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Spring 2022: Pharmacy Law > Reading 10 > Flashcards

Reading 10 Flashcards

Covers CSA security, records and reports, controlled substance ordering rules, and inventories.

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1
Q

What factors might the DEA take into account when evaluating pharmacies’ safety measures?

A
  • type of activity conducted
  • type and form of controlled substances handled
  • quantity of controlled substances handled
  • type of vault/safe/secure enclosure used to store the controlled substances
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2
Q

True or false: pharmacies must store all controlled substances in the same area.

A

false; “for CII-V, pharmacies and institutional practitioners can disperse such substances throughout the stock of non-controlled substances in such a manner as to obstruct the theft or diversion of the controlled substances”

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3
Q

Is a locked safe required for controlled substance storage?

A

no

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4
Q

What is the requirement for C-I drug storage?

A

“stored in a securely locked, substantially constructed cabinet”

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5
Q

Where must controlled substances be stored if they are kept in a practitioner’s office or clinic?

A

locked cabinet

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6
Q

How must practitioners store thiafentanil, carfentanil, etorphine, and/or diprenorphine?

A

“in a safe or steel cabinet equivalent to a US Government Class V security container”

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7
Q

Who CAN’T be hired when working with controlled substances?

A
  • convicted of a felony related to controls, OR
  • has had an application for registration with the DEA denied, registration revoked, or has surrendered their DEA registration for cause
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8
Q

True or false: someone arrested for a felony cannot work in a pharmacy dispensing controlled substances.

A

false; arrested is different than convicted

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9
Q

What can be done if an employer wants to hire someone who meets the criteria for denial?

A

they can request a waiver from the DEA

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10
Q

What must be included on a DEA employment waiver?

A
  • detailed description of the individual’s previous violations with supporting documents
  • extent of the individual’s potential access to controlled substances
  • registrant’s proposed safeguards to prevent by individual
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11
Q

Can an employee request a DEA waiver?

A

no

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12
Q

What questions may an employer ask to assess a hiree’s potential risk for controlled substance diversion?

A
  • if they have been convicted of a felony/misdemeanor, or charged with committing a criminal offense
  • if they have ever knowingly used controlled substances not prescribed to them
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13
Q

How long should controlled substance records be kept by all registrants?

A

at least 2 years from the record or inventory date

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14
Q

What must registrants record for their recordkeeping purposes?

A

“a complete and accurate record of each substance manufactured, imported, received, sold, delivered, exported, or otherwise disposed of by them” in addition to records of destruction

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15
Q

True or false: DEA registrants must maintain a perpetual inventory.

A

false

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16
Q

What information must be maintained by pharmacies and other dispensers about their controlled substances?

A
  • name and address of the person to whom it was dispensed
  • date of dispensing
  • number of units/volume dispensed
  • written/typewritten name or initials of the individual who dispensed/administered the substance
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17
Q

What are the basic rule around storing controlled substance records?

A

C-II stuff must be kept separate from all other records; III-V can be kept separately from the non-controls, or in a way that the information is readily retrievable

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18
Q

What is the three file system?

A

include C-IIs in one file, III-V in the second file, and non-controls in the third file

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19
Q

What is the two-file system?

A

C-IIs in one file and all others in another

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20
Q

What are the two ways in which a prescription can be considered “readily available”?

A
  • have a red “C” no less than 1 inch high, stamped in the lower right corner on the prescription’s face
  • pharmacy’s computer system can identify prescriptions by their number and retrieve them in the system by prescriber name, patient name, drug dispensed, and date filled
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21
Q

Does the DEA allow central recordkeeping?

A

yes (if the registrant notifies the DEA in writing)

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22
Q

What must be included in a registrant’s notification to the DEA that they will be storing records in a centralized location?

A
  • nature of the records
  • exact location
  • registrant name
  • registrant DEA number
  • registrant type
  • whether central records will be manual or computer-readable
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23
Q

In general, a registrant can start maintaining centralized records ____ days after the DEA received notification unless they receive denial from the DEA

A

14

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24
Q

If allowed to store records centrally, records must be transferred to the central location within _____ business days.

A

2

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25
Q

What three items CANNOT be stored centrally?

A
  • executed order forms (i.e., completed DEA 222)
  • inventories
  • prescriptions
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26
Q

What schedules can be ordered on a regular invoice, the same as non-controls?

A

III-V

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27
Q

What is the official order form for C-Is and -IIs?

A

DEA Form 222

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28
Q

True or false: ALL distributions of C-IIs must be done on a 222 Form.

A

mostly true; the only way to deliver these drugs without a 222 is with a prescription

29
Q

Today, the 222 Form is a ________.

A

single-sheet form

30
Q

Who must order and execute 222s?

A

the individual who signed the most recent registration paperwork; if they are unavailable, can use a POA

31
Q

True or false: there can only be one POA for an institution’s 222 Forms.

A

false; can have multiple but they must fill out separate POAs

32
Q

Give an example of how a 222 signed by a POA should look.

A

Roberta Registrant by Frieda Farmacist, Attorney in Fact.

33
Q

Who may obtain copies of 222s?

A

registrants registered to handle C-IIs

34
Q

What must be submitted to receive initial 222 order forms?

A

DEA Form 222a (often done as part of the registration process)

35
Q

What pre-printed information should a 222 already have?

A
  • registrant name
  • registrant address
  • registration number
  • authorized activities
  • schedules the registrant may handle
36
Q

What implements may be used to fill out a 222?

A
  • typewriter
  • computer printer
  • pen
  • indelible pencil (dye in the lead)
37
Q

What is considered an “item” on a 222 form?

A

“one or more commercial containers of the same substance in the same finished form and in the same quantity.”

38
Q

True or false: purchasers must include the NDC number of the drug they’re requesting.

A

false (but is usually completed by the supplier noting the exact product sent with the order)

39
Q

How does one prevent the fraudulent addition of items to a 222 after it has been finished?

A

they indicate the last line completed on the form in the space provided at the bottom

40
Q

How many lines are on a 222 Form?

A

20

41
Q

How many suppliers can be listed on a DEA 222?

A

1

42
Q

What MUST be done after a 222 form has been signed and completed?

A

copy or scan it; the original will be sent to the supplier

43
Q

How do you void an original 222 with an error on it?

A

write “VOID” across the front

44
Q

True or false: purchasers don’t need to keep voided forms since they aren’t being executed.

A

false

45
Q

What will a supplier do with the completed DEA 222 Form?

A

they keep it and forward a copy to the DEA by the end of the month, or report it through ARCOS

46
Q

If the supplier cannot fill the entire order when received due to stock or another issue, the supplier may partially fill the order and supply the balance within ___ days of the date on the order form.

A

60

47
Q

Endorsing an order is an _______ process.

A

all-or-nothing; either the original supplier endorses the entire order, or they keep it

48
Q

Endorsing an order must be done within the 60-day time frame, and the new supplier must complete the order within ____ days of the original order date.

A

60

49
Q

What must a supplier do if they encounter an issue with the order form?

A

send it back to the purchaser with a statement explaining why the form can’t be filled

50
Q

If a supplier must void or cancel part of the order received, they must notify the purchaser in writing and then ______________________________.

A

draw a line through the voided items and print “canceled” in the space provided for the number of items shipped on the original DEA 222.

51
Q

How can a purchaser cancel all or part of their 222 order?

A

by notifying the supplier in writing (mail, fax, email)

52
Q

What must the purchaser record when a 222 order is received?

A

the date(s) received and the number of containers of each item received from the supplier (on the 222 copy, or electronically linking the receipt to the 222)

53
Q

What are considered to be “unfilled order forms”?

A

222s that are lost in the mail or lost by the supplier before being filled

54
Q

What happens if a 222 is lost in the mail or by a supplier prior to fulfillment?

A

the purchaser must execute a new, identical 222 Form and send it to the supplier again, with a statement containing the order number from the original form the date of the lost form, and a note that the substances ordered were not received

55
Q

What should a supplier do if a lost form ever shows up?

A

send the forms back to the purchaser, so that they may add it to the original copy

56
Q

What must happen if an unused 222 Form is lost or stolen?

A

purchaser must immediately notify the DEA, and (if known) provide the form number; if not known, must provide the approximate date the forms were ordered

57
Q

True or false: registrants are automatically allowed to order manually and electronically.

A

false; must apply for a digital certificate from the DEA

58
Q

What is the secure ordering system for transmitting an electronic 222 called?

A

Controlled Substance Order System (CSOS)

59
Q

Unlike paper 222s, electronic orders _____________________________.

A

may include substances from any schedule and non-controlled drugs

60
Q

Can endorsements happen for virtual 222s?

A

no; but still can partially fill the order and have 60 days to complete it

61
Q

For accepted digital 222 orders, suppliers must keep the original and linked records for two years and forward a copy of the electronic order to the DEA within ___ business days of completing the electronic order.

A

2

62
Q

What would make a controlled substance considered to be “on hand” for an inventory?

A

If they are in possession of or under the control of the registrant, including:

  • substances returned by a customer
  • substances ordered by a customer but not yet invoiced
  • substances stored in a warehouse on behalf of a registrant
  • substances in possession of employees of the registrant and intended for distribution as complimentary samples
63
Q

Registrants have to inventory all controlled substances on hand at least once every ___ years after the initial inventory.

A

2

64
Q

True or false: the time of day that an inventory is taken is irrelevant.

A

false; must note open or close of business on the inventory with the date

65
Q

True or false: you must give an EXACT count of C-I and -II substances on hand.

A

true

66
Q

When can we estimate CIII-Vs for inventory?

A

if the bottle holds 1000 product units or less

67
Q

True or false: when completing the inventory, you must handle all controlled substances and can’t use a printout or system-based perpetual inventory to determine your numbers.

A

true; you are required to pour out and count all products requiring an exact count and must at least hold a bottle, feel the weight, shake it, or look inside when estimating

68
Q

What should be included in each controlled substance’s record?

A
  • drug name
  • dosage form
  • strength
  • number of loose units
  • number of full containers
69
Q

How do you calculate the amount of controlled substances stolen after a robbery?

A

quantity from last inventory + drugs purchased since - drugs dispensed/distributed/returned/lost/stolen/destroyed

then, subtract the above number from the quantity on hand

Spring 2022: Pharmacy Law (20 decks)

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