Published August 16, 2010
The information leaflets pharmacies give to customers along with their prescriptions vary widely in their content, and may often be difficult for people to read and understand, according to a new study.
The findings, researchers say, argue for a standard approach to generating the pharmacy leaflets, including oversight by the U.S. Food and Drug Administration (FDA).
As it stands, the information on prescription-drug labels is regulated by the FDA, but the information leaflets dispensed by pharmacies are not. Private publishing companies provide the content for the leaflets, and then pharmacies — or their computer software vendors — determine the formatting of the leaflets, which includes picking and choosing what drug information to include or leave out.
As a result, leaflet information about the same drug, provided by the same publisher, can vary widely from pharmacy to pharmacy, explained Dr. Carole L. Kimberlin, one of the researchers on the new study.
In their study, Kimberlin and her colleagues at the University of Florida, Gainesville, found a "great deal of variance" among leaflets for two common drugs — the blood-pressure drug lisinopril (Prinivil, Zestril) and the diabetes medication metformin (Glucophage, Fortamet and others) — dispensed at 365 U.S. retail pharmacies.
The leaflets ranged in word count from about 30 to 2,500 — with, not surprisingly, the longer ones being most likely to contain all the information that is recommended by the FDA. (Though the agency has no power to regulate the leaflets, it has set a guidance document with standards that all pharmacy medication leaflets should strive to provide.)
But even though the longer leaflets provided more information, few came close to meeting all of the FDA standards. Three percent of lisinopril prescriptions came with leaflets that met at least 80 percent of the "usefulness criteria" the researchers adapted from the FDA standards; the same was true of just one metformin prescription.
In general, Kimberlin told Reuters Health, the biggest shortcoming was in the leaflets' readability. On average, leaflets from all pharmacies met less than half of the criteria for "comprehensibility/legibility."
For example, Kimberlin said, the content should be written at sixth- to eighth-grade reading level, but only 10 percent of lisinopril and 6 percent of metformin leaflets met that standard.
Too-small fonts, large blocks of text with little white space between lines, and general clutter — many leaflets also contained ads or store coupons, for example — were other issues with formatting, the study found.
"There was a lot of distracting information," Kimberlin said, noting that this makes it more difficult for consumers to dig out the key points on the safe and effective use of the drug.
Important information was also sometimes entirely absent. For example, although about 90 percent of the leaflets provided all the serious side effects of the two drugs, nearly one-third of metformin did not mention the potential for drug-drug interactions.
According to Kimberlin and her colleagues, the findings point to a need for uniform consumer medication information, with "explicit guidance and regulatory authority through the
Back in 1995, the FDA was poised to do that, but Congress stopped the agency from taking that authority. The current findings, Kimberlin's team writes, indicate that "private sector initiatives to provide useful (consumer medication information) have failed."
For now, consumers can take their own steps to make sure they have the key information they need for any new prescription. Basically, Kimberlin said, they need to ask their doctors and pharmacists questions.
"Make sure you know what the drug is for, and how to take it," she advised.
That, Kimberlin noted, includes knowing whether the new prescription is safe to take along with any other products a person may be using — including over-the-counter medications and herbs or other "alternative" remedies.
She said that patients should also be aware of a drug's potential side effects and what to do if they arise, as well as how to monitor their new medication's effectiveness.
With lisinopril and metformin, for example, at-home blood pressure checks and blood sugar monitoring, respectively, will help patients and their doctors know whether the drugs are working.