Regulatory Focus™ > News Articles > At 160 Million Patients, FDA's Mini-Sentinel Isn't so 'Mini' Anymore

At 160 Million Patients, FDA's Mini-Sentinel Isn't so 'Mini' Anymore

Posted 31 January 2014 | By Alexander Gaffney, RAC 

Despite its name, Mini-Sentinel, the US Food and Drug Administration's (FDA) ambitious attempt at creating an active surveillance system, isn't so miniature. In fact, according to data released by the project this week, it's positively massive.

Background

Before we dig into those numbers, some background information is in order.

Mini-Sentinel was created in 2008 as an effort to create a nationwide system to track products regulated by FDA after their approval. With the Food and Drug Administration Amendments Act (FDAAA) placing a far greater emphasis on post-approval requirements for drugs (instead of requiring all data to be submitted prior to approval), regulators and legislators realized FDA needed a way of keeping better track of adverse events to inform their ongoing assessments of product safety.

FDAAA called for the creation of the Mini-Sentinel system, and in 2010 FDA partnered with the Brookings Institute to bring together 21 different health care system providers capable of providing Mini-Sentinel with a constant stream of data and advice.

A Torrent of Data

While only some of those partners provide FDA with data, those that do provide it with a ton.

Just how much data was on display in a report released by Mini-Sentinel this week reviewing the data obtained through the first three years of Sentinel's operation.

As of July 2012, the Mini-Sentinel System's Distributed Database (MSDD) includes information on 160 million individuals, 3.5 billion medication dispensings-more than 45 million per month-and 3.8 billion unique medical encounters.

For reference, the entire population of the United States was just 314 million in 2012, meaning the Mini-Sentinel database contained data on more than half the United States.

Digging into the Numbers

Where the system gets it data from varies. Nearly half, or 59.4 million unique members, are from a single source, while two others respectively contributed 31.7 and 32.7 million members to the database. Most other contributions were smaller, like the 400,000 patients contributed by yet another source. Looking at the list of Sentinel contributors, this makes sense. Some of the contributors are massive healthcare systems like Kaiser Permanente, while others are independent medical centers like the Vanderbilt University Medical Center.

But more than just the quantity of the data is the quality of the data. Mini-Sentinel's summary report notes that the longitudinal data they have on some patients allows them to track their health over a period of more than 10 years, and half the database for more than one year. That data is extremely useful for regulators because some drugs, such as those for chronic conditions, may have adverse events that only become apparent over a long time.

And while the data it receives is by no means perfect or complete, it has allowed the Mini-Sentinel group, which exists independently of FDA, to provide the agency with key information on the safety of products far more quickly than the agency could do by itself in the past.

"Mini-Sentinel is building the capacity to respond to many of FDA's safety questions within days or weeks," the group wrote on its website.

In other words, thanks to big data, the only thing "mini" about the Sentinel system may wind up being the waiting time between regulators asking a question and receiving an answer.

 

Mini-Sentinel Report


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