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Pharmacy Law and Ethics (2) > Controlled Substances (Part 2) > Flashcards

Controlled Substances (Part 2) Flashcards

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1
Q

What must ALL controlled substance prescriptions have (6):

A
  • signature and date written
  • full name and address of the patient
  • drug name, strength, dosage form
  • quantity prescribed
  • directions for use
  • name, address, and DEA number of the practitioner
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2
Q

Prescriber’s signature must be______

A

indelible (cannot be erased)

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3
Q

T/F Prescriber’s “agent” may not prepare prescriptions for practitioners to sign

A

False; they may prepare rx, but its the responsibility of the practitioner to assure accuracy

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4
Q

T/F Pharmacists are not held accountable for assuring accuracy of the prescription.

A

FALSE; pharmacist has corresponding responsibility

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5
Q

T/F Practitioners MAY prescribe and pharmacies MAY receive, dispense, and archive electronic prescriptions, including controls

A

TRUE

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6
Q

What must prescribers use to electronically sign the prescription?

A

a two-factor credential

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7
Q

When can a paper copy of an electronic rx be given to the patient

A

if it is clearly labeled with “COPY ONLY NOT VALID FOR DISPENSING”

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8
Q

How long does a back-up of an electronic rx be kept for?

A

2 years and must be backed up daily

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9
Q

When multiple prescriptions are received, the pharmacist must exercise ______ to determine whether or not the prescription was filled

A

due diligence

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10
Q

What must a pharmacist do If a paper or oral prescription indicates the original prescription was transmitted electronically to another pharmacy?

A

the pharmacist must check with the “other” pharmacy to determine if the e-prescription was received and dispensed

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11
Q

T/F If the e-prescription was received but NOT dispensed, the pharmacy must mark the e-prescription “VOID”

A

TRUE

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12
Q

T/F If the e-prescription was received AND dispensed to the transferred pharmacy, the pharmacy presented with the paper / oral prescription MAY NOT dispense the drug and MUST mark the paper / oral prescription “VOID”

A

TRUE

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13
Q

When can a practitioner administer or dispense a CII in the course of professional practice without a prescription

A

for maintenance or detoxification treatment if requirements are met

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14
Q

______ may administer or dispense a CII upon receipt of a written prescription or an order to be dispensed for immediate administration to the ultimate user

A

institutional practitioners

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15
Q

RPh may dispense CII in an emergency upon receipt of oral authorization by a prescriber, but what must be true (3)

A
  • immediate administration is necessary for proper treatment
  • no appropriate alternative is available
  • no way for the prescriber to provide a written prescription to the patient before dispensing
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16
Q

T/F The quantity prescribed and dispensed for emergency rx, it is limited to an amount adequate for emergency period ONLY

A

TRUE

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17
Q

How long does the prescriber have to deliver a hand written prescription for the quantity dispensed during the emergency for a Schedule II? What happens if they don’t? What needs to be written on the RX?

A

7 days;
the RPh must notify the DEA;
“Authorization for Emergency Dispensing”

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18
Q

T/F Central fill pharmacies MAY prepare CIIs for dispensing from oral authorization

A

FALSE; central fills MAY NOT; they take too long and would have to send rx to dispensing pharmacy

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19
Q

When can CIIs be faxed: (3)

A
  • a resident of long term care facility (LTCF must be written on it)
  • if patient enrolled in hospice (HOSPICE must be written on it)
  • home infusion pharmacy receives rx for parental administration
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20
Q

LTCF

A

Long term care facility

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21
Q

Is an assisted living facility the same as a LTCF?

A

NO

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22
Q

T/F Faxing a CII prescription to the dispensing the pharmacy for any other reason is for informational purposes only.

A

TRUE

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23
Q

When can dispensing occur for faxed CIIs?

A

only after the original prescription is presented

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24
Q

RPh are NEVER allowed to change this on CIIs: (3)

A

Patient’s name
Drug prescribed
Prescriber’s signature

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25
Q

What can RPh add to CII prescriptions? (2)

What must be documented?

A
  • strength
  • quantity
  • the date and time the RpH spoke with the prescriber with brief explanation; RPh must initial
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26
Q

T/F Refills for Schedule II are not prohibited

A

FALSE; are prohibited

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27
Q

T/F Partial Filling of Schedule II prescriptions are permissible

A

TRUE

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28
Q

When are partial fills of Schedule IIs permissible? (2)

A
  • RPh is unable to supply the full quantity because of inventory
  • patient is in a LTCF or has “terminal illness”
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29
Q

Requirements when RPh is unable to supply full quantity for Schedule II (2)

A
  • quantity dispensed must be noted on face of RX and remaining portion filled within 72 hours
  • if not filled in 72 hours, RPh must notify prescriber
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30
Q

Requirements when patient is in LTCF or has terminal illness for Schedule II drugs (3)

A
  • Quantity dispensed, date, remaining quantity authorized for dispensing, and RPh identification must be recorded with each partial fill
  • Total quantity dispensed in partial filling cannot exceed total quantity prescribed
  • Prescription is valid for partial filling for up to 60 days from issue date
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31
Q

Institutional RPh and RPh may dispense a Schedule III, IV or V drug pursuant to: (4)

A
  • Written prescription signed by a practitioner
  • Fax of a written prescription transmitted by the prescriber
  • Electronic prescription meeting CSA requirements
  • Oral prescription that is promptly reduced in writing by the RPh
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32
Q

_______ may administer or dispense CIII, CIV, or CV directly to a patient in the course of professional practice without a prescription

A

Prescriber

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33
Q

CIII and CIV controlled substances MAY NOT be refilled ________ from the date of issuance or exceed the number of refills permitted, if allowed by the prescriber

A

more than 5 times in a 6 month period

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34
Q

CV prescription refills must be in accordance with _____. What is this requirement in GA?

A

prescriber allowances and state regulations; CV controlled substances follow same rules as CIII and CIV in GA

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35
Q

What should the record of each refill for CIII, CIV, V include: (5)

A
  • Name and dosage form of the drug dispensed
  • Date filled
  • Quantity dispensed
  • Initials of dispensing pharmacist
  • Total number of refills remaining, if any, for the prescription
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36
Q

When may prescribers authorize additional refills to a CIII or CIV prescription orally: (2)

A
  • Total quantity authorized, including original amount, does not exceed 5 refills in 6 months
  • Quantity of each additional refill is equal to or less than the original quantity prescribed
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37
Q

T/F Prescriber must issue a “new” prescription for any quantity beyond 5 refills, or 6 months

A

TRUE

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38
Q

When an RPh receives an oral authorization for a Schedule III, IV, V what should be included on the original paper RX: (4)

A
  • Date of authorization
  • Quantity permitted per refill
  • Number of additional refills authorized
  • RPh’s initial who received authorization
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39
Q

What are the 2 types of systems a pharmacy can use for record keeping of Schedule III, IV, and Vs?

A
  • Paper system (Back of the original Rx)

- Computerized record-keeping system

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40
Q

When using the paper system: the RPh must record what on the original paper RX: (4)

A
  • Date of authorization
  • Quantity permitted per refill
  • Number of additional refills authorized
  • RPh’s initial who received authorization
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41
Q

T/F Paper system must provide on-line retrieval of original Rx’s currently authorized for refilling and refill history

A

FALSE: computer system

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42
Q

Computer System record keeping of Schedule III, IV, and V should include: (3)

A
  • Hard-copy printout (log) of each day’s controlled substance refill data must be verified
  • dated
  • and signed the pharmacist
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43
Q

Partial filling of Schedule III,IV, and V are allowed provided: (3)

A
  • Each partial fill is recorded in the same manner as a refill
  • Total quantity dispensed in all partial fillings does not exceed the total quantity prescribed
  • Dispensing does not occur 6 months beyond the date the prescription was issued
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44
Q

Schedule II-V prescription label must contain: (8)

A
  • Date of fill
  • Pharmacy name and address
  • Serial number of the prescription
  • Name of patient
  • Name of prescriber
  • Directions for use
  • Warning statement “Caution: Federal law prohibits the transfer…”
  • Other cautionary statements, if needed or required by law
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45
Q

What in addition to federal requirements are the labels in GA for a Schedule II-V drug to include: (3)

A
  • Telephone number of dispensing pharmacy
  • Date of initial fill or refill
  • Drug expiration date, if any
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46
Q

T/F Institutional Schedule II rx labels ARE required to contain the same information as all the schedules

A

FALSE: ARE NOT

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47
Q

INSTITUTIONAL Schedule II-V prescription labels ARE NOT required to contain the same information as a normal label provided: (3)

A
  • Drug is NOT in the possession of the user prior to administration
  • Institution maintains appropriate records related to administration, control, dispensing, and storage
  • System used by the RPh to fill the prescription can identify the supplier, product, directions for use, and cautionary statements
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48
Q

Schedule III, IV, or V original Rx information may be transferred ______ between pharmacies for refill purposes

A

one-time

49
Q

Pharmacies electronically sharing a real-time online database may transfer Schedule III, IV, or V Rx information ______

A

up to the maximum number of refills permitted

50
Q

T/F Pharmacies electronically sharing a real-time online database DO NOT have to satisfy all the same information requirements as “manual” transfers

A

FALSE; DO

51
Q

Original and transferred prescription records must be maintained for ______

A

2 years from the date of last refill

52
Q

T/F All transfers must be communicated directly between two licensed pharmacists (getting a “copy”
“Transferring pharmacist” and “Receiving pharmacist”.

A

TRUE

53
Q

What must “transferring pharmacist” do when transferring an RX: (3)

A
  • Invalidate the original prescription
  • Record name, address, DEA registration, and name of “receiving RPh”
  • Record the date of transfer and name of “transferring RPh”
54
Q

How do you invalidate the original prescription during a transfer?

A

Write “Void” on the face of the paper original prescription

55
Q

Where do:
-the name, address, DEA registration, and name of “receiving RPh”
-the date of transfer and name of “transferring RPh”
need to be recorded when transferring an rx: (2)

A
  • Recorded on the back of the invalidated paper prescription

- Information documented in the electronic Rx record

56
Q

T/F Schedule II can be transferred.

A

FALSE: CAN’T because they do not have refills

57
Q

What must “receiving pharmacist” do when transferring an RX: (3)

A
  • Write “TRANSFER” on the face of the prescription
  • Enter all information required for prescriptions by the Controlled Substance Act
  • Create an electronic Rx record
58
Q

What all is required for prescriptions that are transferred under the Controlled Substance Act: (5)

A
  • Date of original Rx was written and dispensed
  • Original # of refills and # of valid refills remaining
  • Date and location of previous refill(s)
  • Pharmacy’s name, address, DEA registration and prescription number from which the Rx information was transferred from
  • Name of “transferring pharmacist”
59
Q

T/F Schedule III, IV, or V Rx’s MAY NOT be transmitted electronically or by fax from a retail pharmacy to a central fill pharmacy

A

FALSE: MAY

60
Q

Retail pharmacy transmitting rx to central fill: (6)

A
  • Write “CENTRAL FILL” on the face of the original Rx
  • Record the name, address and DEA registration number of the central fill pharmacy
  • Date of transmission to the central fill pharmacy
  • Indicate the number of refills already dispensed and the number of refills remaining
  • Maintain original Rx for 2 years from the date of the last refill
  • Keep record of receipt of the filled prescription (date, method of delivery, and name of retail employee accepting delivery)
61
Q

Central fill pharmacy receiving the Rx must: (3)

A
  • Keep a copy of faxed Rx or electronic record of all information transmitted by retail pharmacy
  • Record date of receipt of transmitted prescription, name of filling RPh, and filling/refill dates
  • Record the date the filled Rx was delivered to and the method of delivery to the retail pharmacy
62
Q

T/F A Schedule V substance that IS NOT a prescription drug pursuant to federal, state, or local law may be dispensed by a RPh without and rx prescription.

A

TRUE

63
Q

T/F Dispensing of C-V without a RX can be made by pharmacy tech.

A

FALSE: made only by a RPh

64
Q

Quantity dispensed in 48 hour period for C-V without a Rx can not be more than: (2)

A
  • 240mL or 48-dosage units of an opium containing substance (OPIUM)
  • 120mL or 24-dosage unites of any other controlled substance
65
Q

T/F You can not break a stock bottle and it must have OTC label for C-V without a Rx

A

TRUE

66
Q

Controlled substance log book for C-V without a rx must be maintained for 2 years by the RPh containing:(4)

A
  • Name and address of purchaser
  • Name and quantity of controlled substance purchased
  • Date of purchase
  • Name or initials of dispensing RPh
67
Q

How old must one be to purchase C-V without an Rx?

A

at least 18 years of age

68
Q

In GA…RPh may sell or dispense up to ______ dosage units of an exempted non-pseudoephedrine Schedule V substance in a 48-hour period if

A

4 ounces or 32 dosage units

69
Q

In GA…RPh may sell or dispense up to 4 ounces or 32 dosage units of an exempted non-pseudoephedrine Schedule V substance in a 48-hour period if: (2)

A
  • RPh has applied reasonable means to determine the product is being used for a legitimate medical purpose
  • Purchaser has completed the controlled substance “log” book requirements
70
Q

What form must be submitted to the DEA when destruction is complete for reverse distributor?

A

DEA form 41

71
Q

For disposal or destruction of Schedule III, IV, or V drugs:

A

Pharmacy maintains a record of drug name, dosage form, strength, quantity and date transferred

72
Q

For disposal or destruction of Schedule II drugs:

A

Reverse distributor must issue a DEA Form 222 or its electronic equivalent to the pharmacy

73
Q

“Reverse distributors” are registered with the _____ for controlled substance disposal / destruction

A

DEA

74
Q

Registered pharmacies may distribute controlled substances between each other a quantity for general dispensing provided that: (3)

A
  • Distribution is recorded by the distributing and receiving pharmacy
  • DEA Form 222 is used if Schedule II
  • Total number of dosage units of all controlled substances distributed in a calendar year DOES NOT exceed 5% of the total number of dosage units distributed and dispensed in the same calendar year
75
Q

If the Total number of dosage units of all controlled substances distributed in a calendar year DOES exceed 5% of the total number of dosage units distributed and dispensed in the same calendar year what must be done?

A

the practitioner must register as a distributor

76
Q

T/F Prescribers ARE required to keep records of Schedule II, III, IV, and V’s that are prescribed in the normal course of their practice unless it is a part of a maintenance or detox program

A

FALSE; ARE NOT

77
Q

T/F Prescribers ARE required to keep records of Schedule II, III, IV, and V’s that are dispensed in their practice

A

TRUE

78
Q

T/F Prescribers ARE required to keep records of Schedule II, III, IV, and V’s administered in their practice IF they regularly engage in administering controlled substances and charge patients for the service

A

TRUE

79
Q

Options for filing controlled substance rx: (2)

A
  • two file system

- three file system

80
Q

Two file system option 1: (2)

A
  • Schedule II prescriptions in a SEPARATE file

- Schedule III, IV, and V prescriptions are marked with 1” high red “C” stamp and filed with non-controlled substances

81
Q

Two file system option 2: (2)

A
  • Schedule II, III, IV, and V prescriptions are filed together (Schedule III, IV, and V prescription are marked with a 1” high red “C” stamp)
  • Non-controlled substance prescription are in SEPARATE file
82
Q

Three file system (3)

A
  • Schedule II prescriptions in a SEPARATE file
  • Schedule III, IV, and V prescriptions in a SEPARATE file
  • Non-controlled substance prescriptions in a SEPARATE file
83
Q

How often does a controlled substance inventory need to be taken?

A

every 2 years “ biennial inventory”

84
Q

How long must the inventory records be kept for?

A

at least 2 years

85
Q

T/F Schedule I and II inventory records must be maintained in a SEPARATE file from all others

A

TRUE

86
Q

T/F Schedule III, IV, and V inventory records must be maintained in a SEPARATE file or in a manner that makes them READILY RETRIEVEABLE from ordinary records

A

TRUE

87
Q

T/F Inventory records should be maintained in written, typewritten, or printed form and signed by anybody

A

FALSE; signed by the person conducting the inventory

88
Q

T/F Controlled substance financial and shipping records may be kept at that location provided the registrant has notified the DEA of the intent of central record keeping

A

FALSE; central location

89
Q

When does each registrant have to take inventory on the date the change was made: (2)

A
  • When a non-controlled substance becomes a controlled substance
  • when a controlled substance changes schedules
90
Q

What has to be completed when conducting inventory: (3)

A
  • An exact count is required for all sealed, unopened containers
  • An exact count is required for Schedule II opened containers
  • An estimated count is acceptable for Schedule III, IV or V’s if the package size contains
91
Q

Where do Schedules II-V that are authorized for chemical analysis have to be stored?

A

in a securely locked, substantially constructed cabinet

92
Q

Pharmacies MAY store Schedules II-V by: (2)

A
  • keeping them in a locked secure cabinet

- dispersing them through the non-controlled substance stock in an effort to prevent theft or diversion

93
Q

Where must Carfentanil, etorphine, and diprenorphine be stored?

A

in a safe or steel cabinet that is equivalent to a US Government Class V security container

94
Q

When does significant theft or loss of a controlled substance need to be reported to the DEA?

A

immediately upon discovery

95
Q

Along with reporting to the DEA when there is theft what else should a pharmacy do: (2)

A
  • Pharmacies should also notify local law enforcement as required by law
  • Pharmacy must complete a DEA Form 106 to formally document the quantities and circumstances of theft or loss
96
Q

______ are responsible for reporting in-transit loss of controlled substances to the DEA

A

suppliers

97
Q

________ are responsible reporting loss after a RPh has signed for or taken custody of a shipment

A

pharmacies

98
Q

If an in-transit loss occurs but it is not discovered until AFTER the RPh has taken custody _______

A

the RPh must submit a DEA Form 106

99
Q

Controlled Substance Registrant Protection Act of 1984 allows for federal investigation of thefts and robberies if:

A
  • Replacement cost of controlled substance taken is ≥ $500
  • Someone is killed or suffers “significant bodily injury” during the commission of the crime
  • Interstate or foreign commerce is involved in planning or executing the crime
100
Q

Combat Methamphetamine Epidemic Act of 2005 was signed into law under __________

A

the USA Patriot Act in 2006

101
Q

Combat Methamphetamine Epidemic Act of 2005

A

Restricts the sale of and applies to all cough and cold products that contain ephedrine, pseudoephedrine (PSE), or phenylpropanolamine (PPA)

102
Q

What is the retail limit for PSE purchasers for a day?

A

≤ 3.6gm/day

103
Q

What is the retail limit for PSE purchasers for a 30-day period?

A

≤9gm in a 30-day period

104
Q

What is the retail limit for PSE purchaser via mail order?

A

≤ 7.5gm in a 30-day period

105
Q

T/F Non-liquid forms of PSE do not have be sold in blister packs with no more than 2 dosage units per pack

A

FALSE; MUST

106
Q

Where are ALL PSE products to be kept: (2)

A
  • behind the counter (not necessarily the pharmacy counter)

- in a locked display case on the selling floor

107
Q

T/F PSE Products must be handed directly to the purchaser

A

TRUE

108
Q

T/F Retail seller do have to have a pharmacy in order to sell PSE combination products

A

FALSE: Do not

109
Q

Logbooks for Combat Methamphetamine Epidemic Act of 2005 must: (2)

A
  • be maintained for 2 years

- requirements do not apply to purchases of “single sale” packages that contain ≤ 60mg of PSE

110
Q

T/F Written or electronic logbook must be maintained of PSE transactions where the purchaser records their signature, name, address, and date and time of sale.

A

TRUE

111
Q

T/F Retailer must verify information recorded against valid photo ID. Retailer must enter product and quantity sold for PSE

A

TRUE

112
Q

What must retailers that sale PSE do:

A

Retailers must train applicable sale personnel and submit self-certifications to the attorney general

113
Q

T/F PSE is NOT an “exempt Schedule V” controlled substance in GA

A

FALSE; IS

114
Q

What must a pharmacist do IN GA when PSE products are sold: (2)

A
  • Pharmacist must apply reasonable means to determine that the product being purchased is for a legitimate medical purpose
  • Pharmacist must approve all sales and transactions
115
Q

T/F In GA after transactions have been approved, other pharmacy personnel MAY NOT be directed by the RPh to complete the transaction

A

FALSE: may be directed by RPh to complete the transaction

116
Q

In GA where do PSE products have to be kept?

A

Products must be kept in the pharmacy prescription department

117
Q

(Specific to Schedule II) INSTITUTIONAL Schedule II prescription labels ARE NOT required to contain the same information as a normal provided: (1)

A
  • less than 7-day supply is dispensed a one time
118
Q

(Specific to Schedule III-V) INSTITUTIONAL Schedule III, IV, and V prescription labels ARE NOT required to contain the same information as a normal provided: (1)

A
  • less than 34-day supply or 100 dosage units is dispensed at one time

Pharmacy Law and Ethics (2) (7 decks)

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