PTU FINAL EXAM

PTU FINAL EXAM Food, Drug, and Cosmetic Act of 1938 purity, strength, and safety Pure Food and Drug Act of 1906 forbade the manufacture or transport or sale of mislabeled or adulterated food or drugs and poisonous patent medicines. Durham-Humphrey Amendment of 1951 • Created a distinction between "OTC" and "Legend Drugs". 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 DAW 5 Substitution allowed - brand drug dispensed as generic DAW 6 override DAW 9 Other. Reserved and currently not in use. Fentanyl CII duragesic, actiq, abstral, lazanda, fentora Hydromorphone CII diludad Hydrocodone CII lortab, vicodin, norco, tussionex, vicoprofen Meperidine CII demerol Oxycodone/APAP CII perocet Metadone CII dolophine Oxycodone CII oxycontin Morphine Sulfate CII MS contin, oramorph, kadian, avaniza Adderall CII amphetamine stimulant Vyvanse CII lisdexamfetamine stimulant Dexedrine CII dextroamphetamine stimulant Methylphenidate CII concerta, ritalin, methylin, daytrana, metadate, quillivant stimulant Focalin CII dexmethylphenidate stimulant Subutex CIII Buprenorphine Fiorinal CIII butalbital/aspirin/caffeine Testosterone CIII androgel, androderm, depo-testosterone Suboxene CIII buprenorphine/naloxene Tylenol #3 CIII acetominophen/codeine Phentermine CIV adipex-P Alprazolam CIV xanax Clonazepam CIV klonopin Lorazepam CIV ativan Carisoprodol CIV soma Triazolam CIV halcion Temazepam CIV restoril Diazepam CIV valium Modafil CIV provigil Zolpidem CIV ambien Tramadol