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Module 2
Section 3 Generic products
Question | Answer |
---|---|
The generic name of a medication is often derived from which three factors? | The medication's chemical name, structure, or class |
Three reasons why generic medications are preferred by pharmacists | Saves patients money, helps the pharmacy to keep prescription prices competitive, and sometime required by third-party insurance programs |
Term for a medication that is available from more than one manufacturer | Multiple-source prduct |
Why are some medications not available as generics? | They are still protected under patents. |
What are three ways a prescriber can indicate on a prescription form that generic substitution is not allowed? | Dispense as written (DAW), Brand Medically necessary, No Substitution. |
FDA publication that serves as the basis for generic product evaluation and selection? | Orange Book (officially titled Approved Drug Products with Therapeutic Equivalence Evaluations) |
Which three criteria must generic medication manufacturers demonstrate in order to receive FDA approval? | The medication is pharmaceutically equivalent, therapeutically equivalent, and bioequivalent to the brand-name medication. |
Four factors required to demonstrate pharmaceutical equivalence | Same active ingredients, dosage form, route of administration, and strength. |
Which term describes medications that are pharmaceutical equivalents and have the same clinical effect and safety profile? | Therapeutic equivalent |
Which term describes medications that have different active ingredients but have similar clinical effects? | Therapeutic alternative |