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- Discontinuities, Gaps, and Hand-Off Problems 1
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- Nonsurgical Procedural Complications 1
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Journal Article > Study
Bennett CL, Nebeker JR, Lyons EA, et al. JAMA. 2005;293:2131-2140.
This article summarizes the structure, funding, organization, and methods of an independent and clinically based surveillance program identifying serious and unrecognized adverse drug events (ADEs). The authors provide a detailed account of the process involved, from investigating a possible serious ADE to disseminating their findings to the Food and Drug Administration (FDA), manufacturers, conferences, journals, and the news media. They also share initial results of their operations with details of 16 drugs associated with serious ADEs, including tabular display of the cases reported and the inconsistencies in the dissemination of safety information. The authors conclude by sharing potential implications of the program's efforts and how this surveillance method may provide additional opportunity to detect and prevent serious ADEs.
Gulliver D. Sarasota Herald Tribune. November 7, 2006:BS1.
This article reports on the death of a restrained patient and outlines the factors affecting the subsequent reporting of the event.
Wright S. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; January 5, 2010. Report No. OEI-06-09-00360.
Journal Article > Study
Harmful medication errors involving unfractionated and low-molecular-weight heparin in three patient safety reporting programs.
Grissinger MC, Hicks RW, Keroack MA, Marella WM, Vaida A. Jt Comm J Qual Patient Saf. 2010;36:195-202.
Patient safety reporting systems are commonplace in most organizations as a tool to identify, track, and potentially prevent adverse events despite their known limitations. Heparin is a high-risk medication that frequently generates incident reports, and significant efforts have been established to ensure its safe use. This study reviewed reported heparin errors from three large patient safety reporting systems—MEDMARX, the Pennsylvania Patient Safety Authority, and the University Health Consortium (an alliance of academic medical centers)—to capture events from more than 1000 organizations. Of the 300,000 medication events reported, approximately 4% involved heparin products, with the administration phase being the most frequently cited. As this was the first study to combine three large sources of reporting data for a single process, the authors point out the consistent patterns detected, suggesting diminishing returns from aggregating reports around common events.
Preventable tragedies: superbugs and how ineffective monitoring of medical device safety fails patients.
US Senate Health, Education, Labor, and Pensions Committee. January 13, 2016.
Insufficient sterilization of duodenoscopes and other medical equipment has been linked to health care–associated infection outbreaks. This report summarizes findings from a government investigation into existing methods for monitoring and reporting device problems and provides recommendations for Congress, hospitals, and the Food and Drug Administration to augment identification and prevention of safety issues associated with medical devices.