MPJE – Michigan Questions and Answers with Certified Solutions

MPJE – Michigan Questions and Answers with Certified Solutions Misbranding Drugs which are sold, dispensed or distributed in violation of labeling requirements of FDCA Adulterated 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