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JP Exam 2 > Lecture 4 - 7/14/2022 > Flashcards

Lecture 4 - 7/14/2022 Flashcards

1
Q

DEA Form 41 info

A

Destruction & Disposal form

used when non-recoverable breakage or spillage occurs

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2
Q

DEA Form 222 Info

A

Order form for Schedule I & II, electronic equivalent is CSOS

Form required for each distribution, purchase or transfer oa schedule II controlled substance

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3
Q

DEA Form 106 Info

A

Documents thefts or significant losses of controlled substances

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4
Q

Records of Theft or Loss tips (Federal)

A
  1. notify the Field Division Office of the Administration in his area, in writing, of the theft or significant loss of any controlled substances within 1 business day of discovery of such loss or theft
  2. complete, submit to the Field Division Office in his area, DEA Form 106 regarding the lessor theft
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5
Q

Power of Attorney Info

A

A registrant may authorize one or more individuals, whether or not located at his or her registered location, to issue order for Schedule I/II controlled substances on the registrant’s behalf by executing a power of attorney for each individual

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6
Q

What to consider if determining whether a loss is significant

A

(1) The actual quantity of controlled substances lost in relation to the type of business;
(2) The specific controlled substances lost;
(3) Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;
(4) A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known,
(5) Whether the specific controlled substances are likely candidates for diversion;
(6) Local trends and other indicators of the diversion potential of the missing controlled substance.

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7
Q

Loss or theft MA Law

A

Registrant are required to report the loss of any controlled substances upon discovery to the Drug Control program within 24hrs of discovery

who the report is to depends on licensure

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8
Q

Prescriptions for Controlled substances are required to….

A
  1. be dated as of, signed on, the day issued
  2. full name and address of patient
  3. drug name, strength, dosage form
  4. quantity prescribed
  5. directions for use
  6. name, address and registration number of practitioner
    • Additional in MA **
      1. interchange is mandated unless the practitioner indicates ‘no substitution’ in accordance with the law
  1. for any Schedule 2 opioid, shall include notion on prescription that pt may fill, upon request, prescription in an amount not to exceed the recommended full quantity indicated
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9
Q

Faxing prescription

A

Permit generally only if pharmacist receive the original written and signed prescription before actual dispensing

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10
Q

When can a Fax prescription serve as original

A
  1. 21 CFR 1306.11(e) CII narcotic to be compounded for IV, IM, SC, Intraspinal, parenteral administration
  2. 21 CFR 1306.11 (f) CII drug for residents of LTC facilities
  3. 21 CFR 1306.11(g) CII narcotic patients of hospice care program certified by/or paid for by Medicare
    Note: LTC not limited to CII narcotics
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11
Q

Emergency Oral Prescription Requirements

A
  1. quantity prescribed and dispensed is limited to amount adequate to treat pt during emergency period
  2. prescription contains all info req except for actual signature of prescribing practitioner, and prescription is immediately entered into a compliant electronic pharmacy system or otherwise reduced to writing by the dispensing pharmacist
  3. if prescribing practitioner is not known to the dispensing pharmacist, the dispensing pharmacist makes reasonable good faith effort to determine that the orally transmitted automation was used by a prescribing practitioner
  4. W/in 7 business days, prescribing practitioner shall have Electronic or written prescription for the emergency quantity prescribed and delivered to the pharmacy and have written “ Authorization for Emergency Dispensing” and comply w/ Federal and State law. Can be delivered in person or mail, but if mail must be postmarked within 7 day
  5. once received, dispensing pharmacist should attach the prescription to orally transmitted emergency prescription. Must notify nearest offie of DEA if prescribing individual fails to deliver a written prescription within accordance of 105 CMR 721.060(B)(4)
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12
Q

What is an emergency situation

A
  1. Situation where prescribing practitioner intends to prescribe a CS, the immediate admin of which is necessary for proper treatment of the ultimate user and….
    a. it is not reasonably possible to generate or transmit an electronic prescription to be presented to the person dispensing the CS prior to dispensing or….
    b. prescribing practitioner determines that the Electronic prescription req would result in a delay that would adversely impact patients medical condition or….
  2. any other emergency situation defined in Der guidance by commissioner
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13
Q

Can Schedule II have refills?

A

No its Federally prohibited

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14
Q

Controlled Substances Schedule III - IV refills?

A

Authorization of refills is permitted

limited to more than 5 times within 6 months

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15
Q

Controlled Substances Schedule V refills?

A

no limits, but generally included CV in the CIII-CIV rule

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16
Q

What to do if Lost or Stolen DEA 222 Form

A
  1. Verify w/ supplier that DEA 222 Form was not received by supplier
  2. notify DEA in writing with serial # of lost or stolen form, date, and statement that CS were never received
  3. File the statement with copy 3 of lost or stollen form
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17
Q

A CSOS order may not be filled if…

A
  1. The required data fields have not been completed.
  2. The order is not signed using a digital certificate issued by DEA.
  3. The digital certificate used has expired or been revoked prior to signature.
  4. The purchaser’s public key will not validate the digital certificate.
  5. The validation of the order shows that the order is invalid for any reason.
    If the order meets any of the above it is an unaccepted and defective electronic order
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18
Q

Disposal and Destruction process

A

DEA Form 41 completed by authorized reverse distributor

  1. A pharmacy may transfer controlled substances to a DEA registered reverse distributor who handles the disposal of controlled substances.
  2. When a pharmacy transfers schedule II controlled substances to a reverse distributor for destruction, the reverse distributor must issue an official order form (DEA Form 222) or the electronic equivalent to the pharmacy.
  3. When schedules III-V controlled substances are transferred to a reverse distributor for destruction, the pharmacy must maintain a record of distribution that lists the drug name, dosage form, strength, quantity, and date transferred.
  4. The authorized reverse distributor completes and files the DEA Form 41
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19
Q

Loss Vs Breakage and Spillage

A

Breakage and Spillage doesn’t constitute a loss, since registrant can account for the controlled substances.

These incidents don’t req notification to DEA

If they’re recoverable, there’s options to dispose of them (Promptly destroy, send to reverse distributor, contact DEA and req assistance)

** If the breakage or spillage is clearly observed, but the controlled substances are not recoverable, the registrant should document the circumstances of the event in his or her records. ** (DEA Form 41)

20
Q

Multiple C2 prescriptions for same patient/same drug

A
  1. A practitioner may provide individual patients with multiple prescriptions for the same schedule II controlled substance to be filled sequentially.
  2. The combined effect of these multiple prescriptions is to allow the patient to receive, over time, up to a 90-day supply of that controlled substance.
  3. All RXs must be dated with the date of issuance (i.e. date written)
  4. Subsequent RXs must contain a “do not dispense before date”
21
Q

Transferring Refills C3-C5

A

Authorized refills maybe transferred from one pharmacy to another once within the 6-month period

** Exception - if sharing online database one-time restriction doesn’t apply **

22
Q

Federal Expiration of CII?

A

No time limit exists

23
Q

Massachusetts Expiration of CII?

A

Invalid 30 days after the date of issuance

24
Q

Federal Limit on amount prescribed for CII?

A

None

States may have more restrictive rules

25
Q

Massachusetts limits on amount prescribed for C2 & C3?

A

Controlled C2 or C3 prescriptions shall not be filled for more than a 30 day supply on a single filling

26
Q

Exceptions to Massachusetts limit on amount prescribed for C2 or C3

A

**dextro amphetamine sulphate and methylphenidate hydrochloride may be filled for up to a 60 day supply of such substance upon any single filling if for the treatment of minimal brain dysfunction or narcolepsy; (If script doesn’t say “For ADHD” then cant assume and that it meets the exception. ***

** implantable infusion pumps consisting of Schedule II or Schedule III controlled substances may be filled for a maximum of 90 days. Note: MUST FOLLOW USP <797> Beyond Use Date (BUD) **

27
Q

Supply limitation for opiate naive or minor patient?

A

7 day supply max

Naive = never used, so if says they never pick up prescriptions = assume they’re naive

28
Q

Limits on who can prescribe, Out of State providers for C2 non-narcotic (non opioids)

A

Has to be filled within 5 days of being written

Can be from any state

29
Q

Limits on who can prescribe, out of State providers for C2 narcotics (opioids/pain meds)

A

Has to be filled within 5 days of being written

Has to be from Maine or Contiguous state (Touching)

VT/NH/ME/NY/CT/RI

30
Q

Can you dispense controlled substances without a prescription in MA?

A

Nah

31
Q

Requirements if Dispensing a controlled substance without prescription

A
  1. Dispensing may only be done by a pharmacist
    2.No more than 240mL or 48 units of an opium containing compound or
    no more than 120mL or 24 dosage units of any other controlled substance may be sold in any 48-hour period
    3.Purchaser must be 18 years of age (requires ID)
    4.Bound book kept for recording all sales
32
Q

Partial Fill C2 (Federal) permitted if…

A
  1. if cant fill full amount but remainder can be filled in 72hrs
  2. Terminally ill (same as LTC)
  3. LTC (can do partial up to 60 day from issuance, can do a 30 day supply but have 2 months to do it)
  4. Pt requests
33
Q

CARA allowed for….

A

pharmacies to provide partial fills of a CII medication up to 30 days from the date of the prescription, if requested by the patient or provider

some states may have stricter requirements or limits

34
Q

C2 needs 2 pieces of required info….

A

interchange is mandated unless indicated

patient may request partial of what’s being recommended

35
Q

Partial Fill C2 (Mass) laws

A

.

36
Q

Partial Fills for C3-C5 (Federal)

A

Partial refills of Schedule III, IV, and V controlled substance prescriptions are permissible under federal regulations provided that:

  1. each partial filling is dispensed and recorded in the same manner as a refilling (i.e., date refilled, amount dispensed, initials of dispensing pharmacist, etc.),
  2. the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and
  3. no dispensing occurs after 6 months past the date of issue

Mass Law = Same

37
Q

Things that may never be changed or added C2 - C5

A
  1. pts name
  2. controlled substance prescribed (except generic sub)
  3. prescribers name
  4. prescribers signature
  5. earliest date to be filled (C2 only)
38
Q

Things that may be changed or added without consultation w/ provider C2

A
  1. pt address if omitted

2. DEA if omitted

39
Q

Things that may be changed or added without consultation w/ provider C3-C5

A
  1. Pts address if omitted

2. Prescribers DEA

40
Q

Things that may be changed or added only after consultation w/ provider C2

A
  1. Date of issue only added if omitted
  2. prescribers address
  3. pts address added if omitted w/o consult, changed after consult with prescriber or authorized agent**
  4. prescribers DEA number added w/o consult**
  5. Directions
  6. dosage form
  7. strength
  8. quantity prescribed
  9. supervising physician of Mid Lvl Prescriber
  10. Following can be added and prescribers office notified if omitted
    a. No sub
    b. partial fill
41
Q

Things that may be changed or added only after consultation w/ provider C3-C5

A
  1. date written if omitted
  2. prescribers address
  3. pt address if omitted w/o consult, changed after consult**
  4. DEA added w/o consult
  5. directions for use
  6. dosage form
  7. dosage strength
  8. quantity prescribed
  9. refil info
  10. supervising physician
  11. no sub can be added and office notified if omitted
42
Q

What has to documented with each change to a Controlled prescription

A
  1. the date
  2. item changed or added
  3. name of authorizing prescriber
  4. name of pharmacist accepting/making change
43
Q

Can days supply dispensed be changed?

A

ex. 30 DS w/ 11 refills vs 90DS w/ 3 refills

maybe changed without consultation only for drugs that dont require PMP reporting and w/ pharmacist professional judgement

44
Q

Can days supply dispensed be changed?

A

ex. 30 DS w/ 11 refills vs 90DS w/ 3 refills

maybe changed without consultation only for drugs that dont require PMP reporting and w/ pharmacist professional judgement

45
Q

C2 partial for doctor thats out of state?

A

Initial partial has to be within 5 days of prescription issue date, remaining portion maybe filed within 30 days of prescription issue date

46
Q

Partial C2 fill

A
  1. only pharmacy dispensing original quantity may dispense remaining portion
  2. if partial requested by patient, they have 30 days to get remainder….if partial initiated by pharmacy due to OOS, they have 72hrs to fill remainder.
47
Q

Partial C2 fill Mass Law

A
  1. only pharmacy dispensing original quantity may dispense remaining portion
  2. if partial requested by patient, they have 30 days to get remainder….if partial initiated by pharmacy due to OOS, they have 72hrs to fill remainder.

JP Exam 2 (5 decks)

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