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Azadeh Shoaibi

FDA Compliance

PRISM Identifies Vaccine Safety Issues

Making sense of vast streams of healthcare data

Published: Wednesday, April 26, 2017 - 12:01

The word “prism” might make you think of a triangular piece of glass that separates white light into a rainbow of colors. But at the U.S. Food and Drug Administration (FDA), it means a powerful, computer-based system that separates critical bits of information from vast streams of healthcare data in order to investigate adverse events and determine if there is a connection to a specific vaccine.

The FDA “prism”–called Post-licensure Rapid Immunization Safety Monitoring System (PRISM)—might not have such a colorful name, but it’s a bright light in the agency’s continual efforts to identify adverse effects in a timely manner.

PRISM is a cooperative effort between the FDA’s Center for Biologics Evaluation and Research and its partners in the healthcare and medical insurance communities. It analyzes health-insurance claims data from four national healthcare plans: Aetna, HealthCore (Wellpoint), Humana, and OptumInsight (United Healthcare).

Since it was first inaugurated in 2010, PRISM has made valuable contributions to public safety.

For example, the FDA was able to use the system to reassure the public that there was no link between an influenza vaccine and increased risk of febrile seizure in children (convulsion or seizure brought on by a fever). Another PRISM study comprising more than 1.4 million doses of Gardasil found no evidence of venous thromboembolism after vaccination among females 9 to 26 years old. The FDA also used PRISM to identify a link between a rotavirus vaccine (RotaTeq) and an increased risk of intussusception in infants.

These case studies, along with other information, were discussed at a public meeting in December 2016 held to discuss what the system has accomplished and how it’s used in the regulatory process. The purpose of the workshop was to describe the Sentinel Initiative (a national electronic system for medical product safety surveillance) and the PRISM program, illustrate how the FDA uses PRISM for regulatory responsibilities, and discuss the future direction of PRISM, including its further integration into the regulatory review process.

Stakeholders, including manufacturers, academics, the public, and other federal agencies, that participated in the workshop had an opportunity to weigh in with their opinions about the system, discuss its limitations, and offer ideas for improving it.

PRISM is one component of the FDA’s Sentinel Initiative, which monitors the safety of a variety of FDA-regulated medical products by examining information in electronic healthcare databases.

Sentinel performs what is called “active” surveillance, as opposed to “passive” surveillance. Passive FDA surveillance systems depend on industry, consumers, patients, and healthcare professionals to recognize and report suspected adverse events to an FDA website, such as the Vaccine Adverse Event Reporting System (VAERS). This means that the FDA might not become aware of potential problems related to a licensed product for months.

Unlike passive surveillance, Sentinel’s active surveillance lets the FDA initiate its own studies using existing electronic healthcare data in a timely manner. Sentinel also allows the FDA to evaluate safety issues in targeted groups (e.g., children) or to evaluate specific conditions (e.g., heart attacks) that are not usually reported as possible adverse events of medical products through passive reporting systems.

So by adding an active surveillance capability to the FDA’s toolbox, Sentinel broadens the agency’s ability to monitor the safety of a spectrum of licensed medical products in support of the FDA’s mission to protect and advance public health.

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About The Author

Azadeh Shoaibi’s picture

Azadeh Shoaibi

Azadeh Shoaibi, Ph.D., is the Sentinel lead at FDA’s Center for Biologics Evaluation and Research.