Healthcare Research and Quality (R01-HS07107-01)
- Topics
- Health Sciences › Health Professions › Emergency Medical Services › Patient Safety and Medication Errors
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Geriatrics and Gerontology › Pharmaceutical Practices and Patient Outcomes
- Keywords
- adverse drug reactions, medication errors, system failure, error prevention, laboratory findings, hospital information systems, patient safety, prospective cohort
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