MPJE – Michigan, Exam predictor Questions and answers, 2022/2023. Rated A

Document Content and Description Below

MPJE – Michigan, Exam predictor Questions and answers, 2022/2023. Rated A Misbranding - ✔✔Drugs which are sold, dispensed or distributed in violation of labeling requirements of FDCA Adu... lterated or Misbranded?: False/misleading labeling - ✔✔Misbranded Adulterated or Misbranded?: Packaging fails to identify name & address of manufacturer, packager of distributor, and quantity of drug - ✔✔Misbranded Adulterated or Misbranded?: Any word or statement required on label is not prominent, conspicuous and readable - ✔✔Misbranded Adulterated or Misbranded?: Drug has habit-forming substance and label fails to list name and proportion of substance and "Warning—may be habit forming" - ✔✔Misbranded Adulterated or Misbranded?: If established name or mutli-ingredient products don't identify each active ingredient - ✔✔Misbranded Adulterated or Misbranded?: Drug is liable to deterioration and label doesn't warn to that effect - ✔✔Misbranded Adulterated or Misbranded?: Misleading container, imitates another drug or offered for sale under the name of another drug - ✔✔Misbranded Adulterated or Misbranded?: Dosage, frequency, duration or route of admin suggested in the labeling is dangerous - ✔✔Misbranded Adulterated or Misbranded?: Pharmacist dispensed a medication without a refill or prescription - ✔✔Misbranded Adulteration - ✔✔Failure of drug or device to satisfy FDA purity standards Adulterated or Misbranded?: Consists in whole or in part of filthy, putrid or decomposed substance - ✔✔Adulterated Adulterated or Misbranded?: Prepared, packaged or held under unsanitary conditions, whereby it MAY have become contaminated w/ filth or MAY have been rendered injurious to health (don't have to prove, just say it MAY have) - ✔✔Adulterated Adulterated or Misbranded?: Drug is manufactured in facility in violation of cGMPs - ✔✔Adulterated Adulterated or Misbranded?: Container is composed of poisonous or deleterious substance that may render contains injurious to health - ✔✔Adulterated Adulterated or Misbranded?: Bears unsafe color additive for purposes of coloring only - ✔✔Adulterated Adulterated or Misbranded?: Drug labeled in official compendium but strength differs from or quality or purity falls below compendium standards - ✔✔Adulterated Adulterated or Misbranded?: Drug not listed in official compendium and its strength differs from or its quality or purity falls below what is represented on label - ✔✔Adulterated Adulterated or Misbranded?: Any substance mixed w/ the drug to reduce strength, or any substance that has been substituted for the drug - ✔✔Adulterated Adulterated or Misbranded?: Pharmacist dispenses expired products - ✔✔Adulterated Labeling - ✔✔Anything accompanying the product (ex: package insert, med guide, advertisements, physician's desk reference, side effects statement, promotional material, the actual label, etc.) OTC Labeling - minimum font size? - ✔✔Size 6 Federal Food Drug & Cosmetic (FDC) Act - ✔✔-Required new drugs to be shown safe before marketing -Authorized factory inspections Prescription Drug Marketing Act - ✔✔-Bans the sale of samples -Requires drug wholesalers to be licensed by the states -Restricts reimportation from other countries Michigan Board of Pharmacy Members - ✔✔11 members - 6 RPh and 5 Public Michigan Board of Pharmacy Disciplinary Subcommittee - ✔✔-2 public and 3 professional members -Vote on disciplinary actions -Must have 1 public member to vote along with the majority for a decision to be made (gives the public members a "super vote") Package Insert - ✔✔-Contains essential information for safe and effective use of the drug (Ex. Black Box Warnings) -Can give to the patient Patient Package Insert - ✔✔-Community or outpatient pharmacies must give with every dispensing for the drugs that require one (ex: estrogen products) -Institutional law: must be given before the first administration and every 30 days -Physician canNOT opt out for a patient -It is considered misbranded if not given Medication Guide - ✔✔-Required by FDA on certain products that cause "a serious and significant public health concern" -Required in the community setting with EVERY dispensing (misbranded if not given) -Physician CAN request the patient does not receive one but patient can override this request -Institutional setting: it's unnecessary to dispense b/c there's a professional available at all times to answer questions. Consumer Medication Information - ✔✔-Not a requirement -It's printed consumer medication information provided to patients at the time a new Rx is filled HIPAA Privacy Policy - ✔✔-Notice given to every individual -Good faith effort to obtain the patient's written acknowledgment of the receipt of the notice OBRA 90 and the Michigan "counseling rule" - ✔✔-OBRA 90: Requires pharmacists to offer to counsel ALL Medicaid patients or caregiver on the first fill of a new medication (and on refills if deemed necessary) -Counseling Rule: Michigan requires the ALL patients or caregiver (regardless of insurance carrier) being counseled on the first fill of a new medication. -NOTE: Info shall be provided if requested for any Rx by the patient or patient's caregiver or agent OBRA 90: Items to discuss with patient - ✔✔-Name and description of the medication -Route, dosage form, dosage, and duration of drug therapy -Special directions and precautions -Common, severe side effects or drug interactions -Techniques for self-monitoring drug therapy and actions required -Proper storage -Prescription refill information -Action to be taken in the event of a missed dose OBRA 90: Items needed for maintaining records - ✔✔-Name, address, phone number, DOB (or age), gender -RPh comments relevant to the client's drug therapy -Patient history when significant, disease states, known allergies, and drug reactions -Comprehensive list of medications and relevant devices -Offer to counsel the patient—they can accept or reject the offer Drugs Exempt from Childproof Packaging - ✔✔Sublingual Nitroglycerin, Potassium supplements, Isosorbide dinitrate 10mg or less (SL or chewable), Erythromycin, Anhydrous cholestyramine (powder), Sodium Fluoride, Betamethasone, Mebendazole, Cholestipol, Prednisone, Norethindrone acetate, Medroxyprogesterone, Sucrase, Methylprednisone, Pancrelipase, Oral contraceptives / Estrogen replacement therapy (HRT) NDC Number Requirements - ✔✔Required on all Rx and OTC products When can non-child resistant packaging be used? - ✔✔-Dispensing to patients in a nursing home/hospital -Drugs to be administered by institutional personnel -Samples, Starter packs -Topical application -Dosage form not intended for oral administration -Bulk containers received by the pharmacy -Unit dose packaging (birth control) -Patient, physician, or caregiver can request exemption Adulterated or Misbranded?: Re-selling a repackaged medication - ✔✔Misbranded Unit dose packaging expiration dates - ✔✔6 months, or 25% of the remaining time between the date of repackaging and the original expiration date.... whichever comes first Adulterated or Misbranded?: Drug is not dispensed in a childproof container - ✔✔Misbranded Activities that are violations of the FDCA - ✔✔-Adulteration -Misbranding -Placing an unapproved drug into Interstate Commerce OTC Labeling Requirements - ✔✔-Active Ingredients -Purpose -Uses -Warnings -Directions ("Adequate directions for use") -Other Information -Inactive Ingredients -Statement of identity of the drug -Name & address of manufacturer, packager, or distributor -Net quantity of contents -NDC Can samples, or "complimentary starter doses", ever be in a community pharmacy? - ✔✔No. Can a hospital pharmacy house complimentary starter doses of non-controlled drugs? - ✔✔Yes, but: A physician (MD or DO) must delegate in writing to a pharmacist at that hospital that the pharmacist can receive and dispense the sample. The pharmacist can then dispense the samples to ANY prescriber (including PA and NP) in the hospital. NOTE: Both the RPh's and physician's names must be on the drug sample for the RPh to receive it. Can a hospital pharmacy house complimentary starter doses of controlled substances? - ✔✔No. Drug Product Selection - ✔✔Another brand of a generically equivalent product, identical in dosage form and content of active ingredients These are drugs the RPh can dispense w/out the prescriber's authorization Can and should a pharmacist apply drug product selection? - ✔✔-Pharmacist MAY if he/she wants to (but it is not required). -Pharmacist MUST if the patient asks. What must appear on the drug receipt? - ✔✔-Brand name of drug dispensed -If no brand name, need name the manufacturer or supplier of the drug -Strength of the drug, if significant -Quantity dispensed -Name and address of pharmacy -Serial number of the Rx -Prescriber's name -Patient's name -Price paid by patient -Date the prescription was most recently dispensed. [Show More]

Last updated: 2 years ago

Preview 1 out of 45 pages