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Pharmacy Law 2022 > Ch. 11 etc > Flashcards

Ch. 11 etc Flashcards

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1
Q

Who can have a pharmacy permit?

A

Individuals, corporations or partnerships

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2
Q

How long is a pharmacy permit valid?

A

All expire on Dec 31st

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3
Q

What are the physical requirements of a pharmacy?

A 
Well-lit
Ventilated
Climate controlled
Safely enclosed structure
Restricted area
Electronic record keeping
Sufficient space
Sink with hot and cold water
Security system
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4
Q

Who can have access to the pharmacy?

A

Pharmacists must lock doors when dept is closed. Emergency access is kept outside of the pharmacy and it must be logged if used by a non-pharmacist

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5
Q

What references are required to be in a pharmacy?

A

LABOP laws and regulations (printed)

Current and appropriate references for pharmacy practice (online or printed)

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6
Q

What are the rights of the PIC?

A

Circumvention -> they have the right to be the final decision maker

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7
Q

What are the responsibilities of a PIC?

A 
Permit application
Authority and accountability
Policy and procedure manual
Records
Recall
D/C and outdated meds
Must be present in pharmacy =/> 20 hours per week
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8
Q

When must the board be notified if a new PIC is named?

A

Within 30 days of the old one leaving and name new pic within 10 days of old leaving

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9
Q

If an old pic who voluntarily leaves role, when must they notify the board?

A

within 10 days prior to leaving role unless replaced sooner

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10
Q

What do you need to be a PIC?

A

An affidavit of responsibility

2 years of experience being a pharmacist

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11
Q

What are the requirements for a pharmacy being open?

A

Open for at least 10 hours per week
Hours must be posted in a visible place
Pharmacists must always be there if pharmacy open

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12
Q

When is a rest break required?

A

> /= 6 hours

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13
Q

Can a pharmacy be open without a pharmacist

A

Yes, if the pharmacist remains on site, is available for emergencies, and believes the pharmacy is safe
CPT or intern must be present

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14
Q

How long are the breaks for a pharmacist?

A

No more then two 30 minute breaks per 12 hours

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15
Q

What happens if a pharmacist must leave?

A

The pharmacy must close, a sign must be posted

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16
Q

What can you NOT advertise?

A

No controlled substances
Untrue claims
Prescription pads with advertising info

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17
Q

How long should records be kept for if medicare is involved (feds)

A

10 years

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18
Q

Is there a required prior authorization form?

A

Yes, in louisiana all insurances must use the LA approved PA form.

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19
Q

What do you need to open up a pharmacy?

A

CDS, Pharmacy and Applications signed by a PIC within 30 days prior to opening

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20
Q

What should be public notice when closing a pharmacy?

A

Let the public know in > 10 days prior
Closure date
When and where scripts are transferred
Statement that transfers can go anywhere

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21
Q

What should be board notice when closing a pharmacy?

A

Let the board know prior >10 days
Closure date
Name of transferring pharmacy
Where are the drugs going?

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22
Q

Do CIII-CV need forms when you close?

A

No, only CIIs

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23
Q

When do you need a new license based on change of ownership?

A

Sale of pharmacy, death of sole proprietor, addition or deletion of partners, bankruptcy, 50% ownership change

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24
Q

If you are moving nearby what should you do?

A

Notify board, submit to an inspection

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25
Q

If you are moving further what should you do?

A

Forfeit old license, get a new one. Submit to an inspection

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26
Q

An employed or contracted pharmacist may access a system off site as long as:

A

Pharmacy has established controls to confidential records.
Pharmacists does not receive written rxs
No part of the pharmacy’s dispensing system info is duplicated

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27
Q

How often should hospital pharmacies maintain their inventories of CI and CIIs?

A

perpetially

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28
Q

Labels on a prescription drug order must include:

A

Name and location of patient, drug name and strength, dose

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29
Q

When should drug cabinets be used?

A

When a pharmacist is not available

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30
Q

When do pharmacists dispense to out patients?

A

Discharge from hospital
Research related patient
Employee of hospital

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31
Q

What is an automated medication system?

A

Remote dispensing system- bidirectional audio visual tech

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32
Q

What pharmacies do not have to register the AMS?

A

Facility that already has a CDSL
Hospital or institutional facility licensed by the state department of health
Within detention or correctional facility
A remote dispensing system can be placed in a healthcare setting that the PIC is okay with
If a pharmacy is in the same building

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33
Q

How to get, maintain, and when do you lose the license for an AMS?

A

Application must be on paper (no faxes)
Registration is tied to pharmacy and location. Changes must be made known to board.
Renewal is yearly (June 30th)

34
Q

What happens when a pharmacy stops using the AMS?

A

Notify the BOP within 10 days. You may not transfer ownership.

35
Q

What must a PIC do for the AMS?

A 
Ensure its working well
Establish a QA program
Give access
Ensure it's properly stocked
Retain records for 2 years
Document temp
36
Q

When should medication orders be reviewed?

A

Prospectively

37
Q

How long should records for the AMS be maintained for?

A

1 year

38
Q

What data should be recorded for the AMS?

A 
Identity of system accessed
ID of person accessing
Type of transaction
Name or ID of pt
Name, strength, dosage form, and quantity of drug
ID of person restocking meds
39
Q

Who can restock the AMS?

A

A licensed pharmacy person. Non-pharmacist must be supervised by a pharmacist

40
Q

What does the board consider an institution?

A 
Nursing home
Rehab center
Drug abuse treatment center
Family planning clinic
Penal institution
Athletic facility
41
Q

What is a drug cabinet?

A

Medication storage outside of a pharmacy.

Usually for emergency use and can only be used when the pharmacy is closed.

42
Q

Who decides what goes in a drug cabinet?

A

PIC

43
Q

What goes in a drug cabinet?

A

Quantities needed for acute issues

44
Q

How is accountability held for drug cabinets?

A

A valid medical order must be provided for every med taken out.
Must be inspected every 30 days by the pharmacy

45
Q

Who does not need an EDK permit?

A

Hospital or have an institutional pharmacy permit

46
Q

How do you apply for an EDK permit?

A

Provider pharmacy applies and may have unlimited number of EDK permits

47
Q

Who is responsible for all EDKs?

A

PIC

48
Q

How is accountability held for EDKs?

A

Who prescribed and administered

Resident name, drug info, time and date of administration

49
Q

How often must EDKs be inspected?

A

every 30 days

50
Q

Are you allowed to have controls in EDKs?

A

Yes but no more than 8 units of 8 diff CDSs

51
Q

What kind of inventory must a drug abuse treatment center pharmacy have?

A

perpetual inventory for everything

52
Q

Do pharmacies serving prisons have to have a permit?

A

Yes

53
Q

What if a penal permit expires?

A

Complete an application form
If expired for < 1 year: Approval by board’s admin personnel
If expired for > 1 year - < 5 years: Approval by member of board
If expired for > 5 years: Approval from full board and hearing

54
Q

What kinds of drugs can be donated?

A

Anything but CS

No expired drugs

55
Q

What is a nuclear pharmacy?

A

handles radiopharmaceuticals

56
Q

What are the requirements to be licensed as a nuclear pharmacy?

A

Must have LA radioactive Material license
Must have nuclear PIC
Must have dispensing, receiving, and storage area
Must have appropriate equipment, plumbing, and supplies

57
Q

How many hours of CE are required for nuclear pharmacists?

A

Must obtain 5 hours of CE yearly in applications and procedures specific to nuclear (this is apart of the 15 total. hours)

58
Q

What are the labeling requirements for the immediate container?

A 
Radiation symbol
Caution
Prescription control number
Name of radionuclide
Amount of radioactive material
59
Q

What are the labeling requirements for the outer container?

A 
Radiation symbol
Caution
Name of radionuclide
Chemical form
Amount
Liquid vol
Calibration time and date
60
Q

Who can be a charitable pharmacy?

A

Must be a charitable org

61
Q

Do you need a permit to give out free drugs?

A

YEs if you are a pharmacy

62
Q

What are the requirements for an oos pharmacy?

A

Have a PIC licensed in LA

The PIC must be licensed in LA and home state

63
Q

How do OOS pharmacies provide counseling?

A

Through a toll free number that should be on every bottle

64
Q

When does a DMSE permit expire?

A

Aug 31st every year

65
Q

How long is a short term pharmacy good for?

A

30 days

66
Q

How long is a short term pharmacy good for?

A

30 days

67
Q

A single container of marijuana may contain how much?

A

1 month supply

68
Q

Producer labeling of marijuana must include?

A 
Batch/lot number
Potency of THC and CBD in mg
Net weight 
Product exp
Any caution statements
69
Q

Who is not allowed to work at a dispensary?

A

Anyone without a TM designation and no access to PMP and no tech candidates

70
Q

How long must you have your license before getting the TM designation?

A

2 years

71
Q

Who can dispense marijuana

A

Only pharmacist

72
Q

Who can sell marijuana?

A

Pharmacist, tech, intern

73
Q

Who can destroy weed?

A

PIC with one witness documenting

74
Q

What are the drugs of concern?

A

Butalbital
Naloxone
Promethazine liq
Gabapentin

75
Q

When are pmps reported?

A

ASAP

By the end of the next business day of dispensing

76
Q

What form of prescription for MJ is not allowed?

A

oral form

77
Q

What is the Louisiana Medical Marijuana Tracking System (LMMTS)?

A

is a “seed-to-sale” information system designed to capture and manage data from multiple stakeholders in the production and distribution of medical marijuana products

78
Q

Requests for marijuana products shall expire ___________ after the date of issue, unless a shorter period of time is indicated by the physician.

A

1 year

79
Q

What is the max day supply for MJ?

A

90 days

80
Q

Who appoints where MJ can be produced?

A

LDAF (Louisiana Department of Agriculture and Forestry)

81
Q

The pharmacist shall not dispense any marijuana product that does not bear the producer label required by the __________.

A

LDAF (Louisiana Department of Agriculture and Forestry)

Pharmacy Law 2022 (8 decks)

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