Drug Substitution and Generic Drug Laws Flashcards
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ANDA is the abbreviation for:
Answer: Abbreviated New Drug Application
ANDA stands for Abbreviated New Drug Application, the regulatory pathway generic manufacturers use to obtain FDA approval without conducting full clinical trials.
A 'B' rating (e.g., BX, BN) in the Orange Book indicates that the drug product:
Answer: Is not currently considered therapeutically equivalent to other products with the same active ingredient
A 'B' rating indicates FDA does not currently consider the product therapeutically equivalent to other drugs with the same active ingredient due to actual or potential bioequivalence issues.
Therapeutic substitution differs from generic drug substitution because therapeutic substitution:
Answer: Involves replacing the prescribed drug with a chemically different drug that has similar therapeutic effects
Therapeutic substitution replaces a prescribed drug with a chemically different entity having similar therapeutic effects, whereas generic substitution replaces it with the same chemical entity from a different manufacturer.
Under most state drug product selection laws, when a pharmacist substitutes a generic drug, the patient must be:
Answer: Notified of the substitution and given the opportunity to request the brand-name product
Most state laws require pharmacists to notify patients of generic substitution and offer them the option to receive the brand-name drug, protecting patient autonomy.
The 'first-to-file' provision of the Hatch-Waxman Act rewards the first generic manufacturer to challenge a brand drug patent with:
Answer: 180 days of marketing exclusivity before other generics may enter the market
Under Hatch-Waxman, the first generic manufacturer to file a Paragraph IV patent certification receives 180 days of marketing exclusivity as an incentive to challenge brand drug patents.
Narrow therapeutic index (NTI) drugs require special consideration during generic substitution because:
Answer: Small differences in blood drug levels can result in therapeutic failure or serious toxicity
NTI drugs have a narrow margin between therapeutic and toxic blood concentrations, meaning even minor bioequivalence differences can have significant clinical consequences.
A prescriber who wishes to prevent generic substitution should write which of the following on a prescription?
Answer: DAW or Brand Medically Necessary
Writing 'DAW' (Dispense as Written), 'Brand Medically Necessary,' or 'No Substitution' instructs the pharmacist to dispense the specific brand-name product without generic substitution.