PTU Final Exam 2024 Questions and Answers

PTU Final Exam 2024 Questions and Answers Food, Drug, and Cosmetic Act of 1938 -Answer-purity, strength, and safety Pure Food and Drug Act of 1906 -Answer-forbade the manufacture or transport or sale of mislabeled or adulterated food or drugs and poisonous patent medicines. Durham-Humphrey Amendment of 1951 -Answer-• Created a distinction between "OTC" and "Legend Drugs". Patient Package Insert (PPI) -Answer-Manufacturer's patient product information included with the product package. Hatch-Waxman Act of 1984 -Answer-promoted the manufacturing of generic drugs and new medications MedGuides -Answer-FDA-approved documents created to educate patients about how to minimize harm from potentially dangerous drugs Class I recall -Answer-Serious adverse effects on health or death Class II recall -Answer-temporary or reversible adverse effects Class III recall -Answer-Unlikely to cause adverse health consequences Market Withdrawal -Answer-permanent removal from the market, drug is harmful of unapproved pharmacological alternative -Answer-same active ingredient, different dosage form/strength therapeutic alternative -Answer-different active ingredient, same drug class DAW 0 -Answer-no preference, OK to substitute DAW 1 -Answer-substitution not allowed by prescriber DAW 2 -Answer-substitution allowed, patient requested specific product DAW 7 -Answer-substitution not allowed; brand mandated by law DAW 8 -Answer-Substitution allowed; generic drug not available in marketplace DAW 3 -Answer-Substitution allowed; pharmacist-selected product dispensed DAW 4 -Answer-Substitution allowed - generic drug not in stock DAW 5 -Answer-Substitution allowed - brand drug dispensed as generic DAW 6 -Answer-override DAW 9 -Answer-Other. Reserved and currently not in use. Fentanyl -Answer-CII duragesic, actiq, abstral, lazanda, fentora Hydromorphone -Answer-CII diludad Hydrocodone -Answer-CII lortab, vicodin, norco, tussionex, vicoprofen Meperidine -Answer-CII demerol Oxycodone/APAP -Answer-C