Health plans help FDA monitor drug safety

WASHINGTON, D.C.-As part of an ongoing effort to improve the safe use of drugs in clinical practice, the FDA has contracted with four healthcare organizations to perform drug safety studies using large databases from across the country.

Approximately $5.2 million over five years will be awarded for the entire program to Ingenix Inc., a wholly owned subsidiary of UnitedHealth Group, Auburndale, Mass.; Vanderbilt University, Nashville, Tenn.; Kaiser Foundation Research Institute, Oakland, Calif.; and Harvard Pilgrim Health Care Inc. (HPHC), Wellesley, Mass. (on behalf of the HMO Research Network Center for Education and Research on Therapeutics, or CERT).

Crystal Rice, spokesperson for the FDA's Center for Drug Evaluation and Research, tells MANAGED HEALTHCARE EXECUTIVE, that the FDA Office of Drug Safety has four goals: conduct safety analyses to the benefit of the public's health; respond expeditiously to urgent public safety concerns; provide a mechanism for collaborative pharmacoepidemiological research designed to test hypotheses, particularly those arising from suspected adverse reactions reported to FDA; and enable rapid access to U.S. population-based data sources to ensure public safety.

"These proactive efforts should enhance the FDA's ability to identify and assess issues and potential risks related to pharmaceutical agents in a more timely fashion than ever before," says Terri Madison, PhD, MPH, president of i3 Drug Safety, which will lead the Ingenix program. i3 is Ingenix's pharmaceutical research and services subsidiary, which houses its drug safety group.

The Ingenix i3 program is built around a team of leading epidemiologists, complex analytic tools, and a large, longitudinal patient database, says Ryan Stewart, vice president, strategy and communications at Ingenix. "We will work with the FDA to monitor the safety of new drugs as well as conduct ad hoc safety studies on established pharmaceutical agents," Stewart says.

The approach Kaiser is taking with these population data is complementary to the FDA's adverse drug reaction reporting system, says Joe Selby, director, Kaiser Permanente Division of Research. "It is especially well-suited for detecting smaller increases in risk for common events," Selby says.

By linking prescription data to the subsequent awareness of various clinical events, Selby says that Kaiser can calculate and compare incidence rates for persons exposed to a drug with rates for similar persons not exposed. "Kaiser is able to link prescription use data with hospital admission, outpatient visits and laboratory results," he says. "Together these data sources capture the bulk of all serious adverse events, whether they are suspected or not.

"There is a growing appreciation that spontaneous reports are not a good way to detect the small to moderate increases in risks," Selby continues. "When these risk measures are for common events, they can amount to large numbers of excess events, but they may go unsuspected because they occur commonly even in the absence of the drug. The approach that will be used here is designed to detect those small increases by creating comparisons between large numbers of users and similar non-users."

Vanderbilt will perform drug safety studies using large Medicaid databases from the states of Tennessee and Washington. Medicaid enrollees were chosen for the study because they often are under-represented in employment-based insurance databases and premarketing trials, according to Wayne Ray, PhD, the principal investigator of the project, and professor of preventive medicine, Vanderbilt University Medical Center, and co-investigator William Cooper, MD, MPH, associate professor of pediatrics at Vanderbilt.