PHRD5045 Pharmacy Law - Federal/CO CSA (Exam #2)

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daynuhmay
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241168
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PHRD5045 Pharmacy Law - Federal/CO CSA (Exam #2)
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2013-10-18 03:45:12
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Pharmacy Law Federal Colorado CSA
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Pharmacy Law Federal Colorado CSA
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  1. high potential for abuse; no accepted medical use in US
    Scheduel I drugs
  2. high potential for abuse; severe physical/psychological dependence potential

    *accepted US medical use
    Schedule II drugs
  3. 7 examples of Schedule I drugs
    • 1) heroin
    • 2) LSD
    • 3) peyote
    • 4) marijuana
    • 5) MDMA
    • 6) mescaline
    • 7) unapproved GHB
  4. physical dependence is severe
    CS II
  5. physical dependence is moderate
    CS III
  6. physical dependence is low/limited
    CS IV
  7. physical dependence is extremely low
    CS V
  8. 3 things the RPh CANNOT change on a on a CS II Rx
    • 1) patient name
    • 2) CS prescribed (except to generic, per CO law)
    • 3) signature
  9. high psychological dependence potential
    Schedule III drugs
  10. 5 examples of CS III drugs
    • 1) Fiorinal ((w/ ASA)
    • 2) THC
    • 3) Tylenol 3
    • 4) Vicodin (hydrocodone + APAP)
    • 5) anabolic steroids
  11. hydrocodone vs. hydrocodone+APAP
    • hydrocodone: CS II
    • hydrocodone + APAP: CS III
  12. Fiorinal vs. Fiorocet
    • Fiorinal: butalbital, caffeine, & ASA; CS III
    • Fiorocet: butalbital, caffeine, & APAP; non-controlled
  13. required to register with the DEA if involved in dispensing a controlled substance (6)
    • 1) pharmacy
    • 2) manufacturers
    • 3) distributors
    • 4) individual practitioners (IP; prescribers)
    • 5) exporters/importers
    • 6) researchers
  14. registration with the DEA must be renewed every ____. 
    3  years
  15. how hospital IPs allowed to prescribe CS
    hospital assigns specific internal code number to the IP as a suffix to the institution's DEA number
  16. types of Rx drugs that can be mailed
    all
  17. conditions for mailing of CS
    • 2 wrappers:
    • inner container: sealed, labeled w/ pharmacy name & address
    • outer container: no markings to indicate contents
  18. "A Rx for a CS to be effective must be issued __________ by an IP acting in the usual course of his professional practice."
    ...for a legitimate medical purpose...
  19. labeling requirements under Federal CSA (7)
    • 1) pharmacy name/address
    • 2) Rx serial #
    • 3) Rx fill date
    • 4) IP name
    • 5) pt name
    • 6) directions for use
    • 7) cautionary statements
  20. which drugs require this label?

    "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed."
    CS II-IV
  21. 3 kinds of required CS records
    • 1) inventory
    • 2) receipt
    • 3) dispensing
  22. record of new CS inventory (of existing stock) required every ____. 
    2 years
  23. details required in inventory (3)
    • 1) date
    • 2) time
    • 3) drug (strength, form, number)
  24. when estimated inventory counts are acceptable
    CS III-V if container holds <1000
  25. when exact inventory counts are required
    • CS II
    • CS III-V if container holds >1000 and is opened
  26. CO requirements for dispensing record keeping
    • 3 separate Rx dispensing files:
    • 1) CS II
    • 2) CS III-V
    • 3) all non-CS drugs
  27. form required for any distribution of C-I and C-II drugs
    DEA Form 222
  28. practitioners who can prescribe CS without a DEA # (3)
    • 1) PHS
    • 2) Bureau of Prison 
    • 3) military physicians
  29. if  CS III-V are shared on a real-time, online database, how many times can it be transferred?
    # max refills permitted
  30. 3 exceptions to written CS II prescriptions
    • 1) fax
    • 2) emergency
    • 3) partial dispensing
  31. when fax CS II Rx are allowed (3)
    • 1) home infusion/IV pain
    • 2) long term facility care (LTFC)
    • 3) hospice
  32. in emergency situations pharmacist may dispense CS II on oral/fax prescriber authorization if (4):
    • 1) Rx immediately written (except for Dr's signature)
    • 2) qty is limited to tx during emergency period 
    • 3) pharmacist attempts to verify authenticity
    • 4) IP must provide signed, written Rx to pharmacist w/in 7 days (or pharmacist must notify DEA) -> 72hrs in CO
  33. when partial dispensing of CS II is allowed (4):
    • 1) full qty not available
    • 2) must dispense balance w/in 72hr or IP must write new Rx
    • 3) qty dispensed noted on front of Rx
    • 4) LTCF or "terminally ill" pt - partial fill allowed for max 60 days
  34. what must be included in the note on an Rx for a partially dispensed CS II (4)?
    • pharmacist name
    • date
    • # dispensed
    • # left
  35. transfer, delivery, or distribution of Rx to non-consumers
    casual sale
  36. amount of CS allowed to be sold as casual sale
    5% of dispensed CS in a calendar year
  37. form that must be filled out upon significant loss/drug theft of CS
    • DEA Form-106
    • 2 copies to DEA, 1 copy in pharmacy
  38. 4 differences between Fed & CO CSA
    • 1) CO does NOT allow OTC sale of CS V
    • 2) CO does NOT allow unlimited refills of CS V (5 refills or 6mos)
    • 3) CO only has ONE method to file Rx's involving controlled & non-controlled drugs (Fed has 3)
    • 4) CO requires IP of oral emergency CS II to provide signed, written Rx to pharmacist w/in 72hr (Fed allows 7 days)
  39. 7 types of medical professionals allowed to prescribe medication under CO law
    • 1) Advanced Practice Nurse
    • 2) Dentist
    • 3) Optometrist
    • 4) Physician
    • 5) PA
    • 6) Podiatrist
    • 7) Vet
  40. (5) requirements for an APN/RN/CNP to hold CO Rx authorization
    • 1) listed on Board of Nursing APN Registry
    • 2) written collaborative agreement w/ CO doc
    • 3) RXN # from Board of Nursing
    • 4) own DEA#
    • 5) w/in nurse's practice area
  41. 3 characteristics of CO Rx authorized DDS/DMD
    • 1) CO license
    • 2) any drug necessary to proper practice of dentistry
    • 3) NO CS II for self/family
  42. 3 characteristics of CO Rx authorized OD
    • 1) CO license
    • 2) certified as TPA (therapeutic optometrist)
    • 3) NO CS II's
  43. 3 characteristics of CO Rx authorized PA
    • 1) CO Certification by Board of Medical Examiners
    • 2) written Rx on supervising physician's Rx forms w/ preprinted name, address, telephone # of supervising MD & PA
    • 3) own DEA #
  44. required to be in child-resistant containers
    • 1) all oral Rx drugs
    • 2) some OTCs (ASA, Fe, APAP, IBU, lidocaine, napoxen, diphenhydramine, loperamide)
  45. exception for child-resistant containers (4)
    • 1) elderly/handicapped if labeled
    • 2) rapid access (angina) meds
    • 3) IP requests
    • 4) pt requests

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