Health-IT researchers are joining with the pharmaceutical industry and, indirectly, the Food and Drug Administration
(FDA) to develop and evaluate new electronic drug-safety tools. Along the way, they hope to prove the financial value of electronic health records and other digital clinical information.
The collaboration, dubbed Connecting Communities for Drug Safety, will employ health-IT to find new ways of measuring risks and benefits of drug therapies as part of a national effort to create an “active” national drug-safety surveillance system for post-market drugs and prevent a repeat of the embarrassing, expensive Vioxx withdrawal in 2004. (See “Safety Last?”)
Anecdotes suggest that health care providers with EHRs had an easy time pinpointing which of their patients were on Vioxx when the FDA ordered the Cox-2 inhibitor off the market, but participants in Connecting Communities for Drug Safety hope to turn up scientific evidence. “It holds promise for the post-marketing side,” Michael Ibara, head of pharmacovigilance information management for the Pfizer Safety and Risk Management Department, says of electronic clinical data.
New York City-based Pfizer is one of three pharmaceutical companies participating in the collaborative, along with Eli Lilly & Co. and Johnson & Johnson. (Pfizer had to pull its own Cox-2 inhibitor, Bextra, in the wake of the Vioxx recall.) Ibara says that the drug companies are providing funding and some subject-matter experts for the work, including epidemiologists to advise the primary researchers.
“We need to express in real terms the value of electronic clinical information … and create a business case,” says Janet Marchibroda, executive director of the eHealth Initiative (eHI) and its related eHealth Initiative Foundation, which are leading the effort. “Drug safety is one of many business cases.”
The collaboration expects to inform and build off the research of the Reagan-Udall Foundation, a private, independent, nonprofit organization authorized by the recently signed Food and Drug Administration Amendments Act of 2007. The Reagan-Udall Foundation is charged with improving much-maligned FDA safety procedures and with modernizing development and innovation of products under the agency’s purview.
“Collaborative partnerships like these will provide critical insights to identify and advance new, innovative approaches to improving the quality and safety of medical products,” foundation chair Mark McClellan, the former FDA and Centers for Medicare and Medicaid Services chief, said in a written statement.
Last week, McClellan, who now directs the Engelberg Center for Health Care Reform at the Brookings Institution, a Washington, D.C., think tank, gave a speech to biotechnology executives, in which he reportedly heaped praise on the drug-safety monitoring aspects of the FDA Amendments Act.
The Connecting Communities for Drug Safety Collaboration has designated Partners HealthCare System in Boston and Regenstrief Institute in Indianapolis as “learning laboratories” for the program, and two well-known figures in health-IT are leading those efforts, namely Partners CIO John Glaser and Regenstrief director of medical informatics J. Marc Overhage, M.D.
Both were traveling Tuesday and unavailable for comment, but Overhage offered a statement in an eHI press release: “New, innovative approaches are needed to increase the timeliness and effectiveness with which we can identify drug safety issues. This collaboration gives us an opportunity to assess the feasibility of using clinical data for these issues, and develop methodologies that can be replicated by others,” he said.
Over the next 12 months, Partners and Regenstrief will mine clinical and administrative data for “safety signals,” in hopes of developing technical guides for drug safety programs, according to eHI. They will focus on three use cases: cholesterol-lowering drugs and laboratory results associated with liver failure; bleeding from anti-clotting drug warfarin; and a specific list of adverse drug reactions called “designated medical events.”
Separate studies will use data from EHRs, clinical information gleaned from claims data, and a combination of both. “In terms of us using clinical data, we’re breaking new ground,” Marchibroda says. “Electronic data is better than today’s system, which basically is a review of individual cases.”
Adds Ibara, “We’re taking a very focused look at how EHR data can supplement and expand what we learn from claims data.”
Marchibroda calls the drug-safety research the first step in a program to be announced early next year in which health-IT interests study the efficacy of consumer access to clinical information. For that, the eHealth Initiative likely will tap into existing care management and disease management programs, Marchibroda says, though details have not been finalized.
For Connecting Communities for Drug Safety, eHI has set up a Web page at http://www.ehealthinitiative.org/drugsafety/, but to date, it only contains the press release announcing the new collaboration.
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