Different structures and coding schemes may limit rapid evaluation of a large pool of potential drug safety signals using multiple longitudinal healthcare databases. To overcome this restriction, a semi-automated approach utilising common data model (CDM) and robust pharmacoepidemiologic methods was developed; however, its performance needed to be evaluated. Twenty-three established drug-safety associations from publications were reproduced in a healthcare claims database and four of these were also repeated in electronic health records.
View Article and Find Full Text PDFObjective: Active drug safety surveillance may be enhanced by analysis of multiple observational healthcare databases, including administrative claims and electronic health records. The objective of this study was to develop and evaluate a common data model (CDM) enabling rapid, comparable, systematic analyses across disparate observational data sources to identify and evaluate the effects of medicines.
Design: The CDM uses a person-centric design, with attributes for demographics, drug exposures, and condition occurrence.
Purpose: The availability of large databases with person time information and appropriate statistical methods allow for relatively rapid pharmacovigilance analyses. A semi-automated method was used to investigate the effect of fluoroquinolones on the incidence of C. difficile associated diarrhea (CDAD).
View Article and Find Full Text PDFClin Pharmacol Ther
August 2007
Robust tools for monitoring the safety of marketed therapeutic products are of paramount importance to public health. In recent years, innovative statistical approaches have been developed to screen large post-marketing safety databases for adverse events (AEs) that occur with disproportionate frequency. These methods, known variously as quantitative signal detection, disproportionality analysis, or safety data mining, facilitate the identification of new safety issues or possible harmful effects of a product.
View Article and Find Full Text PDFBackground: Surfactant abnormalities have been described in bacterial pneumonia.
Objective: To determine the safety and effect of exogenous surfactant replacement in patients with ventilator-associated pneumonia (VAP).
Methods: Patients with VAP were randomized in a double-blind study to receive either an artificial surfactant (Exosurf) consisting mostly of disaturated phospholipids (DSPL) or saline via a continuous nebulizer system for 5 days.