A new study analyzes the impact of changes in the shape and color of pills on patient adherence to drug regimens. Following a group of patients who were hospitalized with heart attacks and began a cardiac drug regimen upon discharge, the study calculated instances of medication non-persistence and changes in pill color and size. Overall, the authors found that the odds of non-persistence increased by 34% after a change in pill color and 66% after a change in pill shape. For patients taking drugs that have multiple generic versions, these findings could have serious implications for medication adherence and health outcomes.
As discussed in a previous blog post, the FDA has issued draft guidance recommending that generic drug manufacturers adopt similar dimensions and volume as the reference listed drug (the guidance does not cover pill color). Urging generic manufacturers to use similar physical attributes as the brand could help patients adhere to drug regimens, but could could also lead to trademark disputes that would delay generic competition.