FDA prioritizes drug safety, expects industry to be proactive

December 1, 2009

More than 4 million annual provider visits, including visits to the ER, can be attributed to adverse drug events

NATIONAL REPORTS-Early last month, the FDA launched the Safe Use Initiative, which aims to create and facilitate public and private collaborations within healthcare to reduce preventable harm associated with medication misuse, errors and other medication-related problems.

"Too many people suffer unnecessary injuries from avoidable medication misuse, errors and other problems." says FDA Commissioner Margaret A. Hamburg, MD, "The FDA is launching the Safe Use Initiative to develop targeted solutions for reducing these injuries."

"All participants in the healthcare community have a role to play in reducing the risks and preventing injuries from medication use." says Janet Woodcock, MD, Director of the FDA's Center for Drug Evaluation and Research.

At present, millions of Americans require prescription and/or over-the-counter (OTC) medications to improve or preserve their health; with as many as 3 billion prescriptions written annually. As a result of this vast use of medications, it is estimated that at least 1.5 million preventable adverse drug events occur annually, resulting in hundreds of thousands of injuries and deaths.

Adverse events from medication use have been linked to more than 4 million visits to emergency departments, provider offices or other outpatient settings and greater than 100,000 hospitalizations each year. According to FDA officials, "many injuries associated with medication use could be prevented with currently available knowledge."

In fact, current estimates suggest anywhere from 11% to 50% of injuries could be preventable.

During the initiative's first year, the FDA plans to implement a small number of safety programs. Some key interventions include evaluating consumer medication information; communicating the risk of overexposure to acetaminophen; safeguards for alcohol-based surgical preparations and avoiding contamination of multiple use medication vials. FDA intends to hold a series of public meetings to gather feedback.