Law Exam 3 - 2

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  1. Where a PPI or a Medication Guide is required, the combination of a prescription container label and either a PPI or a Medication Guide fulfills the _______________________________.
    Food, Drug and Cosmetic Act (FDCA) requirement that "adequate directions for use"
  2. In a cases where a PPI or MedGuide is not given when required, the drug product is __________________.
  3. Where a PPI or a Medication Guide is not required, the prescription container label provides __________________________ for the patient.
    "adequate directions for use"
  4. According to federal law, a PPI must be distributed with each and every filling to patients with drug products containing:
    • Estrogenic substances (e.g., Premarin or conjugated estrogens)
    • Oral contraceptives, including those oral contraceptives containing only a progestin
  5. When the drug product is being administered to a bed patient in a hospital (i.e., an inpatient) or a resident of a long-term care facility (LTCF), the PPI must be provided:
    • Before the first dose is administered
    • AND
    • Every thirty days thereafter as long as the therapy continues
  6. (T/F) The prescriber can request that a PPI is to be withheld from a patient?
  7. The _________________________ must provide PPIs to the pharmacy.
    Manufacturer or distributor
  8. The labeling for some ________________________ requires two PPIs to be given to the patient.
    • Oral contraceptives
    • (i.e., the long or detailed form and the short or brief summary form).
  9. When in doubt about whether to provide a PPI or MedGuide, the pharmacist should____________________________________________.
    review the manufacturer's or distributor's labeling for each drug product
  10. (T/F) The pharmacists has the option to distribute consumer medication information (CMI) produced by commercial vendors as a substitute when a PPI is required for a particular drug.
  11. (T/F) The distributing a PPI to patients is required with progestational drug products that are not approved as an oral contraceptive (e.g., Provera® or medroxyprogesterone acetate).
    • False, not required
    • However, use professional judgment in deciding whether or not to provide the PPI to a patient.
  12. Does a PPI have to be provided to a patient with a compounded drug product containing an estrogenic substance?
    • No. That is because a compounded drug product is not an FDA-approved drug
    • However, counseling would be wise
  13. The FDA requires a Medication Guide to be distributed with certain drug products that ____________________________________________________.
    Pose a serious and significant public health concern
  14. A Medication Guide is intended to help prevent_________________________________________.
    Serious adverse effects and improve patient compliance (i.e., adherence)
  15. When must a MedGuide be distributed?
    • With:
    • Isotretinoin, warfarin (e.g., Coumadin®)
    • Quinine (i.e., Qualaquin®)
    • Varenicline (i.e., Chantix®)
    • Antidepressants ("to all patients of all ages")
    • NSAIDs ("even OTC NSAIDs if you dispense them as a prescription")
    • Fentanyl transdermal system (e.g., Duragesic®)
  16. A comprehensive list of available Medication Guides may be found at:
    CDER website
  17. A Medication Guide must be distributed with each and every filling of a prescription (i.e., all new and refill prescriptions) for Isotrentoin, Quinine, Varencycline, Antidepressants, NSAIDs and Fentanyl transdermal drug products for_____________, but not ___________.
    • Outpatients
    • Hospital inpatients or residents of a LTCF
  18. (T/F) A prescriber can request that a Medication Guide is to be withheld from a patient.
    • True
    • Such a request can be overridden by the patient.
    • It would be wise to have such a request in writing.
  19. The __________________________ must provide Medication Guides, or the means to produce Medication Guides, to the pharmacy.
    Manufacturer or distributor
  20. (T/F) A Medication Guide is equivalent to a PPI
  21. Patient leaflets or written drug information other than a PPI or Medication Guide are referred to as______________________________.
    consumer medication information (CMI)
  22. Written drug information includes:
    • PPI or Medication Guide
    • consumer medication information (CMI)
    • Vaccine Information Statements (VISs)
  23. A _________________ must be given to patients prior to most vaccines being administered to them.
    Vaccine Information Statements (VISs)
  24. What are the exceptions where a Vaccine Information Statements (VISs) does not need to be given?
    • Shingles
    • Though, strongly recommended
  25. According to federal law, there is an exemption for controlled substances dispensed for administration to____________________________.
    Institutionalized patients
  26. An institutionalized patient is defined as one who is a bed patient in a hospital (i.e., an inpatient), and does not include __________________________________.
    A resident in a long-term care facility (LTCF).
  27. The label exemption is applicable to controlled substances administered to a hospital inpatient provided that:
    • Dispensed at 1x:
    • < 7-day supply of a Schedule II controlled substance
    • OR
    • < 34-day supply or 100 dosage units (whichever is less) of a Schedule III, IV, or V
    • AND
    • Controlled substance is not in the possession of the ultimate user prior to administration
    • AND
    • Institution maintains appropriate safeguards, records, control, dispensing, and storage
    • AND
    • Adequate to identify the supplier, product, patient, directions for use and cautionary statements
  28. (T/F) The label exemption is not applicable to all drugs administered to hospital inpatients via a unit dose system, from ward stock (e.g., a drug room, Pyxis medication management system, etc.), crash carts (e.g., a code blue bag, drawer, or cart), etc.
    False, it is applicable (not shouldn’t be in the statement)
  29. (T/F) The label exemption does not apply to legend drug products dispensed pursuant to prescriptions for administration to residents of a LTCF.
  30. (T/F) Drug products stored in an emergency box in a Nebraska LTCF are subject to the label exemption.
  31. (T/F) A LTCF in Nebraska cannot have any legend drug product on the premises, unless it is labeled for a specific patient as outlined in this lesson or it is stored in an emergency box as allowed by Nebraska statute.
  32. A LTCF in Nebraska cannot have any ________________ on the premises, unless it is labeled for a specific patient or it is stored in ____________________ as allowed by Nebraska statute.
    • legend drug product
    • An emergency box
  33. A LTCF in Nebraska can __________________________on the premises for administration to multiple patients.
    have nonlegend drug products (e.g., acetaminophen, aspirin, milk of magnesia, etc.)
  34. In a LTCF, _________________________ do not have to be labeled for a specific patient, but can be administered to a patient only pursuant to a valid order from a prescriber.
    Nonlegend drug products
  35. When can Non-legend drugs be administered to a patient in a LTCF?
    Only pursuant to a valid order from a prescriber
  36. The ___________________________________ requires that hazardous household products (which include medications) must be sold in child-resistant packaging (with a few exceptions).
    Poison Prevention Packaging Act of 1970 (PPPA)
  37. (T/F) “child-resistant” means the same thing as “child-proof”; and the terms can be used interchangeably.
    False, Child-resistant is the correct term
  38. (T/F) “child-resistant” means the same thing as "special packaging." ”; and the terms can be used interchangeably.
  39. A container can be considered child-resistant if _____________________________________________________________.
    80% of children under 5 years of age CANNOT open it and 90% of adults CAN open it
  40. The strategy behind Child-resistant packaging is to:
    Frustrate the child long enough so that he/she will go on to something else
  41. When should you include a warning on the label: "Keep all medication out of the reach of children" on a prescription?
    • If it is in conventional (i.e., easy-to-open, flip-top, standard) packaging
    • Best practice = even if it is on a CRC

    • What are the categories of medication that require child-resistant containers?
    • In general, it includes most OTC drugs and most legend drugs
    • All legend drugs and controlled substances must be dispensed in child-resistant containers except those specifically exempted by law
    • This is true of most OTC products as well.
  42. The child-resistant container statute addresses only drugs for____________________.
    Oral use in humans
  43. If you are dispensing a prescription for an animal, do you need to use a child-resistant container by law?
    • No
    • but a lot of pharmacists do as a precaution – this is a good risk management strategy
  44. Are ophthalmics or topicals required to be CRCs?
Card Set:
Law Exam 3 - 2
2015-04-25 03:18:52
Law Exam
Law Exam 3
Law Exam 3
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