Magazine article Drug Topics

FDA Eyes Sentinel Network for Postmarket Safety

Magazine article Drug Topics

FDA Eyes Sentinel Network for Postmarket Safety

Article excerpt

Now that we have electronic record technology, how should we set up a postmarketing surveillance system for drugs, biologicals, and medical devices? The Food & Drug Administration began exploring that question with a request for comments and two days of hearings last month in Rockville, Md.

The agency envisions that such a "sentinel network" will be established through several broad-based, public/private partnerships and will integrate existing and planned efforts to analyze and disseminate information to practitioners and patients at the point of care. The FDA said new information technology and privatesector interest in postmarket safety provide an opportunity to better integrate postmarketing surveillance.

FDA commissioner Andrew C. von Eschenbach, M.D., told attendees, "If we have the ability to extract these data, acquire them, assemble them, and analyze them, we, in fact, have an opportunity to rapidly and radically transform the evolution of knowledge-knowledge of what is happening with regard to disease and health in the human condition." He said such a system could be "one of the most profound contributions to the new era in health care."

Janet Woodcock, M.D., the FDA's chief medical officer, told the hearing that rather than assembling a "grand database," the agency is looking to build on public/private efforts, using national communication standards-particularly those for electronic health records, including those being worked out under contract with the Office of the National Coordinator for Health Information Technology.

Finally, calling for risk communication to be integrated into the work flow of clinical practice, Woodcock said the current system "is extremely fragmented and isn't working very well. We cannot just bombard physicians, pharmacists, and nurses with pieces of paper."

At the March meeting, staff from the FDA and other federal agencies heard presentations on a variety of information and research systems that might be part of, or models for, such a sentinel network. Within the pharmacy arena, Benjamin Bluml, R.Ph., VP of research for the American Pharmacists Association, described that group's Pharmacy Research Network, with its more than 200 sites that track patients, adverse events, compliance, and drug interactions. Under development for three years in conjunction with the company Applied Clinical Intelligence, the network's phase III and phase IV work has resulted in numerous adverse events targeted in the pharmacies and fed back to both the manufacturer and the reporting system, said Bluml. …

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