A patient of mine was recently hospitalized for high blood pressure after missing his medications. I saw him in clinic a week later to discuss a workable plan. He explained to me how he avoided his current "white" blood pressure pill and would prefer using the "red" circular one instead. Talking to him helped me realize how he associated the shapes and colors of his pills with specific diseases — and how the consistency of their appearance was linked to his adherence.
While I love to take care of my octogenarian patients, I am constantly worried about their medications and, like other physicians, spend a considerable amount of time making sure my patients arrange pills in a designated box and have an easy schedule to follow. However, when patients are given a generic version of the same medication they're used to taking, they sometimes choose to avoid it because it looks unfamiliar. This unfortunately leads to hospital admissions, which, in addition to increasing health care costs, significantly affect their quality of life.
A link between change in medication dimensions and patient compliance and clinical outcomes has been noted in relation to heart disease and seizures. Yet it's remained an issue because of a legal restriction known as "trade dress." Trade dress means that a medication cannot be replicated in aspects that are identified by consumers to be linked to the original medication. Therefore a branded medication and its generic version look distinct by design; this principle extends to the shape, size and color of medications as well, as companies insist that color is a functional aspect of the original product.
The United States Supreme Court has held that color can be proprietary if it's associated with a particular brand — Viagra's little blue pill, for example. But in clinical practice, my patients often associate the color of their medications with their specific diseases, not the medication's brand. Therefore the statement made by pharmaceutical companies does not appear to hold true, but the FDA hasn't intervened, largely because not enough momentum has been generated to highlight this as a dire patient safety concern.
Most of health care is consumed by patients in the latter end of the age spectrum, and many of their hospital admissions have to do with their medications — side effects or non-adherence to dosage directions. Elderly patients often rely on consistency and repetition in their schedules due to memory loss and dementia. If the colors of medications keep shifting continuously they may not be able to keep up with these changes. This leaves them at high risk to frequently visit clinics and emergency rooms.
A multi-pronged approach will be required to remedy the situation. Behavioral change through patient education should be the first step that physicians take. Strengthening social support for our patients is the second step, but will vary from person to person depending upon their available network. The most important step, however, is lobbying for a minor change in the terminology of what trade dress entails to allow generic medications to look like those they copy.
Highlighting patient safety is the key to create this policy change. I cannot imagine how challenging it must be for my patient, who is suffering from dementia and heart disease, to feel lost and confused every day in a rainbow of pills. I worry that he may return to the hospital if he does not take the right medication.
Dr. Ali Thaver is an internal medicine resident at Johns Hopkins Bayview Medical Center; his email is firstname.lastname@example.org.