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 CIV ultram Phenobarital CIV luminal Codiene combination products CV no more than 200 mg/100 mL phenergan, robitussin AC Diphenoxylate combination product CV no more than 25 mg, no less than 25 mcg of atropine lomotil Pregabalin CV lyrica Locasamide CV vimpat DEA # verification add 1st, 3rd, 5th digits= sum of 1 add 2nd, 4th, 6th digits, then multiply by 2= sum 2 sum 1 + sum 2= verification number last digit must match last number of DEA # REMS program transmucosal fentanyl, abstral, actiq, fentora, lazanda, subsys au both ears ad right ear as left ear ou both eyes od right eye os left eye 1 mL 20 drops Markup Percentage markup/cost x 100 Excipients inactive substances used as a carrier for the active ingredients of a medication Buccal tablet