Making the Link - Pharmaceutical Executive


Making the Link
Post-marketing safety studies have one big problem: They're too slow. That's why companies are turning increasingly to databases that link prescribing data with patient outcomes.

Pharmaceutical Executive


The major advantage of claims databases is their large sample size. For products already on the market, thousands of patients can be identified in a matter of weeks, and results can be available relatively quickly. These databases become even more powerful when they are combined with tools for automatically detecting safety signals.

Claims databases can also be used to establish registries. Traditionally, registries could be established for a rare disease, a subset of a patient population with special attributes, or patients receiving a certain drug (e.g. the clozapine and Accutane registries). With the expansion of claims databases and advances in information technology, larger registries can be built faster at substantially less expense.

A common criticism of research using claims data is the potential for "up-coding"—when a physician bills an incident as something more serious than it really is in order to ensure insurance reimbursement. But there are ways to work around up-coding. For example, a scientist trying to learn the number of hip fractures in a given population would not simply count claims for hip fracture. Instead, that scientist would look for hip fractures combined with a cluster of reimbursement codes associated with imaging studies and surgical procedures. Epidemiologists experienced in using these data know what criteria to specify.

FDA recognizes that a new standard must evolve—one of routine, proactive safety surveillance. The history of drug safety assessment tells us that this is an ongoing process. Drug companies should take a more proactive stance in setting the standard for drug safety monitoring. Let's not wait for legislation to define the future of drug safety monitoring. Using a combined arsenal of standard PV activities, enhanced with integrated clinical trial databases that are systematically maintained and mined post-approval, and supplemented with other data sources such as healthcare claims data, let's make proactive monitoring of drug safety the routine standard.

Terri Madison is president of i3 Drug Safety; Arnold Chan, MD, is a senior scientist with i3 Drug Safety and director of i3 Aperio; John Seeger, is a senior scientist with i3 Drug Safety.


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