How Do Generic Drug Appearances Affect Patient Adherence?

Could changes in the physical attributes of generic drugs affect patient adherence? The FDA seeks to survey pharmacists and patients to find out.

The proposed surveys would examine how patients adhere to existing treatment when pharmacists change generic drug suppliers, which could in turn alter a medication’s color, shape, and size.

“The purpose of these surveys is to gather information on the awareness of patients and pharmacists about changes in the appearance of medications, the frequency with which changes in appearance occurs, strategies that pharmacists use to inform patients when the appearance of their medications changes, and the outcomes associated with these strategies,” the FDA wrote in response to a related public comment.

The agency clarified that the survey results will not be used to “require the generic industry [to] change the appearance of their medicines,” but instead “inform the development of patient education about differences in pill appearance and inform the development of education for pharmacists on strategies to counsel patients when the appearance of their medications changes.”

The FDA pointed out that previous studies have indicated patients are more likely to stop taking their generic medications when their drugs' physical attributes change.

One empirical analysis published in the July 15, 2014, issue of the Annals of Internal Medicine looked at more than 10,000 patients who recently experienced a heart attack and found differences in drug appearance were associated with greater nonadherence to vital cardiovascular treatment.

In fact, a change in drug shape increased the likelihood that a patient would not refill his or her prescribed medication by 66%, while a change in drug color increased those chances by 34%.

For its proposed study, the FDA plans to ask a national cohort of pharmacists about “the frequency with which their pharmacy changes suppliers that lead to variations in the appearance of the generic drugs that they dispense, as well as strategies they use with patients to address the transition to pills that have a different appearance.”

Pharmacists will also be surveyed about “how often patients report confusion about pill appearance, and how often patients ultimately refuse to accept the new product.”

The Office of Management and Budget is reviewing the FDA’s proposed “Survey of Pharmacists and Patients; Variations in the Physical Characteristics of Generic Drug Pills and Patients’ Perceptions,” which has a comment period that ends on June 15, 2015.

The FDA has been investigating this topic for several years. In December 2013, it released a draft industry guidance document on the subject.