Brand-name drugs come in distinct colors, but their generic equivalents often come in different colors, depending upon the manufacturer. And that may affect whether or not a person takes the medication, according to a pilot study.
Researchers at Brigham and Women's Hospital in Boston found that patients are up to 50 percent more likely to stop taking a generic medication if its color differs from that of its brand-name cousin. Generic drugs account for an estimated 70 percent of all prescriptions filled in the U.S.
"Changes in the physical appearance of pills may be causing some confusion among patients," said study author Dr. Aaron Kesselheim, assistant professor of medicine at Harvard Medical School. "In talking with my patients, this issue comes up a lot. They don't understand why their pill looks different."
Failure to take a prescribed medication — a behavior known as non-adherence — costs $290 billion annually in additional health complications, according to the New England Healthcare Institute, a nonprofit think tank. In the U.S., experts estimate that a third to a half of all treatment failures can be linked to drug non-adherence by patients resulting in an additional 183 million doctor visits each year.
The study researchers examined a large national database of prescriptions filled for Blue Cross/Blue Shield patients across the country. The researchers focused on a group of drugs used to treat epilepsy and seizures, because skipping the medication for even a day can be harmful. The seven different types of antiepileptic drugs on the market are available in a total of 37 colors. The colors of brand-name and generic pills within the same family can differ, but so can the colors of generic drugs that have the same function.
The study focused on 11,472 patients who hadn't refilled their generic drug prescription for up to 10 days. The researchers compared these delinquent patients with 50,050 patients who refilled their generic prescriptions regularly. Patients whose medication had changed color were 27 percent more likely not to refill it than were people whose pill color hadn't changed. More than half of patients diagnosed with epilepsy did not refill their drug prescriptions if the pill color had changed.
"Pill color is one of the things that policymakers should look at when they're trying to figure out ways of addressing this epidemic of non-adherence," Kesselheim said.
The study had limitations. The researchers examined only antiepileptic drugs, which aren't as widely used as other medications. Also, the researchers didn't determine whether the color changes affected the health of patients.
According to the U.S. Food and Drug Administration, brand-name and generic drugs don't have to look alike because the appearance of a pill has no effect on its clinical function. However, "we show a clear functionality to the color of the pill," Kesselheim said, referring to the role the pill color plays in prescription refill rates. "Whether the FDA should reconsider the fact that it doesn't mandate generic and brand-name drugs to look alike is an important societal level issue to come out of this research."
Physicians and pharmacists should do a better job of letting patients know that generic drugs and their brand-name cousins may differ in color, and reassure patients that this won't change how the drug works in the body, he said.
The study appears online Dec. 31 in the journal the Archives of Internal Medicine.