Color of generic drugs may affect medication adherence

Changes in tablet color significantly increase the odds that patients will stop taking their medications, according to a study published online first Dec. 31, 2012, in JAMA Internal Medicine (formerly known as the Archives of Internal Medicine).

Aaron S. Kesselheim, MD, JD. MPH, lead author with Brigham and Women's Hospital and Harvard Medical School, and colleagues, wanted to determine whether switching among different-appearing antiepileptic drugs (AEDs) is associated with increased rates of medication nonpersistence (failing to fill a prescription within 5 days of the elapsed days).

"Our study supports a reconsideration of current regulatory policy that permits wide variation in the appearance of bioequivalent drugs," Dr. Kesselheim wrote.

The researchers reviewed the cases of 11,472 patients with nonpersistence after switching to different-appearing antiepileptic drugs (AEDs).

The AEDs dispensed included 37 different colors and four shapes. Color discordance preceded 1.2% of the cases, and shape discordance preceded 0.16% of the cases. Within the seizure disorder diagnosis subgroup, the risk of nonpersistence after changes in pill color was also significantly elevated.

In an accompanying editorial, FDA officials said that the agency is working on the challenges with generic drugs, including the variance in colors and shapes. Generic drug manufacturers need to "consider pill size, shape, and color with more consistent regard, not only for proprietary issues but also for the information we are gaining concerning the realities of patient use," wrote Lawrence X. Yu, PhD, and Gregory P. Geba, MD, MPH, of FDA's Office of Generic Drugs.

In addition, healthcare providers "will need to educate patients more effectively about generic drugs and must foresee possible patient concerns over product appearance," Drs. Yu and Geba wrote.

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