verified answers (detailed answers) already graded
A+
Patient Package Insert (PPI)
Manufacturer's patient product information included with the
product package.
Hatch-Waxman Act of 1984
promoted the manufacturing of generic drugs and new
medications
MedGuides
FDA-approved documents created to educate patients about how
to minimize harm from potentially dangerous drugs
Class I recall
Serious adverse effects on health or death
,Class II recall
temporary or reversible adverse effects
Class III recall
Unlikely to cause adverse health consequences
Market Withdrawal
permanent removal from the market, drug is harmful of unapproved
pharmacological alternative
same active ingredient, different dosage form/strength
therapeutic alternative
different active ingredient, same drug class
DAW 0
no preference, OK to substitute
, DAW 1
substitution not allowed by prescriber
DAW 2
substitution allowed, patient requested specific product
DAW 7
substitution not allowed; brand mandated by law
DAW 8
Substitution allowed; generic drug not available in marketplace
DAW 3
Substitution allowed; pharmacist-selected product dispensed
DAW 4
Substitution allowed - generic drug not in stock