The FDA’s big data, postmarket drug surveillance program

It’s called Sentinel, and here’s a new Health Policy Brief from Health Affairs that describes it.

Overall, the FDA and Harvard Pilgrim say that they have access to prescription medication data on approximately 178 million people, with the routine accrual of medication data on 48 million currently enrolled or treated at the eighteen core partner organizations. Sentinel, they say, has 358 million person-years of data that include 4.0 billion prescriptions, 4.1 billion doctor or lab visits and hospital stays, and 42.0 million acute inpatient stays.

The data derive primarily from medical bills (claims), but a growing portion comes from EHRs or laboratory results (approximately 10 percent)—a portion expected to grow steadily in coming years. Here’s how the system works to proactively assess drug safety:

  • Prompted by a signal from FAERS [the FDA’s Adverse Event Reporting System], clinical trials, meta-analyses, case reports, or other regulatory bodies outside the United States showing a potential link between a prescription drug and an adverse event or safety risk, the FDA and Harvard Pilgrim staff and authorized researchers from collaborating institutions send a query via a secure portal to Sentinel’s network of data partners.
  • The data partners then conduct the query within their systems. All use the same analytical program. The partners are required to update their data sets periodically, with the largest data partners doing this quarterly and less frequent updates coming from smaller partners.
  • The findings are returned from each data partner through a secure portal. A team of data experts ensures the data quality before giving the FDA the findings.

There’s lots more in the brief, including limitations, controversies, aspirations, and so forth.


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