Managing Drug-Risk Information — What to Do with All Those New Numbers

Abstract

In the late 1970s, many pharmacies and governmental and private insurers began electronically 'recording patient-specific data from filled prescriptions, as physicians, hospitals, and insurers began capturing computerized information on diagnoses, admissions, office visits, and procedures. By the mid-1980s, researchers began trying to use these data to relate drug exposures to adverse events. Despite the increasing availability of information on medication use and clinical outcomes in tens of millions of patients, the Food and Drug Administration (FDA) has relied primarily on analysis of individual case reports submitted by health care professionals or pharmaceutical manufacturers to assess side effects, of approved drugs. In 2007 Congress passed a law instructing the FDA to develop a system to make use of the terabytes of data on drug exposure and clinical events that the health care system generates. Nearly 2 years later, the FDA requested proposals to build such a 'Sentinel' system, to be restricted to private-sector U.S. health insurers and funded at a level somewhere between $7 million and $120 million over 5 years. The Sentinel system will have the potential to identify and quantify adverse-event signals with unprecedented power and speed. (PsycINFO Database Record (c) 2016 APA, all rights reserved)