We’ve all had the experience when we’ve been prescribed a drug and then been given a pamphlet at the pharmacist’s explaining all the important things we should know about taking the drug. Unfortunately, these information leaflets can vary widely in their content, and may often be difficult to read and understand.
The information on prescription-drug labels is regulated by the FDA, but the information leaflets dispensed by pharmacies are not. Private publishing companies usually provide the content for the leaflets, and then pharmacies pick and choose 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, as researchers found in a recent study.
Scientists at the University of Florida, Gainesville, looked at leaflets that ranged in word count from about 30 to 2,500. The longer leaflets were most likely to contain all the information that is recommended by the FDA. But even though the longer leaflets provided more information, few came close to meeting all of the FDA standards. Only three percent of one prescription drug came with leaflets that met at least 80% of the “usefulness criteria” the researchers adapted from the FDA standards.
The research team also found that important information was sometimes entirely absent. For example, although about 90% of the leaflets provided all the serious side effects of two particular drugs, when it came to a third drug, nearly one-third did not mention the potential for drug-drug interactions.
In general, the biggest shortcoming in the leaflets was readability. On average, leaflets from all pharmacies met less than half of the criteria for comprehensibility/legibility. For example, the content should be written at sixth- to eighth-grade reading level, but only 10% of one drug’s leaflets and six percent of another 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.
The researchers are concerned that, when there is a lot of distracting information, it makes it more difficult for consumers to dig out the key points on the safe and effective use of the drug. They concluded that the findings point to a need for better and more consistent medication information — preferably regulated by the FDA.
For now, you can take your own steps to make sure you have the key information you need for any new prescription. Keep in mind that this may mean asking your doctor and/or pharmacist questions. At the very least, make sure you know what the drug is for, and how to take it. You should also know about possible interactions with other drugs/herbs that you are taking.