FDA: The new format will put the most important information on one page marked "Highlights."

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 United States 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.

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.

In addition, there is 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.

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

This is cache, read story here