drug injury reporting

Problems Found With Drug Injury Reporting System

by Staff Blogger | February 3rd, 2015

Each year, a large number of Americans suffer drug injuries as a result of taking medications prescribed by their doctors. The U.S. Food and Drug Administration (FDA) is in charge of recording the incidents and developing plans of action to address dangerous drugs. However, a new study has found that reporting system may be heavily flawed.

An article from The Wall Street Journal explains that while the FDA Adverse Event Reporting System (FARS) allows anyone to file a report of a drug injury or defective medical device, drug manufacturers report 97 percent of incidents. Unfortunately, these reports are often lacking vital information that could prevent further injuries, such as dates and patients’ ages.

Additionally, changes in regulations governing the marketing of medical devices and drugs have occurred since the reporting system was last updated. This can also result in a lack of vital information in adverse event reports.

So what is being done to correct these issues? The FDA has launched it’s Sentinel Initiative to monitor drug safety, and the program is now ramping up.

The drug injury lawyers with Ferrer, Poirot & Wansbrough are aware of the dangers a drug injury can pose to a patient. That’s why we’re hopeful that the FDA is successful in improving the way drug and defective medical device injuries are reported.