Harry Enchin


June 2011

Document Type


Degree Name



Dept. of Medical Informatics and Clinical Epidemiology


Oregon Health & Science University


The FDA has received millions of reports of adverse events over the last ten years. Clinician ability to identify potential drug-drug interactions in routine practice, even when aided by decision support software, is limited. To date, the literature does not report any attempts to use FDA Adverse Event Reporting System (AERS) data in clinical decision support systems. Data availability of data elements for patient and administrative information, drug information, and diagnoses, reaction and outcomes, varies widely. The research question in this preliminary project is to determine if the data elements found in the FDA adverse event case reports were used and displayed by drug-drug interaction software, would that display be useful to clinicians in making prescribing or other therapeutic decisions? We surveyed physicians thought to use drug-drug interaction software in routine clinical practice. Survey questions were constructed to confirm use and frequency of use of drug-drug interaction software and determine the relative importance to the respondents of access to a specific data element within a data category (e.g. administrative data, drug information, diagnoses). The survey instrument also attempted to elicit ways that adverse event data elements could be presented, other than as a list of relevant case reports, to help clinicians in detecting or preventing adverse events. Clinicians feel that there are several FDA AERS data elements the would be important in the detection and prevention of drug-drug interactions. Unfortunately, we saw that for some of these elements, drug availability is lacking. The most useful display of adverse event report data would enable quick access to concise sorted summaries of the relevant AERS reports, though constrained by availability of data elements. We suggest that a future study include a sample illustration of how AERS reports may be presented to clinicians in a concise manner as the preliminary study indicated that clinicians do not have a strong affinity for viewing detailed AERS reports.




School of Medicine



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