Law Exam 3 - 4

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kyleannkelsey
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301486
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Law Exam 3 - 4
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2015-04-24 23:19:48
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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. Acording to Nebraska law, what is a Prescription medication distribution machine?
    A type of automated medication system that packages, labels, or counts medication in preparation for dispensing of medications by a pharmacist pursuant to a prescription
  2. In an automated dispensing machine, all drugs shall be:
    • In the manufacturer's original packaging
    • OR
    • In containers repackaged in compliance with state and federal laws, rules, and regulations relating to repackaging, labeling, and record keeping
  3. A prescription medication distribution machine may be operated only by:
    • A licensed pharmacy where a pharmacist dispenses medications to patients for self-administration pursuant to a prescription
    • OR
    • In a long-term care automated pharmacy
  4. ________________________________________________may be transferred into or dispensed from automatic counting machines in Nebraska.
    Non-controlled substances and Schedule III, IV, and V controlled substances
  5. _____________________________ cannot be transferred into or dispensed from automatic counting machines in Nebraska.
    Schedule II controlled substance
  6. In Nebraska, the expiration date for drugs transferred to cassettes of a prescription medication distribution machine must be:
    • Whichever is shorter:
    • The expiration date as determined by the manufacturer/distributor
    • OR
    • Maximum of one year from the date of transfer,
  7. In the event that a cassette holds drugs reflecting different lot numbers and expiration dates, the ________________________ will apply.
    Shortest expiration date
  8. In the event of a FDA or state ordered Class I or Class II recall, and a cassette holds drugs from multiple lot numbers, what should be done?
    All dosage units remaining in the cassette must be removed from commerce
  9. Inventory transferred to an automated medication distribution machine in a Nebraska hospital or to a Nebraska long-term care automated pharmacy is NOT excluded from the 5% limit on total prescription drug sales revenue in Nebraska’s Wholesale Drug Distributor Licensing Act.
    False, it IS excluded
  10. The Automated Medication Systems Act in Nebraska allows for pharmacist remote order enter pursuant to:
    Medical orders in a hospital, long-term care facility, or pharmacy licensed under the Health Care Facility Licensure Act
  11. A pharmacist providing pharmacist remote order entry shall:
    • 1. Be located with the United States;
    • 2. Maintain security and privacy
    • 3. Be linked to one or more hospitals, long-term care facilities, or pharmacies for which services are provided via computer link, video link, audio link, or facsimile transmission
    • 4. Have access to each patient's medical information necessary to perform via computer link, video link, or facsimile transmission a prospective drug utilization review...; and
    • 5. Be employed by or have a contractual agreement to provide such services with the hospital, long-term care facility, or pharmacy where the patient is located.
  12. In Nebraska, Telepharmacy means the provision of:
    Pharmacist care, by a pharmacist located within the United States, using telecommunications, remote order entry, or other automations and technologies to deliver care to patients or their agents who are located at sites other than where the pharmacist is located.
  13. Can a pharmacy technician dispense drugs in a pharmacy without a supervising pharmacist being present in the pharmacy?
    No
  14. Does Nebraska does allow the dispensing of drugs directly to a patient from a kiosk?
    No
  15. (T/F) Any automated machine that dispenses, delivers, or makes available, other than by administration, prescription medication directly to a patient or caregiver without the provision of pharmacist care is prohibited.
    True
  16. Nebraska’s Automated Medication Systems Act prohibits certain acts:
  17. A resident of the LTCF cannot obtain medication through the automated medication system
    • AND
    • shall not restrict or impair the ability of a resident of the facility to obtain medications from the pharmacy of the resident’s choice.
  18. When dispensing a new prescription, a pharmacist must determine if the new prescription is:
    • 1. within the prescriber's legal scope of practice
    • 2. authentic or valid
    • 3. complete
    • 4. for a legitimate medical purpose (for all controlled substances)
    • 5. within the prescriber's DEA registration (for all controlled substances)
    • 6. appropriate for the patient (this is what most of your pharmacy education is about)
  19. When dispensing a refill prescription, a pharmacist must determine if a bona fide _______________________still exists.
    Patient-physician relationship
  20. What does a pharmacist do when a prescriber retires? Are any remaining refills still valid?
    According to federal and Nebraska law, a patient-physician relationship still exists for a prescriber that has retired and has not surrendered his/her license to practice and/or DEA registration and any remaining refills are still valid unless he/she has indicated otherwise
  21. What does a pharmacist do when a prescriber retires or dies? Are any remaining refills still valid?
    • No, Patient-physician relationship no longer exists and any remaining refills may no longer be valid
    • According to the DEA, prescriptions written or authorized on or prior to the date of the death of a prescriber or the date that a DEA registration is surrendered are valid and may be filled or refilled as deemed medically necessary by the dispensing pharmacist.
  22. What does a pharmacist do when a prescriber retires and surrender his/her DEA registration? Are any remaining refills still valid?
    • Patient-physician relationship no longer exists and any remaining refills may no longer be valid
    • Handle case by case, check with state pharmacy regulator
    • According to the DEA, prescriptions written or authorized on or prior to the date of the death of a prescriber or the date that a DEA registration is surrendered are valid and may be filled or refilled as deemed medically necessary by the dispensing pharmacist.
    • Handle case by case, check with state pharmacy regulator
  23. Is a prescription from a prescriber not licensed in Nebraska, but licensed in a state other than Nebraska, an authentic prescription in Nebraska?
    Yes, as long as the prescription is within the legal scope of practice that would otherwise be applicable to that prescriber if he/she was licensed in Nebraska.
  24. Is a prescription from a prescriber not licensed in Nebraska, but licensed in the District of Columbia or a territory of the United States (e.g., Puerto Rico), an authentic prescription in Nebraska?
    • Yes, as long as the prescription is within the legal scope of practice that would otherwise be applicable to that prescriber if he/she was licensed in Nebraska.
    • Is a prescription from a foreign prescriber that is not licensed in any state in the United States an authentic prescription?
    • No for most states, but could be “yes” in some states.
  25. Does a pharmacist who is an owner of a pharmacy and the owner of the drug products, or an employee pharmacist, need a prescription for any legend drug product that he/she may need for his/her own personal use?
    Yes
  26. Can a pharmacist dispense legend drugs to himself/herself and to his/her family members?
    Yes, but such dispensing must always be pursuant to a valid prescription
  27. Before a male or female patient receives his/her isotretinoin prescription each month, the prescriber must __________________ the patient and document in the iPLEDGE system that the patient has been counseled about the risks of isotretinoin.
    Counsel
  28. As part of the ongoing risk management program, it is crucial that a female patient of childbearing potential selects and commits to use _____________________________ for one month before, during, and for one month after isotretinoin therapy.
    Two forms of effective contraception simultaneously
  29. As part of the ongoing risk management program, it is crucial that a female patient of childbearing potential selects and commits to use for ______________________________ isotretinoin therapy.
    One month before, during, and for one month after
  30. A female patient must have _____________________________________ before receiving the initial isotretinoin prescription.
    Two negative urine or blood (serum) pregnancy tests
  31. A _____________________ is required to be dispensed with all isotretinoin prescriptions.
    Medication Guide
  32. According to federal law, a refill authorization cannot exceed _______________________________ from the date of issue for a Schedule III or IV controlled substance.
    Five refills within six months
  33. According to federal law, a refill authorization cannot exceed five refills within six months from the date of issue for a Schedule _______ controlled substance.
    III or IV
  34. According to federal law, there is no limit on the number of refills or time limit for a __________________________ or noncontrolled substance.
    Schedule V controlled substance
  35. According to Nebraska law, a refill authorization cannot exceed five refills within six months from the date of issue for a Schedule ______________ controlled substance.
    III, IV, or V (just III and IV for federal law)
  36. According to Nebraska law, there is no limit on the number of refills within ___________ months from the date of issue for noncontrolled substances.
    Twelve (6 for federal law)
  37. If a prescription is written for #30 tablets (30-day supply) with five (5) refills, is it acceptable to initially dispense #90 tablets (90-day supply) with one (1) refill left?
    • While there are NO SPECIFIC FEDERAL OR NEBRASKA LAWS that address this particular scenario, it MAY BE ACCEPTABLE TO USE PROFESSIONAL JUDGMENT on a case-by-case basis to dispense #90 tablets and give one refill for a drug product that is a noncontrolled substance without checking with the prescriber.
    • However, it MAY NOT BE ACCEPTABLE to do this according to the LAW IN SOME STATES or according to most THIRD-PARTY CONTRACTS.
    • In addition, it would be very wise to CHECK WITH THE PRESCRIBER before doing that FOR ANY CONTROLLED SUBSTANCE prescription.
    • This should not be done for any drug product prescribed by a PSYCHIATRIST (or any prescriber for that matter) for a psychiatric patient without checking with the prescriber.
  38. Can additional refills be added to an existing or old prescription without assigning a new prescription number?
    • Yes, According to federal and Nebraska law, some states don’t allow it though
    • Refills cannot go beyond the original expiration date for the existing or old prescription (i.e., 12 months for a non-controlled substance prescription in Nebraska or 6 months for a Schedule III, IV, or V controlled substance prescription in Nebraska)
    • Cannot go beyond the total number of refills allowed by law for a given type of prescription
    • Documetntation often is lost with this, so usually not done
  39. Can you refill a prescription for a Schedule II controlled substance in case of a true emergency?
    No. You can never refill a Schedule II controlled substance prescription.
  40. How often can a PRN or AD LIB refill authorization be refilled?
    Without limits and essentially mean the pharmacist has to use professional judgment in making a decision as to when to refill the prescription
  41. A pharmacists working in states that do not recognize these refill authorizations have been charged with fraud by third party payers because they allegedly refilled prescriptions without valid authorizations, this would be considered what type of infraction?
    • Misbranding
    • Because they dispensed it without a valid prescription as required
  42. In Nebraska if the refill designation on the prescription is PRN (i.e., Pro re nata)
    • 1. Controlled substance in Schedules III, IV, or V, refill five times in the six months from the date of issuance.
    • 2. Noncontrolled drug, device or biological, refill for 12 months from the date of issuance.

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