Lecture 2- Brand/Generics/Sigs Flashcards
Do you need to contact the physician in order to substitute a brand name medication with a generic?
NO
Brand drug
Manufacturer has patent to market drug under brand name for a set period
Generic drug
Drug can be marketed by other companies once patent expires
Do you need to provide safety and efficacy tests for generic drugs?
NO
What constitutes pharmaceutical equivalent?
Contain the same active ingredients, are of the same dosage form and route of administration, and are formulated to contain the same amount of active ingredient and meet compendial or other standards such as strength, quality,
purity, identity
What constitutes Therpeutic equivalent?
Pharmaceutical equivalents for which bioequivalence has been demonstrated, and they can be expected to have
the same clinical effect and safety profile when administered to patients under the conditions specified in the
labeling.
What constitutes Pharmaceutical alternative?
Contain the same therapeutic moiety , but are different salts, esters, or complexes of that moiety or are different
dosage forms or strengths. (e.g. tetracycline hcl 250mg capsules vs tetracycline phosphate complex 250mg
capsule; extended-release vs immediate release)
what is “A” rated?
Drug prouct the FDA considers to be therapeutically equivalent to other pharmceutically equivalent products.
CAN SUBSTITUTE without contacting doctor.
What is “B” rated?
Drug the FDA considers not to be therapeutically equivalent to other pharmaceutically equivalent products.
CANNOT SUBSTITUTE, must contact doctor!
What is “AB” rated?
If brand or generic medication produce similar clinical effects and are bioequivalent.
They can interchange.
What is “AA” rated?
Conventional dosage form products not presenting bioequivalence problems
What is “AB” rated?
Meets bioequivalnce requirements
Can be subsitituded without contacting doctor
What is “Bx” rated?
Insufficient data to determine therapeutic equivalence.
Cannot be interchanged.
Contact doctor.
What is the DAW code 0?
No product selection indicated (either is okay)
What is the DAW code 1?
Substitution not allowed by prescriber
