Pharma, Patient Engagement

FDA studying how generics’ size, shape and color impact medication adherence

The FDA is studying whether generic pill size, shape and color impact patient adherence.

When it comes to medication adherence, issues like side effects, cost and ease of intake are most commonly cited issues for noncompliance. But what about the drug’s appearance?

The Food and Drug Administration is studying how a drug’s color, shape and size impact a patient’s likelihood to remain on a treatment regimen, Alexander Gaffney of RAPS reports.

The agency just approved a new study, called “Pharmacists and Patients; Variations in the Physical Characteristics of Generic Drug Pills and Patients’ Perceptions.” The FDA writes:

When pharmacists switch generic drug suppliers, patients refilling their generic prescriptions may therefore experience changes in their drugs’ appearances. These changes may result in patient confusion and concerns about the safety and effectiveness of the generic drug products. 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.”

Gaffney explains why such a study’s actually meaningful:

For certain physical attributes, this line of thinking makes a certain amount of sense. If a patient if used to taking a brand-name drug that’s the size of a piece of M&M candy, and is then switched to a generic drug the size of a marble, the patient might find it more difficult to take the drug, and might even stop taking it altogether.

The FDA adds that varying the pill appearance might not only impact patient compliance, but also lead to medication errors. Gaffney adds that while the FDA can’t really control a generic’s appearance, thanks to trademarks already in place by manufacturers,  but it can help inform “strategies that pharmacists use to inform patients when the appearance of their medications change.”