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)