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Open Access Research article

Evaluating adverse drug event reporting in administrative data from emergency departments: a validation study

Corinne M Hohl123*, Lisa Kuramoto3, Eugenia Yu4, Basia Rogula3, Jürgen Stausberg5 and Boris Sobolev36

Author Affiliations

1 Department of Emergency Medicine, University of British Columbia, 855 West 12th Avenue, Vancouver, BC V5Z 1 M9, Canada

2 Department of Emergency Medicine, Vancouver General Hospital, 855 West 12th Avenue, Vancouver, BC V5Z 1 M9, Canada

3 Centre for Clinical Epidemiology & Evaluation, Vancouver Coastal Health Research Institute, 828 West 10th, Vancouver, BC V5Z 1 M9, Canada

4 Department of Statistics, University of British Columbia, 900 West 10th Ave, Vancouver, BC V5Z 1 M9, Canada

5 InstitutfürMedizinischeInformationsverarbeitung, Biometrie und Epidemiologie, Ludwig-Maximilians-UniversitätMünchen, München, Germany

6 School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada

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BMC Health Services Research 2013, 13:473  doi:10.1186/1472-6963-13-473

Published: 12 November 2013

Abstract

Background

Adverse drug events are a frequent cause of emergency department presentations. Administrative data could be used to identify patients presenting with adverse drug events for post-market surveillance, and to conduct research in patient safety and in drug safety and effectiveness. However, such data sources have not been evaluated for their completeness with regard to adverse drug event reporting. Our objective was to determine the proportion of adverse drug events to outpatient medications diagnosed at the point-of-care in emergency departments that were documented in administrative data.

Methods

We linked the records of patients enrolled in a prospective observational cohort study on adverse drug events conducted in two Canadian tertiary care emergency departments to their administrative data. We compared the number of adverse drug events diagnosed and recorded at the point-of-care in the prospective study with the number of adverse drug events recorded in the administrative data.

Results

Among 1574 emergency department visits, 221 were identified as adverse drug event-related in the prospective database. We found 15 adverse drug events documented in administrative records with ICD-10 codes clearly indicating an adverse drug event, indicating a sensitivity of 6.8% (95% CI 4.0–11.2%) of this code set. When the ICD-10 code categories were broadened to include codes indicating a very likely, likely or possible adverse event to a medication, 62 of 221 events were identifiable in administrative data, corresponding to a sensitivity of 28.1% (95% CI 22.3-34.6%).

Conclusions

Adverse drug events to outpatient medications were underreported in emergency department administrative data compared to the number of adverse drug events diagnosed and recorded at the point-of-care.

Keywords:
Adverse drug event; Adverse drug reaction; Administrative data; Emergency department; Validation; Post-market surveillance; Drug safety