Case Studies: Adverse Event Reporting System Brings Safety

The proliferation of new pharmaceuticals and an accompanying boom in prescriptions have created an unwanted side effect: a meteoric rise in the number of unforeseen negative reactions by individual patients and dangerous interactions among drugs. The rapid disclaimer talk at the end of all those TV spots can't hide the fact that a large percentage of approved drugs end up having serious side effects that aren't detected until they reach the marketplace.

The situation put the U.S. Food & Drug Administration (FDA) in a delicate position: People not only wanted new medicines, they also needed them. But rigorous and scientific testing during the pre-market phase cannot always fully disclose the side effects of a new drug, and many drugs may have the potential for serious, unidentified problems when they enter the marketplace. So the FDA approached Booz Allen Hamilton with a challenge: partnering with them to find a better way to collect, evaluate, coordinate, and communicate reports of the drug reactions that occur once new products reach the marketplace.

The solution was the Adverse Event Reporting System (AERS), an automated system that not only enabled the FDA to act in a timely manner, but also re-enforced the agency's pre-eminence as a worldwide leader in drug-safety monitoring. When Computerworld magazine honored AERS as a laureate for its 21st Century Achievement Awards, it cited the innovative use of information technology that had significant and lasting benefit to society.