When the FDA began drafting plans to meet Congress' drug safety legislation, the agency predicted that postmarket surveillance would ultimately become as big a task as premarket review. Since then, the system those plans spawned--named Mini-Sentinel--has given credence to the prediction by growing to cover more than 160 million patients.
The scale of the FDA postmarketing data gathering system was revealed in a report released this week summarizing the first three years of the operation. As of July 2012 the database included details of 160 million individuals, 3.5 billion medication dispensings and 3.8 billion unique medical encounters, Regulatory Focus reports. The figures surpass the goals set by Congress, which called for data from 100 million patients by the start of July 2012. Last year Mini-Sentinel received a 35% funding boost in recognition of its unexpectedly fast growth.
Having such a large data set gives the FDA a new way to quickly detect, analyze and evaluate the risks posed by drugs. In presentations, Mini-Sentinel staffers have demonstrated how they can dig into the database to show hospital visits for acute myocardial infarction stratified by age and sex. At the end of December, the FDA revealed a practical application for the database when it requested feedback on a study protocol. The proposal outlined the use of Mini-Sentinel data to assess rates of bleeding and thromboembolic outcomes associated with use of Boehringer Ingelheim's blood thinner, Pradaxa.
Mini-Sentinel is designed to cut the time taken to run such assessments. Its scale--both in terms of how many patients are covered and for how long--also creates new ways to assess risks. With many patients now taking multiple drugs over many years, the potential for unexpected interactions and long-term effects has escalated. Aggregating and analyzing data from Kaiser Permanente and other healthcare providers on Mini-Sentinel is one part of FDA's response to new drug safety challenges.
- read Regulatory Focus' article
- view the full report (PDF)