Law Chapter 5

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Law Chapter 5
2011-10-08 22:00:53
Law Chapter

Law Chapter 5
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  1. Controlled substance Rx defined as
    • order for medication dispensed to ultimate user
    • does not include orders in hospital charts
    • prohibition against prescriptions for office use
  2. Communication of Rx to the pharmacy
    • may be an individual under the direct supervision of prescriber
    • may not be a nurse or other at an offsite location unless they report directly to the doctor
    • secretary may prepare rx for physician's signature
    • C2-5 may be transmitted electronically as long as DEA requirements are met
  3. normal provider DEA number
    • 2 letters 7 numbers
    • A, B or F then last initial
  4. Midlevel practitioner DEA number
    begins with M
  5. Distributor DEA number
    begins with P or R
  6. Practitioners certified to prescribe suboxone
    DEA begins with X
  7. Checking DEA numbers
    (1st+3rd+5th) +[(2nd+4th+6th)x2] = the 7th digit in the DEA number
  8. Those allowed to dispense CS
    • pharmacist in usual corse of professional practice who is registered or works for a registered entity
    • Ancillary personnel if allowed by state
    • IPs may dispense if allowed by state
  9. Information on CS script
    • date of issuance (no pre or post dating)
    • full name and address of pt
    • drug name and strength
    • dosage form
    • quantity
    • directions for use
    • name, address and DEA number of prescriber
  10. Correcting errors and ommisions on C2-C5
    • pharmacist may add or change any information after consultation with practitioner and documentation
    • except pt's name, name of drug and prescribers signature
  11. Emergency situations with CIIs
    • oral or fax rx is permissable
    • original must be received in 7 days
  12. When the faxed Rx serves as the original:
    • narcotic compouneded drug for direct infusion
    • LTCF
    • Hospice
  13. Partial fill of CII
    • balance must be filled w/in 72 hours
    • up to 60 days for LTCF or terminally ill pt providing record keeping requirements are met
  14. Multiple CII Rx for same drug and same pt on same day
    • total qty cannot exceed 90 days
    • doctor determines legitimate medical purpose
    • date to be filled is written on the Rx
  15. C3-5 dispensing
    • may be written, faxed, oral or electronic
    • oral orders must be promply reduced to writing
  16. C 3 and 4 drugs refilling
    • limit of 6 months or 5 refills whichever is first
    • physician may authorize additional refills if original Rx was written with less than 5 refills.
    • must document on original script
    • refill qty cannot exceed original qty
  17. Refilling CIII and IV
    • signed by pharmacists who refills each time within 72 hours of refill
    • may use logbook instead
    • records must be maintained for 2 years
    • must have backup system incase computer goes down
  18. Labeling for CSs must include
    • date of initial fill
    • date of dispensing
    • "do not transfer" statement
    • all required info
    • labeling requirements not applicable for institutionalized patients
  19. controlled Rx may be transfered
    • none if CII
    • one time if C3-5
    • as many times as there are refills between chain stores
  20. Requirements of the transfering pharmacy
    • write void on the face of the transfered script
    • record on the back of the Rx:
    • Name
    • Address
    • DEA # of pharmacy transfered to
    • Date of transfer and name of transfering pharmacist
  21. requirements for pharmacy receiving transfer
    • write transfer on the face of transferred rx
    • record all info on C3-5 rxs:
    • Date of original rx
    • number of original fills
    • date of 1st dispense
    • # refills remaining & dates/locations of other fills
    • transfering pharmacy name, address DEA, Rx #
  22. Transferred Rx paper work must be kept for
    2 years
  23. Internet pharmacy that sell Rx meds to customers without Rx or issuing pursuant to surveys
    rogue internet pharmacy
  24. Ryan Haight Act efines a valid Rx as one that
    • has been issued for a legit medical purpose by a practitioner who has conducted at least one in person medical evaluation
    • only applies to controlled substances
  25. Pharmacies that fill CS rx through internet pharmacies or websites that provide physicians for on line consults
    • have special DEA registration requirements
    • pharmacies submit separate DEA registration and maintain online dispensing records
  26. Prescribers who work with internet websites
    must conduct at least one in person evaluation of the patient before prescribing
  27. Central filling pharmacies
    • fill rx for other retail pharmacy
    • fill both new and refills
    • must be transported to pharmacy for patient
    • label indicates which pharmacy dispensed the drug
    • cannot accept Rx directly and cannot provide rx directly to/from pt or prescriber
  28. corresponding responsibility doctrine
    applies to pharmacists at both facilities of a central filling set up
  29. Automated dispensing systems
    • stores
    • pkg
    • counts
    • labels
    • dispenses medication
    • maintains transaction information
  30. Purpose of automated dispensing systems in LTCFs
    reduce stock of excess controlled substances
  31. DEA has taken the position that LTCFs cannot
    transfer CS back to the pharmacy
  32. Pharmacy that installs ADS at LTCF
    must maintain separate DEA registration at LTCF location
  33. State PMPs require pharmacies to
    electronically transmit records of CS Rxs dispensed to the state
  34. State PMPs
    • enable state to determine possible diversion and abuse situations
    • allow practitioners to request pt specific info
  35. NASPER
    enabled states to obtain federal grant support for PMP programs
  36. Three types of records that every registrant must keep
    • inventory
    • drugs received
    • drugs dispersed
  37. negligent recordkeeping is a violation of the
  38. General record keeping requirements
    • keep for 2 years
    • may be kept at a central location as long as DEA knows
    • must be able to obtain records within 2 days at DEA request
    • C 1 and C2 records must be maintained separately
  39. Prior to beginning business and every ___ years and inventory must be done of all CS on hand
    2 years
  40. On hand means
    in possesion of or under the conrol of the registrant
  41. Inventory
    • taken at beginning or end of business day
    • must be written, typed or printed
  42. Newly scheduled drugs
    must be inventoried on date of scheduling
  43. Exact count must be made on
    C1 and C2
  44. Estimated count is permissibe for C3-5 unless
    container holds more than 1000 units
  45. Acceptable records of receipt
    • invoices
    • form 222
    • pharmacy must record date received on invoice
  46. If invoice contains both CS and nonCS
    CS must be identifiable in a manner so as to be readily retrievable
  47. Records of dispersal
    • Rx
    • record books
    • form 222
    • invoices
    • records of disposal
    • theft or loss
  48. In some states CV may be sold w/o rx as long as:
    • dispensing done by a pharmacist
    • no more than 8oz of opium or 4oz of any other CS dispensed w/in 48 hrs to the same person
    • purchaser must be 18 and have ID
    • sale must be recorded
  49. distributin from pharmacy to another practitioner
    • invoice required for C3-5
    • Form 222 for all C2
    • total distributed must not exceed 5% of total units of CS distributin and dispensed in 1 year.
  50. Disposal or destruction
    • must request DEA form 41 online
    • must record name of drug, number of containers and content of each to be disposed
  51. DEA allows destruction without DEA presence in one of 3 manners
    • witnessed by 2 people who should be health care licensees or law enforcement
    • forward CS to a DEA registered distributor
    • Blanket authorization for hospitals and clinics that have to dispose used needles, syr or other injections.
  52. Requirements for loss or theft
    • registrants must report significant losses and theft in writing to the field office of the administration
    • must report immediately upon discovery
    • Form 106 to document loss
  53. Factors to consider to determine significant loss
    • types and amounts of CS lost or stolen
    • activities and individuals involved in the loss
    • pattern of loss
    • local trends in the area
  54. DEA form 222
    • required for distribution of C1 or C2
    • forms obtained by requests in writing to nearest DEA office
    • 7 or 14 forms will be mailed
    • each form has 3 copies
    • forms are serial numberd
    • no errors may be corrected nor any info changed
  55. Execution of form 222
    • all copies executed simultaneously
    • 1 item per line (10 max)
    • number of last line noted on each form
    • NDC # optional
    • sign and date
  56. copy 1 of DEA 222
  57. Copy 2 of DEA 222
  58. Copy 3 of DEA 222
  59. Upon receipt of order purchaser must
    record # of containers and each item received
  60. Partial fills by the supplier must be fulfilled within
    60 days
  61. Electronic order system (CSOS)
    • may be used instead of form 222
    • purchaser can order any drug
    • registrant must obtain a digital certificate for each DEA registered location
  62. when C1 and C2 drugs are distributed among registrants
    Form 222 must be used
  63. If unfilled order form is lost
    • purchaser must execute another form
    • statement noting serial number of lost form
    • date of lost form
    • CS that were not received
  64. In the case of lost or stolen forms the party must maintain together
    • copy 3 of second (new) order form and lost order form with statement
    • copy of statement must be sent with copies 1 and 2 to supplier
  65. If forms are stolen or lost other than in transmission
    • must notify DEA and provide serial numbers of missing forms
    • if found notify DEA
  66. Executed form 222s
    • maintained separately from all other records
    • retained for 2 years
    • copy 3 must be kept at the registered location
  67. Purpose of DEA E-rx rule
    • provide allowance for e-rx of CS in C2-5
    • not a mandate
    • ensures that e-rx dose not facilitate diversion
    • prevents non-registrants from accessing e-rx applications to alter or generate fraudulent rx's
  68. Unsigned e-rxes must
    be treated in the same manner as other unsigned CS prescriptions