FDA's Sentinel Initiative identifies drug safety problems

The advancement of electronic health records (EHRs), new software tools, the advent of big data analytics; and the increased focus on coordination and alignment among health systems, doctors, payers, and government is leading FDA to more quickly recognize adverse events associated with prescription drugs.

To that end, FDA's Sentinel Initiative aims to use big data and broad networks to proactively and systematically detect and respond to emerging risks associated with prescription medicines. In the June 4 Health Affairs’ Health Policy Brief, the organization discusses the limits of FDA's Adverse Event Reporting System (FAERS) database, which contains information on adverse event and medication error reports submitted to FDA by doctors, nurses, pharmacists and others, and the benefits of agency’s Sentinel Initiative.

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One of the primary problems with FAERS is that reporting is voluntary and thus incomplete. Estimates are that only around 10% of adverse events are reported to FAERS, according to the Brief. In addition, Reports to FAERS are not validated because of their sheer volume.

Many of the reports also do not contain enough data to permit a full evaluation of a potential problem such as whether there is a causal relationship between a drug and an event. “Use of FAERS reports is also often difficult because there are no related data describing the overall use of the drug, which would serve as the denominator in any prevalence analysis,” the Brief stated.

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As a result, FDA developed its Sentinel program, one of the largest distributed-network medical data projects in the United States. The network consists primarily of 18 organizations that include some of the nation's largest health insurers such as Aetna, Anthem, Humana and Kaiser Permanente along with various disease registries. FDA also has access to selected data from 88 hospitals and other inpatient facilities.

FDA has 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 18 core partner organizations. “Sentinel…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 Brief stated.

As of February, 2015, queries that occurred under the Mini-Sentinel phase of the initiative have led to assessments of 137 drugs. Of those, FDA has probed 18 and has issued a drug safety communication in four cases. For example, a Sentinel probe confirmed FAERS reports and anecdotal accounts from doctors and patients that patients who took the antihypertensive drug olmesartan for long periods of time developed intestinal problems. As a result, FDA added a warning to the drug's label.

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