Evaluation of adverse drug reaction formatting in drug information databases.

The research evaluated the differences in formatting of adverse drug reaction (ADR) information in drug monographs in commonly used drug information (DI) databases. A cross-sectional analysis of formatting of ADR information for twenty commonly prescribed oral medications in seven commonly used DI databases was performed. Databases were assessed for presentation of ADR information, including presence of placebo comparisons, severity of ADR, onset of ADR, formatting of ADRs in percentile (quantitative) format or qualitative format, whether references were used to cite information, whether ADRs are grouped by organ system, and word count of the ADR section. Data were collected by two study investigators and discrepancies were resolved via consensus. Chi-square analyses and one-way analysis of variance (ANOVA) were used to evaluate for mean group differences in categorical and continuous data, respectively. The seven DI databases varied significantly on each analyzed ADR variable, including variables known to impact interpretation such as placebo comparisons and qualitative versus quantitative formatting. Placebo comparisons were most common among monographs in Micromedex In-Depth Answers (70%) but were absent among monographs in Epocrates, Lexicomp, and Micromedex. Quantitative information was commonly used in most databases but was absent in Epocrates. Average word counts were higher in Clinical Pharmacology and Micromedex In-Depth answers compared to other databases. Substantial variation in ADR formatting exists between the most common DI databases. These differences may translate into alternative interpretations of medical information and, thus, impact clinical judgment. Further studies are needed to assess whether these differences impact clinical practice.

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Copyright © 2020 Sean M. McConachie, Derek Volgyi, Hannah Moore, Christopher A. Giuliano.