The Food and Drug Administration has partnered with a subsidiary of one of the nation’s largest health insurers to obtain information on adverse effects of prescription drugs after they have been approved for use.
The insurer, WellPoint, is developing a Safety Sentinel System in collaboration with FDA and academic researchers seeking to detect adverse drug effects faster than is now the norm. WellPoint’s subsidiary, HealthCore Inc., will mine the company’s records on its 35 million insured members to look for correlations between drug use and health problems.
"To rapidly and successfully identify emerging safety problems, we need to bring all health care stakeholders to the table," Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said in a statement. "The FDA is planning a larger public/private partnership, and we're excited that WellPoint is building a system that could inform this initiative."
WellPoint spokesman Kristin Binns said the Safety Sentinel System will begin operating before year’s end with records for about 20 million patients. Full operation with all 35 million patients’ records is expected in early 2009.
“We have to be sure the data is validated,” Binns said, noting that WellPoint has different Blue Cross and Blue Shield plans in more than a dozen states. She said HealthCore wants to produce timely alerts for doctors and regulators about actual or potential drug-related problems, but at the same time it does not want to issue unwarranted alerts.
The company has not decided how notifications of the problems or potential problems will be issued and who will receive them, Binns said.
In addition to detecting health problems associated with a particular drug, WellPoint officials said they expect to detect problems that occur when two or more drugs or other treatments interact in unexpected ways.
FDA is increasing its capacity to detect problems with drugs after the agency approves their sale, a capacity known as post-market surveillance. The Wall Street Journal reported that the agency will partner with insurers and others with large databases of medical treatments rather than building a database of its own.
Last year, the Defense Department agreed to share information from its huge medical-records system with FDA for post-market surveillance.
From the battlefield to the home front: Managing medical data
Government Health IT presents Col. Claude Hines Jr., program manager for the Defense Health Information Management System, in this recent InSight eSeminar. Col. Hines discusses the health information technology and tactical challenges faced by the military medical community in Iraq, Afghanistan and other areas of conflict. In doing so, he describes the current information technology solutions for transferring clinical data between battlefield care givers to health care personnel at military treatment facilities worldwide.
