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Pill Appearance Key to Patient Compliance

By BiotechDaily International staff writers
Posted on 31 Jul 2014
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SARTORIUS AG
Heart attack patients are 30% more likely to discontinue generic cardiovascular medications if their pills change in color or shape, according to a new study.

Researchers at Brigham and Women's Hospital (Boston, MA, USA) conducted cohort and nested case–control studies to determine whether nonpersistent use of generic drugs among 11,513 patients with cardiovascular disease (CVD) after myocardial infarction (MI) is associated with inconsistent appearance of their medications. Study patients were those who discontinued their index medication for at least one month, while control patients continued treatment uninterrupted. Rates of changes in pill color and shape during the year after MI were calculated, and the odds of discordance among case and control patients were compared.

The results showed that 29% of the patients had a change in pill shape or color during the study, correlating with a total of 4, 573 episodes of non-persistence. Statins had the most changes in appearance, whereas β-blockers had the fewest. The researchers found that the odds of nonpersistence in case patients increased by 34% after a change in pill color and 66% after a change in pill shape. Further adjusting the odds ratios for pharmacy changes or use of a mail-order pharmacy did not change the statistically significant associations with nonpersistence, except for color alone. The study was published on July 14, 2014, in Annals of Internal Medicine.

“Some pharmacies do alert patients to changes in medication appearance by placing a sticker on the container. But pill bottles can have so many stickers that the message might be missed,” said lead author Aaron Kesselheim, MD. “Patients need to know that it's common for generics to change their appearance, and that doesn't mean they're working any differently. If patients are concerned by a shift in their medication's shape or color, they should call their doctor or pharmacist rather than just abandoning the drug—even for a short time.”

Currently, the US Food and Drug Administration (FDA) do not interfere with the visual appearance of drugs, which are considered a form of intellectual property. However, the US Supreme Court ruled in 1995 that if the color of a medical pill served a specific function, then competitors were allowed to copy it.

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