“Drug Leaflets Need More Information”

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Drug Leaflets Need More Information

June 25, 2002 WASHINGTON (AP) -- Think those leaflets that drugstores dispense with prescription drugs tell the patient everything necessary to take the medicine safely? Think again.

The government sent patients to buy popular prescription drugs at pharmacies around the country and found only half the leaflets they received adequately warned of the drugs' risks.

Indeed, a surprising number didn't contain life-or-death warnings, such as that men who take the heart medicine nitroglycerin shouldn't also use the impotence remedy Viagra. The mix can kill.

The Food and Drug Administration will ask its scientific advisers next month how to improve the quality of the leaflets, which often are patients' last line of defense against a preventable side effect.

So far, FDA doesn't plan new regulation of the leaflets. Because the drugstores' voluntary system clearly reaches many patients, the FDA instead plans to try persuading companies writing bad leaflets to do a better job.

Until the issue is settled, some consumer advocates say patients shouldn't rely solely on drugstore printouts. Instead, ask pharmacists for FDA-approved "professional labeling" that doctors read, or check the FDA's Web site before swallowing a new pill, says pharmacist Larry Sasich of the consumer advocacy group Public Citizen.

An estimated 2 million Americans are hospitalized annually from drug side effects, and 100,000 die. While some side effects are unavoidable, experts say the vast majority of prescription-caused deaths are preventable - and education is a big means of protection.

Does aspirin, your heart medicine, even that morning grapefruit, mix dangerously with your latest pill? What if your new allergy doctor doesn't know you also have, say, bad kidneys that might not tolerate another drug?

Consumer-friendly prescription leaflets are supposed to help answer such questions. But there's no oversight of most of leaflets to ensure they're accurate.

While the FDA closely regulates drug warnings written for doctors, it mandates that only a handful of prescriptions with special dangers come with information written especially for patients, brochures called Medguides.

For other prescription drugs, Congress gave pharmacies until 2001 to distribute useful information on their own to 75 percent of Americans. Lawmakers outlined quality criteria for these voluntary leaflets. If drugstores didn't meet the goal, FDA could intervene.

With FDA money, University of Wisconsin researchers hired shoppers to buy four drugs each at 384 pharmacies: the popular cholesterol-lowering Lipitor, the heart medicines atenolol and nitroglycerin, and glyburide for diabetes.

Some 89 percent came with leaflets, good news at first glance.

But did they provide good information? Wisconsin researchers compared the leaflets with Congress' quality criteria, and found "half of the stuff doesn't reach a minimal passing score," said FDA pharmacist Tom McGinnis.

The worst flaw was leaving out important warnings:

-One drugstore's leaflet filled two pages while another provided only a few paragraphs about the same drug.

-One in three nitroglycerin leaflets failed to mention that deadly Viagra interaction.

-Only 36 percent of atenolol leaflets fully warned not to suddenly stop the pills, which can cause a dangerous blood pressure jump.

-Lipitor patients need regular tests to ensure their livers are handling the drug. But most Lipitor leaflets didn't even mention that testing, nor warn patients to tell their doctor if they drink frequently - overuse of alcohol increases the liver risk.

"The results are appalling," said Public Citizen's Sasich, who wants the FDA to mandate Medguides for all prescriptions. "The private sector had ... five years to get it right. How much time do you need?"

Pharmacists, who oppose such regulation, say the study shows improvement. A decade ago, hardly anybody got reliable leaflets.

Pharmacists don't write the leaflets but buy them from a complex web of drug-information brokers and software companies. The National Association of Chain Drug Stores thinks the software middlemen are cutting the important warnings and is helping the FDA track that down.

Improving quality might require "some more assertive, forceful action by the FDA," such as leaning on the bad-data producers, said Zellmer of the American Society for Health-System Pharmacists, a pharmacists group that also is a small supplier of leaflets.

Copyright 2002 The Associated Press. All rights reserved.

Martha Murdock, DirectorNational Silicone Implant Foundation | Dallas Headquarters"Supporting Survivors of Medical Implant Devices"4416 Willow LaneDallas, TX 75244-7537