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MPJE > MPJE > Flashcards

MPJE Flashcards

1
Q

Created law that mandated safety of all drugs

A

Food Drug Cosmetic FDCA 1938

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2
Q

Created the FDA

A

Food Drug Cosmetic Act FDCA 1938

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3
Q

Created Rx/OTC

A

Durham-Humphrey Amendment 1951

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4
Q

Authorized verbal rxs and refills

A

Durham-Humphrey Amendment 1951

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5
Q

Law that required drugs to be safe AND effective

A

Kefauver-Harris amendment 1962

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6
Q

Created FDA oversight of drug advertisement

A

Kefauver-Harris amendment 1962

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7
Q

Increased safety of drugs & created GMPs

A

Kefauver-Harris amendment 1962

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8
Q

Bans the re-importation of drugs made in the US

A

PDMA 1987 (prescription drug marketing act)

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9
Q

Bans sale, trade, or purchase of drug samples

A

PDMA 1987 (prescription drug marketing act)

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10
Q

Mandates storage, handling, and record keeping requirements of samples

A

PDMA 1987 (prescription drug marketing act)

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11
Q

Only instance where a retail pharmacy may have samples

A

Pharmacy must be affiliated with a healthcare entity (i.e owned by hospital) (PDMA 1987)

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12
Q

Prohibits the resale of drugs purchased by hospitals and healthcare facilities (acquisition cost lower)

A

PDMA 1987 (prescription drug marketing act)

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13
Q

Created sterile compounding outsourcing facilities (503B facilities) following cGMPs regulated by FDA
No pt. specific compounding

A

DQSA - Drug Quality and Security Act 2013

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14
Q

Florida requirement for in-state 503B facility

A

Must obtain Special Sterile Compounding Permit

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15
Q

Florida requirement for out-of-state 503B facility

A

Must obtain Nonresident Sterile Compounding Outsourcing Facility Permit

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16
Q

Federally regulated outsourcing sterile facility

non patient specific

A

503B facility

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17
Q

Compounding (sterile) pharmacies not registered with FDA as outsourcing facility

A

503A pharmacy/facility

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18
Q

Does a 503A pharmacy need individual prescription to compound a sterile drug?

A

Yes!

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19
Q

What federal USP statute guides 503A pharmacies?

A

USP 797 quality standards for sterile compounding

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20
Q

How often must a 503B facility report drugs sold

A

Initially, then q6months

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21
Q

503B facility must report serious ADE within __ days

A

15

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22
Q

Law that provides “track and trace” system for drugs as they move through supply chain

A

Drug Supply Chain Security Act - DSCSA

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23
Q

Law that establishes standards for wholesaler licensure

A

Drug Supply Chain Security Act - DSCSA

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24
Q

Requires “Transaction data” between wholesalers and pharmacies

A

Drug Supply Chain Security Act - DSCSA

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25
Q

Requires pharmacies to report/properly handle illegitimate drugs

A

Drug Supply Chain Security Act - DSCSA

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26
Q

Exceptions to “distribution” (where pharmacy doesn’t need distribution license/pass on transaction data)

A

Same ownership, dispenser to dispenser for patient specific need, emergency medical reason, “minimal quantities” to licensed practitioner for office use

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27
Q

Adulteration v. Misbranding - Drug contains fility, putrid, or decomposed substance

A

Adulterated

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28
Q

Adulteration v. Misbranding - Prepared or held under unsanitary conditions

A

Adulterated

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29
Q

Adulteration v. Misbranding - Drug held in container that is poisonous/deleterious to drug

A

Adulterated

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30
Q

Adulteration v. Misbranding - Contains unsafe color additive

A

Adulterated

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31
Q

Adulteration v. Misbranding - Products claims to meet USP standards for strength & quality, but doesn’t

A

Adulterated

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32
Q

Adulteration v. Misbranding - Drug differs in strength or quality compared to what label states

A

Adulterated

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33
Q

Adulteration v. Misbranding - Label does not state name of mfr, packer, or distributor

A

Misbranded

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34
Q

Adulteration v. Misbranding - Label does not state name of drug

A

Misbranded

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35
Q

Adulteration v. Misbranding - Label does not state quantity

A

Misbranded

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36
Q

Adulteration v. Misbranding - Label does not state weight of active ingredient

A

Misbranded

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37
Q

Adulteration v. Misbranding - Label does not state “rx only” if rx only

A

Misbranded

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38
Q

Adulteration v. Misbranding - Route of admin not stated on label if not for oral use

A

Misbranded

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39
Q

Adulteration v. Misbranding - Pharmacist dispenses rx w/o authorization

A

Misbranded

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40
Q

Adulteration v. Misbranding - Pharmacist fills for wrong drug/str/sig

A

Misbranded

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41
Q

Adulteration v. Misbranding - Pharmacist fill for wrong str

A

Misbranded AND adulterated

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42
Q

Adulteration v. Misbranding - Pharmacist fills drug w/o REMS requirement

A

Misbranded

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43
Q

Adulteration v. Misbranding - Pharmacist dispenses expired drug

A

Adulterated. Also misbranded if pharmacist places a beyond use date that exceeds mfr expiration date

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44
Q

Recall type - reasonable probability of serious ADE/death

A

Class I

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45
Q

Recall type - May cause temporary/reversible ADE where serious ADE chance is remote

A

Class II

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46
Q

Recall type - Not likely to cause adverse health consequences

A

Class III

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47
Q

Patient package insert (lay person level) require for:

A

Oral contraceptives/estrogen containing products. If hospitalized/institutionalized, initially and every 30 days.

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48
Q

PPPA

A

Poison Prevention Packaging Act 1970

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49
Q

Law that created mandate for child resistant containers for all drugs and some OTC drugs

A

Poison Prevention Packaging Act 1970

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50
Q

Exemptions to PPPA (page 44)

A

Contraceptives, estrogens, medroxyprogesterone, SL NTG, effervescent ASA/APAP, UD potassium, Sodium Fluoride (264mg max/package)

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51
Q

Exemptions to PPPA (page 44)

A

Cholestyramine, Erythromycin, Prednisone (105mg max/package), Medrol (84 mg max/package)

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52
Q

Exemptions to PPPA (page 44) Prednisone mg

A

105mg/package

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53
Q

Exemptions to PPPA (page 44) Medrol mg

A

84mg/package

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54
Q

Exemptions to PPPA (page 44) Sodium Fluoride mg

A

Sodium Fluoride (264mg max/package)

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55
Q

Authority to schedule controlled substances (federal)

A

US Attorney General

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56
Q

Authority to schedule controlled substances (Florida)

A

Florida AG may add/delete/reschedule

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57
Q

Codeine or opium not mixed with other drug is schedule

A

Schedule II

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58
Q

Codeine solution C-V limit

A

2mg/1mL (like Robitussin w/codeine = 100mg/10mg/5mL)

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59
Q

Codeine C-III limit (tablet)

A

90mg/tablet mixed with other drug like apap

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60
Q

Codeine solution C-III limit (liquid)

A

18mg/1mL

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61
Q

Opium C-V limit

A

1mg/1ml

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62
Q

Opium C-III limit solution (federal)

A

5mg/ml

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63
Q

Opium C-III limit solid dosage (federal)

A

25mg/tablet

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64
Q

Opium C-V limit (Florida)

A

1mg/ml if greater concentration, CII

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65
Q

Pharmacies and practitioners must register w/DEA every ___ years

A

3

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66
Q

Form ___ is used to register w/DEA

A

224

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67
Q

Form ___ is used to renew w/DEA

A

224a

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68
Q

DEA number for dispensers (pharmacies/practitioners) start with ______

A

A, B, or F

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69
Q

Mid-level practitioners DEA # starts with _____

A

M

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70
Q

Verify DEA #

A

Add 1st, 3rd, 5th #; Add 2nd, 4th, and 6th # & x by 2, add two sums, and last number should be last # DEA

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71
Q

If full amount of CII can’t be filled by wholesaler, the order may be partial and sent to pharmacy within ___

A

60 days

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72
Q

Theft or significant loss must be reported to DEA within ___

A

1 business day in writing

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73
Q

Florida law requires theft or significant loss be reported to _____

A

DEA within 1 business day, BOP within 1 business day (by PDM/CP), and county sheriff within 24 hours

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74
Q

To report theft or significant loss to the DEA, form ___ is used

A

106

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75
Q

Disposal or destruction of controls uses form ___

A

41

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76
Q

Form 41 procedure (disposal destruction of controls) other than Class I institutional

A

Fill and sign. Must be done by PDM or Consultant pharmacist of record and a witness and sent to closest DEA office within 1 business day

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77
Q

To report illegitimate drugs, form ______ is used

A

Form FDA 3911

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78
Q

Per CMS regs, LTC facilities must have a Medication Regiment Review _____ by a consultant pharmacist

A

Every 30 days

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79
Q

Irregularities in LTC facility found on Medication Regiment Review must be reported to

A

Attending MD, Medical Director, DON

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80
Q

Inventory of controls

A

Exact # for CII, estimated # for CIII-V unless bottle holds more than 1000 doses

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81
Q

Controlled substance records must be kept for ___ years

A

2

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82
Q

Rx records must be kept for _____

A

4 years from the last date of fill

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83
Q

Central record-keeping for controls are permitted EXCEPT for _____

A

Executed 222 forms, prescriptions, or inventories

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84
Q

How many CE hours must a pharmacist take relating to opioids/controls?

A

2 CE

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85
Q

Every pharmacy must maintain a summary record of control substances dispensed for last ___ days and made available w/in _____ hours

A

60 days , 72 hours

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86
Q

Summary record of controlled substances includes:

A

Name of drugs, volume dispensed, specific patients, specific prescribers

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87
Q

Fraudulent controlled substance rxs must be reported to ____ within _______

A

sheriff/chief law enforcement within 1 business day/24 hours (whatever is later)

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88
Q

Optometrists can only prescribe the following controls:

A

Ultram, Tylenol w/codeine #3 (max 72 hour supply unless consulting w/md)

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89
Q

PAs can prescribe up to a ___ day supply of CII

A

7 day

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90
Q

PA can prescribe mental health control to minor?

A

No!!!!

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91
Q

APRN can prescribe up to a ___ day supply of CII

A

7 day - does not apply to psychiatric CII written by psychiatric APRN

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92
Q

Can PA/APRN prescribe in pain management clinics?

A

No!!!

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93
Q

APRN can prescribe mental health control to minor?

A

No!!! Exception psych specialist

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94
Q

Can a pharmacist fill a control for an out of state doctor?

A

Only if rx is validated AND is for a chronic/recurrent condition

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95
Q

Can a pharmacist fill and out of state rx for non control?

A

Yes, but only for chronic/recurrent condition

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96
Q

Is a telehealth rx permitted for controls in Florida?

A

Yes, but only for A) Psych B) Hospital Inpatient C) Hospice D) Nursing Home

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97
Q

Is E-prescribing mandatory?

A

Yes!!!

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98
Q

Notable exceptions to e-prescribing

A

Emergency to pt, hospice/nursing home pt, price shopping

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99
Q

Can a control and non control appear on the same hard copy blank?

A

No!!!

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100
Q

Refills permitted for CII?

A

No!!!!

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101
Q

Verbal for CII permitted?

A

No! Except for emergencies

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102
Q

Verbal for CIII-V permitted?

A

Yes

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103
Q

Max quantity for a verbal CIII rx?

A

30 days

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104
Q

Faxes for CIII-V?

A

Yes, but must bear prescribers original signature

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105
Q

All prescriptions (including CII) must be filled within ____

A

1 year after issue date or earliest fill date

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106
Q

In general, do quantity limits apply to CII?

A

No

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107
Q

Max amount of CII PA/APRN can prescribe?

A

7 days, except for psych APRN for psych CII

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108
Q

Instances where CII may be faxed to pharmacy and function as original rx

A

Home infusion/IV pain, LTCF, Hospice

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109
Q

A pharmacist may issue up to a ___ supply of CII from a verbal emergency rx

A

72 hours

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110
Q

A doctor has ____ days to send covering rx for verbal emergency rx

A

7 days; must state “authorization for emergency dispensing”

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111
Q

CII acute pain max day supply

A

3 days, with exceptions

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112
Q

Exception to 3 day acute pain CII

A

7 day max if exception! Permitted if greater than 3 days clinically indicated, “acute pain exception” noted on rx, prescriber documents in pt record

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113
Q

For treatment of non acute pain using CII, prescriber must indicate

A

“Non-acute pain” on face of rx

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114
Q

Greater than 7 day supply for opioid CII for acute pain?

A

No, except for Injury Severity Score of >9; prescriber must also write for antagonist (Naloxone)

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115
Q

C-V OTC max codeine per 48 hours

A

120mg/4oz

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116
Q

C-V OTC max opium per 48 hours

A

240mg/8oz

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117
Q

Consultant pharmacist course hour requirement

A

12

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118
Q

Consultant pharmacist requirement initial licensure

A

Take a course no less than 12 hours, take cognitive test, “intern” w/consultant pharmacist for at least 40 hours for no more than 3 months (no more than 1 year after taking course/test)

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119
Q

Consultant pharmacist preceptor requirement

A

Must be CPoR (consultant pharmacist of record) at institutional pharmacy & 1 year experience. Max 2 students at a time

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120
Q

CE requirements for pharmacist

A

30/2 years. 10 must be live. 2 must be in med error. 2 must be in validating controlled substances. 3 must be in vaccines/epi if vaccinator. Initial renewal - 1 hour HIV/AIDS

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121
Q

Consultant pharmacist who wish to monitor and order labs must complete a ___ hour cert course initially

A

3 hour

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122
Q

PMP not required for patients under ___ years of age

A

16

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123
Q

PMP not required for patients under ___ care

A

Hospice

124
Q

Max Day supply for optometrist to prescribe control

A

72 hour, unless consult with ophthalmologist (MD)

125
Q

Optometrists can prescribe oral carbonic anhydrase inhibitors for a max of

A

72 hours (acetazolamide, methazolamide)

126
Q

Pharmacy tech CE requirement

A

20/2 years. 2 must be in med error. 4 must be live. 1 hour HIV/AIDS (first renewal)

127
Q

BOP constituency

A

9 members. 7 are pharmacists. 2 are retail. 2 are institutional. 3 are random pharmacists. 2 are random people having no affiliation w/pharmacy whatsoever. All must be residents of Florida. Pharmacists must be residents for at least 4 years. One constituent must be 60 or older.

128
Q

BOP members serve terms of ___ years

A

4

129
Q

MPJE is required when a pharmacist license is placed on retired status for ____ years or more

A

5 years or more if actively practicing in another state

If not practicing, NAPLEX also required

130
Q

Methods of obtaining CE

A

ACPE program, Board Hearing in Risk Management (5 day/10 per cycle), Volunteering (5 CE), post-professional programs from school of pharmacy (5CE/semester hour), Expert Witness for DOH (5CE), Presenter of live CE

131
Q

Consultant pharmacist - initial course requirement

A

12 hour course

132
Q

After completing initial course of 12 hours, consultant pharmacist must complete ____ hours of specific training

A

40 hours

133
Q

Consultant pharmacist who wish to monitor and order labs must complete a ___ hour cert course

A

3 hour

134
Q

Consultant pharmacist must complete ____ hours of CE for CE renewal in addition to the regular 30 hours

A

24 hours

135
Q

Consultant pharmacist who wish to monitor and order labs must complete a ___ hour cert course upon license renewal

A

1 hour

136
Q

____ hours internship are required for pharmacist licensure

A

2080 hours

137
Q

Pharmacy techs must be ____ years old to register

A

17

138
Q

Pharmacy tech CE requirement

A

20/2 years. 2 must be in med error. 4 must be live. 1 hour HIV/AIDS

139
Q

A delinquent pharmacist license must be renewed within ____ years

A

2 years

140
Q

MPJE/NAPLEX is required when a pharmacist license is placed on retired status for ____ years or more

A

5 Years or more

141
Q

MPJE is required when a pharmacist license is placed on retired status for ____ years or more

A

5 years or more if actively practicing in another state

142
Q

Pharmacist:Tech ratio

A

Law says 1:1. However, clarification states that: sterile is 3:1, non-sterile is 6:1, and non-dispensing is 8:1

143
Q

Non-pharmacy entities that may dispense rx drugs

A

Vet office, Medical Oxygen supplier

144
Q

Pharmacist wishing to immunize must complete ____ hours of CE in vaccination upon initial licensure

A

20 hours INCLUDING CPR

145
Q

To maintain immunizer license, a pharmacist must complete ___ hours of vaccine or epipen CE

A

3 hours

146
Q

A pharmacist may enter a protocol w/physician to vaccinate if they have ______ of liability insurance

A

$200,000 or more

147
Q

Pharmacist immunization records must be maintained for ____ years

A

5 Years

148
Q

Can Florida pharmacists vaccinate minors?

A

No!

149
Q

CQI committee must review QA related events at least every ____

A

3 months

150
Q

Pharmacy inspection is required ____ during first year of operation

A

twice

151
Q

A pharmacy that has passed inspection for 3 years straight requires inspection every _____

A

2 years

152
Q

A pharmacy that fails inspection must be inspected ___

A

annually

153
Q

Customized medication packet beyond use date:

A

120 days (or less if mfr expiration date is less)

154
Q

Customized medication packet must contain

A

Physical descriptions of drugs

155
Q

Information for electronic prescription storage must be back up at least ______

A

Weekly

156
Q

Central Fill/originating pharmacy label requirements

A

Both have to be on the label. Name and address of originating pharmacy must be on label. Central fill pharmacy may be identified by code.

157
Q

May a central fill pharmacy fill for controls?

A

No!!!!

158
Q

A pharmacist may enter a collaborative practice with a physician to treat chronic health conditions provided they complete a ____ hour course initially

A

20 hour (8 live) - also worth 20 ce

159
Q

A pharmacist may enter a collaborative practice with a physician to treat chronic health conditions provided they maintain _____ in liability insurance

A

$250,000

160
Q

Pharmacist mediated collaborative practice records must be maintained for ____ years

A

5 years

161
Q

Collaborative practice agreements are for a duration of ____ years if not renewed

A

2 years

162
Q

A pharmacist who wishes to enter collaborative practice must complete ____ hours of CE in addition to regular CE requirements upon renewal

A

8 CEs

163
Q

Minor, non chronic conditions a pharmacist (with written protocol from physician) may diagnose/treat

A

Flu, Strep, Lice, Skin conditions (ringworm etc), minor uncomplicated infections

164
Q

A pharmacist who wishes to diagnose/treat minor, non-chronic conditions must initially complete

A

20 hour course (8 live)

165
Q

Appointment of new PDM/PDM who leaves must be reported within ____

A

10 days

166
Q

Retail pharmacies must be open a minimum of ___ hours per week

A

20 hours

167
Q

Pharmacist may issue emergency refill for all medications

A

Yes, except CII

168
Q

Nuclear Pharmacist must have ____ hours in didactic training

A

200

169
Q

Nuclear pharmacist must have a _____ hour internship

A

500

170
Q

Nuclear pharmacist must have ____ hours of CE upon renewal

A

24

171
Q

Florida Negative Forulary

A

Conjugated Estrogens, (Thorazine) Chlorpromozine, (Creon) Pancrelipase, Theophylline

172
Q

Immediate Use CSP

A

Not made in a cleanroom/SCA. Max 3 sterile ingredients & 2 entries into one container.

173
Q

Low Risk CSP

A

Mixed according to 797. Single dose for single patient

174
Q

Medium Risk CSP

A

Mixed according to 797. Batch for multiple patient, single patient with multiple doses, or TPN

175
Q

High Risk CSP

A

Mixed according to 797. Starter ingredient is not sterile -or- any risk mixed without complete garb

176
Q

CSP must be within ____ % of stated potency on label

A

10%

177
Q

For high risk CSP, gloved fingertip test & media fill tests are done at least every ____ months

A

At least every 6 months

178
Q

For medium and low risk CSP, gloved fingertip test & media fill tests are done at least every ____ months

A

At least every 12 months

179
Q

Initial qualification fingertip test CFU

A

3 sets (6 plates) with 0 CFU

180
Q

Requalification fingertip test CFU

A

1 set (2 plates) no more than 3 CFU/plate

181
Q

Sterile compounding area temperature should not exceed ___ C

A

20C

182
Q

Examples of PEC (Primary Engineering Control) for CSPs

A

“Hoods” Laminar Airflow Bench and/or biological safety cabinets

183
Q

PEC ISO rating must be

A

ISO5

184
Q

PECs must have _______ airflow

A

Unidirectional

185
Q

ALL Buffer rooms must be ISO ____

A

ISO7

186
Q

Anteroom that opens into a positive pressure buffer room must be

A

ISO8

187
Q

Anteroom that opens into a negative pressure buffer room must be ISO

A

ISO7

188
Q

SCA (segregated compounding area) ISO rating is ______

A

Not applicable - no ISO rating required as these rooms are purpose built standalone rooms

189
Q

SEC (Secondary engineering control) is _____

A

Anteroom/buffer room

190
Q

PEC and SEC must be certified every ____ months

A

Every 6 months

191
Q

Order for PPE for CSP

A

Cover Head/Hair > don Mask > don Shoe covers > Wash hands > step to clean side of room > don gown > alcohol hands > don sterile gloves

192
Q

Sterilization of high risk CSP starting w/non-sterile products is achieved by ________

A

Terminal sterilization (autoclaving) or filtration

193
Q

In-use time for SDV if opened and maintained inside ISO 5 environments (PEC)

A

6 hours

194
Q

In-use time for SDV if opened or maintained outside ISO 5 environments (PEC)

A

1 hour

195
Q

In-use time for MDV

A

28 days (without regard to being opened/maintained ISO5)

196
Q

In-use time for ampules

A

Use and discard

197
Q

BUD for CSP for immediate use

A

1 hour

198
Q

BUD for low risk CSP made in SCA

A

12 hours (whether room temp or refrigerated)

199
Q

BUD for low risk CSP at room temperature

A

48 hours

200
Q

BUD for medium risk CSP at room temperature

A

30 hours

201
Q

BUD for high risk CSP at room temperature

A

24 hours

202
Q

BUD low risk CSP under refrigeration

A

14 days

203
Q

BUD for medium risk CSP under refrigeration

A

9 days

204
Q

BUD for high risk CSP under refrigeration

A

3 days

205
Q

BUD for all categories of risk stored frozen

A

45 days

206
Q

BUD for high-risk CSP @ RT/refrigeration

A

24 hours/3 days

207
Q

BUD for low-risk CSP @ RT/refrigeration

A

48 hours/14 days

208
Q

BUD for medium-risk CSP @ RT/refrigeration

A

30 hours/9 days

209
Q

Action level (CFU) for ISO5 air/surface

A

> 1/3

210
Q

Action level (CFU) for ISO7 air/surface

A

> 10/5

211
Q

Action level (CFU) for ISO8 air/surface

A

> 100

212
Q

Additional HD requirements to SEC

A

Appropriate air exchange, external venting

213
Q

Pharmacies must comply with a patient request for PHI under HIPAA within ____ days

A

30 days

214
Q

Pharmacies must amend PHI requested by patient within ____ days

A

60 days

215
Q

Patients must be notified of a HIPAA breach within ____ days

A

60 days

216
Q

Tamper evident packaging is required for all OTCs except

A

Toothpaste, lozenges, insulin, dermatological preparations

217
Q

Adipex Schedule

A

4

218
Q

Phenobarbital Schedule

A

4

219
Q

Ultram Schedule

A

4

220
Q

BZD schedule

A

4

221
Q

Fiorinal schedule

A

3

222
Q

Amobarbital schedule

A

2

223
Q

Pentobarbital schedule

A

2

224
Q

Suboxone/Subutex schedule

A

3

225
Q

Ketamine schedule

A

3

226
Q

Soma schedule

A

4

227
Q

Diethylpropion schedule

A

4

228
Q

Butrans schedule

A

3

229
Q

Lyrica schedule

A

5

230
Q

Loss or theft of PSE must be reported within ___ days

A

15 days

231
Q

Form 41, used to document destruction of controls, must be delivered to nearest DEA office within ____

A

1 day

232
Q

Destruction of controls does not require form 41 if the destroying pharmacy is a class _____

A

Class 1 pharmacy (nursing home) provided there are two witnesses

233
Q

Pharmacies may offer “take backs” of CDS if they modify ______

A

their registrations to act as a collector

234
Q

CDS inventory is required when:

A

Pharmacy initially opens for business, every two years, newly scheduled/change in schedule

235
Q

Records of controlled substances must be maintained for ____

A

2 years

236
Q

Hard-copy printout of controlled drug dispensing must be made within ____ hours

A

72 hours OR daily signed log book must be kept

237
Q

Hard-copy printout of controlled drug dispensing must include previous _____ days of dispensing

A

60

238
Q

Types of APRNS

A

Clinical Nurse Specialist (CNS), Certified Registered Nurse Anesthetist (CRNA), Certified Nurse-Midwife (CNM), Certified Nurse Practitioner (CNP)

239
Q

_____ are exempt from mandatory counterfeit proof rx pads when prescribing CDS

A

Vets!

240
Q

Faxes as originals for CIIs are permitted for

A

LTCF, hospice, home infusion/iv pain

241
Q

30 day rule for partial filling of CII

A

Permitted if patient requests! Up to a 30 day supply

242
Q

60 day rule for partial filling of CII

A

Permitted for LTCF and terminally ill patients. Must be completed within 60 days

243
Q

Who can dispense CII

A

Only community pharmacies (including community pharmacy attached to a hospital)

244
Q

Who can dispense CIII

A

Only community pharmacies (including community pharmacy attached to a hospital)

245
Q

DATA waived patient amount for physicians

A

30, 100, or 275

246
Q

DATA waived patient amount for PA/APRN

A

Initial = 30; after one year, may be increased to 100

247
Q

DATA-waived practitioners are those who can prescribe

A

Suboxone/Subutex

248
Q

PSE Hcl daily limit not base

A

36 120mg tablets

249
Q

PAs may not prescribe:

A

anesthetics or radiographic contrast materials exception in hospital

250
Q

An intern who is a foreign pharmacy graduate is supervised at a ratio of 1 pharmacist: ____ inter

A

1 intern (1:1 ratio)

251
Q

Foreign pharmacy graduates must complete ___ hours of supervised work activity to be eligible for licensure

A

500 hours

252
Q

If rx is for an animal, ______ must appear on the rx

A

Owner name and animal specie

253
Q

To become consultant pharmacist:

A

Take 12 hour course (including cognitive test), 40 hours of precepted work

254
Q

To renew consultant pharmacist license:

A

Take 24 consultant pharmacist CE (1 CE must be in ordering lab tests if desired) in addition to regular 30 hours required

255
Q

Passing an on-site inspection is required when:

A

New pharmacy is opened, new ownership, change of address/location

256
Q

Is a pharmacy permit transferable?

A

No!

257
Q

Retail pharmacy wholesale distributor distributes _____ % or less

A

Distributes 30% or less of total annual purchases of rx drugs

258
Q

Retail pharmacy wholesale distributor may distribute to:

A

Other retail pharmacies, modified class II pharmacy, or licensed healthcare practitioner

259
Q

Immunization records must be retained for ____ years

A

5 years

260
Q

CQI committee reviews CQI related events no fewer than every _____ months

A

3 months

261
Q

A hard copy printout summary of dispensed controls covering the previous 60 day period, shall be made available within ____ following a request for it by any law enforcement personnel entitled
to request such summary under authority

A

72 hours

262
Q

If pharmacy does not have a bound log book, a hard copy print out of rx summary must be printed within ___

A

72 hours of the date dispensed and signed within 7 days

263
Q

Hard copy printout of rxs must be produced within _____ hours for DOH official

A

48 hours

264
Q

Pharmacist CE required for collaborative practice

A

20 initially, 8 on renewal

265
Q

C-SCA are used to compound

A

Hazardous drugs (USP 800)

266
Q

Summary records for CQI must be kept for _____

A

4 years

267
Q

Examples of references

A

USP/NF, Facts, Remingtons, US Dispensatory

268
Q

Max day supply of NSAIDS orderable by a pharmacist

A

6

269
Q

Max day supply Pyridium orderable by a pharmacist

A

2

270
Q

Minimum patient age orderable by pharmacist for antihistamines

A

6 Years and older

271
Q

Minimum patient age orderable by pharmacist for decongestants

A

6 years and older

272
Q

Drug therapy management

A

Can participate w/ physician, PA, dentist, podiatrist - not aprn. Requires CQI

273
Q

Collaborative practice records must be maintained for _______

A

5 years

274
Q

A pharmacist must complete ____ CE related to collaborative practice each renewal

A

8 CE in addition to regular CE requirements

275
Q

A pharmacy may delay commencement of operation by notifying the BOP in writing within ______

A

14 days

276
Q

A pharmacy that commences operations must notify the board in writing within ____

A

2 days

277
Q

A pharmacy must commence operations within ____ after obtaining permit, or write to BOP indicating why not

A

6 months

278
Q

A pharmacist may substitute a biologic product if it both

A

biosimilar AND interchangeable per the FDA

279
Q

T or F - pharmacy must have a consultation area that is signed as such

A

True - OBRA 90

280
Q

Upon closing a pharmacy, the permit must be returned to ______

A

The Board of Pharmacy

281
Q

Upon closing a pharmacy, the permit must be returned within ______

A

10 days to the BOP

282
Q

Upon closing a pharmacy, CDS registration and blank 222 forms are returned to ____

A

Miami DEA regional office

283
Q

Unclaimed Rxs may be returned to pharmacy stock, but must be used within _____

A

1 year

284
Q

ER prescriber may dispense up to a ____ supply of medication if community pharmacy services are not available

A

1 day

285
Q

Automated systems (ie Pyxis) require a prospective DUR unless the medications are

A

override medication, low-risk override medication, physician controlled medication

286
Q

For override medications, a pharmacist must perform a _______ DUR

A

retrospective

287
Q

Daily audit records for automated systems (i.e Pyxis) are required to be maintained for ______

A

60 days if non controlled, 4 years if controlled.

288
Q

Contents of emergency med kits for nursing homes are determined by facility ______

A

consulting pharmacist, DON, medical director

289
Q

If controlled substances are constituents of an automated pharmacy system (ie Pyxis) in LTCF, Hospice, or correctional facility, a _______ is required

A

separate DEA registration in the name of the provider pharmacy

290
Q

For sterile compounding, Florida law adopts ____ chapters of USP

A

797, 71 (sterility), 85 (endotoxin), 731 (loss on drying)

291
Q

BOP must be notified within ___ days if commencement/cessation of practice was a result of investigation in another jurisdiction

A

20 days

292
Q

All crimes must be reported to the BOP within _____

A

30 days

293
Q

Fines must be paid to BOP within

A

90 days

294
Q

Minor violations are called

A

Notice of deficiencies (are not disciplinary actions)

295
Q

Who investigates complaints against pharmacies/cists/techs/interns made to BOP

A

Medical QA division of Florida DOH

296
Q

Medical QA division of Florida DOH makes a final decision re:disciplinary action within

A

6 months

297
Q

A pharmacist seeking to administer long acting antipsychotic medications must obtain ____ CE

A

8 CE

298
Q

Can a dispensing practitioner dispense CII or CIII?

A

No, but there are exceptions (pg 262)

299
Q

T or F - Rxs are required for syringes/needles

A

No, if 18 or older. Yes if under 18

300
Q

Dispensing practitioner max CIII amount for post surgery is a _____ day supply

A

14 day supply

301
Q

Donor, recipient, and destruction records must be maintained at least _____ by the participant facility for cancer drug donations

A

3 years

302
Q

Retention of signed Notice of Privacy Practices is required for _____ years

A

6 years

303
Q

Summarization of Quality-Related Events must be maintained for ____ years.

A

4

304
Q

Required elements for PMP

A
  • Prescribing practitioner name, DEA and NPI number -Date of the prescription
  • Date Rx filled and the method of payment
  • Name, address, telephone number, and date of birth of patient
  • Name, NDC number, quantity, and strength of the controlled substance dispensed
  • Name, DEA number, pharmacy permit number, and address of the pharmacy
  • Whether drug was dispensed as an initial Rx or a refill, and the number of refills ordered
  • Name of the individual picking up the Rx and type and issuer of the ID provided
305
Q

Any pharmacy desiring to discontinue business activities altogether or with respect to controlled substances (by transferring such business) must submit in person or by registered or certified mail (return receipt requested) to the DEA _____ days in advance of the date of the proposed transfer

A

14

MPJE (1 decks)

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