MPJE Drug Substitution and Generic Drug Laws 2

Question 1

ANDA is the abbreviation for:

Accepted Answer

Abbreviated New Drug Application

Answer

Approved New Drug Authorization

Answer

Alternate New Drug Approval

Answer

Advanced New Drug Assessment

Question 2

A 'B' rating (e.g., BX, BN) in the Orange Book indicates that the drug product:

Accepted Answer

Is not currently considered therapeutically equivalent to other products with the same active ingredient

Answer

Is therapeutically equivalent and freely substitutable

Answer

Is a single-source brand with no generic available

Answer

Has received accelerated approval from the FDA

Question 3

Therapeutic substitution differs from generic drug substitution because therapeutic substitution:

Accepted Answer

Involves replacing the prescribed drug with a chemically different drug that has similar therapeutic effects

Answer

Involves dispensing a different manufacturer's version of the same chemical entity

Answer

Is permitted without prescriber authorization in most states

Answer

Requires less regulatory oversight than generic substitution

Question 4

Under most state drug product selection laws, when a pharmacist substitutes a generic drug, the patient must be:

Accepted Answer

Notified of the substitution and given the opportunity to request the brand-name product

Answer

Automatically charged the same copay as the brand-name drug

Answer

Required to sign a written consent form prior to dispensing

Answer

Provided a written statement from the prescriber approving substitution

Question 5

The 'first-to-file' provision of the Hatch-Waxman Act rewards the first generic manufacturer to challenge a brand drug patent with:

Accepted Answer

180 days of marketing exclusivity before other generics may enter the market

Answer

Permanent patent rights over the generic formulation

Answer

Automatic FDA approval without bioequivalence testing

Answer

A 5-year data exclusivity period

Question 6

Narrow therapeutic index (NTI) drugs require special consideration during generic substitution because:

Accepted Answer

Small differences in blood drug levels can result in therapeutic failure or serious toxicity

Answer

They are always more expensive than other drug products

Answer

They require a DEA registration number for dispensing

Answer

They are excluded from the Orange Book rating system

Question 7

A prescriber who wishes to prevent generic substitution should write which of the following on a prescription?

Accepted Answer

DAW or Brand Medically Necessary

Answer

Generic Acceptable

Answer

Formulary Substitution Permitted

Answer

May Substitute Equivalent