Challenges for the FDA The Future of Drug Safety: Workshop Summary (2007) / Chapter Skim
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5 Enhancing Postmarket Safety Monitoring
5 Enhancing Postmarket Safety Monitoring
Pages 32-48
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From page 32... ...
increase their intra mural and extramural programs that access and study data from large automated healthcare databases and (b) include in these programs studies on drug utiliza tion patterns and background incidence rates for adverse events of interest, and (c)
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From page 33... ...
. Discussion at the symposium focused on how to enhance the current postmarket safety monitoring system by implementing the recommendations of the IOM report listed above, including upgrading AERS, developing an active surveillance system based on automated health care databases, and building internal epidemiological and informatics capacity at the FDA.
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Among the multitude of ways postmarket safety data could be used, the panelists agreed on three areas appropriate for active surveillance: (1) monitoring for specific adverse events related to a particular drug (based on pharmacological data and possible signals from clinical trial data)
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. These initiatives are aimed at the development of an active surveillance system that could be used to access data that already exist, looking for patterns of adverse events that may be related to specific drugs that would not be noticed through passive surveillance.
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Platt argued that health plans -- which serve large, defined populations and share many priorities with public health agencies -- could play a substantial role in forming such a public–private partnership. Specifically, health plans' administrative and claims databases, enhanced by other data, such as laboratory test results, and with access to full-text medical records (especially to electronic medical records, which are becoming increasingly available)
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Using data from the Health Maintenance Organization Research Network (HMORN) CERTs (Centers for Education and Research on Therapeutics)
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Multiple panelists agreed that using enhanced claims data, including links to full-text medical records, would be an efficient way to conduct postmarket monitoring on a real-time basis. 4Menactra was licensed to prevent meningococcal disease (meningitis)
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DRG) Net worth Member identifier • • Quantity and • Admission and • Education date dispensed Plan • • discharge dates Member identifier Race and ethnicity Drug strength • Gender • • • Date and place of • Laboratory test name service Life stage Days supply • Age • • • Result Dollar amounts Lifestyle indicators • Dollar amounts Dates of eligibility • • • • Administrative Pharmacy Physician and Laboratory Consumer Claims Facility Claims Test Data Data Data Data Results Data Machine Readable Dataset Per-Project Data Chart Hospital Clinical Tissue Surveys Reviews Inpatient Measures Samples FIGURE 5-2 Proposed composition of an enhanced claims database.
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From page 40... ...
are already collaborating with the FDA on stimulating analyses of this type, the private sector has expressed willingness to help, and academia must be engaged. The FDA currently has postmarket surveillance contracts with medical record–linked claims databases from the Health Maintenance Organization Research Network (HMORN)
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focus on the period of uncertainty following approval; (2) detect classic "drug list" events, drug- or class-specific events, increases in events with large public health consequences, and unsuspected events; (3)
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McClellen suggested that even if the system has access to good population-based data, not all questions would be answerable with observational data alone. Consequently, resources would still be required for postmarket clinical studies focused on cases in which detection of safety signals is insufficient for resolving whether a drug causes an elevated risk of an adverse event.
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The proposed public–private partnership would require funding, including both core funding to build the necessary infrastructure and develop routine postmarket surveillance, and separate funding for individual projects to follow up on and confirm potential safety signals.
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Once the infrastructure was in place, the incremental cost of conducting further studies and the value of having a more comprehensive population database available for conducting analyses would translate into a much higher return on investment than would be obtained if the system continued to collect and analyze adverse event data on a drug-by-drug and manufacturerby-manufacturer basis. Not only would a comprehensive approach be less expensive, but it would also generate better information and bettertargeted and timelier postmarket clinical studies.
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From page 45... ...
Dieck discussed the benefits as well as the limitations of automated databases. She agreed with some of the earlier presenters that rapid epidemiological studies involving real-world data on large samples are the cornerstone of postmarket safety monitoring, and that they could also serve as an important resource for estimating background rates and drug effects.
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From page 46... ...
• Public-use data may derive from skewed populations that make the data problematic for answering certain types of safety questions. For example, VA data, as rich as they may be, are for a military population, Medicare data for the elderly, Medicaid data for those on government assistance, and heath maintenance organization (HMO)
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The centers figure will not look as good when xeroxed The offer advanced degree-granting programs in clinical and translational science; involve investigators from a wide range of medical, veterinary, and other biomedical disciplines; and interact with the FDA, industry, and other institutions. The ultimate objective is to build a national consortium and forge new partnerships with public and private health care organizations.
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From page 48... ...
McClellan summarized the discussion of a public–private partnership for the development of a national active surveillance network to monitor drug safety. He stated that it is "an issue whose time has come because .
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