Health

Pharmacy Leaflets

By CBSNews.com staff CBSNews.com staff

January 31, 2002 / 8:41 AM EST / CBS

Depending on your pharmacy for information on the side effects and potentially deadly interactions of prescription medications could be putting your life in jeopardy. More than 10,000 Americans die annually from adverse drug reactions, prompting critics to charge that the printed handouts that accompany prescription medications are largely unregulated and may not be reliable.

"It's a leap of faith because we don't know whether that piece of paper is accurate or not," says Arthur Levin, a consumer advocate with the Center for Medical Consumers.

Levin says that, with rare exceptions, patient information about more than 10,000 prescription medicines does not come from the FDA or directly from drug manufacturers. Unlike the detailed inserts which manufacturers put in their packaging, which is generally considered reliable, the short leaflets that pharmacies attach to prescription orders are written by private publishing houses who sell the information to pharmacies.

Larry Sasich of the advocacy group Public Citizen says there are glaring holes in the system. A leaflet analysis by his group turned up a number of what he terms dangerous omissions or misleading information.

One example is a recent leaflet on the osteoarthritis drug Celebrex. The leaflet warns that Celebrex "could cause stomach bleeding," but the warning from the manufacturer is much stronger, saying 1 to 4% of patients can experience serious complications, including perforation of the stomach or intestines. The leaflet makes no mention of that.

By law, pharmacists in 42 states, including New York and New Jersey, are required to discuss medications with customers, but some pharmacists are too busy to counsel everyone, and doctors usually provide only basic information. As a result the questionable leaflet may sometimes be the sole resource a patient has.

Sasich says that for 30 years pharmaceutical companies and trade organizations representing pharmacies have systematically blocked tougher laws, adding that drug companies and pharmacies believe they'll lose money if patients are scared off by longer lists of drug warnings.

"It's outrageous when we see that groups that represent health professionals have been such roadblocks," he says.

The publishers maintain their information is accurate and comprehensive and critics acknowledge some of it is, but because there's no oversight, there's no way to tell.

According to one publisher, the information in their leaflets is written by pharmacists and medical writers and approved by a physician. They say it comes directly from manufacturer data and published medical journals. But the company admits that most information packages pharmacies buy are updated just once every 3 months, which means critical warnings might not reach the patient on time.

"People don't understand the enormity of the risk," Levin, the consumer advocate, says.

The FDA is in the process of conducting a year-long nationwide surve on the quality of patient information leaflets.

Here's how you can protect yourself:

Always talk to your pharmacist about your prescriptions, even if it means waiting in line.

Ask for a package insert from the drug manufacturer. That's the blue sheet with the tiny writing. It lays out the risks in detail.

Refer to the Physicians' Desk Reference (PDR) guide at the library or consult the PDR or FDA Web site.