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On the Trail of Drug Risks

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Yet another potentially rich source of data about drug problems is patient records. The FDA’s Sentinel Initiative, launched in 2008, is charged with developing tools and policies for a new national database that will utilize health information routinely collected by hospitals, insurance companies, physician offices and other sites. “Vioxx was something we should have known about, but no one was looking at the data, which was embedded in health insurance claims,” says Jeff Brown, an associate professor of population medicine at Harvard Medical School. “Our goal is to monitor those data sources.”

Brown is involved in what’s known as Mini-Sentinel, a pilot program joining Harvard Pilgrim, Kaiser Permanente, Humana, Aetna and other large health plans in efforts to amass data from electronic health records, administrative and insurance claims, and health registries. Mini-Sentinel has established a network of electronic health records of more than 130 million people, and researchers are using those to monitor the safety of medical products. Because patient records aren’t designed to capture adverse drug events, researchers must use epidemiological methods to find problems that may be inferred from billing codes in insurance claims.

Recently, Mini-Sentinel assessed the risk of serious bleeding associated with the use of the anticoagulant dabigatran (Pradaxa). After the 2010 approval of Pradaxa, the FDA received a flood of reports that the drug caused bleeding. The Mini-Sentinel partners searched their data about patients who’d taken the drug, but analysis ultimately found no evidence that bleeding rates for new users of dabigatran were any higher than for new users of warfarin, another common anticoagulant—a result that was consistent with observations from the clinical trial used to approve the drug. The study took several weeks to conduct, though Brown says upgrades could eventually reduce that time frame to days.

In another study utilizing patient information, a 2009 pilot known as ASTER (Adverse Drug Event Spontaneous Triggered Event Reporting), sponsored by Pfizer, Partners HealthCare and others, evaluated whether electronic health records could improve physician reporting of drug problems. A special screen was added to the records so that physicians who had dropped a medication because of a patient’s adverse reaction could enter details about the problem and send them immediately to the FDA. Though only 2 of the 26 physicians participating in the study had submitted an adverse event report in the prior year, during the seven-month study the full group filed 200, with one in five deemed serious. “As a proof complete success,” says Michael Ibara, head of Pharmacovigilance Information Management at Pfizer. But he notes that turning that concept into reality would require scrutinizing regulations pertaining to adverse event reporting, among other obstacles.

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1. “Novel Data-Mining Methodologies for Adverse Drug Event Discovery and Analysis,” by Rave Harpaz et al. Clinical Pharmacology & Therapeutics, June 2012. A leading researcher in biomedical informatics and colleagues discuss the potential and challenges of developing data mining tools and using diverse data sources.

2. “The U.S. Food and Drug Administration’s Mini-Sentinel Program: Status and Direction,” by Richard Platt et al. Pharmacoepidemiology and Drug Safety, January 2012. A report on the FDA’s drug surveillance pilot, using electronic health records of 100 million people, by the lead investigator at the Harvard Pilgrim Health Care Institute.

3. “Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998–2005”, by Thomas Moore et al., JAMA Internal Medicine, Sept. 10, 2007. The first analysis using the FDA’s adverse event reporting database uncovered a number of disturbing trends during the time period, including a nearly threefold increase in reported serious injuries, disability and death associated with drug therapy, suggesting inadequacies in the existing surveillance system.

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