FDA Submits Proposal to Collect Information Regarding the Impact of Physical Differences in Generic Drug Pills on Medication Adherence

May 27, 2015

Topics: Medication Errors

Food and Drug Administration (FDA) has proposed a series of surveys to gather information on patient awareness about changes in the appearance of their medications, how often the change in appearance occurs, and what strategies pharmacists use to inform patients when these changes occur. The survey results will be used to inform the development of patient education about differences in pill appearance and the development of education for pharmacists on strategies to counsel patients when their medications change appearance, the agency notes in a Federal Register announcement. In 2014, FDA proposed a similar survey of patients and pharmacists to determine how the color, shape, and size of drug products affected patient adherence rates.

Generic drugs make up about 85% of human prescription drugs in the United States, according to FDA. “While generic drugs are required to be pharmaceutically equivalent and bioequivalent to their brand-name counterparts, generics made by different manufacturers may differ substantially from their brand-name therapeutic equivalents and from each other in their physical appearance (e.g., color, shape, or size of pills),” notes FDA. Electronic or written comments on the proposed survey may be submitted to FDA by June 15, 2015, by following the instructions in the Federal Register announcement.