A medication's color and shape may be more than a trademark. A study published in the Archives of Internal Medicine Monday indicates that they may also play a role in adherence, as patients are less likely to stick to their medication regimens if the generics don't match that of a branded version, or are uniform within the generic category.
The study notes that the FDA doesn't require bioequivalents to have a uniform look, and that trademark concerns may also keep generics from appearing like “me-too” versions of the branded versions.
The test case in this study were anti-epileptics, and focused on eight drugs that met three criteria: they were approved to treat seizures, were pills and had at least one branded and one generic version during the five-year study. Among the findings: the test meds had 37 different colors and four different shapes during the study, and when patients fell off their medication regimens it was usually when their medications no longer looked like they used to.
The researchers concluded that a visual shift in the color of the “right” medicine could contribute to lack of medication adherence, and that when the shape changes, that could also bias patients into thinking that generics are not as good as branded drugs.
Missing, however, is the evaluation of the drug marketing itself, which cautions patients to stay consistent with their medications and urges vigilance in identifying the drugs they are taking. Epilepsy patients are encouraged not to change their seizure medications if things are going well. This message is of particular conflict when a patent is expiring, since the financial ideal would be to transition patients from an expiring drug to a new one.
This reporter's personal experience as a copywriter makes that point plain -- when working on an account in which a client had an new epilepsy medication that could be pitched to the same audience as the patient pool taking an older medication, the direction from the drugmaker was unequivocal: do not encourage jumping. It's not good for patients. Work on the older drug, which was done concurrently with the pitch for the newer one, reinforced this point.
Patient testimonials used in work for the older drug had a round table-like setting in which patients or their caregivers talked about changing medications. Among the stories were that some of them had had the patient medications swapped for a generic without their knowing. Possible causes include lack of a Dispense As Written directed from the doctor which would require the branded drug, or because a doctor changed the medication without informing the patient. In either case, the advocates said patients had unwittingly taken the alternate medication and only discovered there had been a change because they began having seizures. The client result: adherence copy that stressed checking medications to ensure it was the same medication every time and to change medications only after speaking with a physician.
Researchers sideswipe this knowledge by noting observational studies have shown generic anti-epileptics “may not have the same clinical effects as their brand-name counterparts,” only to be countered by studies that show the exact opposite. But this leaves out the marketing component, which stresses consistency and messaging indicating that patients should be suspect of changes in their medications.