The little white bag you get from the pharmacy that holds your medicine often comes with an attachment. It's a flier that's supposed to give you information about your drug. It tells you what it's called, how to take it and what problems might arise.
The trouble is, it's often several pages long -- and filled with technical medical jargon and legal-speak.
Sometimes you can't find where the most important information is, so a lot of people wind up just chucking it in the trash.
The Food and Drug Administration is about to make some changes.
Joe Graedon, a pharmacologist who runs a website called the People's Pharmacy, helps people get information about drugs. He says there are only a few key things people really need to know.
Things like how to take the drug, and "What are the most common side effects? What are the symptoms to be looking for? And then, you know, what should you do if they happen?" he says.
He doesn't put much stock in the leaflets because they're inconsistent. Even when they're supposed to be about the same drugs, he's heard from patients that they can be confusing.
"When we began to hear that certain medications -- for example some statin-type drugs like maybe Lipitor or Zocor -- could interact with grapefruit juice, there was a tremendous amount of confusion," he says.
At the time, some of these leaflets told consumers who were taking these drugs that they should avoid grapefruit juice. But some told people to wait 24 hours between drinking the juice and taking the drug, he says. Some didn't say anything at all.
A critical element of drug safety is safe use — of using it properly. And without appropriate information, a patient may not be able to do that.
Both Content And Format Inconsistencies
It's not just contradictory information. A more basic problem with the leaflets is length.
University of Florida professor Carole Kimberlin worked with colleagues to sample leaflets from some 400 pharmacies across the country recently at the request of the FDA. They found wide differences.
"Some of them were as little as 30 words, while others were over 2,500 words," she says.
Even when the leaflets contain the right information, patients often have to search with a magnifying glass to find the important stuff, she says. Less than a third of the fliers in the study used a standard 10-point type. Some of them used 6-point type or smaller, Kimberlin says.
"I had difficulty reading it," she says.
And that can be frustrating, says Rachel Behrman, the FDA's deputy director in the medical policy office in the agency's drug center. "I'm sure you've had the experience of picking up something for yourself or for a family member and getting very, very tiny type and run-on sentences and so forth," she says.
The University of Florida study showed that while 94 percent of patients are getting written information with their prescriptions, only 75 percent of them are getting information that's considered useful.
That study was published in the Archives of Internal Medicine this month.
Those results are slightly better than a study the FDA commissioned in 2001, in terms of content. But the overall formatting and readability of the leaflets have decreased since then.
Voluntary Efforts
It's a complicated issue, and the FDA has been working since the late 1960s on ways to improve the information patients get about their drugs.
It proposed a Medguide regulation in 1995 that would have required manufacturers to provide certain information for patients if the drugs posed a "serious and significant public health concern."
Under pressure from the drug industry and pharmacies, who said those rules would be hard to quantify and too expensive to implement, Congress blocked the FDA's efforts in 1996. Instead, Congress told the agency to oversee a voluntary private-public sector agreement on principles for good drug information, and conduct studies to assess how well it was working.
Groups like the National Council on Patient Information and Education began hosting meetings to hash out voluntary standards.
But Behrman says now, 14 years later, it's time to admit that voluntary efforts aren't working. People are confused, and it's time to try something new.
"The Medguide experiment, I like to say, is a spectacular failure," she says.
A Path To Change
Last year, the agency began work on a new rule to standardize the patient leaflets -- and combine all the various printed information patients get now into one single document.
Behrman is confident that political times, and technology, have changed to make it easier to do. The new and improved leaflets can suggest online links, for example, for people who want more information.
There's lot at stake, she says. Medication errors injure about 1.5 million people a year in the U.S. and cost billions of dollars, according to the National Academies of Sciences.
"A critical element of drug safety is safe use -- of using it properly. And without appropriate information, a patient may not be able to do that," she says.
A major provider of patient medical data, the American Society of Health-System Pharmacists, takes issue with the Florida study, and with the idea of a regulation replacing voluntary efforts.
Gerald McEvoy, ASHP's assistant vice president for drug information, says that the issue is more complex than FDA says.
Part of the complexity stems from how the patient information is generated. There are many overlapping layers. Drug companies, data providers and pharmacies are all involved at various stages of development.
"I think everyone would agree there are issues with what patients are or are not receiving in the retail pharmacies when they pick up their prescription," he says.
But he doesn't think a new FDA rule will solve the problems. He thinks that the drug industry will fight every word of the requirements in the new documents and drag the process out. The best approach is to keep working on meeting voluntary standards and getting more clear guidance from the agency, McEvoy says.
Meanwhile, FDA's Behrman says the agency will continue to work with all interested parties to make patient information more user-friendly -- but they are pursuing explicit authority to make them do it.
For now, patients should use the leaflets and talk to their doctors and pharmacists, researcher Kimberlin says. Especially if they feel like something's wrong.
"Rather than just saying, 'Well, I'll just see if it gets worse,' or, you know, 'I'll wait a while, maybe next time I'll go in, I'll ask' -- don't do that. Call them," she says.
Copyright 2022 NPR. To see more, visit https://www.npr.org. 9(MDAzMjM2NDYzMDEyMzc1Njk5NjAxNzY3OQ001))
