Law Exam 3 - 6

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  1. According to federal law "the partial filling of a prescription for a controlled substance listed in Schedule II is permissible if
    • the pharmacist is unable to supply the full quantity called for
    • AND
    • makes a notation of the quantity supplied on the face of the written prescription or written record of the emergency oral prescription, or in the electronic prescription record
  2. After a partial fill of a Schedule II, the remaining portion of the prescription may be filled within _________________ of the first partial filling
    • 72 hours
    • however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall notify the prescribing individual practitioner
    • No further quantity may be supplied beyond 72 hours without a new prescription
  3. For the partial filling of a Schedule II controlled substance prescription, there is a difference between filling and dispensing, what does this mean?
    • The remaining portion of a Schedule II controlled substance prescription may be FILLED within 72 hours of the first partial filling
    • The second partial filling may actually be DISPENSED to the patient after the 72-hour period has passed.
  4. A Schedule II controlled substance prescription may be partially filled if:
    • If the pharmacist is unable to supply the full quantity called for"
    • OR
    • If the patient requests it
  5. (T/F) According to federal law, "a prescription for a Schedule II controlled substance written for a patient in a Long Term Care Facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness may be filled in partial quantities to include individual dosage units.
    • True
    • The pharmacist must record on the prescription whether the patient is "terminally ill'' or an "LTCF patient.''
  6. (T/F) If there is any question whether a patient may be classified as having a terminal illness, the pharmacist must contact the practitioner prior to partially filling the Schedule II prescription.
  7. For each partial filling of a controlled substance to a LTCF or terminally ill patient, the dispensing pharmacist shall record on the back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable):
    The date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist
  8. Schedule II prescriptions for patients in a LTCF or patients with a medical diagnosis documenting a terminal illness shall be valid for a period not to exceed _______________ from the issue date unless sooner terminated by the discontinuance of medication.
    60 days
  9. According to federal law, for a partial fill of a Schedule II prescription to a terminally ill or LTCF patient, the pharmacist needs to notify the prescribing individual practitioner if the remaining portion is not or cannot be filled within the 60-day period for situations involving terminally ill patients or residents of a LTCF.
    False, they do not need to notify the practitioner
  10. Is it acceptable to partially fill of refill a Schedule II controlled substance prescription?
    It is acceptable to partially fill, but not refill
  11. In order to include these new uses (indications) for the product in the product labeling, the manufacturer would have to:
    File another NDA (as an amendment to the original) and receive approval to include the newly discovered indication in the package insert.
  12. The prescriber can legally prescribe for non-indicated purposes because:
    It is considered within the art and science of medicine
  13. (T/F) Pharmacists can legally dispense drugs prescribed for off-label uses.
    • True
    • If you are not aware of an off-label use, you need to research it, buy into it, and believe it is medically acceptable
  14. (T/F) Sometimes, clinical experience with successful off-label usage can result in research that is later used to support an amended NDA.
  15. Methadone (a Schedule II narcotic) can be dispensed in the outpatient pharmacy setting (i.e., as a prescription) but it can only be for______________________.
    analgesic purposes
  16. Methadone CANNOT be prescribed to either_______________ or ______________.
    Maintain or detoxify an addict
  17. If methadone is dispensed as an analgesic, must the Rx say ‘for pain’?
    There is no requirement to do this in either federal or Nebraska law
  18. In a narcotic treatment program, methadone is dispensed for administration, and these are not prescriptions, they are:
    Orders for administration
  19. If a physician has methadone in his/her office, s/he can administer it one day at a time only and for no more than _____________ before a patient must go into a treatment program.
    3 days
  20. The physician can obtain methadone from a pharmacy registrant using:
    A paper DEA Form 222 and then can have the addict come in for 3-days maximum administration of methadone
  21. In an inpatient hospital setting, if the patient is only there as an ____________ the hospital can dispense for administration to the patient one day at a time with the same 3-day maximum.
  22. If the patient is in the hospital for treatment of ______________________, the hospital can maintain and detoxify without the 3-day time limitation for Methadone.
    Any condition other than addiction
  23. What is Methadone usually used in the hospital setting for?
    Terminal cancer patients as an analgesic
  24. VOLUNTARY restrictions, established by the manufacturers of methadone hydrochloride ____________ dispersible tablets, limit distribution of this strength and formulation of methadone to hospitals and to facilities authorized for the detoxification and maintenance treatment of opioid addiction.
  25. Can Suboxone is buprenorphine + naloxone, used to detoxify addicts be given outside of a narcotic addiction treatment program?
    Yes, according to The Drug Addiction Treatment Act of 2000 (DATA)
  26. What is the pharmacist’s role in assuring the safe use of this product?
    You must make sure physician is in compliance with DATA (the treatment act mentioned above).
  27. What trating do you need to make sure a phsyican has to prescribe suboxone outpatient?
    • subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties
    • OR
    • subspecialty board certification in addiction medicine or at least 8 hours of authorized training on the treatment or management of opioid-dependent patients
    • AND
    • The capacity to provide or to refer patients for necessary ancillary services, such as psychosocial therapy
    • How can you tell if a prescriber meets the requirements for prescribing buprenorphine-containing products?
    • DEA issues a unique ID number that is verifiable
  28. Buprenorphine was rescheduled from Schedule V to Schedule____________.
  29. How can a pharmacist verify if a physician has a waiver to prescribe buprenorphine (Subutex® or Suboxone®) for the treatment of opioid addiction?
  30. The SAMHSA Buprenorphine Physician Locator web site
    Note, however, that the site does not list every physician with a valid waiver, only those who have agreed to be listed on the site. To verify thsose not listed, contact by phone
  31. Is there a limit on the number of patients a practitioner may treat with buprenorphine at any one time?
    • Yes. DATA 2000, maximum of 30 patients on opioid therapy at any one time for the first year
    • One year after the date on which a physician submitted the initial notification, the physician may submit a second notification of the need and intent to treat up to 100 patients.
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Law Exam 3 - 6
2015-04-25 04:16:07
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