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MPJE > Law > Flashcards

Law Flashcards

1
Q

What is a DEA number composed of? How do you verify it?

A

2 letters + 7 numbers
Physician first letter is A,B,F,G
2nd letter is first letter of last name

Add 1st,3rd,5th digits up
Add 2nd, 4th, and 6th digits up and x2
Add the two totals together
the last digit of the total should equal the last digit of the DEA number

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2
Q

Do community pharmacies need to be registered with DEA?

A

Yes, every retial pharmacy must be but hospital pharmacies do not need to register with the DEA they are covered under hospital registration

Must obtain state permit first from BOP

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3
Q

Can a pharmacist dispense a controlled substance to a friend of the patient?

A

Only if they live in the same household

Only the patient or member of their household can pick it up

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4
Q

Is there a quantity limit on C2s?

A

No but no refills and expires 6 months from date it was issued

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5
Q

Can a C2 be called in over the phone?

A

ONLY in emergency situations and the quantity is limited to the emergency period and the prescriber must personally call-in the rx not an agent

The pharmacy must reduce the rx to writing and needs everything but sig

The prescriber has 7 days to get you a written or electronic signature and pharmacist HAS to notify DEA office if you do not receive this rx in 7 days

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6
Q

Can they fax a C2

A

They can only so it is ready ahead of time for the patient BUT it is not a valid script and you need another copy of of it before dispensing it to the patient

However there are 3 ways that a pharmacy may legally receive a fax rx for a C2 where it serves as the original rx and you do not need a written copy

  1. C2 narcotic to be compounded for direct administration to patient by parenteral route
  2. C2 for a resident of a long-term care facility (nursing home, retirement home, mental care)
  3. C2 narcotic for a hospice patient (prescriber must note on rx that patient is in hospice)
    * *These have to be narcotics(opioids) for 1 and 3 but can be anything (stimulants) for long term care patients**
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7
Q

Partial filling on C2 rx how many days do they have to fill the rest?

A

Total amount of rx may be filled no later than 30 days from the DATE on which the rx was WRITTEN (not filled)

If C2 rx is an emergency oral rx, then you are restricted to 72 hours from when written to fill rest

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8
Q

Partial filling for C2 rx for terminally ill patients

A

Can partially fill C2 rx for patients in LTCFs or for terminally ill patients up to 60 days from the date the rx was WRITTEN (not filled)
**pharmacist must write “terminally ill or LTCF patient” on the rx

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9
Q

Multiple C2 rxs on the same day rules: How many days supply, post date?

A

Can write for multiple rxs for the same patient and the same drug on the same day but can not exceed 90 day supply and each rx must be on a separate blank

Must write earliest date that each rx can be filled (do not fill until)

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10
Q

Can C3-5 rxs be called into a pharmacy?

A

Yes, they can be written, faxed, electronic, or called in

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11
Q

C3-4 have how long do you have to fill them?

A

may be refilled up to 6 months from date it was issued or 5 times, whatever comes first

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12
Q

C5 rxs how many refills and expiration?

A

C5 do not have an expiration date and do not have a limit on the amount of refills

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13
Q

Partial filling for C3-5?

A

No dispensing occurs after 6 months from date it was written for C3-4

Can refill more than 5x if they are all partial fills and not full fills

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14
Q

What is considered a targeted controlled substance and how must these be sent from the prescriber?

A

Targeted controlled substances refer to C2 opioids and select C3 opioids (buprenorphine and codeine combination products)

These must be sent electronically unless:

  1. dispensing to ultimate user or inpatient (nursing home, LTCF, hospice)
  2. technology failure
  3. federal property
  4. if pharmacist receives paper copy (written, fax, oral) they are not required to verify if it falls under these rules, it is the physician’s responsibility
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15
Q

How many days supply can you prescribe for acute pain rx for targeted controlled substances?

A

may not exceed a 5-day supply, initially unless for post-operative acute pain and they may not exceed 7-day supply, initially

acute pain is expected to last for <3 months and does not include cancer, hospice, palliative, or substance use disorder

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16
Q

Recording refills of controlled substance rxs: Two ways pharmacist verify that the refill data entered into system is correct

A

System provides a hard copy printout of each day’s controlled substance order refill data, the printout is verified and signed by each pharmacist who refilled rxs listed on the printout within 72 hours (printout must be maintained in a separate file at the pharmacy)

OR

May maintain logbook that signs a statement verifying the controlled rxs that pharmacist refilled that day (must sign every day)

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17
Q

What can you NOT change on C2 rx?

A

The pharmacist cannot change the patient’s name, name of controlled C2 (unless generic sub), or prescriber’s signature (new rx must be issued)

  • -all have to do with names
  • -can add a date but can not CHANGE the date

This has to be direct communication from pharmacist to practitioner

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18
Q

What form do you use to order C2 drugs?

A

DEA form 222

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19
Q

Who can sign and date form 222?

A

Has to be signed by the person who signed the DEA registration or a power of attorney (POA)

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20
Q

Partial order fills by the supplier must be completed within how many days following the date of the DEA form 222?

A

60 days from the date of the purchaser (pharmacy)

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21
Q

Who can be a power of attorney?

A

The POA does not have to be located at the registered location, and can be more than one person

Only certain people can authorize POA:

  1. The registrant (if individual); or a partner of the registrant (if partnership); officer of the registrant (if a corporation)
  2. Executed POA form is signed by person who is being granted POA, registrant, and 2 witnesses
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22
Q

Do you need to notify the DEA if you lose or get stolen 222 forms?

A

If they are lost or stolen from the purchaser (other than in the course of transmission) you must notify the DEA and state the serial number of each form stolen or lost
-if serial number unknown, must report the dates of issuance

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23
Q

How long do you need to keep executed 222 forms?

A

must be kept separately from all other records for 3 years under NC Law and must be kept AT the registered location (includes copy 3 or purchaser’s copy of single sheet form)
**electronic copies of single sheet 222 form may be stored on a system that is different location but need to be readily retrievable

Can keep unexecuted forms at different location

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24
Q

Electronic Controlled Substance Ordering System (CSOS) what is it

A

Can use it to order controlled substances instead of 222 form and this is special because you can order C2-5 not just C2
-when you receive the items you must record the quantity/date and link this with the originally electronic order

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25
Q

Ordering C3-5 drugs

A

Not same restrictions as C2 drugs
DO NOT need POA
Pharmacy must keep a receipt (invoice or packing slip) of drugs received and confirm order is accurate

C3-5 if on same invoice of noncontrolled need to mark them and make them easily appealable

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26
Q

Can shipping and financial records for controlled substances be kept at a central location?

A

Yes, with notification to the DEA

Registrant may began central recordkeeping 14 days after the DEA receives notification but must be able to be delivered to registered location within 2 business days at request of DEA OR allow DEA to inspect central location without a warrant

**executed order forms, prescriptions, and inventory records CANNOT be kept at central location (just invoices and packing slips can be)

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27
Q

Can you store C2 records with C3s? C3s with non-controls?

A

C2 records and inventories have to be kept separate from all other records

C3-5 can be kept with non-controls if they are readily retrievable from other records

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28
Q

What should you do if there is a “theft or significant loss” of ANY controlled substance?

A

MUST notify DEA, in writing, within one business day of discovery

Must complete DEA form 106 AFTER the pharmacy conducts an investigation and confirms the left or loss is significant

Pharmacist manager must notify NC BOP of any theft (controlled or non-controlled) and fill out a “drug disaster and loss report” within 10 days of the theft

If the loss is determined to not be significant, the registrant should place a record of the occurrence in a theft and loss file for future reference

ALL thefts must be reported to DEA but not all losses need to be

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29
Q

In-Transit loss of controlled substance what form should you fill out

A

IF the pharmacy signs for the shipment and discovers a loss, then pharmacy must complete a DEA form 106

But if lost in-transit and shipment fails to reach pharmacy, the supplier is responsible not the pharmacist

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30
Q

Any unusual or excessive loss of sudafed must be reported to the local DEA office by phone or ASAP followed by submitting what form within how many days of discovery?

A

form 107 within 15 days

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31
Q

What form must you fill out if you want to dispose of controlled substances?

A

form 41 and requires 2 witnesses

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32
Q

Initial inventory records for all controlled substances on hand must be taken before a pharmacy begins a business and these can be kept at a central location?

A

NO, have to be kept at each registered location in written, typed, or printed form (HAVE TO BE IN HARD COPY AND NOT ELECTRONICALLY)

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33
Q

How often does an inventory of controlled substances need to be done after the initial inventory is done?

A

Every 2 years needs to be done and requires same info as initial inventory (take at end or beginning of day and note that)

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34
Q

How many mL or dosage units can you sell a C5 OTC product of opium or other controlled substance without a prescription

A

Certain C5 products like Cheratussin AC can be sold OTC without rx

No more than 240 mL (8oz) or 48 dosage units of an opium containing product within 48 hours

No more than 120 mL (4oz) or 24 dosage units of any other controlled substance within 48 hours

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35
Q

What form for methadone for addiction?

A

Form 363

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36
Q

When can retail pharmacies dispense methadone?

A

Only for pain, can not dispense for opioid addiction. Has to be done at methadone clinic

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37
Q

Office-based opioid addiction treatment allows qualifying prescribers to prescribe what from their office?

A

any opioid in C3-5 (so not methadone) that was FDA approved for treatment of opioid addiction (buprenorphine products)

Must apply for a waiver, be registered by DEA, and licensed by state medial board

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38
Q

When can a pharmacist deliver a filled rx for buprenorphine to the practitioners office for addiction?

A

Only when it is an implant or injection since these need to be administered by the office

The rx can not be for office stock

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39
Q

Can central fill pharmacy fill control?

A

Yes

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40
Q

How can rxs be sent for controlled drugs from retail pharmacy to central fill?

A

Can send a copy via fax or electronically

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41
Q

How long do original rx records need to be kept? They need to be readily retrievable which means what? How long for Medicaid or medicare part D?

A

Every original rx order should be kept for 3 years and must be retrievable with 48 hours of NC board request

NC mediacid requires hardcopy to be kept for 5 years
Medicare Part D requires 10 years

Must also keep the record of dispensing for 3 years for all

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42
Q

Can you capture and maintain an electronic image of the rx for recordkeeping?

A

Yes, you can throw away original rx and just keep electronic image but must be able to retrieve within 48 hours

CAN NOT do this for controlled substances per federal law

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43
Q

Automated Data Processing System: Pharmacist who is responsible for accuracy of data entered into the system must sign an acknowledgment within how many hours of dispensing a drug?

A

within 72 hours

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44
Q

How much sudafed can you sell to 1 person?

A

3.6 g/day

9 g/30 day period

7.5 g/30 day period by mail order

Have to be 18 years of age, sold behind pharmacy counter, and only sold in blister packages

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45
Q

How long must sudafed records be kept and how long do you have to make them available?

A

Records made available within 48 hours and kept for 2 years

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46
Q

Requirement to become a CPP: If you have a PharmD how many years of clinical experience must you have? What about if you have a Bachelor of pharmacy? How many ACPE certificate programs must you complete?

A

PharmD: 3 years clinical experience + 1 ACPE certificate program in the area covered by CPP agreement

Bachelor: 5 years experience + 2 ACPE certificates

Or you can have a BPS certification, geriatric certification or residency program with 2 years of experience

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47
Q

How many CE hours do you need to renew your CPP?

A

Each CPP shall earn 35 hours of CE each year (and practice relevant)

15 normal CE hours (with 5 live) that are required for any pharmacist count towards this so really you need 20 more CE hours than retail pharmacist

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48
Q

CPP agreement: How often must you meet with supervising physician and how long should this documentation of meeting be kept for? When should you notify the board by if you discontinue working?

A

Monthly meeting for the first 6 months and then every 6 months thereafter

Must keep documentation of meeting for 5 years by both parties involved

Notify BOP within 10 days of stopping work

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49
Q

How much CE do you need to do to maintain an immunization certificate?

A

3 hours of CE (vaccine topics) every 2 years

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50
Q

For any immunization that is recommended by the CDC how old does the patient have to be to get it from pharmacist?

A

18 years or older and a prescription from MD/DO

For pneumococcal, herpes zooster, hep A/B, meningococcal, tetanus, HPV they can get it without rx just need written protocol and 18+

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51
Q

Can give flu vaccine to persons at least how old?

A

10+ with written protocol

6+ with prescription

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52
Q

How often must immunization written protocol be reviewed with the physician?

A

annually

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53
Q

Must notify the patient’s PCP within how many hours after administering ANY vaccine?

A

72 hours, if they do not have a PCP then tell them the benefits of having one

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54
Q

Access the NC immunization registry prior to giving a vaccine and record any vaccine given (NOT FLU) in the registry within how many hours?

A

72 hours after administration of vaccine

55
Q

Can an outsourcing facility compound non-sterile drugs?

A

Yes, but cannot only compound non-sterile drugs. Must also compound sterile drugs

Allowed to manufacture and send interstate shipments of larger quantities of compounded drugs without rx being issued (unlike traditional compounding where it can not exceed 5% of total rxs)

56
Q

Do outsourcing facilities need to be a licensed pharmacy?

A

Not required to be a licensed pharmacy but must be under direct supervision of a licensed pharmacist

Required to register as wholesaler and would need pharmacy permit if they directly dispense to patients

Subject to CGMP and are under the standards of FDA

57
Q

Pharmacies who perform any type of compounding shall notify the BOP (both on initial app and each year) of:

A
  1. whether they compound
  2. good-faith estimate of % of pharmacy’s dispensing that involves compounding
  3. whether they engage in non-sterile or sterile compounding
  4. what risk level of sterile compounding they perform defined by USP 797
58
Q

As a pharmacist, can you compound an OTC product for a patient without an rx?

A

NO, need to be patient-specific if traditional pharmacy

59
Q

Dispensers must have systems in place to identify and quarantine suspect/illegitimate products and notify the FDA/trading partners if one is found within how long? How long must this documentation or product disposition be kept for?

A

within 24 hours

documentation of investigation or product disposition to be kept for 6 years

60
Q

Track and Trace: How long are transaction records to be maintained for after the transaction?

A

6 years and most likely all electronically

61
Q

Are internet based prescriptions legal?

A

If they are generated without a physical exam or a prior prescriber-patient relationship then they are NOT valid (for controlled and non-controlled)

DEA considers a valid rx to be issued from at least one in-person evaluation on the patient for a legit medical purpose

62
Q

Can you dispense a controlled medication by means of the internet?

A

Yes but pharmacy must hold a modified DEA registration (all controls in all schedules)

63
Q

What do you need to provide to NC in order to be an internet pharmacy? What if you want to dispense controlled substances?

A

Must be certified by the national association of BOP under its digital pharmacy accreditation program

Provide NC BOP with names of corporate officers and stakeholders
Provide % of annual business that is conducted via the internet

Controlled:

  • notify DEA and each state BOP intent of dispensing through internet within 30 days of starting
  • register for DEA # AND then apply for modification
64
Q

How often does the internet pharmacy (if dispensing controlled substances) need to report to DEA???

A

Report on monthly basis to DEA the amount of each controlled substance dispensed if:
1. 100 or more rxs for controlled substances filled or 5,000 or more dosage units filled for ALL controlled substances combined

IF amounts are less than above, a report is still required that indicates a negative response (due on 15h of each month)

These include ALL controlled substances filled even by means other than internet (normal walk-in)

65
Q

Do you need a pharmacy permit to participate in the drug and medical device repository program?

A

Yes you do unless a “dispensing physician” registered with the board who provides services to patients of a free clinic that does not have a pharmacy permit may accept and dispense donated drugs

Free clinics must also register for a pharmacy permit but they are able to apply for a “limited service permit”

66
Q

Can a pharmacist accept the following drugs for the repository program?

Controlled substance
Biologic
Compounded drug
Refrigerated drug

A

No controlled substances

Biologic only if donated by manufacturer or wholesaler

No compounded drugs or parenteral admixtures

Refrigerated only if donated by manufacturer, wholesaler, or pharmacy that has stored it properly and never dispensed

67
Q

Local health department clinics must secure the services of a pharmacist-manager who shall review dispensing records how often? Do they have limited drugs they can dispense?

A

Pharmacist manger must review records at least weekly and within 24 hours if the health department personnel dispenses to more than 30 patients in 24 hours

Limited to drugs in a formulary approved by the BOP (TB, STDs, contraceptives, etc)

68
Q

What schedule are dronabinol oral solution? What about capsules?

A

Capsules are schedule 3

Oral solution is schedule 2

69
Q

What schedule is HCG? Anabolic steroids?

A

schedule 3 both

70
Q

Not more than 1.8 g of codeine per 100 mLs or not more than 90 mg/dose unit with opium or nonnarcotic ingredient is what schedule?

A

schedule 3 unless exceeds this quantity then schedule 2

71
Q

Tramadol and Soma are what schedule?

A

4

72
Q

What schedule is phenteramine?

A

4

73
Q

Lomotil is what schedule?

A

5

74
Q

Pregabalin (lyrica) is what schedule ? what about gabapentin?

A

5 but gabapentin is non-controlled

75
Q

Do out-of-state prescription drug manufacturers or repackagers shipping directly to NC have to register with the NC department of ag food and drug protection division?

A

Yes they do and they are subject to inspection

given license and assigned reg #

Pharmacies are exempt if receive patient specific prescription

76
Q

All wholesale distributers must retain their records for how long?

A

6 years per drug supply chain security act

77
Q

If PA/NP want to dispense drugs what is the requirement? How often must a pharmacist review the drugs dispensed by them?

A

Need to be under the supervision of licensed pharmacist (a dispensing physician is not allowed to be their supervisor)

unless handing out drug samples at no fee

Pharmacist must retrospectively review all drugs on a weekly basis
-all drugs dispensed must be pre-labeled and prepackaged

78
Q

Pharmacist in charge during a disaster or emergency shall report within how many days to the BOP any disaster, accident, theft, or emergency which may affect the strength, purity, or labeling of drugs

A

10 days

79
Q

Naloxone is rx only but has a standing order that means what?

A

Pharmacist can dispense it to anyone without a script from a dr but they have to generate their own script

80
Q

How many days notice do pharmacy get of a audit?

A

14 day notice

81
Q

Who has to register with the NC drug control unit if handling controlled substances?

A

Hospital pharmacies

82
Q

Medication orders from a healthcare facility shall in the absence of a indicated quantity be deemed to a what day supply?

A

30 day unless otherwise noted

There will always be some stop date or policy but if not 30 day is max so order is not good forever

83
Q

Auxiliary medication inventories what is it? and do you need a rx in order to get them? Can controlled substances be kept in them?

A

Contains drugs only in amounts sufficient to meet IMMEDIATE therapeutic needs of patients (maintenance meds not stored here)

Dr. will give order first to nurse and they will get it but afterwards Dr. must send a script to pharmacy and records need to be kept

Yes controlled can be kept in them

used for emergent situations

84
Q

For automated dispensing machines do medication orders need to be retrospectively or prospectively verified by a pharmacist?

A

Need to be prospectively done before the nurse removes the drug but there are exceptions

exceptions: override medications and physician controlled medications so retro these ones
- also nurse can pull subsequent doses of an order already verified (levo QD x 7 days)

85
Q

Need to be a validating technician in order to supervise and check the tech check tech rx what credentials do you need

A

Be registered with NC BOP
Be a certified tech
Hold associate’s degree in pharmacy technology

86
Q

Does a pharmacy providing remote medication verification for hospital pharmacies need a NC permit? Do the pharmacists need to be licensed by NC BOP?

A

Yes must notify the BOP and apply for permit

Also out-of-state remote med order processing pharmacy must register with BOP as an out-of-state pharmacy

All pharmacists who work there must be licensed by the NC BOP (even if located in another state, since they will be verifying medications within the state of NC)

87
Q

In a hospital if there is no pharmacist present, you can train and authorize a nurse to remove drugs from the pharmacy… Do they need to contact the pharmacist? Within how many hours does the pharmacist have to verify the order?

A

Yes, they can only do it after the “on call” pharmacist is contacted

The pharmacist has 24 hours to verify the drug

88
Q

In hospital pharmacies keep all records of ordering, receiving, dispensing and must be kept for how long?

A

3 years

89
Q

In hospital pharmacy record and identify the responsible pharmacists and techs for medication compouding and dispensing and this should be kept for how long?

A

30 days (very unique)

90
Q

How many days supply can an emergency department dispense to a patient?

A

not more than 24 hour supply or smallest available quantity

drugs should be prepackaged and pre-labeled by pharmacist

only if a 24 hour outpatient pharmacy is not available or open

91
Q

If a retail pharmacy wants to install an automated dispensing machine at a LTCF, do they need another DEA registration? Does the LTCF need anything?

A

Yes, they must have a separate DEA registration at LTCF location but can keep the records for that at their brick and morter pharmacy
-need to use form 222 to transfer C2 from their pharmacy to LTCF

LTCF must apply for NC BOP permit

92
Q

Can a LTCF nurse/employee be an agent of a prescriber since usually they are not employed by them?

A

If there is a written agreement they can

93
Q

For an emergency kit at a LTCF that a pharmacy places there, does the pharmacy need another DEA registration for that? Does the LTCF need a DEA registration?

A

LTCF does NOT need DEA registration

Pharmacy does NOT need a separate DEA reg, they can use their typical DEA registration and considered an extension of that

94
Q

LTCF emergency kits: Can contain no more than how many controlled drug entities? How many doses of each of those entities?

A

No more than 7 controlled drug entities (C2-5)

No more than 5 doses of each controlled entity for each 50 licensed beds

95
Q

Breach of PHI: How long must you keep documentation of a breach of PHI? If you decide a breach met an exclusion do you still have to document?

A

Either way, the event must be documented and kept for 6 years

96
Q

If there is a breach of PHI, on the federal level how long do you have to notify the patient? The secretary of DHHS? How many individuals do you need to hve to tell the media?

On the state level, how long to notify person and NC attorney genera consumer protection divison? How many people to notify all consumer reporting agencies?

A

Federal: must notify individual without delay and no later than 60 days after discovery by mail or electronically

  • secretary of DHHS must also be notified within 60 days after the end of the calendar year in which it was discovered
  • if >500 ppl, notify media and DHHS no later than 60 days

State: Notify person and NC attorney without unreasonable delay
->1000 ppl, all consumer agencies

97
Q

If a communication about a product or service that encourages people to purchase or use the product is done by face-to-face is that marketing?

A

NO only telephone, mail, email j

You can hand them printed information also

Also as long as the covered entity does not receive financial incentive it is not marketing

98
Q

What types of insulin are OTC?

A

Regular insulin (Humulin R) and insulin NPH (Humulin N) are OTC

99
Q

Non-Sterile: Repackaging BUD if the labeling does not include an “in-use” time:

  1. Nonaqueous formulations (tabs, capssules) ?
  2. Water-containing oral formulations (solutions)?
  3. Water-containing topical/dermal formulations?
A
  1. 6 months or the expiration date of drug product, whichever is shorter
  2. 14 days
  3. 30 days
100
Q

PA/NP must consult with their supervising physician prior to prescribing targeted controlled substances when all of the following apply:

  1. facility mainly treats pain
  2. use of targeted drug will or expected to exceed x days
  3. targeted drug is continously prescribed to the same patient, NP/PA must consult with their supervisor at least once every x days
A
  1. 30 days

3. 90 days

101
Q

Do PAs and NPs have to write their supervising physicians name on each rx and license number?

A

Only NPs

PAs do not have to do this

102
Q

Can other medications be written on the same script as C2 medications?

A

Yes they can

103
Q

Can rx blanks for controlled substancs be pre-printed?

A

NO but can do this for non control

104
Q

Can you dispense a rx written by an out of state prescriber? Foreign prescriber?

A

Non control: Yes

Control: NC control substance act states that practioner must be licensed in NC to administer or prescribe controlled substances

Foreign: Non-control if you believe there is a valid patient/prescriber relationship
-control if they have a DEA # which is very unlikely

105
Q

Can you fill telemedicine prescriptions?

A

Non-control: Yes if you assume the rx is legit

Control substances for pain: NO

106
Q

If a prescriber writes prn as the amount of refills for a rx, how long is it good for? what does it mean if they write prn x 2 years

A

it shall not be refilled more than one year after the date issued

good for 2 years if prn x 2 years

107
Q

If a patient is out of refills and the pharmacist is unable to obtain a refill from the prescriber, the pharmacist can dispense a one time emergency refill for up to how many days supply? Can it be for controlled medications? How much time do you have to notify the prescriber? What happens if the prescriber is inable to provide medical services due to dying or going on extended vacation?

A

30 days supply

Can be for control but NOT for C2

72 hours to notify prescriber

If they die or go on extended vacation you can prescribe a one time fill of up to 90 days (not if office is just closed for weekend)

108
Q

Once a prescription is transferred, how long can it be filled for? Control? Non-control?

A

Once transferred, cannot be filled more than 1 year from transfer date for non control

C3-4 expire 6 months after they were written so shorter

109
Q

How many times can C3-5 prescriptions be transferred ?

A

Only transferred to another pharmacy on a one-time basis

if same company you can transfer it up to max refills permitted

110
Q

What staff members can transfer C3-5?

A

Only direct communication between 2 licensed pharmacists

Electronic controlled substance can be transferred electronically and do not need phone call

111
Q

For controlled substance prescriptions that have not been filled yet (On file), can a pharmacy forward the rx to another pharmacy?

A

C2-5 need to be filled once and then they can forward that script if it is a written, fax, or phone in rx

if it is ELECTRONIC rx then it can be forwarded before being filled

112
Q

Who can transfer non control substances?

A

Pharmacist, Interns, certified techs (have to be certified)

113
Q

When receiving a transferred rx from another pharmacy, do you need to write the manufacturer/brand of the drug dispensed? How about address of pharmacy? Phone # of pharmacy?

What if its a controlled substance, anything unique?

A

Yes need brand and address but do NOT need phone #

Very important for narrow therapeutic drugs as well

Controlled drugs need:

  • date of original dispensing
  • rx number from where the rx was “originally filled” (if different than current pharmacy)
  • dates and locations (if different) of previous fills
114
Q

A pharmacist or designee must notify the prescriber “within reasonable time” if dispensing an interchangeable biological product and they must give them what information? When DONT they need to notify them?

A

Must give them the product name and manufacturer

DONT need to notify if a refill rx is not changed from the product dispensed on the prior filling of the rx

115
Q

What is unique about filling a narrow therapeutic index drug?

A

Must be refilled using the same drug manufacturer as the previous fill
-includes a new rx which is a continuation of previously initiated therapy

Unless you receive approval from prescriber and patient then you can change

Carbamazepine, cyclosporine, digoxin, Synthroid, lithium, phenytoin, tacro, warfarin

116
Q

What requirements need to be on the label of the rx? Do you need prescriber name? Address and phone # of pharmacy?

A

You need prescriber name
You need address of pharmacy
You DO NOT need phone # of pharmacy

Others:
Name of pharmacy
Serial # of rx
Date of rx filled
Name of patient
Name and strength of drug 
Generic name of drug (even if brand dispensed)
Directions for use
Cautionary statements
Filled by with name of dispensing pharmacist (at min first initial and last name)
Expiration date
If tranq/sedative need warning about alcohol

C3-5 refills need BOTH the date of initial filling AND date of current dispensing

117
Q

If a prescription is dispensed in a container other than manufacturer original container, what is the expiration date that should be written on it?

A

Shall be the earlier of either one year from date dispensed or the manufacturer’s expiration date

118
Q

Do C2-5s need “caution: Federal law prohibits the transfer of this drug to anyone other than whom it was prescribed”?

A

C2-4 need this

C5 DOES NOT

119
Q

Can prescribers make a request for all of a patients rx to be in non child proof?

A

NO they can make individual requests but only patients can make blanket waiver

120
Q

The patient must present a valid ID to pick up any controlled substance?

A

False

ANY C2 and select C3s (codeine combination products) the person picking it up must have a valid ID

121
Q

What schedule of controls are contained in the NC CSRS

A

C2-5 so all

122
Q

How long do you have to report information to the NC controlled substances reporting system (CSRS)?

A

No later than the close of the next business day after the prescription was dispensed

123
Q

Samples of C5 non-narcotic, non anorectic drugs do not have to be uploaded to CSRS. What are examples

A

Pregabalin
Lacosamide

ONLY SAMPLES not rx

124
Q

For targeted controlled substances when must a pharmacist check the CSRS report for the last 12 months prior to dispensing?

A
  1. Suspect patient is using it non-medically (drug seeking or diversion)
  2. Prescriber is located outside the usual geographic area served by pharmacy
  3. patient resides out of area usually served
  4. patient pays with cash despite have insurance on file
  5. Patient demonstrates potential misuse of drug
125
Q

How many hours of CE does a pharmacist need to do each year and how many need to be live?

A

15 hours of CE with 5 being live

Can get up to 5 hours for precepting if you do at least 160 hours

126
Q

How long do you have to notify the BOP of change of name, address, or employement?

A

30 days

127
Q

If there is a change of pharmacy manager or ownership, how long do you have to complete an inventory of all controlled substances?

A

10 days

128
Q

How long does pharmacy manager have to report to BOP of a drug dispensed that has caused or contributed to death of patient?

A

14 days death rule

129
Q

If pharmacy is closing for good, when do you have to notify public and how long do you need to keep a closed sign posted for?

A

Notify public within 30 days and keep sign posted for 15 days after closing date

130
Q

Out of state pharmacy: DO they need to obtain a NC pharmacy permit from BOP and do the pharmacists need to be licensed in NC?

A

They HAVE to obtain NC pharmacy permit but pharmacists only need to be licensed in the state they are dispensing so not NC

131
Q

Out of state pharmacy should notify the BOP within how long of recepit of any order by BOP imposing disciplinary action on the pharmacy?

A

5 days

132
Q

After what date must a pharmacy close and re-apply for new permit if they lit it lapse?

A

March 31st

it is considered lapsed by march 1st but can still operate

133
Q

Do noncertified techs need highschool diploma or equivalent? How many days do they have to complete training by pharmacist?

A

Yes or enrolled in a one currently

180 days

134
Q

Pharmacy must close if pharmacist is not present for how long?

A

90 min

MPJE (2 decks)

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