law 5b

as a practical matter, generic drugs marketed ________1984 and approved under an ANDA/SNDA should have _____rating because the drug price competition and patent term restoration act requires that generic drug must demonstrate proof of bioequivalence before approval

after; "A"

drug product substitution describes activity where a pharmacist dispenses a drug product that is ____

different from the brand of manufacturer's generically equivalent drug that was prescribed

in mandatory substitution states, pharmacists must substitute a less expensive generic equivalent drug for the brand name drug unless the prescriber writes " ___"

dispense as written

orange book coding exemption: "AB" describes drugs with ____

scientifically resolved actual or potential bioequivalence problems

narrow therapeutic index drugs are defined as drugs where _____

small differences in dose or blood concentration may lead to dose and blood concentration dependent therapeutic failures or serious adverse drug reactions including disability and death

in order for a generic drug to gain FDA approval, it must:

1. contain the same active ingredients as the brand name drug 2. same dosage form and administered the same way 3. be identical in strength 4. have same conditions/indications of use 5. be bioequivalent (same ADME) 6. same standards for identity, strength, purity and quality 7. manufactured under the same standards

as defined by FDA regulation, a narrow therapeutic index rug is defined as one where there is :

1. less than a 2 fold difference between the drug's median lethal dose (LD50) and the median effective dose (ED50) or 2. less than a 2 fold difference between the drug's minimum toxic conc (mtc) and the minimum effective conc (mec) in the blood and 3. safe and effective use of the drug products requires careful dosage titration and patient monitoring

orange book rating system: fda uses a 2 letter coding system. the first letter of the code is either an A for ______ or B for ____

bioequivalent; bioequivalence problem

it is in the best interest for patients for pharmacist not to switch pharmaceutically equivalent products without consulting the orange book, especially with ____drugs

narrow therapeutic index drug

an essential factor in drug product selection is the _____

necessity that the originally prescribed drug and the other drug product selected has to be generally/pharmaceutically equivalent

FDA published "approved drug products with therapeutic equivalence evaluations" aka ______ to assist pharmacists/hc professionals with drug product selection

orange book

the __________lists thousands of currently marketed, fda-approved, multisource drug products that the fda has approved as safe and effective

orange book

in _______states, like Michigan, a pharmacist MAY dispense a generic if the prescriber issues the prescription in a way that permits DPS and shall do so if the patient requests unless the prescriber prohibits DPS

permissive

therapeutic equivalence = ___ and ___

pharmaceutically equivalent and bioequivalent for same use

orange book rating system: fda uses a 2 letter coding system. the second letter of the code describes ___

the dosage form or nature of the product

fda approved drug products that are generic/pharmaceutical equivalents are rated in the orange book for ___

therapeutic equivalence

pharmaceutical equivalents that are bioequivalent are presumed by the fda to be ____

therapeutically equivalent

true or false pharmacists should exercise sound professional judgment when engaging in drug selection of even A-rated narrow therapeutic index drugs

true

true or false the orange book is the ONLY definitive source for therapeutic equivalence and brand name drug data

true

true or false without the prescriber's permission, true "drug product substitution" is NOT allowed in most states, in particular michigan, even if the consumer wishes a substitute

true

under michigan law, substitution is defined to mean the dispensing ________; in michigan, drug product substitution is ____

without the prescriber's authorization, a different drug in place of the drug prescribed; illegal!

is drug product selection legal?

yes, it is (substitution is illegal on the other hand)