School of Pharmacy Study: FDA Adverse Drug Reports Swelled in Past Decade

Study of the past 10 years of data revealed a need to improve data, say drug safety researchers.

By Steve Berberich
April 5, 2011

In recent years, U.S. Food and Drug Administration (FDA) reports of adverse events related to drugs have increased dramatically.

Researchers at the University of Maryland School of Pharmacy revealed in a new study of adverse events linked to medications?compiled by the FDA since 1969?that 55 percent have been reported to the agency in the past decade.

However, study leader Sheila Weiss Smith, PhD, a professor of pharmaceutical health services research (PHSR) at the School, says the most important conclusion from the study should be that the quality of the data needs to improve. “Yes, growth in the volume of reports was amazing, but the absolute number doesn’t have meaning by itself,” she says.

Weiss Smith says the number of reports doesn’t reflect the actual number of adverse events linked to drugs.

According to the FDA’s website, the agency’s Adverse Event Reporting System (AERS) is “designed to support the FDA’s post-marketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses AERS to monitor for new adverse events and medication errors that might occur with these marketed products.”

Drug makers are required by federal regulations to report possible health problems possibly linked to their products. But, reporting to the FDA by doctors, patients, and others is voluntary.

Weiss Smith says currently there are a lot of reasons why people make adverse drug reports to the FDA. Safety warnings in recent years have contributed to an uptick of the adverse event reports, for example, she says.

Other possible explanations could be that an aging population is taking more prescription drugs, more people are taking medications for multiple medical conditions, and more people overall are taking multiple drugs for longer periods of time with the potential for harmful drug interactions.

There is a lot of room for improvement in adverse events reporting, she says. For example, they found one-third of the events reported did not include the patient’s age. “Without ages, you have to throw out those reports. One of the reasons we did the study is that the reporters should improve the quality of their reports.”

“In the past decade, 2.2 million events reported to AERS represented a 1.65-fold increase from the prior decade, or a mean annual rate of 11.3 percent,” the authors wrote in the study published in the current issue of the journal Archives of Internal Medicine.

The AERS data is used by the FDA to search for new safety concerns over a product and evaluating the manufacturer’s compliance to reporting regulations.

The academic study of the AERS data is just one example of hundreds of post-market studies of drugs and medical devices reported by PHSR faculty.