FDA intends to survey pharmacists and patients to find out whether the shape, size, or color of a pill influences adherence to the prescribed dosing regimen. FDA previously issued a draft guidance recommending generic manufacturers make their pills look similar to the brand name drug, indicating its interest in how aesthetic changes in pill appearance are linked to health outcomes.
About 85 percent of all medications prescribed in the U.S. are generic drugs, and because generics are often treated interchangeably, the appearance of a patient's medication may change depending on the generic supplier.
According to the FDA information collection notice, "[s]tudies indicate that patients are more likely to stop taking their generic medications when they experience a change in their drugs' physical characteristics, leading to harmful clinical and public health consequences, as well as increased health care costs." FDA says it will ask pharmacists how often generic suppliers change and whether they employ strategies to help patients transition between pills with a different appearance. FDA will also poll patients, focusing on older adults with epilepsy, diabetes, hypertension, hyperlipidemia, depression, HIV, or combinations of these six conditions.
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