COMMENTS AND RESPONSES Burden of Changes in Generic Pill Appearance TO THE EDITOR: There are many reasons for patient nonadherence

Abstract

to a prescribed therapeutic regimen. Kesselheim and colleagues (1) identify an important contributor: variability in the appearance (for example, shape, color, and size) of tablets. We realize that changes in pill appearance and packaging can contribute to patient nonadherence, and the U.S. Food and Drug Administration (FDA) has published draft guidance addressing certain aspects of these concerns (2–4). Because generic drugs currently represent nearly 85 % of pre-scriptions dispensed, patients will continue to experience changes in pill appearance as economic forces lead to product turnover in phar-macies and mail-order houses. These points of distribution may not carry the same manufacturer’s generic product between the time of initial dispensing and refill. In addition, appearance changes are not just an issue with generic drugs; brand-name drugs sometimes have postapproval manufacturing changes that affect patient acceptance. For example, in 2007, Dilantin (Pfizer) was changed from a whit