Sometime this month, federal authorities begin monitoring electronic records for the ounce of prevention that could lead to pounds of cure for patients and the companies that dispense their drugs.
Late last month, the Federal Drug Administration unveiled its “Sentinel Initiative” to query existing databases for evidence of problem pharmaceuticals that are causing adverse effects in patients.
To date, the FDA has relied on doctor testimony, documentation from clinical trials and medical journal reports for advance intelligence on problem drugs. That passive, ad-hoc system has several limitations, however, including the inability to determine the percent of a patient population that has experienced problems.
The FDA”™s hope is that it will be able to spot problems virtually in “real time” allowing a product to be yanked until problems are resolved. Medicare data on prescription-drug use will be available to help government agencies and academic researchers improve the safety, quality and efficiency of health care services.
“This initiative will tremendously increase the FDA”™s capacity to monitor the use of medical products on the market,” said Mike Leavitt, secretary of the Department of Health and Human Services, in a prepared statement. “We are moving from reactive dependence on voluntary reporting of safety concerns to proactive surveillance of medical products on the market.”
The Washington, D.C.-based Pharmaceutical Research and Manufacturers of America issued a statement in support of the new system.
The system would unify surveillance programs already in place with a broad set of partners ”“ including the National Institutes of Health, the national Centers for Disease Control and Prevention, and the University Health Systems Consortium ”“ as well as tap electronic records in the nascent Nationwide Health Information Network and Medicare Part D programs.
The system would be expanded through voluntary partnerships with the private sector, particularly organizations that maintain large electronic claims and medical-records data. For instance, if the FDA were to receive reports of adverse effects linked to a new drug, the agency would query participating partners to see if they are observing similar instances.
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Companies like Norwalk-based IMS Health Inc. and Stamford-based Thomson Reuters Corp. have built large businesses by tracking drug data made available by doctor”™s groups and other sources.
That surveillance in turn could have a major ”“ and possibly positive ”“ impact on area employers like Boehringer Ingelheim Pharmaceuticals Inc., which has its U.S. headquarters in the Danbury area.
The FDA did not indicate whether the system would be expanded in time to include medical devices, which could impact locally based manufacturers like Fairfield-based General Electric Co. and Tyco International Ltd.”™s U.S. Surgical Corp. subsidiary in Norwalk.
The idea for the creation of such a surveillance system was made in a 2006 report by the Institute of Medicine on ways to improve drug safety, and Congress authorized the measure last year. The law calls for the Department of Health and Human Services to be able to access data from 25 million patients within two years, and 100 million by July 2012.
The federal agencies have not specified a cost for the system, but have indicated it would be minimal, involving the efforts of staff already employed by the agencies.
The FDA would not have access to individual medical records, save in the case of data from the Medicare Part D program. Those latter records would not include patients”™ names or other identifying information.
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