A modular, prospective, semi-automated drug safety monitoring system for use in a distributed data environment.

ABSTRACT:

Purpose

The aim of this study was to develop and test a semi-automated process for conducting routine active safety monitoring for new drugs in a network of electronic healthcare databases.

Methods

We built a modular program that semi-automatically performs cohort identification, confounding adjustment, diagnostic checks, aggregation and effect estimation across multiple databases, and application of a sequential alerting algorithm. During beta-testing, we applied the system to five databases to evaluate nine examples emulating prospective monitoring with retrospective data (five pairs for which we expected signals, two negative controls, and two examples for which it was uncertain whether a signal would be expected): cerivastatin versus atorvastatin and rhabdomyolysis; paro

SUBMITTER: Gagne JJ 

PROVIDER: S-EPMC4159708 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature