FDA Changing Drug Package Inserts

Jan. 18, 2006 — -- For the first time in 25 years, the Food and Drug Administration will change the requirements for the lengthy package inserts that are included with most prescription drugs.

The change is similar to the food-label update of several years ago meant to help consumers better understand the nutritional content of their food purchases. In this case, the revamped package inserts are intended to help physicians, pharmacists and patients better understand the benefits and risks of the drugs.

Doctors and pharmacists, who frequently rely on other resources like the Physicians Desk Reference or the Internet, said they welcomed any improvements in the package inserts.

"Current package inserts are often copious, written in a very small type and buried in numerous pages. All too often, this is confusing, even to physicians," said Dr. Bruce Cronstein, director of the division of clinical pharmacology at the New York University School of Medicine. "The FDA improvement will simplify getting drug information to physicians and give them a better understanding of the ingredients."

Tracy Hughes, a pharmacist in Iowa, agreed.

"Right now, as a pharmacist, the package insert is the last place I look for information because it is hard to find and read," she said.

The most noticeable changes are a table of contents; inclusion of the date of initial product approval; a new "highlights" section, which lists the most pertinent benefits and risks for a drug; and a toll-free number and Internet reporting of adverse effects.

Drug manufacturers will also be required to include a "list of all substantive recent changes made within the year," according to an FDA press release.

The change was prompted by the increase in medical errors, the release stated.

"Each year approximately 300,000 preventable adverse events occur in hospitals in this country, many as a result of confusing medical information," the release stated. "Research shows that less warning information has a greater impact. Therefore, the new prescription label format provides the most important information about a prescription product in a format that is better understood, more easily accessible and more memorable for physicians."

The inserts, which list drug information, warnings, side effects and prescribing information, will be updated gradually, starting with new drugs before moving on to drugs already on the market. But all the information will soon be online on the FDA's Web site, www.fda.gov.