Prescription Labels Geared Toward Pharmacies, Not Patients

The Institute of Medicine estimates that 1.5 million medication errors occur each year in the United States and poor labeling is one cause of the mistakes. While the Food and Drug Administration has some standards on what prescription labels must include, few regulations guide the format of the information, said lead author William Shrank, M.D., of Brigham and Women's Hospital at Harvard Medical School

In the study, six pharmacies in four cities filled identically written prescriptions for four commonly prescribed medications. The pharmacies included the two largest chains, two grocery stores and two independent pharmacies.

Shrank, who is with the Division of Pharmacoepidemiology and Pharmacoeconomics, and colleagues evaluated 85 labels. The researchers found the pharmacy name or logo was the most prominent item on 84 percent of the labels, with an average 13.6-point font size. By comparison, the instructions averaged a 9.3-point size and medication names averaged an 8.9-point font. Warning stickers were in a much smaller, 6.5-point font on average.

"Medical education guidelines explicitly suggest that font size must be 12 point or larger to optimize patients' ability to read health information," according to the authors.

All of the labels listed the pharmacy name first, and instructions appeared fifth on 89 percent of labels. When color font or boldface was present, it was most often for pharmacy information rather than for instructions or warnings.

The authors suggest that one way to improve readability and patient understanding of labels is for FDA to initiate a national standard for their format and content -- much like it did with the "Nutrition Facts" labels required on food packaging.

"The FDA has attempted to improve drug labels on numerous occasions over the last three decades without much success," Shrank said. "However, I believe that the growing concern regarding prescription drug safety and the greater role of the government in paying for drugs since [the introduction of] Medicare Part D, may provide an environment conducive to policy change."

However, Jennifer Athay, a staff pharmacist with the American Pharmacists Association, said that it would be very difficult to have a federally mandated, standardized label required across the board.

"Logistically, there is no way to get all the information someone needs to know on a little prescription bottle or tube," she said. "Size tends to be an issue, so the complete information you need to know is dispensed in the extra paperwork you get from the pharmacists." She added that patients should ideally get detailed information when physicians first prescribe the medication to them.

Reference: Shrank WH, et al. The variability and quality of medication container labels. Arch Intern Med 167(16), 2007