Law Exam 3 - 3

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  1. All _____________ products – either OTC or legend for oral use in humans – are required to be in child-resistant containers.
  2. Are Suppositories required to be packaged in child-resistant containers?
  3. (T/F) When a legend drug switches to over-the-counter status, most are no longer required to be in child-resistant containers.
    False, they are usually still required
  4. In general, are ibuprofen, naproxen, ketoprofen, and the H2 antagonists required to be in CRCs?
  5. Imitrex is in a bubble pack, should it be in a CRC?
    • Some bubble packs may be child-resistant, but not all are.
    • There should be an indication on the container as to whether it meets CRC standards.
  6. All drug packages must ________________________ as to whether packaging meets CRC requirements.
    Pass a statistical test
  7. (T/F) Any drug can be repackaged by the pharmacist into a larger child-resistant container if necessary.
  8. What about “Nutraceuticals”, should they be in CRCs?
    These are not considered drugs, so they are not required to be in CRCs
  9. What about vitamins with additional ingredients like fluoride or iron which can be toxic to little kids, should they be CRCs?
    • it must be a child-resistant container if:
    • > 50 mg of elemental fluoride
    • OR
    • 250 mg or more of elemental iron
    • Ferrous sulfate 325 mg tablets sold OTC must be in CRCs
  10. What are some of the specific exceptions to child-resistant packaging requirements discussed in class?
    • Requests from patients or prescribers to use conventional packaging
    • Some dosage forms
    • METHYLPREDNISILONE not more than 84 mg per container
    • ORAL CONTRACEPTIVES in a calendar pack
  11. What drugs should never be in CRCs?
  12. Can a patient come to you and request all prescriptions in easy-open packages?
  13. Do you need to have it in writing that a patient requested easy-open-packages?
    • NO, this doesn’t need to be in writing according to criminal law
    • But according to civil law (i.e., to protect you from being sued) you should get it in writing
    • You should also frequently update the request
    • In the state of Nebraska, it is a good idea to update the request annually because prescriptions for controlled substances are good for six months from the date of issue and one year for legend drugs.
    • You should point out each time that the package is not child-resistant.
  14. It is recommend to have the patient sign a ________________ placed on the back of such prescriptions which states that the patient will be responsible for keeping all meds out of the reach of children if they refuse a CRC.
    “rubber stamp” statement
  15. Can you ask elderly patients “Do you want an easy-open container for your medication?”
    Yes, this is allowed under the law
  16. Can a prescriber ask you to dispense all prescriptions in an easy-open container now and in the future for one of your mutual patients?
    No, only on a prescription-by-prescription basis
  17. If the patient comes in with three prescriptions, and the prescriber has asked that all three be dispensed in easy-open container, can this be done?
    Yes, it just cannot be a blanket decision that is made on all future prescriptions
  18. Can the pharmacist cannot make a blanket decision to have all current and future controlled substances dispensed in a Non-CRC?
    No, no one but the patient can make a blanket statement
  19. (T/F) The patient may ask that all of his or her prescriptions be dispensed in non-child-resistant packaging.
    True, but, the pharmacist is not allowed to interpret a single request on one prescription to mean that the patient wants non-child-resistant packaging on all future prescriptions
  20. All oral aspirin products must be in child-resistant containers with this exception:
    • When the manufacturer has multiple package sizes of a product in the same strength
    • For example, aspirin 325 sold in packages of 30, 50 and 100 tablets, ONE of those sizes can be marketed in an easy-open container (and the other two sizes must be in child-resistant packaging)
    • The non-child-resistant package must be marked: “This package for households without young children.”
  21. When would you have to have the statement, “This package for households without young children.”
    If aspirin is sold in non-child-resistant package
  22. If a single strength of aspirin comes in only one size (e.g. 200 tablets), can it be sold in a CRC?
    No, special packaging must be used
  23. Can we reuse a child-resistant container on a refill?
    • No
    • You must use a new container
    • Exception: any threaded container (screw top) can be reused BUT THE LID MUST BE REPLACED (e.g., on a liquid container)
  24. Can a container that is easy-open in one position and child-resistant in another position be used legally?
    Legally it is alright but it has flaws
  25. What if a patient with an Rx for Lomotil® which has diphenoxylate 2.5 mg and atropine sulfate 0.025 mg reverts to the easy-open setting?
    This combination is extremely toxic and only takes a few tablets to harm a small child, so legal but not a good idea
  26. Should drugs dispensed to an inpatient in a hospital be in a CRC?
    There are no requirements to use child-resistant containers for such patients
  27. Should drugs dispensed to a patient in a long-term care/nursing home be in a CRC?
  28. Should drugs dispensed to a nursing home patient who wants to go home for the Thanksgiving weekend be in a CRC?
    This happens. You need to have a waiver because children might have the opportunity to get into their meds.
  29. With the exception of long-term care facilities, federal law ___________________ the use of automation in the dispensing of drug products to patients.
    Does not address
  30. According to federal law, only a retail pharmacy may install an automated dispensing system (ADS) in a long-term care facility (LTCF) if ______________________ .
    Allowed by state law
  31. According to federal law what is an Automated dispensing system (ADS)?
    A mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, packaging, counting, labeling, and dispensing of medications, and which collects, controls, and maintains all transaction information
  32. According to federal law, the dispensing of Schedule II, III, IV, or V controlled substances in a LTCF through the use of an ADS must be ______________________ and NOT _________________________.
    • Pursuant to a prescription
    • Pursuant to a chart order
  33. Each retail pharmacy that installs ADSs in a LTCF is required to have ________________________________for each LTCF in which they are located.
    A separate DEA registration (i.e., a different DEA number)
  34. (T/F) Automated Dispensing System are exempt from application fees though require additional registrations.
  35. An affidavit documenting_________________________________________________, must be included with the Application to the DEA for Registration of an ADS.
    The authorization to install and operate ADSs in the LTCF from the state in which the LTCF is located
  36. The distribution of Schedule II controlled substances from a retail pharmacy registrant to an ADS registrant must be pursuant to a _____________________.
    DEA Form 222
  37. The distribution of Schedule III, IV, or V controlled substances from a retail pharmacy registrant to an ADS registrant must be pursuant to____________.
    An invoice
  38. The distribution of Schedule _________controlled substances from a retail pharmacy registrant to an ADS registrant must be pursuant to a DEA Form 222.
  39. The distribution of Schedule _________ controlled substances from a retail pharmacy registrant to an ADS registrant must be pursuant to an invoice.
    III, IV, or V
  40. Separate inventory records must be maintained for any controlled substances stored_______________.
    In the ADSs
  41. (T/F) Distributions of controlled substances that a registered retail pharmacy makes to automated dispensing systems at long-term care facilities for which the retail pharmacy also holds registrations do NOT count toward the 5 percent limit for occasional distributions to other registrants.
  42. In Nebraska, What is an ADS?
    • Type of automated medication system that stores medication to be administered to a patient by a person credentialed under the Uniform Credentialing Act
    • AND
    • A mechanical system that performs operations or activities, other than compounding, administration, or other technologies, relative to storage and packaging for dispensing or distribution of medications and that collects, controls, and maintains all transaction information
    • AND
    • Must be used under a pharmacists care
  43. What is a Chart order by Nebraska law?
    An order for a drug or device issued by a practitioner for a patient who is in the hospital, drug rehab or LTCF where the chart is stored, A chart order does not include a prescription.
  44. What is a Medical Order in Nebraska law?
    A prescription, a chart order, or an order for pharmaceutical care issued by a practitioner
  45. What is pharmacist care according to Nebraska law?
    The provision by a pharmacist of MTM, with or without the dispensing of drugs or devices, intended to achieve outcomes related to the cure or prevention of a disease, elimination or reduction of a patient's symptoms, or arresting or slowing of a disease process
Card Set:
Law Exam 3 - 3
2015-04-25 03:19:21
Law Exam
Law Exam 3
Law Exam 3
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