Dental CE Course: Common Misconceptions with Bioequivalence and INterchangeability

Bioequivalence is a comparison of two or more products with respect to their bioavailabilities. Bioequivalence of trade and generic products or different dosage forms of the same product needs to be determined before the products can be legally interchanged. Numerous factors can affect bioavailability (and bioequivalence) determinations. Patient factors include variations in absorption power and the pH (or acidity) of the gastrointestinal (GI) tract, gastric emptying rate, intestinal motility, GI tract perfusion, first-pass drug metabolism, age, sex, weight, disease status and interactions with other substances including drugs and rather common food. Thus, there is a great potential for wide variability among the pharmacokinetic profiles among patient populations and bioequivalence determinations. As pharmacists and nurses, we are in an optimal position to prevent or intervene when a patient is experiencing drug-drug and drug-food interaction resulting in bioavailability alterations with outcomes including sub-therapeutic responses or adverse events. While product interchange between trade and generic medications or between dosage forms of the same product is typically not a problem, this activity is going to highlight some examples of when it is a concern.