FDA Wants Drug Inserts You Can Understand

By Dunstan Prial, The Record, Hackensack, N.J.

Feb. 10–The FDA is dealing with complex, confusing drug package inserts by requiring a highlights page with a section for warnings and adverse reaction information. The rule will cover all drugs approved after June 30 and be phased in for some other drugs.

The informational pamphlet included with a prescription for Lescol, a popular cholesterol drug, runs eight columns over four broad pages.

The dizzyingly complex prose, printed in tiny type that all but shouts for a large magnifying glass, is broken up by molecular diagrams, dosage and “Steady-State Pharmacokinetic Parameter” tables and bar graphs representing changes in something called “Minimum Lumen Diameter.”

A pamphlet included with the cancer treatment Eloxatin is twice as long and at least twice as complex.

Simply put, these pamphlets, included with every container of prescription drugs prescribed in the U.S. and commonly referred to as package inserts, are virtually incomprehensible.

Recognizing this, the U.S. Food and Drug Administration recently approved a new format for making important prescription drug information more accessible and easier to comprehend both for patients and their doctors.

Under the new format, the information deemed most important will be gathered into a single page called “Highlights.”

The highlights page will not replace the old package insert, but rather serve as a supplement.

At the top of the highlights page, partitioned off by a black box and printed in boldface type, is a single section for warnings and adverse reactions.

On a Lescol package insert printed in May 2003, the warnings section was located on the back of the pamphlet, many hundreds of words and eight charts from the beginning. Further on, almost at the end of the pamphlet, was the section for adverse reactions.

“Take a look at this and let me know if a patient can understand this,” said Marcia Jacinto, director of pharmacy services at Englewood Hospital and Medical Center, waving a six-page package insert.

Apparently it isn’t just patients who are confused.

In announcing the new format, U.S. Surgeon General Richard Carmona said many of the estimated 300,000 preventable mistakes that lead to death or injury in hospitals each year are caused by confusing information.

“Americans are overwhelmed with the complexity of health information,” Carmona said in a statement announcing the new format. “We have hit a point of information overload and the public health message is being diluted. This is of great concern when it comes to making sure a patient knows how to use prescription drugs safely and effectively.”

Jacinto praised the structure of the highlights page, in particular the combined section for warnings and adverse reactions.

In addition, she cited a new requirement that any changes related to the drug, such as previously undiscovered side effects, revealed since the drug was first approved be included in the highlights section. In the past, those changes might have been sprinkled throughout the pamphlet and possibly overlooked by patients and doctors.

Finally, Jacinto noted the highlights section will include an area that informs patients of such useful information as how to store the drugs, and what to do in the event of an overdose or if the patient forgets to take the medicine at the prescribed time.

The new format will also include a table of contents to help patients and doctors more easily find information, and a phone number and a Web site where patients and doctors can report suspected side effects not included in the warnings.

“I think this is very, very useful, not only for the patients but also for the physicians who don’t have the time to go through all this information,” Jacinto said.

Several doctors contacted for this story declined to comment, saying they preferred to wait until the new regulations are in place and they have seen the updated format.

The new rule will be in effect for all drugs approved after June 30, and will be phased in gradually for drugs approved in the last five years, according to the FDA.

The new format has generated some controversy. Big pharmaceutical companies have complained to the FDA that the streamlined labels could open them up to lawsuits from patients who claim they weren’t properly warned about side effects.

That led the FDA to claim that federal regulations supersede state liability laws, a move that has drawn criticism from consumer advocates.

—–

To see more of The Record, or to subscribe to the newspaper, go to http://www.NorthJersey.com.

Copyright (c) 2006, The Record, Hackensack, N.J.

Distributed by Knight Ridder/Tribune Business News.

For information on republishing this content, contact us at (800) 661-2511 (U.S.), (213) 237-4914 (worldwide), fax (213) 237-6515, or e-mail reprints@krtinfo.com.