Law Exam 3 - 1

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kyleannkelsey
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301483
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Law Exam 3 - 1
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2015-04-24 23:18:22
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Law Exam
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Law Exam 3
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Law Exam 3
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  1. What is a Label
    Printed, written, or graphic matter placed on the container itself
  2. What is Labeling
    Label on the container of the drug, plus any other printed, written, or graphic matter provided with the dispensed drug product (PPI, MedGuide or CMI)
  3. The following information is required by law* to be on the prescription container label of a drug dispensed pursuant to a prescription:
    • (FN) pharmacy name, address and telephone number
    • (FN) serial number and date of the prescription
    • (FN) patient's and perscribers name
    • (FN) directions for use and any cautionary statements contained in the prescription
    • (F) if central fill is used, a unique identifier of the central fill pharmacy (i.e., DEA registration number) and name, address, and telephone number
    • (F) federal transfer warning for certain controlled substances (c)
    • (F) toll-free number for reporting side effects (d)
    • (N) name of the drug, device, or biological, unless instructed to omit by the prescriber
    • (N) dosage form and strength of the drug or biological
    • (N) quantity of drug, device, or biological in the container; except for unit-dose containers
    • (N) pharmacy telephone number
    • *FN = federal & Nebraska, F = federal, N = Nebraska
  4. In Nebraska, if the prescriber is a physician assistant (PA), the container label shall bear the name of the physician assistant and__________________________________, the name of the supervising physician.
    If required for purposes of reimbursement
  5. The label of any controlled substance in Schedules ______________ that is dispensed to a patient pursuant to a valid prescription, shall contain the following warning - CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.
    II, III, and IV
  6. (T/F) A patient can transfer his/her controlled substance to a pharmacy or prescriber.
    False, Cannot
  7. (T/F) The requirement for Schedule II-IV drugs to say “CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.” On the label can be satisfied with an auxiliary label on the container.
    True
  8. What situation is the statement “CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.” Not required on a prescription label.
    Schedule V controlled substance or a non-controlled substance
  9. (T/F) Many pharmacists have decided to be more stringent than federal law and place the transfer warning “CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.” on the label of every dispensed prescription.
    True
  10. The side effects statement, "Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088." applies to
    New and refill prescriptions dispensed to consumers
  11. The side effects statement, "Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088." DOES NOT apply to
    Dispensing or administering to inpatients or health care facility under a licensed practitioner, or in supervised home health care
  12. If the side effects statement "Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088." is not on the prescription container label itself, it may be distributed through:
    • A sticker (i.e., auxiliary label) on the unit package or container
    • Preprinted pharmacy prescription vial cap
    • Separate sheet of paper
    • Consumer medication information (CMI)
    • FDA-approved Medication Guide
  13. Under what circumstances would you retain the brand name of the product on the label?
    • Patient or the prescriber request
    • For safety reasons always identify warfarin sodium as the generic for Coumadin
    • It may be wise for the pharmacist to do this for any product where a new generic has recently been made available.
  14. In a situation where the Pt or prescriber requests that the brand name be retained on the product label, the Nebraska Board of Pharmacy recommends what format (to protect a person from trademark infringement by the manufacturer, fraud by an insurance company, or misbranding)?
    Furosemide 40 mg tab (DPS for Lasix)
  15. What charges could be made if a person retains the brand name on a generic drug label incorrectly?
    Trademark infringement by the manufacturer, fraud by an insurance company, or misbranding
  16. If a generic drug distributor or manufacturer gave its generic furosemide the name of Water Pill, would it be acceptable to label a prescription with Water Pill 40 mg tab if that is what was actually dispensed to the patient instead of the Lasix 40 mg tab as originally ordered?
    • Yes.
    • The following labels would be acceptable:
    • Furosemide 40 mg tab
    • Furosemide 40 mg tab (DPS for Lasix)
    • Water Pill 40 mg tab (only if that is what was actually dispensed to the patient)
  17. Are there any drug products where both the generic and brand names should be placed on the label even without a request from the patient or prescriber and why?
    • Yes, for safety reasons one should always identify warfarin sodium as the generic for Coumadin (i.e., DPS for Coumadin)
    • If a patient has both in his/her medicine cabinet will hopefully not take both at the same time
    • It may be wise for the pharmacist to do this for any product where a new generic has recently been made available.
  18. United States Pharmacopeia (USP) Chapter 17 on Prescription Container Labeling became an official standard on 5/1/13. Elements of this new standard include:
    • 1. Emphasizing instructions and other information important to patients
    • 2. Improving readability
    • 3. Giving explicit instructions
    • 4. Including purpose for use
    • 5. Addressing limited English proficiency
    • 6. Addressing visual impairment
    • United States Pharmacopeia (USP) ________________ on Prescription Container Labeling became an official standard on 5/1/13. The new standards emphasize instructions and other information important to patients, improving readability, give explicit instructions, include purpose for use, address limited English proficiency and address visual impairment.
    • Chapter 17
  19. Enforcement of the new standard “United States Pharmacopeia (USP) Chapter 17 on Prescription Container Labeling” will be the decision of individual state boards of pharmacy. As of this date, the Nebraska Board of Pharmacy ________________ (has/has not) adopted that standard.
    Has not
  20. Good pharmacy practice additions on all prescription container labels could include such items as:
    • 1. how to administer the drug
    • 2. the route of administration
    • 3. other truthful information as an addition to the information on the label itself, or in the form of auxiliary labels
    • 4. a beyond-use date
    • 5. the initials of the dispensing pharmacist
    • 6. the number of refills remaining
  21. Make sure that an auxiliary label clearly states what you want to tell the patient. Do not__________________________________________________.
    Use more auxiliary labels than necessary (i.e., avoid the Christmas tree appearance or sticker shock)
  22. It may be wise to ______________________ of an auxiliary label to some patients.
    • Explain the meaning
    • (e.g., "For external use only" [i.e., "to be used only on your skin"] or "This medicine contains ACETAMINOPHEN. Taking more acetaminophen than recommended may cause serious liver damage.")
  23. When a pharmacist intern or pharmacy technician fills prescriptions under the supervision of a pharmacist. Ideally, the initials of both should appear on the prescription container label. However, if the pharmacy’s computer software only allows for one set of initials, the initials of ________________________ should appear on the label.
    The supervising pharmacist
  24. In Nebraska, the pharmacy may allow for the dispensing of more than one drug, device or biological in the same container only when:
    • Such container is prepackaged by the manufacturer, packager, or distributor and shipped directly to the pharmacy in this manner
    • OR
    • Each drug or biological product is individually wrapped or hermetically sealed by either the pharmacist, dispensing medical practitioner, manufacturer, packager, or distributor
    • OR
    • The container does not accommodate greater than a 31-day supply of compatible dosage units and is labeled so as to identify each drug or biological in the container
  25. How must a nonlegend drug dispensed pursuant to a prescription be labeled?
    Since it is being treated as a legend drug (i.e., dispensed pursuant to a prescription), it must be labeled as all other persecriptions
  26. (T/F) According to federal law, the prescription container label is usually all that is required for the labeling of most drug products dispensed pursuant to a prescription.
    True
  27. (T/F) However, a patient package insert (PPI) or a Medication Guide (MedGuide) must be provided to patients with all dispensed drug products.
    False, only some require this

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