One of my friends, Dr. Aaron Kesselheim, at Brigham and Women’s Hospital and Harvard Medical School recently reported that patients seem less likely to take their medications if the pill color changes between prescriptions, which can happen when switching from a brand name to generic drug, says a new study. Currently, the U.S. allows cheaper generic drugs to be sold to patients after a brand-name counterpart’s market exclusivity ends. The U.S. Food and Drug Administration (FDA) states that generic drugs must be essentially as effective as the brand-name drugs, but may be different colors, shapes and sizes. One reason for the same drug having different appearances is that brand-name manufacturers may claim legal ownership of their drugs’ physical appearances.
That confusion may lead to patients being unsure about their medications and end with them not taking the drugs.
The researchers used a national database of medical claims from the early 2000s to compare people who got their seizure drugs refilled on time to those who did not.
Overall, they had information on about 61,000 people who were taking one of eight drugs, which were offered in 37 colors and four shapes.
The researchers found that changes in pill color between prescriptions rarely occurred, but there was a difference between those who filled their orders and those who did not.
Of the approximately 11,500 people who did not fill their prescriptions, 1.2 percent had their drugs change color. That compared to 0.97 percent of people who got their prescriptions filled on time. Not very impressive numbers but with the millions of elderly patients, the impact can be significant.
Dr. Kesselheim points out that if patients are taking nine medicines, they get at least 36 ‘opportunities’ a year to experience a color change. This seemingly small risk then starts to appear very substantial. A patient taking five medicines twice a day, each produced by five different generic manufacturers, theoretically the patient faces over 3,000 possible arrays of pill appearances a year for what are, chemically and clinically speaking, the same drugs.
Perhaps equivalent generic medicines should be required to look like their brand-name counterparts. Dr. Kesselheim said that until there is a better solution, it’s important for patients to know that a pill’s clinical impact doesn’t change just because it looks different.
SOURCE: http://bit.ly/W1EWU3, and JAMA Internal Medicine, online December 31, 2012.