Can Generic Drug Appearance Impact Patient Adherence?
The FDA wants to know how patient perceptions of medications change when pharmacies switch from brand to generic drugs or from one generic to another, as in the case of a change in suppliers.
Changes in a drug’s size, shape or color can confuse patients and raise concerns about its safety and effectiveness, increasing the likelihood that they will stop taking the medication, the agency says. The FDA wants to understand what factors are most likely to trigger nonadherence and come up with ways to modify them.
To do this, the FDA plans to mail 2,161 questionnaires to pharmacists, asking how often they change suppliers and how they explain those changes to patients. The agency also plans to call patients 50 years and older who are taking drugs for diabetes, hypertension, epilepsy, high cholesterol, depression and HIV to get a sense of their beliefs about generic drugs, outcomes related to changes in appearance and how pharmacists alert them to changes.
Responses to the two surveys will be used to develop programs to educate patients on differences in pill appearance and pharmacists on counseling patients in these cases.
The FDA raised the prospect of the surveys last October. Patient perceptions of the effectiveness of generics were highlighted in the agency’s fiscal 2015 GDUFA regulatory sciences priorities.
Read the Federal Register notice at www.fdanews.com/05-15-15-patientadherence.pdf. — Lena Freund