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Adverse Drug Events Among Hospitalized Medicare Patients: Epidemiology and National Estimates from a New Approach to Surveillance

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Background: Although adverse drug events (ADEs) are a well-recognized problem among hospitalized patients, there is no system for monitoring them. Six high-alert medications and associated adverse events were selected for inclusion in the Medicare Patient Safety Monitoring System (MPSMS), a national surveillance system designed to identify and track over time inpatient adverse events within the hospitalized fee-for-service Medicare population.

Methods: Explicit chart review algorithms were used to identify medication exposures and associated adverse events from the the 2004 MPSMS sample's medical records. The associations of ADEs with patient characteristics, length of stay, mortality, and 30-day readmission were assessed with bivariate analyses and hierarchical linear regression modeling (HGLM) approaches. National ADE rates and numbers of adverse events were estimated using weighted HGLM.

Results: On the basis of 25,145 hospital visits in the 2004 MPSMS sample, an estimated 8.2% of patients exposed to warfarin experienced associated ADEs, as did 13.6% exposed to heparin, 10.7% exposed to insulin/hypoglycemic agents, and 0.5% exposed to digoxin. Some 0.6% of patients exposed to antibiotics experienced antibiotic-associated Clostridium difficile infection (CDI). Patients with ADEs had increased length of stay and in-hospital and 30-day mortality, except that patients with antibiotic-associated CDI did not have increased in-hospital mortality, and patients with ADEs associated with heparin did not have increased 30-day mortality. An estimated 888,000 ADEs occurred in hospitalized Medicare patients from these medications alone.

Discussion: This new approach to detecting ADEs and estimating the national burden of ADEs from selected medications may be adapted for other types of ADEs in the Medicare population and may offer guidance to policy-makers on appropriate areas of focus for patient safety.

Document Type: Research Article

Publication date: January 1, 2010

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  • Published monthly, The Joint Commission Journal on Quality and Patient Safety is a peer-reviewed publication dedicated to providing health professionals with the information they need to promote the quality and safety of health care. The Joint Commission Journal on Quality and Patient Safety invites original manuscripts on the development, adaptation, and/or implementation of innovative thinking, strategies, and practices in improving quality and safety in health care. Case studies, program or project reports, reports of new methodologies or new applications of methodologies, research studies on the effectiveness of improvement interventions, and commentaries on issues and practices are all considered.

    David W. Baker, MD, MPH, FACP, executive vice president for the Division of Healthcare Quality Evaluation at The Joint Commission, is the inaugural editor-in-chief of The Joint Commission Journal on Quality and Patient Safety.

    Also known as Joint Commission Journal on Quality Improvement and Joint Commission Journal on Quality and Safety
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