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MPJE > VA Dispensing > Flashcards

VA Dispensing Flashcards

1
Q

Are there special requirements for delivering prescriptions by mail or other delivery services?

A

Yes. They must include a notice that the med can degrade along with a phone number patients can call to get information about drug degradation.

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2
Q

What entities have to have a controlled substance registration?

A

Anyone who manufacturers, distributes or dispenses Schedule I-V medications and is not a permitted pharmacy or licensed pharmacist.

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3
Q

What form is sent to the DEA for registration of the pharmacy? Do you also have to apply to the VA BOP?

A

DEA 224 form; get the state registration first then apply for a controlled substance registration through the DEA w/224 form

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4
Q

Can one entity be required to have more than one controlled substance registration?

A

Yes, a separate registration is required for each principal place of business where the activity takes place

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5
Q

How often must your controlled substance registration be renewed?

A

every 3 years

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6
Q

Does a chain pharmacy need to re-register every individual pharmacy separately for controlled substance registration?

A

No. The owner may use Form 224b, the Retail Pharmacy Registration Affidavit for Chain Renewal and provide a list of pharmacies whose registrations are being renewed.

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7
Q

What information goes on the permit application to operate a pharmacy?

A

The corporate name and trade name, the pharmacist who will be practicing at that location, and the hours during which the pharmacy will be open.

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8
Q

If the pharmacy wants to change its hours of operation are there requirements?

A

Yes. Any change that is going to be longer than one week must be reported to the BOP in writing and posted conspicuously at least 14 days prior to the change.

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9
Q

What happens with the PIC leaves the pharmacy and what does the new PIC have to do?

A

Out-going PIC must immediately surrender his permit to the board, in-coming PIC must obtain a new permit and make an inventory of all schedule I-V drugs. Out-going PIC doesn’t have to take an inventory but it is recommended.

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10
Q

What is the notice requirement prior to closing a pharmacy for more than one week?

A

The owner has to post a notice at least 30 days prior to the closing or mail a notice 14 days prior to the closing to all customers with refills. The notice must include the name of the pharmacy to which the prescriptions are being transferred to.

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11
Q

Who is responsible for the automated dispensing systems in the hospital?

A

PIC

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12
Q

Do drugs in the automated dispensing system have to be in manufacturer sealed original packaging or unit dose containers?

A

Yes, except multi-dose packaging for oral medication is allowed if approved by the PIC after consultation with the hospital committee.

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13
Q

What are the requirements for a continuous quality improvement program?

A

Each pharmacy must have a program that provides a systemic and ongoing process to analyze of dispensing errors. The pharmacy must use that to come up with responses to improve pharmacy systems and procedures to reduce or prevent future errors.

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14
Q

Are pharmacies outside of VA that ship, mail or deliver Schedule II-Schedule VI drugs or devices into the Commonwealth required to register with the BOP?

A

Yes, they have to register and must have a PIC who has a VA license.

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15
Q

Are VA pharmacies allowed to engage in wholesale distribution of prescription drugs without being licensed as Wholesale Distributors?

A

Yes as long as distributions do not exceed 5% of their annual gross sales of prescription drugs or 5% of the total dosage units dispensed annually.

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16
Q

What is adulteration?

A

When the drug doesn’t meet the quality or purity requirements for the medicine. This likely occurs when:

  1. It contains dirty or decomposed substance
  2. It was made or stored under unsanitary conditions
  3. It was not manufactured using current good manufacturing practice.
  4. It contains a poisonous or deleterious substance
  5. It claims to be a drug which is recognized in an official compendium but doesn’t meet the standards, such as strength for that product
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17
Q

What is misbranded?

A

When the drug’s label is false or misleading, doesn’t contain all the information required by law, is a non-prescription medication that doesn’t contain adequate directions for use by a layperson.

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18
Q

What are the specific labeling requirements for dispensed prescriptions?

A
  1. Name and address of pharmacy
  2. Prescription number or serial number
  3. Date dispensed
  4. name of the prescriber
  5. name of the patient
  6. drug name and strength
  7. directions for use and cautionary statements
  8. the number of dosage units dispensed
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19
Q

Which drugs will need to include the words “CAUTION: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed.” on the label?

A

Schedule II, III, or IV

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20
Q

What additional information needs to be on the label for a prescription that was filled at a central fill pharmacy?

A

A unique identifier (such as the central fill pharmacy’s DEA registration number) indicating that the prescription was filled at the central fill pharmacy.

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21
Q

What if the labeling on a drug says the drug is a specific medicine and the medicine in the container is not that drug?

A

It is both misbranded and adulterated.

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22
Q

What are controlled paraphernalia?

A

Syringes, needles or other instruments used to administer drugs by injection and gelatin capsules, glassine envelopes and other containers for packaging individual quantities of controlled drugs

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23
Q

Who is allowed to distribute needles, syringes, gelatin capsules, quinine or any of its salts?

A

A pharmacist or someone with a license or permit from the Board.

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24
Q

What are the requirements when a pharmacist dispenses syringes, needles, gelatin capsules or quinine? What record of dispensing is required?

A
  1. Require the person requesting to provide ID including proof of age
  2. Provide a written legitimate purpose for use of the product
    Record required:
  3. date of dispensing
  4. name and quantity of the product
  5. the price of the product
  6. name and address of the purchaser
  7. reason for the purchase
  8. pharmD initials
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25
Q

Are pharmacies required to have security systems in VA?

A

yes; they must fully protect the prescription department and be capable of detecting all kinds of break-ins

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26
Q

What are the requirements for an alarm system? Who has access to the codes? When does the system have to be activated?

A
  1. it has to be monitored
  2. It has to have a battery or other backup source of power
  3. it must be capable of sending an alarm even when the communication line isn’t working

Only pharmacists employed by the pharmacy has access (except for emergencies). Must be activated whenever the prescription department is closed.

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27
Q

What if emergency access to the pharmacy is needed?

A

The PIC may place a key and the alarm code in a sealed envelope so that other pharmacy staff can get into the pharmacy in an emergency. The envelope must have the pharmacist signature across the seal and be kept in a safe or vault.

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28
Q

Are interns and techs allowed to possess the key and alarm code?

A

No. They are only allowed access when the pharmacist is on duty.

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29
Q

What if a pharmacist has an emergency and is unable to open the pharmacy as schedule, cannot get alternate coverage, and a patient needs an already filled prescription?

A

A tech or member of the pharmacy’s management may enter the pharmacy to retrieve the prescription if a pharmacist has verbally approved the access.

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30
Q

After an emergency entry to the pharmacy (by someone other than a pharmacist), what information must be recorded:

A
  1. the date and time of entry
  2. the name and signature of the pharmacy tech
  3. the name, title and signature of the manager accompanying the tech
  4. the pharmacist name who granted permission and the telephone number where he was reached
  5. the name of the patient who requested the medication and a description of the emergency
  6. a list of all prescriptions retrieved during the entry
  7. Time of exit and re-securing of the prescription department

The PIC must change the alarm code within 48 hours of this documentation

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31
Q

For how long do records of tech entry to the pharmacy in an emergency have to be maintained?

A

For one year

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32
Q

Can a pharmacy store prescriptions awaiting pickup outside the prescription department?

A

Yes if the pharmacist approves it. The prescriptions awaiting pickup must be stored securely.

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33
Q

Is a log required for prescriptions picked up when the pharmacist is not on duty?

A

Yes. It must include the patient’s name, prescription number, date of delivery, and signature of the person receiving the prescription.

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34
Q

How long must the pharmacy keep a record of prescription pick-up when the pharmacist is not on duty?

A

one year

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35
Q

How should the pharmacy store CII drugs within the prescription department?

A

They can be stored in a locked location, like a safe, or they can be dispersed throughout the pharmacy.

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36
Q

Does a safe for CII drugs have to be locked at all times?

A

It does not need to be locked when the pharmacy is open and a pharmacist is on duty.

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37
Q

What are the requirements if a pharmacy wants to destroy of drugs itself?

A

It must notify the Board in writing at least 14 days prior to the destruction.
Notification must contain:
1. date, time, manner and place of destruction
2. name of the pharmacists who will witness the destruction

Destruction must be done with the PIC and a pharmacist not employed by the pharmacy.

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38
Q

What form is used as a record of the destruction of drugs and for how long must it be maintained?

A

DEA Form 41; 2 years

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39
Q

How does a pharmacy have to maintain its inventory and drug records?

A

Schedule I & II records have to be separate from all other records

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40
Q

What are the perpetual inventory requirements?

A

The pharmacy must maintain a perpetual inventory of Schedule II drugs received and dispensed. This perpetual inventory must be reconciled every month.

41
Q

How are the records of non-Schedule II drugs kept?

A

Schedules III, IV and V can be kept separate or with records of Schedule VI drugs but not with other records of the pharmacy.

42
Q

Can order forms, prescriptions and inventories of Schedule II through V drugs be kept off-site?

A

No, they have to be kept at the same address as the stock of drugs that they pertain to. Other records such as invoices can be kept off-site but the pharmacy must be able to make the records available within 48 hrs

43
Q

What needs to go on the inventory in addition to the drug information?

A
  1. Signature of the person taking the inventory
  2. Date of inventory
  3. Whether inventory was taken before opening of business or after close of business for that day.
44
Q

What about inventories at 24-hour pharmacies?

A

The record of the inventory needs to indicate whether the inventory was completed prior to or after the delivery or distribution of drugs for that day.

45
Q

How do you file order forms, prescriptions and inventories ?

A

They have to be filed chronologically and maintained for a minimum of two years from the date of transaction.

46
Q

What are the requirements for hard copy prescription record-keeping?

A
  1. They must be kept for two years from the date of last refill.
  2. They are filed chronologically (by date of dispensing or entry into the automated data processing system)
47
Q

How are Schedule II prescriptions filed?

A

They have to be filed separately from other prescriptions.

48
Q

How are Schedule III-V prescriptions filed?

A

They can be filed with Schedule VI prescriptions or separately. If filed with Schedule VI they must be readily retrievable.

49
Q

Describe two ways that Schedule III-V scripts are made “readily retrievable.”

A
  1. A red “C” no smaller than an inch is placed in the right corner of the prescription.
  2. A computer system identifies Schedule III-V prescriptions by prescription number and allows retrieval
50
Q

How much ephedrine or related compound can a pharmacy sell to a single person in a day? What is the limit over a 30 day period?

A

3.6 grams; 9 grams

51
Q

Where can the pharmacy display ephedrine?

A

Behind the counter or in a locked case.

52
Q

What goes in the ephedrine log the pharmacy has to maintain?

A
  1. Purchaser’s name and address
  2. Purchaser’s birthday and signature
  3. product name and quantity sold
  4. date and time of the sale
53
Q

What is contained in the statement signed by the purchaser of ephedrine?

A
  1. Acknowledgment of the sales limits

2. Acknowledgement that providing a false statement can result in criminal penalties

54
Q

How long do the ephedrine records need to be maintained?

A

2 years from the date of last entry

55
Q

What about ephedrine sold pursuant to a prescription?

A

The ephedrine rules do not apply to prescriptions

56
Q

Can the pharmacy sell ephedrine if the monitoring system generates a stop alert?

A

Not unless there is reasonable fear of imminent bodily harm

57
Q

What if your electronic record system is down for ephedrine sales?

A

The pharmacy must maintain a written log of sales until the system is restored and then enter that information into the electronic system

58
Q

Can law enforcement access the ephedrine records?

A

Yes. The state police or other state or federal law enforcement agencies can access these records.

59
Q

Are there restrictions in VA on the sale of dextromethorphan?

A

Yes. you cannot sell to a minor (person under 18 yrs). A purchaser has to present an ID to buy dextromethorphan. If the purchaser’s appearance indicates the purchaser is 25 yrs or older you do not have to ask for ID.

60
Q

Does VA allow medical marijuana?

A

Yes in a limited fashion. Cannabinoid oils for medical use are allowed with certification from a doctor and guidance from a pharmacist. These oils are only available from specially licensed pharmaceutical processors. Flowers and leaves of plants are not allowed.

61
Q

How does a patient purchase cannabinoid oils in VA?

A

First the patient or guardian must obtain a written certification from a registered physician. Next, the patient or guardian may register with the BOP and finally patients may visit a pharmaceutical processor to meet with a pharmacist and purchase products

62
Q

Can patients buy cannabinoid-containing products at the drugstore?

A

No. As of 2019 only 5 processors are licensed to sell cannabinoid oils in VA.

63
Q

Does VA allow any dosage form besides CBD oil?

A

It doss NOT allow vaping or edibles.

64
Q

What are the requirements for CBD and THC content?

A
    • At least 5 mg of CBD per dose

- - No more than 10 mg THC per dose

65
Q

What is required to be on a label of a unit dose medication?

A

drug name, strength, lot number and expiration date

66
Q

What unit dose record must be maintained?

A
  1. name of the person who filled the cart

2. name of the pharmacist who checked the cart

67
Q

How long does the cart fill record need to be kept?

A

1 year

68
Q

How many days supply can a pharmacy provide to hospitals and long-term care facilities? These are facilities where only persons licensed to administer are administering drugs.

A

7 days supply

69
Q

How should drugs in the unit dose system be placed in the patient’s drawer?

A

In slots labeled or coded by time of administration

70
Q

Hospitals and long-term care facilities may use drugs that are dispensed in unit-packaging by a robotic system. Does a pharmacist have to check every individual package dispensed?

A

NO. But when the robot is filled with drugs, a pharmacist must verify accuracy. He also must do a random check of 5% of all meds dispensed by the robot everyday.

71
Q

Can the PIC of the hospital authorize nurse access to drugs to obtain emergency medications when the pharmacy is closed?

A

Yes. The drug must be in the manufacturers original container or a unit dose container and the stock must be in a secure location outside of the pharmacy.

72
Q

What record is required for after hours nurse access to drugs?

A
  1. date of withdrawal
  2. patient name
  3. drug name, strength, dosage form and dose prescribed
  4. number of doses removed
  5. signature of the authorized nurse
73
Q

How long does this record need to be kept (nurse access to drugs for emergencies)?

A

1 year

74
Q

Do floor stock drugs have to be checked by a pharmacist prior to delivery and what goes on the delivery record?

A

Yes, the pharmacist has to sign or initial or electronically record the check.

  1. date
  2. drug name and strength
  3. quantity
  4. the hospital unit receiving the drug
  5. dispensing pharmacist and receiving nurse signatures
75
Q

Can prescription drugs be floor stock in a long-term care facility?

A

Not unless they’re in an emergency drug box or stat drug box.

76
Q

Are there limitations on the routes of administration for drugs kept in emergency kits/crash cart?

A

Yes, they have to be administered by injection or inhalation except for SL nitroglycerin, diazepam rectal gel and intranasal naloxone.

77
Q

How long after an emergency kit is opened does it have to be returned to the pharmacy for replenishing?

A

72 hours

78
Q

Is a prescription required for drugs used from an emergency kit?

A

Yes, the prescriber must provide one within 72 hours.

79
Q

What is a stat drug box and what are the requirements for it?

A

It is a drug box prepared by pharmacy to provide initial therapy prior to receipt of drugs ordered from the pharmacy. A prescription or order is required before a drug can be removed and the same type of security requirements are required as required for an emergency kit (lock and seal).

80
Q

Can controlled substances be loaded into a nursing home’s automated dispensing device?

A

Yes, but the nursing home must get a controlled substances registration and a nurse must sign for all drugs (CII-VI) that get loaded into the machine.

81
Q

Does a nursing home need a controlled substances registration if they only have stat drug boxes or emergency drug kits?

A

NO

82
Q

At the end of the day a printout of the day’s prescription dispensing is made. Can you just file it?

A

No. It has to be verified, dated and signed by the pharmacist who dispensed the prescription or verified the data entry. It must be signed with the name as it appears on the pharmacy license.

83
Q

Can a bound log book or separate file be used instead of the daily printout?

A

Yes and the individual pharmacist must sign the log each day.

84
Q

How long do dispensing records need to be maintained? Where is this data maintained?

A

2 years; on the pharmacy premises

85
Q

How long do bulk reconstitution, bulk compounding or repackaging of drug records have to be maintained?

A

Until the drug expires, or one year, whichever is longer

86
Q

What do the bulk compounding, bulk reconstitution or repackaging of drug records need to show?

A
  1. name of drug used
  2. strength
  3. date repackaged
  4. quantity prepared
  5. initials of verifying pharmacist
  6. assigned lot number
  7. manufacturer or distributors name and lot number
  8. expiration date
87
Q

What goes on subsequently repackaged or reconstituted units?

A
  1. drug name and strength
  2. the pharmacy assigned lot number or the manufacturer or distributor’s name and lot number
  3. Appropriate expiration date as determined by the pharmacist in accordance w/USP guidelines
88
Q

When a pharmacy uses automated devices or dispensers, how long does the filling record need to be kept?

A

one year from the date of illing

89
Q

What information should be kept for each bin of an automated device or dispenser in the pharmacy?

A
  1. drug name and strength
  2. drug manufacturer/distributor and lot number
  3. expiration date for all lots placed in the bin
  4. date of filling
  5. expiration date
  6. pharmacist initials
90
Q

What are the requirements for returning a drug to stock?

A

The expiration date needs to be added to the label, which will be either the manufacturer’s expiration date or one year from the date of dispensing whichever is earlier. The dispensed drug cannot have left the pharmacy. The restocked drug needs to be used to fill the next prescription the pharmacy receives for that drug.

91
Q

What if you don’t have a lot number on the label of the drug that is being returned to stock and don’t have it in your records?

A

The drug has to be discarded.

92
Q

What schedules of prescriptions can be transferred between pharmacies?

A

Schedule III through VI, as long as there are refills remaining and the prescription is not expired.

93
Q

When a transfer is done both pharmacies need to record information either in writing or by recording electronically. What information do they need to record?

A
  1. name and address of the other pharmacy
  2. date of transfer
  3. name of the pharmacist
  4. DEA # for CIII-V
    Additional information written on the face of the prescription: the word “transfer,” all of the prescription info required on the original, date of original dispensing, number of remaining refills, the date of last dispensing
94
Q

How long do you have to keep transfer records?

A

2 years from the date of the last refill

95
Q

What if the two pharmacies exchanging transfers share a common database?

A

The receiving pharmacy does not need to maintain a hard copy as long as the system can generate one upon request.

96
Q

How long do dispensing error records need to be maintained?

A

12 months

97
Q

If the patient has taken the drug involved in a dispensing error, is the pharmacist required to notify the prescriber?

A

Yes

98
Q

How long does a pharmacist have to document a dispensing error?

A

As soon as possibly preferably but no later than 3 days after discovery. Documentation should include a description of the event and categorization and analysis of the event

MPJE (11 decks)

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