LA MPJE Flashcards

1
Q

Can marijuana pharmacies advertise?

A
  • Not to the public! Can advertise directly to practitioners

- allowed to have 2 signs on outside of bldg, max 1600 sq. inches

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2
Q

Re-use of prescription vials

A

Ok for glass, no allowed for plastic

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3
Q

Who needs a CDS?

A

Every person/entity who does or proposes to manufacture, distribute, prescribe, or dispense controlled substances

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4
Q

All rx records should be kept for how long?

A
  • 2 years

- up to 10 years if medicare (federal) involved

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5
Q

How long is PTC registration good for?

A
  • 2 years, non renewable
  • if a PTC leaves training program, the license dies. If they return to program, license can be re-activated, but original 2 year expiration remains
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6
Q

how does a pharmacist qualify to be PIC?

A
  • active LA pharmacist license
  • have been a pharmacist at least two years, in any state
  • complete and notarize PIC affidavit
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7
Q

How many EDK permits may one pharmacy have?

A

Unlimited, but remember the PIC of the provider pharmacy is still responsible for all EDKs

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8
Q

Who keeps the pieces of the 222 triplicate?

A

Copy 1 - Supplier
Copy 2 - DEA
Copy 3 - purchaser

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9
Q

What is floor stock used for?

A

For first dose and as needed doses only

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10
Q

A pharmacy must be open at least ___ hrs per week

A

10 hrs

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11
Q

Process of a drug becoming scheduled

A
  • Secretary of HHS recommends, AG considers and decides

- If the UN passes a rule, then the HHS Sec must consider scheduling

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12
Q

What products have NDCs?

A

All Rx-only products must have an NDC, although it doesn’t have to appear on the label. NDC not required for non-Rx

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13
Q

Generic drugs can deviate ___% from their reference product

A

-20% to +20%

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14
Q

Partial filling C-II’s for reasons other than inventory

A
  • ok for LTCF or terminally ill pts…must be written on rx
  • each partial fill must be noted on original script, or kept electronically
  • must fill entire amt within 60 days
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15
Q

BUD of compounded prescriptions (in absence of stability data)

A
  • Aqueous solutions: 14 days at cold temperature
  • Nonaqueous solutions: 25% of time left or 6 mos
  • For all others: duration of therapy, with max of 30 days
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16
Q

Anti-tampering requirements

A

An indicator that provides visible, enduring evidence that a package has been opened and potentially tampered

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17
Q

what are automated medication systems (AMS)?

A
  • mechanical systems that store/package/deliver meds
  • require their own permit (and CDSL if appl)
  • must be in a licensed hospital or healthcare area
  • may be profile- or non-profile driven
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18
Q

When do AMS permits expire?

A

Annually on June 30th

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19
Q

When can prescribers fax C-IIs?

A
  • LTCF residents
  • Hospice-enrolled patients
  • Home infusion pharmacies
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20
Q

Pharmacy technician certificates expire every ____

A

annually, on June 30th

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21
Q

documenting C-IIs when a central fill will fill it

A

-retail pharmacist writes “Central fill” on hard copy along with name, address, DEA # of pharmacy

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22
Q

Can patients return prescriptions?

A

Prescriptions may not legally be returned, exchanged, or redispensed once they have left the pharmacy premises. Especially for controls

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23
Q

what is telepharmacy?

A
  • a means of reaching patients in rural areas without easy access to prescription
  • allows for off-site dispensing by a pharmacy machine
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24
Q

Executive director

A
  • a pharmacist who is not a member of the board

- handles a lot of functions/operations of BOP

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25
Q

Requests for non-safety caps

A
  • Prescriber can make one-time exclusion to PPA
  • Pharmacist can make no exclusion
  • Patient can make a single or blanked exclusion
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26
Q

Expiration vs BUD dating for drugs

A
  • expiration is based on drug chemical stability, established by manufacture
  • BUD is prescription-patient specific
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27
Q

General qualifications to be pharmacy technician candidate (PTC)

A
  • at least 18 yo
  • HS graduate, or have GED
  • proof of professional eligibility (training program, experience, and/or PTCB)
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28
Q

interlocutory

A
  • summary hearing
  • has quick turnaround
  • used when there is a clear danger to the public
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29
Q

Allowed qty of controlled substances in an EDK

A

8 x 8 rule

-up to 8 unique controlled meds, up to 8 doses of each drug

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30
Q

For a C-II, what elements can a pharmacist never change/add?

A
  • Patient’s name
  • Drug’s name (except for generic subsitution)
  • Date of issue
  • Prescriber signature
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31
Q

Can you advertise your pharmacy?

A

Yes!

  • but no advertising of controlled drugs
  • currently ok to advertise compounding
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32
Q

Can practitioners prescribe narcotic drugs for detox/maintenance?

A
  • Generally no, can only administer such drugs

- however they can prescribe Subutex/Suboxone for this purpose

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33
Q

Can techs compound high risk sterile products?

A

YES!

This is a new change, mentioned in the Jan 2018 BOP newsletter. Note that PTCs still cannot do high risk though

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34
Q

T/F: Do out-of-state manufacturers and distributors need a CDS license?

A

Yes, if transporting inside LA

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35
Q

Tylenol with codeine is schedule ____

A

C-III

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36
Q

T/F: Transfers of C-IIs between central fill/retail pharmacy require a 222 form

A

False, they are exempt

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37
Q

inventory of drug cabinet

A
  • perpetual inventory of all controlled drugs stored

- PIC is responsible for conducting inventory

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38
Q

Special regulations: ipecac syrup

A
  • warning saying for emergency use only

- no more than 30 mL per bottle

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39
Q

When are you allowed to substitute generic for brand?

A
  • when prescriber did not write/mark DAW
  • patient provides informed consent
  • generic is cost saving

if paid by medicare/medicaid, wording must be “Brand (medically) necessary” to apply

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40
Q

Additional labeling requirements for veterinary prescriptions

A
  • Client name and patient species

- “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian”

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41
Q

Inventory requirements for PSE

A

Every two years, however pharmacies are excluded

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42
Q

Anabolic steroids are schedule ____

A

C-III

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43
Q

what special requirements exists to be licensed as a nuclear pharmacy?

A
  • have LA Radioactive Material License
  • have nuclear PIC
  • have dispensing, receiving, and storage areas
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44
Q

What “perks” do active duty military and their spouses receive?

A
  • applications are marked priority

- may receive a speak work pass, valid for 120 days

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45
Q

A pharmacy may be considered a distributor of CDSs when ______

A
  • 5% or more of your dosage units sold during a calendar year are CDS
  • you are then a distributor and must register as one
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46
Q

receiving verbal prescription orders

A
  • can be done by pharmacist, intern, tech
  • must be written down immediately, or pharmacist can input it directly into computer
  • sign/initial transfer, + pharmacist if necessary
  • only pharmacists can do controls
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47
Q

naloxone dispensing

A
  • ok to dispense to person who is not expected to need it

- pharmacists can enter into non-patient specific standing order with physician to prescribe it

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48
Q

Can a pharmacist dispense CDS in a clinic/amb care setting?

A

No. Pharmacists’ CDS dispensing authority is limited to being at a physical pharmacy. Physicians, nurses, and vets can dispense in clinic settings with their CDS license

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49
Q

display of permits in pharmacy

A

required for pharmacy, not personnel

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50
Q

When should you do a CDS inventory?

A
  • annually
  • when old PIC leaves and when new PIC starts
  • theft or substantial loss of CDS
  • permanent closure of pharmacy
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51
Q

Z drugs are schedule ____

A

C-IV

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52
Q

Do out-of-state pharmacists dispensing to patients in LA need to be licensed pharmacists in LA?

A

No – not unless they are PIC of an out of state pharmacy. Only the PIC needs to have a LA pharmacist license

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53
Q

How do out of state pharmacies meet counseling requirements?

A

By providing a toll-free number for call pharmacy. Must be on every bottleq

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54
Q

How many attempts can you have to pass the NAPLEX/MPJE?

A

three

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55
Q

Thalidomide REMS

A

STEPS

  • pharmacy must register
  • requires written Rx’s
  • patient must be on birth control
  • max 28 DS
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56
Q

When do DME permits expire?

A

annually on August 31

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57
Q

Bioequivalent

A
  • Having the same rate and extent of absorption as a reference product
  • Aka pharmaceutical equivalent
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58
Q

Can hospitals have off-site pharmacies for inpatient services?

A

Yes, provided there is always a pharmacist on call for emergencies

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59
Q

Under the supervision of a pharmacist, interns can do anything a pharmacist can do, except:

A
  • present himself as a pharmacist
  • sign/initial any document that must be signed/initialed by a pharmacist
  • independently supervise techs
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60
Q

BOP members

A

17 total

  • 2 from each district
  • 1 consumer representative
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61
Q

T/F: a new permit is required when a pharmacy changes location

A

Depends.
If in “reasonably close proximity” to the old location, can keep same permit and just notify board of address change.
If farther, old permit must be cancelled and new one obtained

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62
Q

Who is responsible for proper prescribing of CDS?

A

The prescribing practitioner bears most of the liability, but the pharmacist has a corresponding liability

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63
Q

qualifications to apply for a MJ pharmacy permit

A
  • no political contribution within last 2 yrs to any statewide elected official
  • they or family have not service on BOP in last 2 yrs
  • must have 100,000 escrow acct during building of pharmacy
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64
Q

What kinds of drugs may be donated to a penal pharmacy?

A
  • Non-controlled, non-expired drugs

- PIC is responsible for ensuring drugs are good

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65
Q

expiration of pharmacy intern license

A
  • one year after EXPECTED graduation date
  • or once the intern is licensed as a pharmacist
  • foreign grads have 2 yr licenses
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66
Q

What is a special event pharmacy?

A
  • meant for short term events

- permits are valid for 30 days, with single renewal of add’l 30 days allowed

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67
Q

standing committees

A

permanent BOP committees

-executive, regulatory revision, reciprocity, impairments, violations, reinstatement

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68
Q

physical space requirements of a pharmacy

A
  • total > 300 sq ft
  • work counter > 24 sq ft
  • aisles > 30” wide
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69
Q

how to dispose of CDS

A
  • complete DEA 41 and submit to Special Agent
  • agent will advise to either transfer to a licensed person for disposal, deliver to DEA, destroy in presence of agent, etc
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70
Q

How often must a drug cabinet be inspected?

A
  • every 30 days, plus or minus 5 days

- done by “the pharmacy” (so not nec. PIC)

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71
Q

T/F: Prescribers must keep records of CDSs prescribed.

A

False, only must record CDSs that were dispensed, not if they were prescribed or administered
-unless they are prescribing for detox/addiction tx

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72
Q

pharmacy intern licenses for foreign grads expire _____ after the date of issue

A

2 years

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73
Q

How long are intern hours good for?

A

Intern hours expire two years after the intern license expires

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74
Q

If a patient is prescribed ibuprofen 800 mg, can you tell the patient to just take 4 OTC tablets per dose instead?

A

No.

These preparations have not been tested for bioequivalence, and you cannot truly make that recommendation to a patient

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75
Q

What can you do with CIII-V drugs upon permanent closure?

A
  • can give to another pharmacy
  • can return to wholesaler
  • can destroy (form 41)
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76
Q

What are remote processing services?

A
  • processing of order or Rx by one pharmacy on behalf of another
  • includes all components of the dispensing process except for final transfer
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77
Q

pharmacist interns can accumulate up to ___ hrs/week

A

50

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78
Q

Selling needles/syringes without a prescription

A
  • Allowable.
  • Pharmacist is the one with the authorization to sell, but tech/clerk can conduct the actual transaction
  • Must be stored securely so customers cannot grab off the shelf
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79
Q

Form for destruction of controlled substances

A
  • DEA Form 41

- Witnessed by at least two HCPs, or an LEO

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80
Q

When must pharmacy permit (and CDS, if appl) applications be completed?

A

-At least 30 days prior to intended opening

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81
Q

A DEA registration expires after _____

A

-36 months (3 yrs)

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82
Q

how long is a special work pass valid for?

A

120 days

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83
Q

security of EDK

A
  • stored within a secure enclosure at the facility

- tamper evident ability

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84
Q

What is a drug cabinet?

A
  • NOT an ADS
  • for use when a pharmacist unavailable
  • intended for emergency use
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85
Q

notification requirements for change of PIC

A
  • permit holder notifies board within 10 days of old PIC leaving, must name a new PIC during this time
  • new PIC must notify board within 10 days of old one leaving
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86
Q

T/F: Pharmacists must register on the BOP’s imz registry

A

true

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87
Q

Techs need ___ CE hrs to renew their licenses

A

10 hrs, must be appropriate for tech level (not pharmacist)

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88
Q

Class 100 environment

A

“think clean room”

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89
Q

employee requirements of MJ pharmacy

A
  • min age 18
  • interns, techs, and pharmacist must all have TM designation and access to PMP
  • no tech candidates allowed
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90
Q

Storage requirements for 222 forms

A
  • kept separately from other information

- maintained for at least two years

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91
Q

Diphenoxylate with atropine is schedule ____

A

C-V

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92
Q

Who owns a prescription during its lifetime?

A

Prior to filling, owned by patient. After filling, owned by pharmacy. Patients can only receive copies from that point onward

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93
Q

T/F: Pharmacists can fill prescriptions from internet-based physicians

A

False, there is no valid patient-physician relationship

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94
Q

T/F: impaired pharmacists may not practice pharmacy

A

False. They may practice so long as they pose no danger to the public. (not sure how often this is the case with addicted RPhs, though)

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95
Q

For a C-II, what elements can a pharmacist add/alter after consulting with prescriber?

A
  • Drug strength
  • Quantity prescribed
  • Directions for us
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96
Q

appointment process for board members

A
  • nomination ballots go out > 60 day prior to vacancy
  • nominees can be nominated by residents of their district
  • ballots counted publicly, top 3 names go to gov. for selection
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97
Q

Can you fill prescriptions for CSs written by a foreign prescriber?

A

No, per federal rules

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98
Q

labeling requirements for drugs dispensed by hospital pharmacy for use within the facility

A
  • name and location of patient
  • name/strength of drug
  • dose to be administered
  • if compounded or sterile, BUD, who made it, who verified it
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99
Q

Who is responsible for maintaining EDKs?

A

The PIC of the provider pharmacy, who also serves as the “PIC” of the EDK

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100
Q

You are preparing unit-dose packages using a stock bottle. What is the appropriate BUD?

A
  • 25% of remaining shelf-life, up to one year

- customized patient med packs are limited to 60 days

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101
Q

Promethazine with codeine is schedule _____

A

C-V

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102
Q

When accruing intern hrs for future pharmacist licensure, what qualifications must the supervising pharmacist have?

A
  • must have been practicing as a pharmacist in his jurisdiction at least two years before the intern begins accruing hrs
  • no probation/restriction during the time hours are reported
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103
Q

What qualifies as a quorum for the BOP?

A

simple majority (9 members)

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104
Q

Requirements for pharmacist license display

A
  • must be on display at primary practice site

- you do NOT have to have a copy/ID card on you at any time, even if practicing elsewhere

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105
Q

Oral C-II prescriptions

A
  • limited quantity for emergency periods only

- prescriber must send written form to pharmacy within 7 days

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106
Q

telepharmacies must have no other pharmacies within ____ miles of them

A

20 miles

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107
Q

How much time does a supplier have to complete an order from a 222 form?

A

Must be completed within 60 days. May be partially filled in the meantime

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108
Q

qualifications to be pharmacy technician

A
  • 18 years old, HS diploma or GED
  • completion of training program, OR obtain 600 hrs of practical experience
  • pass exam (PTCB)
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109
Q

Can you fill out-of-state controls?

A

For CII-III opioids:

  • If you can access PMP for that state, yes, with no add’l restrictions
  • If not, then you can only fill 10 DS…unless rx is marked cancer pain or terminally ill

For other controls:
Yes, no restrictions

110
Q

Can an pharmacist/intern with a lapsed license work as a tech/PTC?

A

No. They are not qualified to apply for tech/PTC

111
Q

Pregnancy categories

A
A - Good studies in humans
B - Animal studies show no risk
C - No or bad animal studies
D - documented risk to fetus
X - fetal risk outweighs any maternal benefit
112
Q

What individuals are exempt from DEA registration?

A
  • military physicians (use service ID)
  • physicians in training (use institution’s DEA with unique suffix)
  • LEOs
  • End users (patient)
  • During official crisis/emergency
113
Q

Requirements to permanently close a pharmacy

A
  • public notice at least 10 days out

- board notice at least 10 days out – when, who’s getting the rx transfers, who’s getting the drugs?

114
Q

purpose of Collaborative Drug Therapy Management

A

-allows a pharmacist to coordinate with a physician to care for the physician’s patients

115
Q

Can a pharmacy be open without a pharmacist?

A
  • Yes, if the pharmacist remains on site and is available for emergencies
  • Tech or intern must remain present
  • RPh can have max 2 30-min breaks per 12 hrs
  • breaks < 5 min don’t count
116
Q

storage of controlled substances

A

may be stored in a locked, substantial cabinet, or dispersed along with non-controls

117
Q

What info is not req’d on prescription labeling per federal rules?

A
  • name/strength of drug

- Mfr and lot number

118
Q

requirements for technicians working at a telepharmacy site

A
  • must have at least two yrs as a certified technician

- are included in the remote pharmacist’s tech ratio

119
Q

Buprenorphine is schedule ____

A

C-III

120
Q

When do pharmacists licenses expire?

A

December 31 of each year

121
Q

How long is a pharmacy permit valid?

A

All permits expire Dec 31

122
Q

Storage of drugs within the EDK

A
  • must meet the storage requirements of each individual drug

- specific drugs may be stored outside of actual EDK if necessary (ie refrigerator), must document this

123
Q

Technical aspects of a fax machine receiving prescriptions

A
  • Must be located in the pharmacy

- must use non-fading paper with non-fading ink

124
Q

Isotretinoin REMS

A

iPledge

  • 2 forms of contraceptive with monthly pregnancy tests
  • Rx must be dispensed within 28 days of visit to MDO
125
Q

Patents last ___ years

A

17 years (but 12 for biologics)

  • can extend another 6 mos for peds, or 1 yr to lifetime for orphan drugs
  • First generic drug gest 6 mos exclusivity
126
Q

Dronabinol is schedule ___

A

C-III

127
Q

procedure for public comments at BOP meetings

A
  • at beginning of meeting

- max 3 min/person, max 30 min per meeting

128
Q

Is there a maximum day supply for C-IIs?

A
  • No limit per federal law
  • But max is generally accepted as 90 days
  • LA practitioner can write 3 rx’s for total 90DS, with them spaced out with DNF until dates
129
Q

PSE/ephedrine limits

A

3.6 g base per day
9 g base per 30 days
7.5 g per 30 days for mail orders

130
Q

pharmacist:intern ratio

A

1: 1

- However if interns are part of COP-associated rotation, 3:1

131
Q

Partial filling C-IIs due to being out of stock

A
  • okay for any patient

- pt must return and p/u remainder within 72 hrs of initial fill, or lose the remaining

132
Q

To approve a generic drug, its mfr must file a _____ which proves the drug is ________

A
  • must file an ANDA

- proving the drug is bioequivalent to its reference (not safe or effective)

133
Q

profile-driven vs non-provile driven

A

Profile-driven essentially means it is attached to specific patients/orders, and a pharmacist reviews meds before access is allowed by floor staff

134
Q

What conditions need to be met to give “loaners”

A
  • medication necessary for pt health, but out of refills/expired
  • physician is unavailable
  • max 72 hr supply, although you can exceed that for unbreakable products like an inhaler
135
Q

Form 224 must be signed by ________

A

The registrant (owner of the pharmacy). NOT the PIC

136
Q

When is a pharmacist considered absent?

A
  • When the pharmacist is off-site (short on-site breaks are not considered absences)
  • the prescription dept must close if pharmacist is absent
137
Q

How often must PIC be present at pharmacy?

A
  • at least 20 hrs per week

- if site open < 20 hrs per week, then at least 50% of normal business hrs

138
Q

Can a pharmacist administer medications?

A

-Yes, if the physician writes and authority to administer (AA) rx

139
Q

requirements for CDS license

A

-have appropriate Louisiana professional license/permit (MD, DDS, pharmacy permit, etc)

140
Q

How often must an EDK be inspected?

A
  • every 30 days, plus or minus 5 days

- done by provider pharmacy, not nec. PIC

141
Q

how many hrs of pharmacist CE are required each year?

A
  • 15 hrs/yr, if 3 of those hours are live

- 20 hrs/yr otherwise

142
Q

What can medical psychologists prescribe?

A

non-opioid CII to CVs. Note they cannot dispense, only prescribe

143
Q

THC variance allowed in marijuana

A

15% allowed variance

-If labeled 10 mg THC, must be be between 8.5 and 11.5 mg

144
Q

How many telepharmacies may a central pharmacy have?

A

maximum of 2

145
Q

How to get professional eligibility to become PTC

A
  • enrollment in approved technician training program
  • pass exam + completion of high school/GED
  • be licensed as tech in another state at least 1 year + have passed exam
146
Q

Are you allowed to compound drugs withdrawn/removed from market?

A

Yes, but not if the drugs were withdrawn due to safety concerns (most)

147
Q

What requirements are there if you want to keep your rx record electronic?

A
  • records must be searchable
  • must be kept for at least two years after LAST refill
  • backup must be done daily
148
Q

T/F: a patient may issue a blanket waiver to deny counseling forever

A

False

149
Q

How many intern hrs must an intern have to become licenses as pharmacist?

A
  • 1740 hrs, of which 1500 must be practical experience (under qualified pharmacist providing pharmacy primary care)
  • graduates of approved COPs automatically receive 1740 hrs
150
Q

Can you dispense a CDS written for “office use”

A

No

151
Q

What can you do with C-II drugs upon permanent closure?

A

either

  • return to wholesaler via 222
  • destroy or turn into DEA via form 41
152
Q

Can you compound a product and sell it to a physician’s office?

A

No. Previously was ok per LA law, but federal law considers this “outsourcing” and must be registered as an outsourcing facility

153
Q

What must be included on an inventory?

A
  • drug name, strength, formulation
  • number of unopened containers x qty of each container
  • number of units of each open bottle
154
Q

Who is eligible to get meds from a penal pharmacy?

A
  • offenders residing in the penal institution

- offenders in another penal institution

155
Q

If you discover a significant loss of CDS then later recover it, should you still report the loss?

A

Yes — check LABOP rules 2737

156
Q

T/F: hospitals can dispense to both inpatients and outpatient under the same permit

A

False

  • hospital outpatient dispensing requires separate permit
  • outpatient cannot acquire drugs through the hospital permit
  • maintain completely separate drug inventories
157
Q

Benzodiazepenes are schedule ____

A

C-IV

158
Q

Examples of what the board consider an ‘institution’?

A

NOT a hospital

  • nursing home
  • rehab center
  • drug abuse treatment center
  • family planning clinic
  • penal institution
  • athletic facility
159
Q

How to report theft or significant loss of CDS

A
  • Notify NOLA office of DEA and Board of pharmacy within ONE business day
  • Submit Form 106 to DEA (does not have to be done within 1 day if you need to investigate, but notification MUST still be sent)
160
Q

Dextromethorphan restrictions

A
  • Must be at least 18 to purchase OTC

- provide positive ID

161
Q

A patient is interested in taking St. John’s Wort but requires a liquid formulation. Could you compound this for her?

A

Probably not. FDA frowns on compounding using ingredients from non-FDA approved mfrs. Since this SJW is likely an OTC herbal company, they would not qualify

162
Q

what can pharmacists in a CDTM do?

A
  • monitor/modify specific drug therapy
  • collect/review patient history
  • obtain/review vital signs
  • order/evaluate lab work
  • counsel on specific diseases/conditions
163
Q

Allowed inactive ingredients

A
  • “anything goes” for PO

- sterile products cannot have any added colors. Inert gasses are allowed

164
Q

T/F: anytime the spare/emergency key to the pharmacy is used, the person using it must document it in the log book

A

False. Only non-pharmacists have to document in the log book

165
Q

what non-controls are considered “drugs of concern” on the PMP

A
  • butalbital + 325 mg or more APAP

- naloxone

166
Q

off-site satellite pharmacy

A
  • a separate, smaller pharmacy at the same address as the primary “provider” pharmacy
  • requires separate application
167
Q

A lot where tablets were improperly pressed and falling apart would likely result in a Class (I/II/III) recall.

A

Class III

168
Q

special requirements to be a nuclear pharmacist?

A
  • must be listen on a LA radioactive material license

- must obtain 5 CE yearly specific to nuclear pharmacy

169
Q

T/F: remote processor pharmacies can store medications

A

No, their function is in data processing only? No physical transfer of prescription products

170
Q

Who signs an application/renewal for pharmacy permit?

A

PIC and the owner of the pharmacy

171
Q

how often must a PIC visit/inspect a telepharmacy site?

A

every 30 days

172
Q

Kefauver-Harris

A

1962 amendment to FDCA.

Required extensive pre-clinical trials before allowing human trials.

173
Q

Who reports a CDS loss/theft when a central pharmacy loses it?

A

Whoever is contracted with the courier

174
Q

Can institutional pharmacies dispense to patients that are outpatients/not directly treating?

A

No, institutional pharmacies are focused wholly on the patients of that institution. (No employees)

175
Q

what controls can NPs prescribe?

A
  • CIIs for attention deficit only

- CIII-Vs

176
Q

What is considered “positive ID”?

A
  • Essentially two-step authentication.
  • a private password, PLUS
  • either manual signature on rx, magnetic card reader, bar code reader, biometrics, or a register for RPh to sign
177
Q

qualifications for BOP pharmacist members

A
  • LA resident at least 6 mos
  • currently licensed in LA and active in pharmacy
  • 5 yrs LA pharmacy experience
  • no felons or hx board probation
178
Q

Carisoprodol is schedule ___

A

C-II (federally C-IV)

179
Q

Mailing prescriptions

A

Okay per USPS. Meds cannot be considered “poison” or an “alcoholic beverage”.
(UPS/FedEx also ok)

180
Q

Who needs a community pharmacy permit?

A

Individuals/entities who operate a pharmacy and dispense prescription drugs to patients in Louisiana

181
Q

tampering

A

intentionally tainting a consumer product, including its labeling, container, or contents

182
Q

A CDS license expires after ____

A

1 year

183
Q

A manufacturer labeling a bottle of simvastatin 40 mg as simvastatin 20 mg instead would likely cause a Class (I/II/III) recall.

A

Class II

184
Q

Can pharmacists treat minors under a CDTM?

A

Generally not allowed to treat patietns < 18 yo. Allowed for smoking and imz

185
Q

Substituting biosimilar for brand

A
  • must notify prescriber within 5 days of dispensing the name and mfr of dispensed product
  • only required on initial fill, unless you switch products
186
Q

Who is exempt from CDS licensure?

A
  • employees of a licensed company – except sales reps
  • researchers
  • people who possess CDS pursuant to a valid rx
187
Q

How are controlled prescription records stored in the pharmacy?

A
3 options:
-CII, CIII-V, legend
-CII-V, legend
-CII, CIII-V with legend
(if CIII-V are combined with any group, they must be stamped with red C stamp)
188
Q

restrictions when dispensing to institutionalized patients

A
  • max 34 DS or 100 dosage units (whichever less)

- end user cannot possess medication

189
Q

Emergency scheduling

A
  • AG can put a substance n schedule I only

- valid for 1 yr, can extend add’l 6 mos

190
Q

Special regulations: mineral oil

A

Label must have warning saying it cannot be used in infants, and not to lay down after taking

191
Q

Durham-Humphrey

A

1951 amendment to the FDCA.

Created Rx vs OTC classes

192
Q

Can hospitals with on-site pharmacies use remote processing so they don’t have to employ pharmacists?

A

Not really, this is not the intent of the law.

  • Hosps with 100+ occupied beds must have at least one on duty RPh at all times.
  • ok to have no on-site RPh is < 100 occupied beds and using remote processing
193
Q

Who applies for an EDK?

A

The provider pharmacy, NOT the facility where the EDK will be (LTCF, etc)

194
Q

Records requested by the board for inspection must be provided within _____

A

72 hrs

-potentially sooner if board inspector requires it

195
Q

When are exact inventory counts required?

A
  • for all C-I and C-IIs

- for CIII-V when bottle size > 1,000

196
Q

Butalbital with APAP or ASA is schedule ____

A

C-III

197
Q

T/F: Institutions do not need permits for any EDKs

A

Depends!

  • If institution has an institutional pharmacy permit, no.
  • Otherwise, yes it must have a permit
198
Q

Inventory requirements for controls for hospital pharmacies

A
  • CI-II must have perpetual inventory

- annual inventory of all controls

199
Q

requirements for pharmacist providing CDTM

A
  • active pharmacist license
  • must register with board
  • no hx of license suspension, restriction, etc.
200
Q

EDK permits

A
  • required if if EDK is not at a hospital or at a facility with an institutional pharmacy permit
  • separate permit required for each EDK
  • applied for by the provider pharmacy
  • permit expires annually on July 1
201
Q

When is codeine C-V?

A
  • max 200 mg per 100 mL

- combined with other non-controlled ingredients

202
Q

T/F: pharmacists are allowed to let nurses counsel patients on their behalf

A

True, in hospital/institutional settings

203
Q

Can scanned prescriptions be considered originals?

A
  • yes, except for C-IIs

- if scanning, hard copy can be kept for only one year

204
Q

what controls can PAs prescribe?

A

CII-V to the extent delegated by supervising physician

205
Q

How many members serve on each committee?

A

At least 3 members. In the case of the executive committee, it is the officers

206
Q

what is a drug abuse treatment center? (DATC)

A

-an inpatient or outpatient clinic where patients are treated for abuse issues

207
Q

Form required for pharmacy to register for DEA license

A

Form 224

208
Q

How many marijuana pharmacies does LA allow?

A
  • maximum of 10 pharmacies

- 1 per each of nine “health” regions, with an add’l 10 that can be issued if need is present

209
Q

What happens after an EDK is opened?

A
  • facility notifies pharmacist within 24 hrs

- staff will do shift counts on controlled substances until the pharmacist comes to reseal EDK

210
Q

minimum age to be licensed as pharmacist

A

21

211
Q

Requirements for a pharmacist to administer meds (vaccines)?

A
  • complete an approved course (usually APhA course)
  • BLS certification
  • provide docs of completion to BOP
  • display certificate
  • 1 hr CE in field per year
212
Q

Prior to filling for a pt, the pharmacist must make a reasonable attempt to obtain what info from pt?

A
  • name, address, telephone number
  • DOB/age, gender
  • allergies, disease states
  • list of all current meds
213
Q

What can you dispense for outpatient detox treatment?

A
  • FDA-approved CIII-V drugs (only Suboxone/subutex meets this req)
  • methadone for detox cannot be filled by pharmacy
214
Q

Board decisions on hearings

A
  • due within 30 days of hearing

- goes into effect 11 days after respondent receives notice of decision, unless respondent appeals

215
Q

What qualifies as childsafe packaging

A

No more than 20% of children can open package, while no fewer than 10% of adults are unable to open package

216
Q

How long should CDS records be stored?

A

At least 2 years

217
Q

tech:pharmacist ratios

A

-3:1, including up to 1 one PTC

218
Q

Per FDCA, prescriptions may be audited for up to ___ years

A

Up to 5 years. Note that it is unusual to be audited under FDCA

219
Q

Who can prescribe controlled substances?

A
  • Independent practitioners: physicians, dentists, vets
  • Midlevels if done per protocol
  • Therapeutic optometrists
  • Medical psychologists, but NOT narcotics
220
Q

when must interns submit their applications?

A

prior to the end of their first semester of pharmacy school

221
Q

how much THC is allowed is marijuana packaging?

A
  • max 10 mg per dosage form
  • if multidose, max 100 mg
  • no single container can container > 30 day supply
222
Q

violations committee

A
  • one of BOP committees

- decides type of hearing appropriate for violations

223
Q

If a bottle of warfarin 5 mg was labeled 3 mg by the mfr, this would likely cause a Class (I/II/III) recall.

A

Class I

224
Q

Marijuana grown from somewhere besides the source approved by LDAF is considered _______

A

Adulterated and misbranded

225
Q

Inventories of controlled substances are required every _____

A

Every year

  • Federal law says every 2 yrs, but state is more strict
  • LA allows non-pharmacies to do inventory every other yr
226
Q

How long should your copies of 222 forms be retained?

A

At least two years

227
Q

Can community pharmacies enlist the services of remote processor pharmacies?

A

No – restricted to hospital only

228
Q

May an intern administer vaccines?

A

Yes, as long as both the intern and pharmacist are certfied for imz/BLS

229
Q

What references must be kept in a pharmacy?

A
  • printed copies of LaBOP laws and regs

- access to current references on pharmacology, drugs interxns, dosing/toxicity, counseling

230
Q

Up to ___ prescriptions can be written on a single paper

A

four

231
Q

Classes of recalls

A

Class I - potential for serious illness/death
Class II - potential for reversible AE, death highly unlikely
Class III - not likely to cause AEs

232
Q

Partial filling of C-II

A
  • can be done if OOS, must be fulfilled within 72 hrs
  • can be done for terminally ill or LTCF pts, must be fulfilled within 60 days of first fill
  • remember – still no refills
233
Q

What can PTCs not do that techs can?

A
  • receive verbal intial rx orders
  • give/receive verbal transfers
  • compound high risk sterile products
234
Q

an application to become a pharmacist is valid for _____

A

1 yr after submission

235
Q

Do partial fills count toward the 5 allowed refills for a CIII-V?

A

No, the DEA has clarified that they do not count.

236
Q

informal hearing

A
  • info used here cannot be used at later hearings
  • attending members must recuse themselves from future hearings
  • the charge may ‘die’ here
237
Q

Who is a remote dispenser?

A
  • a LA-permitted pharmacy who provides centralized dispensing service for another permitted pharmacy in LA
  • the “central fill site” ie not the one that patients will pick up their scripts from
238
Q

Pregabalin is schedule ___

A

C-V

239
Q

board member terms

A
  • six year terms, staggered
  • terms begin July 1
  • except for consumer member, who serves “at pleasure of the gov”
240
Q

OBRA 90 requirements

A
  • Drug use review
  • Counseling for patients reimbursed by federal policy
  • Patient medication histories
241
Q

Do physicians practicing at multiple sites need multiple CDS licenses?

A

Depends.

  • if only prescribing, one CDS will cover the prescriber’s activities
  • if dispensing, administering, etc. each site needs a CDS
242
Q

Is a DEA registration needed for a practitioner’s office?

A

No, unless controls are stored there. (Double check this…wouldn’t most offices have some controls on hand?)

243
Q

“Usable” marijuana exludes what components?

A

Does not include seeds, stalks, or roots

244
Q

What are valid MJ “prescriptions”?

A
  • written rx
  • escribed rx
  • emergency CII-like phone orders are allowable
245
Q

Under what circumstances can a hospital pharmacy dispense to outpatients?

A
  • to hospital outpatient for personal use on hospital premises
  • for take-home use to extend for limited/reasonable time tx that was begun as inpatient
  • to hospital’s employees/students for their personal use or for the their dependents
246
Q

What form do you use to order additional 222 forms?

A

DEA 222a

247
Q

A prescription must be at least ____ in size

A

4 x 5 inches

248
Q

How long must you keep privacy-related forms per HIPAA?

A

6 years

249
Q

required questions to ask potential pharmacy employees

A
  • convicted of felony within 5 yrs?
  • convicted of misdemeanor within 2 yrs?
  • knowingly used drugs illegally within 3 yrs?
250
Q

DATC pharmacies do inventory how often?

A

perpetual

251
Q

Clozaril REMS

A

Clozaril National Registry

  • “No blood, no drug”
  • Weekly CBC x 6 mos, QOW CBC x 6 mos, then monthly CBC
252
Q

Loaning CDSs to another pharmacy

A
  • allowable, but remember the 5% rules

- if CII, must fill out a 222 with you as the distributor

253
Q

when does an AMS permit expire?

A

Annually on JUne 30

254
Q

For a C-II, what elements can a pharmacist add without consulting prescriber

A
  • Patient’s address
  • Drug dosage form
  • Prescriber’s DEA
255
Q

NDCs can be recycled after ______

A

after 5 years of non-use

256
Q

Products excluded from PPA

A
  • products intended for emergency use (nitrates)
  • products commonly prepackaged (Zpak, birth control, etc)
  • these are not blanket exclusions, any excluded products have to be specifically stated in the rules
257
Q

Who is authorized to prescribe in LA?

A

Physicians, PAs, NPs, therapeutic optometrists, dentists, veterinarians

258
Q

What must pharmacy do when pharmacist is absent?

A

Must close!

-post 8.5x11” sign saying “Prescription dept closed” in 1” lettering

259
Q

How to dispose of MJ

A
  • mix with at least 50% non-marijuana waste, ground up

- must be done by PIC and one witness

260
Q

Compounding personnel require ___ annual CEs related to compounding

A

One hour

261
Q

special allowances during a State of Emergency

A
  • emergency RFs allowed in affected parishes for essential therapies
  • max 30 DS
  • write “emergency prescription” on hard copy
  • non-LA pharmacists may work in affected parishes
262
Q

counseling on naloxone

A
  • physician required to train caregiver when prescribing
  • under standing order, pharmacist must educate on recognizing opioid o/d, storage/administration, and emergency follow up
263
Q

How often is the Board required to meet?

A

At least once every 12 mos. Typically meets more often

264
Q

Quality control program for clean room

A
  • certify clean room at least every 6 mos

- test samples of finished products

265
Q

rules for late renewal of expired CDS license

A

pay registration + late fees
-if exp < 1 yr, admin assistant may review
-if exp 1-5 yrs, one board member may review
if exp > 5 yrs, full board hearing req’d

266
Q

what is an emergency drug kit?

A
  • a kit containing emergency drugs that meet an immediate need of an LTCF paitent
  • intended for one-time use. Once accessed, the pharmacy will restock it, re-lock it and return it to original area
267
Q

Do warehouses housing controls need a DEA registration?

A

No, only the seller needs it

268
Q

placehold for info about LINKS because idk what it is

A

n

269
Q

Regulation of off-label use

A
  • “discouraged” by FDA
  • mfr is allowed to distribute research on off-label usage
  • mfr is not liable for harm occurring secondary to off-label use
270
Q

T/F: for legal purposes, off-site pharmacy sites contracting with a hospital are considered themselves a hospital pharmacy

A

False!

271
Q

Storage of drugs unfit to be dispensed (misbranded, adulterated, recalled, expired, etc)

A
  • Must be stored outside of the pharmacy

- Expired drugs however are allowed to be stored within the pharmacy, as long as they are in a separate space