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FDA modernizes information systems, expands access to drug safety and use information.
Public and private healthcare experts have been struggling for years to establish electronic health-information systems able to track and transfer a broad range of data in patients' medical records. The fragmented nature of existing health information and the inability of health information technology (HIT) systems to communicate with one another has made the task extremely difficult. Add to that concerns about patient privacy and protecting access to personal health information (PHI), and the endeavor becomes even more daunting.
A primary strategy of eHealth advocates is to offer incentives and penalties to spur physician adoption of electronic health record (EHR) systems. Such measures were included in a 2008 Medicare bill as well as in the 2009 stimulus legislation, formally known as the American Recovery and Reinvestment Act (ARRA). The Health IT (HITECH) portion of ARRA authorized $20 billion to promote the adoption of EHR systems by healthcare providers, to support interconnectivity on a regional basis, and to expand the Office of the National Coordinator for Health Information Technology (ONC) in the Department of Health and Human Services (HHS), now headed by Harvard Medical School professor and health policy guru David Blumenthal.
HITECH strengthens privacy and disclosure requirements for eHealth systems as a way to enhance public trust in EHR programs. In the process, the measure threatens to restrict the services that pharmaceutical companies and other third parties can offer healthcare plans and providers such as medication-management and disease-management programs.
At the same time, the HITECH bill encourages electronic prescribing as one of several criteria that providers must meet to make "meaningful use" of certified EHR systems and thus qualify for Medicare bonus payments, not to mention to avoid future penalties [see sidebar, "Electronic prescribing grows"]. Providers are also required to submit insurance claims electronically; track patients' medications and laboratory results electronically; provide patient access to their health records; and use computerized order systems. There are a lot of complaints about the deadlines and criteria specified in a proposed rule on meaningful use that was issued in late December to implement HITECH. And there's still a need for standards and procedures for certifying that EHR systems perform required functions and are secure and interoperable.
In Washington this month
In addition to doling out incentives for EHR adoption, HHS is providing some $2 billion to: help providers adopt HIT that fits standards; assist states and communities in establishing health information exchanges; develop interoperability standards; and examine a range of technical and policy issues that impede HIT adoption. All these efforts aim to support a Nationwide Health Information Network that will provide more information on healthcare costs, quality, and outcomes needed for a more effective healthcare marketplace. EHR systems are important, but will accomplish little, says Blumenthal, unless health data "can flow freely, privately, and securely to the places where they are needed."
Although the US Food and Drug Administration does not benefit directly from HITECH funding, increased connectivity among healthcare entities promises to support more efficient drug testing and development, along with more timely medical product monitoring and oversight. To take advantage of these developments, FDA first has to update its internal IT operations to improve its capacity for reviewing applications for new drugs and medical products; for receiving and archiving clinical-trial data and regulatory submissions; for tracking manufacturing facilities and product supply chains; and for expanding oversight of the safety of drugs and medical products on the market.
A report from FDA's Science Board in 2007 described the sorry state of the agency's IT infrastructure. The report noted that much clinical-trial data was available only in paper form, and that FDA's decentralized IT operations have created different systems in agency centers without common standards for data exchange. Much of FDA's IT infrastructure was more than five years old and thus unable to support advanced analysis such as that using genomics information related to medical products. FDA has an IT plan for drugs and biologics, as authorized by the Prescription Drug User Fee Act (PDUFA) IV of September 2007, but the plan falls short of addressing broader agency information problems.
The Science Board report renewed efforts to overhaul FDA's information systems. The agency announced in September 2008 a 10-year, $2.5-billion bioinformatics project to modernize agency IT infrastructure for data management, data warehousing, IT infrastructure, and IT security. One aim is to coordinate the many IT modernization activities launched over the years, which range from establishing an electronic document room and an Advanced Submission and Tracking Review system, to creating a risk-based import screening system (PREDICT), and a centralized electronic system to manage advisory committees.
However, Congress' Government Accountability Office (GAO) reported in June 2009 that FDA still needs a comprehensive IT strategic plan with specific goals, strategies, milestones, and performance measures to tackle its many information challenges. Agency officials promised to complete such a plan last year, but the plan has been delayed by difficulties in establishing advanced IT systems at the agency's White Oak, Maryland, campus. (Under the President's proposed fiscal year 2011 budget, the White Oak campus will become the sole FDA headquarters). Last August, the Science Board reported that FDA was making progress in creating a more effective IT infrastructure and in harmonizing data standards, but that it still needs standards-based electronic data exchange capacity, more IT expertise to manage these programs, and additional investment in scientific computing systems.
Electronic prescribing grows
Enhancing drug safety
One important FDA IT initiative is to provide more timely information on the safety of all regulated products. To this end, the agency is centralizing adverse-event analysis through its Adverse Event Reporting Systems (AERS) and is creating a MedWatch Plus single portal for public reporting of adverse events. Work continues on a final rule requiring electronic filing of adverse-event reports for drugs, vaccines, and medical products. Small drug and biotechnology manufacturers fear the mandate may be costly and difficult to implement.
Probably the most high-profile project involves establishing a proactive electronic information system that can detect signals of adverse events for medical products. The aim, as specified in the FDA Amendments Act of 2007 (FDAAA), is to augment AERS with a more active program able to monitor health records on 100 million people by July 2012.
FDA aims to meet this goal through a series of steps over several years. The agency launched the Sentinel Initiative in 2008 and now is establishing a "mini-Sentinel" system that will tap into medical records held by large healthcare plans and insurers. FDA will pose queries about medical products to databases established by CIGNA, Kaiser Permanente, and the health maintenance organization Research Network, among others. A second phase next year will expand the program by accessing data from Medicare and other government healthcare programs. The queries may be triggered by evidence of possible risks seen in clinical trials or by adverse-event reports on marketed drugs. FDA can ask Sentinel partners to monitor for certain events and to assess evidence of health conditions associated with drug use as part of its effort to see if quickly gathering more information strengthens initial safety signals.
The agency recently signed a $72-million contract with the Harvard Pilgrim Healthcare system to coordinate operations for a distributed data model that can obtain near real-time signals and ensure data quality from appropriate sources. The program already can access information on 60 million patients, according to Richard Platt of Harvard Pilgrim and Harvard Medical School, who heads the project. That's well above the 25 million patients that FDAAA instructs FDA to monitor by July 1, 2010. Mini-Sentinel also will work with researchers and technical experts at academic centers, private firms, and nonprofit organizations to examine methods for querying against a common data model and to establish policies and standards for validating and analyzing information from diverse information sources.
Platt and others discussed the technical, legal, and administrative issues involved in building the Sentinel System at a January workshop organized by Mark McClellan, former FDA commissioner and now director of the Engelberg Center for Healthcare Reform at the Brookings Institution. FDA Commissioner Margaret Hamburg opened the conference by noting the growing importance of postmarketing surveillance of regulated products. She cited key questions that need to be addressed to have a fully functioning Sentinel System such as how to design a common data model that can compare and analyze data sets, and the need for consensus on methodologies for proving and disproving causal relationships between a product and an outcome.
Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), described Sentinel as one element in a broader agency effort to encourage safe use of medications, to revamp FDA's pharmacovigilance system, and to explore the use of social media to publicize safety issues. FDA also is participating in numerous worldwide collaborations that aim to better understand drug effects in different populations.
Judy Racoosin, the FDA scientific lead on Sentinel, emphasized that the initial system will help the agency understand the intricacies of gathering safety signals on drugs from multiple sources and closer to real time. Sentinel is "very much a work in progress," Woodcock commented, noting that it will be very different in five years as the science and technology mature.
FDA's decision to launch Sentinel based on a distributed data model reflects earlier research by academic experts and by the Observational Medical Outcomes Partnership (OMOP), an industry-funded collaboration involving FDA, the Foundation for the National Institutes of Health, and the Pharmaceutical Research and Manufacturers of America (PhRMA). Through this partnership, manufacturers are working to define viable approaches for assessing drug safety and for communicating those findings to health professionals and patients. At the Sentinel workshop, Patrick Ryan, manager of drug-development sciences at GlaxoSmithKline (London), noted that OMOP is assessing the diversity in analysis methods and making all of its research available to the public.
Participation and privacy
OMOP's agenda reflects strong industry interest in shaping and supporting Sentinel policies and operations. Unfortunately, this coalition is the primary way for manufacturers to influence the project. There are no industry representatives on the Sentinel planning board, and OMOP is not an official participant in the program, largely due to concerns among some stakeholders that manufacturer involvement could rtaint the validity of results. Pharmaceutical companies may feel compelled to build independent versions of Sentinel if excluded from the FDA project and denied access to Sentinel data. Woodcock noted that the mini-Sentinel system can't yet support third-party postmarketing analysis, and that FDA will have to deal with industry access once the "industrial strength Sentinel" emerges.
Ensuring the privacy and security of patient health records is also key to shaping the Sentinel program. One core advantage of the distributed data model is that FDA avoids building its own mega-database and instead leaves individual patient health information with the insurance company or healthcare system that holds the records. That data source evaluates the information, transmits summaries to Sentinel, and confirms a specific diagnosis or report if needed. It remains to be seen, however, how well FDA can assess safety signals with this arrangement. FDA staffers will be able to access de-identified data from Medicare and perform their own analysis, but it still may be hard to confirm whether a safety issue is real based on such limited information.
Another tricky issue for industry and policymakers is the timing of public disclosure of safety information. "The biggest risk to Sentinel is false positives," comments Marcus Wilson, president of HealthCore, the data analysis subsidiary of WellPoint. Information that is released too early increases the possibility that a report may be wrong or incomplete and, thus, raises unnecessary alarm. But delaying communication on an emerging safety issue may result in patient harm and expose program participants to "failure to warn" liability charges. At the Sentinel workshop, attorney Kristen Rosati encouraged FDA to develop model procedures for when, how, and to whom to report drug safety findings to set a policy that can be applied in court.
FDA also has to determine how it will use Sentinel findings in regulatory decisions. Confirmation of safety signals could result in changes in a product's labeling, agency alerts to healthcare professionals, and public warnings about appropriate drug use. Despite concerns about the completeness, objectivity and timing of drug-safety reports, "What we're going to get is going to be better that what we have right now," Woodcock predicted.
Sentinel's prime purpose is to serve FDA's regulatory mission, but it eventually may be part of a multipurpose network that provides safety information to multiple public and private users, said McClellan. For example, the program can support the International Serious Adverse Events Consortium's search for genetic links to drug-induced safety problems. In the longterm, Sentinel may be part of a larger health information system that provides data for outcomes studies, comparative-effectiveness research (CER), and health-system quality reporting. Manufacturers support building such a network, said Paul Stang of Johnson & Johnson, but building one requires more investment.
Carolyn Clancy, director of the Agency for Healthcare Research and Quality, concluded the workshop by describing a range of initiatives to improve patient registries and to build distributed data research networks that can answer queries related to the effectiveness and safety of medical services and products. An overarching goal is to identify synergies between postmarketing surveillance and CER and to provide incentives for healthcare providers to participate in eHealth activities.
Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634, firstname.lastname@example.org