Free online CME offered on drug label revisions

Each year, changes are made to about one in four prescription drug labels approved by the Food and Drug Administration. The revisions on medications include new dosing recommendations and adjusted contraindication warnings.

Such frequently changing labels present a challenge to time-pressed physicians whose many responsibilities include keeping up with the latest information about the medications they prescribe, said Edward Fotsch, MD, chief executive officer of PDR Network LLC, a major provider of pharmaceutical information to physicians that produces the Physicians' Desk Reference.

PDR Network and The Doctors Company, a national medical liability insurer, are offering free online continuing medical education to educate physicians about changing labels (link).

It's a new campaign that the two companies plan to maintain indefinitely, Dr. Fotsch said.

The goal is to help improve patient safety and reduce medical liability cases, he said. About 30% of medical liability lawsuits involve medications, and courts routinely rely on FDA-approved drug labels to define the standard of care to which physicians are held, according to a 2010 report by attorneys with Vaslas Lepowsky Hauss & Danke LLP in New York City.

Laws vary from state to state, but keeping up with FDA labels before prescribing a medication can help physicians avoid lawsuits or "be extremely helpful in defending a lawsuit," said the report, which was commissioned by PDR Network (link).

Unfortunately, many physicians don't consider the potential consequences until they are faced with a lawsuit or other prescribing-related trouble, Dr. Fotsch said.

"There is a lack of awareness that this is an issue," he said. "In medical school, I don't know that I was ever told that I had to keep up with these changes."

The CME courses allow physicians to learn about labeling changes on their own time while earning AMA PRA category 1 credit. The initiative coincides with FDA efforts to reduce preventable harm related to pharmaceutical products, said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research.

"We know that physicians and other prescribers are increasingly busy and can struggle to find time to stay current with all the changes in pharmaceutical labeling," she said in a statement.