FDA Studies Role Of Shape, Color, And Size In Drug Regimen Adherence

In an ongoing study of generic drug adherence, the FDA will be studying the role of color, along with a pill’s other physical attributes, to ascertain if changes in a drug’s appearance affects patient’s confidence in continuing treatment, according to Regulatory Affairs Professionals Society (RAPS).

Unless a prescriber indicates otherwise, pharmacies are free to issue generics to patients, and while the FDA carefully evaluates chemical or bio-equivalency and efficacy, there are no rules set in place which mandate that the drug must look exactly like the generic’s brand-name counterpart.

Last year, the FDA issued a non-binding guidance, which suggested that changes in drug appearance, color, size, or shape could affect whether or not a patient continued their treatment. For instance, a generic pill that was much larger and harder to swallow might make a patient reluctant to continue with it. Even less obvious changes in appearance, the FDA found, had an effect on patient’s confidence.

"Studies indicate that patients are more likely to stop taking their generic medications when they experience a change in their drugs' physical appearances, leading to harmful clinical and public health consequences, as well as increased health care costs from avoidable morbidity and mortality," FDA explained.

RAPS pointed out that the original guidance didn’t go into great detail about color — a specific focus the FDA now wants to address.

According to Tessa Cohen, writer for The Atlantic, multiple trials have found that color plays a role in the efficacy of a treatment. Specific colors are chosen based on what condition the pill is indicated to treat. Yellow is a popular color for anti-depressants, blue for sedatives, and red or orange for stimulants.

Furthermore, changes in color or other aspects of appearance are often frustrating and confusing for patients. A study conducted last year at Brigham and Women’s Hospital (BWH) found that patients given a different color drug from what they’re used to taking are 50 times more likely to stop taking it.

The FDA plans to conduct multiple surveys of both pharmacists and patients.

According to RAPS, the pharmacy surveys will ask what effort is made to inform patients about color changes in order to ease their transition to a new generic. These surveys will also ask how often pharmacies change generic suppliers.

One patient-focused survey will poll patients over 50 who are receiving treatment for epilepsy, diabetes, hypertension, hyperlipidemia, depression, HIV, or combinations of these conditions. Another survey will poll patients whose pills have changed in appearance and monitor their impressions.