Original ResearchEmergency department visits for outpatient adverse drug events: Demonstration for a national surveillance system
Introduction
In the early 1990s, adverse drug events were shown to be a significant public health problem in hospitalized patients.1, 2, 3 Stimulated by the Institute of Medicine report To Err Is Human,4 health care organizations and government agencies are actively developing interventions to reduce inpatient medication errors and prevent adverse drug events from occurring in hospitals. For example, the Leapfrog Group for Patient Safety called for the implementation of computerized order entry systems,5 and the US Food and Drug Administration (FDA) began work toward requiring the use of bar codes for drug products.6
Adverse drug events occurring in outpatient settings and treated in emergency departments (EDs) receive much less attention than adverse drug events occurring in hospitalized patients. However, more than 80% of community-dwelling adults use medications weekly, and approximately threefold more patients are treated in EDs than are admitted to hospitals each year.7, 8 To identify and help prioritize medication safety issues in outpatient settings, a thorough, timely, and nationally representative surveillance system for outpatient adverse drug events is needed.9, 10
We chose to address adverse drug events as injuries (bodily lesions or suspected bodily lesions resulting from acute overexposure to chemical energy)11 because, although the injury model may not detect all medication errors, it focuses on concrete outcomes, lends itself to monitoring by methods of public health surveillance, and allows application of interventions according to injury prevention strategies.12 Although injuries from outpatient adverse drug events may be treated in a variety of settings, the ED is a logical setting in which to conduct surveillance for clinically important, acute injuries of outpatient adverse drug events.
The National Electronic Injury Surveillance System–All Injury Program is a collaborative effort between the Consumer Product Safety Commission (CPSC) and the Centers for Disease Control and Prevention's (CDC) National Center for Injury Prevention and Control (CDC “Injury Center”) to characterize nonfatal injuries treated in EDs.13, 14 The National Electronic Injury Surveillance System–All Injury Program provides detailed information on the burden, risk factors, and outcomes of injuries.15, 16, 17 In this demonstration project, key data elements of FDA's passive reporting system, MedWatch,18 were incorporated into data collection. We sought to determine operational feasibility by assessing report timeliness and completeness. We sought to determine the utility of adverse drug event surveillance data by reporting patient demographics, outcomes, and associated variables for adverse drug events from this multisite investigation of adverse drug events treated in EDs.
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Setting
The 64 hospitals participating in the National Electronic Injury Surveillance System–All Injury Program are a nationally representative, multistage stratified sample of all hospitals (excluding psychiatric and penal institutions) in the United States and its territories, with a minimum of 6 beds and a 24-hour ED.14 CPSC and CDC's Injury Center jointly train National Electronic Injury Surveillance System–All Injury Program coders and supervisors. Trained coders located at each hospital review
Results
During the study period, 90,810 patients were treated in these 9 hospital EDs. More than one quarter of the patients (n=24,428) were treated for unintentional injuries and reported in the National Electronic Injury Surveillance System–All Injury Program. Of patients treated for unintentional injuries, 598 patients with physician-documented adverse drug events were identified (0.7% of all patients; 2.4% of patients with unintentional injuries). Nearly one fifth of patients with adverse drug
Limitations
Our findings have several limitations. First, outpatient adverse drug event estimations based on ED surveillance may not capture all serious outpatient adverse drug events and may include nonserious outpatient adverse drug events. Patients with serious outpatient adverse drug events may be treated in other settings (eg, primary care offices, outpatient offices or non–hospital-based urgent care centers) or may not be treated in any health care setting. Other patients with serious adverse drug
Discussion
This demonstration project was the first assessment of outpatient adverse drug events treated in EDs involving simultaneous data collection at multiple sites across the United States. We sought to evaluate the operational feasibility and epidemiologic usefulness of enhancing adverse drug event case identification and data collection in an existing ED-based injury surveillance system.
Enhanced adverse drug event surveillance of outpatient adverse drug events treated in 9 National Electronic
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Author contributions: DSB and DAP conceived the project and obtained institutional funding. AKM undertook recruitment of participating hospitals. DSB and AKM supervised the training of coders and data collection. ABM, AKM, and JLA provided statistical advice and advice on study design. DSB and KNW managed the data, including quality control, and analyzed the data. DSB drafted the manuscript, and all authors contributed substantially to its revision. DSB takes responsibility for the paper as a whole.
Funding and support: The authors report this study did not receive any outside funding or support.
The information in this manuscript reflects the opinion of the authors but has not been reviewed by and may not necessarily reflect the views of the US Consumer Product Safety Commission.