The Food and Drug Administration is about to make changes to drug information — often filled with technical medical jargon — to help consumers understand the risks and benefits of the drugs they take. “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.
” The FDA has been working to change the information since the 1960s, but the drug and pharmacy lobbies helped Congress block changes in the mid-1990s that they said would be too hard to quantify and too expensive. But, “[l]ast 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” (Fulton, 8/17).
Also, “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. … 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” (8/16).