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TX MPJE > Brinkley review > Flashcards

Brinkley review Flashcards

1
Q

recall classifications

A

Class I – worst, reasonable likelihood of serious AEs
Class II – temporary or reversible AEs
Class III – least concerning, not likely to cause AEs

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2
Q

patient package inserts (PPIs)

A
  • required for estrogen- and progestin-containing products

- must be given to inpatient at first administration and q30 days thereafter

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3
Q

Med guides

A
  • required for many different products that FDA deems necessart
  • no requirement for inpatient distribution
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4
Q

major exclusions from Poison Prevention Packaging Act

A
  • bulk containers not intended for household use
  • drugs for institutionalized patients
  • several products intended for emergency/rapid use
  • several products commonly dispensed in unit dose forms
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5
Q

A medication regimen review must be performed for LTC patients every _______

A

-every 30 days

This is a CMS requirement

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6
Q

mailing prescriptions by USPS

A
  • allowed provided contents are not alcoholic beverages, poisonous, or flammable
  • controlled drug outer packaging cannot contain any words/symbols indicating its contents
  • UPS and FedEx can deliver any Rx drugs and are not subject to above restrictions
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7
Q

For what purposes can a pharmacy use/disclose PHI without authorization from the patient?

A
  • for treatment
  • for payment
  • for healthcare operations
  • gov’t functions: LEOs, PMPs, adverse event reporting
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8
Q

How long do pharmacies have to respond to patient requests for their own PHI?

A

-within 30 days, but can request an extension for another 30 days

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9
Q

How long do pharmacies have to respond to patient requests to amend their PHI or obtain record of disclosures?

A

within 60 days, but can request extension for another 30 days

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10
Q

Notification requirements when there is a breach of patients’ PHI

A
  • notify patient within 60 days of discovery
  • for breaches < 500 individuals, maintain log and reports to HHS annually
  • for breaches > 500, notify HHS and local media within 60 days
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11
Q

DEA form for applying for a DEA number

A

Form 224 (for prescribers and dispensers)

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12
Q

Can federal/military prescribers write CII’s in Texas?

A
  • only if on official TSBP prescription pad, which requires DEA registration in Texas
  • otherwise can be filled only at federal facility/base
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13
Q

A new owner can use the previous owner’s DEA for up to how long after the purchase?

A
  • up to 45 days

- previous owner must grant POA to purchaser

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14
Q

What’s the highest concentration a pharmacy can compound narcotics?

A
  • up to 20%

- any more and the pharmacy would need to be registered with DEA as a manufacturer

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15
Q

scheduling concentrations of codeine

A
  • CIII 18 mg/ml

- CV 2 mg/mL or 90 mg per dosage unit

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16
Q

scheduling concentrations of opium

A
  • CIII 5 mg/ml

- CV 0.5mg/mL (less than that of federal limit)

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17
Q

where do triplicate forms of 222 go?

A
  • Purchaser keeps copy 3, sends copies 1 and 2 to supplier

- supplier keeps copy 1, sends copy 2 to DEA

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18
Q

If a C-II order cannot be completed in its entirety, the supplier has ____ days to do so

A

60 days

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19
Q

What items must the C-II purchaser record on their copy of the 222 form after receiving the shipment?

A
  • number of containers received

- date received

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20
Q

Invoices for controlled substances must be initialed/dated by that pharmacist, except in what cases?

A

Class C-ASC and Class F pharmacies

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21
Q

5% rule

A
  • a pharmacy can distribute of up to 5% of the total controlled substances dispensed during a 12-month period
  • any more requires registering with DEA as a distributor
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22
Q

storage of controlled substances

A
  • can be in a secure locked cabinet or unsecured scattered throughout – but not together on an unsecured shelf
  • C-II’s must be securely locked in Class C and Class F pharmacies
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23
Q

how long to report CS theft or significant loss

A
  • 1 business day

- can take time to investigate before submitting form 106, but keep DEA updated, esp. if taking longer than 2 mos

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24
Q

form for theft/loss of controlled substances

A

DEA form 106

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25
Q

“Federal law prohibits transfer of this drug to any person other than…” is required for which drugs

A

CII through CIV only, although post pharmacy systems will include this on CV as well

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26
Q

form for disposal and destruction of controlled substances

A

DEA form 41

-must be submitted at least 2 weeks prior to proposed destruction date

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27
Q

how many must witness destruction of controlled substances

A

at least 2 witnesses

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28
Q

how often does DEA require an inventory of CSs

A

every 2 years (biennial)

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29
Q

how often does TSBP require inventory of CSs

A

annually

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30
Q

exact vs estimated count during inventory

A
  • exact for all CII’s
  • exact for all containers holding > 1000 tablets
  • estimates allowed for the rest
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31
Q

when is a perpetual inventory required?

A
  • CII’s in class C pharmacies
  • all controls at remote locations
  • all controls at class C-ASCs
  • all controls at class F
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32
Q

which CS inventories do NOT require notarization

A

initial and change of PIC

33
Q

how long after conducting CS inventory must the inventory be notarized?

A

within 3 days, excluding Sat/Sun and federal holidays

34
Q

how must CS hard copies be stored?

A

TSBP mandates three separate files: non-controls, C-III through C-V, and C-II

35
Q

what controlled substance records cannot be kept centrally, but must stay on site at the pharmacy?

A
  • inventories
  • executed 222s
  • hard copy scripts
36
Q

how can a pharmacy request central record keeping of records related to CSs?

A
  • notify nearest DEA field office of intention

- if DEA does not deny request, it is ok to start central storage 14 days after giving notifcation

37
Q

what prescriptions can a Designated Agents communicate for a prescriber

A
  • CIII through CV and noncontrols

- cannot authorize emergency fills of C-IIs…only the prescriber themself can do this

38
Q

T/F: quantity must be written numerically for all controlled rx’s

A

True – only exception is for e-Rx. If the quantity is not spelled out, the pharmacist should call prescriber to verify qty

39
Q

what elements CANNOT be changed on a C-II rx?

A
  • name of patient
  • name of drug
  • name of prescriber
  • date of rx
40
Q

what are quantity limits for C-IIs?

A
  • no quantity limit for a CII rx

- when a prescriber issues multiple CII rx’s at once, they are collectively not to exceed a 90 DS

41
Q

when can a faxed C-II serve as the original rx?

A
  • CII narcotics for patients using home infusion/IV pain tx
  • CII’s for patients in LTCFs
  • CII narcotics for patients in hospice care
42
Q

T/F: faxed CII’s can be valid emergency CII’s

A

True, but the same rules apply for receiving a valid rx in a timely manner. ie the fax is NOT the original rx

43
Q

what is the quantity limit for emergency CII fills?

A

No specific quantity limit. Amount must be limited to the qty necessary to treat patient during the emergency period

44
Q

how long does the prescriber have to send in a valid rx following a CII emergency fill?

A
  • must be sent within 7 days of authorizing emergency fill

- rx should be marked “authorization for emergency dispensing”

45
Q

partial filling of CII’s

A
  • per 2016 federal law, can be partial filled for up to 30 days BUT the stricter TX law of completion within 72 hrs still stands
  • terminal and LTCF patients can get partials as many times as needed as long as they are completed within 60 days
46
Q

CII dispensing upon discharge from hospital

A
  • discharged pts can receive up to a 7 day supply without having to get it on an official TX CII rx
  • must be dispensed from hospital pharmacy
47
Q

transferring controlled rx’s

A
  • can be done only once per rx

- only refills can be txr’d, meaning you cannot transfer on hold prescriptions

48
Q

what schedules does the PMP collect/report rx data for?

A

CII through CV

49
Q

how long does the pharmacy have to transmit data to PMP?

A

-no later than the next business day after the date the rx was completely filled

50
Q

restrictions on methadone

A
  • can only be dispensed at retail level for analgesia (not detoxification)
  • methadone 40mg cannot be purchased by retail pharmacies, only by hospitals and detox centers
51
Q

short vs long term detox

A
  • short term means weaning over no more than 30 days

- long term means weaning over 30 to 180 days

52
Q

patients not enrolled in a drug detox program can receive narcotics for detox/maintenance under what circumstances?

A
  • a physician can administer (not prescribe) up to 3 day supply until individual is enrolled in detox
  • hospital can administer narcs if pt is in hospital for a condition other than their addiciton
53
Q

DATA-waived practitioner

A
  • prescribers authorized to prescribe certain CIII-V narcotics for detox purposes – mainly subutex and suboxone
  • have “X” code along with DEA
54
Q

how many patients can a DATA-waived prescriber treat

A
  • physicians can treat 30, 100, or 275 patients depending on their authorization
  • midlevels are limited to 30 pts
55
Q

PSE limits

A
  • 9 grams per month, 3.6 grams/day

- if mail order, 7.5 grams/month

56
Q

minimum age to purchase PSE products

A

16 yrs, shown my state or federal photo ID

57
Q

restrictions on auto-refills for CSs

A
  • not allowed for CIII

- ok for CIV and CV

58
Q

storage of PSE products

A

behind secure counter, or in locked cabinet within 30 ft of and in direct eye line of pharmacy counter

59
Q

restrictions on out-of-state prescribers

A
  • no restrictions on independent practitioners…same as if in state
  • out of state midlevels have no restrictions on non-controls, but cannot prescribe controls
60
Q

restrictions on Canadian/Mexican prescribers

A
  • written rx’s only…no electronic or verbals

- no controlled rxs

61
Q

can you transfer rx’s written by Mexican/Canadian prescribers

A
  • ok to transfer between two TX pharmacies

- cannot transfer from a pharmacy in another state

62
Q

can midlevels prescribe controls?

A
  • yes, if they are based in Texas

- rx and any refills are valid for only 90 days

63
Q

what happens to refills on an rx if the prescriber dies?

A
  • no set in stone rules/laws

- TX Medical Board has stated it is ok to fill a single 30 ds while patient finds another provider

64
Q

how many midlevels can a physician supervise?

A
  • no more than 7 PAs/APRNs

- more allowed for underserved areas, LTCFs, or facility-based practices

65
Q

T/F: rx label must have name of supervising physician for rx’s written by midlevels

A

False – is okay if label has only prescribing midlevel

66
Q

when can midlevels write C-IIs?

A
  • in hospital-based practices

- for terminally ill patients receiving hospice care

67
Q

requirements for scripts written by midlevels

A
  • name/address/phone # of both prescriber and their supervising physician
  • DEAs of both practitioners, if controlled
68
Q

T/F: an out of state APRN can write for tylenol #3

A

False — no controls can be filled if written by out of state midlevel

69
Q

list the classes of pharmacy

A
  • class A: community
  • class B: nuclear
  • class C: institutional
  • class D: clinic
  • class E: nonresident

A, C, and E can have S-designations if producing sterile products

70
Q

TSBP members

A

11 total members

  • 7 pharmacists
  • 1 tech
  • 3 public members
71
Q

requirements for pharmacist TSBP members

A
  • resident of TX
  • currently practicing pharmacy
  • licensed in TX for preceding 5 yrs
  • CANNOT be a lobbyist, employee/consultant of Texas healthcare trade company (applies to spouse too)
72
Q

terms of TSBP members

A
  • 6 year terms

- cannot serve more than 2 consecutive full terms

73
Q

how does one become a TSBP member?

A

-appointment by governor, with advice/consent of senate

74
Q

how many times can a pharmacist candidate take the NAPLEX/MPJE

A

up to 5 times

75
Q

what is an intern trainee

A
  • a type of pharmacist intern

- for individuals in their first professional year at a Texas pharmacy school

76
Q

what is a student intern

A
  • a type of pharmacist intern

- must have completed at least 30 credit hours of a professional program (doesn’t specify a Texas program)

77
Q

How does a student intern lose their intern status?

A
  • leaving (i assume without graduating??) the pharmacy school
  • failing the MPJE and/or NAPLEX
  • not taking the MPJE and NAPLEX within 6 mos of graduation
78
Q

how many intern hours must a pharmacist have to be licensed?

A

-1500 hours

79
Q

what restrictions do intern trainees have compared to other types of pharmacist interns?

A
  • can do any role other interns can (ie an do anything a pharmacist can do as long as they are supervised)
  • however, they can ONLY do this at sites that are assigned to them by their pharmacy school

TX MPJE (1 decks)

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