Community pharmacists' understanding and perceptions of FDA therapeutic equivalence standards

Background: Pharmacists need to demonstrate knowledge of and have confidence in Food and Drug Administration (FDA) therapeutic equivalence (TE) standards to improve acceptance of generic medicines amongst patients and other healthcare professionals. Objective: To evaluate community pharmacists' understanding, interpretation and perceptions of the FDA TE standards to identify if further education is needed on this topic. Methods: An anonymous, 13-item survey was piloted and then distributed by e-mail to a random sample of 287 Indiana community pharmacists. The 5-min survey included demographic, knowledge-based, and perception-based questions on FDA TE criteria that participants were given one week to complete. Participants completed the survey using a Web-based survey tool (Qualtrics). Results: 192 pharmacists completed the survey achieving a response rate of 66.9%. Only 7.3% of respondents correctly identified FDA bioequivalence criteria for approval of generic drug products. Two questions presented TE codes from the Orange Book and asked respondents to identify if a pair of drug products were therapeutically equivalent: 62.6% and 61.0% of respondents answered correctly. However, 89.4% of respondents correctly indicated that the Orange Book is the location of FDA TE evaluations. 74.9% of responding pharmacists indicated a positive perception of the rigor of FDA approval standards associated with generic medications and 66.0% believed that generic drug products made by different manufacturers are of similar quality. Conclusions: The results suggest that community pharmacists need additional education on the interpretation of TE codes and FDA bioequivalence criteria for approval of generic drug products. The safety and efficacy of generics are often questioned by patients and physicians. It is important for pharmacists to be knowledgeable of FDA TE standards as they are experts in medicines and need to be confident with the criteria to effectively convey them to patients and healthcare professionals.