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HHS Hopes Ability To Search Databases Will Increase Drug Safety

Greg Lavine

Health and Human Services Secretary Mike Leavitt on May 22 announced the start of the Sentinel Initiative, a new program intended to detect patterns in adverse reactions to drugs and medical devices.

The program will allow investigators from FDA and elsewhere to query various electronic health record databases that contain information on adverse drug events.

Records from Medicare Part D prescription drug claims databases will be among the first to be available for research.

"It will be a quantum leap forward in FDA's capacity to monitor the use of medical products that are currently on the market," Leavitt said during a press conference in Washington, D.C.

Though the Sentinel program launched May 22, the Centers for Medicare and Medicaid Services (CMS) could not begin to release information on claims until late June. Information from the claims data given to FDA or other researchers will not include details that would identify individual patients, said Kerry Weems, acting CMS chief.

"With Sentinel, the FDA will eventually be able to query databases of tens of millions of patients almost simultaneously," Leavitt said. "It will no longer have to wait for reports to trickle in from the field. It will be able to proactively identify specific adverse effects among particular patient populations."

Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, explained that the Part D records can be linked to other Medicare records containing details on physician and hospital visits.

For example, FDA could ask for details about several months' worth of health records after any patient received a certain vaccine, she said. Any adverse events could potentially be linked to the treatment in question.

"It's really a process to develop a national distributed electronic system for monitoring medical product safety," she said.

FDA plans to add access to other databases, including claims from public and private health care payers, electronic health care records, and patient registry data. This program will work in conjunction with the existing MedWatch program to which health care providers report adverse reactions, said FDA Commissioner Andrew von Eschenbach.

"[The program] will give us the opportunity to see the signals of potential adverse events that could never be predicted or anticipated in the clinical trials or in the early regulatory process," von Eschenbach said.

Woodcock said FDA is in talks with a number of health care plans, medical data providers, and hospital systems, though she declined to name any specific companies.

While some information will be free of charge, a number of potential partners would charge fees for releasing query results. Talks are expected to continue before any agreements are signed.

Under the planned system, FDA will submit queries to various public and private databases to investigate suspicions about adverse effects from medical products, von Eschenbach said.

Weems said working with the Medicare Part D database could provide information that would help prevent more patients from suffering adverse reactions. Medicare spends about $900 million a year treating patients who encounter known adverse drug reactions, he said.

Woodcock acknowledged some concerns that the data generated through this system would not be as statistically powerful as information from a randomized trial. She said it is possible at some point FDA could see data from similar patient populations who did not take the drug in question, to serve as a sort of control group.

In the meantime, the system moves FDA ahead of the passive monitoring system that is now the main way to find patterns in adverse events.

"Although it won't answer all the questions, it provides a tremendous source of new information," Woodcock said of the Sentinel Initiative.

Cynthia Reilly, director of Clinical Standards and Quality for ASHP, said that as private insurers and other groups join the effort, the Sentinel Initiative will become a more powerful tool.

"The Sentinel Initiative provides a significant step toward improving drug safety by harnessing extensive data that represent use of drug products under real-world conditions," she said.

A white paper titled "The Sentinel Initiative: A National Strategy for Monitoring Medical Product Safety" is available from FDA.