Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

To be considered a therapeutic equivalent, a drug must be...

1. Only pharmaceutically equivalent

2. Pharmaceutically equivalent and bioequivalent

3. A unique formulation

4. Approved through a new drug application

The correct answer is: Pharmaceutically equivalent and bioequivalent

To be deemed a therapeutic equivalent, a drug must be both pharmaceutically equivalent and bioequivalent. Pharmaceutical equivalence means that the drugs contain the same active ingredients, are of the same dosage form, and meet identical strength or concentration specifications. Bioequivalence, on the other hand, means that the drug's absorption, distribution, metabolism, and excretion in the body are comparable to the reference product; this ensures that the therapeutic effects of the drugs will also be similar when administered to patients. In essence, even if two drugs are formulated similarly, without proving that the bioavailability (the degree and rate at which the active drug ingredient is absorbed and becomes available at the site of action) is the same, they cannot be categorized as therapeutic equivalents. This distinction is vital in pharmacy practice as it directly impacts decisions made regarding drug substitution and patient care. The other options do not encompass both required criteria for therapeutic equivalence. Merely being pharmaceutically equivalent does not ensure similar efficacy and safety in clinical use without bioequivalence. Unique formulations or drugs that have gone through new drug applications may not align with established therapeutic equivalence principles unless they meet the defined criteria of both pharmaceutical and bioequivalence.